Trihexyphenidyl Hydrochloride (Page 3 of 3)

Concomitant Use with Levodopa


When trihexyphenidyl HCl 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 trihexyphenidyl HCl dosage of 3 to 6 mg daily, in divided doses, is usually adequate.

Concomitant Use with Other Parasympathetic Inhibitors


Trihexyphenidyl HCl 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.
Trihexyphenidyl HCl tablets — The total daily intake of trihexyphenidyl HCl tablets 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

Trihexyphenidyl Hydrochloride Tablets, USP 2 mg are white colored, round debossed with N, T on either side of the score line and ‘2’ on the other side.

Trihexyphenidyl Hydrochloride Tablets, USP 2 mg are available in

Bottle of 100 tablets (NDC 63850-0021-1)

Bottle of 250 tablets (NDC 63850-0021-2)

Bottle of 1000 tablets (NDC 63850-0021-3)

Trihexyphenidyl Hydrochloride Tablets, USP 5 mg are white colored, round debossed with N, T on either side of the score line and ‘5’ on other side.

Trihexyphenidyl Hydrochloride Tablets, USP 5 mg are available in

Bottle of 100 tablets (NDC 63850-0022-1)

Bottle of 1000 tablets (NDC 63850-0022-2)

Dispense in a tight container with child-resistant closure.
Store at 20°-25°C (68°- 77°F). [See USP controlled room temperature.]
Manufactured by:
NATCO PHARMALIMITED
Kothur-509 228,
A.P, India.
Rev: 01/Sep/2010

Trihexyphenidyl Hydrochloride Tablets, USP 2 mg-Bottle of 100 tablets

NDC 63850-0021-1
RX Only
Each tablet contains:
Trihexyphenidyl Hydrochloride USP, 2 mg
Dosage:
See package insert for dosage and full prescribing information.
Dispense in a tight container with child-resistant closure.Store at 20° — 25°C (68° — 77°F).[See USP controlled room temperature.]

thphcl2mg-bottleof1oocontainerlabel
(click image for full-size original)

Trihexyphenidyl Hydrochloride Tablets, USP 2 mg-Bottle of 250 tablets

NDC 63850-0021-2

RX Only

Each tablet contains:
Trihexyphenidyl Hydrochloride USP, 2 mg
Dosage:
See package insert for dosageand full prescribing information.
Dispense in a tight container with child-resistant closure.Store at 20° — 25°C (68° — 77°F).[See USP controlled room temperature.]

thphcl2mg-bottleof250containerlabel
(click image for full-size original)

Trihexyphenidyl Hydrochloride Tablets, USP 2 mg-Bottle of 1000 tablets

NDC 63850-0021-3

RX Only

Each tablet contains:
Trihexyphenidyl Hydrochloride USP, 2 mg

Dosage:
See package insert for dosage and full prescribing information.

Dispense in a tight container with child-resistant closure.Store at 20° — 25°C (68° — 77°F).[See USP controlled room temperature.]

thphcl2mg-bottleof1000containerlabel
(click image for full-size original)

Trihexyphenidyl Hydrochloride Tablets, USP 5 mg-Bottle of 100 tablets

NDC 63850-0022-1

RX Only

Each tablet contains:
Trihexyphenidyl Hydrochloride USP, 5 mg
Dosage:
See package insert for dosage and full prescribing information.
Dispense in a tight container with child-resistant closure. Store at 20° — 25°C (68° — 77°F).[See USP controlled room temperature.]

thphcl5mg-bottleof100containerlabel
(click image for full-size original)

Trihexyphenidyl Hydrochloride , 5 mg-Bottle of 1000 tablets

NDC 63850-0022-2

RX Only

Each tablet contains:
Trihexyphenidyl Hydrochloride USP, 5 mg
Dosage:
See package insert for dosage and full prescribing information.
Dispense in a tight container with child-resistant closure.Store at 20° — 25°C (68° — 77°F)[See USP controlled room temperature.]

thphcl5mg-bottleof1000containerlabel
(click image for full-size original)
TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63850-0021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL) TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code N;T;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63850-0021-1 100 TABLET in 1 BOTTLE None
2 NDC:63850-0021-2 250 TABLET in 1 BOTTLE None
3 NDC:63850-0021-3 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091630 10/17/2010
TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63850-0022
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL) TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code N;T;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63850-0022-1 100 TABLET in 1 BOTTLE None
2 NDC:63850-0022-2 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091630 10/07/2010
Labeler — Natco Pharma Limited (650224736)
Establishment
Name Address ID/FEI Operations
Natco Pharma Limited-Pharma Division 918588174 MANUFACTURE (63850-0021), MANUFACTURE (63850-0022)

Revised: 10/2019 Natco Pharma Limited

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