Yes

Progestin

Treatment of amenorrhea, abnormal uterine bleeding, endometriosis, uterine carcinoma

D

Thrombophlebitis, thromboembolic disorders, cerebral hemorrhage, liver impairment, carcinoma of the breast, hypersensitivity to hydroxyprogesterone or any component, undiagnosed vaginal bleeding

Use with caution in patients with asthma, seizure disorders, migraine, cardiac or renal impairment, history of mental depression; use of any progestin during the first 4 months of pregnancy is not recommended; observe patients closely for signs and symptoms of thrombotic disorders

>10%:

Cardiovascular: Edema

Endocrine & metabolic: Breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea

Gastrointestinal: Anorexia

Local: Pain at injection site

Neuromuscular & skeletal: Weakness

1% to 10%:

Central nervous system: Mental depression, insomnia, fever

Dermatologic: Melasma or chloasma, allergic rash with or without pruritus

Gastrointestinal: Weight gain or loss

Genitourinary: Changes in cervical erosion and secretions, increased breast tenderness

Hepatic: Cholestatic jaundice

Toxicity is unlikely following single exposures of excessive doses; supportive treatment is adequate in most cases

Decreased effect: Rifampin may increase clearance of hydroxyprogesterone

Store at <40°C (15°C to 30°C); avoid freezing

Natural steroid hormone that induces secretory changes in the endometrium, promotes mammary gland development, relaxes uterine smooth muscle, blocks follicular maturation and ovulation and maintains pregnancy

Metabolism: Hepatic

Peak serum concentration: I.M.: 3-7 days; concentrations are measurable for 3-4 weeks after injection

Elimination: Renal

Adults: Female: I.M.: Long-acting progestin

Production of secretory endometrium and desquamation: (Medical D and C): 125-250 mg administered on day 10 of cycle; repeat every 7 days until suppression is no longer desired.

Uterine carcinoma: 1 g one or more times/day (1-7 g/week) for up to 12 weeks

Administer deep I.M. only

Thyroid function tests and liver function tests and endocrine function tests

May cause insomnia or depression

None reported

No information available to require special precautions

No effects or complications reported

Maintain a regular schedule of injections as prescribed. This drug can only be given deep I.M. injection. If diabetic, monitor serum glucose closely. You may experience some sensitivity to sunlight; wear protective clothing, use sunblock, or avoid sunlight. You may experience dizziness; use caution when driving or engaging in tasks that require alertness until response to drug is known. Report rash, alopecia, radically increased weight gain or swelling, anorexia, muscular weakness, fever, or unresolved nausea or vomiting. Report immediately any swelling or warmth in calves, chest pain or respiratory difficulty, severe headache or acute dizziness, numbness and/or tingling in extremities. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate barrier contraceptive measures (serious fetal damage has occurred). Consult prescriber if breast-feeding.

Patients should receive a copy of the patient labeling for the drug

Injection:

Hylutin®, Hyprogest®: 250 mg/mL (5 mL)