AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)

Mevcut itibaren:

Zydus Lifesciences Limited

INN (International Adı):

AMITRIPTYLINE HYDROCHLORIDE

Kompozisyon:

AMITRIPTYLINE HYDROCHLORIDE 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infarc

Ürün özeti:

Amitriptyline Hydrochloride Tablets USP, 10 mg are white to off white colored, round shaped, biconvex, film-coated tablets debossed with "ZA" over "1" on one side and plain on other side and are supplied as follows: NDC 70771-1173-1 in bottle of 100 tablets NDC 70771-1173-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 25 mg are light green colored, round shaped, biconvex, film-coated tablets debossed with "ZA" over "2" on one side and plain on other side and are supplied as follows: NDC 70771-1174-1 in bottle of 100 tablets NDC 70771-1174-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 50 mg are brown colored, round shaped, biconvex, film-coated tablets debossed with "ZA" over "3" on one side and plain on other side and are supplied as follows: NDC 70771-1175-1 in bottle of 100 tablets NDC 70771-1175-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 75 mg are light blue colored, round shaped, biconvex, film-coated tablets debossed with "12" over "28" on one side and plain on other side and are supplied as follows: NDC 70771-1176-1 in bottle of 100 tablets NDC 70771-1176-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 100 mg are orange colored, round shaped, biconvex, film-coated tablets debossed with "12" over "29" on one side and plain on other side and are supplied as follows: NDC 70771-1177-1 in bottle of 100 tablets NDC 70771-1177-0 in bottle of 1,000 tablets Amitriptyline Hydrochloride Tablets USP, 150 mg are cream to beige colored, modified capsule shaped, biconvex, film-coated tablets debossed with "1230" on one side and plain on other side and are supplied as follows: NDC 70771-1178-1 in bottle of 100 tablets NDC 70771-1178-0 in bottle of 1,000 tablets Store at 20º to 25ºC (68º to 77ºF) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Revised: 9/2023
Document Id: 67501ce8-1792-4ebc-b579-98977278d9bb
34391-3
Set id: 4159b10e-f589-486c-969d-9b4544b098b5
Version: 5
Effective Time: 20230920
Zydus Lifesciences Limited

Ürün özellikleri

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
ZYDUS LIFESCIENCES LIMITED
----------
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1173-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 10 mg
Rx only
100 Tablets
NDC 70771-1174-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 25 mg
Rx only
100 Tablets
NDC 70771-1175-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 50 mg
Rx only
100 Tablets
NDC 70771-1176-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 75 mg
Rx only
100 Tablets
NDC 70771-1177-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 100 mg
Rx only
100 Tablets
NDC 70771-1178-1 in bottle of 100 Tablets
Amitriptyline Hydrochloride Tablets USP, 150 mg
Rx only
100 Tablets
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1173
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE -
UNII:1806D8D52K)
AMITRIPTYLINE
HYDROCHLORIDE
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
5mm
FLAVOR
IMPRINT CODE
Z A;1
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1173-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
12/26/2017
2
NDC:70771-
1173-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
12/26/2