isometheptene/dichloralphenazone/acetaminophen (Rx)

Brand and Other Names:Midrin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

isometheptene/dichloralphenazone/acetaminophen

capsule: Schedule IV

  • 65mg/100mg/325mg
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Migraine Headache

2 capsules PO at onset of headache, then 1 capsule PO q1hr until headache relieved up to a cumulative dose of 5 capsules/12 hr

Tension Headache

1-2 capsules PO q4hr; not to exceed 8 capsules/24 hr

Safety and efficacy not established

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Interactions

Interaction Checker

and isometheptene/dichloralphenazone/acetaminophen

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

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          Minor

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            Adverse Effects

            Frequency Not Defined

            Rash

            Transient dizziness

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            Warnings

            Contraindications

            Hypersensitivity

            Hepatitis or severe hepatic/renal impairment

            Glaucoma

            Severe renal impairment

            Hypertension

            Heart disease

            Hepatic impairment

            Within 14 days of MAO inhibitors

            Cautions

            Risk of hepatotoxicity higher in alcoholics, or with use of more than one acetaminophen-containing product

            Acetaminophen: 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

            G6PD deficiency

            May cause sedation; avoid driving car or operating machinery

            May increase respiratory depressant effects; caution with head injury, COPD, or other conditions with decreased respiratory drive

            Controlled substance (dichloralphenazone); may cause tolerance/dependence

            Caution in cardiovascular disease, hepatic impairment, G6PD deficiency

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Excreted in breast milk; caution advised

            Dichloralphenazone: prodrug of chloral hydrate and phenazone; trichloroethanol (active metabolite of chloral hydrate), acetaminophen, and phenazine are excreted in breast milk

            According to the American Academy of Pediatrics, chloral hydrate and acetaminophen are compatible with breastfeeding

            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.

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            Pharmacology

            Mechanism of Action

            Isometheptene: Elicits sympathomimetic effect; constricts dilated cerebral/cranial arterioles

            Dichloralphenazone: Elicits mild sedative effect; reduces emotional response to painful stimulus

            Acetaminophen: Inhibitis prostaglandin sythesis in CNS and may block peripheral pain impulse generation; acts on hypothalamus to antipyresis

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            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.
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