Sante
Generic Name
Paracetamol (Acetaminophen)
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sante 1000 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Sante 1000 mg Tablet contains Paracetamol, a common pain reliever and fever reducer used for mild to moderate pain and fever.
Uses & Indications
Dosage
Adults
1000 mg (1 tablet) every 4-6 hours as needed. Do not exceed 4000 mg (4 tablets) in 24 hours. The minimum dosing interval should be 4 hours.
Elderly
Same as adults. Exercise caution in elderly patients with pre-existing hepatic or renal impairment.
Renal_impairment
For severe renal impairment (creatinine clearance <10 ml/min), the dosing interval should be extended to every 8 hours.
How to Take
For oral administration. Tablets should be swallowed whole with water, with or without food.
Mechanism of Action
Paracetamol is thought to act primarily in the central nervous system by inhibiting prostaglandin synthesis, which leads to its analgesic and antipyretic effects. It has minimal anti-inflammatory action.
Pharmacokinetics
Onset
Analgesic effect usually starts within 30-60 minutes.
Excretion
Mainly renal excretion of inactive glucuronide and sulfate conjugates. Less than 5% of the dose is excreted as unchanged paracetamol.
Half life
Plasma elimination half-life ranges from 1 to 4 hours, which can be prolonged in liver disease, renal impairment, and overdose.
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract following oral administration. Peak plasma concentrations are reached within 30-120 minutes.
Metabolism
Primarily metabolized in the liver via glucuronidation and sulfation pathways to inactive metabolites. A small amount is metabolized by cytochrome P450 (CYP2E1) to N-acetyl-p-benzoquinone imine (NAPQI), a highly reactive and potentially toxic intermediate, which is rapidly detoxified by glutathione.
Side Effects
Contraindications
- Hypersensitivity to paracetamol or any excipients of the formulation.
- Severe hepatic impairment or active liver disease.
Drug Interactions
Alcohol
Increased risk of hepatotoxicity, especially with chronic heavy alcohol consumption.
Cholestyramine
May decrease the absorption of paracetamol if administered within one hour.
Warfarin and other coumarins
May enhance the anticoagulant effect of warfarin and other coumarins with prolonged regular daily use, increasing the risk of bleeding.
Metoclopramide and Domperidone
May increase the absorption rate of paracetamol.
Phenobarbital, Carbamazepine, Phenytoin
Concurrent use with enzyme-inducing drugs may increase the risk of hepatotoxicity due to increased production of the toxic metabolite NAPQI.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of sight and reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, anorexia, pallor, and malaise within 24 hours, potentially followed by liver damage (hepatic necrosis) and acute renal failure. Treatment involves immediate gastric lavage, activated charcoal, and administration of the antidote N-acetylcysteine (NAC) as soon as possible.
Pregnancy & Lactation
Paracetamol is generally considered safe for use during all trimesters of pregnancy and during breastfeeding when used at recommended doses. However, it should only be used after consulting a healthcare professional.
Side Effects
Contraindications
- Hypersensitivity to paracetamol or any excipients of the formulation.
- Severe hepatic impairment or active liver disease.
Drug Interactions
Alcohol
Increased risk of hepatotoxicity, especially with chronic heavy alcohol consumption.
Cholestyramine
May decrease the absorption of paracetamol if administered within one hour.
Warfarin and other coumarins
May enhance the anticoagulant effect of warfarin and other coumarins with prolonged regular daily use, increasing the risk of bleeding.
Metoclopramide and Domperidone
May increase the absorption rate of paracetamol.
Phenobarbital, Carbamazepine, Phenytoin
Concurrent use with enzyme-inducing drugs may increase the risk of hepatotoxicity due to increased production of the toxic metabolite NAPQI.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of sight and reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, anorexia, pallor, and malaise within 24 hours, potentially followed by liver damage (hepatic necrosis) and acute renal failure. Treatment involves immediate gastric lavage, activated charcoal, and administration of the antidote N-acetylcysteine (NAC) as soon as possible.
Pregnancy & Lactation
Paracetamol is generally considered safe for use during all trimesters of pregnancy and during breastfeeding when used at recommended doses. However, it should only be used after consulting a healthcare professional.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies, Superstores
Approval Status
Approved
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Paracetamol has been extensively studied for its efficacy and safety in numerous clinical trials for pain and fever reduction. Its widespread use and long history of research support its therapeutic applications.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) in cases of suspected overdose, chronic high-dose use, or in patients with pre-existing liver conditions.
- Renal function tests (creatinine, BUN) in patients with pre-existing renal impairment or suspected renal injury.
Doctor Notes
- Emphasize strict adherence to dosing guidelines to prevent unintentional overdose, especially when patients are using multiple OTC products.
- Caution patients with chronic alcohol use disorder or pre-existing liver disease regarding the increased risk of hepatotoxicity. Consider lower doses or alternative treatments in such cases.
- Educate patients on the signs and symptoms of liver toxicity and when to seek immediate medical attention.
Patient Guidelines
- Always follow the recommended dosage and do not exceed the maximum daily dose.
- Avoid taking other medications containing paracetamol simultaneously.
- If symptoms persist for more than 3 days (fever) or 5 days (pain), consult your doctor.
- Keep out of reach of children and pets.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. 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
Sante 1000 mg Tablet is generally considered safe for driving and operating machinery, as it is not known to cause drowsiness or impair mental alertness.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids.
- Avoid or limit alcohol consumption while taking paracetamol, especially if taking high doses or for prolonged periods, due to increased risk of liver damage.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.