Thursday, 30 August 2012

Paromomycin Sulfate


Class: Amebicides
VA Class: AP900
Chemical Name: O - 2,6 - Diamino - 2,6 - dideoxy - β - L - idopyranosyl - (1 - 3) - O - β - D - ribofuranosyl(1 - 5) - O - [2 - amino - 2 - deoxy - α - D - glucopyranosyl - (1 - 4)] - 2 - deoxystreptamine sulfate (salt)
Molecular Formula: C23H45N5O14• xH2SO4
CAS Number: 1263-89-4

Introduction

Antibacterial and antiprotozoal; aminoglycoside antibiotic obtained from cultures of Streptomyces rimosus var. paromomycinus.122 a


Uses for Paromomycin Sulfate


Amebiasis


Treatment of acute and chronic intestinal amebiasis caused by Entamoeba histolytica.100 110 116 117 118 122


Treatment of asymptomatic cyst passers (intraluminal infections), especially in children and pregnant women.100 110 116 117 118


Not effective for and should not be used alone for treatment of extraintestinal amebiasis (including amebic liver abscess) caused by E. histolytica.117 122 Used to eradicate encysted E. histolytica in the intestinal lumen as follow-up after treatment with a tissue amebicide (metronidazole or tinidazole).100 110


Treatment of mild to moderate or severe symptomatic intestinal amebiasis or extraintestinal disease (including amebic liver abscess) involves the use of both a tissue and a luminal amebicide to ensure eradication of tissue-invading trophozoites as well as cysts in the intestinal lumen.100 110 116 117 118


Regimen of choice for symptomatic intestinal amebiasis or extraintestinal disease (including liver abscess) is a nitroimidazole derivative (oral metronidazole or oral tinidazole) followed by a luminal amebicide (oral iodoquinol or oral paromomycin).100 110 116 117 118


Some strains of Entamoeba are nonpathogenic (e.g., E. dispar, E. hartmanni) and asymptomatic intraluminal infections with these organisms generally do not require treatment.100 116 117 118


Balantidiasis


Has been used for treatment of balantidiasis caused by Balantidium coli.a


Not a drug of choice.100 110 Tetracycline is the drug of choice and metronidazole and iodoquinol are alternatives for treatment of balantidiasis.100 110


Cestode (Tapeworm) Infections


Has been used for treatment of cestodiasis (tapeworm infection) caused by certain cestodes pathogenic to humans including Diphyllobothrium latum (fish tapeworm), Dipylidium caninum (dog and cat tapeworm), Hymenolepis nana (dwarf tapeworm), Taenia saginata (beef tapeworm), and T. solium (pork tapeworm).a


Not a drug of choice.110 Praziquantel, niclosamide (not commercially available in the US), and nitazoxanide usually recommended for treatment of these tapeworm infections.110


Cryptosporidiosis


Treatment of cryptosporidiosis caused by Cryptosporidium parvum in patients with HIV infection; used alone or in conjunction with azithromycin.100 111 115 120 126 127 128


No anti-infective has been found to reliably eradicate Cryptosporidium, although several drugs (e.g., paromomycin, azithromycin, nitazoxanide) appear to suppress the infection.114 126 127 128


CDC, NIH, IDSA, and others state that the most appropriate treatment for cryptosporidiosis in HIV-infected individuals is the use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea.126 127 128


Dientamoeba fragilis Infections


Treatment of infections caused by Dientamoeba fragilis.110


Iodoquinol, paromomycin, tetracycline, or metronidazole are drugs of choice for treatment of D. fragilis infections.110


Giardiasis


Treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis).100 110 119


Drugs of choice are metronidazole, tinidazole, or nitazoxanide; alternatives are paromomycin (especially in pregnant women), furazolidone (not commercially available in the US), or quinacrine (not commercially available in the US).100 110


Although paromomycin may be less effective than the other agents, it is poorly absorbed from the GI tract and may be useful for treatment of giardiasis in pregnant women.100 110 119


Hepatic Encephalopathy


Has been used in the management of hepatic coma as an adjunct122 to protein restriction and supportive therapy to inhibit nitrogen-forming bacteria in the GI tract.a


Not a preferred or alternative treatment; nonabsorbable disaccharides (lactulose) or certain other anti-infectives (neomycin or metronidazole) usually recommended.123 124 a


Leishmaniasis


Has been used topically (in conjunction with topical methylbenzethonium chloride) for treatment of cutaneous leishmaniasis, including infections caused by Leishmania major, L. braziliensis, and L. mexicana.103 104 105 106 110 121 129


Has been used IM for treatment of visceral leishmaniasis (kala azar) caused by L. donovani.121 129 130


For treatment of cutaneous leishmaniasis, pentavalent antimony compounds (IM or IV sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]) are drugs of choice;110 121 129 topical paromomycin or IM or IV pentamidine are alternatives.110 121


For treatment of visceral leishmaniasis, pentavalent antimony compounds (e.g., IM or IV sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]) or IV amphotericin B (conventional or liposomal) are drugs of choice;110 121 129 130 IM or IV pentamidine or IM paromomycin are alternatives.110


Topical paromomycin should be used only in geographic regions where cutaneous Leishmania species have low potential for mucosal spread.110 Topical treatment cannot cure lymph node infection or protect against mucosal disease if metastasis has already started.121


Paromomycin Sulfate Dosage and Administration


Administration


Oral Administration


Administer orally with a meal.122


Topical Administration


Has been administered topically for treatment of cutaneous leishmaniasis as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum.103 104 105 106 110 A topical preparation is not commercially available in the US.


IM Administration


Has been administered IM for treatment of visceral leishmaniasis (kala azar).129 130 A parenteral preparation is not commercially available in the US.


Dosage


Available as paromomycin sulfate; dosage expressed in terms of paromomycin.122


Pediatric Patients


Amebiasis Caused by Entamoeba histolytica

Asymptomatic Cyst Passers (Intraluminal Infections)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122


Symptomatic Intestinal Amebiasis or Extraintestinal Disease (Including Amebic Liver Abscess)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122 Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).100 110


Cestode (Tapeworm) Infections

Diphyllobothrium latum (Fish Tapeworm), Dipylidium caninum (Dog and Cat Tapeworm), Taenia saginata (Beef Tapeworm), or T. solium (Pork Tapeworm) Infections

Oral

11 mg/kg every 15 minutes for 4 doses.125 a


Hymenolepis nana (Dwarf Tapeworm) Infections.

Oral

45 mg/kg daily, given as a single daily dose, for 5–7 days.125 a


Cryptosporidiosis

Oral

25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected children or adolescents.127 128 Maximum dosage is 500 mg 4 times daily in children.128


Dientamoeba fragilis Infections

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110


Giardiasis

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110


Leishmaniasis

Cutaneous Leishmaniasis

Topical

Apply topically (as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum) twice daily for 10–20 days.103 104 105 106 110 121


If effective, clinical healing of lesions usually is complete within several weeks to a month after topical paromomycin treatment is completed.103 104 105


In patients with recurrent disease (leishmaniasis recidivans), more prolonged topical treatment (e.g., twice daily for about 3 months) may eliminate the protozoa from cutaneous lesions.103


Visceral Leishmaniasis (Kala Azar)

IM

11–20 mg/kg daily for 10–21 days.121 129 130


Adults


Amebiasis Caused by Entamoeba histolytica

Asymptomatic Cyst Passers (Intraluminal Infections)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122


Symptomatic Intestinal Amebiasis or Extraintestinal Disease (Including Amebic Liver Abscess)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122 Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).100 110


Cestode (Tapeworm) Infections

Diphyllobothrium latum (Fish Tapeworm), Dipylidium caninum (Dog and Cat Tapeworm), Taenia saginata (Beef Tapeworm), or T. solium (Pork Tapeworm) Infections

Oral

11 mg/kg given every 15 minutes for 4 doses.a


Hymenolepis nana (Dwarf Tapeworm) Infections.

Oral

45 mg/kg daily, given as a single daily dose, for 5–7 days.a


Cryptosporidiosis

Oral

25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected adults.127


1.5–2.25 g daily, in 3–6 divided doses, given for 10–14 days has been used.111 112 113 Occasionally, more prolonged therapy (e.g., 4–8 weeks) may be necessary.111


Dientamoeba fragilis Infections

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110


Giardiasis

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110


Hepatic Encephalopathy

Adjunct in the Management of Hepatic Coma

Oral

4 g daily in divided doses given for 5–6 days.122


Leishmaniasis

Cutaneous Leishmaniasis

Topical

Apply topically (as a preparation containing paromomycin 15% and methylbenzethonium chloride12% in white petrolatum) twice daily for 10–20 days.103 104 105 106 110 121


If effective, clinical healing of lesions usually is complete within several weeks to a month after topical paromomycin treatment is completed.103 104 105


In patients with recurrent disease (leishmaniasis recidivans), more prolonged topical treatment (e.g., twice daily for about 3 months) may eliminate the protozoa from cutaneous lesions.103


Visceral Leishmaniasis (Kala Azar)

IM

11–20 mg/kg daily for 10–21 days.121 129 130


Special Populations


No special population dosage recommendations at this time.


Cautions for Paromomycin Sulfate


Contraindications



  • Known hypersensitivity to the drug.122




  • Intestinal obstruction.122



Warnings/Precautions


Warnings


Nephrotoxicity, Ototoxicity, Neuromuscular Blockade

Like other aminoglycosides, paromomycin has the potential to cause nephrotoxic, ototoxic, and probably neuromuscular blocking effects if absorbed systemically.a 130


Avoid high dosage or prolonged therapy.a


Use oral paromomycin with caution in patients with ulcerative intestinal lesions since inadvertent GI absorption of the drug may result in renal toxicity.122


Sensitivity Reactions


Tartrazine Sensitivity

Capsules may contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.122 Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.122


General Precautions


Superinfection

As with other anti-infectives, use of paromomycin may result in overgrowth of nonsusceptible organisms, including fungi, and patients should be carefully monitored for development of new infections caused by nonsusceptible organisms.122 Secondary Staphylococcus enterocolitis may occur.a


Appropriate therapy should be instituted if superinfection occurs.122


Specific Populations


Pregnancy

Category C.125


Because oral paromomycin is minimally absorbed from the GI tract, it may be a drug of choice for treatment of amebiasis100 110 116 117 118 or giardiasis in pregnant women.100 110


Lactation

No specific precautions in breast-feeding women.125


Common Adverse Effects


Oral: GI effects including anorexia,a nausea,122 vomiting,a epigastric burning and pain,a increased GI motility,a abdominal cramps,122 diarrhea,122 pruritus ani.a


Topical (combined with topical methylbenzethonium chloride): Local reactions including burning,104 105 121 pruritus,121 erythema,129 pain,129 edema,129 blisters.121 129


IM: Injection site pain, fever, elevated liver enzymes, reversible ototoxicity.130


Interactions for Paromomycin Sulfate


No formal drug interaction studies to date.a


Paromomycin Sulfate Pharmacokinetics


Absorption


Bioavailability


Poorly absorbed from the GI tract.122


Impaired GI motility or intestinal lesions or ulcerations may facilitate GI absorption.122 a


Rapidly absorbed following IM injection (parenteral preparation not commercially available in the US); peak plasma concentrations attained within 1 hour.130


Elimination


Elimination Route


Almost 100% of an oral dose is eliminated unchanged in feces;122 a any absorbed drug is slowly excreted in urine.a


Special Populations


Impaired renal function: Accumulation can occur.a


Stability


Storage


Oral


Capsules

15–30°C; protect from moisture.122


Actions and SpectrumActions



  • Broad spectrum of activity;122 a active against bacteria, protozoa, and cestodes.a




  • Like other aminoglycosides, paromomycin is bactericidal and appears to inhibit protein synthesis in susceptible bacteria at the 30S segment of the ribosome.a




  • Has an antibacterial spectrum similar to that of neomycin.122 Active against some gram-positive bacteria (e.g., some strains of Staphylococcus) and many gram-negative aerobic bacteria, but generally inactive against Pseudomonas aeruginosa and anaerobic bacteria.a Has some activity against Mycobacterium tuberculosis.a




  • A luminal or contact amebicide; acts principally in the intestinal lumen.a A direct-acting amebicide effective either in the presence or absence of bacteria.a




  • Active against Entamoeba histolytica;a believed to act against both the trophozoite and encysted forms of Entamoeba.a Limited in vitro studies indicate some activity against Acanthamoeba.101




  • Active against certain cestodes (tapeworms) pathogenic to humans including Diphyllobothrium latum (fish tapeworm), Dipylidium caninum (dog and cat tapeworm), Hymenolepis nana (dwarf tapeworm), Taenia saginata (beef tapeworm), and T. solium (pork tapeworm).a



Advice to Patients



  • Importance of taking with a meal.122




  • Importance of completing full course of treatment, even if feeling better after a few days.122




  • Importance of notifying clinician of persistent or worsening symptoms of infection.122




  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness.122




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.122




  • Importance of informing patients of other important precautionary information.122



Preparations


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













Paromomycin Sulfate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



250 mg (of paromomycin)



Paromomycin Sulfate Capsules



Caraco



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 August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



100. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.



101. Samples JR, Binder PS, Luibel FJ et al. Acanthamoeba keratitis possibly acquired from a hot tub. Arch Ophthalmol. 1984; 102:707-10. [PubMed 6372764]



102. Caccio S, Pinter E, Fantini R et al. Human infection with Cryptosporidium felis: case report and literature review. Emerg Infect Dis. 2002; 8:85-6. [PubMed 11749756]



103. El-On J, Weinrauch L, Livshin R et al. Topical treatment of recurrent cutaneous leishmaniasis with ointment containing paromomycin and methylbenzethonium chloride. BMJ. 1985; 291:704-5. [IDIS 205687] [PubMed 3929905]



104. El-On J, Livshin R, Even Paz Z et al. Topical treatment of cutaneous leishmaniasis. BMJ. 1985; 291:1280-1.



105. El-On J, Livshin R, Even-Paz Z et al. Topical treatment of cutaneous leishmaniasis. J Invest Dermatol. 1986; 87:284-8. [IDIS 219637] [PubMed 3734476]



106. Weinrauch L, Katz M. Leishmania aethiopica: topical treatment with paromomycin and methylbenzethonium chloride ointment. J Am Acad Dermatol. 1987; 16:1268-70. [PubMed 3597872]



107. Hewitt RG, Yiannoutsos CT, Higgs ES et al. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. Clin Infect Dis. 2000; 31:1084-92. [IDIS 456006] [PubMed 11049793]



108. Zierdt CH, Swan JC. In vitro response of Blastocystis hominis to antiprotozoal drugs. J Protozool. 1983; 30:332-4. [PubMed 6631776]



110. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website ().



111. Clezy K, Gold F, Blaze F et al. Paromomycin for the treatment of cryptosporidial diarrhoea in AIDS patients. AIDS. 1991; 5:1146-7. [PubMed 1930784]



112. Fichtenbaum CJ, Ritchie DJ. Use of paromomycin for treatment of cryptosporidiosis in patients with AIDS. Clin Infect Dis. 1993; 16:298-300. [IDIS 308997] [PubMed 8443313]



113. Armitage K, Flanigan T, Carey J et al. Treatment of cryptosporidiosis with paromomycin: a report of five cases. Arch Intern Med. 1992; 152:2497-9. [IDIS 306602] [PubMed 1456862]



114. Chen XM, Keithly JS, Paya CV et al. Cryptosporidiosis. N Engl J Med. 2002; 346:1723-31. [PubMed 12037153]



115. White AC, Chappell CL, Hayate CS et al. Paromomycin for cryptosporidiosis in AIDS: a prospective double-blind trial. J Infect Dis. 1994; 170:419-24. [IDIS 335902] [PubMed 8035029]



116. Ravdin JI. Amebiasis. Clin Infect Dis. 1995; 20:1453-66. [IDIS 349015] [PubMed 7548493]



117. Aucott JN. Amebiasis and “nonpathogenic” intestinal protozoa. Infect Dis Clin North Am. 1993; 7:67-85.



118. Reed SL. Amebiasis: an update. Clin Infect Dis. 1992; 14:385-93. [IDIS 292053] [PubMed 1554822]



119. Hill DR. Giardiasis: issues in diagnosis and management. Infect Dis Clin North Am. 1993; 7:503-25. [PubMed 8254157]



120. Smith NH, Cron S, Valdez LM et al. Combination drug therapy for cryptosporidiosis in AIDS. J Infect Dis. 1998; 178:900-3. [IDIS 413483] [PubMed 9728569]



121. Berman JD. Human leishmaniasis: clinical, diagnostic, and chemotherapeutic developments in the last 10 years. Clin Infect Dis. 1997; 24:684-703. [IDIS 384365] [PubMed 9145744]



122. Caraco Pharmaceutical Laboratories. Paromomycin sulfate capsules, USP prescribing information. Detroit, MI; 1997 Mar.



123. Blei AT, Cordoba J, the Practice Parameters Committee of the American College of Gastroenterology. Hepatic encephalopathy. Am J Gastroenterol. 2001; 96:1968-76. [PubMed 11467622]



124. Chung TR, Podolsky DK. Cirrhosis and its complications. In: Harrison’s principles of internal medicine. 16th ed. Kasper DL, Braunwald E, Fauci AS et al, eds. New York: McGraw-Hill; 2007.



125. Robertson J, Shilkofski N, eds. The Harriet Lane handbook: a manual for pediatric house officers. 17th ed. Philadelphia, PA: Elsevier Mosby: 2005:916-7.



126. Chen XM, Keithly JS, Paya CV et al. Cryptosporidiosis. N Engl J Med. 2002; 346:1723-31. [PubMed 12037153]



127. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.



128. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-14):1-92.



129. Murray HW, Berman JD, Davies CR et al. Advances in leishmaniasis. Lancet. 2005; 366:1561-77. [PubMed 16257344]



130. Sundar S, Jha TK, Thakur CP et al. Injectable paromomycin for visceral leishmaniasis in India. N Engl J Med. 2007; 356:2571-81. [PubMed 17582067]



a. AHFS drug information 2008. McEvoy GK, ed. Paromomycin. Bethesda, MD: American Society of Health-System Pharmacists; 2008:850-1.



More Paromomycin Sulfate resources


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Compare Paromomycin Sulfate with other medications


  • Amebiasis
  • Cryptosporidiosis
  • Dientamoeba fragilis
  • Dog Tapeworm
  • Fish Tapeworm Infection
  • Giardiasis
  • Hepatic Coma
  • Hymenolepis nana, Dwarf Tapeworm
  • Taenia saginata, beef tapeworm
  • Taenia solium, pork tapeworm

Tuesday, 28 August 2012

Fero-Folic 500


Generic Name: multivitamin with iron (MUL tee VYE ta mins with i ron)

Brand Names:


What is Fero-Folic 500 (multivitamin with iron)?

Multivitamin are a combination of many different vitamins that are normally found in foods and other natural sources.


Iron is normally found in foods like red meat. In the body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.


Multivitamin and iron are used to provide vitamins and iron that are not taken in through the diet. They are also used to treat iron or vitamin deficiencies caused by illness, pregnancy, poor nutrition, digestive disorders, and many other conditions.


Multivitamin and iron may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Fero-Folic 500 (multivitamin with iron)?


Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects. Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms if you take too much.

Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin with iron.

What should I discuss with my healthcare provider before taking Fero-Folic 500 (multivitamin with iron)?


Iron and certain vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

If you have any medical conditions, ask your doctor before taking a multivitamin with iron. If you have certain conditions, you may need a certain vitamin formulation or special tests while taking this product.


Do not take multivitamin with iron without telling your doctor if you are pregnant or plan to become pregnant. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Multivitamin 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 Fero-Folic 500 (multivitamin with iron)?


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


Never take more than the recommended dose of multivitamin with iron. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Take your multivitamin with a full glass of water. You may take the multivitamin with food if it upsets your stomach.

The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing.


Measure the liquid form of this multivitamin using a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Liquid multivitamin may sometimes be mixed with water, fruit juice, or infant formula (but not milk or other dairy products). Follow the directions on the medicine label.


Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

It is important to take multivitamin with iron regularly to get the most benefit.


Store this medication at room temperature away from moisture and heat. Keep the liquid medicine from freezing.

Store multivitamin in their original container. Storing multivitamin in a glass container can ruin the medication.


What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 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. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms.

Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).


What should I avoid while taking Fero-Folic 500 (multivitamin with iron)?


Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.


Avoid taking an antibiotic medicine within 2 hours before or after you take multivitamin with iron. This is especially important if you are taking an antibiotic such as ciprofloxacin (Cipro), demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), norfloxacin (Noroxin), ofloxacin (Floxin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).


Certain foods can also make it harder for your body to absorb iron. Avoid taking this multivitamin within 1 hour before or 2 hours after eating fish, meat, liver, and whole grain or "fortified" breads or cereals.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

Fero-Folic 500 (multivitamin with iron) 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 serious side effects such as:

  • bright red blood in your stools; or




  • pain in your chest or throat when swallowing a ferrous fumarate tablet.



When taken as directed, multivitamin are not expected to cause serious side effects. Less serious side effects may include:



  • constipation, diarrhea;




  • nausea, vomiting, heartburn;




  • stomach pain, upset stomach;




  • black or dark-colored stools or urine;




  • temporary staining of the teeth;




  • headache; or




  • unusual or unpleasant taste in your mouth.



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 Fero-Folic 500 (multivitamin with iron)?


Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking multivitamin with iron, tell your doctor if you also use:



  • acetohydroxamic acid (Lithostat);




  • cimetidine (Tagamet);




  • deferoxamine (Desferal);




  • etidronate (Didronel);




  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




  • dimercaprol (an injection used to treat poisoning by arsenic, lead, or mercury);




  • penicillamine (Cuprimine);




  • pancrelipase (Cotazym, Creon, Ilozyme, Pancrease, Ultrase);




  • trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Septra, TMP/SMX); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.



This list is not complete and there may be other medications that can interact with or be affected by multivitamin with iron. 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 Fero-Folic 500 resources


  • Fero-Folic 500 Side Effects (in more detail)
  • Fero-Folic 500 Use in Pregnancy & Breastfeeding
  • Fero-Folic 500 Drug Interactions
  • Fero-Folic 500 Support Group
  • 0 Reviews for Fero-Folic 500 - Add your own review/rating


  • Multivitamin with Iron Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Anemagen MedFacts Consumer Leaflet (Wolters Kluwer)

  • BiferaRx MedFacts Consumer Leaflet (Wolters Kluwer)

  • Chromagen Forte MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ferocon MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ferotrin Prescribing Information (FDA)

  • Ferralet 90 Prescribing Information (FDA)

  • Ferralet 90 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ferrex 150 Forte Prescribing Information (FDA)

  • Ferrex 150 Forte Plus Prescribing Information (FDA)

  • Ferrex 150 Forte Plus MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ferrex 28 Prescribing Information (FDA)

  • FerroGels Forte MedFacts Consumer Leaflet (Wolters Kluwer)

  • FerroGels Forte Prescribing Information (FDA)

  • FoliTab 500 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fumatinic MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hematogen Forte Prescribing Information (FDA)

  • Integra MedFacts Consumer Leaflet (Wolters Kluwer)

  • Integra F MedFacts Consumer Leaflet (Wolters Kluwer)

  • Integra F Prescribing Information (FDA)

  • Integra Plus MedFacts Consumer Leaflet (Wolters Kluwer)

  • Integra Plus Prescribing Information (FDA)

  • Irospan 24/6 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Irospan 24/6 Prescribing Information (FDA)

  • NovaFerrum Prescribing Information (FDA)

  • NovaFerrum MedFacts Consumer Leaflet (Wolters Kluwer)

  • Proferrin-Forte MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tricon Prescribing Information (FDA)



Compare Fero-Folic 500 with other medications


  • Anemia
  • Vitamin/Mineral Supplementation and Deficiency


Where can I get more information?


  • Your pharmacist can provide more information about multivitamin with iron.

See also: Fero-Folic 500 side effects (in more detail)


Halcion



Generic Name: triazolam (Oral route)

trye-AZ-oh-lam

Commonly used brand name(s)

In the U.S.


  • Halcion

Available Dosage Forms:


  • Tablet

Therapeutic Class: Hypnotic


Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting


Uses For Halcion


Triazolam is used to treat insomnia (trouble with sleeping). This medicine is only for short-term use, usually 7 to 10 days. Triazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.


This medicine is available only with your doctor's prescription.


Before Using Halcion


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of triazolam in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triazolam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving triazolam.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Amprenavir

  • Atazanavir

  • Boceprevir

  • Darunavir

  • Delavirdine

  • Efavirenz

  • Fosamprenavir

  • Indinavir

  • Itraconazole

  • Ketoconazole

  • Lopinavir

  • Nefazodone

  • Nelfinavir

  • Ritonavir

  • Saquinavir

  • Telaprevir

  • Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alfentanil

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Butabarbital

  • Butalbital

  • Carisoprodol

  • Chloral Hydrate

  • Chlorzoxazone

  • Codeine

  • Dantrolene

  • Ethchlorvynol

  • Fentanyl

  • Fluconazole

  • Fospropofol

  • Hydrocodone

  • Hydromorphone

  • Levorphanol

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Mibefradil

  • Morphine

  • Morphine Sulfate Liposome

  • Oxycodone

  • Oxymorphone

  • Pentobarbital

  • Phenobarbital

  • Primidone

  • Propoxyphene

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Thiopental

  • Voriconazole

  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Aprepitant

  • Clarithromycin

  • Dehydroepiandrosterone

  • Diltiazem

  • Erythromycin

  • Fluvoxamine

  • Fosaprepitant

  • Modafinil

  • Omeprazole

  • Ranitidine

  • Rifampin

  • Rifapentine

  • Roxithromycin

  • Rufinamide

  • St John's Wort

  • Theophylline

  • Troleandomycin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse, or history of, or

  • Drug abuse or dependence, or history of—Dependence on triazolam may develop.

  • Breathing problems or lung disease, severe or

  • Depression, or history of, or

  • Sleep apnea (temporary stopping of breathing during sleep)—Use with caution. May make these conditions worse.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Halcion


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


Take triazolam just before going to bed, when you are ready to go to sleep.


This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For insomnia:
      • Adults—0.125 to 0.25 milligram (mg) at bedtime.

      • Children—Use and dose must be determined by your doctor.



Precautions While Using Halcion


It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


Triazolam may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, nausea or vomiting, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth or throat while you are using this medicine.


Do not take itraconazole (Sporanox®), ketoconazole (Nizoral®), or nefazodone (Serzone®) while you are using this medicine. Taking these medicines together with triazolam may increase the chance of serious side effects.


If you develop any unusual or strange thoughts and behavior while taking triazolam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.


This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake. If these reactions occur, tell your doctor right away.


This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.


This medicine may cause some people, especially older persons, to become drowsy, dizzy, or less alert than they are normally. Even though triazolam is taken at bedtime, it may cause some people to feel drowsy or less alert the next morning. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to think or see well.


Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and have memory problems because the effects of the medicine have not had time to wear off.


Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, sweating, tremors, vomiting, or unusual behavior.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.


Halcion Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Shakiness and unsteady walk

  • unsteadiness, trembling, or other problems with muscle control or coordination

Rare
  • Being forgetful

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • continuing ringing or buzzing or other unexplained noise in the ears

  • discouragement

  • false or unusual sense of well-being

  • fast, pounding, or irregular heartbeat or pulse

  • feeling sad or empty

  • hearing loss

  • irritability

  • lack of appetite

  • loss of interest or pleasure

  • nightmares

  • sleeplessness

  • tiredness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

Incidence not known
  • Abdominal or stomach pain

  • actions that are out of control

  • aggressiveness

  • anxiety

  • changes in patterns and rhythms of speech

  • chest pain

  • chills

  • clay-colored stools

  • confusion about identity, place, and time

  • dark urine

  • decrease in frequency of urination

  • decrease in urine volume

  • difficulty in passing urine (dribbling)

  • dizziness

  • drowsiness

  • dry mouth

  • environment seems unreal

  • fainting

  • falling

  • false beliefs that cannot be changed by facts

  • feeling of unreality

  • fever

  • headache

  • hyperventilation

  • inability to move eyes

  • increased blinking or spasms of the eyelid

  • increased muscle spasm

  • irregular heartbeats

  • loss of appetite

  • loss of bladder control

  • loss of memory

  • nausea

  • nervousness

  • nightmares

  • painful urination

  • problems with memory

  • rash

  • relaxed and calm

  • restlessness

  • seeing, hearing, or feeling things that are not there

  • sense of detachment from self or body

  • shortness of breath

  • sleep walking

  • sleepiness

  • slurred speech

  • sticking out of tongue

  • talking, feeling, and acting with excitement

  • trouble in breathing, speaking, or swallowing

  • uncontrolled twisting movements of the neck, trunk, arms, or legs

  • unpleasant breath odor

  • unusual excitement, nervousness, restlessness, or irritability

  • unusual facial expressions

  • unusual tiredness or weakness

  • vomiting of blood

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Lightheadedness

Rare
  • Any change in vision

  • blistering, crusting, irritation, itching, or reddening of skin

  • change in taste or bad, unusual, or unpleasant (after) taste

  • cracked, dry, or scaly skin

  • cramps

  • diarrhea

  • difficulty having a bowel movement (stool)

  • dry mouth

  • swelling

  • weakness

Incidence not known
  • Decreased interest in sexual intercourse

  • inability to have or keep an erection

  • increase in sexual ability, desire, drive, or performance

  • increase interest in sexual intercourse

  • itching skin

  • loss in sexual ability, desire, drive, or performance

  • menstrual changes

  • redness, swelling, or soreness of the tongue

  • swelling or inflammation of the mouth

  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Halcion side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Halcion resources


  • Halcion Side Effects (in more detail)
  • Halcion Dosage
  • Halcion Use in Pregnancy & Breastfeeding
  • Drug Images
  • Halcion Drug Interactions
  • Halcion Support Group
  • 3 Reviews for Halcion - Add your own review/rating


  • Halcion Prescribing Information (FDA)

  • Halcion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Halcion Concise Consumer Information (Cerner Multum)

  • Halcion Monograph (AHFS DI)

  • Triazolam Prescribing Information (FDA)

  • Triazolam Professional Patient Advice (Wolters Kluwer)



Compare Halcion with other medications


  • Insomnia

Saturday, 25 August 2012

Mifepristone


Pronunciation: MIF-eh-pri-stone
Generic Name: Mifepristone
Brand Name: Mifeprex

Serious and sometimes fatal infections or bleeding may rarely occur following any abortion, including those resulting from the use of Mifepristone. Read the Medication Guide and Patient Agreement that come with Mifepristone, and ask your doctor any questions that you may have. Make sure you are given clear instructions and understand whom to call and what to do in case of an emergency, including going to the nearest emergency room if your doctor is not available. Contact your doctor immediately or, if unavailable, seek emergency medical care if you experience persistent fever, severe abdominal pain, fast heartbeat, prolonged heavy vaginal bleeding, or fainting. If Mifepristone does not work within 2 days, your doctor may give you another medicine called misoprostol. If you experience stomach pain or discomfort, weakness, nausea, vomiting, or diarrhea more than 24 hours after taking misoprostol, contact your doctor immediately or seek emergency medical care. If you go to an emergency room or another health care provider, take the Medication Guide with you so that they will know that you are taking Mifepristone. If Mifepristone does not cause a complete abortion, surgery may be necessary. Talk with your doctor for more information.





Mifepristone is used for:

Ending pregnancy in women who have been pregnant for 49 days (7 weeks) or less. It may be used with other medicines. If Mifepristone does not work, surgery to end the pregnancy may be necessary.


Mifepristone is a synthetic steroid. It works by blocking a hormone (progesterone) necessary for pregnancy to continue.


Do NOT use Mifepristone if:


  • you are allergic to any ingredient in Mifepristone, misoprostol, or similar medicines

  • you are taking blood thinners (eg, warfarin, heparin) or corticosteroids (eg, prednisone, dexamethasone)

  • you have an intrauterine device (IUD) in place

  • you have a pregnancy outside the uterus (ectopic pregnancy)

  • you have adrenal gland problems (chronic adrenal failure) or Addison disease

  • you have bleeding problems or certain blood problems (eg, porphyria)

  • you have an undiagnosed growth in the abdomen

  • you are unable to follow-up with your heath care provider or you are unable to get emergency medical care for any serious problems that might occur within several weeks after taking Mifepristone

  • you do not understand the effects of Mifepristone, the follow-up treatment procedures, or you are unable to comply with the instructions given by your health care provider

Contact your doctor or health care provider right away if any of these apply to you.



Before using Mifepristone:


Some medical conditions may interact with Mifepristone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have breathing, heart, liver, lung, or kidney problems; diabetes; anemia; or high blood pressure

  • if you will be undergoing general anesthesia

  • if you are older than 35 years of age and you also smoke 10 or more cigarettes per day

Some MEDICINES MAY INTERACT with Mifepristone. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • St. John's wort because the effectiveness of Mifepristone may be decreased

  • Anticoagulants (eg, warfarin) or corticosteroids (eg, hydrocortisone) because the risk of side effects, including excessive bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mifepristone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Mifepristone:


Use Mifepristone as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Mifepristone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mifepristone refilled.

  • Mifepristone is supplied by your health care provider and is not available at a pharmacy.

  • Mifepristone requires 3 visits to your health care provider.

  • On day 1 at your health care provider's office, you will read the Medication Guide and discuss the benefits and risks of using Mifepristone to end your pregnancy. If you decide Mifepristone is right for you, sign the Patient Agreement. After your physical exam, you will take 3 tablets of Mifepristone.

  • On day 3 at your health care provider's office, if you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your health care provider may give you other medicines for these symptoms.

  • Around day 14 at your health care provider's office, you will return for an important follow-up visit. You must return about 14 days after you have taken Mifepristone to be sure the pregnancy has ended. If the pregnancy has not ended, there is a chance of birth defects. Your health care provider will discuss with you your choices, including surgical abortion.

  • Avoid drinking grapefruit juice while taking Mifepristone.

  • You must follow the dosing schedule as directed by your doctor. If you miss an appointment, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Mifepristone.



Important safety information:


  • Mifepristone may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mifepristone. Using Mifepristone alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

  • Make sure that your health care provider gives you clear instructions and a telephone number that you can call in case of an emergency, or if you have any problems or concerns.

  • If you are using an IUD, it should be removed before treatment with Mifepristone begins.

  • Mifepristone should not be used if your pregnancy is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. In fact, it may cause very serious internal or external bleeding.

  • You can become pregnant again immediately after using Mifepristone. To avoid pregnancy, start using birth control as soon as your pregnancy ends and before you start having sexual intercourse again.

  • Before you have any medical or dental treatments, emergency care, laboratory tests, or surgery, tell the doctor or dentist that you are using Mifepristone.

  • LAB TESTS, including human chorionic gonadotropin (hCG) levels and ultrasonographic scan, and health care provider's appointments will be required to monitor your progress. Be sure to keep all doctor and lab appointments.

  • Mifepristone is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result. It is unknown if Mifepristone is excreted in breast milk. Because the effects of Mifepristone on infants are unknown, contact your doctor if you are breast-feeding to determine if you should discard your breast milk for a few days following treatment.


Possible side effects of Mifepristone:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Abdominal (menstrual-like) pain and/or cramping; anxiety; back pain; chills/shaking; diarrhea; dizziness; headache; indigestion; nausea; tiredness; vaginal bleeding or discharge; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast heartbeat; fever (100.4 degrees F or higher); heavy vaginal bleeding (enough to soak through 2 thick full-size sanitary pads per hour for 2 straight hours, or if you are concerned about heavy bleeding); infection; pelvic pain; severe abdominal pain; vaginal discomfort, itching, or unusual discharge.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Mifepristone side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Mifepristone:

Store Mifepristone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mifepristone out of the reach of children and away from pets.


General information:


  • If you have any questions about Mifepristone, please talk with your doctor, pharmacist, or other health care provider.

  • Mifepristone is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mifepristone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mifepristone resources


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


  • Mifepristone Professional Patient Advice (Wolters Kluwer)

  • Mifepristone Monograph (AHFS DI)

  • mifepristone Advanced Consumer (Micromedex) - Includes Dosage Information

  • mifepristone Concise Consumer Information (Cerner Multum)



Compare Mifepristone with other medications


  • Abortion
  • Cushing's Syndrome

erythromycin Oral, Parenteral



e-rith-roe-MYE-sin


Commonly used brand name(s)

In the U.S.


  • E.E.S. 200

  • E.E.S. 400

  • E.E.S. Granules

  • Eryped

  • Eryped 200

  • Eryped 400

  • Erythrocin

  • Erythrocin Stearate

  • Ilosone

In Canada


  • E.E.S. 100

  • Ees 200

  • Novo-Rythro Estolate Suspension

  • Novo-Rythro Ethyl Succinate Suspension

  • Novo-Rythro Stearate

Available Dosage Forms:


  • Suspension

  • Powder for Suspension

  • Tablet

  • Tablet, Chewable

  • Capsule

Uses For erythromycin


Erythromycins are used to treat many kinds of infections. Erythromycins are also used to prevent "strep" infections in patients with a history of rheumatic heart disease who may be allergic to penicillin.


These medicines may also be used to treat Legionnaires' disease and for other problems as determined by your doctor. They will not work for colds, flu, or other virus infections.


Erythromycins are available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, erythromycins are used in certain patients with the following medical conditions:


  • Acne

  • Actinomycosis

  • Anthrax

  • Chancroid

  • Gastroparesis

  • Lyme disease

  • Lymphogranuloma venereum

  • Relapsing fever

Before Using erythromycin


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


erythromycin has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.


Geriatric


erythromycin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older adults may be at increased risk of hearing loss, especially if they are taking high doses of erythromycin and/or have kidney or liver disease.


Pregnancy


Erythromycin estolate has caused side effects involving the liver in some pregnant women. However, none of the erythromycins has been shown to cause birth defects or other problems in human babies.


Breast Feeding


Erythromycins pass into the breast milk. However, erythromycins have not been shown to cause problems in nursing babies.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Heart disease—High doses of erythromycin may increase the chance of side effects in patients with a history of an irregular heartbeat.

  • Liver disease—Erythromycins, especially erythromycin estolate, may increase the chance of side effects involving the liver.

  • Loss of hearing—High doses of erythromycins may, on rare occasion, cause hearing loss, especially if you have kidney or liver disease.

Proper Use of erythromycin


Generally, erythromycins are best taken with a full glass (8 ounces) of water on an empty stomach (at least 1 hour before or 2 hours after meals). If stomach upset occurs, these medicines may be taken with food. If you have questions about the erythromycin medicine you are taking, check with your health care professional.


For patients taking the oral liquid form of erythromycin:


  • erythromycin is to be taken by mouth even if it comes in a dropper bottle. If erythromycin does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid

  • Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

For patients taking the chewable tablet form of erythromycin:


  • Tablets must be chewed or crushed before they are swallowed.

For patients taking the delayed-release capsule form (with enteric-coated pellets) or the delayed-release tablet form of erythromycin:


  • Swallow capsules or tablets whole. Do not break or crush. If you are not sure about which type of capsule or tablet you are taking, check with your pharmacist.

To help clear up your infection completely, keep taking erythromycin for the full time of treatment, even if you begin to feel better after a few days. If you have a "strep" infection, you should keep taking erythromycin for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking erythromycin too soon, your symptoms may return.


erythromycin works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.


Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For erythromycin base

  • For oral dosage forms (capsules, tablets):
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



  • For erythromycin estolate

  • For oral dosage forms (capsules, oral suspension, tablets):
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



  • For erythromycin ethylsuccinate

  • For oral dosage forms (oral suspension, tablets):
    • For treatment of infections:
      • Adults and teenagers—400 to 800 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1.6 grams two hours before your dental appointment or surgery, then 800 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



  • For erythromycin gluceptate

  • For injection dosage forms:
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.

      • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.



  • For erythromycin lactobionate

  • For injection dosage forms:
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.

      • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.



  • For erythromycin stearate

  • For oral dosage forms (oral suspension, tablets):
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day; or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



Missed Dose


If you miss a dose of erythromycin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using erythromycin


If your symptoms do not improve within a few days, or if they become worse, check with your doctor.


erythromycin Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Fever

  • nausea

  • skin rash, redness, or itching

  • stomach pain (severe)

  • unusual tiredness or weakness

  • vomiting

  • yellow eyes or skin–with erythromycin estolate (rare with other erythromycins)

Less common - with erythromycin injection only
  • Pain, swelling, or redness at place of injection

Rare
  • Fainting (repeated)

  • irregular or slow heartbeat

  • loss of hearing (temporary)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abdominal or stomach cramping and discomfort

  • diarrhea

  • nausea or vomiting

Less common
  • Sore mouth or tongue

  • vaginal itching and discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



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