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USP DI Vol. II - ANTIDYSKINETICS (Systemic)

ANTIDYSKINETICS (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Akineton 2
  • Artane 5
  • Artane Sequels 5
  • Cogentin 1
  • Kemadrin 4
  • Parsidol 3
  • Trihexane 5
  • Trihexy 5

In Canada?

  • Akineton 2
  • Apo-Benztropine 1
  • Apo-Trihex 5
  • Artane 5
  • Artane Sequels 5
  • Cogentin 1
  • Kemadrin 4
  • Parsitan 3
  • PMS Benztropine 1
  • PMS Procyclidine 4
  • PMS Trihexyphenidyl 5
  • Procyclid 4

Other commonly used names are: Benzatropine Profenamine

Note:

For quick reference, the following antidyskinetics are numbered tomatch the corresponding brand names.

This information applies to the following medicines:
1.Benztropine (BENZ-troe-peen)??
2.Biperiden (bye-PER-i-den)
3.Ethopropazine (eth-oh-PROE-pa-zeen)
4.Procyclidine (proe-SYE-kli-deen)
5.Trihexyphenidyl (trye-hex-ee-FEN-i-dill)?
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

Note:

This information does not apply to Amantadine,Carbidopa and Levodopa, Diphenhydramine, Haloperidol, and Levodopa.


Category

  • Antidyskinetic?Benztropine; Biperiden; Ethopropazine; Procyclidine; Trihexyphenidyl

Description

Antidyskinetics are usedto treat Parkinson's disease, sometimes referred to as ``shaking palsy.''By improving muscle control and reducing stiffness, this medicine allows morenormal movements of the body as the disease symptoms are reduced. It is alsoused to control severe reactions to certain medicines such as reserpine (e.g.,Serpasil) (medicine to control high blood pressure) or phenothiazines, chlorprothixene(e.g., Taractan), thiothixene (e.g., Navane), loxapine (e.g., Loxitane), andhaloperidol (e.g., Haldol) (medicines for nervous, mental, and emotional conditions).

Antidyskinetics may also be used for other conditions as determined byyour doctor.

These medicines are available only with your doctor's prescription in thefollowing dosage forms:

    Oral
  • Benztropine
    • Tablets (U.S. and Canada)
  • Biperiden
    • Tablets (U.S. and Canada)
  • Ethopropazine
    • Tablets (U.S. and Canada)
  • Procyclidine
    • Elixir (Canada)
    • Tablets (U.S. and Canada)
  • Trihexyphenidyl
    • Extended-release capsules (U.S. and Canada)
    • Elixir (U.S. and Canada)
    • Tablets (U.S. and Canada)
    Parenteral
  • Benztropine
    • Injection (U.S. and Canada)
  • Biperiden
    • Injection (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 antidyskinetics,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to antidyskinetics. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. However, antidyskinetics have not been shownto cause problems in humans.

Breast-feeding?It is not known if antidyskinetics pass into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who are taking thesemedicines and who wish to breast-feed should discuss this with their doctor.

Since antidyskinetics tend to decrease the secretions of the body, it ispossible that the flow of breast milk may be reduced in some patients.

Children?Children may be especially sensitive to the effectsof antidyskinetics. This may increase the chance of side effects during treatment.

Older adults?Agitation, confusion, disorientation, hallucinations,memory loss, and mental changes are more likely to occur in elderly patients,who are usually more sensitive to the effects of antidyskinetics.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases 2 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 takingan antidyskinetic, it is especially important that your health care professionalknow if you are taking any of the following:

  • Anticholinergics (medicine for abdominal or stomach spasms or cramps)or
  • Central nervous system (CNS) depressants (medicine that causes drowsiness)or
  • Tricyclic antidepressants (medicine for depression)?Using thesemedicines together with antidyskinetics may result in additive effects, increasingthe chance of unwanted effects

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

  • Difficult urination or
  • Enlarged prostate or
  • Glaucoma or
  • Heart or blood vessel disease or
  • High blood pressure or
  • Intestinal blockage or
  • Myasthenia gravis or
  • Uncontrolled movements of hands, mouth, or tongue?Antidyskineticsmay make the condition worse
  • Kidney disease or
  • Liver disease?Higher blood levels of the antidyskinetics mayresult, increasing the chance of side effects

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, and do not take it for a longer period oftime than your doctor ordered. To do so may increase the chance of side effects.

To lessen stomach upset, take this medicine with meals or immediately aftermeals, unless otherwise directed by your doctor.

Dosing?The dose of antidyskinetics will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of benztropine, biperiden, ethopropazine, procyclidine,and trihexyphenidyl. If your dose is different, do notchange it unless your doctor tells you to do so.

The number of capsules, tablets, or teaspoonfuls of elixir that you takedepends on the strength of the medicine. Also, the numberof doses you take each day, the time allowed between doses, and the lengthof time you take the medicine depend on the medical problem for which youare taking antidyskinetics.

    For benztropine
  • For oral dosage forms (tablets):
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?To start, 0.5 to 4 milligrams (mg) a day, dependingon your condition. Your doctor will adjust your dose as needed; however, thedose is usually not more than 6 mg a day.
      • Children?Use and dose must be determined by your doctor.
  • For injection dosage form:
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?1 to 4 mg a day, depending on your condition. Your doctorwill adjust your dose as needed; however, the dose is usually not more than6 mg a day.
      • Children?Use and dose must be determined by your doctor.
    For biperiden
  • For oral dosage forms (tablets):
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?2 mg up to four times a day. Your doctor will adjustyour dose, depending on your condition; however, the dose is usually not morethan 16 mg a day.
      • Children?Use and dose must be determined by your doctor.
  • For injection dosage form:
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?2 mg, injected into a muscle or vein. The dose may berepeated if needed; however, the dose is usually not given more than fourtimes a day.
      • Children?Use and dose is based on body weight and must be determinedby your doctor.
    For ethopropazine
  • For oral dosage forms (tablets):
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?50 mg one or two times a day. Your doctor will adjustyour dose as needed; however, the dose is usually not more than 600 mg a day.
      • Children?Use and dose must be determined by your doctor.
    For procyclidine
  • For oral dosage forms (elixir or tablets):
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?To start, 2.5 mg three times a day after meals. Yourdoctor may need to adjust your dose, depending on your condition.
      • Children?Use and dose must be determined by your doctor.
    For trihexyphenidyl
  • For extended-release oral dosage forms(extended-release capsules):
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?5 mg after breakfast. Your doctor may add another 5mg dose to be taken twelve hours later, depending on your condition.
      • Children: Use and dose must be determined by your doctor.
  • For other oral dosage forms (elixir ortablets):
    • For Parkinson's disease or certain severe side effects caused bysome other medicines:
      • Adults?To start, 1 to 2 mg a day. Your doctor may adjust yourdose as needed; however, the dose is usually not more than 15 mg a day.
      • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is within 2 hours of your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store the capsule or tablet form of this medicine in the bathroom,near the kitchen sink, or in other damp places. Heat or moisture may causethe medicine to break down.
  • Keep the liquid form of this medicine from freezing.
  • 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

Yourdoctor should check your progress at regular visits, especially for the firstfew months you take this medicine. This will allow your dosage to be changedas necessary to meet your needs.

Your doctor may want you to have your eyes examined by an ophthalmologist(eye doctor) before and also sometime later during treatment.

Do not stop taking this medicine without first checkingwith your doctor. Your doctor may want you to reduce gradually theamount you are taking before stopping completely, to prevent side effectsor the worsening of your condition.

This medicine will add to the effects of alcohol and other CNS depressants(medicines that slow down the nervous system, possibly causing drowsiness).Some examples of CNS depressants are 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; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above whileyou are using this medicine.

Do not take this medicine within 1 hour of taking medicine for diarrhea.Taking these medicines too close together will make this medicine less effective.

If you think you or anyone else has taken an overdose of this medicine,get emergency help at once. Taking an overdose of this medicine may lead tounconsciousness. Some signs of an overdose are clumsiness or unsteadiness;seizures; severe drowsiness; severe dryness of mouth, nose and throat; fastheartbeat; hallucinations (seeing, hearing, or feeling things that are notthere); mood or mental changes; shortness of breath or troubled breathing;trouble in sleeping; and unusual warmth, dryness, and flushing of skin.

This medicine may cause your eyes to become more sensitive to light thanthey are normally. Wearing sunglasses and avoiding too much exposure to brightlight may help lessen the discomfort.

This medicine may cause some people to have blurred vision or to becomedrowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you are dizzy or are not alertor able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when youget up from lying or sitting. Getting up slowly may help. If the problem continuesor gets worse, check with your doctor.

This medicine may make you sweat less, causing your body temperature toincrease. Use extra care to avoid becoming overheatedduring exercise or hot weather while you are taking this medicine, since overheatingmay result in heat stroke. Also, hot baths or saunas may make you feeldizzy or faint while you are taking this medicine.

This medicine may cause dryness of the mouth. For temporary relief, usesugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.However, if your mouth continues to feel dry for more than 2 weeks, checkwith your medical doctor or dentist. Continuing dryness of the mouth may increasethe chance of dental disease, including tooth decay, gum disease, and fungusinfections.


Side Effects of This Medicine

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

Check with your doctor as soon as possibleif any of the following side effects occur:

    Rare

      Confusion (more common in the elderly or with high doses); eye pain; skin rash

    Symptoms of overdose

      Clumsiness or unsteadiness; drowsiness(severe); dryness of mouth, nose, or throat (severe); fast heartbeat; hallucinations(seeing, hearing, or feeling things that are not there); mood or mental changes; seizures; shortness of breath or troubled breathing; troublein sleeping; warmth, dryness, and flushing of skin

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

      Blurred vision; constipation; decreased sweating; difficult or painfulurination (especially in older men); drowsiness; dryness of mouth, nose, or throat; increased sensitivity of eyes to light; nausea orvomiting

    Less common or rare

      Dizziness or lightheadedness when getting up from a lying orsitting position; false sense of well-being (especiallyin the elderly or with high doses); headache; loss of memory (especially in the elderly); muscle cramps; nervousness; numbness or weakness in hands or feet; soreness ofmouth and tongue; stomach upset or pain; unusual excitement (more common with large doses of trihexyphenidyl)

After you stop using this medicine, your body may need time to adjust.The length of time this takes depends on the amount of medicine you were usingand how long you used it. During this period of time check with your doctorif you notice any of the following side effects:

Anxiety; difficulty in speaking or swallowing; dizziness or lightheadedness when getting up froma lying or sitting position; fast heartbeat; loss of balance control; mask-like face; muscle spasms, especially of face, neck, and back; restlessness or desire to keep moving; shuffling walk; stiffness of arms orlegs; trembling and shaking of hands and fingers; trouble in sleeping; twisting movements of body

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.


Revised: 05/11/93