Full Prescribing Info
Diclofenac Na, paracetamol, chlorzoxazone.
Each tablet contains diclofenac sodium (as enteric-coated granules) 50 mg, paracetamol 325 mg and chlorzoxazone 250 mg. It also contains sunset yellow FCF as colourant.
Pharmacology: Classification: Anti-inflammatory, analgesic and muscle relaxant.
Mechanism of Action: Diclofenac sodium is a nonsteroidal compound, a phenylacetic acid derivative with analgesic, antipyretic and anti-inflammatory effects. Diclofenac sodium inhibits the biosynthesis and release of prostaglandins which are known to be implicated in the pathogenesis of inflammation, pain and fever. Absorption occurs in the GIT to give peak plasma concentration approximately 2 hrs after ingestion. There is at least 99% binding to plasma proteins and excretion of metabolites is mainly in the urine.
Paracetamol has analgesic and antipyretic effects similar to those of aspirin. However, it has no anti-inflammatory effect and does not share the antirheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the GIT. The concentration in plasma reaches a peak in 30-60 min and the plasma t½ is about 2 hrs after therapeutic doses. It is distributed into most body tissues. It crosses the placenta and is present in breast milk.
Chlorzoxazone is a centrally-acting muscle relaxant. Chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. Chlorzoxazone is rapidly absorbed from the GIT. It is metabolized to 6-hydroxychlorzoxazone and then eliminated in the urine.
For the relief of mild to moderate pain and fever, inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, painful postoperative and posttraumatic inflammation, swelling and dysmenorrhoea and as an adjunct to physical therapy in the treatment of painful musculoskeletal disorders.
Dosage/Direction for Use
Adults: Usual Dose: 1 tab 3 times daily with or after meals.
Muscle Spasm: 1 tab 3 or 4 times daily. The initial dosage for severe muscle spasm should be 2 tabs 3 or 4 times daily.
Treatment of overdose should be symptomatic and supportive and may include the following: Induce vomiting or perform gastric lavage.
Administer activated charcoal.
Antacids may relieve adverse GI effects.
Nephritis or nephrotic syndrome, thrombocytopenia, hemolytic anaemia and severe cutaneous or other hypersensitivity reactions may respond to glucocorticoid administration.
Administer as required: Plasma volume expanders for severe hypotension; diazepam or other benzodiazepine for convulsions; vitamin K1 for hypoprothrombinemia; and/or dopamine plus dobutamine IV to prevent or reverse early indications of renal failure.
Hypotension may be counteracted by the use of dextran plasma, concentrated albumin or a vasopressor agent eg, noradrenaline.
Sensitivity to any of the ingredients of Lobak.
Known hypersensitivity to diclofenac sodium and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions eg, asthma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contraindicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.
Special Precautions
Dosage in excess of those recommended by the physician may cause liver damage. Patients suffering from liver or kidney disease should take paracetamol only under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage.
Do not use continuously for >10 days without consulting a doctor.
Lobak should be used with caution in patients with asthma.
Use in the elderly: Use with care.
Adverse Reactions
Diclofenac Sodium: Gastrointestinal disorders including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and GI bleeding have been reported. Other side effects include vertigo, headache, skin rashes, pruritus, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, edema, palpitations, blurred vision and other ocular reactions.
Hypersensitivity reactions may occur and include fever and rashes.
Diclofenac sodium may cause cystitis and haematuria as well as acute renal failure, interstitial nephritis and nephrotic syndrome.
Other adverse effects include anaemia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis and abnormalities in liver function tests.
Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion or renal insufficiency are at greater risk of developing renal dysfunction.
Paracetamol: Skin rashes and other allergic reactions may occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions.
In few cases, the use of paracetamol has been associated with the occurrence of thrombocytopaenia, neutropaenia, pancytopaenia, leucopaenia and agranulocytosis. The dose should be reduced in renal functional impairment.
Prolonged excessive use may cause irreversible kidney damage.
Chlorzoxazone: Occasionally, patients may develop GI disturbances. It is possible, in rare instances, that chlorzoxazone may have been associated with GI bleeding.
Drowsiness, nausea, dizziness, lightheadedness, malaise or overstimulation may be noted by an occasional patient.
Rarely, allergic-type skin rashes, petechiae or ecchymoses may develop during treatment. Angioneurotic oedema and anaphylactic reactions are extremely rare. Rarely, a patient may note discolouration of the urine resulting from a phenolic metabolite of chlorzoxazone.
It should be used with caution in patients with known allergies or with a history of allergic reactions to medicines. If a sensitivity reaction occurs eg, urticaria, redness or itching of the skin, the medicines should be stopped. If any signs or symptoms suggestive of liver dysfunction are observed, Lobak should be discontinued.
Drug Interactions
Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of aspirin.
When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations. Concomitant administration of glucocorticoids or other nonsteroidal anti-inflammatory agents may aggravate GI side effects.
Concurrent administration with two or more nonsteroidal anti-inflammatory agents may promote the occurrence of side effects.
Paracetamol should also be given with care to patients taking other drugs that affect the liver eg, the barbiturates.
The absorption of paracetamol may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid.
Store in a cool, dark and dry place.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB55 - diclofenac, combinations ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Tab 10 x 10's.
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