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Analgesic Anti-inflammatory Patches

For ACUTE inflammatory conditions


Tei-Kok Inc., Japan.

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NITOFEN- Ketoprufen patches for Topical pain relief

  1. 1.??????? Contents: A patch contains 20mg Ketoprufen (active compound), Liquid paraffin, l-Menthol, Crotamiton, Alicyclic saturated hydrocarbon resin, Styrene-isoprene-styrene block Co-polymer, Butylated hydroxyl toluene & Polybutene.
  2. 2.??????? Physical Characters: Plasters impregnated with translucent colorless adhesive glue extended on the backing material with a mild odour. Size 7CM X 14 CM Reorder Code KP-07.
  3. 3.??????? Pharmacological characters: Ketoprufen (Generic name)

(RS)-2-(3-Benzoylphenyl) Propanic acid, C16H14O3; Mol Weight: 254.28; Melting Point: 94-97 C.

White crystalline Powder, soluble in Methanol, Freely soluble in Ethanol (95) or Diethyl Ether; insoluble in H2O.

  1. 4.??????? Indications: Analgesia- anti inflammation in the following conditions when accompanied by chronic symptoms: Lumbago, Muscular facial lumbago, Spondylisis deformans, lumbar sprain, Osteoarthritis, Periarthritis, Tendinitis, Peritendinitis, Tennis elbow etc., Dosage: once every day on the affected area

5-1: General Warning: A. This drug gives symptomatic relief from inflammation and pain due to causes like injury etc but it doesnft treat the underlying cause of such symptoms. B. On areas with infection, this has to be used in addition to treating the infection. C. Chronic disorders may warrant additional treatment apart from this. D. When using for long periods, beware of direct and indirect adverse reactions.

5-2: Contra indications: A. Donft@use in patients who have past history of topical allergy (erythema, rash etc) or systemic allergy to similar drug previously. B.Donft use in patients who have allergy or symptoms of Asthma followed by usage of Aspirin or anti-histamines. Extra care to be applied while using in patients with Bronchial asthma as this may provoke the existing Asthmatic problem.

5-3: Ketoprufen enhances the effect of Methotrexate and inhibits its renal clearance

5-4: Adverse reactions: Look for symptoms of contact dermatitis, photosensitivity, anaphylaxis, asthmatic attack (especially in patients sensitive to aspirin) and local adverse reactions like rashes, swelling, irritation and if they develop, stop using and consult the physician to take remedial measures

5-5: Warning to pregnant women: Please inform your physician about pregnancy as the safety of this medication during pregnancy, lactation as well as usage in children, infants and elderly has not been established.

5-6: Photosensitivity: Contact dermatitis and photosensitivity are likely and so the area of application should be protected from exposure to sunlight especially UV light during as well as a few weeks after application with proper measures

  1. 6.??????? Donft use this product on mucous membrane, ulcer or open wounds and Eczema. When necessary fix the patch with surgical adhesive tape.
  2. 7.??????? The Pharmaco kinetics: Plasma Ketoprufen concentrations following a single dosage of 20mg plaster when applied on the back skin of 20 healthy male volunteers reached a peak level app. 9.1 Hrs after application.

Cmax (ng/mL) 184.36+58.6; Tmax (hr): 9.1+2.2; AUC0 > 48 (ng.hr/mL): 3385.86+1275.84

Pharmacology: Inhibitory activities on Carragenin induced hind paw edema and adjuvant arthritis models of rats when studied has proven the efficacy of this patch and also the analgesic effect were also more potent with this than non-treated controls of rats when quantified by the Randall-Selitto techniques.
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