What is Octodiol?
Octodiol is a form of estrogen, a female sex hormone that regulates many processes in the body.
Some Octodiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms (such as dryness, burning, and irritation). Other vaginal Octodiol products are used for treating vaginal menopause symptoms and symptoms that affect other parts of the body (such as hot flashes). This type of vaginal Octodiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is directly applied.
This medication guide provides information about Octodiol for local treatment of vaginal symptoms of menopause (such as dryness, itching, irritation, and pain during sexual intercourse).
Octodiol (local) may also be used for purposes not listed in this medication guide.
Octodiol indications
Octodiol is a Hormone Replacement Therapy (HRT). It contains the female hormone Octodiol.
Octodiol is used in postmenopausal women, particularly in women who have had their womb removed (have had a hysterectomy) and therefore do not require combined oestrogen/progestagen therapy.
Octodiol is
Used for: Relief of symptoms occurring after menopause: During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Octodiol alleviates these symptoms after menopause. Octodiol should only be prescribed if the symptoms seriously hinder the patient’s daily life.
Prevention of osteoporosis (thinning of the bones), if the patient is at high risk of future fracture and if unable to take other medications for this purpose.
There is only limited experience of treating women older than 65 years.
How should I use Octodiol?
Use Octodiol emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Octodiol emulsion. Talk to your pharmacist if you have questions about this information.
- If you are switching from oral estrogen to Octodiol emulsion, stop taking the oral estrogen and wait 1 week before using Octodiol emulsion. However, if symptoms return, you may start using Octodiol emulsion sooner.
- Wash your hands with soap and water both before and after using Octodiol emulsion.
- Sit in a comfortable sitting position and apply Octodiol emulsion to clean, dry skin of the leg. Cut or tear the pouch of medicine and empty the entire contents of the pouch onto the top of the thigh. Rub the medicine in well into the thigh and calf of the leg for 3 minutes until it is completely absorbed. Rub any medicine remaining on the hands onto the buttocks. If you are using two pouches of Octodiol emulsion, apply the second pouch of medicine to the opposite leg in the same way.
- Allow the medicine to dry completely before covering with clothing to avoid transfer to other people.
- Grapefruit and grapefruit juice may increase the risk of Octodiol emulsion's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Octodiol emulsion.
- If you miss a dose of Octodiol emulsion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Octodiol emulsion.
Uses of Octodiol in details
This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure) and by men to treat prostate cancer.
How to use Octodiol intramuscular
Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
This medication is injected into a muscle as directed by your doctor, usually every 4 weeks. For the treatment of prostate cancer, this medication is usually given every 1 to 2 weeks. The dosage is based on your medical condition and response to treatment.
If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If stored at low temperatures, crystal may form in the liquid. To dissolve these crystals, simply warm the product to room temperature prior to use. Learn how to store and discard medical supplies safely.
Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder of when to receive your doses.
Tell your doctor if your condition does not improve or if it worsens.
Octodiol description
Generally refers to the 17-beta-isomer of Octodiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Octodiol-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the placenta. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of Octodiol binds weakly to estrogen receptors (receptors, estrogen) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.
Octodiol dosage
Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin.
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause
Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause
Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
Treatment Of Hypoestrogenism Due To Hypogonadism, Castration, Or Primary Ovarian Failure
Start therapy with 0.025 mg per day applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Octodiol transdermal system, especially in women with an intact uterus.
Prevention Of Postmenopausal Osteoporosis
Start therapy with 0.025 mg per day applied to the skin once weekly.
Application Of The Octodiol Transdermal System
Site Selection
- The adhesive side of Octodiol should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.
- Octodiol should not be applied to or near the breasts.
- The sites of application must be rotated, with an interval of at least 1-week allowed between applications to the same site.
- The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off.
- Application to areas where sitting would dislodge Octodiol should also be avoided.
Application
- Octodiol should be applied immediately after opening the pouch and removing the protective liner.
- Octodiol should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
- If the system lifts, apply pressure to maintain adhesion.
- In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
- Only one system should be worn at any one time during the 7-day dosing interval.
- Swimming, bathing, or using a sauna while using Octodiol has not been studied, and these activities may decrease the adhesion of the system and the delivery of Octodiol.
Removal Of The Octodiol Transdermal System
- Removal of Octodiol should be done carefully and slowly to avoid irritation of the skin.
- Should any adhesive remain on the skin after removal of the Octodiol system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
- Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.
How supplied
Dosage Forms And Strengths
- Octodiol (Octodiol transdermal system), 0.025 mg per day—each 6.5 cm² system contains 2 mg of Octodiol
- Octodiol (Octodiol transdermal system), 0.0375 mg per day—each 9.375 cm² system contains 2.85 mg of Octodiol
- Octodiol (Octodiol transdermal system), 0.05 mg per day—each 12.5 cm² system contains 3.8 mg of Octodiol
- Octodiol (Octodiol transdermal system), 0.060 mg per day—each 15 cm² system contains 4.55 mg of Octodiol
- Octodiol (Octodiol transdermal system), 0.075 mg per day—each 18.75 cm² system contains 5.7 mg of Octodiol
- Octodiol (Octodiol transdermal system), 0.1 mg per day—each 25.0 cm² system contains 7.6 mg of Octodiol
Octodiol (Octodiol transdermal system), 0.025 mg per day — each 6.5 cm² system contains 2 mg of Octodiol USP Individual Carton of 4 systems NDC 50419-454-04
Octodiol (Octodiol transdermal system), 0.0375 mg per day — each 9.375 cm² system contains 2.85 mg of Octodiol USP Individual Carton of 4 systems NDC 50419-456-04
Octodiol (Octodiol transdermal system), 0.05 mg per day — each 12.5 cm² system contains 3.8 mg of Octodiol USP Individual Carton of 4 systems NDC 50419-451-04
Octodiol (Octodiol transdermal system), 0.06 mg per day — each 15 cm² system contains 4.55 mg of Octodiol USP Individual Carton of 4 systems NDC 50419-459-04
Octodiol (Octodiol transdermal system), 0.075 mg per day — each 18.75 cm² system contains 5.7 mg of Octodiol USP Individual Carton of 4 systems NDC 50419-453-04
Octodiol (Octodiol transdermal system), 0.1 mg per day — each 25 cm² system contains 7.6 mg of Octodiol USP Individual Carton of 4 systems NDC 50419-452-04
Storage And Handling
Store at 20°C to 25°C (66°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 86°F (30°C).
Do not store unpouched. Apply immediately upon removal from the protective pouch.
Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.
Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Manufactured by 3M Drug Delivery Systems, Northridge, CA 91324. Revised: Oct 2013
Octodiol interactions
See also:
What other drugs will affect Octodiol?
Some products that may interact with this drug include: "blood thinners" (such as warfarin), corticosteroids (such as prednisone), thyroid replacement medication.
Other medications can affect the removal of Octodiol cypionate from your body, which may affect how Octodiol cypionate works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
This medication may interfere with certain laboratory tests (including blood clotting, thyroid function), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Octodiol side effects
See also:
What are the possible side effects of Octodiol?
See WARNINGS and Boxed Warning regarding the potential adverse effects on the fetus, the induction of malignant neoplasms, gallbladder disease, cardiovascular disease, elevated blood pressure, and hypercalcemia.
Skin irritation: In controlled clinical studies with Octodiol (Octodiol transdermal), the most commonly reported adverse events were topical reactions of erythema and/or pruritus at the application site. In general these reactions caused patients little or no discomfort, and led to premature discontinuation of treatment in 0.9% (3/317) of patients in these trials. The rate of application site reactions, based on 8,135 applications of the 0.025, 0.05, and 0.1 Octodiol (Octodiol transdermal) systems in these trials was 6.1 per 100 applications (4.9, 5.4, 10.7 for the 3 Octodiol (Octodiol transdermal) doses respectively) compared to 6.2 in the placebo treated patients (2,014 applications).
In a placebo-controlled trial of Octodiol (Octodiol transdermal) 0.025, 0.05, and 0.1 conducted in 196 patients in the US, the adverse events reported by at least 5% of patients in 1 or more of the treatment groups are shown in Table 5.
| Table 5: Incidence of Adverse Events >5% in a Placebo-Controlled Study of Octodiol Data Are Expressed as % of Treatment Group | ||||
| Placebo | Octodiol | Octodiol | Octodiol | |
| Adverse Event | 0.025 mg/day | 0.05 mg/day | 0.1 mg/day | |
| (N=54) | (N=48) | (N=47) | (N=47) | |
| Breast Pain | 3.7 | 25.0 | 44.7 | 46.8 |
| Headache | 22.2 | 18.8 | 8.5 | 6.4 |
| Infection | 7.4 | 10.4 | 10.6 | 8.5 |
| Injury Accident | 3.7 | 10.4 | 4.3 | 2.1 |
| Anxiety | 0 | 8.3 | 2.1 | 0 |
| Emotional Lability | 1.9 | 8.3 | 2.1 | 6.4 |
| Arthralgia | 1.9 | 6.3 | 2.1 | 4.3 |
| Flu Syndrome | 7.4 | 6.3 | 6.4 | 8.5 |
| Joint Disorder | 0 | 6.3 | 0 | 0 |
| Pruritus | 1.9 | 6.3 | 12.8 | 0 |
| Rhinitis | 1.9 | 6.3 | 4.3 | 4.3 |
| Abdominal Pain | 9.3 | 4.2 | 10.6 | 2.1 |
| General Edema | 1.9 | 4.2 | 6.4 | 6.4 |
| Monilia Vagina | 5.6 | 4.2 | 8.5 | 4.3 |
| Nausea | 1.9 | 4.2 | 10.6 | 8.5 |
| Peripheral Edema | 0 | 4.2 | 2.1 | 6.4 |
| Sinusitis | 7.4 | 4.2 | 2.1 | 4.3 |
| Asthenia | 1.9 | 2.1 | 10.6 | 6.4 |
| Back Pain | 3.7 | 2.1 | 2.1 | 6.4 |
| Diarrhea | 1.9 | 2.1 | 8.5 | 0 |
| Dysmenorrhea | 0 | 2.1 | 2.1 | 6.4 |
| Enlarged Abdomen | 0 | 2.1 | 2.1 | 6.4 |
| Enlarged Breast | 0 | 2.1 | 2.1 | 8.5 |
| Rash | 5.6 | 2.1 | 4.3 | 2.1 |
| Anemia | 0 | 0 | 6.4 | 4.3 |
| Gastroenteritis | 1.9 | 0 | 0 | 6.4 |
| Hyperlipemia | 5.6 | 0 | 0 | 2.1 |
| Leukorrhea | 0 | 0 | 12.8 | 0 |
| Paresthesia | 1.9 | 0 | 6.4 | 0 |
Urogenital Adverse Events : In the US placebo-controlled study, 72 patients were included who had intact uteri. As expected, after 12-13 weeks of continuous unopposed therapy, findings of endometrial hyperplasia (diagnosed either by endometrial biopsy and/or ultrasonography) were increased with increasing doses of Octodiol (placebo: 0/18 patients; Octodiol (Octodiol transdermal) 0.025: 1/14 (7.1%); Octodiol (Octodiol transdermal) 0.05: 12/22 (54.5%); Octodiol (Octodiol transdermal) 0.1: 10/18 (55.6%). In the 86 patients who had not previously undergone a total hysterectomy, vaginal bleeding was also increased with increasing doses of Octodiol [placebo: 2/21 patients (9.5%); Octodiol (Octodiol transdermal) 0.025: 6/19 (31.6%); Octodiol (Octodiol transdermal) 0.05: 14/25 (56.0%); Octodiol (Octodiol transdermal) 0.1: 12/21 (57.1%)].
In 2 long-term studies involving a total of 488 patients treated for a mean duration of 618 days and up to 3.5 years, the nature and incidence of adverse events did not change with prolonged duration of treatment.
The following additional adverse reactions have been reported with estrogen therapy:
1. Genitourinary System. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; increase in size of uterine leiomyomata; vaginal candidiasis; change in amount of cervical secretion.
2. Breasts. Tenderness, enlargement.
3. Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; gallbladder disease.
4. Skin. Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism.
5. Eyes. Steepening of corneal curvature: intolerance to contact lenses.
6. Central Nervous System. Headache, migraine, dizziness; mental depression; chorea.
7. Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido.
Octodiol contraindications
See also:
What is the most important information I should know about Octodiol?
Octodiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.
Octodiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin while you are using Octodiol, to help lower this risk. Report any unusual vaginal bleeding right away.
Long-term use of Octodiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Octodiol transdermal long term.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Octodiol transdermal.
Octodiol transdermal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
Active ingredient matches for Octodiol:
Estradiol in Czech Republic, Slovakia.
List of Octodiol substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Nuvelle TS Phase I | |
| Oesclim 25 µg/24 h (Lithuania) | |
| Oesclim 37.5 µg/24 h (Lithuania) | |
| Oesclim 75 µg/24 h (Lithuania) | |
| Oestergon | |
| Oestraclin (Spain) | |
| Oestradiol (Bosnia & Herzegowina, Serbia, South Africa) | |
| Injectable; Injection; Estradiol 1 mg / ml | |
| Injectable; Injection; Estradiol 5 mg / ml | |
| Oestradiol Benzoaat (Netherlands) | |
| Oestradiol Benzoate (Ireland, United Kingdom) | |
| Oestradiol Benzoate March (Thailand) | |
| Oestradiol Benzoate March 5 mg/1 mL x 10's (March Pharma) | |
| Oestradiol Benzoate March 5 mg/1 mL x 100's (March Pharma) | |
| Oestradiol Benzoate March inj 5 mg/mL 10 x 1's (March Pharma) | |
| Oestradiol Benzoate March inj 5 mg/mL 100's (March Pharma) | |
| Oestradiol Berco | |
| Oestradiol Galenika (Macedonia) | |
| Oestradiol Implant (Singapore) | |
| Oestradiol Implants | |
| Implant; Injection; Estradiol 100 mg | |
| Implant; Injection; Estradiol 20 mg | |
| Implant; Injection; Estradiol 50 mg | |
| Oestradiol R | |
| Oestring (Sweden) | |
| Oestriol Aspen (Sweden) | |
| Oestro (Argentina) | |
| Oestro Gel (Argentina) | |
| Oestrodose (France, Israel, Tunisia) | |
| Gel; Topical; Estradiol Hemihydrate 0.06% (A. Menarini) | |
| Oestrodose 0.75 mg/1.25 g x 1 Bottle 80 g (A. Menarini) | |
| Oestrodose transdermal gel 600 mcg/g / w/ metering pump 80 g x 1's (A. Menarini) | $ 18.55 |
| Oestrodose 0.06% (France) | |
| Oestrogel (Belgium, Brazil, Bulgaria, China, Czech Republic, France, Greece, Hong Kong, Israel, Luxembourg, Mexico, Romania, Russian Federation, Singapore, Slovakia, Switzerland, Taiwan, Tunisia, United Kingdom, Vietnam) | |
| Gel; Topical; Estradiol 0.06% (Chemech Laboratories Ltd.) | |
| 80g (Chemech Laboratories Ltd.) | $ 3.87 |
| Oestrogel 0.06 % x 80 g (Chemech Laboratories Ltd.) | |
| Oestrogel 0.06 % x 10 g (Chemech Laboratories Ltd.) | |
| Oestrogel 0.06 % x 30 g (Chemech Laboratories Ltd.) | |
| Oestrogel 0.06 % x 80 g x 1's (Chemech Laboratories Ltd.) | |
| Oestrogel 0.06 % x 1 tube 80 g in thöôùc ño lieà u (Chemech Laboratories Ltd.) | |
| Oestrogel 3mg x 5g GEL / 80g (Chemech Laboratories Ltd.) | $ 3.87 |
| Oestrogel 80 gm Gel (Chemech Laboratories Ltd.) | $ 0.24 |
| OESTROGEL 0.06% GEL 1 tube / 80 GM gel each (Chemech Laboratories Ltd.) | $ 7.23 |
| Oestrogel gel 0.06% 80 g x 1's (Chemech Laboratories Ltd.) | |
| Oestrogel topical gel 0.06 % 80 g x 1's (Chemech Laboratories Ltd.) | |
| OESTROGEL topical gel 3 mg x 5 g x 80g (Chemech Laboratories Ltd.) | $ 3.87 |
See 1131 substitutes for Octodiol | |
References
- DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "estradiol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "estradiol". http://www.drugbank.ca/drugs/DB00783 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Octodiol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Octodiol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
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Information checked by Dr. Sachin Kumar, MD Pharmacology
