Depo-Provera (Medroxyprogesterone acetate)
Depo-Provera CI is indicated only for the prevention of
pregnancy. The loss of bone mineral density (BMD) in women of all ages and the
impact on peak bone mass in adolescents should be considered, along with the
decrease in BMD that occurs during pregnancy and/or lactation.
Prevention Of Pregnancy
Both the 1 mL vial and the 1 mL
prefilled syringe of Depo-Provera CI should be vigorously shaken just before
use to ensure that the dose being administered represents a uniform suspension.
The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks)
administered by deep IM injection in the gluteal or deltoid muscle.
Depo-Provera CI should not be used as a long-term birth control method (i.e.
longer than 2 years) unless other birth control methods are considered
inadequate. Dosage does not need to be adjusted for body weight [see Clinical Studies].
To ensure the patient is not pregnant at the time of the first
injection, the first injection should be given ONLY during the first 5 days of
a normal menstrual period; ONLY within the first 5-days postpartum if not
breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum
week. If the time interval between injections is greater than 13 weeks, the
physician should determine that the patient is not pregnant before
administering the drug. The efficacy of Depo-Provera CI depends on adherence to
the dosage schedule of administration.
Side Effect :-
The following important adverse reactions observed with the use
of Depo-Provera CI are discussed in greater detail in the Warnings and
Precautions section (5):
·
Loss of Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
·
Thromboembolic disease [see WARNINGS AND PRECAUTIONS]
·
Breast Cancer [see WARNINGS
AND PRECAUTIONS]
· Anaphylaxis and Anaphylactoid Reactions [see WARNINGS AND PRECAUTIONS]
·
Bleeding Irregularities[see WARNINGS AND PRECAUTIONS]
·
Weight Gain [see WARNINGS
AND PRECAUTIONS]
CLINICAL TRIALS EXPERIENCE
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical studies of a drug
cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.
In the two clinical trials with Depo-Provera CI, over 3,900
women, who were treated for up to 7 years, reported the following adverse
reactions, which may or may not be related to the use of Depo-Provera CI. The
population studied ranges in age from 15 to 51 years, of which 46% were White,
50% Non-White, and 4.9% Unknown race. The patients received 150 mg Depo-ProveraCI every 3-months (90 days). The median study duration was 13 months with a
range of 1-84 months. Fifty eight percent of patients remained in the study
after 13 months and 34% after 24 months.
WARNING:
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