MEGACE ES- megesterol acetate suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Endo Pharmaceuticals Inc.

INN (International Name):

MEGESTROL ACETATE

Sammensetning:

MEGESTROL ACETATE 125 mg in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Megace ES is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Limitations of Use Therapy with Megace ES for weight loss should only be insti­tuted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases. Megace ES is not intended for prophylactic use to avoid weight loss. - History of hypersensitivity to megestrol acetate or any component of the formulation. - Pregnancy [see Warnings and Precautions (5.2), Use in Specific Populations (8.1, 8.3)]. Risk Summary Based on animal data, megestrol acetate may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see Contraindications (4)] . There are no available human data to assess for any drug-associated risks of miscar

Produkt oppsummering:

Megace ES oral suspension is a milky white, lemon-lime flavored oral suspension containing 125 mg per mL. Available in bottles of 150 mL (5 fl oz) NDC 63481-160-38. Store Megace ES oral suspension between 15° to 25° C (59° to 77° F) and dispense in a tight container. Protect from heat. Health Hazard Data There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or overdose at levels approaching recommended dosing levels could result in side effects described above [see Warnings and Precautions (5) and Adverse Reactions (6)]. Women at risk of pregnancy should avoid such exposure.

Autorisasjon status:

New Drug Application

Preparatomtale

MEGACE ES- MEGESTEROL ACETATE SUSPENSION
ENDO PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEGACE ES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MEGACE
ES.
MEG ACE ES (MEGESTROL ACETATE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 12/2018
Warnings and Precautions (5.2) 12/2018
INDICATIONS AND USAGE
Megace ES 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
Obtain a negative pregnancy test in females of reproductive potential
prior to initiating treatment (2.1)
The recommended adult initial dosage of Megace ES oral suspension is
625 mg/day (5 mL/day or one teaspoon daily)
(2.2).
Shake container well before using (2.2).
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).
Pregnancy (4)(8.1).
WARNINGS AND PRECAUTIONS
Use with caution in patients with a history of thromboembolic disease
(5.1).
Fetal Effects: May cause fetal harm. Females of reproductive potential
should be advised to avoid becoming pregnant
(5.2).
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 800mg/20mL of megestrol acetate oral
suspension in the two clinical efficacy trials were nausea, diarrhea,
impotence, rash, flatulence, hypertension, and asthenia
(6.2)