Orcenac SR Tablet

Orcenac SR Tablet is used for: Indicated for the relief of pain and inflammation in both acute and chronic pain like, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain.

Adult: PO Ankylosing spondylitis; Osteoarthritis; Rheumatoid arthritis 100 mg twice daily. SR Tablet: The recommended dose is 200 mg, once daily.

Safety & Efficacy not established.

Avoid if possible or use with caution; avoid in moderate to severe impairment. Dose adjustments: The lowest effective dose should be used for the shortest possible duration. Monitoring In renal impairment monitor renal function; sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure.

Should be taken with food. Take w/ or immediately after meals.

Known hypersensitivity to aspirin or NSAIDs or any components of the drug product. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. In the setting of CABG surgery. Moderate to severe renal impairment; pregnancy (3rd trimester); history of peptic ulceration or GI bleed; patients with infections.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Aceclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure Heart Failure and Edema: Avoid use of Aceclofenac in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. Renal Toxicity: Avoid use of Aceclofenac in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. Exacerbation of Asthma Related to Aspirin Sensitivity: Aceclofenac is contraindicated in patients with aspirin-sensitive asthma. Serious Skin Reactions: Discontinue Aceclofenac at first appearance of skin rash or other signs of hypersensitivity. Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation. Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Monitoring Parameters Monitor blood pressure. Monitor patients with preexisting asthma (without aspirin sensitivity). Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation. There are no adequate and well-controlled studies of Aceclofenac in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Labor or Delivery There are no studies on the effects of Aceclofenac during labor or delivery. In animal studies, NSAIDs, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Lactation Risk Summary Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Aceclofenac and any potential adverse effects on the breastfed infant from the Aceclofenac or from the underlying maternal condition. Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of Aceclofenac in women who have difficulties conceiving.

May increase plasma concentrations of lithium and digoxin. Increased nephrotoxicity when used with diuretics or ciclosporin. Monitor serum potassium when used with potassium-sparing diuretics and ACE inhibitors. May enhance activity of anticoagulants. May increase risk of methotrexate toxicity when administered within 24 hr of methotrexate admin. Increased risk of GI bleed with other NSAIDs. Increased risk of convulsion with quinolones. Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking Aceclofenac with drugs that interfere with hemostasis. Concomitant use of Aceclofenac and analgesic doses of aspirin is not generally recommended. ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with Aceclofenac may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ACE Inhibitors and ARBs: Concomitant use with Aceclofenac in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. Digoxin: Concomitant use with Aceclofenac can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Side effects of Aceclofenac : Gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported. Potentially Fatal: Severe GI bleeding; nephrotoxicity; blood dyscrasias.

Aceclofenac, a phenylacetic acid derivative, has antiinflammatory and analgesic properties. It is a potent inhibitor of cyclo-oxygenase which is involved in the production of prostaglandins.

Orcenac 200 mg SR Tablet manufactured by Novatek Pharmaceuticals Ltd.. Its generic name is Aceclofenac. Orcenac is availble in Bangladesh. Farmaco BD drug index information on Orcenac SR Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.