ISOMETHEPTENE/ACETAMINOPHEN/CAFFEINE - ORAL

PHONETIC PRONUNCIATION:

GENERIC NAME(S): isometheptene mucate/caffeine/acetaminophen

Uses

USES: This combination medication is used to relieve tension and migraine headaches. Headache pain can sometimes be caused by widened blood vessels in the head. Isometheptene works by narrowing these widened blood vessels. Caffeine also works by narrowing widened blood vessels in the head, and is a mild stimulant. Acetaminophen relieves mild to moderate pain from various causes, including headache.

How to use ISOMETHEPTENE/ACETAMINOPHEN/CAFFEINE - ORAL

HOW TO USE: See also Warning section. Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your medical condition and response to treatment. For migraine headache, take this medication at the first sign of a migraine as directed by your doctor, usually 1 to 2 tablets first, followed by 1 tablet every hour until the headache is relieved. Do not take more than 5 tablets in a 12-hour period. For tension headache, take as directed by your doctor, usually every 4 hours as needed. Do not take more than 8 tablets in a 24-hour period. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.

Side Effects

SIDE EFFECTS: See also Warning section. Dizziness, trouble sleeping, nervousness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before taking this medication, tell your doctor or pharmacist if you are allergic to isometheptene, acetaminophen, or caffeine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands), high blood pressure, glaucoma, heart problems (such as chest pain, previous heart attack), kidney disease, liver disease, stroke or "mini-stroke" (transient ischemic attack), use/abuse of alcohol. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Acetaminophen and caffeine pass into breast milk. It is unknown if isometheptene passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: ketoconazole. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. This medication may interfere with certain medical/laboratory tests (including urine catecholamine/5-HIAA levels, dipyridamole-thallium imaging), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine, irregular heartbeat.

Images

PRODRIN CAPLET

color: white
shape: oblong
imprint: PRODRIN

ISOMETHEPT-CAFF-ACETAMINOPHEN

color: white
shape: oblong
imprint: SP 325

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Faq for ISOMETHEPTENE/ACETAMINOPHEN/CAFFEINE - ORAL

What is Isometheptene/Acetaminophen/Caffeine – Oral used for

Isometheptene/Acetaminophen/Caffeine – Oral is a combination medication used to treat tension headaches.

How does Isometheptene/Acetaminophen/Caffeine – Oral work

Isometheptene constricts blood vessels, acetaminophen relieves pain, and caffeine enhances the effects of acetaminophen.

What is the recommended dosage for Isometheptene/Acetaminophen/Caffeine – Oral

The recommended dosage varies based on individual needs. It is important to follow the instructions provided by your doctor or pharmacist.

What are the common side effects of Isometheptene/Acetaminophen/Caffeine – Oral

Common side effects include dizziness, lightheadedness, upset stomach, and increased heart rate. If any severe or persistent side effects occur, contact your healthcare provider.

Can Isometheptene/Acetaminophen/Caffeine – Oral be used with other medications

It is important to inform your doctor about all the medications you are currently taking before starting Isometheptene/Acetaminophen/Caffeine – Oral. Certain drugs may interact and cause adverse effects.

Can Isometheptene/Acetaminophen/Caffeine – Oral be used during pregnancy

It is recommended to consult a healthcare professional before using any medications during pregnancy. The potential risks and benefits should be evaluated.

Can Isometheptene/Acetaminophen/Caffeine – Oral be used while breastfeeding

It is advisable to consult with a healthcare provider before using this medication while breastfeeding. Certain components may pass into breast milk and affect the nursing infant.

How quickly does Isometheptene/Acetaminophen/Caffeine – Oral start working

The onset of action may vary from person to person. It is generally recommended to take the medication early on during the headache to achieve timely relief.

Can Isometheptene/Acetaminophen/Caffeine – Oral be used for migraines

This medication is specifically indicated for tension headaches and may not be as effective for migraines. It is recommended to consult with your doctor for appropriate migraine treatment options.

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Warning

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take. Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine. Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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