Maxzole

Presentation

Maxzole solution for infusion: One bottle with 100 ml solution contains Ornidazole 500 mg.

Descriptions

The mechanism of its action is based reducing the nitrogroup under the influence of the microorganism’s nitroreductases and the activity of the reduced nitroimidazole. The reduction products create compounds with DNA causing it to degrade, and disrupt the DNA replication and transcription processes. Furthermore, the drug’s metabolism products have cytotoxic properties and disrupt cellular respiration processes.

Indications

Parenteral administration of the drug is recommended in patients with acute and severe infections, or when oral administration is impossible, in the following cases and conditions:

• anaerobic systemic infections caused by ornidazole-sensitive microflora: septicemia, meningitis, peritonitis, post-operative wound infections, post-natal sepsis, septic abortion and endometritis;
• prevention of infections caused by anaerobic bacteria, during operative treatment (especially middle and straight intestine surgeries), gynecological surgeries;
• severe intestinal ameobiasis, all extra-intestinal ameobiasis forms, giardiasis, liver abscess.

 

 

Dosage & Administration

The drug is administered intravenously during 15-30 minutes.
In cases of anaerobic infections in adults and children over 12, a first dose of 500-1000 mg is administered, followed by 500 mg doses at 12-hour intervals, or 1000 mg doses at 24-hour intervals, during 5-10 days (sequential dose). After the patient’s state has been stabilized, ornidazole should be administered orally (e.g. one 500 mg tablet at 12-hour intervals).
The daily dose for children under 12 with body mass over 6 kg is calculated as 20 mg/kg of body weight, divided into 2 doses, during 5-10 days.
For prophylaxis of anaerobic infections in adults and children over 12, 500-1000 mg of Maxzole® is administered intravenously thirty minutes before surgery.
For prophylaxis of poly-infections, Maxzole® should be used concurrently with aminoglycosides, penicillin or cephalosporins. The drugs should be administered separately.
Severe intestinal ameobiasis, all extra-intestinal ameobiasis forms. In adults and children over 12, a first dose of 500-1000 mg is administered, followed by 500 mg doses at 12-hour intervals during 3-6 days.
In children under 12 years of age, the dose of Maxzole® is calculated as 20-30 mg/kg of body mass, divided into 2 doses.
In patients with impaired renal function, the interval between the doses should be increased, or the single and daily doses of the drug decreased.
 

Side Effects

Digestive system disorders:  dry mouth, coated tongue, nausea, loss of appetite, stomach pain, diarrhea, vomiting, altered liver function test results.
Nervous system disorders: headache, vertigo, tremor, muscle rigidity, 
Allergic reactions: very rarely – angioneurotic edema; skin rash, itching.

Precautions

Caution must be exercised if the drug is prescribed in patients with hepatic function insufficiency (dose must be decreased), brain damage, hematopoiesis disorders (high risk of leucopenia or neutropenia), and patients who abuse alcohol. 

 

Contraindications

• Hypersensitivity to any of the drug components;
• Organic central nervous system diseases;
• Epilepsy, disseminated sclerosis;
• Circulation disorders;
• Chronic alcoholism;
• First pregnancy trimester and lactation;
• Body mass under 6 kg.

 

Use in Pregnancy & Lactation

Maxzole® is contraindicated during the first pregnancy trimester. In the second and third trimesters, the drug is prescribed only by absolute indications.

Drug Interaction

Ornidazole potentiates the effect of the coumarine range oral anticoagulants, which requires appropriate adjustment of the dose of the latter. Ornidazole prolongs the myorelaxing effect of vecuronium bromide.

Overdose

Symptoms: loss of consciousness, headache, vertigo, trembling, convulsions, depression, peripheral nephritis, nausea, vomiting.
Treatment: symptomatic treatment, specific antidote unknown.

Commercial Packaging

Maxzole IV Infusion: Each box contains 1 Phial of 100 ml solution for injection.

Maxzole IV Infusion: Each Case contains 100 Phials of 100 ml infusion.