ISOMETHEPTENE/ACETAMINOPHEN/DICHLORALPHENAZONE - ORAL

ISOMETHEPTENE/ACETAMINOPHEN/DICHLORALPHENAZONE - ORAL

PHONETIC PRONUNCIATION: (EYE-soe-meth-EP-teen/a-SEET-a-MIN-oh-fen/ DYE-klor-al-FEN-a-zone)

COMMON BRAND NAME(S): Midrin

GENERIC NAME(S): isometheptene mucate/dichloralphenazone/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. Acetaminophen relieves mild to moderate pain from various causes, including headache. Dichloralphenazone has a calming effect to help you relax.


How to use ISOMETHEPTENE/ACETAMINOPHEN/DICHLORALPHENAZONE - 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 2 capsules first, followed by 1 capsule every hour until the headache is relieved. Do not take more than 5 capsules 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 capsules 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. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. 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, drowsiness, 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 dichloralphenazone; or to chloral hydrate; 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, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stroke or "mini-stroke" (transient ischemic attack). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. 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, tell your doctor or dentist 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. This medication 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. Some products that may interact with this drug include: ketoconazole, sodium oxybate. 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. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy, cough-and-cold products, diet aids) because they may contain ingredients that cause drowsiness or could increase your blood pressure. Ask your pharmacist about using those products safely. This medication may interfere with certain laboratory tests (including certain urine glucose tests, urine catecholamine/5-HIAA levels), 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.

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ISOMETHEPT-DICHLORALP-ACETAMIN

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Faq for ISOMETHEPTENE/ACETAMINOPHEN/DICHLORALPHENAZONE - ORAL

Isometheptene/Acetaminophen/Dichloralphenazone is a combination medication used for the treatment of tension headaches.

Isometheptene/Acetaminophen/Dichloralphenazone works by narrowing blood vessels in the brain, reducing inflammation, and providing analgesic (pain-relieving) effects.

Common side effects may include dizziness, drowsiness, upset stomach, nausea, and dry mouth. If you experience any severe side effects, consult your doctor immediately.

It is advised to consult with your healthcare provider before taking this medication while pregnant or breastfeeding to assess any potential risks and benefits.

Follow the instructions provided by your doctor or read the medication guide. Usually, it is taken by mouth with or without food, as directed by your healthcare professional.

It is not recommended to consume alcohol while taking this medication as it may increase the risk of certain side effects such as drowsiness and dizziness.

If you miss a dose, take it as soon as you remember. However, if it is near the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

It is essential to inform your healthcare provider about all the medications you are currently taking, including prescription, over-the-counter drugs, and herbal supplements. Certain medications may interact with Isometheptene/Acetaminophen/Dichloralphenazone and cause adverse effects.

The onset of action varies among individuals. However, most people experience relief within 30 to 60 minutes after taking the medication.


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.