INDOMETHACIN capsule, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)

Disponível em:

Zydus Lifesciences Limited

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Indomethacin extended-release capsules are indicated for: - Moderate to severe rheumatoid arthritis including acute flares of chronic disease - Moderate to severe ankylosing spondylitis - Moderate to severe osteoarthritis - Acute painful shoulder (bursitis and/or tendinitis) Indomethacin is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] Risk Summary Use of NSAIDs, including indomethacin, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid

Resumo do produto:

Indomethacin Extended-release Capsules, 75 mg are white to off white pellets filled in size '1' hard gelatin capsules with dark blue cap printed with "ZA-79" and dark blue body printed with "75 mg" in black ink and are supplied as follows: NDC 70771-1203-6 in bottle of 60 capsules NDC 70771-1203-1 in bottle of 100 capsules NDC 70771-1203-5 in bottle of 500 capsules NDC 70771-1203-0 in bottle of 1,000 capsules NDC 70771-1203-4 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: a811c3c1-e63c-4731-9654-e879217f249e
34391-3
Set id: 50bafabc-319e-4128-bc4a-7a83e7db6a90
Version: 5
Effective Time: 20230926
Zydus Lifesciences Limited

Características técnicas

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
ZYDUS LIFESCIENCES LIMITED
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INDOMETHACIN EXTENDED-RELEASE CAPSULES
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1203-6
Indomethacin Extended-release Capsules, 75 mg
60 Capsules
Rx only
INDOMETHACIN
indomethacin capsule, extended release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1203
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)
INDOMETHACIN
75 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
BLUE (DARK BLUE) , BLUE (DARK BLUE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
19mm
FLAVOR
IMPRINT CODE
Z A;79;75mg
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1203-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2018
2
NDC:70771-
1203-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2018
3
NDC:70771-
1203-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2018
4
NDC:70771-
1203-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2018
5
NDC:70771-
1203-4
10 in 1 CARTON
02/08/2018
5
NDC:70771-
1203-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA202711
02/08/2018
Zydus Lifesciences Limited
LABELER -
Zydus Lifesciences Limited