Each uncoated flavoured dispersible tablet contains Nimesulide BP 100 mg.
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 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.
Panacea Biotec's mouth dissolving formulation of Nimulid MD 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.
Pharmacology: The anti-inflammatory and analgesic activities of Nimesulide, a nonsteroidal anti-inflammatory drug (NSAIDs) of the sulfonanilide class, have been demonstrated in a number of experimental models and in numerous clinical trials. Nimesulide has exhibited potency similar to or greater than that of Indomethacin, Diclofenac, Piroxicam and Ibuprofen in standard animal models of inflammation such as carrageenan-induced rat paw oedema and inflammation, ultraviolet light-induced erythema in guinea-pigs and adjuvant arthritis in rats. The analgesic efficacy of Nimesulide was similar to that of ibuprofen and less than that of Indomethacin in an acetic acid writhing test in rats, and acetic acid and acetylcholine writhing tests in mice.
Nimesulide appears to exert its therapeutic effects through a variety of mechanisms viz: Selective cyclooxygenase 2 inhibitor; Inhibition of generation of superoxide anions from stimulated polymorphonuclear leucocytes; Inhibition of platelet activating factor synthesis; Prevention of Bradykinin/Cytokine induced hyperalgesia of nerves (Inhibiting release of TNF-α); Scavenging of hypochlorous acid; Blocking of histamine release; Prevention of cartilage damage by inhibition of metalloprotease synthesis; Phosphodiesterase type IV inhibition.
Pharmacokinetics: Nimesulide is rapidly absorbed. A maximum Nimesulide plasma concentration is achieved within 1-2 hours of administration. The mean elimination phase half-life (t½) is 2-3 hours. The duration of action is 6-8 hours. Nimesulide is almost completely excreted by the urine route, it does not accumulate even repeated administration.
Nimesulide is effective in reducing pain, associated with the osteoarticular apparatus in particular and should be used no longer than 15 days.
The usual oral dosage is 1 tablet (100 mg) twice daily. The maximum dosage per day is 200 mg and the maximum duration of a treatment course with Nimesulide is 15 days.
No data is available on overdosage toxicity. In the event of an overdosage the stomach may be emptied and symptomatic treatment should be given.
Should not be used in a patient with known hypersensitivity to Nimesulide or a patient with asthma, urticaria or acute rhinitis caused by allergy to aspirin or NSAIDs.
Should not be used in a patient with gastrointestinal bleeding, peptic ulcer, cerebral hemorrhage and other bleeding disorders.
Should not be used in a patient with liver function impairment or concomitant with drug inducing liver toxicity.
Should not be used in a patient with fever, suspected to dengue or flu-like symptoms.
Should be used no longer than 15 days.
Should not be used in a patient with alcoholism or those who regularly drink too much alcohol including drug addiction.
Should not be used in a patient with severe cardiac impairment or severe renal function impairment.
Nimesulide may increase a risk of bleeding or gastrointestinal ulceration.
Used with caution in a patient with cardiac disease, renal function impairment, or hypertension since Nimesulide may result in water retention.
Nimesulide can interfere with platelet aggregation. It should be avoided from patients suspected to dengue or any other causes of platelet disorder.
Periodic liver function monitoring is advisable.
If fever or flu-like symptoms (malaise, shivering) occurs, Nimesulide should be discontinued and the patients should immediately consult with the physician.
If anorexia, nausea, vomiting, abdominal pain, fatigue or dark urine or liver function impairment due to Nimesulide including liver toxicity occurs, Nimesulide should be discontinued and the patients should immediately consult with the physician.
Patients treated with anticoagulant agents, aspirin, salicylates, diuretics, lithium, methotrexate or cyclosporins should consult the physician before using Nimesulide.
Nimesulide should not be used concomitantly with other analgesic agents.
Use in Pregnancy & Lactation: Should not be used in the third trimester of pregnancy and nursing women.
Use in Children: Should not be used in children under the age of 12 years.
Use in the Elderly: Used with caution in elderly since Nimesulide may result in water retention.
Should not be used in the third trimester of pregnancy and nursing women.
The most common adverse reactions are gastrointestinal disturbances (epigastralgia, heartburns, nausea, diarrhea and vomiting). Dermatological reactions include rash and pruritus; central nervous system associated side effects are dizziness, somnolence and headache. Occasionally, excessive perspiration, flushing, hyperexcitability and sleep disorders have been reported. Rarely, a rise in liver enzyme levels have also been reported.
Due to the extensive plasma protein-binding, Nimesulide may be displaced from the binding site by concurrent administration of fenofibrate, salicylic acid, valproic acid and tolbutamide. Moreover, Nimesulide may displace salicylic acid, methotrexate and furosemide from binding sites. Nimesulide reduced the diuretic effect for concomitantly administered furosemide. Concomitant administration of Nimesulide and digoxin showed no effect on serum digoxin concentrations at steady state. Although Nimesulide does not appear to interact with Warfarin, in clinical practice, interaction with oral anticoagulants or other highly protein bound drugs can not be ruled out. Nimesulide may cause enzymatic induction of theophylline when administered concomitantly with it. Nimesulide had no significant effect on fasting blood and glucose tolerance in patients treated with antidiabetic agents.
Store at or below 25°C, protect from light and moisture.
M01AX17 - nimesulide ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products.
Orally disintegrating tab 100 mg (pale yellow coloured, flavoured, round, biconvex, uncoated, plain on both sides) x 1 x 10's.