Grandtab Aceclofenac Tablets

GRANDTAB

Aceclofenac Tablets 100 mg

 

Each film coated tablet contains:

Aceclofenac BP 100 mg

Excipients q.s.

Colour: Titanium Dioxide BP and Red oxide of Iron.

 

PHARMACOLOGY

Pharmacodynamics

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins.

 

Pharmacokinetics

After oral administration, Aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L. The mean plasma eIimination half-life is around 4 hours.

Acecloenac is highly protein-bound (>99%). Aceclofenac circulates mainly as unchanged drug. 4-Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two-thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.

 

INDICATIONS

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

 

DOSAGE AND ADMINISTRATION

Aceclofenac tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.

 

Adults

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

 

Children

There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.

 

CONTRAINDICATIONS

Aceclofenac is contraindicated in patients with peptic ulceration and in pregnancy and lactation. It is also contraindicated in patients with a history of hypersensitivity to any ingredient of the product, gastro-intestinal bleeding, moderate to severe renal impairment, aspirin anti-inflammatory induced allergy.

 

SPECIAL PRECAUTIONS

Cautiously administer to patients with GI disease, ulcerative colitis, Crohn’s disease, haematological abnormalities, hepatic porphyria; history of bronchial asthma, history of heart failure or hypertension; mild renal hepatic or cardiac impairment. May impair ability to drive or operate machinery. Elderly patients.

 

Use in pregnancy

Use of Aceclofenac should be avoided during the first trimester of pregnancy, unless there is an absolute necessity.

 

Use in children

Not recommended.

 

ADVERSE REACTIONS

Aceclofenac is generally well tolerated. In the initial stage of therapy, gastrointestinal disorders, headache, or nausea may appear. These effects are usually mild and disappear with the continuation of the treatment. In the very rare cases in which treatment with Aceclotenac is associated with peptic ulceration or gastrointestinal bleeding, patients usually had history of such disorders or they were taking other medications responsible for the appearance of such disorders.

 

DRUG INTERACTIONS

Anticoagulants, lithium, methotrexate, antacids, probenecid, furosemide, digoxin, corticosteroids, antidiabetics and quinolone antibiotics.

 

OVERDOSAGE

There is no human data available on the consequences of Aceclofenac overdosage. After overdosage, following therapeutic measures are to be taken: absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications.

 

STORAGE

Store below 30°C. Protect from light.

KEEP MEDICINES OUT OF REACH OF CHILDREN

 

PRESENTATION

Available as a 3 blister pack of 10 tablets in a carton, along with the pack insert.

 

Mfg. Lic. No.: G/25/1749

NAFDAC Reg. No.: B4-3941

Manufactured in India by

Globela Pharma Pvt. Ltd.

357, G.I.D.C., Sachin Surat-394 230

Gujarat. (India)

www.globelapharma.com

 

Product of

Grandies Healthcare and Services Ltd.

1 Scotland Crescent Aba, Abia State Nigeria.

grandieshealthcare@yahoo.com.

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