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Artane

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Artane

Artane

INDICATIONS

ARTANE (trihexyphenidyl) is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

DOSAGE AND ADMINISTRATION

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether ARTANE® (trihexyphenidyl HCl) may best be given before or after meals should be determined by the way the patient reacts. Postencephalitic patients, who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances, is sometimes an effective adjuvant. If ARTANE (trihexyphenidyl) tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water.

Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.

Abrupt withdrawal of treatment may result in neuroleptic malignant syndrome (NMS) (see WARNINGS)

Idiopathic Parkinsonism

As initial therapy for parkinsonism, 1 mg of ARTANE (trihexyphenidyl) in tablet or elixir form may be administered the first day. The dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given daily. The total daily dose will depend upon what is found to be the optimal level. Many patients derive maximum benefit from this daily total of 6 to 10 mg, but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg.

Drug-Induced Parkinsonism

The size and frequency of the ARTANE (trihexyphenidyl) dose needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. The total daily dosage usually ranges between 5 and 15 mg although, in some cases, these reactions have been satisfactorily controlled with as little as 1 mg daily. It may be advisable to commence therapy with a single 1 mg dose. If the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer when instituting ARTANE (trihexyphenidyl) therapy and then adjusting the dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions.

It is sometimes possible to maintain the patient on a reduced ARTANE (trihexyphenidyl) dosage after the reactions have remained under control for several days. Instances have been reported in which these reactions have remained in remission for long periods after ARTANE (trihexyphenidyl) therapy was discontinued.

Concomitant Use with Levodopa

When ARTANE (trihexyphenidyl) is used concomitantly with levodopa, the usual dose of each may need to be reduced. Careful adjustment is necessary, depending on side effects and degree of symptom control. An ARTANE (trihexyphenidyl) dosage of 3 to 6 mg daily, in divided doses, is usually adequate.

Concomitant Use with Other Parasympathetic Inhibitors

ARTANE (trihexyphenidyl) may be substituted, in whole or in part, for other parasympathetic inhibitors. The usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of trihexyphenidyl HCl is increased.

ARTANE (trihexyphenidyl) TABLETS and ELIXIR - The total daily intake of ARTANE (trihexyphenidyl) tablets or elixir is tolerated best if divided into 3 doses and taken at mealtimes. High doses ( > 10 mg daily) may be divided into 4 parts, with 3 doses administered at mealtimes and the fourth at bedtime.

HOW SUPPLIED

ARTANE® (trihexyphenidyl HCl) Tablets are available as follows:

2 mg - round, flat, scored, white tablets; engraved “ARTANE (trihexyphenidyl) ” above “2” on one side and “LL” above “A11” below the score on the other side, supplied as follows:

NDC 0005-4434-23 - Bottle of 100
NDC 0005-4434-34 - Bottle of 1000

5 mg - round, flat, scored, white tablets; engraved “ARTANE (trihexyphenidyl) ” above “5” on one side and “LL” above “A12” below the score on the other side, supplied as follows:

NDC 0005-4436-23 - Bottle of 100
NDC 0005-4436-34 - Bottle of 1000

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Dispense in tight containers as defined in the USP.

ALSO AVAILABLE

ARTANE (trihexyphenidyl) is available in Elixir as follows:

2 mg/5 mL - NDC 0005-4440-65 - Bottle of 16 fl oz

Store at controlled room temperature 20° to 25°C (68° to 77°F).

DO NOT FREEZE.

Dispense in tight containers as defined in the USP.

Lederle Pharmaceutical Division of American Cyanamid Company, Pearl River, NY 10965. Rev 03/03.

Last reviewed on RxList: 3/16/2009
This monograph has been modified to include the generic and brand name in many instances.

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