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Metrogyl
DESCRIPTION:
Metrogyl (Metronidazole) is an oral synthetic antiprotozoal and
antibacterial agent.
COMPOSITION:
Each film coated tablet contains:
Metronidazole BP 200 mg / 400 mg.
PHARMACOLOGICAL ACTION:
MECHANISM OF ACTION:
Metronidazole diffuses into aerobic and anaerobic bacteria equally well,
but in the former it remains unchanged while in the later it is reduced. As
a result of biochemical reduction in the cell, the concentration of
unchanged drug is reduced and this probably creates a gradient which
promotes further uptake of the drug into anaerobic organisms. The nitro
group of Metronidazole is reduced in anaerobic bacteria and protozoa by the
pyruvate phosphoroclastic reaction, in which the drug acts as a preferential
electron acceptor.
Oxygen markedly reduced the uptake of Metronidazole in experiments using
certain anaerobic protozoa, suggesting that this process depends on reducing
power inside the cell. The selective uptake and specificity of Metronidazole
for anaerobes may be because their redox process are different from those
aerobes; it has been assumed that the product of reduction of the nitro
group of Metronidazole interacts with the DNA with ultimate inhibition of
nucleic acid synthesis and subsequent cell death. Moreover Metronidazole has
been shown to inhibit DNA synthesis and degrade existing DNA in Clostridium
bifermentans.
INDICATIONS:
Symptomatic Trichomoniasis
Asymptomatic Trichomoniasis
Intestinal Amoebiasis
Amoebic Liver Abscess
Anaerobic Bacterial Infections
Intra-Abdominal Infections
Skin and Skin Structure Infections
Gynaecologic Infections
Bacterial Septicemia
Bone and Joint Infections
Central Nervous Systems (CNS) Infections
Lower Respiratory Tract Infections
Endocarditis
DOSAGE:
In elderly patients the pharmacokinetics of metronidazole may be altered and
therefore monitoring of serum levels may be necessary to adjust the
metronidazole dosages accordingly.
Trichomoniasis In the Female: One-day treatment : two grams of Metrogyl,
given either as a single dose or in two divided doses of one gram each given
in the same day.
Seven day course of treatment : 200 mg three times daily for seven
consecutive days.
Trichomoniasis In the Male : Treatment should be individualized as for the
female.
Amoebiasis:
Adults:
For acute intestinal amoebiasis (acute amoebic dysentry) 800 mg orally three
times daily, 5 to 10 days.
For amoebic liver abscess : 400 mg or 800 mg orally three times daily for 5
to 10 days.
Anaerobic Bacterial Infections:
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for
a 70 kg Adult). A maximum of 4 gm should not be exceeded during a 24 hour
period.
The usual duration of therapy is 7 to 10 days; however, infections of the
bone and joint, lower respiratory tract, and endocardium may require longer
treatment.
WARNINGS:
Convulsive Seizures and Peripheral Neuropathy Convulsive seizures and
peripheral neuropathy, the later 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 Metrogyl therapy. Metrogyl should be administered
with caution to patients with central nervous system diseases.
CONTRAINDICATIONS:
Metrogyl is contraindicated in patients with a prior history of
hypersensitivity to metronidazole or other nitroimidazole derivatives.
In patients with trichomoniasis, Metrogyl is contraindicated during the
first trimester of pregnancy.
PRECAUTIONS:
General: Patients with severe hepatic diseases metronidazole metabolizes
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. In known or previously
recognised candidiasis Metrogyl may prevent more prominent symptoms during
therapy and requires treatment with a candicidal agent.
Pregnancy: Metronidazole crosses the placental barrier and enters the fetal
circulation rapidly. Reproduction studies have been performed in rats at
doses up to five times the human dose and have revealed no evidence of
impaired fertility or harm to the fetus due to Metronidazole.
Nursing Mothers: Because of the potential for tumorogenicity shown for
metronidazole in mouse and rat studies, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the concentration similar to those found in
plasma.
Paediatric Use: Safety and effectiveness in children have not been
established, except for the treatment of amoebiasis.
SIDE EFFECTS:
The following reactions have also been reported during treatment with
Metrogyl (Metronidazole)
Mouth: A sharp unpleasant metallic taste is not unusual.
Hematopoietic : Reversible neutropenia (leukopenia), rarely, reversible
thrombocytopenia.
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic
tracings.
Central Nervous System:
Convulsive seizures, peripheral neuropathy, dizziness, vertigo, in-cordination,
ataxia, confusion, irritability, depression, weakness, and insomnia.
Hypersensitivity: Urticaria,
erythematous rash, flushing, nasal congestion, dryness of the mouth (or
vagina or vulva) and fever.
Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic
pressure.
STORAGE
Store below 30°C in a cool dry place. Protect from light.
Keep out of reach of children.
PRESENTATION
Blister strip of 10 tablets. Bulk pack of 1000 Tablets.
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