Composition:
Ketoprofen 25 mg/g Excipients: – Isopropanol 12 gm – Simulgel 2.25 gm (Copolymer of acrylamide and Sodium acryloyldimethyltaurate, Isohexadecane, Polysorbate 80 and Sorbitan oleate) – Essence Givex Violet 0.15 gm (Cedar wood oil, Orange oil, Linalyl Acetate, Dipropylene Glycol) – Propylene Glycol 8 gm – Water q.s. ad 100 gm
Indications And Usage:
Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions. -Relief of acute painful musculoskeletal conditions caused by trauma, such as sports injuries, sprains, strains and contusions. -Pain of non serious arthritis.
Contraindications:
Patients with a known hypersensitivity to ketoprofen or any of the excipients, aspirin or other non-steroidal anti-inflammatory agents; patients suffering from or with a history of bronchial asthma or allergic disease. Ketolgin® gel should be avoided in patients with exudative dermatoses, eczema, sores and infected skin lesions or broken skin. Ketolgin® gel should not be applied to mucous membranes, anal or genital areas, and eyes or used with occlusive dressings.
Dosage & Administration:
Adults: To be applied two to four times daily to the skin in the painful or inflamed region for up to 7 days. Apply gently but massage well to ensure gel penetration. Elderly: There are no specific dosage recommendations for the elderly.
Children: Not recommended as safety in children has not been established.
Drug Interactions:
Interactions are unlikely as serum concentrations following topical administration are low. Serious interactions have been recorded after the use of high dose methotrexate with non-steroidal anti-inflammatory agents, including ketoprofen, when administered by the systemic route.
How Supplied:
Tubes of 15 or 40 gm Do not exceed the stated dose. For external use only.
Storage:
Stored at temperature not exceeding 30 °C.
Pharmacological Properties:
Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions. Pharmacokinetic properties: Plasma and tissue levels of ketoprofen have been measured in 24 patients undergoing knee surgery. After repeated percutaneous administration of Ketolgin® gel the plasma levels were about 60 fold less (9 – 39 ng/g) than those obtained after a single oral dose of ketoprofen (490 – 3300 ng/g). Tissue levels at the area of application were within the same concentration range for the gel as for the oral treatment, although the gel was associated with a considerably higher inter-individual variability. The bioavailability of ketoprofen after topical administration has been estimated to be Approximately 5% of the level obtained after an orally administered dose based on urinary excretion data. The protein binding in plasma is approximately 99%. Ketoprofen is excreted through the kidneys mainly as glucuronide conjugate.
Pregnancy & Lactation:
No embryopathic effects have been demonstrated in animals and there is epidemiological evidence of the safety of ketoprofen in human pregnancy. Nevertheless, it is recommended that ketoprofen should be avoided during pregnancy. Non-steroidal anti-inflammatory drugs may also delay labor. Trace amounts of ketoprofen are excreted in breast milk, therefore Ketolgin® Gel should not be used during breast feeding.
Overdosage:
Overdose is unlikely by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be supportive and symptomatic.
Side Effects:
Adverse reactions: Skin reactions, including photo sensitivity reactions, pruritus, and localized erythema. These are usually mild and resolve after cessation of the gel. Cases of more severe reactions such as bullous or phylcytenar eczema which may spread or become generalized have occurred rarely.
