acetaminophen/caffeine/isometheptene (Rx)

Brand and Other Names:Prodrin
  • Print

Dosing & Uses

AdultPediatric

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

Next:

Interactions

Interaction Checker

and acetaminophen/caffeine/isometheptene

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            Frequency Not Defined

            Rash

            Transient dizziness

            Previous
            Next:

            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
            Previous
            Next:

            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.

            Previous
            Next:

            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

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            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.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.