Medgyl IV

Medgyl IV





Full Prescribing Info
Each mL contains: Metronidazole 5 mg.
Pharmacology: Metronidazole is active against a variety of anaerobic bacteria particularly Bacteroides fragilis. Its mechanism of action is reflected in a selective toxicity to anaerobic or microaerophilic micro-organisms and other, anoxic or hypoxic cells. In susceptible cells, the nitro group of metronidazole is reduced by electrotransport proteins with low redox potentials (such as ferrodoxin in clostridia); these proteins play a much more important role in the metabolism of such cells than they do in aerobes. Metronidazole thus acts as an electron ink and deprives the cell of required reducing equivalents.
Pharmacokinetics: Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms, with an average elimination half-life in healthy humans of eight hours.
The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6 to 15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation (1-(beta-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid) and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Renal clearance of metronidazole is approximately 10 mL/min/1.73 m2.
Metronidazole is the major component appearing in the plasma, with lesser quantities of the 2-hydroxymethyl metabolite also being present. Less than 20% of the circulating metronidazole is bound to plasma proteins. Both the parent compound and the metabolite possess in vitro bactericidal activity against most strains of anaerobic bacteria and in vitro trichomonacidal activity.
Metronidazole appears in cerebrospinal fluid, saliva, and breast milk in concentrations similar to those found in plasma. Bactericidal concentrations of metronidazole have also been detected in pus from hepatic abscesses.
Decreased renal function dose not alters the single-dose pharmacokinetics of metronidazole is decreased in patients with decreased liver function.
For the 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. For the prevention of post-operative abdominal and pelvic infections due to anaerobic bacteria.
Dosage/Direction for Use
Treatment: Adults and Children over 12 years: 100 mL by intravenous infusion eight hourly. The injection should be infused intravenously at the rate of 5 mL per minute, but maybe administered alone or concurrently but separately, with other bacteriological appropriate antibacterial agents in parenteral dosage forms. Oral medication with 400 mg three times daily should be substituted as soon as this becomes feasible. Treatment for seven days should be satisfactorily for most patients but depending upon clinical and bacteriological assessments, the physician might decide to prolong treatment, e.g. for the eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.
Children under 12 years: As for adults, but the single intravenous dose is based on 1.5 mL/kg body weight. (7.5 mg Metronidazole/kg body mass) and the oral dose of 7 mg/kg body mass.
Or as prescribed by the physician.
Adults and Children over 12 years: 100 mL by intravenous infusion immediately before, during or after an operation, followed by the same dose eight hourly until oral medication can be given to complete a seven-day course. In infants and other patients maintained on intravenous fluids metronidazole injection may be diluted with appropriate volumes of normal saline, dextro-saline, dextrose 5% or potassium chloride injections.
Or as prescribed by the physician.
Metronidazole should not be used on patients with blood dyscrasias or with active disease of the central nervous system. Its use should be avoided during pregnancy. If its use is essential during pregnancy the short high dose regimens should not be used.
Adverse Reactions
Two serious adverse reactions reported in patients treated with Metronidazole have been convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of Metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.
The most common adverse reactions reported have been referable to the gastrointestinal tract particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress, and abdominal cramping. Constipation has been reported.
The following reactions have also been reported during treatment with Metronidazole.
Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis and stomatitis have occurred; these maybe associated with a sudden overgrowth of Candida which may occur during effective therapy.
Hematopoietic: Reversible neutropenia (leucopenia); rarely, reversible thrombocytopenia.
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.
Central Nervous System: Convulsive seizures, peripheral neuropathy, dizziness, vertigo, incoordination, 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. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance.
Other: Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint faints sometimes resembling "serum sickness". A modification of the taste of alcoholic beverages has also been reported. Rare cases of pancreatitis, which abated on withdrawal of the drug, have been reported.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A01AB17 - metronidazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
Soln for inj/infusion (vial) 5 mg/mL x 100 mL x 1's.
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