Flagyl Pediatric 125 mg/5 ml Oral suspension 100 ml

Flagyl Pediatric 125 mg/5 ml Oral suspension 100 ml

Composition:

Active Ingredient: Each 5 ml of oral suspension contains Metronidazole (as benzoate) — 125 mg. 
Excipients:
Sucrose, ethanol (96%), aluminum magnesium silicate, hydroxybenzoate esters (parabens), natural flavoring agents, purified water.

Product Description:

• Flagyl is a synthetic antiprotozoal and antibacterial agent belonging to the 5-nitroimidazole derivative class.
• It acts as a potent intestinal antiseptic and antiprotozoal agent. 
• The nitro group of metronidazole undergoes enzymatic reduction in anaerobic microorganisms and protozoa.
• The resulting active reduced form interacts with bacterial DNA, causing strand breakage and inhibiting nucleic acid synthesis, which leads to cell death.
• The drug is active against anaerobic protozoa (Entamoeba histolytica, Giardia lamblia / Giardia intestinalis, Trichomonas vaginalis) and anaerobic bacteria (Bacteroides spp., Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp.).

Indications for Use:

• Treatment of protozoal and anaerobic bacterial infections in pediatric patients and adults:
• Intestinal and Extraintestinal Amebiasis: Caused by Entamoeba histolytica (including amebic dysentery and amebic liver abscess).
• Giardiasis (Lambliasis): Intestinal protozoal infection caused by Giardia lamblia.
• Urogenital Trichomoniasis: Infection caused by Trichomonas vaginalis.
• Anaerobic Bacterial Infections: Infections of the gastrointestinal tract, intra-abdominal infections, skin and soft tissue infections, bone and joint infections.
• Surgical Prophylaxis: Prevention of postoperative anaerobic infections during gastrointestinal or gynecological surgery.

Method of Administration and Dosage:

• Administered orally.
• Shake the bottle well before each use.
• Intestinal Amebiasis:
  Children: 35 to 50 mg/kg/day divided into 3 equal doses for 7 to 10 days.
  Adults: 500 mg to 750 mg 3 times daily for 7 to 10 days.
• Giardiasis (Lambliasis):
  Children (2 to 5 years): 250 mg (10 mL) daily divided into 2 doses for 5 consecutive days.
  Children (5 to 10 years): 375 mg (15 mL) daily divided into 3 doses for 5 consecutive days.
  Children (10 to 15 years): 500 mg (20 mL) daily divided into 2 or 3 doses for 5 consecutive days.
• Anaerobic Bacterial Infections:
  Children: 20 to 30 mg/kg/day divided into 2 or 3 doses.
• The duration of treatment depends on the type and severity of the infection and should be determined by the treating physician.

Contraindications:

• Known hypersensitivity to metronidazole, other nitroimidazole derivatives, or any of the excipients.
• Organic lesions of the central nervous system (including epilepsy).
• Blood disorders / leukopenia (in history).
• Severe hepatic impairment.
• First trimester of pregnancy.
• Co-administration with disulfiram or alcohol.

Precautions:

• Alcohol Consumption: Avoid alcoholic beverages or alcohol-containing medications during treatment and for at least 48 hours after discontinuation due to the risk of a disulfiram-like reaction (flushing, vomiting, tachycardia).
• Neurological Monitoring: Discontinue treatment if neurological symptoms occur (peripheral neuropathy, dizziness, ataxia, confusion, or convulsions).
• Hematological Monitoring: Perform regular blood counts during prolonged therapy or high-dose regimens.
• Urine Color: Patients should be advised that metronidazole may cause a dark reddish-brown discoloration of urine, which is clinically harmless.
• Carbohydrate Content: Exercise caution in patients with diabetes mellitus due to sucrose content in the suspension.

Adverse Reactions / Side Effects:

• Gastrointestinal System: Epigastric pain, nausea, vomiting, diarrhea, metallic taste, stomatitis, glossitis, loss of appetite.
• Nervous System: Peripheral neuropathy (numbness or tingling in extremities), headache, dizziness, confusion, insomnia, ataxia.
• Allergic Reactions: Urticaria, skin rash, pruritus, angioedema, anaphylactic reactions.
• Hematopoietic System: Leukopenia, neutropenia, thrombocytopenia (rare/reversible).
• Hepato-biliary System: Transient elevation of liver enzymes, cholestatic hepatitis.
• Urinary System: Darkening of urine.

Pregnancy and Lactation:

• Contraindicated during the first trimester.
• Use in the second and third trimesters only if strictly necessary and prescribed by a physician.
• Metronidazole is excreted into breast milk. 
• Breastfeeding should be discontinued during treatment and for 24–48 hours after the last dose.

Storage Conditions:

Store at a temperature not exceeding 30 °C in a dry place, protected from direct sunlight.
Keep out of reach of children.

Packaging:

Amber glass bottle containing 100 mL of oral suspension, enclosed in a cardboard carton with product labeling and a patient information leaflet.