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MEDROXYPROGESTERONE ACETATE

COMPOSITION

MEDROXYPROGESTERONE ACETATE  – 2.5 mg

Each tablet contains:

Medroxyprogesterone Acetate U.S.P. - 2.5 mg

(6-methyl-17 hydroxyprogesterone acetate)

MEDROXYPROGESTERONE ACETATE  – 10 mg

Each tablet contains:

Medroxyprogesterone Acetate U.S.P - 10 mg

(6-methyl-17hydroxyprogesterone acetate)

DESCRIPTION

Medroxyprogesterone acetate (MPA) is a derivative of progesterone that is

active by the parenteral and oral routes of administration. It is a white to offwhite,

odorless crystalline powder, stable in air, melting between 200 and

210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane,

sparingly soluble in alcohol and in methanol, slightly soluble in ether, and

insoluble in water.

HIGHLIGHTS (USPs)

§ Structurally related to progesterone.

§ Safe & effective.

§ No effect on HDL-C levels.

§ No androgenic activity.

CLINICAL PHARMACOLOGY

MEDROXYPROGESTERONE ACETATE  range contains Medroxyprogesterone acetate (MPA), a synthetic

progesterone that is structurally related to Progesterone. MPA can be

regardedas an ideal oral progesterone since it is safe, effective, and does not

possess androgenic activity. Further, it does not have any effect on the HDLC

levels. Hence, it offers advantages over other progestogens.

INDICATIONS AND USAGE

MEDROXYPROGESTERONE ACETATE  10 mg - Menstrual Disorders:

§ Dysfunctional Uterine Bleeding (DUB).

§ Secondary Amenorrhea

o For diagnostic evaluation of endogenous estrogen status.

o Secondary Amenorrhea with adequate estrogen.

o Secondary Amenorrhea with inadequate estrogen.

§ Endometriosis.

§ Postponement of Menstruation.

MEDROXYPROGESTERONE ACETATE  2.5 mg – Hormone Replacement Therapy.

CONTRAINDICATIONS

§ Patients with undiagnosed vaginal bleeding.

§ Pregnancy (especially during the 1st trimester).

§ Patients with P/H/O of arterial damage.

§ Liver dysfunction or disease.

§ Known sensitivity to medroxyprogesterone acetate or any of the inactive

ingredients.

as:

PRECAUTIONS

§ Use with caution in patients with cardiovascular, renal or hepatic

impairment, diabetes mellitus, asthma, epilepsy and migraine, or any

condition which may be aggravated by fluid retention.

§ Exercise caution in patients with P/H/O of mental depression.

§ If jaundice develops, discontinue the drug

ADVERSE REACTIONS

MEDROXYPROGESTERONE ACETATE  range is generally well tolerated. However, may cause effects such

§ Gastrointestinal disturbances & change in appetite.

§ Weight gain and/or fluid retention.

§ Skin reactions, such as acne, melasma or chloasma.

§ Mental depression, fatigue, drowsiness, fever, headache etc.

DOSAGE AND ADMINISTRATION

MEDROXYPROGESTERONE ACETATE  10 mg

a) Dysfunctional Uterine Bleeding:

To control exceesive vaginal bleeding:

§ MEDROXYPROGESTERONE ACETATE  10 mg (to arrest vaginal bleeding):1tid for the first 3-5 days

followed by 1 bid; the total duration of treatment should last 21 days.

§ Continue to use MEDROXYPROGESTERONE ACETATE  10 mg 1tablet OD or BD from 16th to 25th

day of the cycle for next 2 cycles.

b) Secondary Amenorrhea

For diagnostic evaluation of endogenous estrogen status:

§ MEDROXYPROGESTERONE ACETATE  10 mg 2 times daily for 5 days. Withdrawal bleeding indicates

adequate estrogen levels.

Secondary Amenorrhea with adequate estrogen:

§ MEDROXYPROGESTERONE ACETATE  10 mg cyclically from days 16 through 25 for six months; then

stopped and the patient re-evaluated.

Secondary Amenorrhea with inadequate estrogen :

§ Conjugase (Conjugated estrogens 0.625 mg) on days 1 through 25

andMEDROXYPROGESTERONE ACETATE  10 mg on days 16 through 25, followed by five days no

medication. Treatment should be continued for 4-6 months

c) Endometriosis:

§ Medroxyprogesterone Acetate  10 mg 1 - 5 tabs daily for 3-4 months followed by clinical

evaluation. If necessary to continue for further 3 months.

d) Postponement of Menstruation:

§ Treatment to be started 7 days before the anticipated date of menses.

Medroxyprogesterone Acetate  10 mg twice daily till the postponement is desired. Higher dose

required if treatment is started less than 7 days before the anticipated date

of menses.

MEDROXYPROGESTERONE ACETATE  2.5 mg

HRT - 1 tab of MEDROXYPROGESTERONE ACETATE  2.5 mg and 1 tab of Conjugase to be taken as a

continuous combined regimen.

PRESENTATION

MEDROXYPROGESTERONE ACETATE  10 / MEDROXYPROGESTERONE ACETATE  2.5: A strip of 10 tablets.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© DR. PRAVEEN RAMACHANDRA
womenhormone@gmail.com, womenhormone@rediffmail.com