Ibuprofen STELLA 400 mg

OTC

Indication

• Ibuprofen is used in the 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.
• Ibuprofen is also used to reduce fever.

Dosage

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:

• 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.
• Fever reduction:
  5 – 10 mg/kg every 6 – 8 hours up to a maximum daily dose of 40 mg/kg.
• Pain relief:
  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.

Usage

Ibuprofen STELLA 400 mg is administered orally.

• 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 impairment 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.
• 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.

• NSAIDs should be used in caution in elderly and patients with haemorrhagic disorders, hypertension, and impaired renal, hepatic, or cardiac function.
• 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 STELLA 400 mg, prescribe the lowest effective daily dose for the shortest duration possible.
• Use of Ibuprofen STELLA 400 mg is not recommended during pregnancy (especially during the last trimester) or during labor and delivery. Extreme caution when use for nursing women.
• Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.