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| Ibuprofen-HAKIM |
| :: Anti-inflammatory, Nonsteroidal (Systemic) :: |
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 Tab. 200, 400 mg |
| Oral Suspension 100mg/5ml (120 ml) |
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Pharmacologic category
Nonsteroidal Anti-inflammatory Drug (NSAID)
Mechanism of action
Ibuprofen inhibits prostaglandin synthesis by decreasing the activity of the enzyme cyclooxygenase, which results in decreased formation of prostaglandin precursors from arachidonic acid.
Indications
Rheumatoid arthritis; Osteoarthritis; Ankylosing spondylitis; Juvenile arthritis; Psoriatic arthritis; Pain; Acute gouty arthritis; Calcium pyrophosphate deposition disease (Pseudogout); Fever; Dysmenorrhea; Prophylaxis and treatment of vascular headaches.
Side/Adverse effects
a– 1% to 10 %: Edema; Dizziness; Headache; Nervousness; Itching; Rash; Dyspepsia; Vomiting; Abdominal pain, Cramps, and distress; Heartburn; Nausea; Diarrhea; Constipation; Flatulence; Decreased appetite; Tinnitus
b- < 1%: Acute renal failure; Agranulocytosis; Anaphylaxis; Aplastic anemia; Blurred vision; Confusion; Hallucinations; GI ulceration and bleeding; Eosinophilia; Epistaxis; Erythema multiforme; Decreased hearing; Hematuria; Hemolytic anemia; Hepatitis; Hypertension; Inhibition of platelet aggregation; Leukopenia; Pancreatitis; Photosensitivity; Thrombocytopenia; Toxic amblyopia; Toxic epidermal necrolysis; Vesiculobullous eruptions.
Contraindications
Hypersensitivity to ibuprofen, any component of the formulation, aspirin, or other NSAIDs; Patients with "aspirin triad" (bronchial asthma, aspirin intolerance, rhinitis); Pregnancy (3 rd trimester)
Warnings/Precautions
Use with caution in patients with CHF, hypertension, dehydration, decreased renal or hepatic function, history of GI disease (bleeding or ulcers), anemia, asthma, hemophilia or other bleeding problem, alcoholism, diabetes mellitus, SLE, edema, stomatitis or those receiving anticoagulants. Elderly are at a high risk for adverse effects from NSAIDs; therefore use lowest effective dose for shortest period possible. Withhold for at least 4-6 half-lives prior to surgical or dental procedures.
OTC labeling
When used for self-medication, patients should be instructed to contact healthcare provider if used for fever lasting > 3 days or for pain lasting > 10 days in adults or > 3 days in children.
Pregnancy
FDA pregnancy category B. Exposure late in pregnancy may lead to premature closure of the ductus arteriosus and may inhibit uterine contraction. Therefore, it is contraindicated in 3 rd trimester of pregnancy.
Breast–Feeding
Methodology capable of detecting 1 mcg/ml failed to show that ibuprofen is distributed into breast milk.
Drug Interactions
Concurrent use with ibuprofen may decrease the antihypertensive effects of ACE inhibitors, angiotensin II antagonists, loop diuretics and hydralazine. Anticoagulants (Warfarin, heparin, LMWHs) and antiplatelet drugs (ticlopidine, clopidogrel, aspirin, dipyridamole) can cause an increased risk of bleeding. Corticosteroids may increase the risk of GI ulceration; avoid concurrent use. NSAIDs may increase serum creatinine, potassium, blood pressure, and cyclosporine levels; monitor cyclosporine levels and renal function carefully. Ibuprofen may increase the levels/effects of amiodarone, fluoxetine, phenytoin, sertraline, and warfarin. Lithium levels can be increased; avoid concurrent use if possible or monitor lithium levels and adjust dose. Avoid use NSAIDs during moderate or high-dose methotrexate (increased and prolonged methotrexate levels). Ibuprofen increases digoxin plasma concentration.
Monitoring Parameters
CBC; Occult blood loss; Periodic liver function test; Urine output; Serum BUN and creatinine; Periodic ophthalmic exams.
Dietary Consideration
Ibuprofen should be taken with food.
Administration and dosage
Usual adult and adolescent dose:
Antirheumatic (nonsteroidal anti–inflammatory ) – Oral, 1200 to 3200 mg a day in 3 or 4 divided doses. After a satisfactory response has been obtained, dosage should be reduced to the lowest maintenance dose that provides continuing control of symptoms.
Note: Higher doses generally are required in rheumatoid arthritis than in osteoarthritis.
Analgesic (mild to moderate pain); Antipyretic; Antidysmenorrheal-Oral, 200 to 400 mg every 4 to 6 hours as needed.
Usual adult prescribing limits:
Antirheumatic (nonsteroidal anti- inflammatory ) – Up to 3600 mg per day. The maximum dosage should be used only if the clinical benefit increased sufficiently to offset the higher risk of adverse effects.
Analgesic; Antipyretic; Antidysmenorrheal- for patient self – medication (OTC use ): Not to exceed 1200 mg per day.
Usual pediatric dose:
Antirheumatic (nonsteroidal anti – inflammatory) – children 6 months to 12 years of age: Oral, initially 30 to 40 mg per kg of body weight a day in 3 or 4 divided doses, although 20 mg per kg of body weight per day may be sufficient for patients with mild disease. After a satisfactory response has been achieved, dosage should be reduced to the lowest dose needed to control disease activity. Antipyretic – children 6 months to 12 years of age: Oral, 5 mg per kg of body weight for fevers less than 39.17 ˚C (102.5 ˚F) and 10 mg per kg of body weight for higher fevers. Dosage may be repeated, if necessary, at intervals of 4 to 6 hours or more.
Infants up to 6 months of age: Safety and efficacy have not been established.
Usual pediatric prescribing limits:
Antirheumatic–Oral, 50 mg per kg of body weight per day.
Antipyretic–Oral, 40 mg per kg of body weight per day.
How Supplied
- Coated tablet: 200 mg , 400 mg
- Oral suspension: 100 mg / 5 ml , bottles of 120 ml
Storage
Store between 15 and 30˚C (59 and 86 ˚F). Protect from light and moisture.
Protect Oral Suspension from freezing.
References
- USP DI, 2004
- Up To Date, Vol. 13.1 (2005)
- Martindale, The Complete Drug Reference, 33 rd edition 2002
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