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Clofen plus

  • ENG
  • မြန်မာ

 

                               

Each film coated tablet contains:
Aceclofenac BP 100 mg
Chlorzoxazone USP 500 mg
Acetaminophen USP 375 mg
Excipients q.s.

Colour: Sunset Yellow Lake & Titanium Dioxide

 

DESCRIPTION

CLOFEN PLUS is a non-steroidal anti inflammatory drug which acts specifically on inflammatory sites and thereby decreases the inflammation. This medication relaxes muscles and relieve pain and discomfort associated with strains, sprains and other muscle injuries.
Aceclofenacis 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 BI 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.

 

INDICATIONS

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.

 

SIDE EFFECTS

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

 

OVERDOSE

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions.

In cases of significant poisoning acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

 

CONTRAINDICATIONS

CLOFEN PLUS is contraindicated in patients with known hypersensitivity to any of the ingredients of this drug.

 

Use during pregnancy and lactation

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.

 

DRUG INTACTIONS

Interaction with other medicinal products and other forms of interaction
Aceclofenac- No pharmacokinetic 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 fiver.

The following combinations should be avoided:
NSAIDs inhibit the tubular secretion of methotrexate and a slight 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 formed.
NSAID-drugs inhibit the platelet aggregation and damage the mucous membrance 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.

 

DOSAGE

2-3 tablets daily or as directed by the Physician.

 

PRESENTATION

Blister pack of 10 tablets.


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