Aceclofenac / Trypsin : Chymotrypsin

Brands of Aceclofenac / Trypsin : Chymotrypsin in Kenya

Doloact Plus®, Aurochem Pharmaceuticals Pvt Ltd

INDICATIONS :

Doloact Plus is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

CONTRAINDICATIONS :

Hypersensitivity to any of the constituents.

WARNINGS AND PRECAUTION :

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms .

Elderly : The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory disorders : Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, Renal and Hepatic Impairment :
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Effects on renal function are usually reversible on withdrawal of Aceclofenac.

If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac should be discontinued. Hepatitis may occur without prodromal symptoms. Use of Aceclofenac in patients with hepatic porphyria may trigger an attack.

Gastrointestinal bleeding, ulceration and perforation : GI bieeding, ulceration or perforation, which can be fatal, has been reported with all NSAle at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

DRUG INTERACTIONS:

Lithium: Aceclofenac, like many NSAIDs, may increase plasma concentrations of lithium.

Cardiac Glycosides : Through their renal effects, NSAIDs may increase plasma glycoside (including digoxin) levels, exacerbate cardiac failure and reduce the glomerular filtration rate in patients receiving giycosides.

Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics.

Anticoagulants : Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulants such as warfarin. Close monitoring of patients on combined anticoagulant and Aceclofenac therapy should be undertaken.

Antidiabetic agents : Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with Aceclofenac, consideration should be given to adjustment of the dosage of hypoglycaemic agents.

Methotrexate : Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity.

Cardiovascular, Renal and Hepatic Impairment : The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Effects on renal function are usually reversible on withdrawal ofAceclofenac.

& If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac should be discontinued. Hepatitis may occur without prodromal symptoms. Use of Aceclofenac in patients with hepatic porphyria may trigger an attack.

Gastrointestinal bleeding, ulceration and perforation : GI bieeding, ulceration or perforation, which can be fatal, has been reported with all NSAle at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

SIDE EEFECTS :

Gastrointestinal System Duodenal ulcer, Gastrointestinal perforation

Urinary System Interstitial nephritis

Central and Peripheral Nervous System Optic neuritis

PsychiatricHallucination, Drowsiness, Confusion

Skin and Appendages Epidermal necrolysis, Erythema multiforme. Exfoliative dermatitis

Respiratory -Aggravated asthma

Haematological -Aplastic anaemia

Others-Tmnitus, Photosensitivity, Malaise

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:

Clinical | Pharmacokinetic data


Pregnancy Category: Not Recommended
Routes of Administration: Oral
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Legal Status | Dosage forms & Strengths


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What was the patient being treated for
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