Acetaminophen, dichloralphenazone, and isometheptene

Name: Acetaminophen, dichloralphenazone, and isometheptene

What is acetaminophen, dichloralphenazone, and isometheptene?

Acetaminophen is a pain reliever and a fever reducer.

Dichloralphenazone is a sedative that slows the central nervous system.

Isometheptene causes narrowing of blood vessels (vasoconstriction).

Acetaminophen, dichloralphenazone, and isometheptene is a combination medicine used to treat migraine headaches or severe tension headaches.

Acetaminophen, dichloralphenazone, and isometheptene may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

You should not take this medicine if you have liver disease, severe kidney disease, glaucoma, high blood pressure, heart disease, coronary artery disease, circulation problems, peripheral vascular disease, or if you have recently had a stroke or heart attack.

To make sure this medicine is safe for you, tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

What happens if I miss a dose?

Since this medicine is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using acetaminophen, dichloralphenazone, and isometheptene.

Do not take more than 5 capsules in 12 hours to treat a migraine, or 8 capsules in 24 hours to treat a tension headache.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling sleepy.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Precautions

Contraindicated in patients with severe renal or hepatic dysfunction.

Acetaminophen / dichloralphenazone / isometheptene mucate Pregnancy Warnings

Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Dichloralphenazone has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Isometheptene has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/dichloralphenazone/isometheptene should only be given during pregnancy when need has been clearly established.

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to non-pregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.

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