Apap/caffeine/isometheptene mucate

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What is the most important information I should know about APAP/caffeine/isometheptene mucate?

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), o tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.

Do not use more of this medication than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day.

Do not use diet pills, stimulants, or any other cold, allergy, pain, migraine, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP”) and caffeine are contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen or caffeine. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or caffeine.

If you drink more than 3 alcoholic beverages per day, talk with your doctor before taking any medication that contains acetaminophen. Alcohol may increase your risk of liver damage while taking acetaminophen.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is APAP/caffeine/isometheptene mucate?

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.

The combination of acetaminophen, caffeine, and isometheptene is used to treat migraine headaches or severe tension headaches.

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

Precautions

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

glaucoma;
severe kidney disease;
severe liver disease (especially cirrhosis);
severe or uncontrolled high blood pressure; or
heart disease.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

kidney or liver disease;
a history of alcoholism;
high blood pressure;
blood circulation problems; or
if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take acetaminophen, caffeine, and isometheptene, tell your doctor if you are pregnant.

This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Avoid drinking alcohol. Alcohol may increase your risk of liver damage while taking acetaminophen.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. They can add to the side effects of the caffeine in the medication.

Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

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.

Since acetaminophen, caffeine, and isometheptene is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Side Effects

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

Stop using acetaminophen, caffeine, and isometheptene and call your doctor at once if you have a serious side effect such as:

low fever with nausea, stomach pain, and loss of appetite;
dark urine, clay-colored stools; or
jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

dizziness;
mild skin rash;
sleep problems (insomnia); or
feeling nervous, irritable, or jittery.

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.

Interactions

There may be other drugs that can interact with acetaminophen, caffeine, and isometheptene. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.