Ibuprofen Film-coated Tablets

Each Ibuprofen Film-coated Tablets contains 200 mg or 400 mg ibuprofen.
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). It has anti-inflammatory, analgesic and antipyretic properties. It is used for the relief of mild to moderate pain and inflammation in rheumatic diseases and other musculoskeletal and joint disorders, dysmenorrhoea, dental and post-operative pain, headache including migraine. It is also used to reduce fever.

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APIS

Active Pharmaceutical Ingredient	Latin Name	Molecular Formula	Defination	Structural Formula
Ibuprofen film-coated Tablets	Ibuprofen membrana iactaret	C13H18O2	2-(4-Isobutylphenyl)propionic acid

API mixing

Filling

Vial sterilization

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Administration Guidelines for Ibuprofen Film-Coated Tablets

To reduce gastrointestinal complications, this medication should be administered concomitantly with food or milk. Patients are advised to consume the tablets with 200-250 mL of water. Optimal dosing strategy involves using the minimal effective dosage for the briefest clinically indicated period to control symptoms, thereby minimizing adverse reactions. Maintain a minimum 4-hour dosing interval (6 hours for pediatric populations).

Adult Dosage Regimen

Acute management: 400 mg every 6-8 hours (maximum 2400 mg/day)

Maintenance therapy: 200-400 mg every 8 hours

Pediatric Protocol (≥12 years)
Analgesic/Antipyretic Use:
20-40 mg/kg/day divided into 3-4 doses

1-2 years: 50 mg q6-8h

3-7 years: 100 mg q6-8h

8-12 years: 200 mg q6-8h

Juvenile Idiopathic Arthritis:
30-40 mg/kg/day in divided doses

Contraindications

Neonates <3 months

Infants <7 kg body weight

Medical consultation is required if symptomatology persists beyond 72 hours or shows clinical deterioration.

Overdosage

For overdosage of Ibuprofen Film-coated Tablets:

In children ingestion of more than 400 mg/kg may cause symptoms.

Symptoms: Nausea, vomiting, abdominal pain, and tinnitus. In more serious poisoning, CNS toxicity. Occasionally convulsions. Large overdoses are generally well tolerated when no other drugs are involved.

Treatment: Symptomatic and supportive. Within a few hours of ingestion gastric lavage can be performed or activated charcoal administered, and if necessary, correction of serum electrolytes. Convulsions should be treated with intravenous diazepam.

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