Niko-500mg
Manufactured By
National Healthcare P. Ltd.: Derma National
Paracetamol
Generic Name: paracetamol (oral/rectal) (par RA cet a MOL)
Alternate Name: acetaminophen (a SEET a MIN oh fen)
Medically reviewed by Judith Stewart, BPharm. Last updated on Feb 16, 2021.
Uses
Warnings
What to avoid
Side effects
Dosage
Interactions
FAQ
What is paracetamol ?
Paracetamol (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of action of is not known.
Paracetamol is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.
Paracetamol may also be used for other purposes not listed in this medication guide.
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Acetaminophen
Dosage
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Acetaminophen Dosage
Medically reviewed by Drugs.com. Last updated on Jan 28, 2021.
Applies to the following strengths: 160 mg; 80 mg/0.8 mL; 160 mg/5 mL; 500 mg; 650 mg; 80 mg; 325 mg; 500 mg/15 mL; 120 mg; 120 mg/5 mL; 325 mg/10.15 mL; 650 mg/20.3 mL; 10 mg/mL; 80 mg/5 mL; 650 mg/25 mL; 80 mg/mL; 500 mg/5 mL; 48 mg/mL
Usual Adult Dose for:
Fever
Pain
Usual Pediatric Dose for:
Pain
Fever
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments
Usual Adult Dose for Fever
Doses may be given as a single or repeated dose as follows:
Parenteral:
Weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 4000 mg per 24 hours
Weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 75 mg/kg per 24 hours
Oral:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours
Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours
Rectal:
650 mg rectally every 4 to 6 hours
Maximum dose: 3900 mg per 24 hours
Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed
Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.
Usual Adult Dose for Pain
Doses may be given as a single or repeated dose as follows:
Parenteral:
Weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 4000 mg per 24 hours
Weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 75 mg/kg per 24 hours
Oral:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours
Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours
Rectal:
650 mg rectally every 4 to 6 hours
Maximum dose: 3900 mg per 24 hours
Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed
Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.
Usual Pediatric Dose for Pain
Doses may be given as a single or repeated dose as follows:
PARENTERAL:
2 to 12 years: 12.5 mg/kg IV every 4 hours OR 15 mg/kg IV every 6 hours
Maximum Single Dose: 15 mg/kg; not to exceed 750 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours; not to exceed 3750 mg
13 years or older; weight less than 50 kg: 12.5 mg/kg IV every 4 hours OR 15 mg/kg IV every 6 hours
Maximum Single Dose: 15 mg/kg; not to exceed 750 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours; not to exceed 3750 mg
13 years or older; weight 50 kg or greater: 650 mg IV every 4 hours OR 1000 mg IV every 6 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 4000 mg in 24 hours
ORAL:
10 to 15 mg/kg orally every 4 to 6 hours as needed not to exceed 5 doses in 24 hours
-Alternatively, use weight first, then age:
2.7 to 5.3 kg (0 to 3 months): 40 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
5.4 to 8.1 kg (4 to 11 months): 80 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
8.2 to 10.8 kg (12 to 23 months): 120 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
10.9 to 16.3 kg (2 to 3 years): 160 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
16.4 to 21.7 kg (4 to 5 years): 240 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
21.8 to 27.2 kg (6 to 8 years): 320 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
27.3 to 32.6 kg (9 to 10 years): 400 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
32.7 to 43.2 kg (11 to 12 years): 480 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
12 years or older:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours
Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours
RECTAL:
6 to 11 months: 80 mg rectally every 6 hours up to a maximum of 4 doses in 24 hours
12 to 36 months: 80 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
3 to 6 years: 120 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
6 to 12 years: 325 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
12 years or older: 650 mg rectally every 4 to 6 hours up to a maximum of 6 doses in 24 hours
Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed.
Uses:
-For the management of mild to moderate pain and for the management of moderate to severe pain when used with adjunctive opioid analgesics.
Usual Pediatric Dose for Fever
Doses may be given as a single or repeated dose as follows:
PARENTERAL:
Neonates (premature neonates born at least 32 weeks gestational age up to 28 days chronological age): 12.5 mg/kg IV every 6 hours
Minimum Dosing Interval: 6 hours
Maximum Daily Dose: 50 mg/kg/day
Infants (29 days to 2 years old): 15 mg/kg every 6 hours
Minimum Dosing Interval: 6 hours
Maximum Daily Dose: 60 mg/kg/day
2 to 12 years: 12.5 mg/kg IV every 4 hours OR 15 mg/kg IV every 6 hours
Maximum Single Dose: 15 mg/kg; not to exceed 750 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours; not to exceed 3750 mg
13 years or older; weight less than 50 kg: 12.5 mg/kg IV every 4 hours OR 15 mg/kg IV every 6 hours
Maximum Single Dose: 15 mg/kg; not to exceed 750 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours; not to exceed 3750 mg
13 years or older; weight 50 kg or greater: 650 mg IV every 4 hours OR 1000 mg IV every 6 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 4000 mg in 24 hours
ORAL:
10 to 15 mg/kg orally every 4 to 6 hours as needed not to exceed 5 doses in 24 hours
-Alternatively, use weight first, then age:
2.7 to 5.3 kg (0 to 3 months): 40 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
5.4 to 8.1 kg (4 to 11 months): 80 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
8.2 to 10.8 kg (12 to 23 months): 120 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
10.9 to 16.3 kg (2 to 3 years): 160 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
16.4 to 21.7 kg (4 to 5 years): 240 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
21.8 to 27.2 kg (6 to 8 years): 320 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
27.3 to 32.6 kg (9 to 10 years): 400 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
32.7 to 43.2 kg (11 to 12 years): 480 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
12 years or older:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours
RECTAL:
6 to 11 months: 80 mg rectally every 6 hours up to a maximum of 4 doses in 24 hours
12 to 36 months: 80 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
3 to 6 years: 120 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
6 to 12 years: 325 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
12 years or older: 650 mg rectally every 4 to 6 hours up to a maximum of 6 doses in 24 hours
Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed.
Use: For the reduction of fever.
Renal Dose Adjustments
Severe renal impairment (CrCl less than 30 mL/min): Longer dosing intervals and a reduced total daily dose may be warranted
Liver Dose Adjustments
Parenteral:
Severe hepatic impairment, severe active hepatic disease: Use is contraindicated
Mild to moderate hepatic impairment, mild to moderate active hepatic disease: Use with caution; a reduced total daily dose may be warranted
Over the counter products must contain labeling that states:
This product contains acetaminophen. Severe liver damage may occur if:
-Adult takes more than maximum daily dose in 24 hours
-Child takes more than 5 doses in 24 hours
-More than 3 alcoholic drinks are consumed per day while using this product.
Dose Adjustments
Use caution in patients with alcoholism, chronic malnutrition, severe hypovolemia (e.g. due to dehydration or blood loss); A reduced daily dose may be warranted.
Suspected Overdose:
-If an overdose is suspected, obtain a serum drug level as soon as possible, but no sooner than 4 hours after oral ingestion.
-Liver function studies should be obtained and repeated at 24-hour intervals.
-The antidote, N-acetylcysteine (NAC) should be administered as soon as possible according to NAC protocols.
Precautions
US BOXED WARNING: RISK OF MEDICATION ERRORS
Take care when prescribing, preparing, and administering IV acetaminophen injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that
- the dose in milligrams (mg) and milliliters (mL) is not confused;
- the dosing is based on weight for patients under 50 kg;
- infusion pumps are properly programmed;
-the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.
US BOXED WARNING: HEPATOTOXICITY:
This drug has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than 1 acetaminophen-containing product.
US OVER THE COUNTER LABELING: Adults only:
This product contains acetaminophen. Severe liver damage may occur if:
-More than maximum daily dose is taken in 24 hours
-This product is taken with other drugs containing acetaminophen
-Three or more alcoholic drinks are consumer every day while using this product.
US OVER THE COUNTER LABELING: Adults and children under 12 years of age:
This product contains acetaminophen. Severe liver damage may occur if:
-Adult takes more than maximum daily dose in 24 hours
-Child takes more than 5 doses in 24 hours
-This product is taken with other drugs containing acetaminophen
-Persons consume 3 or more alcoholic drinks per day while using this product.
Safety and efficacy for the treatment of acute pain have not been established in patients younger than 2 years.
Consult WARNINGS section for additional precautions.
Dialysis
Children:
Intermittent hemodialysis or peritoneal dialysis: Administer every 8 hours
CRRT: No adjustments necessary
Adults:
Intermittent hemodialysis or peritoneal dialysis: No adjustment necessary
CRRT: Administer every 8 hours