Dosing & Uses
Dosing Forms & Strengths
acetaminophen/caffeine/isometheptene
tablet
- 325mg/20mg/65mg
Migraine Headache
1 or 2 tablets PO at onset of headache, then 1 tablet hourly until relieved; not to exceed 5 tablets/12 hr
Tension Headache
1-2 tablets PO q4hr; not to exceed 8 tablets/24 hr
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Rash
Transient dizziness
Warnings
Black Box Warnings
Medication errors and hepatotoxicity with acetaminophen
- Take care when prescribing, preparing, and administering acetaminophen 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 <50 kg
- Infusion pumps are properly programmed
- The total daily dose of acetaminophen from all sources does not exceed maximum daily limits
- Acetaminophen 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 one acetaminophen-containing product
Contraindications
Glaucoma
Severe renal disease
Severe hypertension
Organic heart disease
Severe hepatic disease
Coadministration or within 2 weeks of MAOIs
Cautions
Cautions with history of hypertension, peripheral vascular disease, and after recent cardiovascular events
Acetaminophen
- Reports of acute liver failure, at times resulting in liver transplant and death; most of the cases of liver injury are associated with doses exceeding 4 g/day, and often involve >1 acetaminophen-containing product (see Black Box Warnings)
- Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash
- Postmarketing reports of hypersensitivity and anaphylaxis
Pregnancy & Lactation
Pregnancy Category: C Lactation: Unknown if distributed in human breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Acetaminophen: Nonnarcotic analgesic; reduces the perception of pain impulses originating from dilated cerebral vessels
Caffeine: Cranial vasoconstrictor; enhances vasoconstrictor effect of isometheptene; also used as a central stimulant for relief of headache
Isometheptene: Sympathomimetic amine that acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
