Isometheptene mucate, dichloralphenazone and acetaminophen

Isometheptene mucate, dichloralphenazone and acetaminophen
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Black Box Warning

LIVER WARNING See full prescribing information for complete Boxed Warning. * This product contains acetaminophen. Severe liver damage may occur if a person takes: More than 4,000 mg of acetaminophen in 24 hours With other drugs containing acetaminophen With 3 or more alcoholic drinks everyday while using this product.

Overview

Isometheptene mucate, dichloralphenazone and acetaminophen is an analgesic that is FDA approved for the treatment of migraine headache. There is a Black Box Warning for this drug as shown here. Common adverse reactions include liver toxicity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Based on a review of this drug (isometheptene mucate) by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the other indication as "possibly" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation.
• Do not exceed the recommended dosage because severe liver damage may occur.
• Tell your doctor about all usage of pain relievers.

FOR RELIEF OF MIGRAINE HEADACHE

• The usual adult dosage is two capsules at once, followed by one capsule every hour until relieved, up to 5 capsules within a twelve hour period.

FOR RELIEF OF TENSION HEADACHE

• The usual adult dosage is one or two capsules every four hours up to 8 capsules a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isometheptene mucate, dichloralphenazone and acetaminophen in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isometheptene mucate, dichloralphenazone and acetaminophen in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isometheptene mucate, dichloralphenazone and acetaminophen in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isometheptene mucate, dichloralphenazone and acetaminophen in pediatric patients.

Contraindications

• ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE AND ACETAMINOPHEN CAPSULES, USP is contraindicated in:

• Hypersensitivity or intolerance to any component of this product
• Cardiovascular or cerebrovascular insufficiency, including recent myocardial infarction or stroke

• Glaucoma
• Severe cases of renal disease
• Hypertension
• Organic heart disease
• Peripheral vascular disease
• Hepatic disease

Warnings

LIVER WARNING See full prescribing information for complete Boxed Warning. * This product contains acetaminophen. Severe liver damage may occur if a person takes: More than 4,000 mg of acetaminophen in 24 hours With other drugs containing acetaminophen With 3 or more alcoholic drinks everyday while using this product.

• Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks.
• This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Remember that alcohol may be a cause of headaches.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Clinical Trials Experience in the drug label.

Postmarketing Experience

• There is a potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash). A very serious allergic reaction, called anaphylaxis, to this drug is unlikely, but if it occurs, discontinue the drug and seek immediate medical attention.
• Transient dizziness, drowsiness, and nausea may occur. This can usually be eliminated by reducing the dose. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
• This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Interactions

• This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate.
• Avoid MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.
• Consider drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., cyclobenzaprine), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).
• This medication may interfere with certain laboratory tests (including certain urine glucose tests, urine catecholamine levels, urine 5-HIAA levels), possibly causing false test results.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• FDA has not assigned a pregnancy category for acetaminophen, dichloralphenazone, or isometheptene. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy.
• Acetaminophen crosses the placenta and is believed to be safe in pregnancy when used intermittently for short durations. No controlled studies have been done to establish the safety of dichloralphenazone or isometheptene or of their combination with acetaminophen. Isometheptene Mucate, Dichloralphenazone and Acetaminophen Capsules, USP should only be given during pregnancy when need has been clearly established.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isometheptene mucate, dichloralphenazone and acetaminophen in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Isometheptene mucate, dichloralphenazone and acetaminophen during labor and delivery.

Nursing Mothers

• Acetaminophen is excreted into human milk in small concentrations. Metabolites of dichloralphenazone are excreted into human milk. There are no data on the excretion of isometheptene into human milk. Problems in humans have not been documented.

Pediatric Use

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatic Use

• There is no specific published information comparing use of this combination medicine in the elderly with use in other age groups. Geriatric patients are more likely to have peripheral vascular disease, and are therefore more likely to be adversely affected by peripheral vasoconstriction, than are younger adults. However, isometheptene may be safer for elderly patients than the ergot derivatives used to abort acute vascular headaches. Also, elderly patients are more likely to have age related renal function impairment, which may require caution in patients receiving acetaminophen and isometheptene.

Gender

There is no FDA guidance on the use of Isometheptene mucate, dichloralphenazone and acetaminophen with respect to specific gender populations.

Race

There is no FDA guidance on the use of Isometheptene mucate, dichloralphenazone and acetaminophen with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Isometheptene mucate, dichloralphenazone and acetaminophen in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Isometheptene mucate, dichloralphenazone and acetaminophen in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Isometheptene mucate, dichloralphenazone and acetaminophen in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Isometheptene mucate, dichloralphenazone and acetaminophen in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Isometheptene mucate, dichloralphenazone and acetaminophen and IV administrations.

Overdosage

• If overdose is suspected, contact your local poison control center at 1-800-222-1222. Symptoms of overdose may include: restlessness, severe drowsiness/dizziness, low body temperature, fast/slow breathing, fast/slow/irregular heartbeat, unresponsiveness.

Pharmacology

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Pharmacology in the drug label.

Mechanism of Action

• Isometheptene Mucate, a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. Dichloralphenazone, a mild sedative, reduces the patient's emotional reaction to the pain of both vascular and tension headaches. Acetaminophen raises the threshold to painful stimuli, thus exerting an analgesic effect against all types of headaches.

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Clinical Studies in the drug label.

How Supplied

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen How Supplied in the drug label.

Storage

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Isometheptene mucate, dichloralphenazone and acetaminophen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE, AND ACETAMINOPHEN ®

Look-Alike Drug Names

There is limited information regarding Isometheptene mucate, dichloralphenazone and acetaminophen Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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