Famagyl Metronidazole Suspension and Tablets

FAMAGYL®

BRAND OF METRONIDAZOLE

 

COMPOSITION

The active ingredient in FAMAGYL is Metronidazole.

 
PRESENTATION

FAMAGYL Suspension: 60m1 in a 60ml bottle with a leaflet. Each 5ml contains Metronidazole Benzoate equivalent to 200mg of Metronidazole.

FAMAGYL 200 Tablets: 10 x 10 blistered tablets in one packet with a leaflet. Each white round tablet impressed with ‘PIL’ on one side and a break-line on the other side contains 200mg of Metronidazole.

FAMAGYL 400 Tablets: l0 x 10 blistered tablets in one packet with a leaflet. Each yellow round tablet impressed with ‘PIL’ on one side and a break-line on the other side contains 400mg of Metronidazole.

 
PROPERTIES

FAMAGYL is a nitroimidazole antibiotic medication used particularly for anaerobic bacteria and protozoal infections. An antibiotic, antiprotozoal and amebicide, it is the drug of choice for first episodes of mild-to-moderate Clostridium difficile infection.

 
MODE OF ACTION

FAMAGYL is selectively absorbed by anaerobic bacteria and sensitive protozoa. Once taken up by anaerobes, it is non-enzymatically reduced by reacting with reduced ferredoxin, which is generated by pyruvate oxido-reductase. Many of the reduced nitroso intermediates will form sulfinamides and thioether linkages with cysteine-bearing enzymes, thereby deactivating these critical enzymes. As many as 150 separate enzymes are affected.

In addition, FAMAGYL metabolites are taken up into bacterial DNA to form unstable molecules. This function only occurs when FAMAGYL is partially reduced. This reduction usually happens only in anaerobic and protozoal cells, so it has relatively little effect upon human cells and aerobic bacteria.

 
INDICATIONS

FAMAGYL is used for treating the following infections:

Bacteria
Bacterial vaginosis; Pelvic inflammatory disease in conjunction with other antibiotics such as ofloxacin, levofloxacin, or ceftriaxone, Anaerobic infections caused by such organisms as Bacteroides fragilis spp, Fusobacterium spp, Clostridium spp, Peptostreptococcus spp, Prevotella spp or any other anaerobes in intra-abdominal abscess. Peritonitis, diverticulitis, empysema, pneumonia, lung and brain abscess, meningitis, diabetic foot ulcer, bone and joint infections, septicemia, endometritis and endocarditis. Pseudomembranous colitis due to Clostridium difficile.

Helicobacter pylori eradication therapy as part of a multi-drug regimen in peptic ulcer disease.

Dental infection of bacterial origin such as periapical abscess, periodontal abscess, acute pericoronitis of impacted and partially erupted teeth. In this case, FAMAGYL is used in conjunction with amoxicillin.

Protozoal
Amoebiasis: Infections caused by Entamoeba histolytica.
Giardiasis: Infections of the small intestine caused by the ingestion of infective cysts of Giardia lamblia. Trichomoniasis: Infections caused by Trichomonas vaginalis which is a common cause of vaginitis and is the most frequently presenting new infection of common sexually transmitted diseases.

Nonspecific
Prophylaxis for those undergoing potentially contaminated colorectal surgery or appendectomies and maybe combined with neomycin.
Crohn’s disease with colonic or perianal involvement. FAMAGYL is more effective in combination with ciprofloxacin in treating this condition.

Preterm births
FAMAGYL can be used in women to prevent bacterial vaginosis associated with preterm births; amongst other risk factors including the presence of cervico-vaginal fetal fibronectin.

 
RECOMMENDED DOSAGE AND ADMINISTRATION

Always take FAMAGYL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure because the dosage depends on the type of infection and how bad it is.

 

Indications Duration of Dosage. Adults & Children over l0yrs 5 – l0yrs 1 – 5yrs
Bacterial Vaginosis 7 – l0 days 5ml or 1(200mg) or
1/4(400mg) 3times daily
2.5ml or 1/2(200mg) or
1/4(400mg) 3times daily
1.25m1 or 1/4(200mg)
3times daily
Amoebiasis 5 – l0 days 20m1 or 4(200mg) or
2(400mg) 3times daily
10mI or 2(200mg) or 1(400mg) 3times daily 5ml or 1(200mg) or
1/2(400mg) 3times daily
Giardiasis 3days. A second course may be necessary 2weeks after 50ml or 10(200mg) or
5(400mg) once daily
25ml or 5(200mg) once daily 10ml or 2(200mg) once daily
Trichomoniasis 7days 5ml or 1(200mg) or 1/2
(400mg) 3times daily
2.5m1 or 1/2(200mg)
3times daily
1.25ml or 1/4(200mg)
3times daily
Acute Ulcerative Gingivitis 3days 5m1 or 1(200mg)
3times daily
2.5m1 or ½(200mg)
3times daily
1.25ml or 1/4(200mg)
3times daily

 

 

ADULT DOSAGE FOR OTHER INFECTIONS

Amebic dysentery and amebic liver abscess: 500-750mg orally 3times daily for 5-l0days.

Anaerobic infections: 7.5 mg/kg orally every 6hours. Do not exceed 4grams daily.
Clostridium difficile infection: 250-500 mg orally4times daily or 500-750mg orally 3 times daily.

Helicobacter pylori: 800-1500 mg orally daily for several days in combination with other drugs.

Pelvic inflammatory disease: 500 mg orally twice daily for 14 days in combination with other drugs.

 
OVER-DOSAGE

Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet, the remaining drug and packet with you to the hospital so they know which drug was consumed.

 
SIDE EFFECTS

Nausea, diarrhea, metallic taste in the mouth, thrombophlebitis, hypersensitivity reactions, headache, dizziness, vomiting, glossitis, stomatitis, dark urine and paraesthesia. High doses or long-term treatment is associated with leukopenia, neutropenia, increased risk of peripheral neuropathy and CNS toxicity.

 
PRECAUTIONS AND WARNING

Check with your doctor or pharmacist before taking FAMAGYL if you are taking anticoagulants, lithium, disulfiram, phenobarbitone, phenytoin, cyclosporine, 5-flourouracil and busulfan.

Do not drink alcohol while taking FAMAGYL.

 
CONTRAINDICATION

Do not take FAMAGYL if you are allergic or sensitive to Metronidazole, pregnant or have liver or kidney disease.

 
PREGNANCY AND LACTATION

FAMAGYL should not be taken in pregnancy unless considered absolutely necessary. It is better not to use if you are breast-feeding because small amount may pass into the mother’s milk.

 
STORAGE

Keep all medicines out of the reach of children. Do not store above 25 degrees centigrade.

Protect from direct sunlight and store in a cool, dry place.

Do not use if carton is tampered with when purchased.

Ask your pharmacist how to dispose of medicines no longer required or have expired.

 
Manufactured and Marketed by

PHIL PHAMATEX INDUSTRIES LIMITED

Marble House,

1 Crystal Glass Close, Amuwo-Odofin

Industrial Estate, Lagos, Nigeria.

Item code: PIL00

Dated Apr 2014

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