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:

Physicians Total Care, Inc.

INN (International Name):

MEGESTROL ACETATE

Sammensetning:

MEGESTROL ACETATE 125 mg in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Megace® ES oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Enter section text here Therapy with megestrol acetate 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. Megestrol acetate is not intended for prophylactic use to avoid weight loss. Enter section text here History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy. Enter section text here Pregnancy Category X [ see WARNINGS and PRECAUTIONS: (5.2)]. No adequate animal teratology information is available at clinically relevant doses. Pregnant rats treated with low doses of megestrol acetate (0.02-fold the recommen

Produkt oppsummering:

Megace® ES oral suspension is a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL. Available in bottles of 150 mL (5 fl oz) NDC 54868-5572-0. Store Megace® ES oral suspension between 15º-25º C (59º-77º 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 (5.0) and ADVERSE REACTIONS (6.0) ]. Women at risk of pregnancy should avoid such exposure.

Autorisasjon status:

New Drug Application

Preparatomtale

MEGACE ES - MEGESTEROL ACETATE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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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. MEGACE ES (MEGESTROL ACETATE)
ORAL SUSPENSION INITIAL U.S.
APPROVAL: 1993
INDICATIONS AND USAGE
Megace® ES 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) (1.0).
DOSAGE AND ADMINISTRATION
The recommended adult initial dosage of Megace® ES oral suspension is
625 mg/day (5 mL/day or one teaspoon daily).
Shake container well before using (2.0).
DOSAGE FORMS AND STRENGTHS
Oral suspension containing 125 mg of megestrol acetate per mL (3.0).
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 therapy 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 and enrolled in the two clinical efficacy trials were
nausea, diarrhea, impotence, rash, flatulence, hypertension,
and asthenia (6.2).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL,
INC. AT 1-800-828-9393, OPTION 3
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Due to