Generic Name: acetaminophen/isometheptene/caffeine (a-SEET-a-MIN-oh-fen/EYE-soe-meth-EPP-teen/KAF-een)
Brand Name: Examples include Migralam and Proctrin
Proctrin contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.
Proctrin is used for:
Treating certain types of headaches (tension, vascular). It may also be used to treat migraine headaches or for other conditions as determined by your doctor.
Proctrin is a combination analgesic, xanthene derivative, and sympathomimetic. It works by decreasing pain and narrowing the blood vessels in the head and brain.
Do NOT use Proctrin if:
- you are allergic to any ingredient in Proctrin
- you have glaucoma, severe kidney problems, high blood pressure, heart problems, or liver problems
- you are taking droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Proctrin:
Some medical conditions may interact with Proctrin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day
- if you have liver or kidney problems, hepatitis, high blood pressure, heart problems, blood vessel problems, or the blood disease porphyria
- if you have had a recent heart attack
- if you have anxiety or trouble sleeping
Some MEDICINES MAY INTERACT with Proctrin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), quinolones (eg, ciprofloxacin), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Proctrin may be increased
- Droxidopa because the risk of severe heart problems, including irregular heartbeat or heart attack, may be increased
- Furazolidone or MAOIs (eg, phenelzine) because the risk of severe side effects, such as severe headache, high blood pressure, or high fever, may be increased
- Isoniazid or other medicines that may harm the liver (eg, methotrexate, ketoconazole) because the risk of side effects on the liver may be increased. Talk with your doctor if you are unsure if any of your medicines may harm the liver.
- Anticoagulants (eg, warfarin), bromocriptine, or theophylline because the side effects may be increased by Proctrin
- Guanadrel or guanethidine because their effectiveness may be decreased by Proctrin
This may not be a complete list of all interactions that may occur. Ask your health care provider if Proctrin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Proctrin:
Use Proctrin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Proctrin may be taken with or without food.
- For a migraine headache - Take Proctrin at the first sign of a headache. If the initial dose does not relieve your headache, additional doses may be needed according to your doctor's instructions. Do not take a dose of Proctrin within 60 minutes of your last dose. Do not take more than 5 capsules or tablets within a 12-hour period.
- For a tension headache - Do not take more than 8 capsules or tablets within a 24-hour period.
- If you miss a dose of Proctrin and you still have a headache, take it as soon as you remember. If you need to take additional doses, continue to follow your doctor's dosing instructions. Do not take Proctrin more often than directed. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Proctrin.
Important safety information:
- Proctrin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Proctrin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Proctrin contains acetaminophen. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.
- If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Proctrin or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Proctrin may increase your risk for liver damage.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Use Proctrin with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Proctrin during pregnancy. Proctrin is found in breast milk. If you are or will be breast-feeding while you are using Proctrin, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Proctrin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; right-sided abdominal pain or tenderness; unusual fatigue; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody vomit; dark urine; excessive sweating; extreme fatigue; irregular heartbeat; nausea and vomiting; stomach pain.Proper storage of Proctrin:
Store Proctrin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Proctrin out of the reach of children and away from pets.
- If you have any questions about Proctrin, please talk with your doctor, pharmacist, or other health care provider.
- Proctrin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Proctrin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Proctrin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Proctrin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Proctrin.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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