Napa Extra
Generic Name
Paracetamol + Caffeine
Manufacturer
Various manufacturers globally (e.g., Beximco Pharma in Bangladesh)
Country
Global
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Description
Overview of the medicine
A combination medication containing paracetamol (acetaminophen), an analgesic and antipyretic, and caffeine, a mild stimulant. It is primarily used for the relief of mild to moderate pain, fever, and to enhance the analgesic effect of paracetamol, particularly in headaches and migraines.
Uses & Indications
Dosage
Adults
Adults and adolescents (12 years and older): 1-2 tablets (Paracetamol 500mg/Caffeine 65mg) every 4-6 hours as needed. Do not exceed 8 tablets (4000 mg paracetamol) in 24 hours.
Elderly
No specific dosage adjustment usually required, but use with caution in elderly patients with impaired liver or kidney function.
Renal_impairment
Dosage reduction may be necessary for severe renal impairment (creatinine clearance < 10 ml/min). Consult a physician.
How to Take
Swallow tablets whole with water. Can be taken with or without food.
Mechanism of Action
Paracetamol (acetaminophen) acts primarily by inhibiting prostaglandin synthesis in the central nervous system, thereby reducing pain and fever. Caffeine, a central nervous system stimulant, augments the analgesic effect of paracetamol by its direct action on pain pathways and by causing cerebral vasoconstriction, which is beneficial in headaches and migraines. It also acts as an adenosine receptor antagonist.
Pharmacokinetics
Onset
Analgesic effect typically begins within 30-60 minutes.
Excretion
Metabolites of both drugs are primarily excreted in the urine.
Half life
Paracetamol: 2-3 hours; Caffeine: 3-7 hours (variable depending on individual metabolism).
Absorption
Both paracetamol and caffeine are rapidly and well absorbed from the gastrointestinal tract following oral administration.
Metabolism
Both paracetamol and caffeine are primarily metabolized in the liver. Paracetamol undergoes glucuronidation, sulfation, and oxidation via CYP enzymes. Caffeine is extensively metabolized by CYP1A2.
Side Effects
Contraindications
- Hypersensitivity to paracetamol, caffeine, or any excipients
- Severe hepatic impairment
- Severe renal impairment
- Uncontrolled hypertension or severe cardiovascular disease
- Anxiety disorders or conditions aggravated by caffeine
Drug Interactions
Alcohol
Increases the risk of paracetamol-induced liver damage.
MAO inhibitors (MAOIs)
Caffeine may enhance the effects of MAOIs, potentially leading to hypertensive crisis.
Warfarin and other anticoagulants
May increase the anticoagulant effect of warfarin and other coumarins with prolonged regular daily use of paracetamol, increasing the risk of bleeding. Intermittent use has little effect.
Cimetidine, oral contraceptives, quinolones
Can inhibit caffeine metabolism, prolonging its half-life and increasing its effects.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of paracetamol can cause severe hepatic necrosis. Symptoms include nausea, vomiting, abdominal pain, and liver damage (may not be apparent for 24-48 hours). Caffeine overdose can cause symptoms like insomnia, restlessness, tremor, confusion, tachycardia, and arrhythmias. Immediate medical attention is crucial. Treatment may involve activated charcoal, N-acetylcysteine for paracetamol toxicity, and supportive care.
Pregnancy & Lactation
Paracetamol is generally considered safe for use during pregnancy, but high doses of caffeine should be avoided. Consult a doctor before use during pregnancy and lactation. Both paracetamol and caffeine pass into breast milk.
Side Effects
Contraindications
- Hypersensitivity to paracetamol, caffeine, or any excipients
- Severe hepatic impairment
- Severe renal impairment
- Uncontrolled hypertension or severe cardiovascular disease
- Anxiety disorders or conditions aggravated by caffeine
Drug Interactions
Alcohol
Increases the risk of paracetamol-induced liver damage.
MAO inhibitors (MAOIs)
Caffeine may enhance the effects of MAOIs, potentially leading to hypertensive crisis.
Warfarin and other anticoagulants
May increase the anticoagulant effect of warfarin and other coumarins with prolonged regular daily use of paracetamol, increasing the risk of bleeding. Intermittent use has little effect.
Cimetidine, oral contraceptives, quinolones
Can inhibit caffeine metabolism, prolonging its half-life and increasing its effects.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of paracetamol can cause severe hepatic necrosis. Symptoms include nausea, vomiting, abdominal pain, and liver damage (may not be apparent for 24-48 hours). Caffeine overdose can cause symptoms like insomnia, restlessness, tremor, confusion, tachycardia, and arrhythmias. Immediate medical attention is crucial. Treatment may involve activated charcoal, N-acetylcysteine for paracetamol toxicity, and supportive care.
Pregnancy & Lactation
Paracetamol is generally considered safe for use during pregnancy, but high doses of caffeine should be avoided. Consult a doctor before use during pregnancy and lactation. Both paracetamol and caffeine pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, supermarkets, general stores worldwide
Approval Status
Generally approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of both paracetamol and caffeine individually and in combination for pain and fever relief.
Lab Monitoring
- Liver function tests (especially with chronic use or risk factors)
- Kidney function tests (in patients with renal impairment)
Doctor Notes
- Counsel patients on paracetamol maximum daily dose to prevent hepatotoxicity.
- Advise patients to limit other sources of caffeine while taking this medication.
- Caution patients with pre-existing liver disease or heavy alcohol consumption.
- Monitor for signs of caffeine sensitivity or dependence with regular use.
Patient Guidelines
- Do not exceed the recommended dose to avoid serious liver damage.
- Do not take with other paracetamol-containing products.
- Limit caffeine intake from other sources (coffee, tea, energy drinks) to avoid excessive stimulation and side effects.
- If symptoms persist for more than a few days, consult a doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Generally considered safe. However, if you experience dizziness, nervousness, or other side effects that impair your ability to concentrate, avoid driving or operating machinery.
Lifestyle Advice
- Ensure adequate hydration, especially if experiencing fever.
- Get sufficient rest to aid recovery from pain or illness.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.