Unigyl Metronidazole Injection For Intravenous Infusion

UNIGYL®
METRONIDAZOLE INJECTION FOR INTRAVENOUS INFUSION U.S.P. (500mg/100mI)

To the Medical / Pharmacy Profession.

The activity of Metronidazole against a wide variety of clinically important anaerobes has been established. It is now clear that metronidazole has universally bactericidal effect on obligate anaerobic organisms for which the in vitro minimum inhibitory and minimum bactericidal concentrations of the medicament are almost identical.

 

INDICATIONS

Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens particularly Bacteroides fragilis and other species of bacteroides and including other species for which metronidazole is bactericidal such as Fusobacteria, Eubacteria, Clostridia and anaerobic cocci. Metronidazole injection has been used successfully in septicaemia, bacteraemia, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, peritonitis and post operative wound infection from which one or more of these anaerobes have been isolated. Prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroides and anaerobic streptococci.

 

DOSAGE AND ADMINISTRATION

Intravenous administration is particularly useful in emergencies and is indicated in patients needing surgery who

* Have or are believed to have anaerobic sepsis such as septicaemia, peritonitis, subphrenic or pelvic abscesses.

* At operations show signs of established or impeding anaerobic sepsis.

* Undergo operations in which contamination occurs with anaerobes from the gastrointestinal or female genital tracts or the oropharynx.

In infants and other patients maintained on intravenous fluids. UNIGYL injection may be diluted with appropriate volumes of normal saline dextrose-saline, dextrose 5 % w/v or potassium chloride injection (20 mmol and 40 mmol).

Do not mix with 10% Dextrose and Ringer lactate solution due to chemical incompatibility. Other antibiotics may be used concurrently, but should not be mixed with Unigyl Injection.

Treatment

Adults and children over 12 years: 100ml by intravenous infusion eight hourly. The injection should be infused intravenously at the rate of 5ml per minute but may be administered alone or concurrently (but separately) with other bacteriologically appropriate antibacterial agents in parenteral dosage forms.

Prevention

Adults and children over 12 years: 100ml by intravenous infusion immediately before, during or after operation followed by the same dose eight-hourly.

Children under 12 years: As for adults but the single intravenous dose is based on 15ml (7.5mg metronidazole)/kg body weight.

 

PRECAUTIONS

The recommended dosages, frequencies of administration and duration of medication have been found effective and well tolerated in nearly all cases.

However regular clinical and biological surveillance are advised if administration of “UNIGYL” for more than 10 days is considered to be necessary, Clinicians who contemplate continuous therapy, for the relief of chronic conditions, for periods longer than those recommended are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy. Such evidence as is available suggests that patients with various degrees of renal impairment handle metronidazole like patient with normal renal function, but there is evidence to suggest that the dosage regimens now being recommended may be more than adequate therapeutically. Daily dosage may be halved for patients with renal failure if the clinician so wishes.

Patients should be advised not to take alcoholic drinks during metronidazole therapy because of the possibility of a disulfiram-like reaction. Metronidazole is also known to interact with phenobarbitone, cimetidine, phenytoin and disulfiram.

Metronidazole enhances the activity of warfarin and if UNIGYL is to be given to patients receiving this or other oral anticoagulants the dosages of the latter should be recalibrated.

Pregnant women tolerate metronidazole well and no adverse effects on their offspring has been reported. As with all medicines UNIGYL should not be given during pregnancy or during lactation unless the physician considers it essential.

 

CONTRA-INDICATION

Unigyl is contraindicated in cases of known hypersensitivity to metronidazole, blood dyscrasias and active CNS disease.

 

SIDE EFFECTS AND ADVERSE REACTIONS

Serious adverse reactions occur very rarely with standard recommended regimens.

There have been occasional report of an unpleasant taste in the mouth, furred tongue, nausea, vomiting, gastrointestinal disturbances, and/or urticaria and angiodema Anaphylaxis may occur rarely. Drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, incoordination of movement and darkening of the urine (due to a Metronidazole metabolite) have been reported but very rarely. During intensive and/or prolonged metronidazole therapy, a few instances of, peripheral neuropathy have been reported but in most cases the reaction disappeared after treatment was stopped or when dosage was reduced. A moderate leucopenia has been reported in some patients but the white cell count has always returned to normal before or after treatment has been completed. Transient epileptiform seizures has been reported in a few patients undergoing intensive, high-dosage metronidazole radio sensitization therapy.

 

STORAGE INSTRUCTION

Protect from light. Store below 30°C.

 

PRESENTATION

Injection (for intravenous infusion) 0.5% w/v in 100mI bottles (500mg Metronidazole in 100mI).

 

WARNING

To be sold by retail on the prescription of a Registered Medical Practitioner only.

Metronidazole has been shown to be carcinogenic in rats. Unnecessary use of the drug should therefore be avoided.

 

Manufactured by

Unique Pharmaceuticals Ltd.

Km 38, Abeokuta Road,

Sango-Ota, Ogun State.

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