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  • Artofen
    / Teva


    Active Ingredient
    Ibuprofen 400 mg

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    50 X 400 mg

    full basket chart 260 1340

    Related information


    Dosage

    Notes: Artofen Tablets should be taken with or after food. Artofen tablets should not to be used for more than 10 days for the treatment of pain, or for more than 3 days for the treatment of fever, unless instructed by the physician. In primary dysmenorrhea, Artofen Tablets should be taken immediately following the onset of pain.
    Artofen 400 mg: Adults and Children 12 Years of Age and Over: 1 tablet, 2-4 times daily. The recommended dose should not be exceeded.


    Indications

    Rheumatoid arthritis, osteoarthritis, relief of mild to moderate pain, primary dysmenorrhea.


    Contra-Indications

    Known hypersensitivity to the drug or to any ingredient of the preparation. Patients with a history of, or existing peptic ulceration.
    Because of potential cross-sensitivity to other NSAIAs, ibuprofen should not be used in patients in whom aspirin or other NSAIAs have induced symptoms of asthma, rhinitis, urticaria, nasal polyps, angioedema, bronchospasm and other symptoms of allergic reactions (anaphylactoid reactions have occurred in such patients). Patients with severe heart failure .Artofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
    Ibuprofen should be administered under close supervision to patients with a history of upper gastrointestinal tract disease.
    If symptoms persist, worsen, or new symptoms develop, the physician should be referred to.
    Use in Pregnancy: Administration of ibuprofen is not recommended during pregnancy. The onset of labor may be delayed and duration of labor increased.
    Use During Lactation:  Ibuprofen appears in breast milk in very low concentrations and is unlikely to affectthe breastfed infant adversely.
    Use in Pediatrics: The use of Artofen in children under 12 years of age should be under medical surveillance.
    Use in the Elderly: No special dosage modifications are required, unless renal or hepatic function is impaired, in which case dosage should be assessed individually.


    Special Precautions

    Pregnancy and lactation: NSAID’s are not recommended. Amounts excreted in breast milk with usual doses are considered too small to be harmful to the nursing infant. Risk of GI ulceration, bleeding and perforation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. Should not be administered to patients with aspirin sensitivity, use with caution in patients with pre-existing asthma.
    See package insert (OTC).


    Side Effects

    Gastrointestinal: Epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of gastrointestinal tract, dyspepsia, gastrointestinal bleeding, peptic ulceration.
    Central Nervous System: Dizziness, severe headache, nervousness, convulsions, pain in the spinal column.
    Dermatological: Rash (including maculopapular type), pruritus, photosensitivity, skin peeling. Rarely exfoliative dermatitis and epidermal necrolysis have been reported with ibuprofen.
    Special Senses: Hearing disturbance..
    Metabolic/Endocrine: Decreased appetite.
    Cardiovascular: Edema, fluid retention.
    Hematological: Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, decreased hemoglobin and hematocrit.
    Allergic: Fever. Bronchospasm may be precipitated in patients with a history of aspirin-sensitive asthma
    Other Hypersensitivity Reactions: Rarely hypersensitivity reactions with cutaneous eruptions, urticaria and pruritus,as well as attacks of asthma, with or without drop in blood pressure, have been observed. In single cases, severe hypersensitivity reactions, manifesting as facial edema, swelling of the tongue, swelling of the larynx, dyspnea, tachycardia, hypotension or severe shock have been reported. If these symptoms occur, immediate medical attention is necessary.
    Other: Stiffness, sudden decrease in the amount of urine, black stools. Renal papillary necrosis which can lead to renal failure.


    Drug interactions

    Lithium, coumarin anticoagulants, heparin, other NSAIDs, ketorolac. ACE inhibitors, thiazide diuretics, antihypertensives. Oral hypoglycemics, methotrexate, cardiac glycosides, spironolactone, corticosteroids, cimetidine, cyclosporin. Phenobarbitone, mifepristone, quinolones, potassium supplements, salt substitutes, phenylpropanolamine, sulphonamides, phenytoin, blockers.
    See package insert (OTC).


    Pregnancy and Lactation

    Pregnancy: Administration of ibuprofen is not recommended during pregnancy. The onset of labor may be delayed and duration of labor increased.
    Lactation: Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breastfed infant adversely.


    Overdose

    Manifestations: Symptoms include nausea, headache, vomiting, dizziness, drowsiness, nystagmus, blurred vision, tinnitus, and, rarely, hypotension, metabolic acidosis, renal failure, and, loss of consciousness. Large overdoses are generally well tolerated when no other drugs are involved.
    Treatment: No special antidote is available. Patients should be treated symptomatically as required. Use supportive care where appropriate. Within one hour of ingestion, activated charcoal or gastric lavage followed by activated charcoal if the dose is greater than 400 mg/kg, can be used.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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