COMPOSITION:
Each gram contains:
Nimesulide BP 10mg
Methyl salicylates IP 100 mg
Menthol IP 50 mga
Capsaicin USP 0.25 mg
in a water soluble base
CLINICAL INFORMATION:
INDICATIONS:
For local application in the treatment of acute and chronic musculoskeletal disorders characterized by pain and inflammation including non-articular rheumatic disorders and soft tissue injuries. These components include low backache, tendonitis, tenosynovitis sprains strains.
DOSAGE AND ADMINISTRATION:
For external use only
Adults: A dosage of nise gel (approx. 3 cm or 1 ¼ inches) from the tube to be applied lightly in a thin layer to the affected site 3-4 times re day, or as directed by the physician. Clean and dry the affected areas thoroughly before treating with the gel. Apply the cream to the affected skin and surrounding areas in a thin layer and rub lightly. Patients should be advised to avoid occlusive dressing. Hands should be washed before and after using this medicine.
CONTRAINDICATIONS:
Patients with known hypersensitive to nimesulide, capsaicin, methyl salicylates or other NSAIDS.
Moderate to severe hepatic impairment
Pregnant and lactating women
WARNINGS AND PRECAUTIONS:
If local irritation develops, use of the gel should be discontinued and appropriate therapy instituted as necessary. Do not apply the gel over eyes, mucosal surface or to any sites affected by open skin lesions, dermatoses or infections or open wounds. Burning and stinging may occur while rubbing the medicine. This usually stops after using the medicine for a few days. Sensitive areas should not be touched while the medicine is on the hands. Nimesulide gel should be used with caution in patients at increased risk of developing salicylate related adverse events.
Use in Elderly Patients:
The pharmacokinetics of oral nimesulide is similar in elderly patients below 80 years of age, with normal renal function, when compared to young healthy volunteers. However, caution should be used when prescribing nimesulide in elderly patients with compromised renal function.
Oral nimesulide has been reported to cause hepatic adverse events, ranging from transient increase in liver enzyme values to severe liver injuries including fatal hepatic failure in a few cases. Most of these patients were elderly women. It is reported that the adverse event appears to be idiosyncratic or immunologic in nature.
Use in children:
Dosage recommendations and indications for use in children have not been established.
INTERACTIONS:
With other Drugs:
No clinically significant interactions involving interference with drug metabolism have been reported with topical application of nimesulide.
USE IN PREGNANT AND LACTATION WOMEN:
Safety and efficacy of nimesulide in pregnant and lactating women has not been established. Therefore, nimesulide is not indicated for use in pregnant and lactating women.
UNDESIRABLE EFFECTS:
Topical nimesulide is generally well tolerated. Reported side effects included mild or moderate local irritation, erythema, rash, desquamation, pruritus and related local reactions at the site of application. Topical capsaicin at concentrations of 1% or greater is associated with neurotoxicity & thermal hyperalgesia. Burning stinging, redness is known with the application of capsaicin cream.
PHARMACOLOGICAL INFORMATION:
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) of the sulphonanilide class that also has analgesic and antipyretic properties. It acts by selective inhibition of cyclooxygenase 2 and a variety of other mechanisms which include inhibition of Protein kinase C translocation phosphodiesterase type IV & proteases, inhibition of histamine & INF α release as well as PAF (platelet activating factor) synthesis.
Capsaicin acts by depleting substance P which is a neurotransmitter for communication of pain and itch sensations from the periphery to the central nervous system. It then blocks further synthesis and transport of substance P within the neuron.
Methyl salicylate is a salicylate acid derivative which is irritant to the skin and is used topically in rubefacient preparations for the relief of pain in musculoskeletal, joint, & soft tissue disorders.
PHARMACEUTICAL INFORMATION:
STORAGE: Keep in a cool place, away from light. Do not refrigerate.
PRESENTATION: NiseTM Gel in 30 g tube.
Replace cap tightly after use.
For further information, please write to
Medical Information cell,
Branded Formulations,
DR. REDDY’S LABORATORIES LT.,
6-3-1192/1/1, White House, Block- 3,
5th Floor, Kundanbagh, Begumpet,
Hyderabad- 500016, A.P.
TM Trademark under registration
Date: 20.10.06