Acetaminophen, caffeine, and isometheptene

Name: Acetaminophen, caffeine, and isometheptene

What is acetaminophen, caffeine, and isometheptene?

Acetaminophen is a pain reliever and a fever reducer.

Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).

Isometheptene also causes narrowing of blood vessels.

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

Acetaminophen, caffeine, 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 use this medicine if you have liver disease, severe kidney disease, heart disease, high blood pressure, or glaucoma.

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 medicine 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 should I discuss with my healthcare provider before taking this medicine?

Do not use acetaminophen, caffeine, and isometheptene 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.

You should not take this medicine if you are allergic to acetaminophen (Tylenol), caffeine, or isometheptene, or if you have:

  • glaucoma;

  • severe kidney disease;

  • liver disease, cirrhosis;

  • high blood pressure; or

  • heart disease.

To make sure this medicine is safe for you, tell your doctor if you have:

  • a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

  • blood circulation problems; or

  • if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether acetaminophen, caffeine, and isometheptene will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take this medicine?

Follow all directions on your prescription label. Do not take more of this medicine than is recommended. An overdose of acetaminophen can damage your liver or cause death.

To treat migraine headache pain:

  • Take the first dose of this medicine as soon as you notice headache symptoms, or after an attack has already begun.

  • If your headache does not completely go away, take 1 tablet every hour until you feel relief.

  • Do not take more than a total of 5 tablets in any 12-hour period to treat a migraine.

  • If you still have migraine symptoms after taking a total of 5 tablets, call your doctor.

To treat tension headache pain:

  • Take the first dose of this medicine as soon as you notice tension headache symptoms.

  • If your headache does not completely go away, take 1 tablet every 4 hours until you feel relief.

  • Do not take more than a total of 8 tablets in any 24-hour period to treat a tension headache.

  • If you still have tension headache pain after taking a total of 8 tablets, call your doctor.

Store at room temperature away from moisture and heat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen, caffeine, and isometheptene can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

This medicine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no 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. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • liver problems--nausea, upper stomach pain, itching, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • dizziness;

  • sleep problems (insomnia); or

  • feeling anxious or restless.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Liver Dose Adjustments

Use with caution in patients with mild or moderated liver disease. Chronic use of acetaminophen is not recommended in patients with liver disease.

Acetaminophen / caffeine / isometheptene mucate Pregnancy Warnings

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 nonpregnant 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. In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly. One study (n=18,478) on the consumption of coffee (with caffeine regarded as the key component in studies of the potential effects of coffee) found that pregnant women who drank 8 or more cups of coffee a day had more than twice the risk of delivering a stillbirth compared with women who did not drink coffee during pregnancy. However, as one letter regarding this study states, the "article raises more issues than it settles" including how much of increase in stillbirths was actually due to the increase in caffeine consumption. Another letter responding to this study claims that consumption of 8 or more cups of coffee is suggestive of addictive behavior. Those with addictive behavior are more likely to be smokers, have a high intake of alcohol, and use illegal drugs. Other questions regarding this study were also raised. Therefore, it has been questioned if the increased risk of delivering a stillbirth that the study associated with consumption of 8 or more cups of coffee per day can be associated with increased risk from increased caffeine consumption.

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. The drug caffeine in general has not been formally assigned to pregnancy category by the FDA. (However, caffeine citrate injection has been assigned to pregnancy category C.) Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus have been similar to those in the mother. One case of maternal caffeine-induced hypokalemic paralysis has been reported. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit their intake of caffeine to a minimum. 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/caffeine/isometheptene mucate should only be given during pregnancy when need has been clearly established.

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