Gebedol

 

Composition:

Each uncoated tablet contains:
Diclofenac Sodium B.P.           50 mg

Paracetamol B.P.                     500 mg
 
Excipients: Maize Starch B.P., Methyl Hydroxybenzoate B.P., Propyl Hydroxybenzoate B.P., Purified Talc B.P., Colloidal Anhydrous Silica B.P. Sodium Starch Glycolate B.P., Magnesium Stearate B.P., Povidone (P.V.P.K. 30) B.P.

Pharmacological Properties and Pharmacodynamic Properties

In GEBEDOL the mechanism of analgesic action of Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation, The mechanism of antipyretic action of paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation center to produce peripheral vasodilation resulting in increased blood flow through the skin sweating and heat loss.

The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

In GEBEDOL Diclofenac Sodium is a non-steroidal agent with marked analgesic/anti-inflammatory properties, it is an inhibitor of prostaglandin synthetase, (cyclo-oxygenase).

 Pharmacokinetic Properties

In GEBEDOL Paracetamol is readily absorbed from the gastro- intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolized in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

In GEBEDOL Diclofenac enters the synovial fluid, where maximum concentrations are measured 2-4 hours after the peak plasma values have been attained. The apparent half-life for eliminations from the synovial fluid is 3-6 hours. Two hours after reaching the peak plasma values, concentrations of the active substance are already higher in the synovial fluid than they are in the plasma and remain higher for up to 12 hours.

Indications

GEBEDOL is indicated in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylitis intervertebral disc syndrome, sciatica, non-articular rheumatic conditions, post-operative and traumatic inflammations, acute gout, painful inflammatory conditions in gynecology and dentistry.

GEBEDOL is also indicated in the treatment of pain and fever. It is used for the rapid relief of pain and fever, pains and aches such as body ache, earache, toothache, fibrositis, myalgia, neuralgia, arthralgia, osteoarthritis and postoperative pain.

Dosage and Administration

Adults: One tablet twice or thrice a day. Or as directed by the Physician.

Adverse Effects

GEBEDOL is generally well tolerated. However adverse effects like nausea, vomiting, epigastric distress, skin rash peptic ulcer, fluid retention, oedema, impairment of hepatic function, acute toxicity may result in hepatic failure.

Contraindications

GEBEDOL is contraindicated in persons who are known to be hypertensive to diclofenac sodium, paracetamol, aspirin or other non- steroidal anti-inflammatory drugs. GEBEDOL Is contraindicated in persons with a history of gastrointestinal bleeding or perforation. relating to previous NSAIDs therapy and in acute porphyria.

Special Precautions

GEBEDOL should be used with caution in individuals with evidence of impairment of hepatic, renal or cardiac function, blood coagulation disorders, recent proctitis, Gl disorders, long term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

GEBEDOL should be administered with caution in patients with acid-peptic disease, blood dyscrasias. Symptoms of Overdosage and its Treatment: Symptoms of overdosage of GEBEDOL include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea disorientation, excitation, coma, drowsiness, tinnitus, fainting, occasionally convulsions. In rare cases of significant poisoning acute renal failure and liver damage are possible.

Treatment includes gastric lavage, activated charcoal and other symptomatic measures as per medical advice. 

Pregnancy and Lactation

GEBEDOL should not be used during the first two trimesters of pregnancy or labor unless the potential benefit outweighs the potential risk to fetus.

GEBEDOL should be used in pregnant women and nursing mothers only if absolutely required. Take medical advice. 

Drug Interactions, Cholestyramine

Reduces absorption of paracetamol.

Charcoal Activated administered immediately reduces absorption of paracetamol.

Domperidone and Metoclopramide

Enhance the absorption of Paracetamol.

Alcohol

Chronic excessive ingestion of alcohol potentiates hepatotoxicity of paracetamol.

Zidovudine

 Effects of Zidovudine may be decreased. Lithium and Digoxin Blood levels of lithium and digoxin increased leading to enhanced efficacy and possible toxicity. Diuretics inhibits diuretics but efficacy of potassium sparing diuretics enhanced.

Methotrexate

Toxicity enhanced.

Salicylates

Paracetamol reduces efficacy of salicylates. Cyclosporine: Increases nephrotoxicity.
Hydantoins: Increases serum levels resulting in toxicity. Storage:
Store at a temperature not exceeding 30°C. Protect from light and moisture.
Keep all medicines out of the reach of children.

GB PHARMA LIMITED
65 Chatsworth Road, London NW2 4BG, United Kingdom
Tel.: +44 (0) 20 8830 1057, Fax: +44 (0) 20 8830 4807. E-mail: info@abpharma.co.uk