Covaryx HS (Oral)

Esterified estrogens and methyltestosterone combination is used to treat menopause symptoms in patients who did not find relief with estrogens alone. These symptoms may include hot flashes, which are feelings of heat, sweating, and warmth in the face, neck, or chest; and vaginal dryness, burning, and itching.

Esterified estrogens are a synthetic mix of estrogens. Estrogen is a hormone that is produced in larger amounts in females. It is important for normal sexual development in females and for regulating the menstrual cycle during childbearing years. Methyltestosterone is a synthetic form of testosterone, a hormone that is produced in larger amounts in males and smaller amounts in females. Menopause symptoms happen when the hormone balance shifts in the female body. This combination of hormones helps relieve menopause symptoms by adding more hormones to the body.

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

It is very important for your doctor to check your progress at regular visits to ensure the medicine is working properly and to decide if you should keep taking it. These visits should happen every 6 to 12 months or as directed by your doctor.

It is unlikely for a postmenopausal woman to become pregnant. However, using this medicine while pregnant could harm your unborn baby. If you think you might be pregnant while using the medicine, tell your doctor immediately.

Very rarely, this medicine can cause serious side effects like a heart attack or stroke. You are much more likely to experience these side effects if you smoke, are overweight, or have diabetes, high blood pressure, or high cholesterol. Discuss any concerns with your doctor.

Using large doses of estrogen alone for a long time may increase the risk of some types of cancer (e.g., endometrial cancer). Talk with your doctor about this risk. If you have vaginal bleeding while taking this medicine, contact your doctor immediately.

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

This medicine may increase the risk of dementia in elderly women (over 65 years of age). Talk with your doctor if you are concerned about this.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor) for an eye check.

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

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

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

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, including 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 for children.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of esterified estrogens and methyltestosterone combination. However, older patients are more likely to develop dementia and age-related kidney, liver, or heart issues, which may require caution and possible dose adjustments for patients taking this medicine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a risk of interaction. In these cases, your doctor might change the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amifampridine
• Anisindione
• Bupropion
• Dicumarol
• Donepezil
• Phenprocoumon
• Somatrogon-ghla

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Ginseng
• Levothyroxine
• Licorice
• Tipranavir
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used close to mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, 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
• Recent heart attack, or history of or
• Severe liver disease or
• Recent stroke, or history of—Should not be used in patients with these conditions.

• Asthma or
• Cancer (e.g., breast, cervix, liver, vagina) or
• History of depression 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
• History of hepatitis (including cholestatic jaundice) or
• Hypercalcemia (high calcium in the blood) or
• Hypocalcemia (low calcium in the blood) or
• Hypothyroidism (underactive thyroid) or
• History of migraine headaches or
• Porphyria (enzyme problem) or
• Systemic lupus erythematosus—Use with caution. May worsen these conditions.

• 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
• History of venous thromboembolism (clot in the veins)—May increase the risk of more serious 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.

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

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.