MEGESTROL ACETATE suspension

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

MEGESTROL ACETATE (UNII: TJ2M0FR8ES) (MEGESTROL - UNII:EA6LD1M70M)

Saadav alates:

AvKARE, Inc.

INN (Rahvusvaheline Nimetus):

MEGESTROL ACETATE

Koostis:

MEGESTROL ACETATE 125 mg in 1 mL

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

MEGESTROL ACETATE - MEGESTROL ACETATE SUSPENSION
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEGESTROL ACETATE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MEGESTROL ACETATE ORAL
SUSPENSION.
MEGESTROL ACETATE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Megestrol acetate oral suspension is a progestin indicated for the
treatment of anorexia, cachexia, or an unexplained,
significant weight loss in patients with a diagnosis of acquired
immunodeficiency syndrome (AIDS) ( 1).
DOSAGE AND ADMINISTRATION
The recommended adult initial dosage of megestrol acetate oral
suspension is 625 mg/day (5 mL/day or one teaspoon
daily). Shake container well before using ( 2).
DOSAGE FORMS AND STRENGTHS
Oral suspension containing 125 mg of megestrol acetate per mL ( 3).
CONTRAINDICATIONS
History of hypersensitivity to megestrol acetate or any component of
the formulation ( 4.1).
Known or suspected pregnancy ( 4.2)( 8.1).
WARNINGS AND PRECAUTIONS
Women of childbearing potential should be advised to avoid becoming
pregnant ( 5.2).
Use with caution in patients with a history of thromboembolic disease
( 5.1).
Clinical cases of overt Cushing’s Syndrome have been reported in
association with the chronic use of megestrol
acetate. In addition, clinical cases of adrenal insufficiency have
been observed in patients receiving or being withdrawn
from chronic megestrol acetate in the stressed and non-stressed state
( 5.3).
New onset and exacerbation of pre-existing diabetes have been reported
( 5.4).
ADVERSE REACTIONS
The most common adverse events occurring in > 5% of all patients
receiving 800 mg/20 mL of megestrol acetate oral
suspension in the two clinical efficacy trials were nausea, diarrhea,
impotence, rash, flatulence, hypertension, and asthenia (
6.2).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AVKARE, INC. AT
1-855-361-3993 OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Du