Drugplain

Esterified Estrogens and Methyltestosterone .625 mg/1

Esterified Estrogens and Methyltestosterone · TABLET · Bryant Ranch Prepack

2 Recalls on Record
Plain English

Esterified Estrogens and Methyltestosterone is a tablet containing esterified estrogens and methyltestosterone at .625 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Esterified Estrogens and Methyltestosterone
Generic Name
Esterified Estrogens and Methyltestosterone
NDC Code (Product)
63629-1980
Manufacturer
Bryant Ranch Prepack
Strength
.625 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Drug Class
Androgen [EPC]
Marketing Start
12/22/2010

Recall History

2 Recalls on Record
Class II04/17/2017

Syntho Pharmaceuticals, Inc.

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

TerminatedVoluntary: Firm initiated
Class II04/17/2017

Syntho Pharmaceuticals, Inc.

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea5 reports
vomiting5 reports
diarrhoea4 reports
drug ineffective4 reports
insomnia4 reports
product dose omission issue4 reports
blood pressure increased3 reports
contusion3 reports
fatigue3 reports
headache3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and 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 FULL STRENGTH and 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 (SEE BOXED WARNING ).

Dosage & Administration

DOSAGE AND ADMINISTRATION 1. Given cyclically for short-term use only: For treatment of moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone. The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Administration should be cyclic (e.g., three weeks on and one week off). Attempts to discontinue or taper medication should be made at three to six month intervals. Usual Dosage Range 1 tablet of ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH or 1 to 2 tablets of ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH daily as recommended by the physician. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Warnings

WARNINGS Associated with Estrogens Induction of malignant neoplasms . Long term continuous administration of natural and synthetic estrogens in certain animal species increases this frequency of carcinomas of the breast, cervix, vagina, and liver. There is now evidence that estrogens increase the risk of carcinoma of the endometrium in humans (See Boxed Warning ). At the present time there is no satisfactory evidence that estrogens given to postmenopausal women increase the risk of cancer of the breast, 18 although a recent long-term follow-up of a single physician's practice has raised this possibility. 18a Because of the animal data, there is a need for caution in prescribing estrogens for women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease, or abnormal mammograms. 2. Gallbladder disease . A recent study has reported a 2 to 3-fold increase in the risk of surgically confirmed gallbladder disease in women receiving postmenopausal estrogens, 18 similar to the 2-fold increase previously noted in users of oral contraceptives. 19-24a In the case of oral contraceptives the increased risk appeared after two years of use. 24 3. Effects simil…

Contraindications

CONTRAINDICATIONS Estrogens should not be used in women with any of the following conditions: 1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. 2. Known or suspected estrogen-dependent neoplasia. 3. Known or suspected pregnancy (See Boxed Warning ). 4. Undiagnosed abnormal genital bleeding. 5. Active thrombophlebitis or thromboembolic disorders. 6. A past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when in treatment of breast malignancy). Methyltestosterone should not be used in: 1. The presence of severe liver damage. 2. Pregnancy and in breast-feeding mothers because of the possibility of masculinization of the female fetus or breast-fed infant.

Drug Interactions

D. Drug Interactions 1. Anticoagulants C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped. 2. Oxyphenbutazone . Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. 3. Insulin . In diabetic patients the metabolic effects of androgens may decrease blood glucose and insulin requirements.

Adverse Reactions

ADVERSE REACTIONS 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. Aggravat…

Frequently Asked Questions

What is Esterified Estrogens and Methyltestosterone used for?

Esterified Estrogens and Methyltestosterone contains Esterified Estrogens and Methyltestosterone. It is a tablet taken oral. Consult your doctor for specific uses.

Is Esterified Estrogens and Methyltestosterone a controlled substance?

Yes, Esterified Estrogens and Methyltestosterone is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Esterified Estrogens and Methyltestosterone?

The generic name for Esterified Estrogens and Methyltestosterone is Esterified Estrogens and Methyltestosterone. There are 3 other brand versions of Esterified Estrogens and Methyltestosterone.

What is the NDC code for Esterified Estrogens and Methyltestosterone .625 mg/1?

The NDC (National Drug Code) for Esterified Estrogens and Methyltestosterone .625 mg/1 is 63629-1980, listed by Bryant Ranch Prepack.

Product NDC

63629-1980

Package NDC

63629-1980-1

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)