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| Ibukim® |
| :: Nonsteroidal Anti- inflammatory Drug (NSAID) :: |
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 Oral Suspension 100mg/5ml (120 ml) |
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Pharmacologic category
Nonsteroidal Anti-inflammatory Drug (NSAID)
Mechanism of action
Ibukim® ( 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 Ibukim® is distributed into breast milk.
Drug Interactions
Concurrent use with Ibukim® 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 . Ibukim® 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 ). Ibukim® 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
Ibukim® 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
- Oral suspension: 100 mg / 5 ml , bottles of 120 ml
Storage
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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