Pharmik Laboratories Ltd.
Hipain TR is indicated for Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Pain, Migraine, Dysmenorrhea, Muscle aches, Acute gout, Inflammation, Renal colic,Tendinitis, Backaches, Dental pain, Menstrual cramps, Bursitis
Precautions and warnings
History of gastrointestinal ulceration, haematemesis or melaena, ulcerative colitis, Asthma or history of asthma, Crohn's disease, bleeding diathesis or haematological abnormalities. Patients with severe hepatic, cardiac or renal insufficiency or the elderly people, Current or previous high blood pressure ( hypertension) should be kept under close surveillance. All patients who are receiving long-term treatment with NSAID agents should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease develop or if other manifestations occur, Diclofenac sodium should be discontinued. Use of Diclofenac tablet in patients with hepatic porphyria may trigger an attack.
Side-effects of Diclofenac is usually mild and transient. It is generally well tolerated. At the starting of the treatment, however, patients may sometimes complain of gastrointestinal discomfort, epigastria pain, eructation, nausea and Diarrhoea, headache and bleeding sometime may occur. Occasionally skin rash, peripheral oedema and abnormalities of serum transaminase have been reported.Very rarely reported side effects include activation of peptic ulcer, haematemesis or melena, blood dyscrasia (extensive usage). There have been isolated reports of anaphylactoid reactions.
May increase serum levels of methotrexate. Concomitant use w/ other NSAIDs or anticoagulants (e.g. warfarin) is associated w/ higher risk of GI bleeding. Increased risk of nephrotoxicity w/ ciclosporin or triamterene. May increase the risk of developing corneal complications in patients w/ significant pre-existing corneal inflammation when use concomitantly w/ ophth preparation containing corticosteroids. Colestyramine and colestipol reduce the bioavailability of diclofenac. Decreased plasma concentration when administered after sucralfate. Ophth application of diclofenac may reduce the efficacy of ophth acetylcholine and carbachol. May increase serum levels of lithium and digoxin.
It is contra-indicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding, or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibitinig activity, it is also contraindicated.
Because of the presence of Lidocaine, it is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare.
Mode of actions
Diclofenac, a phenylacetic acid derivative is a prototypical NSAID. It has potent anti-inflammatory, analgesic and antipyretic actions. It reversibly inhibits the enzyme, cyclooxygenase, thus resulting in reduced synthesis of prostaglandin precursors.
Dosage & Administration
Adults: 1- 3 tablet (50 -150 mg) daily in divided doses preferably with food or after food.
Children: 1- 3 mg/kg body weight per day in divided doses.
Injections are intended for intramuscular injection.
Adults: The dosage is generally one 75 mg ampoule daily. In severe cases (e.g. colic) the daily dose can exceptionally be increased to two ampoules of 75 mg, separated by an interval of a few hours. Alternatively, one ampoule of 75 mg can be combined with other dosage forms (tablets, suppositories) up to a maximum daily dosage of 150 mg.
In migraine attacks, clinical experience is limited to initial use of 1 ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dosage should not exceed 175 mg on the first day.
Children: In juvenile chronic arthritis, 1-3 mg of Diclofenac sodium/kg body weight daily in divided doses.
Elderly patients: The lowest effective dosage is recommended, commensurate with age and physical status or as prescribed by the physician.
Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.
Pregnancy & Lactation
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.