APREPITANT capsule APREPITANT kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

APREPITANT

Composition:

APREPITANT 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aprepitant capsules, in combination with other antiemetic agents, are indicated in patients 12 years of age and older for the prevention of: Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting. Aprepitant is contraindicated in patients: Risk Summary There are insufficient data on use of aprepitant in pregnant women to inform a drug associated risk. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately 1.5 times the adult human exposure at the 125 mg/80 mg/80 mg aprepitant regimen (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryofetal development studies in rat

Product summary:

Aprepitant capsules, USP 40 mg, are hard gelatin capsules with opaque white cap and opaque white body containing white to off white colored pellets. The cap is imprinted with ‘SZ’ and the body is imprinted with ‘525’ in black ink. Aprepitant capsules, USP 80 mg, are hard gelatin capsules with opaque white cap and clear transparent body containing white to off white colored pellets. The cap is imprinted with ‘SZ’ and the body is imprinted with ‘528’ in black ink. Aprepitant capsules, USP 125 mg, are hard gelatin capsules with opaque light blue cap and opaque white body containing white to off white colored pellets. The cap is imprinted with ‘SZ’ and the body is imprinted with ‘529’ in black ink. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

APREPITANT- APREPITANT CAPSULE
APREPITANT- APREPITANT
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APREPITANT CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APREPITANT CAPSULES.
APREPITANT CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Aprepitant is a substance P/neurokinin 1 (NK ) receptor antagonist.
Aprepitant capsules is indicated
•
Limitations of Use (1.3)
•
•
DOSAGE AND ADMINISTRATION
Recommended Dosage for Prevention of Chemotherapy Induced Nausea and
Vomiting (CINV) (2.1)
•
•
•
Recommended Dosage for PONV (2.2)
•
Preparation and Administration (2.3)
•
•
•
DOSAGE FORMS AND STRENGTHS
Aprepitant Capsules, USP: 40 mg; 80 mg; 125 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
1
in combination with other antiemetic agents, in patients 12 years of
age and older for 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)
nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer chemotherapy
(MEC) (1.1)
for prevention of postoperative nausea and vomiting (PONV) in adults
(1.2)
Aprepitant capsules have not been studied for treatment of established
nausea and vomiting.
Chronic continuous administration of aprepitant capsules are not
recommended.
Aprepitant capsules in adults and pediatric patients 12 years of age
and older: is 125 mg on Day 1 and 80 mg on Days
2 and 3.
Administer aprepitant capsules 1 hour prior to chemotherapy on Days 1,
2, and 3. If no chemotherapy is given on
Days 2 and 3, administer aprepitant capsules in morning.
See Full Prescribing Information for recommended dosages of
concomitant dexamethasone and 5-HT3 antagonist for
HEC and MEC.
Adults: 40 mg aprepitant capsules within 3 hours prior to induction of
anesthesia.
Aprepitant capsules can be administered with or