Benztropine Mesylate (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Benztropine mesylate tablets should be used when patients are able to take oral medication.

Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg, to a maximum of 6 mg, or until optimal results are obtained without excessive adverse reactions.

Postencephalitic and Idiopathic Parkinsonism – The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg orally.

As with any agent used in parkinsonism, dosage must be individualized according to age and weight, and the type of parkinsonism being treated. Generally, older patients, and thin patients cannot tolerate large doses. Most patients with postencephalitic parkinsonism need fairly large doses and tolerate them well. Patients with a poor mental outlook are usually poor candidates for therapy.

In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required.

In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary.

Some patients experience greatest relief by taking the entire dose at bedtime; others react more favorably to divided doses, two to four times a day. Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable.

The long duration of action of this drug makes it particularly suitable for bedtime medication when its effects may last throughout the night, enabling patients to turn in bed during the night more easily, and to rise in the morning.

When benztropine mesylate is started, do not terminate therapy with other antiparkinsonian agents abruptly. If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy.

Benztropine mesylate may be used concomitantly with Carbidopa- Levodopa, or with levodopa, in which case periodic dosage adjustment may be required in order to maintain optimum response.

Drug-Induced Extrapyramidal Disorders – In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines), the recommended dosage is 1 to 4 mg once or twice a day orally. Dosage must be individualized according to the need of the patient. Some patients require more than recommended; others do not need as much.

When extrapyramidal disorders develop soon after initiation of treatment with neuroleptic drugs (e.g., phenothiazines), they are likely to be transient. One to 2 mg of benztropine mesylate tablets two or three times a day usually provides relief within one or two days. After one or two weeks the drug should be withdrawn to determine the continued need for it. If such disorders recur, benztropine mesylate can be reinstituted.

Certain drug-induced extrapyramidal disorders that develop slowly may not respond to benztropine mesylate.

HOW SUPPLIED

Benztropine Mesylate Tablets, USP are available as follows:

0.5 mg white, capsule shaped biconvex tablets de-bossed with ‘I’ on the left side of bisect and ‘G’on the right side of the bisect and “318” on the other side, supplied in bottles of 30 (NDC 69097-826-02), 100 (NDC 69097-826-07) and 1000 (NDC 69097-826-15).

1 mg white, modified oval biconvex tablets de-bossed with “I” on the left side of bisect and “G” on the right side of the bisect on one side and “319” on the other side, supplied in bottles of 30 (NDC 69097-827-02), 100 (NDC 69097-827-07) and 1000 (NDC 69097-827-15).

2 mg white, round, flat faced beveled edged tablets de-bossed with ‘I’ on the left side of bisect and ‘G’ on the right side of the bisect and “320” on the other side, supplied in bottles of 30 (NDC 69097-832-02), 100 (NDC 69097-832-07) and 1000 (NDC 69097-832-15).

Dispense in a well-closed container as defined in the USP.

Store at 20° to 25°C (68° to77°F) [See USP Controlled Room Temperature].

*Duvoisin, R.C.; Katz, R.J.; Amer. Med.Ass. 206:1963-1965, Nov. 25, 1968.

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300 Warren, NJ 07059

Revised: 02/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69097-826-07 Rx Only

Benztropine

Mesylate

Tablets, USP

0.5 mg

100 Tablets

Cipla

image
(click image for full-size original)

NDC 69097-827-07 Rx Only

Benztropine

Mesylate

Tablets, USP

1 mg

100 Tablets

Cipla

image
(click image for full-size original)

NDC 69097-832-07 Rx Only

Benztropine

Mesylate

Tablets, USP

2 mg

100 Tablets

Cipla

image
(click image for full-size original)
BENZTROPINE MESYLATE
benztropine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-826
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 4mm
Flavor Imprint Code IG;318
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-826-02 30 TABLET in 1 BOTTLE None
2 NDC:69097-826-07 100 TABLET in 1 BOTTLE None
3 NDC:69097-826-15 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090294 06/29/2016
BENZTROPINE MESYLATE
benztropine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-827
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL ((modified oval)) Size 4mm
Flavor Imprint Code IG;319
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-827-02 30 TABLET in 1 BOTTLE None
2 NDC:69097-827-07 100 TABLET in 1 BOTTLE None
3 NDC:69097-827-15 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090294 06/29/2016
BENZTROPINE MESYLATE
benztropine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-832
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND ((flat faced)) Size 6mm
Flavor Imprint Code IG;320
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-832-02 30 TABLET in 1 BOTTLE None
2 NDC:69097-832-07 100 TABLET in 1 BOTTLE None
3 NDC:69097-832-15 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090294 06/29/2016
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 165104469 analysis (69097-826), analysis (69097-827), analysis (69097-832), manufacture (69097-826), manufacture (69097-827), manufacture (69097-832)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 080334903 analysis (69097-826), analysis (69097-827), analysis (69097-832), pack (69097-826), pack (69097-827), pack (69097-832)

Revised: 05/2020 Cipla USA Inc.

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