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Analgesics & Antipyretics

Ibudolor 200


Pack size:

 Box of 2 blisters x 10 film-coated tablets.

 Box of 10 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains Ibuprofen 200 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Management of mild to moderate pain and inflammation in conditions:

  • Dysmenorrhea, headache, migraine, postoperative pain, dental pain.
  • Musculoskeletal and joint disorders: Ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis including juvenile idiopathic arthritis, peri-articular disorders such as bursitis and tenosynovitis, and soft-tissue disorders such as sprains and strains.
  • Also used to reduce fever.
     
  • For oral administration.

    Adults:
  • Pain and inflammation:
    1.2 g - 1.8 g daily in divided doses although maintenance doses of 600 mg to 1.2 g daily may be effective.
    If necessary, the dose may be increased to 2.4 g daily or 3.2 g daily.
    Patients with rheumatoid arthritis generally require higher doses of ibuprofen than those with osteoarthritis.
  • Fever reduction:
    The recommended dose is 200 - 400 mg every 4 - 6 hours to a maximum of 1.2 g daily.
    Children:
  • Fever reduction:
    5 - 10 mg/kg (depending on the severity of the fever) every 6 - 8 hours up to a maximum daily dose of 40 mg/kg.
  • Pain:
    10 mg/kg every 6 - 8 hours up to a maximum daily dose of 40 mg/kg.
  • Juvenile idiopathic arthritis: 
    30 - 40 mg/kg daily in divided doses.
  • Ibuprofen is not generally recommended for children weighing less than 7 kg and a maximum daily doses of 500 mg in those weighing less than 30 kg.
     

Or as advised by physicians.

 

  • Hypersensitivity to ibuprofen.
  • Active peptic ulceration.
  • Hypersensitivity to aspirin or other NSAIDs (asthma, rhinitis, urticarial after aspirin).
  • Patients with asthma or bronchospasm, bleeding disorders, cardiovascular diseases, history of peptic ulceration, liver or renal failure (glomerular filtration rate GFR < 30 ml/min).
  • Patients who are receiving coumarin anticoagulants.
  • Patients with congestive heart failure, diuretic-induced volume depletion or renal impairement (GFR) < 30 ml/min (because of high risk of developing renal dysfunction).
  • Patients with collagen disease (risk of developing aseptic meningitis. Note that in all case of aseptic meningitis, there has been some form of autoimmune disease in the patient history as predisposing factor).
  • Third trimester of pregnancy.

     

Risk of cardiovascular thrombotic events (see section PRECAUTIONS).
5 - 15% of all patients experienced some type of gastrointestinal side effect.
 

Common

  • Fever, fatigue.
  • Abdominal discomfort, nausea and vomiting.
  • Headache, dizziness, nervousness.
  • Rash, exanthema.

Uncommon

  • Allergic reactions (particularly bronchospasm in patients with asthma), rhinitis, urticaria.
  • Abdominal pain, gastrointestinal bleeding, activation of peptic ulcer.
  • Drowsiness, insomnia, tinnitus.
  • Troubles of vision.
  • Decrease of hearing.
  • Prolonged bleeding time.

Rare

  • Oedema, rash, Stevens-Johnson syndrome, alopecia.
  • Depression, aseptic meningitis, blurred vision, color perception disturbances, toxic amblyopia.
  • Leucopenia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, anaemias.
  • Dyskinesia of gallbladder, abnormalities in liver function tests, hepatotoxicity.
  • Cystitis, haematuria, acute renal failure, interstitial nephritis, nephrotic syndrome.

     

  • NSAIDs should be used in caution in elderly and patients with haemorrhagic disorders, hypertension, and impaired renal, hepatic, or cardiac function.
  • Risk of cardiovascular thrombotic events: Systemic non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. This risk may occur as early as the first weeks of treatment and may increase with duration of use. The cardiovascular thrombotic risk has been observed most consistently at higher doses.
  • Physicians should assess periodically appearance of cardiovascular adverse events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and seek physicians immediately if these symptoms occur.
  • To minimize the risk for an adverse cardiovascular event in patients treated with ibuprofen, prescribe the lowest effective daily dose for the shortest duration possible.
  • Pregnancy: Inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus). Use of ibuprofen is not recommended during pregnancy (especially during the last trimester) or during labor and delivery.
  • Lactation: Ibuprofen dose not enter human milk in significant quantities. Risk for child unlikely at normal doses for the mother.
  • Effects on ability to drive and use machines: Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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