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Saturday, October 29, 2016

Easprin

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Aspirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about aspirin?

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

a recent history of stomach or intestinal bleeding;

a bleeding disorder such as hemophilia; or

an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

asthma or seasonal allergies;

stomach ulcers;

liver disease;

kidney disease;

a bleeding or blood clotting disorder;

heart disease, high blood pressure, or congestive heart failure;

gout; or

nasal polyps.

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

severe nausea, vomiting, or stomach pain;

fever lasting longer than 3 days;

swelling, or pain lasting longer than 10 days; or

hearing problems, ringing in your ears.

Less serious side effects may include:

upset stomach, heartburn;

drowsiness; or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking aspirin, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin); or

another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

This list is not complete and there may be other drugs that can interact with aspirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Easprin resources

Easprin Side Effects (in more detail)
Easprin Use in Pregnancy & Breastfeeding
Easprin Drug Interactions
Easprin Support Group
0 Reviews for Easprin - Add your own review/rating

Aspirin Monograph (AHFS DI)

Aspirin Prescribing Information (FDA)

Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)

Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information

ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Easprin with other medications

Angina
Angina Pectoris Prophylaxis
Ankylosing Spondylitis
Antiphospholipid Syndrome
Aseptic Necrosis
Back Pain
Fever
Heart Attack
Ischemic Stroke
Ischemic Stroke, Prophylaxis
Juvenile Rheumatoid Arthritis
Kawasaki Disease
Myocardial Infarction, Prophylaxis
Niacin Flush
Osteoarthritis
Pain
Prosthetic Heart Valves
Prosthetic Heart Valves, Mechanical Valves
Revascularization Procedures, Prophylaxis
Rheumatic Fever
Rheumatoid Arthritis
Sciatica
Systemic Lupus Erythematosus
Thromboembolic Stroke Prophylaxis
Transient Ischemic Attack

Where can I get more information?

Your pharmacist can provide more information about aspirin.

See also: Easprin side effects (in more detail)

Friday, October 28, 2016

Ferrlecit

Generic Name: Sodium Ferric Gluconate
Class: Iron Preparations
Molecular Formula: C₁₂H₂₂FeO₁₄
CAS Number: 299-29-6

Introduction

Hematinic agent;¹ ⁸ ²⁸ stable macromolecular complex composed of ferric oxide hydrate directly bonded to sucrose and chelated with gluconate.¹ ² ³

Uses for Ferrlecit

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

Treatment of iron deficiency anemia in adult and pediatric hemodialysis patients receiving epoetin alfa therapy.¹ ¹⁵

National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines recommend regular use of IV iron to prevent functional (and absolute) iron deficiency and improve erythropoiesis in most hemodialysis patients receiving epoetin alfa therapy.⁵

Available data suggest that iron sucrose and sodium ferric gluconate may be associated less frequently with serious adverse effects (e.g., hypersensitivity reactions) than iron dextran.² ³ ¹⁰⁰ ¹⁰¹

Safety and efficacy not established for the prevention and/or treatment of iron deficiency anemia not associated with CRF (e.g., HIV- or cancer-related anemia).⁴⁴ ⁹⁷

Ferrlecit Dosage and Administration

General

Goal of iron therapy in patients with CFR is to achieve and maintain a transferrin saturation (TSAT) of at least 20% and a serum ferritin concentration of at least 100 ng/mL.⁵

Monitor maintenance iron status by measuring TSAT and serum ferritin concentration every 3 months.⁵

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer (diluted) by slow IV infusion or (undiluted) by slow IV injection.¹ ² ¹⁹

Dilution

For IV infusion, dilute recommended adult or pediatric dosage in 100 or 25 mL of 0.9% sodium chloride, respectively.¹

Use immediately after dilution.¹

Rate of Administration

IV infusion: slowly (e.g., over 1 hour).¹ ³

IV injection (adults): slowly, up to 12.5 mg/minute¹ ² at the end of dialysis.⁶ ⁷ ¹⁶ ²¹

Dosage

Dosage is expressed in terms of mg of elemental iron.¹ Sodium ferric gluconate injection contains the equivalent of 12.5 mg of elemental iron per mL.¹

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

1.5 mg/kg (up to 125 mg/dose) administered at or during hemodialysis for 8 sequential dialysis sessions.^a

Adults

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

125 mg administered at sequential dialysis sessions or during the dialysis session itself.¹ ³ Most patients will require a minimum cumulative dose of 1000 mg of elemental iron, administered over 8 sessions at or during sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response.¹ ³ ⁵

Once patients achieve TSAT levels ≥20% or serum ferritin concentrations ≥100 ng/mL, continue IV iron therapy at the lowest dose necessary to maintain target hematocrit/hemoglobin levels and iron stores within acceptable limits.¹ Weekly maintenance dosage of 25–100 mg of elemental iron for 10 weeks may be appropriate in hemodialysis patients once optimal hematocrit/hemoglobin stores are attained.⁵

If TSAT ≥50% or serum ferritin concentrations ≥800 ng/mL, withhold iron therapy for up to 3 months.⁵ IV iron therapy may be resumed at a dosage that is 33-50% of the previous iron dosage when TSAT and serum ferritin concentration have decreased to <50% and <800 ng/mL, respectively.⁵

Prescribing Limits

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Maximum dose: 125 mg per session.^a

Cautions for Ferrlecit

Contraindications

Known hypersensitivity to sodium ferric gluconate or any ingredient in the formulation.¹

Evidence of iron overload.¹

Anemias not associated with iron deficiency.¹

Warnings/Precautions

Warnings

Iron Overload

Not easily eliminated from the body (not dialyzable) and accumulation can be toxic; avoid unwarranted therapy.¹

Excess storage of iron may possibly result in a syndrome similar to hemosiderosis, particularly in patients whose anemia is not attributable to iron deficiency (e.g. those with hemoglobinopathies or other refractory anemias that might be erroneously diagnosed as iron deficiency anemia).¹ ⁸

Sensitivity Reactions

Hypersensitivity Reactions

Potentially fatal sensitivity (e.g. anaphylactic or anaphylactoid) reactions possible; use with caution, particularly in patients with a history of allergic reactions to iron dextran.¹

If serious anaphylactoid reactions occur, institute appropriate resuscitative measures.¹

Major Toxicities

Overdose

Excessive dosing may lead to iron accumulation and hemosiderosis. Manifestations of acute toxicity in animals included decreased activity, staggering ataxia, increased respiratory rate, tremor and seizures. Not dialyzable.

General Precautions

Hypotension

Possible hypotension accompanied by flushing, lightheadedness, malaise, fatigue, weakness, or severe pain in the chest, back, flanks, or groin.¹ Such reactions are not associated with sensitivity and usually resolve within 1–2 hours.¹ ² May require volume expansion if symptomatic.

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether sodium ferric gluconate is distributed into milk; use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <6 years of age.¹

Contains benzyl alcohol; not recommended for use in neonates.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; use caution in dosage selection and adjustment.¹

Titrate dosage carefully.¹

Common Adverse Effects

Hypotension, nausea, vomiting and/or diarrhea, pain, hypertension, allergic reaction, chest pain, pruritus, back pain.¹

Interactions for Ferrlecit

No formal drug interaction studies to date.¹

Specific Drugs

Drug	Interaction	Comment
ACE inhibitors	Possible potentiation of adverse effects (e.g., hypotension, sensitivity reactions) associated with IV iron therapy¹⁴	Use concomitantly with caution¹⁴
Iron, oral	Reduced absorption of oral iron¹	Concomitant use not recommended¹

Ferrlecit Pharmacokinetics

Distribution

Extent

Ferric iron in plasma combines with transferrin and is carried to the bone marrow and incorporated into hemoglobin.⁹ ²⁷ ²⁹ ³⁰ ³¹

Elimination

Half-life

Following IV administration, terminal elimination half-life of drug-bound iron was approximately 1 hour in healthy iron-deficient adults.¹

Following IV administration of 1.5 or 3 mg/kg, terminal elimination half-life was was 2 or 2.5 hours, respectively, in iron-deficient pediatric patients.^a

Special Populations

In vitro, <1% of the iron species in a single dose was removed during hemodialysis periods of up to 270 minutes using membranes with pore sizes corresponding to 12,000–14,000 daltons.⁹⁹

Stability

Storage

Parenteral

Injection

20–25°C (may be exposed to temperatures ranging from 15–30°C).¹ Do not freeze.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Sodium ferric gluconate should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.¹

Solution Compatibility¹

Compatible
Sodium Chloride 0.9%

ActionsActions

Replenishs and maintains total body content of iron and has pharmacologic actions similar to those of iron dextran.¹ ⁸ ²⁸

Unlike iron dextran, sodium ferric gluconate is free of ferrous ion and dextran polysaccharides and may be associated with fewer sensitivity reactions.¹ ² ³ ¹⁰

Advice to Patients

Risk of hypersensitivity (e.g., anaphylactoid) reactions.¹

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Sodium Ferric Gluconate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV use	equivalent to iron 12.5 mg/mL	Ferrlecit (with benzyl alcohol 0.9% and sucrose 20% w/v)	Watson

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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57. Eschbach JW, Adamson JW. Recombinant human epoetin alfa: implications for nephrology. Am J Kidney Dis. 1988; 11:203-9. [IDIS 256572] [PubMed 3278599]

58. Kleinman KS, Schweitzer SU, Perdue ST et al. The use of recombinant human epoetin alfa in the correction of anemia in predialysis patients and its effects on renal function: a double blind placebo controlled trial. Abstracts on recombinant epoetin alfa from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:6. Abstract.

59. Casati S, Passerini P, Campise MR et al. Benefits and risks of protracted treatment with human recombinant epoetin alfa in patients having haemodialysis. BMJ. 1987; 295:1017-20. [IDIS 235359] [PubMed 3120854]

60. Eschbach JW, Kelly MR, Haley NR et al. Treatment of the anemia of progressive renal failure with recombinant human epoetin alfa. N Engl J Med. 1989; 321:158-63. [IDIS 257078] [PubMed 2747747]

61. Eschbach JW, Adamson JW. Correction of the anemia of hemodialysis (HD) patients with recombinant human epoetin alfa (r-HuEPO): results of multicenter study. Selected abstracts on recombinant epoetin alfa from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:9.

62. Eschbach JW, Abdulhadi MH, Browne JK et al. Recombinant human epoetin alfa in anemic patients with end-stage renal disease: results of a phase III multicenter clinical trial. Ann Intern Med. 1989; 111:992-1000. [IDIS 261615] [PubMed 2688507]

63. Flaharty KK, Grimm AM, Vlasses PH. Epoetin: recombinant human epoetin alfa. Clin Pharm. 1989; 8:769-82. [IDIS 261096] [PubMed 2680241]

64. Grutzmacher P, Bergmann M, Weinreich T et al. Beneficial and adverse effects of correction of anaemia by recombinant human epoetin alfa in patients on maintenance haemodialysis. Contrib Nephrol. 1988; 66:104-13. [PubMed 3292143]

65. Nielsen OJ, Thaysen JH. Response to epoetin alfa in anaemic haemodialysis patients. J Intern Med.1989; 226:89-94.

66. Scigalla P, Bonzel KE, Bulla M et al. Therapy of renal anemia with recombinant human epoetin alfa in children with end-stage renal disease. Contrib Nephrol. 1989; 76:227- 41. [PubMed 2684524]

67. Macdougall IC, Hutton RD, Cavill I et al. Treating renal anemia with recombinant human epoetin alfa: practical guidelines and a clinical algorithm. Br Med J. 1990; 300:655-9.

68. Macdougall IC, Hutton RD, Cavill I et al. Poor response to treatment of renal anaemia with epoetin alfa corrected by iron given intravenously. BMJ. 1989; 299:157-8. [IDIS 257253] [PubMed 2504356]

69. Pollok M, Bommer J, Gurland HJ et al. Effects of recombinant human epoetin alfa treatment in end-stage renal failure patients: results of a multicenter phase II/III study. Contrib Nephrol. 1989; 76:201-11. [PubMed 2684523]

70. Ortho Biotech Division. Procrit (epoetin alfa) prescribing information. Raritan, NJ; 1997 Feb.

71. Amgen, Inc. Epogen (epoetin alfa) prescribing information (dated 1996 Nov). In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998:505-10.

72. Amgen, Thousand Oaks, CA: Personal communication. (formerly ref # 98)

73. Van Wyck DB. Iron deficiency in patients with dialysis-associated anemia during epoetin alfa replacement therapy: strategies for assessment and management. Semin Nephrol. 1989; 9(Suppl 2):21-4. [PubMed 2669082]

74. Eschbach JW, Egrie JC, Downing MR et al. Correction of the anemia of end-stage renal disease with recombinant human epoetin alfa: results of a combined phase I and II clinical trial. N Engl J Med. 1987; 316:73-78. [IDIS 224456] [PubMed 3537801]

75. Gibilaro SD, Delano BG, Quinn R et al. Improved quality of life while receiving recombinant epoetin alfa (rHuEPO). Abstracts on recombinant epoetin alfa from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:10. Abstract.

76. Van Wyck DB, Stivelman J, Kirlin L et al. Predicting iron status in patients receiving epoetin alfa for dialysis- associated anemia. Abstracts on recombinant epoetin alfa from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:16. Abstract.

77. Eschbach JW, Adamson JW. Guidelines for recombinant human epoetin alfa therapy. Am J Kidney Dis. 1989; 14(Suppl 1):2-8. [PubMed 2667349]

78. Kleinman KS, Schweitzer SU, Perdue ST et al. The use of recombinant human epoetin alfa in the correction of anemia in predialysis patients and its effect on renal function: a double-blind, placebo-controlled trial. Am J Kidney Dis. 1989; 14:486-95. [PubMed 2688405]

79. Lim VS, Kirchner PT, Fangman J et al. The safety and the efficacy of maintenance therapy of recombinant human epoetin alfa in patients with renal insufficiency. Am J Kidney Dis. 1989; 14:496-506. [PubMed 2596476]

80. Klingemann HG. Clinical applications of recombinant human colony-stimulating factors. CMAJ. 1989; 140:137-42. [IDIS 251163] [PubMed 2642725]

81. Van Stone JC. Who should receive recombinant human epoetin alfa? Semin Nephrol.1989; 9(Suppl 2):3-7.

82. Anon. Epoetin alfa for anemia. Med Lett Drugs Ther. 1989; 31:85-86. [PubMed 2671624]

83. Macdougall IC, Cavill I, Davies ME et al. Subcutaneous recombinant epoetin alfa in the treatment of renal anaemia in CAPD patients. Contrib Nephrol. 1989; 76:219-26. [PubMed 2582780]

84. Stone WJ, Graber SE, Krantz SB et al. Treatment of the anemia of predialysis patients with recombinant human epoetin alfa: a randomized, placebo-controlled trial. Am J Med Sci. 1988; 171-9. (IDIS 246785)

85. Mohini R. Clinical efficacy of recombinant human epoetin alfa in hemodialysis patients. Semin Nephrol. 1989; 9:16-21. [IDIS 256554] [PubMed 2648516]

86. Anon. Recombinant human epoetin alfa product approved for use in chronic renal failure. Clin Pharm. 1989; 8:531.

87. Kuhn K, Nonnast-Daniel B, Grutzmacher P et al. Analysis of initial resistance of erythropoiesis to treatment with recombinant human epoetin alfa. Contrib Nephrol. 1988; 66:94-103.

88. Ad Hoc Committee for the National Kidney Foundation. Statement on clinical use of recombinant epoetin alfa in anemia of end-stage renal disease. Am J Kidney Dis. 1989; 14:163-9. [PubMed 2672796]

89. Beresford CH. Epoetin alfa. New Z Med J. 1989; 102:185.

90. Watson AJ, Spivak JL. Recombinant human epoetin alfa therapy in end stage renal failure. J Clin Pharmacol. 1988; 28:1086-8. [IDIS 251301] [PubMed 3072351]

91. Anon. Epoetin alfa. Lancet. 1987; 1:781-2. [PubMed 2882187]

92. Stivelman JC. Resistance to recombinant human epoetin alfa therapy; a real clinical entity? Semin Nephrol. 1989; 9(Suppl 2):8-11.

93. Ogden DA. Monitoring considerations in recombinant human epoetin alfa therapy. Semin Nephrol. 1989; 9(Suppl 2):12-5.

94. Wine.dtd CG. Treatment of the anaemia of chronic renal failure with recombinant human epoetin alfa. Drugs. 1989; 3:342-5.

95. Flaharty KK. Clinical pharmacology of recombinant human epoetin alfa (r-HuEPO). Pharmacotherapy. 1990; 10(2 Part 2):9-14S.

96. Erslev AJ. Epoetin alfa. N Engl J Med. 1991; 324:1339-44. [IDIS 280320] [PubMed 2017231]

97. Reviewers’ comments (personal observations).

98. Strobos J, Seligman P, Nissenson A. Transferrin oversaturation. Am J Kidney Dis. 1999; 34:401-2. [IDIS 433119] [PubMed 10465728]

99. Watson Pharma. Ferrlecit (sodium ferric gluconate complex in sucrose injection) prescribing information. Corona, CA; 2001 Nov.

100. Baille GR, Johnson CA, Mason NA. Parenteral iron products for anemia in end-stage renal disease: comparative considerations. Formulary. 2000; 35:498-513.

101. Health care financing administration. Medicare coverage policy decisions: venofer (iron sucrose injection)(#CAG-00080A) decision memorandum. From the HCFA website: ().

a. Watson Pharma. Ferrlecit (sodium ferric gluconate complex in sucrose injection) prescribing information. Corona, CA; 2004 Feb.

More Ferrlecit resources

Ferrlecit Side Effects (in more detail)
Ferrlecit Use in Pregnancy & Breastfeeding
Ferrlecit Drug Interactions
Ferrlecit Support Group
1 Review for Ferrlecit - Add your own review/rating

Ferrlecit MedFacts Consumer Leaflet (Wolters Kluwer)

Ferrlecit Prescribing Information (FDA)

Ferrlecit Advanced Consumer (Micromedex) - Includes Dosage Information

Sodium Ferric Gluconate Complex Prescribing Information (FDA)

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Anemia Associated with Chronic Renal Failure

Pitcher plant

Generic Name: pitcher plant (pit sher plant)

Brand names: Sarapin

What is pitcher plant?

Pitcher plant is also known as Eve's Cup, Fly Catcher, Huntsman's Cup, Water Cup and others.

Pitcher plant has been used for stomach and digestive problems, for urinary tract disorders, and formerly as a cure for smallpox.

Pitcher plant has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of pitcher plant may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Pitcher plant may also have uses other than those listed in this medication guide.

What is the most important information I should know about pitcher plant?

Do not take pitcher plant without first talking to your doctor or health care provider if you are pregnant or could become pregnant. It is not known whether pitcher plant will harm an unborn baby.

Pitcher plant has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of pitcher plant may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

What should I discuss with my healthcare professional before taking pitcher plant?

Before taking pitcher plant, talk to your doctor, pharmacist, or health care professional if you have allergies (especially to plants), have any medical condition, or if you take other medicines or other herbal/health supplements. Pitcher plant may not be recommended in some situations.

Do not take pitcher plant without first talking to your doctor or health care provider if you are pregnant or could become pregnant. It is not known whether pitcher plant will harm an unborn baby. Do not take pitcher plant without first talking to your doctor or health care provider if you are breast-feeding a baby. It is also not known whether pitcher plant will harm a nursing infant. There is no information available regarding the use of pitcher plant by children. Do not give any herbal/health supplement to a child without first talking to the child's doctor.

How should I take pitcher plant?

The use of pitcher plant in cultural and traditional settings may differ from concepts accepted by current western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

If you choose to take pitcher plant, use it as directed on the package or as directed by your doctor, pharmacist, or other health care provider.

Standardized extracts, tinctures, and solid formulations of herbal/health supplements may provide a more reliable dose of the product.

To ensure the correct dose, measure the liquid forms of pitcher plant with a dropper or a dose-measuring spoon or cup.

Do not use different formulations (e.g., tablets, liquids, teas, and others) of pitcher plant at the same time, unless specifically directed to do so by a health care professional. Using different formulations together increases the risk of an overdose of pitcher plant.

Store pitcher plant as directed on the package.

What happens if I miss a dose?

No information is available regarding a missed dose of pitcher plant. Consult your doctor, pharmacist, or health care professional if you require further information.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

What should I avoid while taking pitcher plant?

There are no restrictions on food, beverages, or activity while taking pitcher plant, unless otherwise directed by your health care provider.

Pitcher plant side effects

Stop taking pitcher plant and seek emergency medical attention if you experience symptoms of a serious allergic reaction including difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives.

Other side effects may also occur with the use of pitcher plant. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pitcher plant?

Interactions between pitcher plant and other prescription or over-the-counter medicines or herbal/health supplements have not been reported. Talk to your doctor, pharmacist, or health care professional before taking pitcher plant if you are taking any other medicines or supplements.

More pitcher plant resources

Pitcher plant Support Group
0 Reviews for Pitcher plant - Add your own review/rating

Sarapin

Compare pitcher plant with other medications

Herbal Supplementation
Indigestion
Infectious Gastroenteritis
Smallpox Prophylaxis
Urinary Tract Infection

Where can I get more information?

Your doctor, pharmacist, or health care provider may have more information about pitcher plant.

Thursday, October 27, 2016

Excedrin Quick Tab Peppermint

Generic Name: acetaminophen and caffeine (a SEET a MIN oh fen and KAF een)

Brand Names: Excedrin Quick Tab Peppermint, Excedrin Quick Tab Spearmint, Excedrin Tension Headache, Excedrin Tension Headache Caplet, Excedrin Tension Headache Express Gels, Excedrin Tension Headache Geltab, Valorin Extra

What is Excedrin Quick Tab Peppermint (acetaminophen and caffeine)?

Acetaminophen is a pain reliever and a fever reducer.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen.

The combination of acetaminophen and caffeine is used to treat pain from conditions such as headache, muscle aches, menstrual cramps, arthritis, backache, toothaches, colds and fevers.

Acetaminophen and caffeine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Excedrin Quick Tab Peppermint (acetaminophen and caffeine)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Excedrin Quick Tab Peppermint (acetaminophen and caffeine)?

Do not take this medication if you are allergic to acetaminophen (Tylenol) or caffeine. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney or liver disease, or a history of alcoholism.

It is not known whether this medicine will harm an unborn baby. Do not take acetaminophen and caffeine without medical advice if you are pregnant. Acetaminophen and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Excedrin Quick Tab Peppermint (acetaminophen and caffeine)?

Use this medication exactly as directed on the label, or as prescribed by your doctor.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and caffeine pill contains 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

The orally disintegrating tablet (Excedrin QuickTabs) should be placed directly on the tongue. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve, especially if you still have a fever after 3 days of using this medication, or pain after 10 days of use. Stop taking acetaminophen and caffeine and call your doctor at any time if your symptoms get worse.

Acetaminophen may cause false urine glucose test results. Talk to your doctor if you have diabetes and you notice changes in glucose test results while taking acetaminophen and caffeine.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen and caffeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include loss of appetite, confusion, nausea, vomiting, diarrhea, sweating, fast or uneven heart rate, seizure (convulsions), pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking Excedrin Quick Tab Peppermint (acetaminophen and caffeine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. They can add to the side effects of the caffeine in the medication.

Excedrin Quick Tab Peppermint (acetaminophen and caffeine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using acetaminophen and caffeine and call your doctor at once if you have a serious side effect such as:

low fever with nausea, stomach pain, and loss of appetite;

dark urine, clay-colored stools; or

jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

sleep problems (insomnia); or

feeling nervous, irritable, or jittery.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Excedrin Quick Tab Peppermint (acetaminophen and caffeine)?

There may be other drugs that can interact with acetaminophen and caffeine. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Excedrin Quick Tab Peppermint resources

Excedrin Quick Tab Peppermint Side Effects (in more detail)
Excedrin Quick Tab Peppermint Use in Pregnancy & Breastfeeding
Excedrin Quick Tab Peppermint Drug Interactions
0 Reviews for Excedrin Quick Tab Peppermint - Add your own review/rating

Compare Excedrin Quick Tab Peppermint with other medications

Cold Symptoms
Headache
Osteoarthritis
Pain
Period Pain
Sinusitis

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and caffeine.

See also: Excedrin Quick Tab Peppermint side effects (in more detail)

NuLYTELY Lemon Lime

Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)

Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs

What is NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

a perforated bowel;

a bowel obstruction or severe constipation; or

colitis or toxic megacolon.

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

nausea or vomiting;

trouble swallowing; or

a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether polyethylene glycol electrolyte solution passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have serious side effects from this medicine.

How should I take NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of these serious side effects:

severe stomach pain or bloating;

no bowel movement within 2 hours after use; or

gagging, choking, or vomiting.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

mild stomach cramps, gas, or bloating;

rectal pain or irritation;

nausea; or

passing gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

There may be other drugs that can interact with polyethylene glycol electrolyte solution. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More NuLYTELY Lemon Lime resources

NuLYTELY Lemon Lime Side Effects (in more detail)
NuLYTELY Lemon Lime Use in Pregnancy & Breastfeeding
NuLYTELY Lemon Lime Support Group
1 Review for NuLYTELY Lemon Lime - Add your own review/rating

Colyte Advanced Consumer (Micromedex) - Includes Dosage Information

Colyte Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Colyte Prescribing Information (FDA)

GoLYTELY Solution (Jug) MedFacts Consumer Leaflet (Wolters Kluwer)

MoviPrep Advanced Consumer (Micromedex) - Includes Dosage Information

MoviPrep Prescribing Information (FDA)

MoviPrep Consumer Overview

MoviPrep MedFacts Consumer Leaflet (Wolters Kluwer)

NuLYTELY Prescribing Information (FDA)

NuLYTELY Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare NuLYTELY Lemon Lime with other medications

Bowel Preparation
Constipation, Chronic
Gastrointestinal Decontamination

Where can I get more information?

Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

See also: NuLYTELY Lemon Lime side effects (in more detail)

Folcaps Care One

prenatal multivitamin/mineral capsule with omega-3 fatty acids

Dosage Form: capsule, gelatin coated
Folcaps™ Care One

Rx Only

Folcaps Care One Description

Folcaps™ Care One is a prenatal multivitamin/mineral capsule with omega-3 fatty acids. Each red soft gelatin capsule for oral administration contains:

* The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil.
Essential Fatty Acids:
Omega-3 Fatty Acids* (DHA, EPA, and ALA)	500 mg
Docosahexaenoic Acid (DHA)	350 mg
Eicosapentaenoic Acid (EPA)	100 mg
Alpha-linolenic Acid (ALA)	50 mg
Vitamins:
Vitamin C (calcium ascorbate, USP and calcium threonate)	25 mg
Vitamin D3 (cholecalciferol, USP)	800 IU
Vitamin E (dl-alpha-tocopheryl acetate, USP)	15 IU
Vitamin B2 (riboflavin, USP)	1.5 mg
Vitamin B3 (niacinamide, USP)	10 mg
Vitamin B6 (pyridoxine hydrochloride, USP)	50 mg
Folic Acid, USP	1 mg
Biotin, USP	300 mcg
Minerals:
Calcium (carbonate, USP)	100 mg
Iron (elemental)
Carbonyl iron, FCC	20 mg
Ferrous aspartate and ferrous glycinate	7 mg
Iodine (potassium iodide, USP)	150 mcg
Magnesium (magnesium oxide, USP)	50 mg
Zinc (zinc oxide, USP)	5 mg
Other:
Docusate Sodium, USP	50 mg

INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil, flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium dioxide, silicon dioxide, and FD&C Red No. 40.

INTENDED USE

Folcaps™ Care One is intended to provide improved nutritional status before, during, and after pregnancy, through dietary supplementation of key vitamin/mineral and omega-3 fatty acids.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis.

Warning

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Precautions

General

Do not exceed recommended dosage. Folcaps™ Care One should be used with caution in patients with known sensitivity or allergy to fish or soy.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Folcaps Care One Dosage and Administration

Usual dosage is one capsule daily, or as prescribed by a physician.

How is Folcaps Care One Supplied

Folcaps™ Care One prenatal multivitamin/mineral capsules are red soft gelatin capsules packaged in bottles of 30 capsules.

(NDC: 68308-167-30)

Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.]

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for:

Midlothian Laboratories

Montgomery, AL 36117

Rev. 4/09

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

NDC 68308-167-30

30 Capsules

Folcaps™

Care One

DESCRIPTION:

Folcaps™ Care One is a prenatal multivitamin/mineral

capsule with omega-3 fatty acids.

INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil,

flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium

dioxide, silicon dioxide, and FD&C Red No. 40.

Rx Only

Midlothian

LABORATORIES

Folcaps Care One
calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopheryl acetate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, calcium carbonate, iron, iodine, magnesium, zinc, docusate sodium, doconexent, icosapent, and linolenic acid capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68308-167
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
calcium ascorbate (calcium ascorbate)	calcium ascorbate	24 mg
calcium threonate (calcium threonate)	calcium threonate	1 mg
Cholecalciferol (Cholecalciferol)	Cholecalciferol	800 [iU]
ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL)	ALPHA-TOCOPHEROL ACETATE	15 [iU]
RIBOFLAVIN (RIBOFLAVIN)	RIBOFLAVIN	1.5 mg
NIACINAMIDE (NIACINAMIDE)	NIACINAMIDE	10 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)	PYRIDOXINE HYDROCHLORIDE	50 mg
FOLIC ACID (FOLIC ACID)	FOLIC ACID	1 mg
BIOTIN (BIOTIN)	BIOTIN	300 mg
CALCIUM CARBONATE (CALCIUM)	CALCIUM CARBONATE	100 mg
IRON (IRON)	IRON	27 mg
IODINE (POTASSIUM CATION)	IODINE	150 ug
MAGNESIUM (MAGNESIUM OXIDE)	MAGNESIUM	50 mg
ZINC (ZINC OXIDE)	ZINC	5 mg
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	50 mg
DOCONEXENT (DOCONEXENT)	DOCONEXENT	350 mg
ICOSAPENT (ICOSAPENT)	ICOSAPENT	100 mg
LINOLENIC ACID (LINOLENIC ACID)	LINOLENIC ACID	50 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN
GLYCERIN
SOYBEAN OIL
FLAX SEED
ETHYL VANILLIN
LECITHIN, SOYBEAN
WAX, YELLOW
TITANIUM DIOXIDE
SILICON DIOXIDE
FD&C RED NO. 40

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	ML;167
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68308-167-30	30 CAPSULE In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/01/2009

Labeler - Midlothian Laboratories (142122824)

Establishment
Name	Address	ID/FEI	Operations
Tishcon Corporation		195342449	MANUFACTURE

Revised: 12/2009Midlothian Laboratories

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Folcaps Care One Side Effects (in more detail)
Folcaps Care One Use in Pregnancy & Breastfeeding
Folcaps Care One Drug Interactions
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Vitamin/Mineral Supplementation during Pregnancy/Lactation

Fentanyl transdermal skin patch

Generic Name: fentanyl transdermal (skin patch) (FEN ta nil trans DERM al)

Brand Names: Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75

What is fentanyl transdermal (skin patch)?

Fentanyl is a narcotic (opioid) pain medicine.

The fentanyl skin patch is used to treat moderate to severe chronic pain. Fentanyl is not for treating mild or occasional pain or pain from surgery.

Fentanyl transdermal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about a fentanyl transdermal skin patch?

MISUSE OF THIS MEDICATION CAN CAUSE HARMFUL OR FATAL SIDE EFFECTS. Do not use this medication unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant. Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug you absorb through your skin and may cause harmful effects. Fentanyl may be habit forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.

The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

What should I discuss with my healthcare provider before using a fentanyl transdermal skin patch?

Do not use this medication unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.

To make sure you can safely use fentanyl transdermal, tell your doctor if you have any of these other conditions:

a breathing disorder such as chronic obstructive pulmonary disease (COPD);

a history of head injury or brain tumor;

a heart rhythm disorder;

liver disease; or

kidney disease.

FDA pregnancy category C. It is not known whether fentanyl will harm an unborn baby. Fentanyl may cause breathing problems, seizure, or addiction and withdrawal symptoms in a newborn if the mother uses the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using fentanyl transdermal. Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while using fentanyl transdermal. Older adults may be more likely to have side effects from this medicine. Fentanyl may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Store the medication in a secure place where others cannot get to it. The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

How should I use fentanyl transdermal skin patches?

MISUSE OF A FENTANYL SKIN PATCH CAN CAUSE HARMFUL OR FATAL SIDE EFFECTS.

Use exactly as prescribed by your doctor. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label.

Read all patient instructions carefully before using a fentanyl transdermal skin patch. Follow the directions on your prescription label.

If the skin must be washed before you apply a skin patch, use clear water only. Allow the skin to dry completely before applying the patch.

Do not use soaps, oils, lotions, alcohol, or other chemicals on the skin where you will apply a fentanyl transdermal skin patch. These substances could increase the amount of fentanyl that your skin absorbs, possibly causing harmful effects.

Apply the skin patch to a flat, dry, hairless area of the chest, back, side, or outer side of your upper arm. To remove any hair from these areas, clip the hair short but do not shave it. Press the patch firmly with the palm of your hand for 30 seconds. Make sure the patch is sticking firmly, especially around the edges. You may wear the patch for up to 72 hours. Never wear more than 1 fentanyl transdermal skin patch at a time unless your doctor has told you to.

After removing a skin patch fold it in half, sticky side in, and flush the patch down the toilet. Apply a new patch to a different skin area on the chest, back, side, or upper arm. Do not use the same skin area twice in a row.

Do not use a fentanyl transdermal skin patch if it has been cut or damaged. Doing so could expose you to too much fentanyl, which can cause a life-threatening overdose.

Store the skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it. Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Keep track of how many skin patches have been used from each new package. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since fentanyl transdermal is used as needed, you may not be on a dosing schedule. If you are using the skin patches regularly, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal.

Overdose symptoms may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while using a fentanyl transdermal patch?

This medication is for use only on the skin. Avoid touching the sticky side of a skin patch with your fingers. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips. If it does, rinse with water. Do not use soap or other chemicals. Fentanyl may impair your thinking or reactions. Do not drive or do anything that requires you to be alert. Avoid drinking alcohol, which can increase dizziness or drowsiness. Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug you absorb through your skin and may cause harmful effects.

A fentanyl transdermal skin patch side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Remove the skin patch and call your doctor at once if you have any of these serious side effects:

slow heart rate, weak or shallow breathing, sighing;

confusion, hallucinations, unusual thoughts or behavior;

severe weakness, feeling like you might pass out;

cold, clammy skin; or

pale skin, easy bruising or bleeding.

Less serious side effects may include:

fever;

constipation, diarrhea;

dry mouth, nausea, vomiting, upset stomach;

headache;

drowsiness, weakness, tired feeling;

feeling anxious or nervous;

cold symptoms such as stuffy nose, sneezing, sore throat;

sweating, skin rash; or

itching, blistering, redness, or swelling where the patch was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fentanyl transdermal Dosing Information

Usual Adult Dose for Anesthesia:

Premedication for Anesthesia:
50 to 100 mcg IM, 30 to 60 minutes prior to surgery.
Lozenge: 5 mcg/kg (400 mcg is the maximum dose).
Lower doses should be used for vulnerable patients.

General Anesthesia:
Total Low dose: 2 mcg/kg (minor procedures).
Maintenance low dose: Infrequently needed.
Total Moderate dose: 2 to 20 mcg/kg.
Maintenance moderate dose: 25 to 100 mcg IV/IM.
Total high dose: 20 to 50 mcg/kg (prolonged surgeries).
Maintenance high dose: 25 mcg to half of the initial dose.

Adjunct to Regional Anesthesia:
50 to 100 mcg IM or slow IV over 3 to 5 minutes as required.

Postoperative :
50 to 100 mcg IM. May repeat dose in 1 to 2 hours as needed.

Usual Adult Dose for Pain:

Transdermal patch - Initial dose: 25 mcg/hour patch (unless opioid tolerance) every 72 hours.

Transmucosal - Initial dose: 200 mcg, place in mouth (between cheek and lower gum) and suck over 15 minutes (do not chew or swallow).

Fentanyl iontophoretic transdermal system - Patients should be titrated to comfort before initiating the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system should be applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm.

Patients must have access to supplemental analgesia during treatment with the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system provides a 40 mcg dose of fentanyl per activation on-demand. It is important to instruct patients how to operate fentanyl iontophoretic transdermal system to self-administer doses of fentanyl as needed to manage their acute, short-term, postoperative pain. Only the patient should administer doses from fentanyl iontophoretic transdermal system. Each on-demand dose is delivered over a 10-minute period. To initiate administration of a fentanyl dose, the patient must press the button firmly twice within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10 minute dosing period.

Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses in the postoperative period than are available from fentanyl iontophoretic transdermal system. Therefore, these patients should be evaluated frequently to ensure they are receiving adequate analgesia.

A maximum of six 40 mcg doses per hour can be administered by fentanyl iontophoretic transdermal system. The maximum amount of fentanyl that can be administered from a single fentanyl iontophoretic transdermal system over 24 hours is 3.2 mg (eighty 40 mcg doses). Each fentanyl iontophoretic transdermal system operates for 24 hours or until eighty doses have been administered, whichever occurs first. Up to three consecutive fentanyl iontophoretic transdermal systems may be used sequentially, each applied to a different skin site for a maximum of 72 hours of therapy for acute, short-term, postoperative pain.

Buccal Tablet
Initial Dose: 100 mcg.
Dose Titration: Patients should be titrated to a dose of fentanyl buccal tablet that provides adequate analgesia with tolerable side effects.

For patients switching from oral transmucosal fentanyl citrate to fentanyl buccal tablet, the starting dose of fentanyl buccal tablet should be as follows. An oral transmucosal fentanyl citrate dose of 200 mcg or 400 mcg converts to an initial fentanyl buccal tablet dose of 100 mcg. An oral transmucosal fentanyl citrate dose of 600 or 800 mcg converts to an initial fentanyl buccal tablet dose of 200 mcg. And, an oral transmucosal fentanyl citrate dose of 1200 mcg or 1600 mcg converts to an initial fentanyl buccal tablet dose of 400 mcg.

Redosing Patients Within a Single Episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one fentanyl buccal tablet dose. Redosing may occur 30 minutes after the start of administration of fentanyl buccal tablet and the same dosage strength should be used.

Buccal soluble film:
For use only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain:

The goal of dose titration is to find the individual patient's effective and tolerable dose. The dose of fentanyl buccal soluble film is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.

Individually titrate fentanyl buccal soluble film to a dose that provides adequate analgesia with tolerable side effects.

Initial dose: All patients must begin treatment using one 200 mcg fentanyl buccal soluble film. Due to differences in pharmacokinetic properties and individual variability, patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg of fentanyl buccal soluble film. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl buccal soluble film as fentanyl buccal soluble film is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl buccal soluble film is not a generic version of any other oral transmucosal fentanyl product.

Following the initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia. If adequate pain relief is not achieved after one 200 mcg fentanyl buccal soluble film, titrate using multiples of the 200 mcg fentanyl buccal soluble film (for doses of 400, 600, or 800 mcg). Increase the dose by 200 mcg in each subsequent episode until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg fentanyl buccal soluble film simultaneously. When multiple 200 mcg fentanyl buccal soluble films are used, they should not be placed on top of each other and may be placed on both sides of the mouth.

If adequate pain relief is not achieved after 800 mcg fentanyl buccal soluble film (i.e., four 200 mcg fentanyl buccal soluble films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg fentanyl buccal soluble film. Doses above 1200 mcg fentanyl buccal soluble film should not be used.

The patient should then get a prescription for fentanyl buccal soluble film of the dose determined by titration (i.e., 200, 400, 600, 800, or 1200 mcg) to treat subsequent episodes.

Single doses should be separated by at least 2 hours. Fentanyl buccal soluble film should only be used once per breakthrough cancer pain episode, i.e., fentanyl buccal soluble film should not be redosed within an episode.

During any episode of breakthrough cancer pain, if adequate pain relief is not achieved from use of fentanyl buccal soluble film, the patient may use a rescue medication (after 30 minutes) as directed by their healthcare provider.

During maintenance treatment, if the prescribed dose no longer adequately manages the breakthrough cancer pain episode for several consecutive episodes, increase the dose of fentanyl buccal soluble film. Once a successful dose has been found, each episode is treated with a single film. Fentanyl buccal soluble film should be limited to four or fewer doses per day. Consider increasing the dose of the around-the-clock opioid medicine used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.

The tongue should be used to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of fentanyl buccal soluble film. The fentanyl buccal soluble film package should be opened immediately prior to product use. Place the entire fentanyl buccal soluble film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the fentanyl buccal soluble film against the inside of the cheek. Press and hold the fentanyl buccal soluble film in place for five seconds. The fentanyl buccal soluble film should stay in place on its own after this period. Liquids may be consumed after five minutes. Fentanyl buccal soluble film, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when used as directed.

The fentanyl buccal soluble film should not be cut or torn prior to use. The fentanyl buccal soluble film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s). Eating food should be avoided until the film has dissolved.

Sublingual tablets:
For use only for the management of breakthrough pain in patients with cancer who are 18 years of age and older and who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking pain relief medication around-the-clock of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equal dose of another opioid medication daily for 7 days or more.

The goal of dose titration is to find the effective and tolerable dose for the individual patient. The dose of fentanyl sublingual is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.

Fentanyl sublingual tablets should be placed on the floor of the mouth directly under the tongue immediately after removal from the packaging. The patient should be instructed not to chew, suck, or swallow the sublingual tablet. Patients should not eat or drink anything until the tablet is completely dissolved. Water may be used to moisten the buccal mucosa before taking fentanyl sublingual in patients who have a dry mouth.

Initial dose: All patients must begin treatment with a single 100 mcg sublingual tablet. Due to differences in pharmacokinetic properties and individual variability, patients switching from another fentanyl product must be started on the 100 mcg sublingual dose. Patients should not be switched on a mcg per mcg basis from any other fentanyl product to fentanyl sublingual as fentanyl sublingual is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl sublingual is not a generic version of any other fentanyl product. Following the initial dose, patients should be followed closely and the dosage level adjusted until the patient reaches a dose that provides adequate analgesia. If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose. If adequate pain relief is not achieved after one 100 mcg tablet, the patient may take a second dose (after 30 minutes). No more than 2 doses may be used to treat one episode of breakthrough pain. Patients must wait at least 2 hours after the last dose to treat another episode of breakthrough pain.

Titration: If adequate pain relief is not achieved after the first 100 mcg dose, the dose should be increased in a stepwise manner over consecutive breakthrough pain episodes until adequate analgesia with tolerable side effects is achieved. The dose should be increased by 100 mcg multiples up to 400 mcg if needed. If adequate analgesia is not obtained with a 400 mcg dose, increase to 600 mcg. If adequate analgesia is not obtained with a 600 mcg dose, increase to 800 mcg. During titration, patients can be instructed to use multiples of 100 mcg tablets and/or 200 mcg tablets for any single dose. Patients should not use more than 4 tablets at one time. If adequate analgesia is not obtained 30 minutes after use, the patient may repeat the same dose. No more than two doses of may be used to treat an episode of breakthrough pain. Rescue medication as directed by the healthcare provider may be used if adequate analgesia is not achieved.

The efficacy and safety of doses higher than 800 mcg have not been evaluated in clinical studies.

Maintenance: Once an appropriate dose for pain management has been established, patients should be instructed to use only one tablet of the appropriate strength per dose. Patients should be maintained on this dose. If adequate analgesia is not obtained, the patient may use a second dose (after 30 minutes) as directed by their health care provider. No more than two doses may be used to treat an episode of breakthrough pain. Patients must wait at least 2 hours before treating another episode of breakthrough pain.

Dose readjustment: If the response (analgesia or adverse reactions) to the titrated dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained.

If more than four episodes of breakthrough pain are experienced daily, the dose of the long-acting opioid used for persistent underlying cancer pain should be reevaluated. If the long-acting opioid or dose of long-acting opioid is changed, the fentanyl sublingual dose should be retitrated as necessary to ensure the patient is on an appropriate dose.

The use of fentanyl sublingual should be limited to treat four or fewer episodes of breakthrough pain per day.

It is important that any dose retitration is monitored carefully by a healthcare professional.

Discontinuation: Patients no longer requiring opioid therapy may discontinue fentanyl sublingual along with a gradual downward titration of other opioids to minimize possible withdrawal effects. Patients who continue to take chronic opioid therapy for chronic pain but no longer need treatment for breakthrough pain may discontinue fentanyl sublingual immediately.

Fentanyl nasal spray:
For use only for the management of breakthrough pain in patients with cancer who are 18 years of age and older and who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

Fentanyl nasal spray should be titrated to a dose that provides adequate analgesia with tolerable side effects.
Initial dose: Treatment of all patients (including those switching from another fentanyl product) should be initiated with 1 spray into 1 nostril.

Maintenance dose: If adequate analgesia is achieved within 30 minutes of administration of 1 spray in 1 nostril, subsequent episodes of breakthrough pain may be treated with this dose. If adequate analgesia is not achieved with the first dose, the dose should be escalated in a step wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved.

Titration: Patients must wait at least 2 hours between doses:
Step 1: 1 spray (100 mcg per spray) into 1 nostril (100 mcg)
Step 2: 1 spray (100 mcg per spray) into each nostril (200 mcg)
Step 3: 1 spray (400 mcg per spray) into 1 nostril (400 mcg)
Step 4: 1 spray (400 mcg per spray) into each nostril (800 mcg)

Maximum dose: 800 mcg per episode of breakthrough pain no more often than every 2 hours and no more than 4 doses per day.

During any episode of breakthrough cancer pain, if there is inadequate pain relief after 30 minutes following fentanyl nasal spray dosing or if a separate episode of breakthrough cancer pain occurs before the next dose is permitted (i.e., within 2 hours), the healthcare provider should be prepared to offer the patient another medication for rescue.

There are no clinical data to support the use of a combination of dose strengths to treat an episode.

Usual Pediatric Dose for Anesthesia:

Doses should be titrated to appropriate effects; wide range of doses exist, dependent upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose
---Continuous IV infusion: 0.5 to 2 mcg/kg/hour
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour
---Continuous sedation/analgesia during extracorporeal membrane oxygenation (ECMO): Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Younger infants:
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Older Infants and Children 1 to 12 years:
---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose.
--- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity.
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour
---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received).

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:
---Children less than 12 kg: 10 mcg/mL
---Children 12 to 30 kg: 25 mcg/mL
---Children greater than 30 kg: 50 mcg/mL
---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose
---Lockout: Usual initial: 5 doses/hour
---Lockout interval: Range: 6 to 8 minutes
---Usual basal rate: 0 to 0.5 mcg/kg/hour

Children greater than 12 years to adult:
Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures.

Continuous sedation/analgesia:
---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour
---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:

---Usual concentration: 50 mcg/mL
---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg
---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes
---Usual basal rate: less than or equal to 50 mcg/hour

Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:
---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication
---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing fentanyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total fentanyl doses are limited to 10 to 15 mcg/kg.
---High dose: 20 to 50 mcg/kg/dose; Note: High dose fentanyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label.

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used.

Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.

Usual Pediatric Dose for Pain:

Usual Pediatric Dose for Sedation:

Saturday, October 29, 2016

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Friday, October 28, 2016

Introduction

Uses for Ferrlecit

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

Ferrlecit Dosage and Administration

General

Administration

IV Administration

Dilution

Rate of Administration

Dosage

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Adults

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Prescribing Limits

Pediatric Patients

Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

IV

Cautions for Ferrlecit

Contraindications

Warnings/Precautions

Warnings

Iron Overload

Sensitivity Reactions

Hypersensitivity Reactions

Major Toxicities

Overdose

General Precautions

Hypotension

Specific Populations

Pregnancy

Lactation

Pediatric Use

Geriatric Use

Common Adverse Effects

Interactions for Ferrlecit

Specific Drugs

Ferrlecit Pharmacokinetics

Distribution

Extent

Elimination

Half-life

Special Populations

Stability

Storage

Parenteral

Injection

Compatibility

Parenteral

Solution Compatibility1

ActionsActions

Advice to Patients

Preparations

Disclaimer

References

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Solution Compatibility¹