Product Information
Registration Status: ActiveSIN04540P
DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50mg/ML is approved to be sold in Singapore with effective from 1990-05-29. It is marketed by PFIZER PTE LTD, with the registration number of SIN04540P.
This product contains Medroxyprogesterone 50mg/ml in the form of INJECTION. It is approved for INTRAMUSCULAR use.
This product is manufactured by PFIZER MANUFACTURING BELGIUM NV in BELGIUM.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Medroxyprogesterone acetate (INN, USAN, BAN), also known as 17α-hydroxy-6α-methylprogesterone acetate, and commonly abbreviated as MPA, is a steroidal progestin, a synthetic variant of the human hormone progesterone. It is used as a contraceptive, in hormone replacement therapy and for the treatment of endometriosis as well as several other indications. MPA is a more potent derivative of its parent compound medroxyprogesterone (MP). While medroxyprogesterone is sometimes used as a synonym for medroxyprogesterone acetate, what is normally being administered is MPA and not MP.
Indication
Used as a contraceptive and to treat secondary amenorrhea, abnormal uterine bleeding, pain associated with endometriosis, endometrial and renal cell carcinomas, paraphilia in males, GnRH-dependent forms of precocious puberty, as well as to prevent endometrial changes associated with estrogens.
Mechanism of Action
Progestins diffuse freely into target cells in the female reproductive tract, mammary gland, hypothalamus, and the pituitary and bind to the progesterone receptor. Once bound to the receptor, progestins slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH surge.
Pharmacokinetics
- Absorption
- Rapidly absorbed from GI tract
- Distribution
- Metabolism
- Hepatic
- Elimination
Clearance
* 64110 +/- 42662 mL/min [postmenopausal women under fasting conditions with a single Dose of 2 × 10 mg] * 74123 +/- 35126 mL/min [postmenopausal women under fasting conditions with a single Dose of 8 × 2.5 mg] * 41963 +/- 38402 mL/min [postmenopausal women following daily administration of one PROVERA 10 mg tablet for 7 days]
Toxicity
Side effects include loss of bone mineral density, BMD changes in adult women, bleeding irregularities, cancer risks, and thromboembolic disorders.
Active Ingredient/Synonyms
(6alpha)-17-(Acetyloxy)-6-methylpreg-4-ene-3,20-dione | 17-Acetoxy-6alpha-methylprogesterone | 17-Acetoxy-6α-methylprogesterone | 17alpha-Hydroxy-6alpha-methylprogesterone acetate | 17α-hydroxy-6α-methylprogesterone acetate | 6-alpha-Methyl-17-alpha-acetoxyprogesterone | 6-alpha-Methyl-17-alpha-hydroxyprogesterone acetate | 6alpha-Methyl-17-acetoxy progesterone | 6alpha-Methyl-17alpha-hydroxyprogesterone acetate | 6alpha-Methyl-4-pregnene-3,20-dion-17alpha-ol acetate | 6α-Methyl-17-acetoxy progesterone | 6α-Methyl-17α-hydroxyprogesterone acetate | Medroxyacetate progesterone | Medroxyprogesterone 17-acetate | Medroxyprogesterone acetate | Methylacetoxyprogesterone | Metigestrona | MPA | Medroxyprogesterone acetate |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.