PRESCRIPTION INFO SHEETS

The following are patient information sheets that contain specific information on certain medication and dosage forms that you may be receiving. The appropriate forms are also included with your prescription order.

You can find these items separated by dosage forms and individual drug names.

InnovaTab™ SUBLINGUAL TABLETS

Instructions and Information

Your medication has been compounded into a sublingual tablet. You should NOT swallow or chew this tablet; this tablet will be placed under your tongue.
Before placing the tablet under the tongue, make sure that your mouth is clean and free of foods or oils that could interfere with the absorption of the medication. There should also be sufficient saliva to dissolve the tablet. Place the tablet under the tongue and do not talk while the tablet is dissolving in order to keep it in place. The tablet will begin to break apart and dissolve as soon as your saliva comes in contact with it. You may move your tongue from side to side to facilitate the breakdown of the tablet. As it dissolves, the medication should be absorbed within one to two minutes. After approximately five minutes, if the tablet is completely dissolved, you should swish the saliva in your mouth and spit out the remaining particles, which are generally inactive ingredients. After taking your sublingual tablet, you should avoid drinking any liquids for at least 10 minutes.
For patients who do not produce enough saliva, take a drink of water prior to placing the tablet under the tongue, leaving a small amount in the mouth.

DuraGel®

Percutaneous Gels for HRT

DuraGel® is a percutaneous hydroalcoholic gel specially formulated by Bellevue Pharmacy. Pharmacokinetic studies using other percutaneous hydroalcoholic gels have demonstrated a prolonged release of hormone through the skin for once a day dosing in most patients¹.

The invisible, odorless, DuraGel® dries within 1 to 3 minutes of application. Bathing or swimming may be done 1 hour after application. Combinations of 2 or more hormones can be combined into a single gel. Percutaneous gels use the natural reservoir effect of the skin to deliver a continuous flow of hormones into the body between applications. The adequacy of the dose can be checked by testing a single saliva sample collected in the early morning approximately two months after dosing begins. Saliva tests may be purchased through Bellevue Pharmacy or ask your medical provider. Bellevue Pharmacy recommends basing dosage adjustments on change in symptoms and/or measurement of hormone levels through saliva analysis. All HRT preparations should be individualized for optimal benefit. To request saliva testing or a change in your gel prescription, call us at Bellevue Pharmacy.

Directions For Use:

Adapt–a-cap

• Remove the childproof cap.
  
• Fit the tip of the syringe into the adapter in neck of bottle and invert.
  
• Shake the gel in the inverted bottle to remove any trapped air
  
• Draw the prescribed dose into the dispenser using the markings on the syringe to read the volume, (1cc = 1ml)
  
• Set the bottle/syringe assembly upright. Remove filled syringe and replace childproof cap for secure closing and storage between uses
  

Dispense contents of syringe across your arms, forearms, shoulders, abdomen, or your inner thighs. Spread evenly with your hand and leave it to dry for approximately 3 minutes. Do not massage or rub the gel. Should the skin remain tacky after 3 minutes, this means that the area of application was in-sufficient. Remember to spread the gel over a larger area next time (lumbar area). Do NOT apply to the breast or vulva region.
DO NOT EXCEED THE PRESCRIBED DOSE!

¹ Slater CC, Souler I, Zhang C, et al., Fertil-Steril. 2001 Jul;76(1):32-37.

HORMONE CREAM

Instructions and Information

This hormone cream has been compounded to your physician’s exact specifications, and you should follow his/her directions as to the dosage and frequency of use.

You should have been provided with a measuring spoon to use to determine the proper amount of cream to apply. The large end of this spoon is ¼ teaspoon, which is equal to one gram when filled level. The smaller end of this spoon is 1/8 teaspoon, which is equal to one-half gram when filled level.

The cream should be massaged into soft skin areas, and the area should be rotated at each application. Suggested areas of application are: inner thighs, wrist/inner arms and abdomen.

Caution: Do not apply to the chest unless otherwise directed by your physician or healthcare provider.

VAGINAL SUPPOSITORIES

Instructions and Information

Your prescription for suppositories is dispensed in sealed disposable plastic molds. During shipment, your suppositories may have lost their shape due to hot weather. Keep them out at room temperature until they seem soft enough to retain their mold shape, then refrigerate until needed.

To use the suppositories, open a single plastic mold, separate the two halves below the pointed end of the suppository and simply pull them apart.

Insertion: Once you have removed the suppository form its mold, slightly wet the suppository with cool water before inserting. The wetting will make the insertion easier and begin the dissolution and melting process that occurs in the vaginal fluids. To insert a suppository into the vagina, use the index finger to push the suppository high into the vaginal canal. After insertion, you must either lie down or sit and rest for approximately 30 – 35 minutes to prevent leakage of wax.

Once the suppositories have melted and the medication has been absorbed, the base material will be expelled from the body. It is recommended that you use a liner to protect clothing from any material expelled from the vagina.

VAGINAL TABLETS & CAPSULES

Instructions and Information

To use the tablet or capsule, simply insert it in the vaginal canal using the applicator provided.
This vaginal tablet or capsule has been compounded to your physician’s exact specifications, and you should follow his/her directions as to the dosage and frequency of use. Should you experience any vaginal irritation, you should consult with your physician.

FOR VAGINAL USE ONLY! DO NOT TAKE ORALLY!

TOPICAL ANESTHETIC

This product is used to temporarily relieve local pain and discomfort associated with sensitive skin and certain dermal irritations. This formula is water soluble and washes away with water.

Application: You should use this product only under the direction of your physician, who will tell you how to apply the product, in what thickness and for what amount of time. Generally, the maximum recommended penetration time should not exceed 30-45 minutes. Always wash your hands after use so as to avoid potential contact with eyes and other sensitive areas.

Precautions: Do not use this product if you are sensitive to local anesthetics (lidocaine, benzocaine, tetracaine, pramoxine). Do NOT use this product on large surface areas and/or multiple sections of the body simultaneously. This is extremely important as systemic absorption could occur resulting in severe itching, swelling or redness of skin, blurred vision, dizziness, convulsions, respiratory problems, shortness of breath or irregular heartbeat. Should this occur, contact your physician or other health care practitioner ASAP. If you are allergic to sulfa ingredients (ie. DMSO), please inform your physician. Avoid use of this product during pregnancy. You may experience a slight tingling where the product is applied, especially if you have sensitive skin - this is normal unless it develops into extreme symptoms mentioned above.

ESTROGEN

Bi-estrogen (Biest) contains estriol (80%) and estradiol 17-beta (20%)
Tri-Estrogen (Triest) contains estriol (80%), estradiol 17-beta (10%) and estrone (10%)

ABOUT YOUR MEDICATION
Estrogens are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle. They are prescribed for several reasons:
- to provide additional hormone when the body does not produce enough of its own, as during the menopause or following certain kinds of surgery.
- in the treatment of selected cases of breast cancer in men and women.
- in the treatment of men with certain kinds of cancer of the prostate.
- to help prevent osteoporosis in women past menopause.
Estrogens may also be used for other conditions as determined by your doctor. If any of the information in this leaflet causes you special concern of if you want additional information about your medication and its use, check with your doctor or pharmacist. Remember, keep this and all other medications out of the reach of children and never share your medication with others.

BEFORE USING THIS MEDICATION
Tell your doctor, nurse, and pharmacist if you...
- are allergic to any medication, either prescription or nonprescription (OTC);
- are pregnant or intend to become pregnant while using this medicine;
- are breast feeding;
- are taking any other prescription or nonprescription (OTC) medication;
- have any other medical problems, especially blood clots (or history of during estrogen therapy), breast cancer (active or suspected), changes in vaginal bleeding, heart or circulation disease, or stroke (for men); or if you smoke.

Take this medication only as directed. Do not take more of it and do not take it for a longer time than your doctor has ordered. Try to take the medication at the same time each day to reduce the possibility of side effects. If you miss a dose of the medication, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

PRECAUTIONS WHILE USING THIS MEDICATION
It is very important that your doctor check your progress at regular visits. These visits will usually be every year. It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Breast cancer has occurred rarely in men taking estrogens.
Cigarette smoking when using birth control pills containing estrogen has been found to increase the risk of serious side effects affecting the heart or circulation. To reduce the risk, do not smoke cigarettes while using estrogen. If you think that you may be pregnant, stop using the medication immediately and check with your doctor. Continued use of some estrogens during pregnancy may cause birth defects in the child. Diethylstibestrol may also increase the risk of vaginal cancer developing in daughters when they reach childbearing age.

POSSIBLE SIDE EFFECTS OF THIS MEDICATION
Along with their wanted effects, estrogens sometimes cause some serious unwanted effects. Rarely, they have caused breast cancer, blood clots, stroke, and heart attack. The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, the estrogen dose. If the uterus has been removed, there is no risk of endometrial cancer.

All estrogens carry a general warning as follows: Do not use estrogens with or without progestins for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) reported increased risks of MI, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. Other doses of conjugated estrogens and medroxyprogesterone acetate and other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Side Effects That Should Be Reported To Your Doctor Immediately
Stop taking this medication and get emergency help immediately if any of the following side effects occur: pain in the calves; sharp chest pain or sudden shortness of breath; coughing blood; abnormal vaginal bleeding; missed menstrual period or suspected pregnancy; lumps in the breast; severe headache or vomiting; dizziness or fainting; vision or speech disturbance; weakness or numbness in an arm or leg; abdominal pain, swelling, or tenderness; yellowing of the skin or eyes; depression.

Other Side Effects That Should Be Reported To Your Doctor
More common- Breast pain; increased breast size; swelling of feet and lower legs
Less common or rare-Changes in vaginal bleeding; lumps in, or discharge from, breast; pains in stomach, side, or abdomen; uncontrolled, jerky muscle movements; yellow eyes or skin
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor or pharmacist. Also, many women who are taking estrogens with a progestin (another female hormone) and have not had their uterus removed will start having monthly vaginal bleeding, similar to menstrual periods, again.

The information in this leaflet has been selectively abstracted from USP DI for use an educational aid and does not cover all possible uses, actions, precautions, side effects, or interactions of this medication. It is not intended as medical advice for individual problems.
© 1992 The United States Pharmacopeial Convention, Inc., July 1992, Estrogens (Oral) 915188
Other information taken from Facts & Comparisons, January 2005

PROGESTERONE

Instructions and Information

The progesterone prescription you are receiving has been compounded to your physician’s exact specifications. You should follow his/her directions as to the dosage and frequency of administration.

To minimize gastric irritation and enhance absorption (for oral capsules), it is recommended that you take the progesterone with food.

Other possible side-effects include somnolence or drowsiness, nausea, flatulence, break-through bleeding, breast tenderness, water retention, lightheadedness, dizziness, and tingling in the hands or feet. These side-effects generally subside after continued use of 1-2 weeks. If they should continue to be bothersome, you should consult your physician to have the dosage and/or frequency of use adjusted. Diabetic patients: Glucose tolerance may be decreased; monitor urine sugar closely and report any abnormalities to physician.

Notify physician if pregnancy is suspected or if any of the following occurs: Sudden severe headache; visual disturbance; numbness in an arm or leg.

Warning: Progestins and estrogens 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 0.625mg) combined with medroxyprogesterone acetate (MPA 2.5mg) relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a sub-study 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.

Other doses of oral conjugated estrogens with medroxyprogesterone and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials. In the absence of comparable data and product-specific studies, the relevance of the WHI findings to other products has not been establised. Therefore, the risks should be assumed to be similar for all estrogen and progestin products. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doeses and for the shortest duration consistent with treatment goals and risks for the individual woman.

TESTOSTERONE

Instructions and Information

The testosterone prescription you are receiving has been compounded to your physician's exact specifications. You should follow his/her directions as to the dosage and frequency of administration.

Some of the reported possible beneficial effects of testosterone include: increased energy levels, increased libido, mood elevation and stability, increased muscle mass, improved memory and cognition, increased bone mass.

Possible known side-effects with testosterone may include loss of scalp hair; spotty dark patches on the face; unusual body hair growth; headache; changes in weight; changes in sex drive; male pattern baldness; acne; fluid retention; anxiety; abnormal skin sensation; lack of menstrual cycle and other menstrual irregularities; deepening voice; and enlargement of the clitoris.

Females - Notify physician if hoarseness, deepening of the voice, increases in facial hair, acne, or menstrual irregularities occur. Notify physician if pregnancy is suspected, as testosterone can cause fetal harm. Pregnant women should avoid skin contact with testosterone gel application sites in men. In the event that unwashed or unclothed skin to which testosterone gel has been applied does come in direct contact with the skin of a pregnant woman, wash the general area of contact on the woman with soap and water as soon as possible.

Males - Do not apply testosterone to the genitals, unless otherwise directed by their healthcare provider. Patients with benign prostatic hypertrophy (BPH) may develop a condition that results in the urethra being blocked. Prolonged erection or excessive sexual stimulation may also develop. Infertility may occur after prolonged administration or excessive dosage. If any of these effects appear, stop administration. If restarted, use a lower dosage. Avoid stimulation to the point of increasing nervous, mental, and physical activities beyond the patient's cardiovascular capacity.

PREGNENOLONE

Instructions and Information

The pregnenolone prescription you are receiving has been compounded to your physician's exact specifications. You should follow his/her directions as to the dosage and frequency of administration.

Pregnenolone is the precursor for all other steroid hormones. Some of the reported possible beneficial effects of pregnenolone include: memory enhancement, mood elevation, anti-arthritis, improvement in joint pain, repair myelin sheath membrane that protects nerve cells, and counter-balance of adverse effects of excess cortisol.

Instructions: Pregnenolone should generally be taken in the morning as a single daily dose.
Possible side-effects of pregnenolone may include difficulty sleeping, irritability, anxiety, acne, headaches. Possible hair loss may occur in certain patients if used for prolonged periods. If these side-effects should occur, you should consult your physician to have the dosage adjusted. Caution: If you are suffer from epileptic seizures or are taking an anti-seizure medication such as Dilantin, Depakote, or Tegretol, you should use pregnenolone only with your doctor's supervision.

DHEA

Instructions and Information

Your prescription for DHEA (dehydroepiandrosterone) is compounded in either a capsule, sublingual tablet or gel formulation. DHEA is the most abundant hormone precursor in the human blood. It is classified as an androgen. DHEA is obtained from the barbasco root, a wild yam in the Mexican forest.

Some of the reported possible beneficial effects of DHEA include: may help to slow down the aging processes and degenerative disease; may inhibit the production of excess fatty acids and cholesterol; may be beneficial to people with Rheumatoid Arthritis; may inhibits the conversion of carbohydrates to fat in the body; may be helpful in cancer, Alzheimer's disease, Multiple Sclerosis, memory loss, chronic fatigue syndrome, Diabetes and Parkinson's disease; may improve muscle strengthening and sense of well-being; may help slow or inhibit osteoporosis.

Instructions: Generally DHEA should be taken in the morning with breakfast. However, if your physician or pharmacist has instructed you differently, then you should follow these instructions.

THYROID REPLACEMENT

Instructions and Information

The thyroid replacement prescription you are receiving has been compounded to your physician's exact specifications. Thyroid replacement may be in the form of liothyronine (T3) and/or levothyroxine (T4). T3 is approximately 4 times as potent as levothyroxine T4 on a microgram for microgram basis. Some thyroid medications such as Armour Thyroid™ are derived from dessicated porcine gland which contain both T3 and T4.

How to take this medication: This medication works best when taken on an empty stomach (1 hour before or 2 hours after a meal) with a full glass of water. Do not stop taking this medication without consulting your physician. Lab tests may be done periodically to monitor the effectiveness of this medication.

Side Effects: Symptoms of hypothyroidism include fatigue, muscle aches, constipation, dry skin or weight gain. These symptoms should disappear as your body adjusts to the medication. If they persist or become bothersome, inform your physician. Notify your physician immediately if you experience headache, chest pain, increased pulse rate, rapid or irregular heart beat, shortness of breath, trembling, sweating, leg cramping, or diarrhea while taking this medication. These are symptoms of hyperthyroidism and the dose of the medication may need to be adjusted. Be sure to tell your physician if you are pregnant. The dose of this medication may need to be adjusted during pregnancy. Small amounts of thyroid hormone appear in breast milk. consult your physician before breastfeeding.

Storage: Store at room temperature between 59 and 86 degrees F, away from moisture and sunlight. Do not store in the bathroom.

Missed Dose: If you miss a dose, take as soon as remembered. Do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. Call your physician or pharmacist if you miss two or more doses in a row.