Progesterone (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
Dosage
Progesterone is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection.
Amenorrhea Five to 10 mg are given for six to eight consecutive days. If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding 48 to 72 hours after the last injection. This may be followed by spontaneous normal cycles.
Functional Uterine Bleeding Five to 10 mg are given daily for six doses. Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Progesterone (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Progesterone (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Progesterone (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (injection) in pediatric patients.
Contraindications
1. Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
2. Liver dysfunction or disease.
3. Known or suspected malignancy of breast or genital organs.
4. Undiagnosed vaginal bleeding.
5. Missed abortion.
6. Known sensitivity to progesterone injection.
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.
Adverse Reactions
Clinical Trials Experience
Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions; mental depression; pyrexia; insomnia; nausea; and somnolence.
A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.
The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: Rise in blood pressure in susceptible individual, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, and dizziness.
The following laboratory results may be altered by the use of estrogen-progestin combination drugs: increased sulfobromophthalein retention and other hepatic function tests; coagulation tests: increase in prothrombin factors VII, VIII, IX, and X; metyrapone test; pregnanediol determinations; thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.
Postmarketing Experience
There is limited information regarding Progesterone (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Progesterone (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Progesterone (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Progesterone (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Progesterone (injection) during labor and delivery.
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.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatic Use
The safety and effectiveness in geriatric patients (over age 65) have not been established.
Gender
There is no FDA guidance on the use of Progesterone (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Progesterone (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Progesterone (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Progesterone (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Progesterone (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Progesterone (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Progesterone (injection) Administration in the drug label.
Monitoring
There is limited information regarding Progesterone (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Progesterone (injection) and IV administrations.
Overdosage
There is limited information regarding Progesterone (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Progesterone (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Progesterone (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Progesterone (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Progesterone (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Progesterone (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
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.
Clinical Studies
There is limited information regarding Progesterone (injection) Clinical Studies in the drug label.
How Supplied
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Progesterone (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Progesterone (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Progesterone (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Progesterone (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.