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OverviewMechanism of ActionHow To UseUsesBenfitsIndicationsMethod of AdministrationDosage StrengthsDosage FormsDietary RestrictionsContraindicationsWarnings and Precautions for usingAdverse ReactionsSide EffectsOverdosage Clinical Pharmacology Clinical StudiesAuthored by Reviewed by References
Benorilate

Benorilate

Indications, Uses, Dosage, Drugs Interactions, Side effects
Benorilate
Medicine Type :
Allopathy
Prescription Type:
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Pharmacological Class:
Nonsteroidal Anti-inflammatory Drugs (NSAIDs),
Therapy Class:
Analgesic, Antipyretic Agents,

Benorilate is a Analgesic and Antipyretic belonging to Non-Steroidal anti-inflammatory Drug

Benorilate is used in the treatment of Analgesia, rheumatoid arthritis, Soft tissue rheumatism, Osteoarthritis, acute gout.

Benorilate is Rapidly metabolised to salicylate and paracetamol after absorption.

Benorilate shows common side effects Heartburn, GI disturbances, drowsiness and hypersensitivity reactions. Occasionally dizziness, tinnitus, and deafness.

Benorilate is available in tablets and suppository.

Benorilate is available in India, Germany, Canada, France, USA.

They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects.

Benorilate is available in the form of tablets and suppository.

Benorilate is used in the treatment of Analgesia, rheumatoid arthritis, Soft tissue rheumatism, Osteoarthritis, acute gout.

Benorilate is an aspirin-paracetamol ester with analgesic, anti-inflammatory and antipyretic properties. It is used in the treatment of mild to moderate pain and fever.

Benorilate is approved for use in the following clinical indications

rheumatoid disorder and gout.

Oral

Analgesia

Adult: For mild to moderate pain: 2 g bid.

Oral

Rheumatoid arthritis

Adult: 2 g bid. Max dose: 6 g daily.

Elderly: 2 g bid. Max dose: 4 g daily.

Oral

Soft tissue rheumatism

Adult: 2 g bid. Max dose: 6 g daily.

Elderly: 2 g bid. Max dose: 4 g daily.

Oral

Osteoarthritis

Adult: 2 g bid. Max dose: 6 g daily.

Elderly: 2 g bid. Max dose: 4 g daily.

Oral

Acute gout

Adult: Up to 800 mg daily may be needed. Reduce to the lowest effective dose after 1-3 days. Usual max duration: Up to 1 wk.

Benorilate is available in the form of tablets and suppository.

Take after eating and with a full glass of water to decrease gastric upset.

Benorilate is contraindicated in patients with:

Previous or active peptic ulceration; child <16 yr except in Kawasaki syndrome, due to risk of Reye's syndrome; lactation, hemophilia and other bleeding disorders. Gout. Hypersensitivity.
  • Use with caution in animals with a history of drug allergy.
  • Stop medication at the first sign of gastrointestinal upset, jaundice or blood dyscrasia. Authenticated cases of agranulocytosis associated with Benorilate have occured in man. Benorilate induced blood dyscrasias have been reported in dogs. Thrombocytopenia and leukopenia are early manifestations followed by nonregenerative anemia. The occurrence of this reaction is not dose depended and is unpredictable. To guard against this possibility, conduct routine blood counts at not more than 7 day intervals during the early course of therapy, and at intervals of not more than 14 days throughout the course of therapy. Any significant fall in the total white count, relative decrease in granulocytes or black or tarry stools should be regarded as a signal for immediate cessation of therapy and institution of appropriate treatment.
  • When treating inflammatory conditions associated with infection, specific anti-infective therapy is required.
  • Response to Benorilate therapy is prompt, usually occurring within 24 hours. If no significant clinical response is evident after 5 days of therapy, re-evaluate diagnosis and therapeutic regimen.

Alcohol Warning

Benorilate may cause liver problems, and using it with substantial quantities of ethanol may increase that risk.

Food Warning

Food may decrease the rate but not the extent of absorption. Benorilate peak serum levels may be delayed if taken with food. Management: Administer with food or milk to minimize GI upset.

  • Common Adverse effects: Tachycardia, hypotension, myocarditis, atrial fibrillation, atrial flutter, angina, CHF, myocardial depression, pericardial effusion/pericarditis, dizziness.
  • Less Common Adverse effects: toxic epidermal necrolysis, cutaneous vasculitis, parotitis, GI disorders, anemia, thrombocytopenia, coagulopathy, leukopenia, neutropenia, agranulocytosis, granulocytopenia, red blood cell aplasia, hepatitis, primary biliary cirrhosis.
  • Rare Adverse Effects: myoglobinuria, glomerulonephritis, renal vasculitis, pulmonary oedema, pulmonary vasculitis, SLE, lymphadenopathy.

Absorption may be reduced by cholestyramine and kaolin; increased by domperidone and metoclopramide. Enhanced effects of coumarin, heparin, phenytoin and valproate; reduced effects of spironolactone and sulfinpyrazone. Risk of side effects increased and hypotensive effect antagonized by ACE inhibitors and angiotensin-2 receptor antagonists; carbonic anhydrase inhibitors, clopidogrel, corticosteroids, coumarin, phenindione, sibutramine and venlafaxine. Caution when using concurrently with cilostazol, mifepristone or other NSAIDs.

The common side effects of Benorilate include the following :

Vomiting, Indigestion, Flatulence, Nausea, Abdominal Pain, Constipation, Epigastric Pain, Diarrhea, Large Intestine Carcinoma.

Abdominal pain, agitation, ataxia, chest pain, cholestatic jaundice, coagulopathy, colitis, coma, dermatitis, diarrhea, drowsiness, dyssomnia, erythema multiforme, exfoliative dermatitis, fecal discoloration, gastritis, hematuria, GI bleeding, hyperventilation, hypotension, hypothyroidism, jaundice, lichenoid eruptions, pemphigus, periarteritis nodosa, pericarditis, photosensitivity, respiratory arrest, rhabdomyolysis, seizures, stomatitis, toxic epidermal necrolysis, urine discoloration. Treatment is supportive; multiple doses of charcoal may be needed to reduce the risk for delayed toxicities.

  • Pharmacodynamics

Benorilate is an aspirin-paracetamol ester with analgesic, anti-inflammatory and antipyretic properties. It is used in the treatment of mild to moderate pain and fever.

  • Pharmacokinetics

Absorption: NA

Distribution: NA

Metabolism: Rapidly metabolized to salicylate and paracetamol after absorption.

Elimination: NA

There are some clinical studies of the drug Benorilate mentioned below:
  1. https://pubmed.ncbi.nlm.nih.gov/1091001/
  2. https://clinicaltrials.gov/ct2/show/NCT01422915
  3. https://clinicaltrials.gov/ct2/show/NCT02263547
  4. https://www.medicines.org.uk/emc/product/128/smpc.

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1364710/
  2. https://reference.medscape.com/drug/colestid-Benorilate -342452
  3. https://go.drugbank.com/drugs/DB00375
  4. https://www.sciencedirect.com/topics/medicine-and-dentistry/Benorilate
  5. https://europepmc.org/article/med/6988203
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Parthika Patel
Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
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Dr JUHI SINGLA
Dr JUHI SINGLA has completed her MBBS from Era’s Lucknow Medical college and done MD pharmacology from SGT UNIVERSITY Gurgaon. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Published on: 17 July 2023 2:24 PM GMT
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