Robafenac Diclofenac Potassium Methocarbamol and Paracetamol Tablets

ROBAFENAC®
(Diclofenac Potassium, Methocarbamol and Paracetamol Tablets)

 

Composition

Each film coated tablet contains:
Diclofenac Potassium USP 50mg
Methocarbamol USP 500mg
Paracetamol USP 325mg
Colour : Titanium Dioxide / Sunset Yellow

 

Pharmacotherapeutic group

Anti inflammatory, analgesic, antipyretic and muscle relaxant.

 

Pharmacodynamics

Robafenac tablets contain the potassium salt of diclofenac, a non-Steroidal compound with analgesic, anti-inflammatory and anti-pyretic properties. Diclofenac is a potent inhibitor of prostaglandin biosynthesis and a modulator of arachidonic acid release and uptake and are therefore suitable for the treatment of acute episodes of pain and inflammation. Methocarbamol acts as short- term adjunct to the symptomatic treatment of acute musculoskeletal disorders associated with painful muscle spasms and Paracetamol has analgesic and antipyretic properties.

 

Pharmacokinetics

Absorption

Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption. The plasma concentrations show a linear relationship to the size of the dose. Methocarbamol is absorbed from the gastro-intestinal tract. Paracetamol is readily absorbed from the gastrointestinal tract.

Metabolism

Diclofenac undergoes first-pass metabolism and is extensively metabolised. Methocarbamol activity derives from the intact molecule and only a small proportion is converted to guaiphenesin. Paracetamol is metabolised in the liver. A minor hydroxylated metabolite which is usually produced in very small amount by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Paracetamol overdosage and cause tissue damage.

Distribution

Diclofenac is highly bound to plasma proteins (99.7%), chiefly albumin (99.4%) Methocarbamol produces peak plasma concentrations after about 1-3 hours. Paracetamol peak plasma concentrations occur about 10 to 60 minutes after oral doses. It is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

Elimination

The total systemic clearance of diclofenac in plasma is 263 ± 56 ml/min (mean ± SD). The terminal half-life in plasma is 1 – 2 hours. Approx. 60% of the dose administered is excreted in the urine in the form of metabolites, and less than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces. Methocarbamol’s terminal elimination half- life ranged from 59 to 90 mins. Paracetamol is excreted in the urine, mainly as the glucuronide and sulphate conjugates. The elimination half-life varies from about 1 to 4 hours.

 

Indications

Robafenac has anti-inflammatory, analgesic and antipyretic actions for the relief of mild to moderate pain and as a short-term adjunct to the symptomatic treatment of acute musculoskeletal disorders associated with painful muscle spasms like Rheumatoid arthritis, osteoarthritis, low back pain, ankylosing spondylitis etc.

 

Dosage and administration

For oral use.

Dosage

As directed by Physician.

Adults: 1 tablet three times daily. Do not take more than 3 tablets per day.

Elderly: Half the maximum dose or less may be sufficient to produce a therapeutic response.

Children: Not recommended.

 

Contraindications

Known hypersensitivity to Robafenac® active ingredients: Diclofenac Potassium, Methocarbamol and Paracetamol.

 

Warnings and Precautions

Robafenac® Tablets should be used with caution in patients with renal and hepatic insufficiency. Care is advised in the administration of Robafenac® tablets to patients with alcohol dependency; avoid concomitant NSAIDs including cyclooxygenase-2 selective inhibitors.

Interaction with other medicinal products

Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (Including aspirin) as this may increase the risk of adverse effects

Anti-hypertensives: Reduced anti-hypertensive effect.

Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: Decreased elimination of lithium

Methotrexate: Decreased elimination of methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

 

Pregnancy and Lactation

Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3). NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to foetus.

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

 

Side Effects

Robafenac® Tablets adverse effects are rare but gastrointestinal in nature and hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including, thrombocytopenia, neutropenia, pancytopenia, leucopenia, agranulocytosis, angioneurotic oedema, anaphylactic reaction, fever and headache.

 

Overdose

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rareIy diarrhoea, disorientation, excitation, coma, drowsiness, tinnitus, fainting, occasionally and convulsions. In rare cases of significant poisoning acute renal failure and liver damage are possible. Management of overdose includes maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. Other measures may be indicated by the patient’s clinical condition.

 

Storage

Store below 30oC in dry place.

Protect from light & moisture.

Keep all medicines out of reach of children.

 

Presentation

2 x 10 Tablets
NAFDAC Reg. No.: B4-5198

 


Manufactured in India by

Ciron Drugs & Pharmaceuticals Pvt. Ltd.
Plot No.35 to 37,43to45, CFC-B,
Dewan Uyog Nagar, Aliyali,
Paighar, Dist. Thane-401 404.
www.cironpharma.com

 

Manufactured for

SOLID ACCORD LIMITED

House 4, 5th Avenue, City Layout,

New Haven, Enugu, Nigeria.

www.solidaccord.com

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