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Delvac Tablet

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Delvac Tablet

Manufacturer

Korea Pharma Co. Ltd, 907-8 Sangshin-Ri, Hyangnam-Eup, Hwaseong-Si, Kyeonggi-Do, Korea.

Therapeutic Class

Non-steroidal anti-inflammatory drugs (NSAIDs), Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN:04-3568): Diclofenac sodium 100 mg.

How to Identify the Product: Yellow coloured enteric-coated oval tablet.

Pack size: pack of 100 tablets.

Delvac

Pharmacology

[DESCRIPTION]

Delvac is yellow colored enteric-coated oval tablet.

[PHARMACOLOGY]

Diclofenac has analgesic, antipyretic and anti-inflammatory action. Diclofenac probably acts by inhibiting the synthesis of prostagland-in.

[PHARMACOKINETICS]

Diclofenac is absorbed from the gastrointestinal tract. Peak plasma concentration occurs about 2 hrs. after ingestion of an enteric-coated table. At therapeutic concentration, it is >99% bound to plasma proteins.

It is metabolized in the liver and excreted mainly in the urine. Small amounts are excreted in the bile.

Indications

Relief of pain and inflammation in rheumatic disease and other musculoskeletal disorders, chronic juvenile arthritis and acute gout.

Control of pain and inflammation in orthopaedic, dental and other minor surgeries.

Contra-indications

Active or suspected peptic ulcer or gastrointestinal bleeding.

Hypersensitivity to Diclofenac.

Patients in whom attacks of asthma, jaundice, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs.

Precautions/Warnings

Delvac should be used with caution in patients with gastric ulceration, renal and hepatic impairment and during pregnancy.

Interactions

Aspirin: When Diclofenac sodium extended-release is administered with aspirin, its protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Cyclosporine: Diclofenac sodium extended-release, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Diclofenac sodium extended-release may increase cyclosporine's nephrotoxicity. Caution should be used when Diclofenac sodium extended-release is administered concomitantly with cyclosporine.

ACE-inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.

Furosemide: Clinical studies, as well as post-marketing observations, have shown that Diclofenac sodium extended-release can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Adverse Effects

Adverse effects are generally mild and infrequent but may include GI discomfort or occasional bleeding, nausea, hypersensitivity reactions, headache, vertigo and hearing disturbances e.g. tinnitus.

Dosage & Administration

Tablets:

Adults: 75-150 mg daily in 2-3 divided doses, preferably after food. Doses should be reduced in long-term use.

Children: 1-3 mg/kg body weight daily in divided doses.

Storage/Handling Recommendations

Store at room temperature with tight container.

Keep out of the reach of children.

Review Date

2016-05-10 06:29:24