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Cenestin
Overview
What is Cenestin?
Synthetic conjugated estrogens, A tablets contain a blend of nine (9) synthetic estrogenic substances. The estrogenic substances are sodium estrone sulfate, sodium equilin sulfate, sodium 17α-dihydroequilin sulfate, sodium 17α-estradiol sulfate, sodium 17β-dihydroequilin sulfate, sodium 17α-dihydroequilenin sulfate, sodium 17β-dihydroequilenin sulfate, sodium equilenin sulfate and sodium 17β-estradiol sulfate.
The structural formulae for these estrogens are:
Tablets for oral administration, are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, A. Tablets also contain the following inactive ingredients: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide, and triethyl citrate.
-0.3 mg tablets also contain FD&C Blue No. 2 aluminum lake and D&C Yellow No. 10 aluminum lake.
-0.45 mg tablets also contain FD&C Yellow No. 6/Sunset Yellow FCF lake.
-0.625 mg tablets also contain FD&C Red No. 40 aluminum lake.
-0.9 mg tablets do not contain additional color additives.
-1.25 mg tablets also contain FD&C Blue No. 2 aluminum lake.
What does Cenestin look like?
What are the available doses of Cenestin?
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What should I talk to my health care provider before I take Cenestin?
Sorry No records found
How should I use Cenestin?
Cenestin therapy is indicated for the:
1. Treatment of moderate-to-severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need 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. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see and ). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
1. For treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. For treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
What interacts with Cenestin?
- Cenestin should not be used in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of cancer of the breast.
- Known or suspected estrogen-dependent neoplasia.
- Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
- Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
- Liver dysfunction or disease.
- Cenestin therapy should not be used in patients with known hypersensitivity to its ingredients.
- Known or suspected pregnancy. There is no indication for Cenestin in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See .)
What are the warnings of Cenestin?
CIPRO HC OTIC should be discontinued at the first
appearance of a skin rash or any other sign of hypersensitivity. Serious and
occasionally fatal hypersensitivity (anaphylactic) reactions, some following the
first dose, have been reported in patients receiving systemic quinolones.
Serious acute hypersensitivity reactions may require immediate emergency
treatment.
1. Cardiovascular disorders.
Estrogen and estrogen/progestin therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogens should be discontinued immediately.
Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.
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2. Malignant neoplasms.
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3. Dementia
In the Women’s Health Initiative Memory Study (WHIMS), 4,532 generally healthy postmenopausal women 65 years of age and older were studied, of whom 35% were 70 to 74 years of age and 18% were 75 or older. After an average follow-up of 4 years, 40 women being treated with CE/MPA (1.8%, n = 2,229) and 21 women in the placebo group (0.9%, n = 2,303) received diagnoses of probable dementia. The relative risk for CE/MPA versus placebo was 2.05 (95% confidence interval 1.21 – 3.48), and was similar for women with and without histories of menopausal hormone use before WHIMS. The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years, and the absolute excess risk for CE/MPA was 23 cases per 10,000 women-years. It is unknown whether these findings apply to younger postmenopausal women. (See and .)
4. Gallbladder disease
A 2 to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.
5. Hypercalcemia
Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.
6. Visual abnormalities
Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or renal vascular lesions, estrogens should be permanently discontinued.
What are the precautions of Cenestin?
A. General
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B. Patient Information
Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Cenestin.
C. Laboratory Tests
Estrogen administration should be initiated at the lowest dose for the approved indication and then guided by clinical response, rather than by serum hormone levels (e.g., estradiol, FSH).
D. Drug/Laboratory Test Interactions
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels, as measured by protein-bound iodine (PBI), T levels (by column or by radioimmunoassay) or T levels by radioimmunoassay. T resin uptake is decreased, reflecting the elevated TBG. Free T and free T concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
E. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term continuous administration of estrogen, with and without progestin, in women, with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See and .)
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.
F. Pregnancy
Cenestin should not be used during pregnancy. (See .)
G. Nursing Mothers
Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Cenestin is administered to a nursing woman.
H. Pediatric Use
Cenestin is not indicated in children.
I. Geriatric Use
There have not been sufficient numbers of geriatric patients involved in studies utilizing Cenestin to determine whether those over 65 years of age differ from younger subjects in their response to Cenestin. In the Women’s Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n = 3,729) were 65 to 74 while 18% (n = 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer’s disease was the most common classification of probable dementia in both the conjugated estrogens plus medroxyprogesterone acetate group and the placebo group. Ninety percent of the cases of probable dementia occurred in the 54% of women that were older than 70. (See .)
What are the side effects of Cenestin?
See and
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
In a 12-week clinical trial that included 72 women treated with 0.625 mg and 2 x 0.625 mg Cenestin and 48 women treated with placebo, adverse events that occurred at a rate of ≥ 5% are summarized in .
In a second 12-week clinical trial that included 52 women treated with 0.45 mg Cenestin and 51 women treated with placebo, adverse events that occurred at a rate of >5% are summarized in .
P-value by Fisher's Exact (2-tail) Test
If a subject experiences the same event more than once, the first occurrence is tabulated.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
| Body System Adverse Event | Cenestin 0.625 mg and 2 x 0.625 mg n (%) | Placebo n (%) | Total n (%) |
| Number of Patients Who Received Medication | 72 (100) | 48 (100) | 120 (100) |
| Number of Patients With Adverse Events | 68 (94) | 43 (90) | 111 (93) |
| Number of Patients Without Any Adverse Events | 4 (6) | 5 (10) | 9 (8) |
| Body As A Whole | |||
| Abdominal Pain | 20 (28) | 11 (23) | 31 (26) |
| Asthenia | 24 (33) | 20 (42) | 44 (37) |
| Back Pain | 10 (14) | 6 (13) | 16 (13) |
| Fever | 1 (1) | 3 (6) | 4 (3) |
| Headache | 49 (68) | 32 (67) | 81 (68) |
| Infection | 10 (14) | 5 (10) | 15 (13) |
| Pain | 8 (11) | 9 (19) | 17 (14) |
| Cardiovascular System | |||
| Palpitation | 15 (21) | 13 (27) | 28 (23) |
| Digestive System | |||
| Constipation | 4 (6) | 2 (4) | 6 (5) |
| Diarrhea | 4 (6) | 0 (0) | 4 (3) |
| Dyspepsia | 7 (10) | 3 (6) | 10 (8) |
| Flatulence | 21 (29) | 14 (29) | 35 (29) |
| Nausea | 13 (18) | 9 (19) | 22 (18) |
| Vomiting | 5 (7) | 1 (2) | 6 (5) |
| Metabolic and Nutritional | |||
| Peripheral Edema | 7 (10) | 6 (13) | 13 (11) |
| Musculoskeletal System | |||
| Arthralgia | 18 (25) | 13 (27) | 31 (26) |
| Myalgia | 20 (28) | 15 (31) | 35 (29) |
| Nervous System | |||
| Depression | 20 (28) | 18 (38) | 38 (32) |
| Dizziness | 8 (11) | 5 (10) | 13 (11) |
| Hypertonia | 4 (6) | 0 (0) | 4 (3) |
| Insomnia | 30 (42) | 23 (48) | 53 (44) |
| Leg Cramps | 7 (10) | 3 (6) | 10 (8) |
| Nervousness | 20 (28) | 20 (42) | 40 (33) |
| Paresthesia | 24 (33) | 15 (31) | 39 (33) |
| Vertigo | 12 (17) | 12 (25) | 24 (20) |
| Respiratory System | |||
| Cough Increased | 4 (6) | 1 (2) | 5 (4) |
| Pharyngitis | 6 (8) | 4 (8) | 10 (8) |
| Rhinitis | 6 (8) | 7 (15) | 13 (11) |
| Skin and Appendages | |||
| Rash | 3 (4) | 3 (6) | 6 (5) |
| Urogenital System | |||
| Breast Pain | 21 (29) | 7 (15) | 28 (23) |
| Dysmenorrhea | 4 (6) | 3 (6) | 7 (6) |
| Metorrhagia | 10 (14) | 3 (6) | 13 (11) |
| Body System and Term | Cenestin 0.45 mg | Control | p-value |
| Any Adverse Event (%) | 40 (75.5%) | 39 (76.5%) | 1.0000 |
| Body As A Whole | 20 (37.7%) | 24 (47.1%) | 0.4275 |
| Asthenia | 6 (11.3%) | 7 (13.7%) | 0.7731 |
| Headache | 6 (11.3%) | 8 (15.7%) | 0.5748 |
| Infection | 1 (1.9%) | 6 (11.8%) | 0.0576 |
| Pain | 6 (11.3%) | 1 (2.0%) | 0.1128 |
| Pain abdominal | 5 (9.4%) | 3 (5.9%) | 0.7159 |
| Cardiovascular | 5 (9.4%) | 10 (19.6%) | 0.1695 |
| Palpitations | 3 (5.7%) | 3 (5.9%) | 1.0000 |
| Vasodilations | 2 (3.8%) | 4 (7.8%) | 0.4324 |
| Digestive | 8 (15.1%) | 7 (13.7%) | 1.0000 |
| Nausea | 5 (9.4%) | 2 (3.9%) | 0.4374 |
| Metabolic and Nutritional | 5 (9.4%) | 3 (5.9%) | 0.1759 |
| Weight increase | 3 (5.7%) | 2 (3.9%) | 1.0000 |
| Musculoskeletal | 5 (9.4%) | 6 (11.8%) | 0.7582 |
| Arthralgia | 5 (9.4%) | 5 (9.8%) | 1.0000 |
| Myalgia | 2 (3.8%) | 6 (11.8%) | 0.1566 |
| Neurological | 15 (28.3%) | 19 (37.3%) | 0.4044 |
| Anxiety | 3 (5.7%) | 1 (2.0%) | 0.6179 |
| Depression | 2 (3.8%) | 7 (13.7%) | 0.0895 |
| Insomnia | 3 (5.7%) | 5 (9.8%) | 0.4839 |
| Nervousness | 2 (3.8%) | 7 (13.7%) | 0.0895 |
| Paresthesia | 4 (7.5%) | 3 (5.9%) | 1.0000 |
| Vertigo | 3 (5.7%) | 3 (5.9%) | 1.0000 |
| Respiratory | 10 (18.9%) | 6 (11.8%) | 0.4173 |
| Upper Respiratory Tract Infection | 7 (13.2%) | 1 (2.0%) | 0.0603 |
| Rhinitis | 3 (5.7%) | 2 (3.9%) | 1.0000 |
| Pharyngitis | 1 (1.9%) | 3 (5.9%) | 0.3581 |
| Urogenital | 19 (35.8%) | 7 (13.7%) | 0.0124 |
| Endometrial thickening | 10 (18.9%) | 4 (7.8%) | 0.1503 |
| Vaginitis | 4 (7.5%) | 1 (2.0%) | 0.3632 |
Genitourinary system.
Breasts.
Cardiovascular.
Gastrointestinal.
Skin.
Eyes.
Central nervous system.
Miscellaneous.
What should I look out for while using Cenestin?
Cenestin should not be used in women with any of the following conditions:
See
What might happen if I take too much Cenestin?
Serious ill effects have not been reported following acute ingestion of large doses of estrogen containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
How should I store and handle Cenestin?
Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].Cenestin (synthetic conjugated estrogens, A) Tablets are available as:Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].Dispense in tight container.Dispense in child-resistant packaging.Keep out of the reach of children.Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.Cenestin (synthetic conjugated estrogens, A) Tablets are available as:Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].Dispense in tight container.Dispense in child-resistant packaging.Keep out of the reach of children.Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.Cenestin (synthetic conjugated estrogens, A) Tablets are available as:Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].Dispense in tight container.Dispense in child-resistant packaging.Keep out of the reach of children.Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.Cenestin (synthetic conjugated estrogens, A) Tablets are available as:Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].Dispense in tight container.Dispense in child-resistant packaging.Keep out of the reach of children.Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.Cenestin (synthetic conjugated estrogens, A) Tablets are available as:Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].Dispense in tight container.Dispense in child-resistant packaging.Keep out of the reach of children.Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.Cenestin (synthetic conjugated estrogens, A) Tablets are available as:Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].Dispense in tight container.Dispense in child-resistant packaging.Keep out of the reach of children.Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate-conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
Non-Clinical Toxicology
Cenestin should not be used in women with any of the following conditions:See
See and
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
In a 12-week clinical trial that included 72 women treated with 0.625 mg and 2 x 0.625 mg Cenestin and 48 women treated with placebo, adverse events that occurred at a rate of ≥ 5% are summarized in .
In a second 12-week clinical trial that included 52 women treated with 0.45 mg Cenestin and 51 women treated with placebo, adverse events that occurred at a rate of >5% are summarized in .
P-value by Fisher's Exact (2-tail) Test
If a subject experiences the same event more than once, the first occurrence is tabulated.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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