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USP DI Vol. II - ISOMETHEPTENE,DICHLORALPHENAZONE, AND ACETAMINOPHEN (Systemic)

ISOMETHEPTENE,DICHLORALPHENAZONE, AND ACETAMINOPHEN (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Amidrine
  • Duradrin
  • I.D.A
  • Iso-Acetazone
  • Isocom
  • Midchlor
  • Midrin
  • Migrapap
  • Migquin
  • Migratine
  • Migrazone
  • Migrend
  • Migrex
  • Mitride

Generic name product may be available in the U.S.

? Not commercially available in Canada.


Category

  • Vascular headache suppressant, migraine

Description

Isometheptene,dichloralphenazone, and acetaminophen (eye-soe-meth-EP-teen, dye-klor-al-FEN-a-zone, and a-seat-a-MIN-oh-fen ) combination is used to treat certain kinds of headaches, such as ?tension?headaches and migraine headaches. This combination is not used regularly (forexample, every day) to prevent headaches. It should be taken only after headachepain begins, or after a warning sign that a migraine is coming appears. Isometheptenehelps to relieve throbbing headaches, but it is not an ordinary pain reliever.Dichloralphenazone helps you to relax, and acetaminophen relieves pain.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

    Oral
  • Capsules (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For this combinationmedicine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to acetaminophen or to this combination medicine. Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies with this combination medicine have not beendone in either humans or animals.

Breast-feeding?Acetaminophen passes into the breast milk in smallamounts. However, this medicine has not been shown to cause problems in nursingbabies.

Children?Studies with this medicine have been done only inadult patients, and there is no specific information about its use in children.

Older adults?Many medicines have not been tested in older people.Therefore, it may not be known whether they work exactly the same way theydo in younger adults or if they cause different side effects or problems inolder people. There is no specific information comparing use of this combinationmedicine in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingthis combination medicine, it is especially important that your health careprofessional know if you are taking any of the following:

  • Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline[e.g., Eldepryl], tranylcypromine [e.g., Parnate])?Taking this combinationmedicine while you are taking or within 2 weeks of taking a monoamine oxidase(MAO) inhibitor may increase the chance of side effects

Other medical problems?The presence of other medicalproblems may affect the use of this medicine. Make sure you tell your doctorif you have any other medical problems, especially:

  • Alcohol abuse or
  • Heart attack (recent) or
  • Heart or blood vessel disease or
  • Kidney disease or
  • Liver disease or
  • Stroke (recent) or
  • Virus infection of the liver (viral hepatitis)?The chance ofside effects may be increased
  • Glaucoma, not well controlled, or
  • High blood pressure (hypertension), not well controlled?Theisometheptene in this combination medicine may make these conditions worse

Proper Use of This Medicine

Take this medicine only as directed by your doctor. Do not take moreof it, do not take it more often than directed, and do not take it every dayfor several days in a row. If the amount you are to take does not relieveyour headache, check with your doctor. If a headache medicine is used toooften, it may lose its effectiveness or even cause a type of physical dependence.If this occurs, your headaches may actually get worse. Also, taking too muchacetaminophen can cause liver damage.

This medicine works best if you:

  • Take it as soon as the headache begins.If you get warning signals of a migraine, take this medicine as soon as youare sure that the migraine is coming. This may even stop the headache painfrom occurring.
  • Lie down in a quiet, dark room until you arefeeling better.

People who get a lot of headaches may need to take a different medicineto help prevent headaches. It is important that you followyour doctor's directions, even if your headaches continue to occur.Headache-preventing medicines may take several weeks to start working. Evenafter they do start working, your headaches may not go away completely. However,your headaches should occur less often, and they should be less severe andeasier to relieve, than before. This will reduce the amount of headache relieversthat you need. If you do not notice any improvement after several weeks ofheadache-preventing treatment, check with your doctor.

Dosing?The dose of this combination medicine willbe different for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of this medicine. If your doseis different, do not change it unless your doctor tells you to do so.

  • For ?tension? headaches:
    • Adults: 1 or 2 capsules every 4 hours, as needed. Not more than 8capsules a day.
    • Children: Dose must be determined by the doctor.
  • For migraine headaches:
    • Adults: 2 capsules for the first dose, then 1 capsule every hour,as needed. Not more than 5 capsules in 12 hours.
    • Children: Dose must be determined by the doctor.

Storage?To store this medicine

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat and moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor:

  • If the medicine stops working as well as it didwhen you first started using it. This may mean that you are in dangerof becoming dependent on the medicine. Do not try to getbetter relief by increasing the dose.
  • If you are having headaches more often than youdid before you started using this medicine. This is especially importantif a new headache occurs within 1 day after you took your last dose of headachemedicine, headaches begin to occur every day, or a headache continues forseveral days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headacheslater on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter[OTC]) and prescription medicines you now take. Taking other medicinesthat contain acetaminophen together with this medicine may lead to an overdose.If you have any questions about this, check with your health care professional.

This medicine may cause some people to become drowsy, dizzy, or less alertthan they are normally. These effects may be especially severe if you alsotake CNS depressants (medicines that slow down the nervous system, possiblycausing drowsiness) together with this medicine. Some examples of CNS depressantsare antihistamines or medicine for hay fever, other allergies, or colds; sedatives,tranquilizers, or sleeping medicine; prescription pain medicine or narcotics;barbiturates; medicine for seizures; muscle relaxants; antiemetics (medicinesthat prevent or relieve nausea or vomiting), and anesthetics. If you are notable to lie down for a while, make sure you know how youreact to this medicine or combination of medicines before you drive, use machines,or do anything else that could be dangerous if you are drowsy or dizzy orare not alert.

Do not drink alcoholic beverages while taking thismedicine. To do so may increase the chance of liver damage caused byacetaminophen, especially if you drink large amounts of alcoholic beveragesregularly. Also, because drinking alcoholic beverages may make your headachesworse or cause new headaches to occur, people who often get headaches shouldprobably avoid alcohol.


Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

    Less common

      Unusual tiredness or weakness

    Rare

      Black, tarry stools; blood in urineor stools; pinpoint red spots on skin; skin rash, hives, or itching; sore throatand fever; unusual bleeding or bruising; yellow eyes or skin

    Symptoms of dependence on this medicine

      Headaches, more severe and/or more frequent than before

    Symptoms of acetaminophen overdose

      Diarrhea; increased sweating; loss of appetite; nausea or vomiting; pain, tenderness, and/or swelling in the upperabdominal (stomach) area; stomach cramps or pain

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

    More common

      Drowsiness

    Rare

      Dizziness; fast or irregular heartbeat

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.


Revised: 12/22/1999