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Progesterone (Progesterone) - Warnings and Precautions

 
 



WARNINGS

The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.

Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.

PRECAUTIONS

General

The pretreatment physical examination should include special reference to breast and pelvic organs, as well as a Papanicolaou smear.

Because progestational drugs may cause some degree of fluid retention, conditions which might be influenced by this condition, such as epilepsy, migraine, asthma, cardiac, or renal dysfunction, require careful observation.

In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind, and adequate diagnostic measures undertaken.

Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.

The age of the patient constitutes no absolute limiting factor although treatment with progestin may mask the onset of the climacteric.

The pathologist should be advised of progestin therapy when relevant specimens are submitted.

There are possible risks which may be associated with the use of progestin treatment, including adverse effects on carbohydrate and lipid metabolism. The dosage used may be important in minimizing these adverse effects.

A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term intramuscular administration of Medroxyprogesterone acetate (MPA) has been shown to produce mammary tumors in beagle dogs. There is no evidence of a carcinogenic effect associated with the oral administration of MPA to rats and mice.

Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays.

Progesterone at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.

Geriatric Use:

The safety and effectiveness in geriatric patients (over age 65) have not been established.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Nursing Mothers:

Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs. The effect of this on the nursing infant has not been determined.

Page last updated: 2013-06-11

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