Tablets

Composition

Ninza-MD contains Nimesulide Mouth Dissolving Tablets

Description

Nimesulide is a selective COX-2 non-steroidal anti-inflammatory drug. This is a unique non-steroidal anti-inflammatory drug. It belongs to selective COX-2 inhibitors, with a potent anti-inflammatory and analgesic activity, when administered orally, rectally, or topically. Due to its analgesic and antipyretic properties, Nimesulide is widely used for the treatment of various inflammatory processes. It also shows less severe gastrointestinal side effects. It is one of the most commonly prescribed NSAIDs for the treatment of various inflammatory conditions such as tonsillitis, pharyngitis, stomatitis, rheumatoid arthritis, osteoarthritis, low back pain, etc.  

 

Advantages

The concept of mouth dissolving tablets emerged from the desire to provide patients with a more convenient means of taking their medication. A mouth dissolving dosage form is designed to release drug rapidly within the oral cavity where it dissolves to form a drug suspension which is then swallowed. The benefits of this approach are as follows:
 ? The faster the drug can get into suspension, the quicker the absorption and ultimate onset of clinical effect. Hence a mouth dissolving dosage form may be particularly suitable for those conditions such as fever, pain, Inflammation, etc where a fast onset of clinical effect is required.
 ? The mouth dissolving system rapidly disintegrates in the oral cavity, hence patients do not have to swallow large cumbersome dosage forms which discourages many from taking their medication. In essence, therefore, the mouth dissolving dosage form combines the benefits of liquid formulations with those of a solid oral dosage form.
? Mouth dissolving formulation of Nimesulide can be described as a highly porous, microfine, matrix tablet. Once placed on the tongue, this matrix rapidly absorbs liquid and disintegrates. The drug, in a stabilized, size-reduced form to ensure an optimal drug suspension, dissolves rapidly in less than 60 seconds.

Mechanism of Action and Pharmacology

Nimesulide Tablet improves the patient's condition by performing the following functions:
•    Blocking the production of prostaglandins thereby relieving pain and inflammation.

Usage

Nimesulide is indicated in reducing pain, fever and inflammatory symptoms of:

•  Chronic arthritis (Osteoarthritis)
•  Respiratory tract infections
•  Otorhinolaryngological diseases
•  Soft tissues and oral cavity inflammation
•  Dysmenorrhoea
•  Phlebitis / thrombosis
•  Urogenital disease
•  Postoperative pain states
•  Sports injuries

Adverse Effects

Gastrointestinal- Abdominal discomfort, heartburn, abdominal cramps, nausea, vomiting and diarrhea.

•  Central Nervous System- Headache, dizziness and drowsiness.
•  Genitourinary- Blood in urine, decrease in urination and kidney failure. Contraindications:
•  Moderate to severe hepatic impairment.
•  Severe renal failure.
•  History of allergy to NSAIDs.
•  Peptic ulcer disease

Drug Interactions

Additive hepatotoxic effects with known hepatotoxins: anti-convulsants (e.g. valproic acid), anti-fungals (e.g. ketoconazole), anti-tuberculous drugs (e.g. isoniazid), tacrine, pemoline, amiodarone, methotrexate, methyldopa, amoxicillin/clavulanic acid. May decrease the oral bioavailability of furosemide and the natriuretic and diuretic response to furosemide. Increased risks of GI and hepatic adverse effects with other NSAIDs, including aspirin. May increase anticoagulant effect of warfarin. Potentiates the action of phenytoin. May be displaced from binding sites with fenofibrate, salicylic acid, and tolbutamide. Interactions between NSAIDs and lithium, probenecid and ciclosporin, have been documented.
Warning and Precautions: Caution should be exercised in patients with history of stomach problem, high blood pressure, fluid retention, elderly, during pregnancy and breast-feeding. Other Precautions: Avoid excess dosage.