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Medroxyprogesterone acetate

Generic Name
Medroxyprogesterone acetate
Brand Names
Depo-provera, Depo-subq Provera, Premphase 28 Day, Prempro 0.625/2.5 28 Day, Provera
Drug Type
Small Molecule
Chemical Formula
C24H34O4
CAS Number
71-58-9
Unique Ingredient Identifier
C2QI4IOI2G

Overview

Medroxyprogesterone acetate (MPA) is a progesterone derivative that is more resistant to metabolism for improved pharmacokinetic properties. MPA can be use to treat secondary amenorrhea, endometrial hyperplasia, abnormal uterine bleeding, osteoporosis, vasomotor symptoms in menopause, vulvar and vaginal atrophy, prevent pregnancy, manage pain in endometriosis, prevent pregnancy, and is also used in palliative care for endometrial and renal carcinoma. Medroxyprogesterone acetate was granted FDA approval on 18 June 1959.

Background

Medroxyprogesterone acetate (MPA) is a progesterone derivative that is more resistant to metabolism for improved pharmacokinetic properties. MPA can be use to treat secondary amenorrhea, endometrial hyperplasia, abnormal uterine bleeding, osteoporosis, vasomotor symptoms in menopause, vulvar and vaginal atrophy, prevent pregnancy, manage pain in endometriosis, prevent pregnancy, and is also used in palliative care for endometrial and renal carcinoma. Medroxyprogesterone acetate was granted FDA approval on 18 June 1959.

Indication

Medroxyprogesterone acetate (MPA) oral tablets are indicated to treat secondary amenorrhea, reduce the incidence of endometrial hyperplasia in postmenopausal women, and to treat abnormal uterine bleeding due to hormonal imbalance, not organic pathology. Oral tablets containing MPA and conjugated estrogens are indicated to prevent postmenopausal osteoporosis and to treat moderate to severe menopausal symptoms such as vasomotor symptoms, vulvar atrophy, and vaginal atrophy. Subcutaneous MPA is indicated to prevent pregnancy and manage pain associated with endometriosis. Intramuscular MPA is indicated to prevent pregnancy, and at higher concentrations for palliative treatment of endometrial or renal carcinoma.

Associated Conditions

  • Abnormal Uterine Bleeding
  • Amenorrhea
  • Endometrial Hyperplasia
  • Endometriosis related pain
  • Metastatic Renal Cell Carcinoma ( mRCC)
  • Osteoporosis
  • Pain
  • Postmenopausal Osteoporosis
  • Pregnancy
  • Vasomotor Symptoms Associated With Menopause
  • Vulvo Vaginal Atrophy
  • Metastatic Endometrial carcinoma

FDA Approved Products

Medroxyprogesterone Acetate
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2015/05/31
NDC:63629-8825
medroxyprogesterone acetate
Manufacturer:Amneal Pharmaceuticals LLC
Route:INTRAMUSCULAR
Strength:150 mg in 1 mL
Approved: 2023/06/13
NDC:70121-1467
medroxyprogesterone acetate
Manufacturer:Mylan Pharmaceuticals Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/03/22
NDC:59762-0056
Medroxyprogesterone Acetate
Manufacturer:PD-Rx Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/03/25
NDC:55289-160
Medroxyprogesterone Acetate
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:INTRAMUSCULAR
Strength:150 mg in 1 mL
Approved: 2021/02/17
NDC:68071-4666

Singapore Approved Products

PROVERA TABLET 10 mg
Manufacturer:Pfizer Italia S.r.l.
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1990/02/10
Approval:SIN03841P
DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 mg/ml
Manufacturer:PFIZER MANUFACTURING BELGIUM NV
Form:INJECTION
Strength:50 mg/ml
Online:Yes
Approved: 1990/05/29
Approval:SIN04540P
PROVERA TABLET 5 mg
Manufacturer:Pfizer Italia S.r.l.
Form:TABLET
Strength:5 mg
Online:Yes
Approved: 1998/12/03
Approval:SIN10513P

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