Flagellat Forte 200 mg/5 ml oral suspension 100 ml

Flagellat Forte 200 mg/5 ml oral suspension 100 ml

Composition:
Each 5 ml contains Benzoyl Metronidazole 320 mg (equivalent to Metronidazole 200 mg).
Excipients:
Methyl paraben, Propyl paraben, Sucrose, Sodium carboxymethyl cellulose, Avicel RC-591, Saccharin sodium, Dibasic sodium phosphate anhydrous, Monobasic potassium phosphate, Glycerin, Tween 20, Orange oil, Quinoline yellow, Phosphoric acid 85%, Purified water.
Description:
Flagellat Forte is an antiprotozoal and antibacterial oral suspension effective against a wide range of anaerobic bacteria and protozoa.
Metronidazole acts by reduction of its nitro group to active metabolites that disrupt DNA synthesis and lead to cell death.
It is well absorbed and distributed throughout body tissues and fluids, including cerebrospinal fluid, vaginal secretions, saliva, and breast milk.
Indications for Use:
For the prophylaxis and treatment of infections caused by or suspected to involve anaerobic organisms, including:
- Septicemia, bacteremia, brain abscess, necrotizing pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, peritonitis, postoperative wound infections.
- Prevention of postoperative anaerobic infections.
- Bacterial vaginosis, acute dental infections, anaerobically infected ulcers and pressure sores.
- Treatment of urogenital trichomoniasis in men and women.
- All forms of amoebiasis, giardiasis, acute ulcerative gingivitis.
- Eradication of Helicobacter pylori (as part of combination therapy in children).
Dosage and Method of Administration:
Prophylaxis:
Adults - 400 mg every 8 hours for 24 hours before surgery, followed by postoperative therapy as indicated.
Treatment: Adults - 800 mg initially, followed by 400 mg every 8 hours for about 7 days depending on infection severity.
Children 8 weeks-12 years: 20-30 mg/kg/day as a single dose or divided every 8 hours.
Children <8 weeks: 16 mg/kg/day once daily or 7.5 mg/kg every 12 hours.
For protozoal infections, dosing depends on pathogen type and age.
For oral use only.
Shake well before use.
Contraindications:
Hypersensitivity to metronidazole, nitroimidazoles, hydroxybenzoates, or any excipients.
Precautions:
- Clinical and laboratory monitoring (including leukocyte count) is advised with prolonged use (>10 days).
- Use with caution in hepatic impairment, hepatic encephalopathy, CNS disorders, or alcoholism.
- May darken urine.
- Contains sucrose and parabens - may cause allergic reactions.
- Contraindicated in patients with hereditary fructose intolerance or glucose-galactose malabsorption.
- In patients with Cockayne syndrome, severe hepatotoxicity may occur - liver function tests are required before, during, and after therapy.
Side Effects:
Rare: dizziness, headache, nausea, diarrhea, rash, pruritus, metallic taste, dark urine.
Very rare: neuropathy, encephalopathy, seizures, pancytopenia, anaphylaxis, hepatic injury, cholestatic jaundice, Stevens–Johnson syndrome, or toxic epidermal necrolysis.
Pregnancy and Lactation:
Should not be used during pregnancy or breastfeeding unless absolutely necessary.
Metronidazole is excreted in breast milk; discontinue breastfeeding during therapy.
Storage Conditions:
Store below 30°C, protected from light.
Keep out of reach of children.
Shake well before use.
Packaging:
A carton box containing a bottle with 100 ml of oral suspension, measuring cup, and a package insert.