Esterified Estrogens and Methyltestosterone
Generic: ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
Basic Information
Manufacturer
STATUS PROJECTS PRIVATE LIMITED
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
289c9515-f17a-4d53-9230-d3aede01bf54
Indications & Usage
5- Indication ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone.
(There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS.
(There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS.
Adverse Reactions
10- Undesirable Effects Associated with Estrogens (See Warnings regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gallbladder disease, and adverse effects similar to those of oral contraceptives, including thromboembolism).
The following additional adverse reactions have been reported with estrogenic therapy, including oral contraceptives: Genitourinary system.
Breakthrough bleeding, spotting, change in menstrual flow.
Dysmenorrhea.
Premenstrual-like syndrome.
Amenorrhea during and after treatment.
Increase in size of uterine fibromyomata.
Vaginal candidiasis.
Change in cervical erosion and in degree of cervical secretion.
Cystitis-like syndrome.
Breasts.
Tenderness, enlargement, secretion.
Gastrointestinal.
Nausea, vomiting.
Abdominal cramps, bloating.
Cholestatic jaundice Skin.
Chloasma or melasma which may persist when drug is discontinued.
Erythema multiforme.
Erythema nodosum.
Hemorrhagic eruption.
Loss of scalp hair.
Hirsutism.
Eyes.
Steepening of corneal curvature.
Intolerance to contact lenses.
CNS.
Headache, migraine, dizziness.
Mental depression.
Chorea.
Miscellaneous.
Increase or decrease in weight.
Reduced carbohydrate tolerance.
Aggravation of porphyria.
Edema.
Changes in libido.
Associated with Methyltestosterone A.
Endocrine and Urogenital.
Female: The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement.
The latter usually is not reversible after androgens are discontinued.
When administered to a pregnant woman androgens cause virilization of external genitalia of the female fetus.
Skin and Appendages: Hirsutism, male pattern of baldness, and acne.
Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis.
Hematologic: Suppression of clotting factors, II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic: Increased serum cholesterol.
Miscellaneous: Inflammation and pain at site of intramuscular injection or subcutaneous implantation of testosterone containing pellets, stomatitis with buccal preparations, and rarely anaphylactoid reactions.
The following additional adverse reactions have been reported with estrogenic therapy, including oral contraceptives: Genitourinary system.
Breakthrough bleeding, spotting, change in menstrual flow.
Dysmenorrhea.
Premenstrual-like syndrome.
Amenorrhea during and after treatment.
Increase in size of uterine fibromyomata.
Vaginal candidiasis.
Change in cervical erosion and in degree of cervical secretion.
Cystitis-like syndrome.
Breasts.
Tenderness, enlargement, secretion.
Gastrointestinal.
Nausea, vomiting.
Abdominal cramps, bloating.
Cholestatic jaundice Skin.
Chloasma or melasma which may persist when drug is discontinued.
Erythema multiforme.
Erythema nodosum.
Hemorrhagic eruption.
Loss of scalp hair.
Hirsutism.
Eyes.
Steepening of corneal curvature.
Intolerance to contact lenses.
CNS.
Headache, migraine, dizziness.
Mental depression.
Chorea.
Miscellaneous.
Increase or decrease in weight.
Reduced carbohydrate tolerance.
Aggravation of porphyria.
Edema.
Changes in libido.
Associated with Methyltestosterone A.
Endocrine and Urogenital.
Female: The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement.
The latter usually is not reversible after androgens are discontinued.
When administered to a pregnant woman androgens cause virilization of external genitalia of the female fetus.
Skin and Appendages: Hirsutism, male pattern of baldness, and acne.
Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis.
Hematologic: Suppression of clotting factors, II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic: Increased serum cholesterol.
Miscellaneous: Inflammation and pain at site of intramuscular injection or subcutaneous implantation of testosterone containing pellets, stomatitis with buccal preparations, and rarely anaphylactoid reactions.