Napa Extra, Ace Plus, Fast Plus, Panadol Extra
Generic Name
paracetamol_caffeine
Manufacturer
Square Pharmaceuticals, Incepta Pharmaceuticals, Beximco Pharmaceuticals, ACI Pharmaceuticals (Bangladesh); various global manufacturers
Country
Bangladesh, India, UK, USA, various
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Description
Overview of the medicine
Paracetamol and caffeine is a combination medicine used for the relief of mild to moderate pain, such as headaches, migraines, toothaches, menstrual pain, and muscle aches. Paracetamol acts as an analgesic and antipyretic, while caffeine enhances the pain-relieving effects of paracetamol and has mild stimulant properties.
Uses & Indications
Dosage
Adults
1-2 tablets (Paracetamol 500 mg / Caffeine 65 mg) every 4-6 hours as needed. Do not exceed 8 tablets in 24 hours.
Elderly
Similar to adults, but caution is advised in elderly patients with impaired liver or kidney function. A lower dose or extended interval may be necessary.
Renal_impairment
Use with caution. Dosage interval should be extended in patients with severe renal impairment (creatinine clearance <10 mL/min). Consult a doctor.
How to Take
Administer orally with water. Can be taken with or without food. Do not exceed the recommended dose or frequency.
Mechanism of Action
Paracetamol works primarily in the central nervous system to inhibit prostaglandin synthesis, thereby reducing pain and fever. Caffeine is a central nervous system stimulant, primarily acting as an adenosine receptor antagonist. It enhances the analgesic effect of paracetamol, potentially by increasing its absorption and acting as a cerebral vasoconstrictor, which can be beneficial in headaches/migraines.
Pharmacokinetics
Onset
Onset of pain relief typically occurs within 30-60 minutes.
Excretion
Both are primarily excreted via the kidneys, mainly as metabolites. A small percentage of unchanged paracetamol and caffeine are also excreted.
Half life
Paracetamol has a plasma half-life of 1-4 hours. Caffeine has a plasma half-life of about 3-7 hours.
Absorption
Both paracetamol and caffeine are rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations for paracetamol are reached in 30-60 minutes, and for caffeine in 30-120 minutes.
Metabolism
Both are primarily metabolized in the liver. Paracetamol undergoes glucuronidation, sulfation, and a minor pathway via CYP2E1 (producing toxic NAPQI). Caffeine is extensively metabolized by CYP1A2 into various metabolites.
Side Effects
Contraindications
- Hypersensitivity to paracetamol, caffeine, or any other component of the formulation
- Severe hepatic or renal impairment
- Severe hypertension or heart disease (due to caffeine)
- Anxiety disorders or panic attacks (due to caffeine)
- G-6-PD deficiency (paracetamol)
Drug Interactions
Alcohol
Increased risk of hepatotoxicity with paracetamol.
Lithium
Caffeine can increase lithium excretion, potentially reducing its therapeutic effect.
Warfarin
Increased anticoagulant effect, leading to increased bleeding risk, especially with long-term, high-dose paracetamol use.
Other caffeine-containing products
Increased risk of caffeine-related side effects.
Cimetidine, Oral Contraceptives, Fluoroquinolone Antibiotics (e.g., Ciprofloxacin)
Reduced caffeine metabolism, leading to increased caffeine levels and potential adverse effects.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of paracetamol overdose include nausea, vomiting, abdominal pain, and liver damage (which may manifest days later). Treatment involves N-acetylcysteine. Caffeine overdose can cause nervousness, insomnia, restlessness, tremors, tachycardia, and palpitations. Management is supportive.
Pregnancy & Lactation
Consult a doctor before use during pregnancy or lactation. While paracetamol is generally considered safe at recommended doses, high doses of caffeine during pregnancy may be associated with certain risks. Both paracetamol and caffeine are excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to paracetamol, caffeine, or any other component of the formulation
- Severe hepatic or renal impairment
- Severe hypertension or heart disease (due to caffeine)
- Anxiety disorders or panic attacks (due to caffeine)
- G-6-PD deficiency (paracetamol)
Drug Interactions
Alcohol
Increased risk of hepatotoxicity with paracetamol.
Lithium
Caffeine can increase lithium excretion, potentially reducing its therapeutic effect.
Warfarin
Increased anticoagulant effect, leading to increased bleeding risk, especially with long-term, high-dose paracetamol use.
Other caffeine-containing products
Increased risk of caffeine-related side effects.
Cimetidine, Oral Contraceptives, Fluoroquinolone Antibiotics (e.g., Ciprofloxacin)
Reduced caffeine metabolism, leading to increased caffeine levels and potential adverse effects.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of paracetamol overdose include nausea, vomiting, abdominal pain, and liver damage (which may manifest days later). Treatment involves N-acetylcysteine. Caffeine overdose can cause nervousness, insomnia, restlessness, tremors, tachycardia, and palpitations. Management is supportive.
Pregnancy & Lactation
Consult a doctor before use during pregnancy or lactation. While paracetamol is generally considered safe at recommended doses, high doses of caffeine during pregnancy may be associated with certain risks. Both paracetamol and caffeine are excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture
Availability
Pharmacies, drug stores
Approval Status
Approved by regulatory bodies worldwide, including DGDA (Bangladesh)
Patent Status
Generic, widely off-patent
Clinical Trials
Numerous clinical trials have demonstrated that caffeine significantly enhances the analgesic efficacy of paracetamol, particularly in conditions like headache. Studies support its use as a combination analgesic.
Lab Monitoring
- Liver function tests (especially with prolonged use or suspected overdose)
- Renal function tests (in patients with kidney impairment)
Doctor Notes
- Advise patients on total daily caffeine intake from all sources.
- Counsel patients on the risks of paracetamol overdose, especially with concomitant alcohol use.
- Monitor for signs of liver toxicity in prolonged or high-dose use.
Patient Guidelines
- Do not exceed the stated dose.
- Avoid concomitant use with other paracetamol-containing products or excessive caffeine intake.
- Consult a doctor if symptoms persist for more than a few days, or if new symptoms occur.
- Avoid alcohol while taking this medicine.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Generally, this medicine does not impair ability to drive or operate machinery. However, if you experience nervousness, dizziness, or insomnia (due to caffeine), exercise caution.
Lifestyle Advice
- Maintain adequate hydration.
- Ensure sufficient rest.
- Avoid excessive consumption of coffee, tea, or energy drinks to manage total caffeine intake.
Alternative Medicines in Bangladesh
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.