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DIVIGEL 0.5 MG GEL 30

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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Type Code S
FDA Approval Date 07/03/2007
FDA Therap Equiv EA
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 30
Units Per Pkg 06/04/2007
Active Ingredients 1265 estradiol 50282
AHFS Class 68160400 ESTROGENS
DEA Class NC
Dose Form GEL IN PACKET (EA)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 60493 estradiol TRANSDERM GEL PACKET 0.5MG/0.5G
Inactive Ingredients 2464 alcohol 64175; 2468 propylene glycol 57556
OMP Family -
Product Category RX Pharmaceuticals
Strength 0.5MG
Common Brand Name COMMON BRAND NAME(S): Divigel
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane, letrozole), fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene, tranexamic acid. This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
Allocation Period -
Case Quantity 12
Drug Form Pack Size 30
Form GELATIN
Hazard Code UN1993 FLAMMABLE LIQUIDS, N.O.S.
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 30
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. Learn how to apply the gel correctly. If you have any questions, ask your doctor or pharmacist. Apply the medication to clean, dry skin on the upper thigh area as directed by your doctor, usually once daily. Switch between the right and left thigh with each application. Avoid applying this medication to broken, irritated skin. Do not apply this medication to the breast, face, or in or around the vagina. Do not let others apply this medication to your body. The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this medication more often than prescribed. After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Wait a few minutes for the application site to dry completely before dressing. Cover the application site with clothing (such as shorts or pants) to prevent others from touching the application area and being exposed to the drug. Wait at least 1 hour before allowing others to touch the skin where the medication was applied. If someone accidentally touches the gel (or the application area within 1 hour), have them wash the area of contact on their body with soap and water as soon as possible. To get the best effect, wait at least 1 hour before showering/swimming to allow the drug to be absorbed through the skin. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Avoid getting this medication in the eyes. If this medication gets in the eyes, rinse them right away with warm water. Tell your doctor if you get any eye irritation. This medication is flammable until dry. Let the gel dry before smoking or going near an open flame. Tell your doctor if your condition does not improve or if it worsens.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose (within 12 hours), skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are using this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details. Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises (such as reading, solving crossword puzzles) to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you. Lifestyle changes that may help reduce hot flashes include stopping smoking, dressing lightly or in layers, avoiding/limiting certain foods (spicy foods, caffeine, alcohol), reducing stress, and exercising regularly.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.
Phonetic Pronunciation (ES-tra-DYE-ol)
Precautions PRECAUTIONS: Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots), family or personal history of a certain swelling disorder (angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, mental/mood disorders (such as dementia, depression), a certain blood disorder (porphyria). Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35. Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions. This drug may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Wear protective clothing when outdoors. Ask your doctor or pharmacist about using sunscreen with this medication. Sunscreen may affect the absorption of this medication if applied on the area of the skin where the medication was applied. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. This product is not meant for children. Children may be accidentally exposed to this medication by touching someone on the area where the medication was applied. If this occurs, the child may have unwanted side effects. Children should avoid contact with any unclothed area where the medication has been applied. Tell the doctor right away if you notice unexpected signs of puberty in a child such as an increase in breast or nipple size. To decrease this risk, carefully follow all directions for the proper use of this drug. This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination. This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, trouble speaking, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting. A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from heat. Do not store near an open flame. Do not open the pouch until ready for use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Symptoms of menopause are caused by the body making less estrogen. If you are using estrogens to treat only vaginal symptoms of menopause (such as vaginal dryness/burning/itching), products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

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The cost of DIVIGEL 0.5 MG GEL 30 is available for registerd members only .
DIVIGEL 0.5 MG GEL 30 is manufactured by VERTICAL PHARMACEUTICALS, INC..
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