A Fenac K

Tablet

50mg

Diclofenac Potassium

Acme Laboratories Ltd.

Unit Price: 3.01 BDT

Packsize: 50's pack

Precaution

History of GI ulceration; impaired cardiac, renal or hepatic function; hypertension; lactation. IV admin in patients with moderate or severe renal impairment; hypovolaemia or dehydration; asthma, porphyria. Monitor LFTs in patients on prolonged therapy. May prolong bleeding time; caution when used in patients with coagulation disorders or on anticoagulants. Prolonged therapy may increase risk of anaemia. 1st and 2nd trimester of pregnancy. Elderly, debilitated patients. Lactation: Excreted in breast milk; not recommended

Indication

Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Pain, Migraine, Allergic conjunctivitis, Dysmenorrhea, Muscle aches, Acute gout, Inflammation, Renal colic, Miosis, Tendinitis, Actinic keratosis, Backaches, Dental pain, Menstrual cramps, Bursitis

Adult Dose

Oral Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Mild-to-Moderate Acute Pain Adult: 50 mg PO q8-12hr Migraine Adult: As diclofenac K: Initially, 50 mg taken at the 1st sign of an attack, an additional dose of 50 mg may be taken after 2 hr if symptoms persist. If needed, further doses of 50 mg may be taken 4-6 hrly. Max: 200 mg/day. Hepatic impairment: Dose adjustment may be needed.

Administration

Should be taken with food. Take immediately after meals.

Side Effect

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.

Pregnancy Category

Pregnancy Published literature reports that use of NSAIDs after 30 weeks’ gestation increases risk of premature closure of fetal ductus arteriosus; data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in first or second trimester of pregnancy are inconclusive; avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester) Infertility Based on mechanism of action, the use of prostaglandin-mediated NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women; published animal studies have shown that administration of prostaglandin synthesis inhibitors has potential to disrupt prostaglandin- mediated follicular rupture required for ovulation; small studies in women treated with NSAIDs have also shown reversible delay in ovulation; consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility Lactation Data from published literature reports with oral preparations of diclofenac indicate presence of small amounts of diclofenac in human milk; there are no data on effects on breastfed infant, or on milk production; consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

Interaction

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.