Abenol

Name: Abenol

Abenol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Bloody or black, tarry stools
  • bloody or cloudy urine
  • fever with or without chills (not present before treatment and not caused by the condition being treated)
  • pain in the lower back and/or side (severe and/or sharp)
  • pinpoint red spots on the skin
  • skin rash, hives, or itching
  • sore throat (not present before treatment and not caused by the condition being treated)
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden decrease in the amount of urine
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Diarrhea
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For the Consumer

Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

  • intravenous solution

Along with its needed effects, acetaminophen (the active ingredient contained in Abenol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen:

Rare
  • Bloody or black, tarry stools
  • bloody or cloudy urine
  • fever with or without chills (not present before treatment and not caused by the condition being treated)
  • pain in the lower back and/or side (severe and/or sharp)
  • pinpoint red spots on the skin
  • skin rash, hives, or itching
  • sore throat (not present before treatment and not caused by the condition being treated)
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden decrease in the amount of urine
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen:

Symptoms of overdose
  • Diarrhea
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area

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 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.

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

Other Comments

Administration advice:
-When calculating daily acetaminophen doses, be sure to account for all acetaminophen-containing products and all routes of administration; do not exceed maximum doses.

Chewable tablets:
-Chew tablets before swallowing

Extended-release:
-Swallow whole; do not crush, chew, split, or dissolve

Oral disintegrating tablets:
-Allow to dissolve in mouth or chew before swallowing

Oral suspension:
-Shake well before using
-Use enclosed measuring device to measure dose

Parenteral:
-Infuse IV over 15 minutes; ensure infusion pumps are properly programmed
-Monitor end of infusion in order to prevent the possibility of an air embolism, especially in cases where this is the primary infusion.
Suppositories: For rectal use only
-Remove wrapper
-Carefully insert suppository well up into the rectum

Reconstitution/preparation techniques:
-For IV doses of 1000 mg: May administer without further dilution; may administer by inserting a vented IV set through the septum of the vial.
-For doses less than 1000 mg: Withdraw the appropriate dose from the vial and place in a separate empty, sterile container (e.g., glass bottle, plastic IV container, or syringe) for IV infusion.
- Administer within 6 hours of penetrating the vacuum seal of the glass vial.
-Do not use if particulate matter or discoloration is observed.
-Do not add other medications to the acetaminophen solution.

IV compatibility:
-Diazepam and chlorpromazine hydrochloride are physically incompatible

Storage requirements:
-IV: Single use only; store at 20C to 25C (68F to 77F); do not refrigerate or freeze

General:
-Drug-induced hepatotoxicity is preventable; all patients and caregivers need to be educated on how to give/take this drug safely and what to do if more than the recommended dose is consumed.
-Use of more than 1 acetaminophen-containing product at one time should be discouraged.
-Hypersensitivity reactions and serious rashes have been reported.

Monitoring:
-Monitor for nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in upper right part of the stomach, yellow of the skin or eyes, and/or flu-like symptoms as this may be an indication of overdose.
-Monitor for skin reactions

Patient advice:
-Patients should be advised to follow package directions for over the counter acetaminophen products including observing the maximum single dose and maximum daily dose limits.
-Patients should be discouraged from using multiple acetaminophen containing products concurrently.
-Patients should be advised that severe liver damage may occur if more than the recommended amount of this drug is taken; patients should seek medical help promptly if they suspect they have taken too much of this drug or if they experience nausea, vomiting, loss of appetite, or yellowing of the skin or eyes.
-Patients should be advised to limit alcohol use while taking this drug.

Acetaminophen Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Yes Comments; -This drug has been used without apparent harmful effects. -This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.

This drug is excreted into breast milk in very small amounts. Peak levels occur 1 to 2 hours after dosing and are undetectable after 12 hours. An infant ingesting 90 mL of breast milk every 3 hours would receive an average of 0.14% (range 0.04% to 0.23%) of the mother's dose; calculated to be a maximum maternal weight-adjusted dose of around 2%. One case of a maculopapular rash has been reported in a 2-month old nursing infant.

Acetaminophen Levels and Effects while Breastfeeding

Summary of Use during Lactation

Acetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Amounts in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare.

Drug Levels

Maternal Levels. A single oral dose of 650 mg of acetaminophen was given to 12 nursing mothers who were 2 to 22 months postpartum. Peak milk levels of 10 to 15 mg/L occurred between 1 and 2 hours after the dose in all patients. Acetaminophen was undetectable (<0.5 mg/L) in all mothers 12 hours after the dose. The authors calculated that an infant who ingested 90 mL of breastmilk every 3 hours would receive an average of 0.88 mg of acetaminophen or 0.14% (range 0.04 to 0.23%) of the mother's absolute dosage.[1] Using data from this study, an infant would receive a maximum of about 2% of the maternal weight-adjusted dosage.

Three women took a single 500 mg dose of acetaminophen. Peak milk levels averaging 4.2 mg/L occurred within 2 hours after the dose.[2] Using data from this study, an infant would receive a maximum of about 3.6% of the maternal weight-adjusted dosage.

Four women who were 2 to 8 months postpartum were given a single 1 gram dose of acetaminophen. Peak milk levels occurred between 1 and 2.5 hours after the dose. The authors estimated that a breastfed infant would receive an average of 1.1% and a maximum of 1.8% of the maternal weight-adjusted dosage. This dose is about 0.5% of the lowest recommended infant dose of acetaminophen.[3]

Infant Levels. No acetaminophen was detected in the urine of 12 breastfed infants aged 2 to 22 months after maternal ingestion of 650 mg of acetaminophen.[1]

Urine was collected for 1 to 3.5 hours after nursing in 6 infants aged 2 to 6 days whose mothers received 1 to 2 grams of acetaminophen 2 to 4 hours before nursing their infant. Infants excreted an average of 401 mcg of acetaminophen and its metabolites in urine during the collection interval. These neonates excreted a greater percentage of drug as acetaminophen and much less as the sulfate metabolite than adults.[3]

Effects in Breastfed Infants

A maculopapular rash on the upper trunk and face of a 2-month-old infant was probably caused by acetaminophen in breastmilk. The rash occurred after 2 days of therapy in the mother at a dose of 1 gram at bedtime. It subsided when the drug was discontinued and recurred 2 weeks later after another acetaminophen dose of 1 gram was taken by the mother.[4]

Two papers report 14 women who breastfed after taking acetaminophen or its prodrug phenacetin with no adverse effects to their infants.[1][5]

In a telephone follow-up study, mothers reported no side effects among 43 infants exposed to acetaminophen in breastmilk.[6]

Two clinicians speculated that breastmilk exposure to acetaminophen during breastfeeding might be a risk factor for asthma and wheezing in the breastfed infants based on their personal observations.[7] However, these observations were uncontrolled and cannot be considered to be valid proof of an association.[8]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Ibuprofen

References

1. Berlin CM Jr, Yaffe SJ, Ragni M. Disposition of acetaminophen in milk, saliva and plasma of lactating women. Pediatr Pharmacol. 1980;1:135-41. PMID: 7202185

2. Bitzen PO, Gustafsson B, Jostell KG et al. Excretion of paracetamol in human breast milk. Eur J Clin Pharmacol. 1981;20:123-5. PMID: 7262173

3. Notarianni LJ, Oldham HG, Bennett PN. Passage of paracetamol into breast milk and its subsequent metabolism by the neonate. Br J Clin Pharmacol. 1987;24:63-7. PMID: 3620287

4. Matheson I, Lunde PKM, Notarianni L. Infant rash caused by paracetamol in breast milk? Pediatrics. 1985;76:651-2. Letter. PMID: 2931668

5. Findlay JWA, DeAngelis RL et al. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981;29:625-33. PMID: 6529531

6. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

7. Nadal-Amat J, Verd S. Paracetamol and asthma and lactation. Acta Paediatr. 2011;100:e2-3. PMID: 21244486

8. Bakkeheim E, Carlsen KH, Lodrup Carlsen KC. Paracetamol exposure during breastfeeding and risk of allergic disease. Acta Paediatr. 2011;100:e3. PMID: 21535130

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