Isometheptene/Dichloralphenazone/Acetaminophen, Oral

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KEY POINTS

• This medicine is taken by mouth to relieve pain caused by migraine and tension headaches. Take it exactly as directed. Taking other medicines that contain acetaminophen while you take this medicine may lead to an overdose.
• This medicine may cause severe liver damage or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: analgesic (pain reliever)

Generic and brand names: isometheptene/dichloralphenazone/acetaminophen, oral

What is this medicine used for?

This medicine is a combination product used to relieve pain of migraine and tension headaches.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Circulation problems
• G6PD deficiency
• Glaucoma
• Severe kidney disease
• High blood pressure
• Heart disease
• Liver disease
• Problems with alcohol abuse

Tell your healthcare provider if you are taking an MAO inhibitor such as isocarboxazid, phenelzine, selegiline, or tranylcypromine. Do not take this medicine and an MAO inhibitor within 14 days of each other.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do NOT take more than prescribed. If the amount of medicine you are prescribed does not relieve your headache, contact your healthcare provider.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you are taking this medicine on a regular schedule and you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, stomach pain, sweating, seizures, confusion, irregular heartbeat, dark urine, yellowing of the skin or eyes.

What should I watch out for?

This medicine may cause severe liver damage if:

• An adult takes more than 4000 mg of acetaminophen in 24 hours
• A child takes more than 5 doses in 24 hours
• You take this medicine with other drugs that contain acetaminophen
• An adult has 3 or more alcoholic drinks every day while using this product

Check the labels of all nonprescription and prescription medicines you take. Taking other medicines that contain acetaminophen while you take this medicine may lead to an overdose. Ask your healthcare provider or pharmacist if you have any questions.

Do not drink alcohol while taking this medicine. Talk with your healthcare provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Extreme tiredness or weakness; yellowing of the skin or eyes; severe headache; rash.

Other: Dizziness, drowsiness, nausea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Acetaminophen and medicines that contain acetaminophen
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion)
• Antidepressants such as amitriptyline, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Cholestyramine (Prevalite)
• Diflunisal
• Doxepin (Silenor)
• Ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Imatinib (Gleevec)
• Isoniazid
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Milnacipran (Savella)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Rifampin (Rifadin)
• Sleeping pills such as eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Spironolactone (Aldactone)
• Warfarin (Coumadin)

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.