Generic: Ibuprofen Oral  |  Dosage Form: Tablet  |  Manufacturer: Zenith Pharmaceuticals Ltd.

Indications

Ibuprofen is indicated in-

• Relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis
• Treatment of primary dysmenorrhea
• Control of mild to moderate pain generally and particularly when pain is associated with inflammation
• Reduction of fever
• Dental and period pain
• Relief of backache
• Rheumatic pain
• Muscular pain

Dosage & Administration

Ibuprofen Tablet-
1. Mild to moderate pain and fever:
Adults and adolescents >40 kg body weight (12 years and above):

• 200-400 mg given as a single dose or 3-4 times a day with an interval of 6 hours as required.
• In migraine headache, 400 mg should be given as a single dose, if necessary 400 mg with intervals up to 6 hours.
• The maximum daily dose should not exceed 1200 mg.

Children 20 kg body weight (6-11 years)

• Children 20-29 kg (6-9 years): 200 mg 1-3 times a day with intervals of 6 hours as required.
• The maximum daily dose should not exceed 600 mg.
• Children 30-90 kg (10-11 years): 200 mg 1-4 times a day with intervals of 6 hours as required.
• The maximum daily dose should not exceed 800 mg.
• Ibuprofen tablet is contraindicated in children below 20 kg body weight or younger than 6 years of age.

2. Primary dysmenorrhoea:

• Adults and adolescents 40 kg body weight (12 years of age and above) 200-400 mg 1-3 times a day, with an interval up to 6 hours, as needed. The maximum daily dose should not exceed 1200 mg.

3. Rheumatic diseases:

• Adults: The recommended dose is 1200-1800 mg daily in divided doses. Maintenance doses of 600-1200 mg daily may be effective in some patients. In acute and severe conditions the dose may be (temporarily) increased to a maximum of 2400 mg in 3 or 4 divided doses.
• Adolescents from 15 to 17 years of age: The recommended dose should be adjusted by weight: 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses.

Ibuprofen SR Capsule-

• Adults, the elderly and children & adolescents between 12 and 18 years
• Initially one (300 mg) or two (600 mg) Ibuprofen SR capsules should be taken twice daily. Not more than 4 capsules are to be taken in 24 hours.
• Ibuprofen SR capsule is not recommended for children below 12 years of age.

Ibuprofen Suspension: Children-

• 3-6 months (body-weight over 5 kg): 1/2 tsp (2.5 ml) 3 times daily
• 6 months-1 year: 0.5 tsp (2.5 ml) 3-4 times daily
• 1-4 years: 1 tsp (5 ml) 3 times daily
• 4-7 years: 1.5 tsp (7.5 ml) 3 times daily
• 7-10 years: 2 tsp (10 ml) 3 times daily
• 10-12 years: 3 tsp (15 ml) 3 times daily
• Not recommended for children weighing less than 5 kg.
• In juvenile rheumatoid arthritis; up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken.

Interaction

Caution should be taken in concomitant use with the medications which could increase the risk of ulceration or bleeding. Concomitant use with acetylsalicylic acid is not recommended. Co-administration with other NSAIDs and high doses of methotrexate should be avoided. Caution should be taken in concomitant use with ACE inhibitors, diuretics, lithium, anti-platelet agents, warfarin, aminoglycosides, corticosteroids, cyclosporin, tacrolimus, mifepristone, quinolone, zidovudine, voriconazole and fluconazole.

Contraindications

It is contraindicated in patients with known hypersensitivity to ibuprofen or any other components of this product. It is also contraindicated in patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy, active or history of recurrent peptic ulcer/haemorrhage, severe renal failure or severe hepatic failure, severe heart failure (NYHA Class IV), last trimester of pregnancy, significant dehydration and cerebrovascular or other active bleeding.

Side Effects

The most common side effects are headache, somnolence, vertigo, fatigue, agitation, dizziness, insomnia, irritability and gastrointestinal ulcer.

Precautions & Warnings

Patients on long term therapy with ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with SLE are more likely than others to develop hypersensitivity to ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma.

Overdose Effects

In case of overdose, gastric lavage and if necessary, correction of serum electrolytes have been recommended. There is no specific antidote for ibuprofen.

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Store below 30°C in a dry place, protected from light. Keep away from the reach of children.