Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Covaryx
  2. Covaryx HS
  3. Essian
  4. Estratest
  5. Menogen
  6. Syntest DS
  7. Syntest HS

Descriptions


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.

This product is available in the following dosage forms:

  • Tablet

Before Using

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

Information about this esterified-estrogens-and-methyltestosterone-oral-route
Pregnancy Category Explanation
All Trimesters X Studies 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.

Breastfeeding

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Other Interactions

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

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

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.

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

  1. Absent, missed, or irregular menstrual periods
  2. acne or oily skin
  3. decreased breast size
  4. enlarging clitoris
  5. hoarseness or deepening of the voice
  6. menstrual changes
  7. stopping of menstrual bleeding
  8. unnatural hair growth or loss

Rare

  1. Continuing nausea
  2. cough
  3. dark-colored urine
  4. difficulty with swallowing
  5. dizziness
  6. fast heartbeat
  7. fever
  8. hives
  9. itching
  10. light-colored stools
  11. loss of appetite
  12. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  13. purple or red-colored spots on the body or inside the mouth or nose
  14. shortness of breath
  15. skin rash
  16. sore throat
  17. tightness in the chest
  18. unusual tiredness or weakness
  19. vomiting
  20. wheezing

Incidence not known

  1. Abdominal or stomach bloating, cramps, or pain
  2. anxiety
  3. bleeding from gums or nose
  4. blistering, peeling, or loosening of the skin
  5. bloating
  6. bloody or cloudy urine
  7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  8. change in vaginal discharge
  9. changes in skin color, pain, or tenderness
  10. chest pain or discomfort
  11. chills
  12. clay-colored stools
  13. clear or bloody discharge from nipple
  14. confusion
  15. constipation
  16. convulsions
  17. darkening of urine
  18. decrease in amount of urine
  19. diarrhea
  20. difficult, burning, or painful urination
  21. difficulty with breathing
  22. difficulty with moving
  23. difficulty with speaking
  24. dimpling of the breast skin
  25. dizziness or lightheadedness
  26. double vision
  27. eye pain
  28. fainting
  29. fever
  30. fluid-filled skin blisters
  31. frequent urge to urinate
  32. headache
  33. heavy bleeding
  34. inability to move the arms, legs, or facial muscles
  35. inability to speak
  36. indigestion
  37. inverted nipple
  38. irregular heartbeats
  39. itching of the vagina or genital area
  40. joint or muscle pain
  41. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  42. light-colored stools
  43. loss of appetite
  44. lump in the breast or under the arm
  45. mood or mental changes
  46. muscle cramps in the hands, arms, feet, legs, or face
  47. muscle pain or stiffness
  48. nausea
  49. noisy, rattling breathing
  50. numbness and tingling around the mouth, fingertips, or feet
  51. pain
  52. pain during sexual intercourse
  53. pain in the ankles or knees
  54. pain or discomfort in the arms, jaw, back, or neck
  55. pain or feeling of pressure in pelvis
  56. painful, red lumps under the skin, mostly on the legs
  57. pains in the stomach, side, or abdomen, possibly radiating to the back
  58. pelvic pain
  59. persistent crusting or scaling of the nipple
  60. pinpoint red or purple spots on the skin
  61. poor insight and judgment problems with memory or speech
  62. red, irritated eyes
  63. redness or swelling of the breast
  64. ringing in the ears
  65. sensitivity to the sun
  66. shortness of breath
  67. skin thinness
  68. slow speech
  69. sore on the skin of the breast that does not heal
  70. sore throat
  71. sores, ulcers, or white spots in the mouth or on the lips
  72. stomach pain
  73. sudden shortness of breath or troubled breathing
  74. sweating
  75. swelling
  76. swelling of the fingers, hands, feet, or lower legs
  77. tenderness of the breast
  78. thick, white curd-like vaginal discharge without odor or with mild odor
  79. tiredness
  80. tremor
  81. trouble recognizing objects
  82. trouble thinking and planning
  83. trouble walking
  84. troubled breathing at rest
  85. unexpected or excess milk flow from breasts
  86. unpleasant breath odor
  87. vaginal bleeding
  88. vision changes
  89. vomiting of blood
  90. weakness
  91. weight gain
  92. 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

  1. Blemishes on the skin
  2. brown, blotchy spots on the exposed skin
  3. decreased interest in sexual intercourse
  4. depression
  5. headache, severe and throbbing
  6. inability to have or keep an erection
  7. increase or decrease in weight
  8. increased hair growth, especially on the face
  9. increased in sexual ability, desire, drive, or performance
  10. increased interest in sexual intercourse
  11. irritability
  12. leg cramps
  13. loss in sexual ability, desire, drive, or performance
  14. loss of hair
  15. mental depression
  16. pimples
  17. redness of the skin
  18. swelling or inflammation of the mouth
  19. 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.