Dosing and uses of Prodrin (acetaminophen/caffeine/isometheptene)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Safety and efficacy not established
Prodrin (acetaminophen/caffeine/isometheptene) adverse (side) 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 and 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 of Prodrin (acetaminophen/caffeine/isometheptene)
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
