Divigel

Serious side effects have been reported with Divigel. See the “Divigel Precautions” section.

Common side effects of Divigel include the following:

• Headache
• Breast pain/tenderness
• Irregular vaginal bleeding or spotting
• Stomach or abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

This is not a complete list of Divigel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Divigel drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Divigel should not be used during lactation. Estrogen has been detected in human breast milk. Estrogen can decrease the quality or quantity of breast milk. Caution should be taken if Divigel is given to a nursing mother. 

Use Divigel exactly as prescribed.

• Divigel should be applied once a day, around the same time each day
• Apply Divigel to clean, dry, and unbroken (without cuts or scrapes) skin. If you take a bath or shower, be sure to apply your Divigel after your skin is dry. The application site should be completely dry before dressing or swimming
• Apply Divigel to either your left or right upper thigh. Change between your left and right upper thigh each day to help prevent skin irritation

TO APPLY:

Step 1: Wash and dry your hands thoroughly.

Step 2: Sit in a comfortable position.

Step 3: Cut or tear the Divigel packet

Step 4: Using your thumb and index finger, squeeze the entire contents of the packet onto the skin of the upper thigh 

Step 5: Gently spread the gel in a thin layer on your upper thigh over an area of about 5 by 7 inches, or two palm prints. It is not necessary to massage or rub in Divigel.

Step 6: Allow the gel to dry completely before dressing.

Step 7: Dispose of the empty Divigel packet in the trash.

Step 8: Wash your hands with soap and water immediately after applying Divigel to remove any remaining gel and reduce the chance of transferring Divigel to other people.

Important things to remember when using Divigel

• Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people
• Allow the gel to dry before dressing. Try to keep the area dry for as long as possible
• Do not allow others to come in contact with the area of skin where you applied the gel for at least one hour after you apply Divigel
• You should not allow others to apply the gel for you. However, if this is necessary, the individual should wear a disposable plastic glove to avoid direct contact with Divigel
• Do not apply Divigel to your face, breast, or irritated skin
• Never apply Divigel in or around the vagina
• Divigel contains alcohol. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day. Do not apply Divigel more than once each day. If you accidentally spill some of the contents of a Divigel packet, do not open a new packet. Wait and apply your normal dose the next day.

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Divigel. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

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

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):

• Wash and dry your hands thoroughly before and after handling the patch.
• Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.
• Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.
• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.
• If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
• Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):

• Washing and drying hands thoroughly before each application.
• Apply while you are sitting comfortably. Apply one pouch to each leg every morning.
• Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Rub any remaining emulsion on both hands on the buttocks.
• Washing and drying hands thoroughly after application.
• To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:

• Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.
• Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.
• If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.
• Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing

The dose medicines in this class 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 these medicines. 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 conjugated estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least 3 months.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • For treating ovary problems (female hypogonadism or for starting puberty):
    • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 milligram (mg) three times a day.
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.

For esterified estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism):
    • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating symptoms of menopause:
    • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.

For estradiol
• For oral dosage form:
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least 3 months.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
    • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.
  • For treating prostate cancer:
    • Adults—1 to 2 milligrams (mg) three times a day.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
• For topical emulsion dosage form (skin lotion):
  • For treating symptoms of menopause:
    • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
• For transdermal dosage form (skin patches):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
    For the Climara patches
    • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

For estradiol cypionate
• For injection dosage form:
  • For treating ovary problems (female hypogonadism):
    • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
  • For treating symptoms of menopause:
    • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.

For estradiol valerate
• For injection dosage form:
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.
  • For treating prostate cancer:
    • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.

For estrone
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating prostate cancer:
    • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.

For estropipate
• For oral dosage form (tablets):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.

For ethinyl estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—1 milligram (mg) three times a day.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—0.15 to 3 milligrams (mg) a day.
  • For treating symptoms of menopause:
    • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

For ethinyl estradiol and norethindrone
• For oral dosage form (tablets):
  • For treating symptoms of menopause:
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
  • To prevent loss of bone (osteoporosis):
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.

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.

If you miss a dose of this medicine, apply 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.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

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.

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

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. This risk seems to increase as the dose and the length of use increase. 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, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

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.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

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

• Breast pain (in females and males)
• fast heartbeat
• fever
• hives
• hoarseness
• increased breast size (in females and males)
• irritation of the skin
• itching of the skin
• joint pain, stiffness, or swelling
• rash
• redness of the skin
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• swelling of the feet and lower legs
• tightness in the chest
• troubled breathing or swallowing
• weight gain (rapid)
• wheezing

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
• chest pain
• chills
• cough
• heavy non-menstrual vaginal bleeding
• lumps in, or discharge from, breast (in females and males)
• pains in the stomach, side, or abdomen
• yellow eyes or skin

• Headache (sudden or severe)
• loss of coordination (sudden)
• loss of vision or change of vision (sudden)
• pains in the chest, groin, or leg, especially in the calf of leg
• shortness of breath (sudden and unexplained)
• slurring of speech (sudden)
• weakness or numbness in the arm or leg

• Abdominal or stomach bloating
• abdominal or stomach cramps
• acid or sour stomach
• anxiety
• backache
• belching
• blindness
• blistering, peeling, or loosening of the skin
• blue-yellow color blindness
• blurred vision
• change in vaginal discharge
• changes in skin color
• changes in vision
• chest discomfort
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• dark urine
• decrease in the amount of urine
• decreased vision
• depression
• diarrhea
• difficulty with breathing
• difficulty with speaking
• dimpling of the breast skin
• dizziness
• double vision
• dry mouth
• eye pain
• fainting
• fluid-filled skin blisters
• full feeling in upper abdomen or stomach
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move the arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increased urination
• indigestion
• inverted nipple
• irregular heartbeats
• light-colored stools
• lightheadedness
• loss of appetite
• loss of bladder control
• lump under the arm
• metallic taste
• migraine headache
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain
• muscle spasm or jerking of all extremities
• muscle weakness
• nausea
• noisy breathing
• numbness or tingling of the hands, feet, or face
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back or neck
• pain or feeling of pressure in the pelvis
• pain, tenderness, swelling of the foot or leg
• painful or tender cysts in the breasts
• painful, red lumps under the skin, mostly on the legs
• pains in the chest, groin, or legs, especially calves of the legs
• partial or complete loss of vision in the eye
• pelvic pain
• persistent crusting or scaling of nipple
• pinpoint red or purple spots on the skin
• prominent superficial veins over affected area
• red, irritated eyes
• redness or swelling of the breast
• sensitivity to the sun
• severe headaches of sudden onset
• skin thinness
• skin warmth
• 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 discomfort, upset, or pain
• sudden loss of consciousness
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• swelling of the abdominal or stomach area
• swelling of the fingers or hands
• thirst
• tremor
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• weight loss

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:

• Abnormal growth filled with fluid or semisolid material
• accidental injury
• bladder pain
• bloated full feeling
• bloody or cloudy urine
• body aches or pain
• coating or white patches on tongue
• congestion
• cough producing mucus
• decrease in amount of urine
• difficult, burning, or painful urination
• discouragement
• dryness of the throat
• ear congestion or pain
• excess air or gas in the stomach or intestines
• fear
• feeling of warmth
• feeling sad or empty
• frequent urge to urinate
• general feeling of discomfort or illness
• headache, severe and throbbing
• increased clear or white vaginal discharge
• irritability
• itching of the vaginal, rectal or genital areas
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• mild dizziness
• neck pain
• nervousness
• pain
• pain during sexual intercourse
• painful or difficult urination
• pain or tenderness around the eyes and cheekbones
• passing gas
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• skin irritation or redness where skin patch was worn
• shivering
• sleeplessness
• sneezing
• sore mouth or tongue
• stuffy nose
• sudden sweating
• tender, swollen glands in the neck
• thick, white vaginal discharge with no odor or with a mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• voice changes

• Blemishes on the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning or stinging of the skin
• diarrhea (mild)
• difficulty with moving
• dizziness (mild)
• increased hair growth, especially on the face
• lower abdominal or stomach pain or pressure
• mood or mental changes
• muscle stiffness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• pounding in the ears
• problems in wearing contact lenses
• slow heartbeat
• tooth or gum pain
• unusual decrease in sexual desire (in males)
• unusual increase in sexual desire (in females)
• white or brownish vaginal discharge

• Abnormal turning out of cervix
• changes in appetite
• dull ache or feeling of pressure or heaviness in the legs
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• irritability
• large amount of triglyceride in the blood
• leg cramps
• patchy brown or dark brown discoloration of the skin
• poor insight and judgment
• problems with memory or speech
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of the scalp hair in some people.

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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from heat or open flame.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Divigel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Divigel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Divigel (estradiol gel packets).

Review Date: October 4, 2017

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis and liver.

How Supplied

Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 0.25, 0.5, and 1.0 g, corresponding to 0.25, 0.5, and 1.0 mg estradiol, respectively.

NDC 68025-065-30, carton of 30 packets, 0.25 mg estradiol per single-dose foil packet
NDC 68025-066-30, carton of 30 packets, 0.5 mg estradiol per single-dose foil packet
NDC 68025-067-30, carton of 30 packets, 1.0 mg estradiol per single-dose foil packet

Keep out of the reach of children.

Storage and Handling

Store at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.]

NDC 68025-066-30

Divigel®
(estradiol gel) 0.1%

0.5 mg

30 packets
0.5 g gel provides 0.5 mg estradiol/packet

Rx only

VERTICAL
PHARMACEUTICALS, LLC