Kaltrofen

Kaltrofen

ketoprofen

Manufacturer:

Kalbe Farma
Full Prescribing Info
Contents
Ketoprofen.
Description
Each enteric coated tablet contains ketoprofen 50 mg or 100 mg.
Each OD capsule contains slow release pellets containing ketoprofen 200 mg.
Each tablet suppositories contains ketoprofen 100 mg.
Each gram of gel contains: ketoprofen 0.025g.
Action
Pharmacology: Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic action. As NSAID, ketoprofen has been shown to have inhibitory effect on prostaglandin synthesis.
Gel: Only a small amount of ketoprofen is absorbed following topical application.
Pharmacokinetics: Kaltrofen tablet is rapidly and completely absorbed from the gastrointestinal tract. When ketoprofen is administered with food, its total bioavailability is not altered; however, the rate of absorption from either dosage form is slowed. Plasma peak levels are reached in ½-2 hrs. In elderly patients, plasma elimination half-life is 5 hrs and 3 hrs in adult patients.
Kaltrofen OD is designed to release the drug at a controlled rate, in the pH environment in the small intestine. The plasma half-life is 5-12 hrs for the slow-release preparation. Peak plasma levels are usually reached 6-7 hrs after dosing. Kaltrofen OD is not recommended for treatment of acute pain because of its controlled-release characteristic.
Suppositories administered late at night provide more effective control of overnight symptom than oral medication. Plasma peak levels are reached in 1-2 hrs, with plasma elimination half-life ranging from 2-3 hrs.
Kaltrofen is well absorbed from the IM route.
Indications/Uses
Symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis, acute gout and osteoarthritis.
Gel: Mild trauma, especially sports injuries, sprains, tendinitis, musculotendinous contusions, swelling and post-traumatic pain.
Dosage/Direction for Use
EC tab 50 mg: 1 tab 3-4 times daily; 100 mg: 1 tab 3-4 times daily immediately after meals or with milk, or according to physician's prescription.
Inj: 50-100 mg every 4 hrs, repeated up to a maximum of 200 mg in 24 hrs. Administer by deep IM injection into the upper, outer quadrant of the buttock. It is recommended that the injection not be used for >3 days. Following a satisfactory response, oral therapy should be instituted.
Supp: When associated with oral treatment during the day, the daily dosage is generally 1 supp to be inserted into the rectum. If used without oral treatment, the usual dose is 1 supp 2 times daily.
Gel: Applied 2-3 times daily on the painful or inflamed area for up to 7 days.
Ensure gel penetration via gentle and prolonged massage.
Safety in children has not been established, so the use of KALTROFEN gel in children is not recommended.
Overdosage
Symptoms of overdosage are hypotension, bronchospasm, gastrointestinal haemorrhage. If these occur, symptomatic and supportive treatment should be instituted.
Contraindications
Hypersensitivity to ketoprofen, acetosal and other NSAIDs. Patients with active peptic ulcer or active inflammatory disease (acute inflammatory) of the gastrointestinal tract. Severe bronchospasm disorder or patients with a history of bronchial asthma or allergic disease. Severe impairment of renal and hepatic function.
Suppositories should not be used following recent proctitis or in association with haemorrhoids.
Gel: Hypersensitivity to NSAIDs, patients suffering from or with history of bronchial asthma or allergic disease.
Infected skin lesions, eczema or broken skin, exudative dermatoses and sores.
Ketoprofen gel should not be administered to patients in whom Acetosal or other NSAIDs have caused asthma, rhinitis or urticaria.
Special Precautions
Since ketoprofen is eliminated by the kidneys and reduces renal blood flow, the dose of ketoprofen in patients with impaired renal function should be reduced and closely monitored.
Kaltrofen should be used cautiously in patients with hepatic dysfunction and patients with gastric hyperacidity disorders.
Administration with food or milk is advised to avoid minor adverse symptoms of the gastrointestinal tract.
Gel: Do not apply to the mucous membranes or eyes.
Caution should still be exercised in patients with a history of or active gastrointestinal bleeding, peptic ulcer, inflammatory disease of the gastrointestinal tract or severe renal impairment; although systemic effects are minimal.
KALTROFEN gel should not be use in children younger than 12 years of age unless otherwise directed by the doctor.
Should a skin rash occur after gel application, stop the treatment.
As is the case with other NSAID's, Ketoprofen does not cure the underlying disease.
Use in pregnancy & lactation: Kaltrofen is not recommended for use in pregnant and nursing women even though there is no record about embryopathic effects.
Gel: KALTROFEN gel should not be use in pregnant woman and during lactation.
Use In Pregnancy & Lactation
Kaltrofen is not recommended for use in pregnant and nursing women even though there is no record about embryopathic effects.
Gel: KALTROFEN gel should not be use in pregnant woman and during lactation.
Adverse Reactions
The most common adverse reactions are dyspepsia, nausea, vomiting, diarrhoea, constipation, headache, dizziness, rash, impairment of renal and hepatic function, abdominal pain, mild confusion, vertigo, edema and insomnia.
Haemorrhagic reaction: Mild thrombocytopenia.
Bronchospasm and anaphylactic reactions are rare.
Use of suppositories is sometimes associated with change in stool consistency mostly of mild softening.
Gel: Skin reaction including pruritus and localized erythema have occurred, particularly during exposure to sunlight or UV light. Patient should avoid sunlight or UV light exposure during treatment with KALTROFEN gel.
The prolonged use of products for topical administration may cause hypersensitivity phenomena.
Although not known for topical use of Ketoprofen, the following adverse events are reported for systemic use: minor adverse events, frequently transient, consist of gastrointestinal effects such as indigestion, dyspepsia, nausea, constipation, diarrhoea, heartburn and various types of abdominal discomfort. Other minor effects such as headache, dizziness, mild confusion, vertigo, drowsiness, oedema, mood change and insomnia may occur less frequently. Major gastrointestinal adverse event such as peptic ulceration, haemorrhage or perforation may rarely occur. Haematological reactions including thrombocytopenia, hepatic or renal damage, dermatological reaction, bronchospasm and anaphylaxis exceedingly rare.
Drug Interactions
Concomitant administration of Kaltrofen and acetosal and other protein-binding drugs (eg, anticoagulants, sulphonylurea, hydantoins) can decrease ketoprofen protein-binding and increase ketoprofen plasma clearance. Although the clinically significant change is not adequate, concurrent use of these drugs is not recommended.
Hydrochlorothiazide given concomitantly with Kaltrofen increases the risk of developing renal function failure.
Co-administration of Kaltrofen with methotrexate must be avoided because ketoprofen will increase the toxicity of methotrexate. Kaltrofen may inhibit tubular secretion of methotrexate.
Complication of warfarin treatment and use of Kaltrofen may cause bleeding in the gastrointestinal tract. Therefore, concomitant administration of these 2 drugs requires close monitoring.
NSAID increases steady-state plasma lithium levels. It is recommended that plasma lithium level be monitored when Kaltrofen is co-administered with lithium.
Probenecid increases free and bound Kaltrofen by reducing the plasma clearance. Therefore, concurrent administration of these 2 drugs is not recommended.
Gel: No interaction of KALTROFEN gel with other drugs have been reported, but it is necessary to monitor patients under treatment with coumarinic substances.
Storage
EC tab/Inj: Store at room temperature (below 30°C). Protect the injection from light.
Supp: Store below 25°C. Protect from heat and light.
Gel: Store below 30°C. Protect from light.
ATC Classification
M02AA10 - ketoprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AE03 - ketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
EC tab 50 mg x 3 x 10's. 100 mg x 30's. Inj 100 mg/2 mL x 5's. Supp 100 mg x 2 x 5's. Gel 0.025 g/g x 30 g x 1's.
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