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Garymet

Agary Pharmaceutical Limited
Plot C39A, Amuwo Odofin Commercial Scheme, Along Alakoso Avenue, Amuwo Odofin, Lagos.
Email: agarypharm@gmail.com
Tel: 0809-275-6424, 0809-275-6425, 0808-745-4848.
Website: http://agarypharm.com/

Brand Name

Garymet

Manufacturer

Agary Pharmaceutical Limited
Plot C39A Amuwo Odofin Comm. Scheme, Along Alakoso Avenue, Amuwo Odofin, Lagos.

Therapeutic Class

Antibacterial, Nitroimidazole

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: A4-3547): Metronidazole 200 mg; yellow scored tablet. marked “AGARY”

Pack Size: 10 x 10’s (in blisters); 1000’s in Jars

GARYMET

Pharmacology

Garymet is metabolised by certain enzymes found in anaerobic organisms. The nitrogen group of Garymet is reduced and the reduced product then attacks the anaerobic organism’s DNA. The resulting damage is lethal to the micro-organism. The reduced Garymet metabolite is very unstable decomposing rapidly inside the bacterial cell and therefore does not reach mammalian cells. Since aerobic organisms and human/animal cells do not contain these reducing enzymes, Garymet is not active in these cells.

Pharmacokinetics:

Garymet is metabolised partially in the liver into unchanged metronidazole, Hydroxymetronidazole (a highly active long acting metabolite) and an acetic acid metabolite which is inactive. The main active metabolite, Hydroxymetronidazole, contributes substantially to Garymet’s effectiveness in terms of antimicrobial activity and duration of action. Garymet has an excellent distribution profile. Concentrations in various important tissues often approach serum levels.

After oral administration, Garymet is rapidly and well absorbed from the intestine into the blood stream reaching plasma concentrations of about
10 mg/L approximately one hour after a single 500 mg dose which is well above Garymet’s effective concentration for target anaerobic pathogens.

Plasma protein binding: Low, 8 - 11%; therefore, a few interactions with other agents. Garymet is excreted as unchanged metronidazole and its various metabolites, principally via the kidneys; 77% of the given dose being recovered from the urine. About 14% of the dose is also excreted via the faeces.

Note: Urine of some patients on Garymet may be reddish-brown due to the presence of azo dyes (unidentified pigments) derived from metronidazole. This is quite harmless and should not be confused with haematuria. Garymet is also excreted via breast milk.

Indications

Treatment of trichomoniasis and amoebiasis; giardiasis and in the prophylaxis and treatment of anaerobic infections including septiceamia, brain abscesses, cellulitis and post-operative wound infections. 

Others include gingivitis (Vincent’s disease) and pelvic inflammatory disease. It is also used to prevent post-operative infections after surgery. Also effective in the treatment of acute dental infections e.g. pericoronitis and apical infections; urogenital vaginosis in the female (Trichomonal vaginitis) and male.

Contra-indications

Garymet is contra-indicated in cases of known hypersensitivity to metronidazole.

Precautions/Warnings

Garymet has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved for the
conditions described in the indications above and dosage section below. 

Convulsive Seizures and Peripheral Neuropathy:

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole therapy. Garymet should be administered with caution to patients with central nervous system diseases.

General:

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. 

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Garymet and requires treatment with a candidacidal agent. 

Prescribing Garymet in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Alcoholic beverages should be avoided while taking Garymet and for at least one day afterward. Patients should be counseled that antibacterial drugs including metronidazole should only be used to treat bacterial infections. They do not treat viral infections. 

When metronidazole is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment, and increase the likelihood that bacteria will develop resistance and will not be treatable by metronidazole or other antibacterial drugs in the future.

Interactions

Alcohol: Patients should be advised not to take alcoholic drinks during Garymet therapy.

Anticoagulants: Some potentiation of anticoagulants activities has been reported when Garymet has been used with certain oral anticoagulants. Dosage of the latter may require adjustment. No interactions have been reported with parental anticoagulants of the heparin type. However, anticoagulant activity should be routinely monitored with these products.

Rare instances of slight and transient fall in blood pressure have been reported; it may therefore be advisable to lower the dosage of any antihypertensive drug which may be given concurrently.

Garymet produces an effect similar to disulfiram (a drug used to treat chronic alcoholics). Garymet should not be given during disulfiram treatment.

Patients taking phenobarbitone (for epilepsy or for sedative purposes) metabolise Garymet much faster than usual - reducing Garymet’s half-life to approximately three hours. It is not uncommon for phenobarbitone to interact with many different types of drugs.

Adverse Effects

No serious adverse reactions have been encountered with the standard recommended dosage. Unpleasant taste in the mouth, nausea, vomiting,
furred tongue, gastro-intestinal disturbance and angioedema occasionally occur. 

Drowsiness, dizziness, headache, ataxia, skin rashes, pruritis, incoordination of movement and darkening of the urine (due to a metronidazole metabolite) have been reported, but very rarely. 

During intensive and for prolonged metronidazole therapy, a few instances of peripheral neuropathy or transient epileptiform seizure have been reported.

Dosage & Administration

Treatment of amoebiasis
Adults and children (over 10 years): 400 - 800 mg three times a day for 5 to 10 days.
Children (7-10 years): 200 - 400 mg three times a day for 5 to 10 days.
Children (3 -7 years): 100 - 200 mg four times daily for 5 to 10 days.

Treatment of infection caused by Trichomonas
Adults and adolescents: 2 g as a single dose, or 200 mg three times a day for 7 days, or 400 mg twice a day for 5 to 7 days. Your partner should also be treated.
Children under 10 years: 40 mg/kg as a single dose or 15 - 30 mg/kg/day two to three times daily for 7 days.

Treatment of infections of the gums (for 3 days) or teeth (for 3-7 days)
Adults and children (over 10 years): 200 mg three times a day.

Treatment of non-specific genital infection in women
Women: 400 mg twice a day for 7 days, or 2 g as a single dose for 1 day only.
Adolescent girls: 400 mg twice daily for 5 to 7 days or 2 g as a single dose.

Treatment of infections of the gums (for 3 days) or teeth (for 3 - 7 days)
Adults and children (over 10 years): 200 mg three times a day.

Treatment of infected leg ulcers or pressure sores (for 7 days)
Adults and children (over 10 years): 400 mg three times a day

Treatment of stomach ulcers caused by Helicobacter pylori
To be taken as directed by your doctor as part of a course with two other medicines.

Prevention of infections after surgery
Adults: 1 g as a single dose 24 hours before surgery then, 400 mg at 8 hourly intervals during the 24 hours before the operation.
Tablets should be swallowed (without chewing) with a half glassful of water. It is recommended that tablets be taken during or after a meal.

Storage/Handling Recommendations

Store below 25oC in a dry place. Protect from light.

Keep all medicines out of the reach of children.

Review Date

2017-09-14 06:05:40