Full Prescribing Info
Medroxyprogesterone acetate.
Each vial of 3 ml suspension contains: Medroxyprogesterone Acetate 150 mg.
Pharmacology: Medroxyprogesterone Acetate prevents follicular maturation, producing long term anovulation in the reproductive-aged woman. Andalan 150 mg administered intramuscularly every three months acts as a contraceptive for women. For the best result, the first dose must be given during the first 5 days of the normal menstrual cycle or in the immediate postpartum period. During treatment, the normal menstrual cycle is replaced by periods of irregular and unpredictable vaginal bleeding, spotting or complete amenorrhea. The time period of bleeding and/or spotting in the majority of women is 7 days or less in one month. Bleeding tends to decrease with continued injection. Sometimes there will be excessive bleeding or the bleeding may last for longer period, especially early in the course of treatment and this can usually be controlled by giving estrogen orally or by intramuscular injection with the dosage equal to 0.05-0.1 mg ethinyl estradiol daily for 7-12 days. Restoration of menstrual cycle to normal may need 5-28 months after the last injection of Andalan.
Andalan is used as a contraceptive method.
Dosage/Direction for Use
The recommended dosage is 150 mg of Andalan every three months by deep intramuscular injection. In order to ensure that the acceptor is not pregnant, the first, injection is administered during the first 5 days of normal menstrual period or before the 6th week postpartum. Andalan does not interfere with lactation. Even though Medroxyprogesterone Acetate is secreted in breast milk in very small amounts, as of present, there have not been any side effects reported on a baby's growth. It is suggested that the physician or others directly responsible for the patient informs the patient that at the beginning of treatment, that there will be changes to the menstrual cycle and unpredictable bleeding or spotting may occur. The symptoms will decrease if the usage of Andalan is continued, without the need of additional treatments. Excessive or prolonged bleeding which becomes troublesome to the acceptor can be controlled by giving estrogen with the dosage equal to 0.05-0.1 mg ethinyl estradiol daily for 7-12 days, orally or parenterally. This treatment can be continued for 1-2 cycles but is not suggested for long term usage.
Hypersensitivity to Medroxyprogesterone Acetate; Vaginal bleeding of unknown cause; Pathological signs of the breast/s; Bleeding of the urinary tract of unknown cause; Pregnancy.
If any acceptor shows symptoms and/or signs thromboembolic disorder, the continuation of using Andalan should be reevaluated .
Any acceptor who develops an acute impairment of vision, proptosis, diplopia, migraine should be evaluated to exclude papilledema or retinal vascular lesions before continuing treatment.
During pregnancy, usage of Andalan is contraindicated. It is not suggested to use Andalan as a pregnancy test or to end a pregnancy.
After administration of Andalan for several times, amenorrhea and anovulation may persist for periods up to 18 months, in rare cases for longer periods.
In some cases anaphylactic and anaphylactoid reactions have occasionally been reported.
Special Precautions
Before using Andalan, it is suggested to carry out breast and pelvic organ examination including a Pap smear.
The administration of Andalan should be done carefully for patients with epilepsy, migraines, asthma, cardiac or renal dysfunction because progesterone may cause fluid retention.
In case of breakthrough bleeding, organic causes should be considered and a diagnostic examination should be carried out. It is not suggested to use estrogen as a routine or as a long term additional treatment to control excessive or prolonged bleeding. If prolonged bleeding is experienced and causes discomfort to the user, another contraceptive should be considered.
Be aware of patients with mental depression history; the treatment must be discontinued if the depression recurs to a serious degree.
A decrease of glucose tolerance test is seen in some acceptors using progestogen. The mechanism of this decrease is still unclear. For that reason, diabetic patients should be observed carefully during progestogen treatment.
Body weight may increase with the usage of Andalan.
The following laboratory tests may be affected by the use of Andalan: Plasma gonadotropin level; Plasma progesterone level; Urinary pregnanediol level; Plasma estrogen level (in the female); Plasma Cortisol level; Glucose tolerance test.
The usage of Andalan may mask the onset of the climacteric symptom.
Certain endocrine test and liver function tests may be affected by using Andalan. If such tests prove to be abnormal in patients using Andalan, it is recommended to repeat the tests after the treatment is stopped for 4-6 months.
Due to the prolonged effect and the resulting difficulty to predict the time of withdrawal bleeding following injection, Andalan is not recommended for treatment of secondary amenorrhea or dysfunctional uterine bleeding.
Pathologist should be informed that the patient have been treated with progestogen when relevant specimens are submitted.
Adverse Reactions
The following adverse reactions are compiled based on the seriousness of condition rather than the frequency of occurrence: Anaphylactic reaction; Thrombophlebitis and pulmonary embolism; Insomnia, nervousness, fatigue, depression, dizziness and headache; Urticaria, pruritus, skin rash, acne, hirsutism and alopecia; Nausea; Tenderness of the breast and galactorrhea; Changes in cervical erosion and secretions; Miscellaneous: hyperpyrexia, changes in bodyweight or development of moonfacies; Local reaction: pain, change in skin colour and residual lump at the site injection.
Store at room temperature (25°-30°C).
MIMS Class
Depot Contraceptives
ATC Classification
G03AC06 - medroxyprogesterone ; Belongs to the class of progestogens. Used as systemic contraceptives.
Susp for inj 150 mg/3 mL (vial) x 20's.
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