Brufen Tablets for Treatment of Arthritis, Dysmenorrhoea, and Pyrexia

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Transcript of Brufen Tablets for Treatment of Arthritis, Dysmenorrhoea, and Pyrexia

Brufen Tablets

Brufen Tablets (Ibuprofen) is used for relief of the signs and symptoms of Rheumatoid arthritis, Osteoarthritis, Juvenile rheumatoid arthritis, Primary dysmenorrhoea, and Pyrexia. Brufen is also used for the relief of acute and/or chronic pain states in which there is an inflammatory component.


Chemical Structure


The active pharmaceutical ingredient present in Brufen Tablets is Ibuprofen. Each 400 mg Brufen Tablet contains 400 mg of Ibuprofen.

Active Ingredient


Recommended Adult Dosage:The recommended initial dosage of Brufen tablets is 1200 mg to 1800 mg daily in divided doses. Some patients can be maintained on 600 to 1200 mg daily.

In severe or acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, providing that the total daily dosage does not exceed 2400 mg in divided doses.

Recommended Dosage


Primary Dysmenorrhoea:For the treatment of dysmenorrhea, beginning with the earliest onset of such pain or menstrual bleeding, Ibuprofen tablets should be given in a dose of 400 mg every 4 to 6 hours as necessary with a maximum total daily dose of 1,600 mg.

Recommended Dosage


Children:The daily dosage of Brufen tablets (Ibuprofen) is 20 mg per kg of body weight in divided doses. In juvenile rheumatoid arthritis up to 40 mg per kg of body weight in divided doses may be given.

In children weighing less than 30 kg the total dose should not exceed 500 mg in a 24 hour period.

Recommended Dosage


Maintenance Dose:In all indications the doses should be adjusted for each patient and the smallest dose that results in acceptable control of the symptoms employed.

In general, patients with rheumatoid arthritis and osteoarthritis tend to require higher doses than patients with other conditions.

Mild to Moderate Pain:

The recommended adult dosage is 400 mg every 4 to 6 hours as necessary for relief of pain.

Recommended Dosage

Contraindications

Brufen Tablets is contraindicated in patients with the following conditions:

Hypersensitivity to Ibuprofen, or any inactive component of this medication.

Ibuprofen should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Side Effects of Brufen Tablets

The common side effects of Brufen Tablets (Ibuprofen) are nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence), dizziness, headache, nervousness, rash (including maculopapular type), pruritus, tinnitus, decreased appetite, edema, and fluid retention.

Side Effects of Brufen Tablets

The rare side effects of Brufen Tablets (Ibuprofen) include Gastic or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis, Depression, insomina, confusion, emotional lability, somnolence, aseptic meningitis with fever and coma, vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia, hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision).

Side Effects of Brufen Tablets

The rare side effects of Brufen Tablets (Ibuprofen) include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs Positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit, congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm, acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria, dry eyes and mouth, gingival ulcer and rhinitis.

Warnings And Precautions

Cardiovascular Thrombotic Events: Increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk.

Hypertension: NSAIDs, including Ibuprofen, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events.

Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen should be used with caution in patients with fluid retention or heart failure.

Warnings And Precautions

Gastrointestinal Effects: NSAIDs, including Ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal.

Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Advanced Renal Disease: Treatment with Ibuprofen tablets is not recommended in these patients with advanced renal disease.

Warnings And Precautions

Anaphylactic/Anaphylactoid Reactions: As with other NSAIDs, anaphylactic/anaphylactoid reactions may occur in patients without known prior exposure to Ibuprofen. Ibuprofen should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

Skin Reactions: NSAIDs, including Ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Warnings And Precautions

Pregnancy: In late pregnancy, as with other NSAIDs, Brufen tablets should be avoided because it may cause premature closure of the ductus arteriosus.

Overdose Symptoms

The following symptoms may be observed following Brufen Tablets (Ibuprofen) overdosage: Depression of the central nervoussystem and the respiratory system..

Overdose Treatment

In cases of acute overdose of Brufen Tablets (Ibuprofen), the stomach should be emptied by vomiting or lavage, although little of the drug will be likely to be recovered if it is more than an hour since ingestion. Because the drug is acidic and excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help reduce the absorption of Ibuprofen.

Brufen Tablets Manufactured by Abbott, India

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Brufen Tablets

The Swiss Pharmacy, Geneva Switzerland