Pertilos Plus
Generic Name
Aceclofenac + Paracetamol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Pertilos Plus is a combination medicine containing Aceclofenac and Paracetamol, used to relieve pain and inflammation associated with various musculoskeletal conditions, fever, and other painful conditions.
Uses & Indications
Dosage
Adults
One tablet twice daily after food.
Elderly
No specific dose adjustment is usually required, but caution is advised. The lowest effective dose for the shortest duration should be used.
Renal_impairment
Use with caution. A reduced dosage may be necessary in patients with mild to moderate renal impairment. Avoid in severe renal impairment.
How to Take
Administer orally, preferably after food to minimize gastrointestinal discomfort. Do not chew or crush the tablet.
Mechanism of Action
Aceclofenac inhibits prostaglandin synthesis by inhibiting cyclooxygenase (COX) enzymes, thereby reducing inflammation, pain, and fever. Paracetamol primarily acts in the central nervous system to inhibit prostaglandin synthesis, providing analgesic and antipyretic effects.
Pharmacokinetics
Onset
Analgesic effect usually starts within 30-60 minutes.
Excretion
Both are primarily excreted in the urine, mainly as metabolites.
Half life
Aceclofenac has an elimination half-life of about 4-4.3 hours. Paracetamol has an elimination half-life of about 2-3 hours.
Absorption
Both Aceclofenac and Paracetamol are rapidly and well absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations of Aceclofenac are reached in approximately 1.25 to 3 hours, and Paracetamol in 0.5 to 2 hours.
Metabolism
Aceclofenac is extensively metabolized in the liver, mainly by CYP2C9. Paracetamol is primarily metabolized in the liver via glucuronidation and sulfation, with a small portion metabolized by CYP enzymes.
Side Effects
Contraindications
- Known hypersensitivity to Aceclofenac, Paracetamol, or any component of the formulation
- Active peptic ulcer or gastrointestinal bleeding
- History of NSAID-induced asthma, urticaria, or allergic-type reactions
- Severe hepatic or renal impairment
- Severe heart failure
- Third trimester of pregnancy
Drug Interactions
Alcohol
Increased risk of hepatotoxicity with paracetamol.
Lithium
Increased plasma levels of lithium.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Cyclosporine and Tacrolimus
Increased risk of nephrotoxicity.
ACE inhibitors and Diuretics
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, drowsiness, dizziness, tinnitus. For paracetamol overdose, severe hepatotoxicity may occur. Management involves gastric lavage or activated charcoal if recent ingestion, followed by supportive care. N-acetylcysteine is indicated for paracetamol overdose.
Pregnancy & Lactation
Not recommended during the third trimester of pregnancy due to potential effects on fetal cardiovascular system. Use with caution in the first and second trimesters only if the potential benefit outweighs the risk. Avoid during lactation as both components pass into breast milk.
Side Effects
Contraindications
- Known hypersensitivity to Aceclofenac, Paracetamol, or any component of the formulation
- Active peptic ulcer or gastrointestinal bleeding
- History of NSAID-induced asthma, urticaria, or allergic-type reactions
- Severe hepatic or renal impairment
- Severe heart failure
- Third trimester of pregnancy
Drug Interactions
Alcohol
Increased risk of hepatotoxicity with paracetamol.
Lithium
Increased plasma levels of lithium.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Cyclosporine and Tacrolimus
Increased risk of nephrotoxicity.
ACE inhibitors and Diuretics
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, drowsiness, dizziness, tinnitus. For paracetamol overdose, severe hepatotoxicity may occur. Management involves gastric lavage or activated charcoal if recent ingestion, followed by supportive care. N-acetylcysteine is indicated for paracetamol overdose.
Pregnancy & Lactation
Not recommended during the third trimester of pregnancy due to potential effects on fetal cardiovascular system. Use with caution in the first and second trimesters only if the potential benefit outweighs the risk. Avoid during lactation as both components pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by relevant authorities (e.g., DGDA in Bangladesh)
Patent Status
Off-patent (for generic components)
Clinical Trials
Extensive clinical trials have established the efficacy and safety of Aceclofenac and Paracetamol combination in managing pain and inflammation. Post-marketing surveillance continues to monitor safety profiles.
Lab Monitoring
- Regular monitoring of renal function (serum creatinine, BUN) and liver function tests (ALT, AST) is recommended, especially during long-term therapy or in patients with pre-existing conditions. Complete blood count (CBC) should also be monitored periodically.
Doctor Notes
- Advise patients to take with food to minimize GI side effects.
- Monitor liver and kidney function in patients on long-term therapy.
- Be aware of potential drug interactions, especially with anticoagulants and other NSAIDs.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Take with food to reduce stomach upset.
- Report any unusual bleeding, persistent stomach pain, dark stools, or severe allergic reactions to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or drowsiness. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid consuming alcohol while taking this medicine.
- Maintain a balanced diet and adequate hydration.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.