Section :
Byrofen
COMPOSITION :
Each F/C tablet contains : Ibuprofen B.P. 200 mg or 400 mg .
Each 5ml (teaspoonful) contains : Ibuprofen B.P. 100 mg.
DESCRIPTION :
Byrofen (Ibuprofen) is a non steroidal anti-inflammatory drug (NSAID), which exerts an inhibitory effect on prostaglandins synthesis by inhibiting the activity of cyclo-oxygenase. Ibuprofen is absorbed from the gastro-intestinal tract and its peak plasma concentrations occur within 1 - 2 hours. Ibuprofen is rapidly excreted in the urine mainly as metabolites and their conjugates. Ibuprofen is well tolerated and is therefore suitable for long term therapy.
INDICATIONS :
Byrofen is indicated for :
- Treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and soft tissue injuries such as sprain and strain.
- Relieve pain in dysmenorrhoea, dental pain and post-operative pain and headache including migraine.
- Reduction of fever and relief of mild to moderate pain.
DOSAGE & ADMINISTRATION :
• Adults :
- The usual dose for painful conditions is 1200 - 1800 mg daily in divided doses. If necessary the dose may be increased
to 2400 mg daily.
- The recommended dose for fever reduction is 200 to 400 mg every 4 to 6 hours to a maximum daily dose of 1200 mg.
• The Byrofen suspension can be used for old patients whenever tablets can not be easily swallowed.
RESTRICTIONS ON USE :
Contraindications
Ibuprofen is contraindicated in patients with known hypersensitivity to the drug.
Precautions
Ibuprofen should not be given to patients with active peptic ulcer, active hepatic disease and renal failure.
Use in pregnancy and lactation
Not recommended.
DRUG INTERACTIONS :
- Patients receiving anticoagulants like coumarin should be monitored.
- Like other NSAIDs, Ibuprofen may enhance the hypoglycemic effect of oral antidiabetics .
- The effect of diuretics and antihypertensive agents may be diminished.
ADVERSE EFFECTS :
- Usually Ibuprofen is well tolerated. Some minor side effects have been occasionally reported such as,
gastrointestinal complaints including nausea, heartburn, gastric pain, vomiting and diarrhea or constipation.
- Other side effects include headache, dizziness, sleep disorders and reversible liver and kidney damage, but were
disappeared on cessation of medication.
STORAGE INSTRUCTIONS:
Tablets : Store below 25°C in a dry place.
Suspension : Store below 25°C. Protect from light.
PRESENTATIONS :
Byrofen 200 mg : Pack of 20 tablets and hospital packs of different sizes.
Byrofen 400 mg : Pack of 20 tablets and hospital packs of different sizes.
Byrofen Suspension : Bottle of 60 ml.
INSTRUCTIONS TO THE PATIENT012-06-067 8/12Keep medicament out of reach of children- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor. Council of Arab Health Ministers
Union of Arab PharmacistsMfd. By
P.O. Box : 4265 Sana’a /Yemen.
