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DRUGS & SUPPLEMENTS
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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.)
SyntestT® and Syntest® H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS .
Estrogens should not be used in women with any of the following conditions:
Methyltestosterone should not be used in:
In the case of oral contraceptives the increased risk appeared after two years of use.24
Thromboembolic Disease: It is now well established that users of oral contraceptives have an increased risk of various thromboembolic and thrombotic vascular diseases, such as thrombophlebitis, pulmonary embolism, stroke, and myocardial infarction.24-31 Cases of retinal thrombosis, mesenteric thrombosis, and optic neuritis have been reported in oral contraceptive users.
There is evidence that the risk of several of these adverse reactions is related to the dose of the drug.32,33 An increased risk of postsurgery thromboembolic complications has also been reported in users of oral contraceptives.34,35 If feasible, estrogen should be discontinued at least 4 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. While an increased rate of thromboembolic and thrombotic disease in postmenopausal users of estrogens has not been found,18-36 this does not rule out the possibility that such an increase may be present or that subgroups of women who have underlying risk factors or who are receiving relatively large doses of estrogens may have increased risk. Therefore estrogens should not be used in persons with active thrombophlebitis or thromboembolic disorders, and they should not be used (except in treatment of malignancy) in persons with a history of such disorders in association with estrogen use. They should be used with caution in patients with cerebral vascular or coronary artery disease and only for those in whom estrogens are clearly needed. Large doses of estrogen (5 mg esterified estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men37 to increase the risk of nonfatal myocardial infarction, pulmonary embolism and thrombophlebitis. When estrogen doses of this size are used, any of the thromboembolic and thrombotic adverse effects associated with oral contraceptive use should be considered a clear risk. Hepatic Adenoma: Benign hepatic adenomas appear to be associated with the use of oral contraceptives.38-40 Although benign and rare, these may rupture and may cause death through intra abdominal hemorrhage. Such lesions have not yet been reported in association with other estrogen or progestogen preparations but should be considered in estrogen users having abdominal pain and tenderness, abdominal mass, or hypovolemic shock. Hepatocellular carcinoma has also been reported in women taking estrogen-containing oral contraceptives.30 The relationship of this malignancy to these drugs is not known at this time.
Elevated Blood Pressure: Increased blood pressure is not uncommon in women using oral contraceptives. There is now a report that this may occur with use of estrogens in the menopause41 and blood pressure should be monitored with estrogen use, especially if high doses are used.
Glucose Tolerance: A worsening of glucose tolerance has been observed in a significant percentage of patients of estrogen containing oral contraceptives. For this reason, diabetic patients should be carefully observed while receiving estrogens.
In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case the drug should be discontinued. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma. . Peliosis hepatis can be a life-threatening or fatal complication. Cholestatic hepatitis and jaundice occur with 17-alpha-alkylandrogens at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued. Edema with or without heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
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As a general principle, the administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk.
Women: Hoarseness, acne, changes in menstrual periods, or more hair on the face.
All Patients: Any nausea, vomiting, changes in skin color or ankle swelling.
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical- uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases. Geriatric patients treated with androgens may be at increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
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It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
. The following additional adverse reactions have been reported with estrogenic therapy, including oral contraceptives:
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.
Numerous reports of ingestion of large doses of estrogen-containing oral contraceptives by young children indicate that serious ill effects do not occur. Overdosage of estrogen may cause nausea, and withdrawal bleeding may occur in females. There have been no reports of acute overdosage with the androgens.
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. Attempts to discontinue or taper medication should be made at three to six month intervals.
1 capsule-shaped tablet of Syntest® (1.25 mg/2.5 mg) or 1 to 2 capsule shaped tablets of Syntest® H.S. (0.625 mg/1.25 mg) 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.
Syntest® is a combination of Esterified Estrogens and Methyltestosterone. Syntest® is supplied in bottles of 100 Tablets. Each light yellow, capsule-shaped, film coated tablet debossed "C010" on obverse and plain on the reverse contains 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP (NDC 11528-010-01).
Syntest® H.S. (Half-Strength) is a combination of Esterified Estrogens and Methyltestosterone. Syntest® H.S. is supplied in bottles of 100 Tablets. Each light pink, capsule-shaped, film coated tablet debossed "C020" on obverse and plain on the reverse contains 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP (NDC 11528-020-01).
Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
INFORMATION FOR THE PATIENT
WHAT YOU SHOULD KNOW ABOUT ESTROGENS
Estrogens are female hormones produced by the ovaries. The ovaries make several different kinds of estrogens. In addition, scientists have been able to make a variety of synthetic estrogens. As far as we know, all these estrogens have similar properties and therefore much the same usefulness, side effects, and risks. This leaflet is intended to help you understand what estrogens are used for, the risks involved in their use, and how to use them as safely as possible. This leaflet includes the most important information about estrogens, but not all the information. If you want to know more, you can ask your doctor or pharmacist to let you read the package insert prepared for the doctor.
USES OF ESTROGEN
Estrogens are prescribed by doctors for a number of purposes, including:
THERE IS NO PROPER USE OF ESTROGENS IN A PREGNANT WOMAN.
ESTROGENS IN THE MENOPAUSE
In the natural course of their lives, all women eventually experience a decrease in estrogen production. This usually occurs between ages 45 and 55 but may occur earlier or later. Sometimes the ovaries may need to be removed before narural menopause by an operation, producing a "surgical menopause."
When the amount of estrogen in the blood begins to decrease, many women may develop typical symptoms: Feelings of warmth in the face, neck, and chest of sudden intense episodes of heat and sweating throughout the body (called "hot flashes" or "hot flushes"). These symptoms are sometimes very uncomfortable. A few women eventually develop changes in the vagina (called "atrophic vaginitis") which cause discomfort, especially during and after intercourse.
Estrogens can be prescribed to treat these symptoms of the menopause. It is estimated that considerably more than half of all women undergoing the menopause have only mild symptoms or no symptoms at all and therefore do not need estrogens. Other women may need estrogens for a few months, while their bodies adjust to lower estrogen levels. Sometimes the need will be for periods longer than six months. In an attempt to avoid overstimulation of the uterus (womb), estrogens are usually given cyclically during each month of use, that is three weeks of pills followed by one week without pills.
Sometimes women experience nervous symptoms or depression during menopause. There is no evidence that estrogens are effective for such symptoms and they should not be used to treat them, although other treatment may be needed. You may have heard that taking estrogens for long periods (years) after the menopause will keep your skin soft and supple and keep you feeling young. There is no evidence that this is so, however, and such long-term treatment carries important risks.
THE DANGERS OF ESTROGENS
For this reason it is important to take estrogens only when you really need them.
The risk of this cancer is greater the longer estrogens are used and also seems to be greater when larger doses are taken. For this reason, it is important to take the lowest dose of estrogen that will control symptoms and to take it only as long as it is needed. If estrogens are needed for longer periods of time, your doctor will want to reevaluate your need for estrogens at least every six months.
Women using estrogens should report any irregular vaginal bleeding to their doctors; such bleeding may be of no importance, but it can be an early warning of cancer of the uterus. If you have undiagnosed vaginal bleeding, you should not use estrogens until a diagnosis is made and you are certain there is no cancer of the uterus.
SPECIAL WARNING ABOUT PREGNANCY
You should not receive estrogen if you are pregnant. If this should occur, there is a greater than usual chance that the developing child will be born with a birth defect, although the possibility remains fairly small. A female child may have an increased risk of developing cancer of the vagina or cervix later in life (in the teens or twenties). Every possible effort should be made to avoid exposure to estrogens during pregnancy. If exposure occurs, see your doctor.
OTHER EFFECTS OF ESTROGENS
In addition to the serious known risks of estrogens described above, estrogens have the following side effects and potential risks:
Some women will have menstrual bleeding when estrogens are stopped. But if the bleeding occurs on days you are still taking estrogens you should report this to your doctor.
SUMMARY
Estrogens have important uses, but they have serious risks as well. You must decide, with your doctor, whether the risks are acceptable to you in view of the benefits of the treatment. Except where your doctor has prescribed estrogens for use in special cases of cancer of the breast or prostate, you should not use estrogens if you have cancer of the breast or uterus, are pregnant, have undiagnosed abnormal vaginal bleeding, or have had a stroke, heart attack or angina, or clotting in the legs or lungs in the past while you were taking estrogens.
You can use estrogens as safely as possible by understanding that your doctor will require regular physical examinations while you are taking them and will try to discontinue the drug as soon as possible and use the smallest dose possible. Be alert for signs of trouble including:
Based on his or her assessment of your medical needs, your doctor has prescribed this drug for you. Do not give the drug to anyone else.
Syntest® is a combination of Esterified Estrogens and Methyltestosterone. Syntest® is supplied in bottles of 100 Tablets. Each light yellow, capsule-shaped, film coated tablet debossed "C010" on obverse and plain on the reverse contains 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP.
Syntest® H.S. (Half-Strength) is a combination of Esterified Estrogens and Methyltestosterone. Syntest® H.S. is supplied in bottles of 100 Tablets. Each light pink, capsule-shaped, film coated tablet debossed "C020" on obverse and plain on the reverse contains 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP.
Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).
Distributed by:
Centrix Pharmaceutical, Inc.
Birmingham, AL 35242 USA
Manufactured by:
ANDAPharm, LLC
Ft. Lauderdale, FL 33309 USA
CENTRIX®, the Centrix Pharmaceutical logo, and Syntest® are registered trademarks of Centrix Pharmaceutical, Inc.
©2007 Centrix Pharmaceutical, Inc.
Iss.04/07
NDC 11528-010-01
Syntest
(esterified estrogens and
methyltestosterone tablets,
1.25mg/2.5mg)
Rx Only
100 Tablets
CP CENTRIX®
PHARMACEUTICAL, INC.
NDC 11528-020-01
Syntest HS
(esterified estrogens and
methyltestosterone tablets,
0.625mg/1.25mg)
Rx Only
100 Tablets
CP CENTRIX®
PHARMACEUTICAL, INC.
Depending on the reaction of the Syntest after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Syntest not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Syntest addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology