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Ansaid Tablets: An anti-inflammatory analgesic agent

Brand Name: Ansaid
Active Ingredient: flurbiprofen
Indication: An anti-inflammatory analgesic agent

Indications and Clinical Use

Ansaid (flurbiprofen) is indicated for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Ansaid is also indicated for the relief of pain associated with dysmenorrhoea.

Contraindications

Ansaid (flurbiprofen) should not be used in patients with active, or recent history of inflammatory diseases of the gastrointestinal tract. Ansaid is contraindicated in patients with a history of hypersensitivity to the drug. It is also contraindicated in patients with syndrome of nasal polyps, angioedema, and bronchospastic reactivity to ASA or other non-steroidal anti-inflammatory drugs.

Warnings

Pregnancy and Lactation: The use of this drug is not recommended during pregnancy and lactation. Use in Children: The use in this age group is not recommended.

AnsaidPrecautions

Ansaid (flurbiprofen) administration should be carefully monitored in patients with a history of gastrointestinal inflammatory disease, as peptic ulceration and gastrointestinal bleeding have been reported in patients receiving this drug. Ansaid should also be used with caution in patients with cardiac decompensation, hypertension and renal diseases. In patients with impaired renal function, the dose should be adjusted accordingly. Renal function should be monitored in patients on long-term treatment with Ansaid. Liver function should also be monitored during long-term treatment with this drug.

Safety of Ansaid in patients with liver disease has not been established. It should be used with caution in patients with potential for abnormal bleeding. Safety of Ansaid in combination with anticoagulants has not been established and if such use is necessary, special caution should be used. If a patient develops blurred and/or diminished vision while receiving Ansaid, the drug should be discontinued and the patient should have an ophthalmologic examination. Ansaid should be used with caution in the elderly, particularly women and the dosage should be adjusted individually. The anti-inflammatory, antipyretic and analgesic effects may mask the usual signs of infection and the physician should be alert to the development of infection in patients receiving the drug.

Drug Interactions:

Concomitant administration of ASA decreases Ansaid peak serum levels, as well as the rate and amount of Ansaid absorbed. In-vitro studies suggest that Ansaid binds to a different primary site on albumin (type II) than drugs such as anticoagulants, sulfonamides and phenytoin (type I). However, patients with such combination therapy should be monitored. Ansaid antagonizes the action of intravenous or oral furosemide.

Ansaid (flurbiprofen): Adverse Reactions

The adverse reaction incidences reported below are based on the dosage regimen utilized in controlled clinical trials which limited the duration of the maximum daily dose of 300 mg to 14 days. Utilization of this daily dose beyond 14 days may result in a higher incidence of side effects.

Gastrointestinal (18.9%):

Dyspepsia 6.9%; Abdominal distress 4.0%; diarrhoea 3.8%; nausea 3.5%; constipation 2.0%; flatulence 0.9%; anorexia 0.4%; vomiting 0.5%; stomatitis 0.4%; gastritis 0.3%; G.I. bleeding 0.3%; glossitis 0.3%; gastric or duodenal ulcer 0.3%; melena 0.2%; eructation 0.1%.

CNS (3.4%):

Headache 1.0%, dizziness 1.0%, insomnia 0.3%, vertigo 0.3%, paresthesia 0.2%, somnolence 0.2%, nervousness 0.1%, mood alteration 0.1%, ataxia 0.1%, tremors 0.1% and weakness 0.1%. Although not seen in this series of patients, depression has been reported.

Cardiovascular (0.2%):

Palpitation 0.1%, hot flushes 0.1%.

Hematological (0.5%):

Anemia 0.3%, petechia 0.1%, purpura 0.1%, epistaxis 0.1%. Although not seen in this series of patients, leukopenia, thrombocytopenia and aplastic anemia have been reported.

Dermatological (2.1%):

Rash 1.4%, pruritis 0.6%, urticaria 0.1%, dry skin 0.1%. Although not seen in this series of patients, 2 cases of Stevens-Johnson syndrome have been reported.

Respiratory System (0.3%):

Asthma 0.2%, dyspnea 0.1%.

Special Senses (2.7%):

Tinnitus 1.7%. Eye: amblyopia (blurred vision) 1.6%, conjunctivitis 0.3%, photo-phobia 0.2%, abnormal accommodation 0.1%, comeal opacity 0.1%. Taste: taste alteration 0.2%.

Hepatic (0.3%):

Hepatitis 0.2%, increased SGOT 0.1%. Increased alkaline phosphatase 0.1%.

Renal (1.6%):

Fluid retention (peripheral edema) 1.0%, urine abnormality (decreased osmolality, albuminuria) 0.3%, dysuria 0.2%, hematuria 0.1%, urinary incontinence 0.1%.

Miscellaneous (0.9%):

Asthenia 0.6%, weight increase or decrease 0.3%, vaginal haemorrhage 0.1%.

Symptoms & Treatment of Overdose

No overdose cases have been reported. When an overdose is taken, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Since the drug is acidic and is excreted in the urine, it would seem theoretically beneficial to administer alkali and induce diuresis. Appropriate supportive treatment should be instituted as necessary.

Adult Dosage

Osteoarthritis: Initially 100 to 150 mg/day in 2 or 3 doses.

Rheumatoid Arthritis: Initially 150 to 200 mg/day in 3 or 4 doses.

Ankylosing Spondylitis: Initially 200 mg/day in 4 doses. Adjust to minimum effective dose. Maximum dose of 300 mg daily should be used only during acute exacerbation of symptoms, and not for maintenance therapy.

Dysmenorrhoea: 50 mg given four times daily.

Availability

Ansaid (flurbiprofen) is available as 50 mg (white) and 100 mg (blue) elliptical, film-coated tablets imprinted with Ansaid logo, in bottles of 100 and 500.

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