Butalbital-Asp-Caffeine

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: acetazolamide, darunavir, dichlorphenamide, ketorolac, lithium, 6-mercaptopurine, methotrexate, methoxyflurane, mifepristone, phenytoin, sodium oxybate, certain antibiotics (including penicillin, sulfonamides such as sulfamethoxazole), certain drugs used to treat gout (including uricosuric drugs such as probenecid, sulfinpyrazone).

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

This drug can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include doxycycline, estrogen, felodipine, lonafarnib, quinidine, rilpivirine, tamoxifen, theophylline, voriconazole, certain beta blockers (such as metoprolol), corticosteroids (such as prednisone), among others.

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 (cannabis), 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 (allergy or cough-and-cold products, other headache medications) because they may contain aspirin, caffeine, or ingredients that cause drowsiness. Also keep in mind that certain beverages (such as coffee, colas, tea) contain caffeine. Ask your pharmacist about using those products safely.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac, naproxen). These drugs are similar to this medication and may increase your risk of side effects if taken together. Ask your doctor or pharmacist for more details.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain medical/lab tests (such as fasting blood glucose, cholesterol levels, prothrombin time, urine 5-HIAA levels, urine VMA levels, certain urine glucose tests, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for migraine headaches.

Nausea, vomiting, stomach upset, gas, shaking (tremor), lightheadedness, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes, fainting, fast/irregular heartbeat, increased thirst/urination, hearing changes (such as ringing in the ears), easy bruising/bleeding, heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, signs of kidney problems (such as change in the amount of urine), unusual tiredness.

Get medical help right away if you have any very serious side effects, including: black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, trouble speaking, weakness on one side of the body.

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: fever, swollen lymph nodes, 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Do not share this medication with others. Sharing it is against the law.

Massage, hot baths, and other relaxation methods can help with tension headaches. Consult your doctor or pharmacist for more details.

Lab and/or medical tests (such as liver/kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Take this medication by mouth as directed by your doctor, usually every 4 hours as needed. Do not take more than 6 capsules/tablets in a 24-hour period. Take with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. To help prevent stomach upset, take it with food or milk.

The dosage is based on your medical condition and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Use the smallest effective dose. Properly stop the medication when so directed.

Inform your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea/vomiting that doesn't stop, severe drowsiness, slow breathing, severe dizziness, ringing in the ears.