Zolterol SR

Zolterol SR

diclofenac

Manufacturer:

Duopharma

Distributor:

International Med

Marketer:

Pharmahealth
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
Chronic therapy of musculoskeletal & joint disorders eg, RA, OA, ankylosing spondylitis & spondyloarthritis; peri-articular disorders eg, bursitis & tendinitis; non-articular rheumatism; painful syndromes of the vertebral column; soft tissue disorders eg, sprains & strains; painful post-op & post-traumatic inflammation & swelling.
Dosage/Direction for Use
Adult 75 mg or 100 mg daily. Max dose: 100 mg daily. Elderly & patient w/ low body wt Initially 75-100 mg daily. Chronic treatment & in mild cases 75 mg daily. Taken preferably in the evening if symptoms are most severe during the night or in the morning.
Administration
Should be taken with food: Swallow whole w/ liqd, do not chew/crush.
Contraindications
Hypersensitivity to diclofenac, aspirin or other NSAIDs. Patients w/ PUD/haemorrhage; history of GI bleeding or perforation related to previous NSAID therapy; active, or history of, recurrent peptic ulcer/haemorrhage. Patients w/ severe heart failure. Treatment of peri-operative pain in CABG surgery setting. Patients w/ asthma & allergic reaction eg, allergic rhinitis, urticaria, angioedema or skin rash precipitated by aspirin or other NSAIDs. Pregnancy.
Special Precautions
Monitor renal & hepatic function, blood counts, & signs of hypersensitivity reactions during prolonged treatment. May trigger allergic reactions, including anaphylactic reactions. Reports of severe cutaneous reactions, including Stevens-Johnson syndrome & toxic epidermal necrolysis (Lyell's syndrome). Discontinue immediately if rash occurs. Caution in patients w/ cardiac impairment & coagulation disorders. Associated w/ serious liver injury in rare cases. Not recommended in patients w/ pre-existing CV or cerebrovascular disease, or presenting risk factors for CV disease. Associated w/ increased risk of serious CV adverse events (eg, MI, stroke or thrombotic events) particularly at higher doses. May lead to onset of new HTN or worsening of pre-existing HTN. Caution in patients w/ HTN. Closely monitor BP during treatment initiation & at regular intervals thereafter. Caution in patients w/ fluid retention or heart failure. Increased risk of serious GI adverse events, including bleeding/ulceration/perforation of the stomach or intestines. Discontinue immediately if GI bleeding or ulcerations occur. Concurrent use of aspirin & NSAIDs. Long-term NSAID administration has resulted in renal papillary necrosis & other renal injury. Not recommended in patients w/ advanced renal disease. May impair ability to drive or operate machinery. Patients w/ renal or hepatic impairment. Elderly. Not recommended for childn.
Adverse Reactions
Epigastric pain, nausea, vomiting, diarrhoea, dyspepsia, hypersensitivity reactions (eg, rashes, angioedema, bronchospasm), headache, dizziness, vertigo, photosensitivity, hair loss, haematuria, hearing disturbances (eg, tinnitus), blood disorders, fluid retention, renal failure, serum aminotransferase elevation.
Drug Interactions
Increased plasma conc of digoxin & lithium. Cases of hypoglycaemic & hyperglycaemic reactions w/ oral antidiabetic agents. Increased serum K levels w/ K-sparing diuretics. Increased risk of GI side effects w/ corticosteroids, glucocorticoids or K supplements. May induce GI ulceration or bleeding w/ anticoagulant or thrombolytic therapy. Increased risk of GI side effects, including ulceration or haemorrhage, w/ concurrent use of ≥2 NSAIDs, including aspirin. May increase the risk of cyclosporine-induced nephrotoxicity. Increased risk of agranulocytosis or bone marrow depression w/ methotrexate.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Zolterol SR FC tab 100 mg
Packing/Price
100's
Form
Zolterol SR FC tab 75 mg
Packing/Price
100's
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