EMEND- aprepitant capsule EMEND- aprepitant kit

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

APREPITANT (UNII: 1NF15YR6UY) (APREPITANT - UNII:1NF15YR6UY)

Dostupno od:

Physicians Total Care, Inc.

INN (International ime):

APREPITANT

Sastav:

APREPITANT 80 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

EMEND, in combination with other antiemetic agents, is indicated for the: - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) [see Dosage and Administration (2.1)] . EMEND is indicated for the prevention of postoperative nausea and vomiting [see Dosage and Administration (2.2)] . EMEND has not been studied for the treatment of established nausea and vomiting. Chronic continuous administration is not recommended [see Warnings and Precautions (5.5)]. EMEND is contraindicated in patients who are hypersensitive to any component of the product. EMEND is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). EMEND should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by aprepitant could result in elev

Proizvod sažetak:

No. 3854 — 80 mg capsules: White, opaque, hard gelatin capsule with “461” and “80 mg” printed radially in black ink on the body. They are supplied as follows: NDC 54868-5231-2 unit-of-use BiPack of 2 NDC 54868-5231-3 unit-of-use BiPack of 4 NDC 54868-5231-1 unit-dose package of 6.   No. 3862 — Unit-of-use TriPack containing one 125 mg capsule and two 80 mg capsules. NDC 54868-5325-0. Storage Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA 9985512 U.S. Patent Nos.: 5,145,684; 5,719,147; 6,048,859; 6,096,742; 6,235,735 Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK       74146

Status autorizacije:

New Drug Application

Svojstava lijeka

EMEND - APREPITANT CAPSULE
EMEND - APREPITANT
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EMEND SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR EMEND.
EMEND (APREPITANT) CAPSULES
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
EMEND is a substance P/neurokinin 1 (NK ) receptor antagonist,
indicated:
in combination with other antiemetic agents for the:
prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of highly emetogenic
cancer chemotherapy (HEC) including high-dose cisplatin (1.1)
prevention of nausea and vomiting associated with initial and repeat
courses of moderately emetogenic cancer
chemotherapy (MEC) (1.1)
for the prevention of postoperative nausea and vomiting (PONV) (1.2)
Limitations of Use (1.3)
Not studied for the treatment of established nausea and vomiting.
Chronic continuous administration is not recommended.
DOSAGE AND ADMINISTRATION
Prevention of Chemotherapy Induced Nausea and Vomiting (2.1)
EMEND is given for 3 days as part of the chemotherapy induced nausea
and vomiting (CINV) regimen that includes a
corticosteroid and a 5-HT antagonist. (2.1)
The recommended dose of EMEND is 125 mg orally 1 hour prior to
chemotherapy treatment (Day 1) and 80 mg
orally once daily in the morning on Days 2 and 3. (2.1)
EMEND (fosaprepitant dimeglumine) for Injection may be substituted for
oral EMEND (125 mg) on Day 1 only as
part of the CINV regimen. (2.1)
Prevention of Postoperative Nausea and Vomiting (2.2)
The recommended oral dosage of EMEND for the postoperative nausea and
vomiting (PONV) indication is 40 mg
within 3 hours prior to induction of anesthesia. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 40 mg; 80 mg; 125 mg (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (4, 6.2)
EMEND should not be used concurrently with pimozide, terfenadine,
astemizole, or cisapride since inhibition of
CYP3A4 by aprepitant could result in elev