Drugs Information Online
Drugs and diseases reference index

Drugs and diseases reference index
Search
EN

Drugs reference index «Syntest H.S.»

Syntest H.S.

Generic Name: esterified estrogens and methyltestosterone (Oral route)

es-TER-i-fide ES-troe-jenz, meth-il-tes-TOS-ter-one

Oral routeTablet
  • Estrogens Increase The Risk Of Endometrial Cancer
    • Three independent case control studies have reported an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods. This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incidence rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade.
    • The three case control studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment and on estrogen dose. In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study suggests that cyclic administration of low doses of estrogen may carry less risk than continuous administration, it therefore appears prudent to utilize such a regimen .
    • Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses .
  • Estrogens Should Not Be Used During Pregnancy
    • The use of female sex hormones, both estrogens and progestogens, during early pregnancy may seriously damage the offspring. It has been shown that females exposed in utero to diethylstilbestrol, a nonsteroidal estrogen, have an increased risk of developing in later life a form of vaginal or cervical cancer that is ordinarily extremely rare. This risk has been estimated as not greater than 4 per 1000 exposures. Furthermore, a high percentage of such exposed women (from 30 to 90 percent) have been found to have vaginal adenosis, epithelial changes of the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy. Although similar data are not available with the use of other estrogens, it cannot be presumed they would not induce similar changes.
    • Several reports suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. One case control study estimated a 4.7-fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 per 1000.
    • In the past, female sex hormones have been used during pregnancy in an attempt to treat threatened or habitual abortion. There is considerable evidence that estrogens are ineffective for these indications, and there is no evidence from well-controlled studies that progestogens are effective for these uses.
    • If Esterified Estrogens and Methyltestosterone Tablets H.S. or Esterified Estrogens and Methyltestosterone Tablets are used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the advisability of pregnancy continuation .
  • Cardiovascular And Other Risks
    • Esterified Estrogens and Methyltestosterone Tablets H.S. and Esterified Estrogens and Methyltestosterone Tablets do not contain a progestin. Esterified Estrogens and Methyltestosterone Tablets H.S. and Esterified Estrogens and Methyltestosterone Tablets are an Estrogen/Androgen product .
    • Estrogens with or without progestins should not be used for the prevention of cardiovascular disease .
    • The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo .
    • The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy .
    • Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman .

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. This product contains an estrogen and androgen, not a progestin. This combination should not be used during a known or suspected pregnancy.

Commonly used brand name(s):

In the U.S.

  • Covaryx
  • Covaryx HS
  • Essian
  • Estratest
  • Menogen
  • Syntest D.S.
  • Syntest H.S.

Available Dosage Forms:

  • Tablet

Therapeutic Class: Estrogen/Androgen Combination

Pharmacologic Class: Estrogen

Uses For Syntest H.S.

Esterified estrogens and methyltestosterone combination is used to treat the symptoms of menopause in patients who did not get relief after being treated with estrogens alone. These symptoms may include a feeling of heat, sweating, and warmth in the face, neck, or chest ("hot flashes"); and dryness, burning, and itching in the vagina.

Esterified estrogens are a man-made mixture of estrogens. Estrogen is a hormone that is produced by the body in greater amounts in females. It is necessary for normal sexual development of the female and for regulation of the menstrual cycle during the childbearing years. Methyltestosterone is a man-made form of testosterone, a hormone that is produced by the body in greater amounts in males and small amounts in females. Menopause symptoms occur when the hormone balance changes in the female body. This combination of hormones will relieve the symptoms of menopause by adding more hormones to the body.

This medicine is available only with your doctor's prescription.

Before Using Syntest H.S.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

The use of esterified estrogens and methyltestosterone combination is not recommended in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esterified estrogens and methyltestosterone combination in the elderly. However, elderly patients are more likely to develop dementia and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Anisindione
  • Bupropion
  • Dicumarol
  • Phenprocoumon

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clarithromycin
  • Ginseng
  • Itraconazole
  • Ketoconazole
  • Levothyroxine
  • Licorice
  • Tipranavir
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal vaginal bleeding, undiagnosed or
  • Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or
  • Breast cancer, or history of or
  • Heart attack, recent or history of or
  • Liver disease, severe or
  • Stroke, recent or history of—Should not be used in patients with these conditions.
  • Asthma or
  • Cancer (e.g., breast, cervix, liver, vagina) or
  • Depression, history of or
  • Diabetes or
  • Edema (fluid retention) or
  • Endometriosis (problem with the lining of the uterus) or
  • Epilepsy or
  • Eye or vision problems (e.g., retinal vascular thrombosis) or
  • Gallbladder disease or
  • Hepatitis (including cholestatic jaundice), history of or
  • Hypercalcemia (high calcium in the blood) or
  • Hypocalcemia (high calcium in the blood) or
  • Hypothyroidism (underactive thyroid) or
  • Migraine headaches, history of or
  • Porphyria (enzyme problem) or
  • Systemic lupus erythematosus—Use with caution. May make these conditions worse.
  • Heart or blood vessel disease or
  • Hypercholesterolemia (high cholesterol in the blood) or
  • Hypertension (high blood pressure) or
  • Hypertriglyceridemia (high triglycerides or fat in the blood) or
  • Venous thromboembolism (clot in the veins), history of—May increase risk for more serious side effects.

Proper Use of esterified estrogens and methyltestosterone

This section provides information on the proper use of a number of products that contain esterified estrogens and methyltestosterone. It may not be specific to Syntest H.S.. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of menopause symptoms:
      • Adults—One to two tablets once a day.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Syntest H.S.

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it. These visits should be every 6 to 12 months or as otherwise directed by your doctor.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Very rarely, this medicine can cause serious side effects such as a heart attack or stroke. You are much more likely to have these side effects if you smoke cigarettes or are overweight, or if you have diabetes, high blood pressure, or a high blood cholesterol. Talk with your doctor if you think you might be at risk.

Using large doses of estrogen alone over a long period of time may increase the risk of some kinds of cancer (e.g., endometrial cancer). Talk with your doctor about this risk. If you have vaginal bleeding with this medicine, call your doctor right away.

This medicine may increase the risk of getting breast cancer. It is very important that you check your breasts on a regular basis for any unusual lumps or discharge, and that you have breast x-rays every year as directed by your doctor. These exams are very important if you have a family member with a history of breast cancer. Talk with your doctor about this risk.

This medicine may increase the risk of getting dementia in elderly women (above 65 years of age). Talk with your doctor if this concerns you.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Using large doses of methyltestosterone over a long period of time may increase the risk of serious liver problems (e.g., peliosis hepatis or liver cancer). Talk with your doctor about this risk.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine. Also, you may need to stop using this medicine for a few weeks before and after having surgery, or if you are inactive for a long period of time.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Syntest H.S. Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Absent, missed, or irregular menstrual periods
  • acne or oily skin
  • decreased breast size
  • enlarging clitoris
  • hoarseness or deepening of the voice
  • menstrual changes
  • stopping of menstrual bleeding
  • unnatural hair growth or loss
Rare
  • Continuing nausea
  • cough
  • dark-colored urine
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives
  • itching
  • light-colored stools
  • loss of appetite
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • purple or red-colored spots on the body or inside the mouth or nose
  • shortness of breath
  • skin rash
  • sore throat
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Incidence not known
  • Abdominal or stomach bloating, cramps, or pain
  • anxiety
  • bleeding from gums or nose
  • blistering, peeling, or loosening of the skin
  • bloating
  • bloody or cloudy urine
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in vaginal discharge
  • changes in skin color, pain, or tenderness
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • clear or bloody discharge from nipple
  • confusion
  • constipation
  • convulsions
  • darkening of urine
  • decrease in amount of urine
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with moving
  • difficulty with speaking
  • dimpling of the breast skin
  • dizziness or lightheadedness
  • double vision
  • eye pain
  • fainting
  • fever
  • fluid-filled skin blisters
  • frequent urge to urinate
  • headache
  • heavy bleeding
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • indigestion
  • inverted nipple
  • irregular heartbeats
  • itching of the vagina or genital area
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • lump in the breast or under the arm
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle pain or stiffness
  • nausea
  • noisy, rattling breathing
  • numbness and tingling around the mouth, fingertips, or feet
  • pain
  • pain during sexual intercourse
  • pain in the ankles or knees
  • pain or discomfort in the arms, jaw, back, or neck
  • pain or feeling of pressure in pelvis
  • painful, red lumps under the skin, mostly on the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pelvic pain
  • persistent crusting or scaling of the nipple
  • pinpoint red or purple spots on the skin
  • poor insight and judgment problems with memory or speech
  • red, irritated eyes
  • redness or swelling of the breast
  • ringing in the ears
  • sensitivity to the sun
  • shortness of breath
  • skin thinness
  • slow speech
  • sore on the skin of the breast that does not heal
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain
  • sudden shortness of breath or troubled breathing
  • sweating
  • swelling
  • swelling of the fingers, hands, feet, or lower legs
  • tenderness of the breast
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • tiredness
  • tremor
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking
  • troubled breathing at rest
  • unexpected or excess milk flow from breasts
  • unpleasant breath odor
  • vaginal bleeding
  • vision changes
  • vomiting of blood
  • weakness
  • weight gain
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Blemishes on the skin
  • brown, blotchy spots on the exposed skin
  • decreased interest in sexual intercourse
  • depression
  • headache, severe and throbbing
  • inability to have or keep an erection
  • increase or decrease in weight
  • increased hair growth, especially on the face
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • irritability
  • leg cramps
  • loss in sexual ability, desire, drive, or performance
  • loss of hair
  • mental depression
  • pimples
  • redness of the skin
  • swelling or inflammation of the mouth
  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.