Metronidazole 250 & 500 mg Tablet 1. NAME OF THE MEDICINAL PRODUCT Metrozole 250mg Tablets Metrozole 500mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION *Each Metrozole 250mg tablet contains: Active ingredient: Metronidazole 250 mg *Each Metrozole 500mg tablet contains: Active ingredient: Metronidazole 500 mg Excipients with known effect Each tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Metrozole 250mg tablet: White to pale yellow flat round tablet scored from one side uncoated tablet The score line is to not to divide into equal doses. It facilitates only easy swallowing. Metrozole 500mg tablet: White to pale yellow round flat scored from one side uncoated tablet. The score line is to divide into equal doses. Dividing the tablets provide an exact "half" dose. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Metronidazole is indicated for use in adults and children according to the following indications: For the prevention and treatment of infections caused by metronidazole-susceptible microorganisms. Crohn's disease. Official guidelines for the appropriate use of antibiotics should be taken into account. 4.2 Posology and method of administration See information below for individual tips. When dose is given in mg/kg below, the maximum dose of 2,400 mg/day should not be exceeded for any indication. Infections caused by aerobic bacteria Adults: 500 mg 3 times a day. Children >8 weeks to 12 years: The usual daily dose is 20-30 mg/kg/day as a single dose or in separate doses of 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg depending on the severity of the infection. The duration of the treatment is usually 7 days. Children <8 weeks: 15 mg/kg as a single daily dose or in divided doses of 7.5 mg/kg every 12 hours. In neonates born after <40 weeks of gestation, accumulation of metronidazole may occur during the first week of life. Therefore, it is desirable to measure the concentration of metronidazole in the serum after several days of treatment. Acute intestinal crisis or liver abscess caused by amoeba Adults: 2 g once a day for 3 days or 750 mg 3 times a day for 5-10 days. Children >10 years: 500 to 750 mg 3 times a day for 5-10 days. Children 7 to 10 years: 250 to 500 mg 3 times a day for 5-10 days. Children 3 to 7 years: 250 mg 4 times a day for 5-10 days. Children 1 to 3 years: 250 mg 3 times a day for 5-10 days. Doses can also be based on body weight: 35-50 mg/kg per day in 3 separate doses for 5 to 10 days, but a maximum of 2,400 mg/day. Asymptomatic amoebic infection of the gastrointestinal tract Adults: 750 mg 3 times a day for 10 days. Children >10 years: 500 to 750 mg 3 times a day for 5-10 days. Children 7 to 10 years: 250 to 500 mg 3 times a day for 5-10 days. Children 3 to 7 years: 250 mg 4 times a day for 5-10 days. Children 1 to 3 years: 250 mg 3 times a day for 5-10 days. Doses can also be based on body weight: 35-50 mg/kg per day in 3 separate doses for 5 to 10 days, but a maximum of 2,400 mg/day. Giardia infection Adults: 2 g once a day for 2-3 days or 250 mg 3 times a day for 7 days. Children >10 years: 2,000 mg once a day for 3 days or 250 mg 3 times a day for 5 days or 500 mg twice a day for 7-10 days. Children 7 to 10 years: 1,000 mg once a day for 3 days. Children 3 to 7 years: 750 mg once a day for 3 days. Children 1 to 3 years: 500 mg once a day for 3 days. Or according to body weight: 15-40 mg/kg per day in 2-3 separate doses. Trichomonas infection Adults and adolescents: 2,000 mg as a single dose or 250 mg 3 times a day for 7 days or 500 mg twice a day for 5-7 days. Children <10 years: 40 mg/kg orally as a single dose or 15-30 mg/kg/day, in 2-3 separate doses for 7 days; a maximum of 2,000 mg/dose. Ulcerative gingivitis Adults: 250 mg 3 times a day for 3 days. Non-specific vaginitis Adults: 2 g day 1 and 3, or 500 mg 2 times a day for 7 days. Adolescents: 500 mg twice a day for 5-7 days or 2,000 mg as a single dose. Crohn's disease Adults: 500 mg 2 times a day. Children: 15 mg/kg/day in 2 separate doses. Prophylactic treatment during surgery when there is a risk of infection caused by aerobic bacteria Adults: 1 g as a single dose. Children <12 years: 20-30 mg/kg as a single dose given 1-2 hours before surgery. Neonates born after <40 weeks of gestation: 10 mg/kg body weight as a single dose before surgery. Possible treatment after surgery As for: Infections caused by aerobic bacteria. Impaired liver function In case of severe impairment of liver function, doses should be reduced. 4.3 Contraindications Hypersensitivity to metronidazole, other nitroimidazole derivatives or any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Official guidelines regarding the appropriate use of antibiotics should be taken into account. Hepatotoxicity in patients with Cockayne syndrome Cases of severe hepatotoxicity/acute liver failure have been reported, including cases of sudden death after initiation of treatment with systemic metronidazole-containing medicinal products in patients with Cockayne syndrome. Therefore, metronidazole should not be used in this patient group unless the benefits outweigh the risks and if no other treatment is available. Liver function tests should be performed immediately before treatment, during treatment and after treatment until liver values are within normal limits or baseline values have been reached. If liver values clearly increase during treatment, treatment with the drug should be discontinued. Patients with Cockayne syndrome should be advised to report any signs of possible liver injury to their physician immediately and to stop taking metronidazole (see section 4.8). Cases of severe blistering skin reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) have been reported with metronidazole. If signs or symptoms of SJS or TEN are present, metronidazole must be discontinued immediately. Hematopoietic diseases and active central nervous system disease Care should be taken when dosing the drug in the case of disease in the hematopoietic tissue and the central nervous system. During treatment for a longer time than usual, it is recommended to monitor side effects in the blood (especially the leukocyte count) and side effects on the nerves, e.g. peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsions). In the continuous treatment of chronic diseases, the benefit of treatment and the risk of peripheral neuropathy should be evaluated. Liver diseases The dose should be reduced in severe hepatic impairment. This is particularly true in the case of hepatic encephalopathy, as side effects of metronidazole may exacerbate its symptoms (see section 4.8). Alcohol, incl. alcohol in medicines Alcohol consumption should be avoided during treatment and for 3 days after the end of treatment, due to the risk of a disulfiram-like effect between metronidazole and alcohol (see section 4.5). This also applies to medicines that contain alcohol, both oral and intravenous. Lithium When lithium and metronidazole are administered simultaneously, the concentration of lithium, creatinine and serum electrolytes must be carefully monitored during treatment and for 2-3 weeks after treatment with metronidazole ends (see section 4.5). Renal disease Metronidazole is removed during hemodialysis and should therefore not be administered until the dialysis is complete
