What is Progynova 21?
Progynova 21 is a form of estrogen, a female sex hormone that regulates many processes in the body.
Some Progynova 21 products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms (such as dryness, burning, and irritation). Other vaginal Progynova 21 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 Progynova 21 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 Progynova 21 for local treatment of vaginal symptoms of menopause (such as dryness, itching, irritation, and pain during sexual intercourse).
Progynova 21 (local) may also be used for purposes not listed in this medication guide.
Progynova 21 indications
Progynova 21 is a Hormone Replacement Therapy (HRT). It contains the female hormone Progynova 21.
Progynova 21 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.
Progynova 21 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’). Progynova 21 alleviates these symptoms after menopause. Progynova 21 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 Progynova 21?
Use Progynova 21 emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Progynova 21 emulsion. Talk to your pharmacist if you have questions about this information.
- If you are switching from oral estrogen to Progynova 21 emulsion, stop taking the oral estrogen and wait 1 week before using Progynova 21 emulsion. However, if symptoms return, you may start using Progynova 21 emulsion sooner.
- Wash your hands with soap and water both before and after using Progynova 21 emulsion.
- Sit in a comfortable sitting position and apply Progynova 21 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 Progynova 21 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 Progynova 21 emulsion's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Progynova 21 emulsion.
- If you miss a dose of Progynova 21 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 Progynova 21 emulsion.
Uses of Progynova 21 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 Progynova 21 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.
Progynova 21 description
Generally refers to the 17-beta-isomer of Progynova 21, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Progynova 21-17-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 Progynova 21 binds weakly to estrogen receptors (receptors, estrogen) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.
Progynova 21 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 Progynova 21 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 Progynova 21 Transdermal System
Site Selection
- The adhesive side of Progynova 21 should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.
- Progynova 21 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 Progynova 21 should also be avoided.
Application
- Progynova 21 should be applied immediately after opening the pouch and removing the protective liner.
- Progynova 21 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 Progynova 21 has not been studied, and these activities may decrease the adhesion of the system and the delivery of Progynova 21.
Removal Of The Progynova 21 Transdermal System
- Removal of Progynova 21 should be done carefully and slowly to avoid irritation of the skin.
- Should any adhesive remain on the skin after removal of the Progynova 21 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
- Progynova 21 (Progynova 21 transdermal system), 0.025 mg per day—each 6.5 cm² system contains 2 mg of Progynova 21
- Progynova 21 (Progynova 21 transdermal system), 0.0375 mg per day—each 9.375 cm² system contains 2.85 mg of Progynova 21
- Progynova 21 (Progynova 21 transdermal system), 0.05 mg per day—each 12.5 cm² system contains 3.8 mg of Progynova 21
- Progynova 21 (Progynova 21 transdermal system), 0.060 mg per day—each 15 cm² system contains 4.55 mg of Progynova 21
- Progynova 21 (Progynova 21 transdermal system), 0.075 mg per day—each 18.75 cm² system contains 5.7 mg of Progynova 21
- Progynova 21 (Progynova 21 transdermal system), 0.1 mg per day—each 25.0 cm² system contains 7.6 mg of Progynova 21
Progynova 21 (Progynova 21 transdermal system), 0.025 mg per day — each 6.5 cm² system contains 2 mg of Progynova 21 USP Individual Carton of 4 systems NDC 50419-454-04
Progynova 21 (Progynova 21 transdermal system), 0.0375 mg per day — each 9.375 cm² system contains 2.85 mg of Progynova 21 USP Individual Carton of 4 systems NDC 50419-456-04
Progynova 21 (Progynova 21 transdermal system), 0.05 mg per day — each 12.5 cm² system contains 3.8 mg of Progynova 21 USP Individual Carton of 4 systems NDC 50419-451-04
Progynova 21 (Progynova 21 transdermal system), 0.06 mg per day — each 15 cm² system contains 4.55 mg of Progynova 21 USP Individual Carton of 4 systems NDC 50419-459-04
Progynova 21 (Progynova 21 transdermal system), 0.075 mg per day — each 18.75 cm² system contains 5.7 mg of Progynova 21 USP Individual Carton of 4 systems NDC 50419-453-04
Progynova 21 (Progynova 21 transdermal system), 0.1 mg per day — each 25 cm² system contains 7.6 mg of Progynova 21 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
Progynova 21 interactions
See also:
What other drugs will affect Progynova 21?
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 Progynova 21 cypionate from your body, which may affect how Progynova 21 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.
Progynova 21 side effects
See also:
What are the possible side effects of Progynova 21?
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 Progynova 21 (Progynova 21 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 Progynova 21 (Progynova 21 transdermal) systems in these trials was 6.1 per 100 applications (4.9, 5.4, 10.7 for the 3 Progynova 21 (Progynova 21 transdermal) doses respectively) compared to 6.2 in the placebo treated patients (2,014 applications).
In a placebo-controlled trial of Progynova 21 (Progynova 21 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 Progynova 21 Data Are Expressed as % of Treatment Group | ||||
Placebo | Progynova 21 | Progynova 21 | Progynova 21 | |
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 Progynova 21 (placebo: 0/18 patients; Progynova 21 (Progynova 21 transdermal) 0.025: 1/14 (7.1%); Progynova 21 (Progynova 21 transdermal) 0.05: 12/22 (54.5%); Progynova 21 (Progynova 21 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 Progynova 21 [placebo: 2/21 patients (9.5%); Progynova 21 (Progynova 21 transdermal) 0.025: 6/19 (31.6%); Progynova 21 (Progynova 21 transdermal) 0.05: 14/25 (56.0%); Progynova 21 (Progynova 21 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.
Progynova 21 contraindications
See also:
What is the most important information I should know about Progynova 21?
Progynova 21 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.
Progynova 21 may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin while you are using Progynova 21, to help lower this risk. Report any unusual vaginal bleeding right away.
Long-term use of Progynova 21 may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Progynova 21 transdermal long term.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Progynova 21 transdermal.
Progynova 21 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 Progynova 21:
Estradiol in Germany, Poland.
Unit description / dosage (Manufacturer) | Price, USD |
Tablet, Film-Coated; Oral; Estradiol Valerate 1 mg | |
Tablet, Film-Coated; Oral; Estradiol Valerate 2 mg | |
Tablet; Oral; Estradiol Valerate 1 mg | |
Tablet; Oral; Estradiol Valerate 2 mg | |
Tablets, Film-Coated; Oral; Estradiol Valerate 1 mg | |
Tablets, Film-Coated; Oral; Estradiol Valerate 2 mg | |
Tablets; Oral; Estradiol Valerate 1 mg | |
Tablets; Oral; Estradiol Valerate 2 mg | |
List of Progynova 21 substitutes (brand and generic names): | |
Progynova TS | |
Patch; Topical; Estradiol Hemihydrate 50 mcg / 24 h | |
Proluton (Argentina, Ethiopia, Italy, Malaysia, Turkey) | |
Injectable; Injection; Progesterone 100 mg / ml (Schering) | |
PROLUTON DEPOT 250 MG INJECTION 1 vial / 1 ML injection each (Schering) | $ 1.43 |
PROLUTON DEPOT 500 MG INJECTION 1 vial / 2 ML injection each (Schering) | $ 2.53 |
Proluton 250mg Injection (Schering) | $ 1.73 |
Proluton 500mg/2ml Injection (Schering) | $ 1.39 |
PROSTIUM E | |
Prosu (Taiwan) | |
Prosu 2 mg x 2 x 10's, 100 x 10's, 1000's | |
Provames | |
Tablet, Film-Coated; Estradiol Hemihydrate 1 mg (Sanofi-aventis) | |
Tablet, Film-Coated; Estradiol Hemihydrate 2 mg (Sanofi-aventis) | |
Tablets, Film-Coated; Estradiol Hemihydrate 1 mg (Sanofi-aventis) | |
Tablets, Film-Coated; Estradiol Hemihydrate 2 mg (Sanofi-aventis) | |
Reglovar (Brazil) | |
Replasyn (Paraguay) | |
Rhoxal-Estradiol Derm 100 | |
Patch; Topical; Estradiol Hemihydrate 8 mg | |
Rhoxal-Estradiol Derm 75 | |
Patch; Topical; Estradiol Hemihydrate 6 mg | |
Ricifon | |
Riselle (Brazil, Czech Republic, Romania) | |
Ritsifon | |
Ronfase (Argentina) | |
Rontagel (Argentina) | |
Roxal-Estradiol Derm 100 | |
Rozval (Colombia) | |
Rubi (Argentina) | |
Sandoz Estradiol (Canada) | |
Sandoz Estradiol Derm (Canada) | |
Sandrena (Australia, Brazil, Chile, India, Italy, Mexico, United Kingdom) | |
Gel; Topical; Estradiol Hemihydrate 0.5 mg / dose (Organon) | |
Gel; Topical; Estradiol Hemihydrate 1 mg / dose (Organon) | |
Sandrena 1mg/g GEL / 28 (Organon) | $ 7.41 |
1 mg x 1 g x 28's (Organon) | $ 7.41 |
SANDRENA topical gel 1 mg x 1 g x 1g (Organon) | $ 7.41 |
Sandrena 0.1% (Chile) | |
Sandrena 1 | |
Gel; Topical; Estradiol Hemihydrate 1 mg / dose | |
Sandrena Gel | |
SANDRENA GEL Granules/ Powder / 1mg/g / 28 units (Infar (India) Ltd) | $ 7.41 |
Sandrena Gel 1 gm Gel (Infar (India) Ltd) | $ 0.26 |
Sinergon Forte (Paraguay) | |
Sisare Gel | |
Sisare Mono (Germany) | |
Gel; Topical; Estradiol 0.5 mg / dose (Organon) | |
Gel; Topical; Estradiol 1 mg / dose (Organon) | |
Sisare mono 0.5mg (Germany) | |
Sisare mono 1mg (Germany) | |
SK-Estrogens | |
See 1124 substitutes for Progynova 21 |
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 Progynova 21 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 Progynova 21. 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
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology