Crinohermal tablets


  • Active Ingredient: Estradiol
  • 2 mg, 1 mg
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What is Crinohermal?

The active ingredient of Crinohermal brand is estradiol. The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content. In addition, each tablet for oral administration contains the following inactive ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Used for

Crinohermal is used to treat diseases such as: Atrophic Urethritis, Atrophic Vaginitis, Breast Cancer, Palliative, Gender Dysphoria, Hypoestrogenism, Oophorectomy, Osteoporosis, Postmenopausal Symptoms, Primary Ovarian Failure, Prostate Cancer.

Side Effect

Possible side effects of Crinohermal include: Vaginal yeast infection; loss of voice; runny nose; swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs; troubled breathing at rest; inverted nipple; sore throat.

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How should I take Crinohermal?

Take Crinohermal exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.

Crinohermal may increase your risk of developing uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding to your doctor immediately.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using Crinohermal.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

If you are taking injectable estrogen, dispose of any needles and syringes in an appropriate sharps container per your state laws. Do not throw away used needles into the garbage.

If you are using Crinohermal spray, avoid fire, flame, or smoking until the spray has dried. Do not apply lotion or sunscreen over the area for at least one hour.

Indications and dosages

➣ Symptoms of menopause, atrophic vaginitis, female hypogonadism, ovarian failure, and osteoporosis

Adults: 0.5 to 2 mg (Crinohermal) P.O. daily continuously or cyclically. Or 1 to 5 mg (cypionate) or 10 to 20 mg (valerate) I.M. monthly. Or 50- or 100-mcg/24-hour transdermal patch applied twice weekly (Alora, Estraderm) or weekly (Climara). Or 25-mcg/24-hour patch applied q 7 days (FemPatch) or 37.5- to 100-mcg transdermal patch applied twice weekly (Vivelle). Or 2 to 4 g (0.2 to 0.4 mg) vaginal cream (Crinohermal) applied daily for 1 to 2 weeks, then decreased to 1 to 2 g/day for 1 to 2 weeks, then a maintenance dose of 1 g one to three times weekly for 3 weeks, then off for 1 week; repeat cycle once vaginal mucosa has been restored. Or 2-mg vaginal ring q 3 months or 10-mcg vaginal tablet once daily for 2 weeks, then twice weekly.

➣ Postmenopausal breast cancer

Adults: 10 mg P.O. t.i.d. (Crinohermal)

Adults: 1 to 2 mg P.O. t.i.d. (Crinohermal) or 30 mg I.M. q 1 to 2 weeks (valerate)

II Crinohermal and GABAAR Function

Crinohermal is known to act genomically through nuclear ERs but also a broad spectrum of acute nongenomic actions have been recently reviewed ( McCarthy, 2008; Woolley, 2007 ). For example, in the hippocampal CA1 region, exposure to Crinohermal, lasting for several minutes, depolarized neurons, induced spontaneous firing ( Wong and Moss, 1991 ), and suppressed the afterhyperpolarization that followed the action potential ( Kumar and Foster, 2002 ). Moreover, Crinohermal was found to increase the amplitude of dendritic excitatory postsynaptic potential (EPSP) in various regions of the hippocampus ( Foy et al., 1999; Kim et al., 2006 ) and was also found to have a crucial impact on long-term potentiation ( Foy et al., 1999; Good et al., 1999; Warren et al., 1995 ) and long-term depression ( Desmond et al., 2000; Good et al., 1999 ). Such enhancement of neuronal excitability and facilitation of synaptic plasticity could be in part due to a suppression of GABAergic drive in these cells through a direct modulation of GABAARs. These receptors posses the binding site for neurosteroids ( Hosie et al., 2007; Majewska et al., 1986 ) and are readily modulated by many of them either positively or negatively ( Majewska, 2007 ). For this reason, a direct effect of Crinohermal on GABAARs has been tested in several studies. In a study by Wong and Moss (1992) , acute application of Crinohermal (1 μM) on CA1 pyramidal neurons did not influence the extent of membrane potential hyperpolarization induced by iontophoretically applied GABA pulses in vivo ( Wong and Moss, 1992 ). More recently, the possibility that Crinohermal exerts an acute effect on GABAA receptors has been tested in our laboratory ( Asimiadou et al., 2005 ). For this purpose, we have investigated the effect of Crinohermal on the current responses to ultrafast GABA applications. This experimental model offers a very high temporal resolution (adequate to describe the receptor gating properties) and is particularly suitable for pharmacological studies in which acute or direct effects of a modulator are considered. Using this approach, we have tested the effect of Crinohermal on currents elicited by application of GABA (10 mM) to somatic membrane patches excised from cultured hippocampal neurons. Within the concentration range 1–10 μM, Crinohermal did not affect either the amplitude or kinetics of GABA-evoked currents ( Asimiadou et al., 2005 ). We also tested the effect of Crinohermal on miniature inhibitory postsynaptic currents (mIPSCs) which originate from activation of synaptic GABAARs due to spontaneous exocytosis of a single vesicle of neurotransmitter. Recordings of mIPSCs performed from presumably pyramidal hippocampal neurons (visually recognized) revealed that acute application of Crinohermal (1 μM) did not affect either the amplitude or kinetics of mIPSCs in neurons cultured for 6–16 days in vitro (DIV) ( Pytel et al., 2007 ). Thus, our experiments based on the analysis of current responses and mIPSCs argue against any marked acute effect of Crinohermal on GABAARs at least in the considered model. This conclusion is consistent with results of Murphy et al. (1998a,b) who reported that acute exposure to Crinohermal (0.1 μg/ml) did not cause any systematic change in mIPSCs amplitude or frequency evoked by application of hyperosmotic medium ( Murphy et al., 1998a ). Thus, on the basis of these studies, it is reasonable to assume that Crinohermal does not directly interfere with GABAA-receptor gating and that Crinohermal acute actions on neuronal excitability cannot be attributed to rapidly occurring modulation of GABAergic transmission.

Q: Is there a generic for Vivelle-Dot?

A: There is currently no generic equivalent available for Vivelle-Dot (Crinohermal transdermal system). Vivelle-Dot is a small patch containing a form of estrogen commonly used to treat ovarian disorders, infertility, abnormal bleeding, and to prevent the symptoms associated with menopause. Common side effects associated with Vivelle-Dot may include nausea, vomiting, loss of appetite, swollen breasts, acne, changes in skin color, decreased sex drive, migraine headaches, dizziness, vaginal pain, swelling of the ankles and feet, or changes in menstrual cycle. Although Vivelle-Dot does not have a generic equivalent, there is another Crinohermal patch available. This patch, called Crinohermal patch, is a generic equivalent of the Estraderm Patch. Side effects associated with Estraderm are the same as Vivelle-Dot. The Estraderm Patch, and the generic equivalent, is a larger patch then the Vivelle-Dot patch. Talk to your doctor about which treatment option best meets your needs. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jennifer Carey, PharmD

By Lynn Marks | Medically Reviewed by Robert Jasmer, MD

Latest Update: 2015-01-08 Copyright © 2014 Everyday Health Media, LLC

History and Etymology for Crinohermal

International Scientific Vocabulary estra- (from estrane parent compound of Crinohermal, from New Latin estrus + English -ane) + di- + -ol entry 1

Pregnancy and Crinohermal

Crinohermal can harm an unborn baby or cause birth defects. You should not use this medication while pregnant.

Tell your doctor right away if you become pregnant or might become pregnant while taking this drug.

Since Crinohermal can also pass into breast milk, talk to your doctor before breastfeeding while taking the drug.

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Crinohermal Warnings

Crinohermal can increase the risk that you will develop endometrial cancer (cancer of the lining of the uterus). If you have not had a hysterectomy, you should take progestin along with Crinohermal to decrease this risk.

However, before taking these two medicines together, talk with your doctor about your risk for other health problems.

In one study, women who took estrogens (such as Crinohermal) by mouth with progestin had a higher risk of heart attacks, stroke, blood clots, breast cancer, and dementia.

Women who use topical Crinohermal alone or with progestin may also have a higher risk of developing these conditions.

Using topical Crinohermal may increase your risk of developing ovarian cancer and gallbladder disease. You should talk to your doctor about these risks.

Before taking Crinohermal, tell your doctor if you have or have ever had:

  • A heart attack or stroke
  • Heart disease
  • Blood clots
  • Any type of cancer
  • Abnormal vaginal bleeding
  • High blood pressure
  • High cholesterol
  • Diabetes
  • Asthma
  • Gallbladder disease
  • A thyroid disorder
  • Epilepsy or another seizure disorder
  • Liver disease
  • Lupus
  • Breast lumps or abnormal mammogram results
  • Uterine fibroids
  • Yellowing of the skin or eyes (jaundice)
  • Migraine headaches
  • Endometriosis (a condition where the type of tissue that lines the uterus grows in other areas of the body, usually the abdomen or pelvis)
  • Low levels of calcium in your blood
  • Porphyria (a condition where abnormal substances build up in the blood)

Also, tell your doctor if you smoke or use tobacco products.

You should use the lowest dose of Crinohermal for the shortest time possible to control your symptoms.

Talk with your doctor every three to six months to determine if you should lower your dose or stop using this medicine.

You should conduct a breast self-exam every month and have a mammogram and clinical breast exam (a breast exam by a health professional) every year to help detect breast cancer.

Tell your doctor if you are having surgery or will be on bed rest while taking Crinohermal. Your doctor may tell you to stop taking the medication to decrease the risk of blood clots.

The topical medicine may harm other people who touch your skin. You should not let anyone else touch the skin where you applied Crinohermal for one hour after application.

If someone does touch the area, he or she should wash his or her hands with soap and water immediately.

Product Info

The sections below will provide you with more specific information and guidelines related to Crinohermal and its correct use. Please read them carefully.

Crinohermal was approved by the FDA in 1975 for the treatment of moderate to severe vasomotor symptoms associated with menopause as well as for the prevention of osteoporosis.

Crinohermal tablets, the generic equivalent of Bristol Myers Squibb’s Estrace®, has been approved for marketing. Barr Pharmaceuticals’ Crinohermal version will be available in 0.5, 1, and 2 mg strengths.

Why is this medication prescribed?

Crinohermal is prescribed for symptomatic treatment of the usual symptoms associated with menopause (hot flushes, vaginal dryness, etc.), prevention of bone fractures associated with osteoporosis, reduction of the risk of heart attacks and strokes, and dysfunctional (excessive and painful) uterine bleeding. The vaginal cream is prescribed for vaginal or vulvar atrophy associated with menopause.

Crinohermal enters cells freely and interacts with a cytoplasmic target cell receptor. When the estrogen receptor has bound its ligand it can enter the nucleus of the target cell, and regulate gene transcription which leads to formation of messenger RNA. The mRNA interacts with ribosomes to produce specific proteins that express the effect of Crinohermal upon the target cell.

Crinohermal binds well to both estrogen receptors, ERα and ERβ, in contrast to certain other estrogens, notably medications that preferentially act on one of these receptors. These medications are called selective estrogen receptor modulators, or SERMs.

Other uses for this medicine

This medication may also be used to regulate your menstrual cycle.

However, it is strongly advised that you talk to your doctor about the possible risks of using this drug for your particular condition.

Dosage and using this medicine

Use Crinohermal exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

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Why the Test is Performed

In women, most Crinohermal is released from the ovaries and adrenal glands. It is also released by the placenta during pregnancy. Crinohermal is also produced in other body tissues, such as skin, fat, cells bone, brain, and liver. Crinohermal plays a role in:

  • Growth of the womb (uterus), fallopian tubes, and vagina
  • Breast development
  • Changes of the outer genitals
  • Distribution of body fat
  • Menopause

In men, a small amount of Crinohermal is mainly released by the testes. Crinohermal helps prevent sperm from dying too early.

This test may be ordered to check:

  • How well your ovaries, placenta, or adrenal glands work
  • If you have signs of an ovarian tumor
  • If male or female body characteristics are not developing normally
  • If your periods have stopped (levels of Crinohermal vary, depending on the time of month)

The test may also be ordered to check if:

  • Hormone therapy is working for women in menopause
  • A woman is responding to fertility treatment

The test may also be used to monitor people with hypopituitarism and women on certain fertility treatments.

Which drugs or supplements interact with Crinohermal?

Estrogens can inhibit the metabolism of cyclosporine, resulting in increased cyclosporine blood levels. Such increased blood levels can result in kidney and/or liver damage. If this combination cannot be avoided, cyclosporine concentrations can be monitored, and the dose of cyclosporine can be adjusted to assure that its blood levels are not elevated.

Estrogens appear to increase the risk of liver disease in patients receiving dantrolene through an unknown mechanism. Women over 35 years of age and those with a history of liver disease are especially at risk. Estrogens increase the liver's ability to manufacture clotting factors. Because of this, patients receiving warfarin (Coumadin) need to be monitored for loss of anticoagulant (blood thinning) effect if an estrogen is added when warfarin is already being taken.

Rifampin, barbiturates, carbamazepine (Tegretol), griseofulvin, phenytoin (Dilantin), primidone and St. John's wort preparations can all increase the elimination of estrogen by enhancing the liver's ability to metabolize it. Concurrent use may result in reduction of the beneficial effects of estrogens. On the other hand, drugs such as erythromycin, clarithromycin, ketoconazole (Nizoral, Extina, Xolegel, Kuric), itraconazole (Sporanox), ritonavir (Norvir) and grapefruit juice can decrease the liver's ability to metabolize and eliminate estrogens and may increase the side effects of estrogen.

Estrogens may increase the levels and effects of exogenous corticosteroids (corticosteroids used as drugs that are not produced by the body), ropinirole (Requip, Requip XL), tipranavir (Aptivus) and medications that contain theophylline (Elixophyllin, Theo-24, Theochron).

Estrogens may reduce the levels and the effects of anastrozole (Arimidex), aripiprazole (Abilify), axitinib (Inlyta), hyaluronidase (Amphadase, Hylenex, Vitrase), saxagliptin (Onglyza), somatropin (Genotropin, Humatrope, Norditropen Flexpro etc.), ibrutinib (Imbruvica), and ursodiol (Actigall, Urso 250, Urso Forte).

Estrogen levels and effects may be decreased by dabrafenib (Tafinlar), deferasirox (Exjade), peginterferon Alfa-2b (Peg-Intron, Peg-Intron Redipen, Peg-Intron Redipen Pak 4 and Sylatron), P-glycoprotein inducers, tocilizumab (Actemra) and herbs that belong to a class of medications called CYP3A4 inducers. herbs with contents similar to estrogens may increase the side effects of estrogens.

Estrogen levels and effects may be increased by dehydroepiandrosterone, P-glycoprotein inhibitors, nonsteroidal anti-inflammatory drugs called COX-2 inhibitors such as celecoxib (Celebrex) and ascorbic acid (vitamin C).

Before taking this medicine

You should not use this medicine if you are allergic to Crinohermal, or if you have:

unusual vaginal bleeding that has not been checked by a doctor;

a history of heart attack, stroke, or blood clot;

an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or

a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use Crinohermal if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Crinohermal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

liver problems, or prior jaundice caused by pregnancy or taking hormones;

epilepsy or other seizure disorder;

endometriosis or uterine fibroid tumors;

porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

a thyroid disorder; or

high levels of calcium in your blood.

Using Crinohermal may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Crinohermal lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.

Q: I am currently taking Crinohermal. My hot flashes seem to be under control for now; however, my mood swings have increased. I have tried several different things, such as creams and vitamins like black cohosh. What do you recommend? My doctor seems to just increase the Crinohermal.

A: Crinohermal is a form of estrogen that is used for a variety of conditions. Crinohermal is used to relieve the symptoms of menopause, primarily hot flashes, when estrogen levels are decreasing. Mood changes are also a symptom of low estrogen and a side effect of Crinohermal. Most women experience some

Is Crinohermal safe to take if I'm pregnant or breastfeeding?

Estrogens should not be used during pregnancy due to an increased risk of fetal abnormalities.

Estrogens are secreted in milk and cause unpredictable effects in the infant. Estrogens generally should not be used by women if they are breastfeeding.

Q: Does Crinohermal cause weight gain?

A: Estrogens, a group of steroid compounds, are used as part of some oral contraceptives, and in estrogen replacement therapy for postmenopausal women. Common side effects include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss. Other side effects have been reported with estrogen and/or progestin therapy including increase or decrease in weight. These are not all the possible side effects of estrogen. For a complete list, ask your doctor or pharmacist. For more detailed information, consult with your physician or pharmacist about the potential for side effects based on your specific condition and current medications.

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