Overview
NAME, BRAND NAME, FORM, STRENGTH, NAFDAC NUMBER AND DISTRIBUTION OF METRONIDAZOLE
Metronidazole, popularly known as Flagyl is available in injection, oral suspension, and tablets. Below is a table that shows the brand, form, strength, NAFDAC number, and distribution of Metronidazole.
NAME | BRAND NAME | FORM | STRENGTH | NAFDAC NUMBER | DISTRIBUTION |
Flagyl | Sanofi Nigeria Limited | Infusion | 0.50% | 04-0293 | N/A |
Metronidazole (WMF 6.2.2) | Formulary (Nigeria) | Suppository | 1g | N/A | N/A |
Exus Metronidazole | Exus Pharmaceutical Ltd | Vaginal tablet | 250mg | B4-2763 | N/A |
Esigyl | Esehi Pharma Ind. Ltd | Oral suspension | 200mg/5ml | A11-0845 | Prescription-only medicine |
Famagyl | Phamatex Nigeria Limited | Oral suspension | 200mg/5ml | B4-1977 | N/A |
Jugyl | Juhel Nigeria Ltd | Oral suspension | 200ml/5ml | 4/1/1931 | N/A |
Zimagil | Gauze Pharm & Lab Ltd | Oral suspension | 200ml/5ml | 4/1/1950 | N/A |
Avrogyl | Avro Pharma Ltd | Tablet | 200mg | A4-4725 | N/A |
Mopson Metronidazole | Mopson Pharmaceuticals Ltd | Tablet | 200mg | 4/9/2014 | N/A |
Metromax | Goldmoore International Ltd | Tablet | 400mg | A4-2599 | N/A |
Vincogyl | Vinco Pharmaceuticals Ltd | Tablet | 400mg | A4-0945 | N/A |
PHARMACOVIGILANCE
Metronidazole is carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described under the Indications.
What Is Flagyl Used For
Infections that often point to Metronidazole use are Anaerobic Bacterial Infections, including gingivitis and other oral infections, Pelvic Inflammatory Disease (with ceftriaxone and doxycycline), Tetanus, Septicemia, Peritonitis, Brain Abscess, Necrotizing Pneumonia, Antibiotic-associated Colitis, leg ulcers, and pressure sores and surgical prophylaxis. Bacterial vaginosis. Skin and soft tissue infections, animal bites (with doxycycline). Tissue nematode infections. Trichomonal vaginitis, Amoebiasis, and giardiasis. Helicobacter pylori eradication.
Flagyl Dosage
Depending on the illness that calls for Metronidazole use, the physician prescribes the dosage. However, high doses in pregnant and breastfeeding patients should be avoided. In addition, limit the use of vaginal Metronidazole to treat refractory infections.
Flagyl dosage For Children
As children have a more delicate immune system, the dosage of Metronidazole should be strictly on physicians’ orders.
RENAL DOSE
- Renal impairment: Patients with end-stage renal disease may excrete Metronidazole and metabolites slowly in the urine, resulting in a significant accumulation of metronidazole metabolites. Monitoring for Metronidazole associated adverse events is recommended.
- Hepatic impairment: For severe hepatic impairment (Child-Pugh C), a reduced dose is recommended. For mild to moderate hepatic impairment, no dosage adjustment is needed (monitor for adverse events)
ADMINISTRATION
For Oral, Intravenous, or Rectal administration, use after meals to minimize gastrointestinal distress and its metallic taste. Metronidazole tablets should be swallowed whole with water, during or after a meal; Metronidazole suspension should be taken one hour before a meal. The IV form should be administered by slow infusion only. Do not give by IV push. ..Avoid alcoholic beverages or products containing propylene glycol.
ADVICE TO PATIENT
Urine may be discolored to a dark or reddish-brown. Discontinue consumption of alcoholic beverages or products containing propylene glycol while on Metronidazole and for at least three days afterward (due to disulfiram-like reaction with alcohol including abdominal cramps, nausea, vomiting, headaches, and flushing. Notify the doctor if numbness or tingling in extremities occurs
CONTRAINDICATION
Psychotic reaction with disulfiram: Oral Metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks.
Interaction with alcohol: Oral Metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing.
Flagyl In Pregnancy
Use of Metronidazole in Pregnancy & Lactation: Metronidazole use during pregnancy has not been reported to have a significant association with teratogen effects. It is the drug of choice among nitroimidazoles during pregnancy and lactation.
STORAGE RECOMMENDATIONS
Store below 25ºc. Protect from light and keep out reach of children