INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PETOGEN 150 mg/mL Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETOGEN 150 mg/mL Injection

COMPOSITION:
Each 1 mL contains 150 mg of
medroxyprogesterone acetate.
Preservatives: Methylparaben 1,7 mg/mL; Propylparaben 0,19 mg/mL.

PHARMACOLOGICAL CLASSIFICATION:
A21.8.2 Progesterone with or without oestrogens.

PHARMACOLOGICAL ACTION:
Medroxyprogesterone acetate is an active semisynthetic derivative of progesterone and features the same pharmacological profile as its parent compound but is remarkably more potent. When parenterally administered it exhibits a typical progestational activity manifestly higher than progesterone. Medroxyprogesterone acetate is endowed with a potent ovulatory inhibitory power on the secretion of the adenohypophyseal gonadotropins. Medroxyprogesterone is a congener of progesterone with an extremely long action when given parenterally.

INDICATIONS:
A long acting contraceptive.

CONTRA-INDICATIONS:
Contra-indicated in patients with undiagnosed vaginal bleeding, possible pregnancy, a past ectopic pregnancy, history during pregnancy of pruritis, herpes, or idiopathic jaundice, hormone-dependent neoplasms, severe liver-impairment, Dubin-Johnson syndrome and Rotor Syndrome.
Also contra-indicated in patients with a history of thrombo-embolic disorders. Patients with breast carcinoma.

WARNINGS:
Discontinue medication pending examination if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilloedema or retinal lesions, medication should be discontinued. A causal relationship has not been established.
Progestogens had been reported to precipitate attacks of porphyria.

DOSAGE AND DIRECTIONS FOR USE:
As a long-acting contraceptive –150 mg every 3 months. This preparation must be used intramuscularly only. Shake well before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Some changes in menstrual bleeding pattern or irregular menstrual bleeding can be expected for virtually all women who undergo contraceptive therapy with medroxyprogesterone.
Other side-effects which may be encountered with Medroxyprogesterone therapy are: headaches, nervousness, depression and other mental changes, abdominal discomfort/swelling, gastrointestinal disturbances, limb pain and/or varicose vein pain, nausea, vomiting, changes in or loss of libido, dizziness, faint feeling, vaginal discharge, vaginal cyst, breast changes including discomfort or occasionally gynaecomastia, lactation, cessation of lactation, dysmenorrhoea, amenorrhoea, breakthrough bleeding, asthenia, bloated feeling, diarrhoea, hair or skin changes e.g. alopecia, chloasma, intertrigo, allergic skin rashes or urticaria, pruritis, pruritis vulva and hives. Further side-effects which may occur include increased appetite, mass gain, anorexia, drowsiness, allergy, generalised pain, urinary frequency, nocturia, hot flushes, heartburn, chest pain, acne, paresthesia, asthma, hematuria, increase in ovarian size, insomnia, fluid retention or oedema, pedal oedema, dysuria, dyspnoea, liver trouble, alteration in liver-function test. Jaundice has been reported. Rupture of varicose vein, eye discomfort and intolerance to contact lenses.
Under the influence of medroxyprogesterone therapy, the uterus may slightly increase in size and develop a consistency compatible with early pregnancy.

Precautions
Before prescribing Petogen, a pretreatment physical examination is recommended, with special reference to breast and pelvic organs, as well as a Papanicolaou smear. The patients medical history should be carefully evaluated and regular examination is recommended during use.
Petogen should be used with caution in patients with cardiovascular, renal, or hepatic impairment, diabetus mellitus, asthma, epilepsy, migraine or other conditions which may be aggravated by fluid retention.
Endocrine and possibly liver function tests may be affected by medroxyprogesterone therapy. Therefore, if further investigation of these functions is indicated the tests should be repeated after the influence of the drug has been dissipated, i.e. after the return of the normal menses.
A decrease in glucose tolerance has been observed in a small percentage of subjects receiving medroxyprogesterone therapy. The mechanism of this decreased tolerance is obscure. For this reason diabetes should be carefully observed while on medroxyprogesterone therapy.
Petogen should also be used with care in persons with a history of mental depression and should be discontinued if the depression recurs to any serious degree.
In relation to the irregular vaginal bleeding which occurs with medroxyprogesterone therapy, non-functional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, it is advisable to secure an endometrial biopsy to rule out the presence of abnormal cells.
Any possible influence of prolonged medroxyprogesterone therapy on the pituitary, ovarian, adrenal, hepatic or uterine function awaits further study.
Because of the occasional occurrence of thrombophlebitis and pulmonary embolism in patients taking combined oral oestrogen-progestogen contraceptive therapy, the physician should be alert to the earliest manifestations of these conditions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should be symptomatic and supportive.

IDENTIFICATION:
1 millilitre white suspension in a 2 mL clear glass vial.

PRESENTATION:
A clear vial containing 1 mL of medroxyprogesterone acetate (150 mg) in suspension.

STORAGE INSTRUCTION:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
J/21.8.2/278

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty) Ltd
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17-03-1993
        12-342/1-00
                        A & S PRINTERS.

Updated on this site: May 2000

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