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DRUGS & SUPPLEMENTS
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Hormonin
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Hormonin uses
Hormonin consists of Estradiol, Estriol, Estrone.Estradiol:
Hormonin information
Hormonin (Estradiol) is a female sex hormone that regulates many functions in the female organism. This medicine is currently available under the form of tablets in two concentrations - 1 mg and 2 mg, respectively.
Hormonin indications
Hormonin (Estradiol) is used for the treatment of menopausal symptoms such as vaginal dryness, irritation or burning, or hot flushes - other symptoms that are not listed here may be treated with this medicine as well. Also, this pharmaceutical preparation can be used as a prophylactic agent for the prevention of a medical condition known as osteoporosis in both female and male patients. In some cases, this medicine may also be employed in conjunction with other drugs as part of the treatment for certain types of cancer, both in the case of women and men.
There may be other uses for Hormonin (Estradiol), which are not covered in this leaflet. If you are interested to find out more about the possible uses of this product, it is recommended that you consult with a pharmacist or a specialized physician.
Hormonin warnings
Hormonin (Estradiol) should not be administered to patients that are suffering from any type of disorder involving blood clots, or from circulatory / cardiac disorders. Patients who present an undiagnosed, abnormal vaginal bleeding may not start taking this medicine until they undergo medical examination and receive their physician's approval. Also, patients that have uterine cancer, breast cancer or any type of hormone-dependant cancer may not start a treatment with Hormonin (Estradiol).
Before you start a therapy course with this drug, it is strongly advised to inform your personal physician of any health problems you may be suffering from. In particular, affections such as hypertension, heart disease, angina, high triglyceride / cholesterol levels, renal or hepatic disease, asthma, migraines, epilepsy (or any other disorder involving seizures), diabetes or gallbladder disease should be mentioned, as well as past surgical procedures such as a hysterectomy. Patients suffering from these conditions may require special dosage adjustments or monitoring during the treatment.
Hormonin (Estradiol) may not be administered during pregnancy. Also, for the duration of the therapy you will need to employ an effective, non-hormonal contraceptive method.
Pharmaceutical products based on Hormonin (Estradiol) (including Hormonin (Estradiol)) increase the patients' risk of developing an affection known as endometrial hyperplasia. This can be countered by administration of progestin medication. It is recommended that you consult with your doctor for more information.
Hormonin intake guidelines
You need to take Hormonin (Estradiol) exactly as directed by your health care specialist. You may take the tablets with a glass of water or with food to reduce stomach upset; however you may not chew, crush or break the tablets.
While following a treatment course with Hormonin (Estradiol) you will need to undergo regular medical examination, typically on a monthly basis. Also, you will need to regularly self-examine your breasts for the presence of lumps.
Hormonin dosage
Your health care specialist will determine the Hormonin (Estradiol) dosage appropriate for your case by taking into consideration a number of factors, most of which are characteristic to you; as such, your medication dosage is very likely to be different from that of other patients'. Because of that, you should never use the Hormonin (Estradiol) dosage that has been prescribed to another patient - you may not obtain the desired results unless you employ the medication dosage best suited for your situation.
At the same time, your physician will inform you regarding the duration of the Hormonin (Estradiol) therapy and the number of daily intakes. Make sure that you understand all of his or her indications. If you have trouble understanding or remembering any of the dosage directions, you should ask your physician to assist you by providing additional information.
Hormonin overdose
If an overdose with Hormonin (Estradiol) is suspected, immediately contact the nearest hospital as the patient may need emergency medical assistance. The most common signs of an overdose are vaginal bleeding, nausea and vomiting.
Hormonin missed dose
In the event that you miss taking one of your Hormonin (Estradiol) doses, take it when you remember before returning to your normal dosing schedule. However, you should skip taking the missed dose if it is almost time for another dose of the medicine. Consult with your physician if you have missed two or more intakes.
Hormonin side effects
Side effects of a treatment with Hormonin (Estradiol) include nausea and vomiting, loss of appetite, swelling of the breasts, sex drive changes, impotence (in the case of men), abnormal vaginal bleeding, vaginal dryness, discomfort or pain, break-through bleeding, menstrual period changes, jaundice, sudden weakness or numbness, breast lumps. These are not all the signs and symptoms that may appear. It is best that you check with your doctor at any point during the course of your therapy if anything unusual occurs.
Although uncommon, allergic reactions to Hormonin (Estradiol) are possible. It is strongly recommended that you cease taking the medicine and contact your personal health care provider if you begin experiencing any of the characteristic symptoms - breathing difficulties, swelling of the throat, lips, tongue or face, rashes and hives.
Hormonin drug reactions
Hormonin (Estradiol) may interact with Phenobarbital, Phenytoin, Ritonavir, Cimetidine, Carbamazepine, Rifampin, blood thinning agents such as Warfarin or with antibiotics (Clarithromycin, Erythromycin, Ketoconazole or Itraconazole). Also, this product may interact with the herbal remedy St. John's wort. These are not all the possible drug reactions; it is best that you tell your prescriber about any other drugs you are currently taking prior to starting your treatment. In most cases, an adjustment to the medication dosage will ensure the safety of the treatment, reducing the risk of accidental interactions.
Estriol:
- Caution
- Description
- Indication
- Dosage and administration
- Warnings
- Precautions
- Adverse reactions
- Clinical pharmacology
- Effectiveness
- Animal safety
- Storage information
- How supplied
NADA 141-325, Approved by FDA
For Oral Use in Dogs Only
CAUTION
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
Hormonin (Estriol) (estriol) Tablets contain 1 mg of Hormonin (Estriol) per tablet.
USP Chemical Name: Estra-1,3,5(10)-triene-3,16,17-triol, (16α,17β)-.
USP Molecular Weight: 288.38
USP Solubility: Soluble in acetone, in chloroform, in dioxane, in ether, and in vegetable oils; sparingly soluble in alcohol; insoluble in water.
INDICATION
Hormonin (Estriol) Tablets are indicated for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
DOSAGE AND ADMINISTRATION
The dose of Hormonin (Estriol) Tablets is not dependent upon body weight. All dogs should receive an initial dose of 2 mg Hormonin (Estriol) Tablets (2 tablets) orally once per day for a minimum of 14 days. After urinary incontinence is controlled, the lowest effective daily dose of Hormonin (Estriol) Tablets should be determined by decreasing the dose in a step-wise manner from 2 mg once daily (2 tablets) to 1 mg once daily (1 tablet), then 0.5 mg once daily (1/2 tablet) depending upon the response of the individual dog. There should be a minimum of 7 days between each dose adjustment. After the lowest daily dose that controls urinary incontinence is identified, the dose may be decreased further by administering once every two days. Dogs should not receive more than 2 mg Hormonin (Estriol) Tablets per day (2 tablets). If the dog does not respond to 2 mg of Hormonin (Estriol) Tablets per day, the diagnosis should be re-assessed.
WARNINGS
Human Warnings
Not for human use. Keep out of the reach of children. Women who are of child-bearing age or those who are breastfeeding should use caution when administering Hormonin Tablets. Wash your hands with soap and water after administration to avoid exposure to the drug. Consult a physician in case of accidental ingestion by humans.
Animal Warnings
Some estrogens have been associated with bone marrow changes and an increased risk of mammary tumors. However, target animal safety study results and foreign post-market pharmacovigilance data for Hormonin (Estriol) Tablets have shown that estriol-treated dogs are at low risk for developing these conditions.
PRECAUTIONS
Evaluation of factors contributing to urinary incontinence should be considered prior of administration of Hormonin (Estriol) Tablets.
Do not use with other estrogens. The concomitant use of Hormonin (Estriol)
Tablets with other estrogens has not been evaluated.
The concomitant use of Hormonin (Estriol) Tablets with glucocorticoids has not been evaluated.
The use of Hormonin (Estriol) Tablets in dogs with liver disease has not been evaluated.
The safe use of Hormonin (Estriol) Tablets has not been evaluated in intact female dogs, pregnant or lactating dogs, male dogs, and dogs less than 1 year of age.
ADVERSE REACTIONS
In the initial phase of a placebo-controlled field study conducted to determine effectiveness, 115 of 226 dogs were dosed with Hormonin Tablets orally at 2 mg per day for 14 days. Adverse reactions during the first study phase included primarily gastrointestinal and estrogenic effects, as summarized in Table 1.
| Adverse Reaction | Hormonin (Estriol) Tablet Group % of dogs (n = 115) | Placebo Group % of dogs (n = 111) |
|---|---|---|
| Anorexia | 13.0% | 3.6% |
| Emesis | 9.6% | 6.3% |
| Polydipsia | 7.0% | 7.2% |
| Swollen vulva | 4.3% | 0.0% |
| Anxiety | 3.5% | 2.7% |
| Sexual attractiveness | 3.5% | 1.8% |
| Somnolence | 1.7% | 0.0% |
| Hypersalivation | 1.7% | 0.0% |
| Estrous behavior | 0.9% | 0.0% |
| Mammary hyperplasia | 0.9% | 0.0% |
In the second phase of the field study, all dogs received treatment with Hormonin (Estriol) Tablets from Day 14 to Day 42; the drug dose was adjusted up or down (not to exceed 2 mg per day) at weekly intervals depending on whether urinary incontinence was controlled. Table 2 summarizes reported adverse reactions in dogs treated with Hormonin (Estriol) Tablets during the second study phase. Adverse reactions tended to lessen when dogs received lower drug doses. One dog that received 10 doses of Hormonin (Estriol) was removed due to suspected uterine stump pyometra. The relationship between this adverse reaction and Hormonin (Estriol) Tablets could not be determined.
| Adverse Reaction | Hormonin (Estriol) Tablets Group % of dogs (n = 224) |
|---|---|
| Anorexia | 12.9% |
| Emesis | 7.6% |
| Licking vulva | 4.5% |
| Swollen vulva | 4.0% |
| Vulvovaginitis | 4.0% |
| Lethargy | 4.0% |
| Polydipsia | 3.6% |
| Aggression | 1.8% |
| Hyperactivity | 1.8% |
| Cystitis | 1.3% |
| Anxiety | 0.9% |
| Mammary hyperplasia | 0.9% |
| Somnolence | 0.9% |
| Estrous behavior | 0.9% |
| Sexual attractiveness | 0.4% |
| Alopecia (local) | 0.4% |
Extended-use studies continued after the field studies involving more than 300 dogs. Additional adverse reactions to those seen in the field studies included hyperpigmentation and lichenification of the vulva. Also, 3 dogs receiving Hormonin (Estriol) Tablets were euthanized due to aggressive behavior.
Foreign market experience
Foreign post-market pharmacovigilance data for Hormonin (Estriol) Tablets were collected from the years 2000 through 2010 by Intervet, Inc. Approximately 20% of reported adverse events were for local or general alopecia. Vaginal hemorrhage, possible stump pyometra, an increase in epileptic seizures, and anemia, leukopenia, and thrombocytopenia were seen in 1 or more dogs. Other adverse events reported were similar to those seen during the US studies.
For technical assistance or to report suspected adverse reactions call Intervet at 1-800-224-5318. For a copy of the Material Safety Data Sheet (MSDS), call 1-800-770-8878.
CLINICAL PHARMACOLOGY
Hormonin (Estriol) is a natural estrogen. Estrogens increase the resting muscle tone of the urethra in females and can be used to treat female dogs with urinary incontinence due to estrogen depletion. Hormonin (Estriol) is rapidly absorbed after oral administration. It has a high affinity for receptors in cells of the lower urogenital tract, but a short receptor occupancy time that limits the undesirable effects of endometrial proliferation, skeletal muscle growth, and bone marrow suppression associated with long-term estrogen-estrogen receptor binding.
As one of the three naturally occurring estrogens, Hormonin (Estriol) is a lipophilic compound that can passively diffuse through cell membranes and bind to estrogen receptors in the nucleus to regulate gene expression. After an oral dose of 2 mg/dog/day in fed female dogs, Tmax occurred between 0.5-2 hrs (average 0.8 hrs) with corresponding Cmax values of 220-1150 pg/mL (average 650 pg/mL). Entero-hepatic recirculation and drug reabsorption may cause a second concentration peak in plasma around 4-12 hrs after dosing. Its elimination T½ ranges from 8 to 12 hours based on a multiple oral dose study in 6 adult female dogs.
However, the apparent Hormonin (Estriol) recycling observed in most dogs produced multiple peaks that confound the accurate determination of T½. The effect of prandial state on oral Hormonin (Estriol) bioavailability has not been evaluated. Repeated oral administration may result in elevated Hormonin (Estriol) systemic exposure.
EFFECTIVENESS
A multi-site, masked, placebo-controlled field study was conducted to evaluate the effectiveness of Hormonin (Estriol) Tablets. Two hundred and twenty-six client-owned, ovariohysterectomized female dogs 1 year of age or older with at least 3 episodes of urinary incontinence each week were randomly allocated to receive either Hormonin (Estriol) Tablets or placebo. Two hundred and six dogs (106 treated with Hormonin (Estriol) Tablets and 100 treated with placebo) from 22 sites were evaluated for effectiveness. Each dog was dosed orally with either two 1 mg tablets of Hormonin (Estriol) Tablets or two tablets of placebo once per day for 14 days. During treatment, owners recorded the frequency of urinary incontinence episodes daily, and investigators rated response to treatment weekly (continent/improved or no change/worse). Treatment success was based upon response to treatment and a targeted reduction in the frequency of urinary incontinence episodes at Day 14 compared to Day 0. The proportion of dogs achieving treatment success was statistically significantly greater (p = 0.0038) in the group treated with Hormonin (Estriol) Tablets (66%) than in the placebo-treated group (37%) at Day 14.
A second phase of the study evaluated decreasing doses of Hormonin (Estriol) Tablets to control urinary incontinence. After Day 14, all dogs (224) received 2 tablets of Hormonin (Estriol) Tablets (2 mg) orally once per day. Starting at Day 21, investigators were permitted to adjust the dose of Hormonin (Estriol) Tablets up or down (not to exceed 2 mg per day) at weekly intervals until Day 42 if urinary continence was controlled. Dose information and urinary incontinence scoring was available for 191 dogs at the end of the study; ninety four dogs were receiving 2 mg of Hormonin (Estriol) Tablets per day, and the other 96 dogs had dose reductions below 2 mg per day. Of the 94 dogs receiving 2 mg of Hormonin (Estriol) Tablets per day during the last week of the study, 81 dogs (86%) had either reduced urinary incontinence (n = 57) or no urinary incontinence (n = 24) compared to Day 0. Of the ninety-seven dogs with dose reductions below 2 mg per day, all dogs receiving 1 mg of Hormonin (Estriol) Tablets once daily (n = 41), 1 mg every other day (n = 5), or 0.5 mg every other day (n = 24) had either reduced or no incontinence compared to Day 0. Twenty-five of 26 dogs receiving 0.5 mg once daily had reduced or no incontinence, and one dog dosed with 2 mg of Hormonin (Estriol) Tablets every other day had reduced incontinence.
There were no clinically significant changes in hematology or serum chemistry during either phase of the study.
ANIMAL SAFETY
In a 26-week safety study, 24 healthy, ovariohysterectomized female Beagle dogs approximately 1 year of age, weighing 7.3 to 10.5 kg, were randomly divided into 4 groups of 6 animals each. Hormonin (Estriol) Tablets were administered orally at doses of 0 (placebo), 1× (2 mg), 3× (6 mg) and 5× (10 mg) the maximum proposed label dose of 2 mg per dog per day. Estrogenic effects such as swollen vulva, mammary hyperplasia, and vulvar discharge occurred frequently in all dogs that received Hormonin (Estriol) Tablets and increased in a dose-dependent manner. On gross necropsy, all dogs treated with Hormonin (Estriol) Tablets had enlarged vulvas except 1 dog that received 2 mg per day. Microscopically, the vulvas and vaginas of treated dogs had a proestrus-like appearance, with or without a lymphoplasmacytic infiltrate. In addition, approximately one-third of the dogs in each group treated with Hormonin (Estriol) Tablets had lymphoplasmacytic infiltrate and urothelium hyperplasia of the renal pelvis. One dog treated with 10 mg per day had urinary bladder inflammation. Dogs that received 6 mg and 10 mg of Hormonin (Estriol) Tablets per day had increased white blood cell counts, absolute neutrophil counts and platelet counts compared to dogs in the other 2 groups. There were no changes related to Hormonin (Estriol) Tablet administration noted in the microscopic evaluation of bone marrow smears. The myeloid:erythroid (M:E) cell ratios were comparable between dogs that received 10 mg of Hormonin (Estriol) Tablets per day and those treated with placebo.
STORAGE INFORMATION
Store at or below 25°C (77°F) with excursions permitted to 40°C (104°F)
HOW SUPPLIED
Hormonin (Estriol) Tablets contain 1 mg of Hormonin (Estriol) in each tablet and are supplied in foil-sealed blister packs of 30 single-scored tablets. Two carton sizes containing either 30 tablets (one blister pack) or 90 tablets (three blister packs) are available.
Made in the Netherlands,
May, 2011
Hormonin (Estriol) is the property of Intervet International B.V. or affiliated companies or licensors and is protected by copyrights, trademark and other intellectual property laws.
Copyright © 2011
Intervet International B.V.
All rights reserved.
117967 R10
Estrone:
Estrone, one of the major mammalian estrogens, is an aromatized C18 steroid with a 3-hydroxyl group and a 17-ketone. It is produced in vivo from androstenedione or from testosterone via estradiol. It is produced primarily in the ovaries, placenta, and in peripheral tissues (especially adipose tissue) through conversion of adrostenedione. Hormonin (Estrone) may be further metabolized to 16-alpha-hydroxyestrone, which may be reduced to estriol by estradiol dehydrogenase.
Indication: For management of perimenopausal and postmenopausal symptoms.
Hormonin (Estrone), a synthetically prepared or naturally occurring steroidal estrogen obtained from pregnant equine urine, is the primary circulating estrogen after menopause. Hormonin (Estrone) is naturally derived from the peripheral conversion of androstenedione by an aromatase enzyme found in adipose tissues and is converted to estradiol in peripheral tissues. The estrogenic potency of Hormonin (Estrone) is one third that of estradiol. Estropipate is piperazine-stabilized Hormonin (Estrone) sulfate. Hormonin (Estrone), and estropipate are used to treat abnormalities related to gonadotropin hormone dysfunction, vasomotor symptoms, atrophic vaginitis, and vulvar atrophy associated with menopause, and for the prevention of osteoporosis due to estrogen deficiency.
Hormonin pharmaceutical active ingredients containing related brand and generic drugs:
Hormonin available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.