Apain Tablet

Apain Tablet is used for: Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Pain, Migraine, Dysmenorrhea, Muscle aches, Acute gout, Inflammation, Renal colic, Tendinitis, Backaches, Dental pain, Menstrual cramps, Bursitis

Oral Enteric-coated tablet: A total of 75-150 mg daily given in two or three divided doses. Sustained-release tablet (SR): One tablet daily, taken whole with liquid, preferably during a meal. Dispersible Tablet (DT): The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of DT daily are sufficient. Timed-release capsule (TR): One capsule daily. Diclofenac TR should be taken preferably after mealtimes. Rheumatoid Arthritis, Osteoarthritis Diclofenac sodium: 50 mg PO q8hr Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr Ankylosing Spondylitis Diclofenac sodium: 25 mg PO 4 or 5 times daily Mild-to-Moderate Acute Pain, Dysmenorrhea 100 mg PO once, then 50 mg PO q8hr PRN Intravenous Postoperative pain Adult: As diclofenac Na: 75 mg infusion in glucose 5% or NaCl 0.9% (previously buffered w/ Na bicarbonate) given over 30-120 min or as bolus inj, may repeat after 4-6 hr if necessary. Max period: 2 days. Intramuscular Rheumatoid arthritis; Sprains; Strains; Tendinitis; Pain and inflammation associated with musculoskeletal and joint disorders; Bursitis; Acute gout; Dysmenorrhoea Adult: As diclofenac Na: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions. Max period: 2 days. Suppository The suppository should be administered rectally. 25 mg or 50 mg suppository only 75-150 mg daily in divided doses P/R.

Oral Juvenile rheumatoid arthritis Enteric-coated tablet: 1-3 mg/kg per day in divided doses. Sustained-release tablet: Not recommended. Suppository (1-12 years): 12.5 mg or 25 mg suppository only 1-3 mg/kg body weight in divided doses per rectally.

Renal impairment With systemic use Avoid if possible or use with caution. Avoid in severe impairment. With intravenous use Avoid intravenous use if serum creatinine greater than 160 micromol/litre. Contraindicated in moderate or severe renal impairment. Dose adjustments With systemic use The lowest effective dose should be used for the shortest possible duration. Monitoring With systemic use In renal impairment monitor renal function; sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure.

It should be taken with food. Take immediately after meals. DT is to be dropped into half a glass of water and the liquid is to be stirred to aid dispersion before swallowing.

It is contraindicated 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.

Cardiovascular risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal Risk may increase with duration of use Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk Use of COX-2 selective NSAID for pain treatment in the first 10­14 days following CABG surgery increased incidence of MI and stroke; use of NSAIDS is contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery Gastrointestinal risk NSAIDs can increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal May occur at any time during use and without warning symptoms Patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events Use caution in patients with bronchospasm, cardiac disease, CHF, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus Platelet aggregation and adhesion may be decreased; may prolong bleeding time Use caution in blood dyscrasias or bone marrow depression; also with thrombocytopenia, agranulocytosis, and aplastic anemia Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers Increase risk of hyperkalemia may occur, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely May cause dizziness blurred vision and neurologic effects that may impair physical and mental abilities Persistent urinary symptoms, including bladder pain and dysuria, hematuria or cystitis may occur after initiating therapy; discontinue therapy with symptom onset and evaluate cause May increase risk of aseptic meningitis (rare), especially in patients with systemic lupus erythrmatosus, and mixed connective tissue disorders Use caution if patient dehydrated before initiating therapy; rehydrate patient before initiating therapy and monitor renal function closely Avoid use of NSAIDs in pregnant women at about >30 weeks gestation Use of NSAIDs at about >20 weeks gestation in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment Serious Skin Reactions NSAIDs, including this drug, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal Gastrointestinal bleeding, ulceration, perforation Risk factors for GI bleeding, ulceration, and perforation Hepatoxicity Increase in transaminase levels reported within 2 months of therapy; may occur at any time Monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy Hypertension NSAIDs can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.

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

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin. Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of diclofenac and anticoagulant therapy, although clinical investigations do not appear to indicate any influence on anticoagulant effect. Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving cyclosporin and diclofenac concomitantly. Methotrexate: Cases of serious toxicity have been reported when methotrexate and NSAIDs are given within 24 hours of each other. Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. Therefore, caution should be exercised when considering concomitant therapy of NSAID and quinolones. Other NSAIDs and steroids: Co-administration of diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With aspirin, the plasma levels of each is lowered, although no clinical significance is known.

Side effects of Diclofenac Sodium : 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 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.

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.

Apain 50mg Tablet manufactured by Kemiko Pharmaceuticals Ltd.. Its generic name is Diclofenac Sodium. Apain is availble in Bangladesh. Farmaco BD drug index information on Apain Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.