CLOFEN PLUS Tablet

Indication:

CLOFEN PLUS is used in the Management of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. NSAIDs are used for the relief of mild to moderate pain, minor febrile conditions and for acute and chronic inflammatory disorders such as osteoarthritis, rheumatoid arthritis, juvenile chronic arthritis and ankylosing spondylitis.

Dosge:

Aceclofenac - Maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Chlorzoxazone - The usual initial dose is 500 mg three to four times daily by mouth. The dose can often be reduced subsequently to 250 mg three or four times daily, although doses of up to 750 mg three or four times daily may be given if necessary.

Acetaminophen- The oral dose for adults is 325 to 650 mg every 4-6 hours. The maximum daily dose is 4 grams. The oral dose for a child is based on the child's age, and the range is 40-650 mg every 4 hours.

Clofen Plus is contraindicated in patients with known hypersensitivity to any of the ingredients of this drug.

The majority of side effects are dyspepsia, abdominal pain, nausea, diarrhoea and dizziness.

Interaction with other medicinal products and other forms of interaction

Aceclofenac - Nopharmacokinetic interaction studies have been performed, except with warfarin.

Chlorzoxazone - The CNS effects may be enhanced by alcohol and other CNS depressants.

Acetaminophen is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize acetaminophen (e.g. carbamazepine, isoniazid, rifampin) may decrease the action of acetaminophen. The potential for acetaminophen to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.

The following combinations should be avoided:

NSAIDs inhibit the tubular secretion of methotrexate and a sight metabolic interaction may also occur, resulting in decreased clearance of methotrexate. Therefore, during treatment with high dose methotrexate prescription of NSAID drugs should always be avoided. Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased serum concentrations of lithium. The combination should be avoided unless frequent monitoring of lithium levels can be performed.

NSAID-drugs inhibit the platelet aggregation and damage the mucous membrane in the gastrointestinal tract which may enhance the activity of anticoagulants and increase the risk of gastrointestinal bleedings in patients using anticoagulant drugs. The combination of aceclofenac with oral anticoagulants of the coumarin group, ticlopidine, thrombolytics and heparin should be avoided unless careful monitoring is exercised.

Aceclofenac should not be given during lactation unless considered essential by the physician.

The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when in the judgment of the physician, the potential benefits outweigh the possible risks.

Acetaminophen is used in all stages of pregnancy. Acetaminophen is excreted in breast milk in small quantities. However, acetaminophen use by the nursing mother appears to be safe.

Aceclofenac should be administered with caution and under close medical surveillance to patients suffering from gastro-intestinal disease and to those with a history of peptic ulceration, cerebra-vascular bleeding, ulcerative colitis. Crohn's disease, SLE, porphyria, hematopoietic or coagulation-disorders.

Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.

Aceclofenac is a novel NSAID known to exhibit multifactor mechanism of action. Aceclofenac was developed in order to provide a highly effective pain-relieving therapy with a reduced side effect profile, especially GI events that are frequently experienced with NSAID therapy.

Chlorzoxazone is a centrally acting skeletal muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain.

Acetaminophen, a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity.