Isometheptene-Dichloralphenazone-Acetaminophen

Isometheptene-Dichloralphenazone-Acetaminophen is a combination medication used to treat migraine headaches or severe tension headaches.

• Isometheptene-Dichloralphenazone-Acetaminophen is available under the following different brand names: Midrin

Common side effects of Isometheptene-Dichloralphenazone-Acetaminophen include:

• dizziness
• drowsiness
• mood changes
• nausea

Serious side effects of Isometheptene-Dichloralphenazone-Acetaminophen include:

• rash
• itching
• swelling of the face, tongue, or throat
• severe dizziness
• trouble breathing

Rare side effects of Isometheptene-Dichloralphenazone-Acetaminophen include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule: Schedule IV

• 65 mg/100 mg/325 mg

Migraine headache

Adult dosage

• Two capsules orally at the onset of headache, then 1 capsule orally every 1 hour until headache relieved; up to a cumulative dose of 5 capsules/12 hours

Tension headache

Adult dosage

• 1-2 capsules orally every 4 hours; not to exceed 8 capsules/24 hours

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Isometheptene-Dichloralphenazone-Acetaminophen has severe interactions with the following drugs:
  • isocarboxazid
  • linezolid
  • phenelzine
  • selegiline transdermal
  • tranylcypromine
• Isometheptene-Dichloralphenazone-Acetaminophen has serious interactions with the following drugs:
  • lonafarnib
  • metoclopramide intranasal
  • olopatadine intranasal
  • pexidartinib
  • pretomanid
  • ropeginterferon alfa 2b
• Isometheptene-Dichloralphenazone-Acetaminophen has moderate interactions with the following drugs:
  • apalutamide
  • atogepant
  • avapritinib
  • axitinib
  • bupivacaine implant
  • busulfan
  • cenobamate
  • dapsone topical
  • daridorexant
  • difelikefalin
  • droxidopa
  • eltrombopag
  • midazolam intranasal
• Isometheptene-Dichloralphenazone-Acetaminophen has serious interactions with at least 49 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Hepatitis or hepatic disease
• Glaucoma
• Severe renal impairment
• Hypertension
• Peripheral vascular disease
• Cardiovascular insufficiency, including recent myocardial infarction (MI) or stroke
• Organic heart disease
• Should not be taken within 14 days of taking monoamine oxidase (MAO) inhibitors

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Isometheptene-Dichloralphenazone-Acetaminophen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Isometheptene-Dichloralphenazone-Acetaminophen?”

Cautions

• Acetaminophen use is associated with rare but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; symptoms may include skin redness, blisters, and rash
• May increase respiratory depressant effects; use caution in patients with head injury, chronic obstructive pulmonary disease, or other conditions with decreased respiratory drive
• Controlled substance (dichloralphenazone); may cause tolerance/dependence
• If therapy seems to become less effective over time, it may be a sign that the patient is becoming dependent on the medication; dose should not be increased to improve relief
• If a new headache occurs within 1 day after taking the medication, or if a headache begins to occur every day or continues for several days in a row, it may be a sign of becoming dependent on the medication; continuing therapy when this occurs may cause even more headaches over time; ask the healthcare professional how to relieve the headaches
• May cause sedation and dizziness, and the patient may become less alert; these effects may increase if additional CNS depressants are coadministered with this medication; medications that may increase CNS effects may include barbiturates, narcotics, antiseizure medications, muscle relaxants, antihistamines, and anesthetics; if unable to lie down after taking the medication, make sure to know how the medication affects alertness before driving or using heavy machinery
• Consuming alcoholic beverages while receiving therapy may increase the risk for liver damage caused by acetaminophen, especially if consuming large amounts of alcohol; alcoholic beverages may also make headaches worse or cause new headaches to occur; alcohol consumption should be avoided by those who experience frequent headaches
• Use caution in patients with known glucose 6-phosphate dehydrogenase or G6PD deficiency; hemolysis reported rarely with acetaminophen use

Pregnancy and Lactation

• Refer to individual monographs
• Lactation
  • Refer to individual monographs