Spedifen

Spedifen

ibuprofen

Manufacturer:

Zambon
Concise Prescribing Info
Contents
Ibuprofen (as arginine)
Indications/Uses
Relief of pain of various etiology (headache, pain after tooth extraction & post-op pain), primary dysmenorrhea; RA, OA, musculoskeletal & traumatic alterations implying pain & inflammation.
Dosage/Direction for Use
Adult 1,200 mg daily in 3-4 divided doses. RA Max: 2,400 mg daily. Primary dysmenorrhea 400 mg 4 hrly.
Administration
Should be taken with food: Take during or immediately after meals. May be taken w/ milk.
Contraindications
Hypersensitivity to other NSAIDs. Active & recurrent peptic ulcer or risk of GI hemorrhage, ulcerative colitis, serious liver &/or kidney failure. History of asthma, rhinitis, urticaria, nasal polyps & angioedema.
Special Precautions
Risk of GI alterations due to NSAIDs. History of bronchospasm. Patients w/ reduced renal, hepatic &/or cardiac function; heart failure & HTN. May prolong bleeding time in patients w/ blood coagulation disorders or undergoing anticoagulant treatment. May impair ability to drive or operate machinery. Pregnancy & lactation. Elderly.
Adverse Reactions
Nausea, vomiting, dyspepsia, gastric pyrosis, abdominal pain, diarrhea, intestinal microlesions, ulcerative activation & hemorrhages. Rash, urticaria & exanthema w/ or w/o itching; signs of hepatic dysfunction & anaphylactic phenomena. W/ prolonged use, alterations of the blood corpuscular elements & water retention w/ possible onset of swellings & edemas.
Drug Interactions
Furosemide & thiazide diuretics; oral anticoagulants; β-blockers, corticosteroids, digoxin, phenytoin, lithium; methotrexate, acetylsalicylic acid, paracetamol.
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Spedifen FC tab 400 mg
Packing/Price
30's (Rp172,000.00/pak)
Form
Spedifen granules for oral soln 600 mg
Packing/Price
40 × 1's (Rp230,000.00/boks)
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