Presentation

Flamyd 250: Each film coated tablet contains Metronidazole BP 250 mg.

Flamyd 500: Each film coated tablet contains Metronidazole BP 500 mg.

Flamyd Gel: Each 1g gel contains Metronidazole BP 7.5 mg.

Flamyd IV: Each 100 ml solution contains Metronidazole BP 500 mg.

Flamyd Suspension: Each 5 ml suspension contains Metronidazole Benzoate BP equivalent to Metronidazole 200 mg.

Description

Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. The intracellular targets of action of metronidazole on anaerobes are largely unknown. The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms.

Indications

Flamyd tablet

1. The prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroides and anaerobic streptococci.

2. The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated.

3. Urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male.

4. Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).

5. All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers).

6. Giardiasis.

7. Acute ulcerative gingivitis.

8. Anaerobically-infected leg ulcers and pressure sores.

9. Acute dental infections due to anaerobic organisms (eg. acute pericoronitis and acute apical infections).

10. H. pylori infection

11. Antibiotic Associated Pseudomembranus colitis

Flamyd Gel

Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).

Flamyd IV Infusion

1. The prevention of postoperative infections due to anaerobic bacteria

2. The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, and post-operative wound infections from which pathogenic anaerobes have been isolated.

Dosage & Administration

Tablet and Suspension

Amoebic dysentery: Duration 5-10 Days;

For Tablet: Adults- 750 mg t.i.d. Children- (7-10 years) 500 mg t.i.d. (3-7 years) 250 mg q.i.d. (1-3 years) 250 mg t.i.d.

For Suspension: Adults- 800 mg t.i.d. Children- (7-10 years) 500 mg t.i.d. (3-7 years) 200 mg q.i.d. (1-3 years) 200 mg t.i.d.

Asymptomatic amoebiasis: Duration 5-10 Days;

For Tablet: Adults- 500-750 mg t.i.d. Children- (7-10 years) 250-500 mg t.i.d. (3-7 years) 250 mg q.i.d. (1-3 years) 250 mg t.i.d.

For Suspension: Adults- 500-800 mg t.i.d. Children- (7-10 years) 200-500 mg t.i.d.; (3-7 years) 200 mg q.i.d.; (1-3 years) 200 mg t.i.d.

Hepatic extraintestinal amoebiasis : Duration 5-10 Days (or 2days);

For Tablet: Adults- 500-750 mg t.i.d.; Children- (7-10 years) 250-500 mg t.i.d.; (3-7 years) 250 mg q.i.d.; (1-3 years) 250 mg t.i.d.

For Suspension: Adults- 500-800 mg t.i.d.; Children- (7-10 years) 200-500 mg t.i.d.; (3-7 years) 200 mg q.i.d.; (1-3 years) 200 mg t.i.d.

Giardiasis: Duration 3 Days;

For Tablet: Adults- 2 g once daily; Children-(7-10 years) 1g once daily; (3-7 years) 750 mg once daily; (1-3 years) 500 mg once daily.

For suspension: Adults- 2 g once daily; Children-(7-10 years) 1g once daily; (3-7 years) 800 mg once daily; (1-3 years) 500 mg once daily.

Trichomoniasis: Duration 7 Days;

For Tablet: Adults- 250 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

For Suspension: Adults- 200 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Or,

Duration 1 Day;

For Tablet: Adults- 2 g single dose;

For Suspension: Adults- 2 g single dose;

Vincent's infection (Ulceration of mucous membrane of respiratory tract & mouth): Duration 3 Days;

For Tablet: Adults- 250 mg t.i.d. or 500 mg b.i.d; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

For Suspension: Adults- 200 mg t.i.d. or 500 mg b.i.d; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Periodontal infection: Duration 3 Days;

For Tablet: Adults- 250 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

For Suspension: Adults- 200 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Severe dental infection: Duration 3 Days;

For Tablet: Adults- 500 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

For Suspension: Adults- 500 mg t.i.d.; Children- (7-10 years) 100 mg t.i.d.; (3-7 years) 100 mg b.i.d.; (1-3 years) 50 mg t.i.d.

Anaerobic infection: Duration 7 Days;

For Tablet: Adults- 500 mg t.i.d.; Children- 7.5 mg/kg body weight t.i.d.

For Suspension: Adults- 500 mg t.i.d.; Children- 7.5 mg/kg body weight t.i.d.

Postoperative anaerobic infection (specially in operation abdominal or gynecological surgery): Duration 7 Days;

For Tablet: Adults- 500 mg t.i.d. before and after operation; Children- 7.5 mg/kg body weight t.i.d.

For Suspension: Adults- 500 mg t.i.d. before and after operation; Children- 7.5 mg/kg body weight t.i.d.

Bacterial vaginitis: Duration 7 Days;

For Tablet: Adults- 500 mg b.i.d.

For Suspension: Adults- 500 mg b.i.d.

Leg ulcers: Duration 1 Day;

For Tablet: Adults- 2 g as a single dose

For Suspension: Adults- 2 g as a single dose

Pressure sores: Duration 7 Days;

For Tablet: Adults- 500 mg t.i.d.

For Suspension: Adults- 500 mg t.i.d.

H. pylori infection: Duration 7 Days;

For Tablet: Adults- 500 mg b.i.d

For Suspension: Adults-500 mg b.i.d

Antibiotic Associated Pseudomembranus colitis: Duration 7 Days;

For Tablet: Adults- 500 mg b.i.d

For Suspension: Adults- 500 mg b.i.d

Flamyd Gel

The recommended dose is one applicator full of FLAMYD GEL (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, FLAMYD GEL should be administered at bedtime.

Flamyd IV Infusion

Flamyd injection should be infused intravenously at an approximate rate of 5 ml/min. Oral medication should be substituted as soon as feasible. Treatment for 7 days should be satisfactory for most patients, but the physician might decide to prolong treatment.

For bacterial infections: Adults: 500 mg (100 ml) 8 hourly. Children: 7.5 mg/kg (1.5 ml/kg) 8 hourly.

For treatment before and during surgery: Adults: 500 mg (100 ml) shortly before operation, repeated 8 hourly. Children: 7.5 mg/kg (1.5 ml/kg) 8 hourly

Side Effects

Pain, tenderness, redness, or swelling over vein in which the medicine is given. Other side-effects are unsteadiness, fever or chills, sore throat, headache, numbness, tingling pain or weakness in the hands or feet, pain, seizures, skin itching, unusual tiredness or weakness, vaginal irritation or discharge.

Precautions

Metronidazole should be given with caution in the following conditions- anaemia or other blood disorders, liver disease, disease of the nervous system, seizures etc.

Use in Pregnancy & Lactation

Metronidazole is pregnancy category B. Metronidazole has not been shown to cause birth defects in animal studies; however, use is not recommended during the first trimester of pregnancy. Use is not recommended in nursing mothers since metronidazole passes into the breast milk.

Commercial Pack

Flamyd 250: Each box contains 10 blister strips of 10 film coated tablets.

Flamyd 500: Each box contains 10 blister strips of 10 film coated tablets.

Flamyd Gel: Flamyd Gel (Metronidazole BP 0.75% vaginal gel) is supplied in a 30 gram tube and packaged with a 5 g vaginal applicator.

Flamyd IV: Each box contains 1 bag of 100 ml solution for intravenous infusion.

Flamyd Suspension: Each bottle contains 60 ml Metronidazole Benzoate suspension.