Flamyd 500

Indications

Flamyd is prescribed for the management of various conditions, including:

• Prevention of post-operative infections caused by anaerobic bacteria, notably Bacteroides species and anaerobic streptococci.
• Treatment of septicemia, bacteremia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis, and post-surgical wound infections linked to anaerobic organisms.
• Management of urogenital trichomoniasis and bacterial vaginosis (non-specific vaginitis).
• Treatment of all forms of amoebiasis, including intestinal, extra-intestinal, and asymptomatic cyst passers.
• Giardiasis, acute ulcerative gingivitis, and acute dental infections associated with anaerobic bacteria.
• Antibiotic-associated pseudomembranous colitis.

Pharmacology

Metronidazole, an antibiotic from the imidazole class, is recognized as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobic bacteria, and its reduced form interacts with DNA, contributing to its bactericidal properties.

Dosage & Administration

Tablets and Suspension:

For Trichomoniasis:

• Adults & Children over 10 years: 200 mg three times daily or 400 mg twice daily for 7 days; 800 mg in the morning and 1-2 gm at night for 2 days; or 2 gm as a single dose.
• Children (7-10 years): 100 mg three times daily; (3-7 years): 100 mg twice daily; (1-3 years): 50 mg three times daily.

For Intestinal Amoebiasis:

• Adults & Children over 10 years: 800 mg three times daily for 5 days; Children (7-10 years): 400 mg three times daily; (3-7 years): 200 mg four times daily; (1-3 years): 200 mg three times daily.

For Extra-intestinal & Asymptomatic Amoebiasis:

• Adults & Children over 10 years: 400-800 mg three times daily for 5-10 days; Children (7-10 years): 200-400 mg three times daily; (3-7 years): 100-200 mg four times daily; (1-3 years): 100-200 mg three times daily.

For Giardiasis:

• Adults & Children over 10 years: 2 gm once daily for 3 days; Children (7-10 years): 1 gm once daily; (3-7 years): 600-800 mg once daily; (1-3 years): 500 mg once daily.

For Acute Ulcerative Gingivitis:

• Adults & Children over 10 years: 200 mg three times daily for 3 days; Children (7-10 years): 100 mg three times daily; (3-7 years): 100 mg twice daily; (1-3 years): 50 mg three times daily.

For Acute Dental Infections:

• Adults & Children over 10 years: 200 mg three times daily for 3-7 days.

For Bacterial Vaginosis:

• Adults & Children over 10 years: 400 mg twice daily for 7 days or 2 gm as a single dose.

For Leg Ulcers and Pressure Sores:

• Adults & Children over 10 years: 400 mg three times daily for 7 days.

For Anaerobic Infections:

• Adults & Children over 10 years: 800 mg initially, followed by 400 mg three times daily for 7 days; Children (1-10 years): 7.5 mg/kg three times daily.

For Surgical Prophylaxis:

• Adults & Children over 10 years: 400 mg three times daily, starting 24 hours before surgery; Children (1-10 years): 7.5 mg/kg three times daily.

Vaginal Gel:

The standard dosage is one full applicator (approximately 5 grams, containing about 37.5 mg of Metronidazole) administered intravaginally once or twice daily for 5 days. For once-daily dosing, apply at bedtime.

Suppository:

For Anaerobic Infections:

• Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
• Children (5-10 years): 500 mg every 8 hours for 3 days, then every 12 hours; over 10 years, use adult dosage.

For Surgical Prophylaxis:

• Adults: 1 g 2 hours before surgery; up to 3 additional doses of 1 g every 8 hours for high-risk procedures.
• Children (5-10 years): 500 mg 2 hours before surgery; up to 3 additional doses of 500 mg every 8 hours for high-risk procedures.

IV Infusion:

Metronidazole IV infusion does not require dilution and should not be mixed with other medications before administration.

• Adults & Children over 12 years: Infuse 500 mg every 8 hours at a rate of 5 ml/min, with a maximum of 4 g in 24 hours. Generally, a 7-day treatment is sufficient, but extensions may be needed for high reinfection risk. For surgical prophylaxis, doses should continue 8-hourly for 24 hours post-surgery.
• Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/min.

Note: Medication should be taken as advised by a registered healthcare provider.

Interactions

• Disulfiram: May lead to psychotic reactions when used concurrently.
• Alcohol: Avoid during treatment and for at least 24 hours after due to disulfiram-like reactions (e.g., flushing, vomiting).
• Oral anticoagulants (e.g., warfarin): May increase bleeding risk; prothrombin time should be monitored closely.
• Lithium: Potential for increased plasma levels.
• Cyclosporine: Requires close monitoring of serum levels.
• Phenytoin/Phenobarbital: May lower plasma levels of Flamyd.
• 5-Fluorouracil: Increased toxicity due to reduced clearance.
• Busulfan: Possible increased plasma levels leading to toxicity.

Contraindications

Flamyd should not be used in patients with a known hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects

Common side effects include a metallic taste, nausea, vomiting, diarrhea, drowsiness, and rashes.

Pregnancy & Lactation

Metronidazole is classified as FDA Pregnancy Category B. While there are no sufficient studies in pregnant women, it should be used only when clearly needed. The drug is excreted in human milk, so caution is advised when administering to nursing mothers.

Precautions & Warnings

• If Flamyd is needed for an extended duration, regular hematological tests, particularly leukocyte counts, are recommended. Monitor for adverse effects such as peripheral or central neuropathy (e.g., paresthesia, ataxia).
• Use with caution in patients with hepatic encephalopathy, and inform patients that Flamyd may cause urine discoloration.

Use in Special Populations

• Hepatic Impairment: Dosage adjustments may be necessary in severe hepatic impairment. Reduce the daily dose to one-third and consider administering once daily.
• Renal Impairment: Dosage adjustment is not required in renal failure. However, patients should be cautioned about potential accumulation of metabolites. After hemodialysis, re-administer Flamyd immediately.

Overdose Effects

Doses up to 12 g have been reported in overdose cases, leading to symptoms such as vomiting, ataxia, and mild disorientation. No specific antidote exists; symptomatic and supportive treatment should be provided.

Therapeutic Class

Amoebicides, Anti-diarrheal Antiprotozoal.

Storage Conditions

Store below 30°C, away from light, and out of reach of children. Do not use after the expiration date.