Description

Lobak- Diclofenac sodium, paracetamol chlorzoxazone tablets

Composition

Diclofenac sodium BP 50mg

(as enteric coated granules)

Paracetamol BP 325mg

Chlorzoxazone USP 250mg

Colour: Sunset yellow FCF

Pharmacological classification: Anti-inflamatory, analgesic and muscle relaxant

Pharmacological action

Diclofenac is a non-steroidal compound, a phenylacetic acid derivative, with analgesic, antipyretic and anti-inflammatory effects. Diclofenac sodium inhibits the biosynthesis and release of postagladins, which are known to be implicated in the biosynthesis of inflammation, pain and fever. Absorption occurs in the gastrointestinal tract to give peak plasma concentrations approximately 2 hours 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 ant rheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak of 30 to 60 minutes and the plasma half-life is about 2 hours 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 gastrointestinal tract. It is metabolized to 6-hydroxychlorzoxazone and the eliminated in urine.

Indications

For the relief of mild to moderate pain and fever, inflammatory and denerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, painful post-operative and post traumatic inflammation and swelling and dysmenorrhoea and as an adjuct to physical therapy in the treatment of painful musculoskeletal disorders.

Contraindications

Sensitivity to any of the Lobak ingredients. It is contraindicated in patients withknown hypersensitivity to diclofenac sodium and in patients who respond to aspirin and aspirin type drugs with sensitivity reactions like ashma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contra-indicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.

Warning

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 your doctor if no relief is obtained from the recommended dosage.

Do not use continuously for more than 10 days without consulting your doctor.

Dosage and direction for use

Usual adult dose: One tablet three times daily, with or after meals or as directed by the physician. For muscle spasm: one tablet 3 to 4 times daily. The initial dosage for severe muscle spasm should be 2 tablets three or four times daily.

Side effects and special precautions

Diclofenac Sodium: Gastrointestinal disorders including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side effects include vertigo, headache, skin rashes, pruritis, tinnitus, depression, drowsiness and 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, intestinal nephritis and nephrotic symptom. Other adverse effects include anemia, 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 a 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. Paracetamol should also be given with care to patients taking other drugs that affect the liver such as the barbiturates. The absorption of acetaminophem (paracetamol) may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid. Prolonged excessive use may cause irreversible kidney damage.

Chlorzoxazone: Occasional patients may develop gastrointestinal disturbances. It is possible, in rare instances, that chlorzoxazone may have been associated with gastrointestinal 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 anaphlylactic reactions are extremely rare. Rarely, a patient may note discoloration of the urine resulting from a phenolic metablolite 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 such as urticaria, redness or itching of the skin, the medicines should be stopped. If any signs or symptoms suggestive of liver dysfunction are observed the medicine should be discontinued.

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 non-steroidal anti-inflammatory agents may aggravate gastro-intestinal side effects. Concurrent administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side effects. Should be used with caution in patients with asthma. Use with care in elderly patients.

Known Symptoms of over dosage and particulars of its treatment

Treatment of over dosage should be symptomatic and supportive and may include the following:

1. Induce vomiting or perform gastric lavage.
2. Administer activated charcoal.
3. Antacids may relieve adverse gastrointestinal effects.
4. Nephritis or nephritic syndrome, thrombocytopenia, hemolytic anemia, and severe cutaneous or other hypersensitivity reactions may respond to glucocorticoid administration.
5. Administer as required plasma volume expanders for severe hypotention; diazepam or other benzodiazepine for convulsions; vitamin k1 for hypoprothrombinemia; and or dopamine plus dobutamine intravenously to prevent or reverse early indications of renal failure.
6. Hypotension may be counteracted by the use of dextran plasma, concentrated albumin or a vasopresssor agent such as noradrenaline.

Presentation

Strip of 10 tablets. Jar of 500/1000 tablets.

Storage instructions

Store at a temperature not exceeding 30 degrees Celsius

Manufactured in India by Geno Pharmaceutical Pvt Ltd

Karaswada, mapusa, Goa 403 526