Evorel; EvorelConti

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Evorel; EvorelConti uses

Evorel; EvorelConti consists of Estradiol Hemihydrate, Norethindrone Acetate.

Estradiol Hemihydrate:


Evorel; EvorelConti information

Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Evorel; EvorelConti indications

Evorel; EvorelConti (Estradiol Hemihydrate) 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 Evorel; EvorelConti (Estradiol Hemihydrate), 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.

Evorel; EvorelConti warnings

Evorel; EvorelConti (Estradiol Hemihydrate) 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 Evorel; EvorelConti (Estradiol Hemihydrate).

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.

Evorel; EvorelConti (Estradiol Hemihydrate) 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 Estradiol (including Evorel; EvorelConti (Estradiol Hemihydrate)) 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.

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Evorel; EvorelConti intake guidelines

You need to take Evorel; EvorelConti (Estradiol Hemihydrate) 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 Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Evorel; EvorelConti dosage

Your health care specialist will determine the Evorel; EvorelConti (Estradiol Hemihydrate) 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 Evorel; EvorelConti (Estradiol Hemihydrate) 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 Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Evorel; EvorelConti overdose

If an overdose with Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Evorel; EvorelConti missed dose

In the event that you miss taking one of your Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Evorel; EvorelConti side effects

Side effects of a treatment with Evorel; EvorelConti (Estradiol Hemihydrate) 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 Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Evorel; EvorelConti drug reactions

Evorel; EvorelConti (Estradiol Hemihydrate) 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.

Norethindrone Acetate:


DESCRIPTION

Evorel; EvorelConti (Norethindrone Acetate)® (norethindrone acetate tablets USP) - 5 mg oral tablets.

Evorel; EvorelConti (Norethindrone Acetate)® (norethindrone acetate tablets USP), (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. The structural formula is as follows:

C22H28O3 M.W. 340.46

Evorel; EvorelConti (Norethindrone Acetate)® (norethindrone acetate tablets USP) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

Evorel; EvorelConti (Norethindrone Acetate) structural formula

CLINICAL PHARMACOLOGY

Evorel; EvorelConti induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone.

Pharmacokinetics

Absorption

Evorel; EvorelConti is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of Evorel; EvorelConti (Norethindrone Acetate) is indistinguishable from that of orally administered norethindrone. Evorel; EvorelConti (Norethindrone Acetate) is rapidly absorbed from Evorel; EvorelConti (Norethindrone Acetate) tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of Evorel; EvorelConti (Norethindrone Acetate) in 29 healthy female volunteers are summarized in Table 1.


Table 1

Pharmacokinetic Parameters after a Single Dose of

Evorel; EvorelConti (Norethindrone Acetate)® in Healthy Women


Evorel; EvorelConti (Norethindrone Acetate)® (n = 29) Arithmetic Mean ± SD


Norethindrone (NET)


AUC (0-inf)(ng/ml*h)


166.90 ± 56.28


Cmax (ng/ml)


26.19 ± 6.19


tmax (h)


1.83 ± 0.58


t1/2 (h)


8.51 ± 2.19


AUC = area under the curve,

Cmax = maximum plasma concentration,

tmax = time at maximum plasma concentration,

t1/2 = half-life,

SD = standard deviation



Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions

Figure 1

Effect of Food

The effect of food administration on the pharmacokinetics of Evorel; EvorelConti (Norethindrone Acetate) has not been studied.

Distribution

Norethindrone is 36% bound to sex hormone-binding globulin and 61% bound to albumin. Volume of distribution of norethindrone is about 4 L/kg.

Metabolism

Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

Excretion

Plasma clearance value for norethindrone is approximately 0.4 L/hr/kg. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following a single dose administration of Evorel; EvorelConti is approximately 9 hours.

Special Populations

Geriatrics

The effect of age on the pharmacokinetics of norethindrone after Evorel; EvorelConti administration has not been evaluated.

Race

The effect of race on the disposition of norethindrone after Evorel; EvorelConti (Norethindrone Acetate) administration has not been evaluated.

Renal Insufficiency

The effect of renal disease on the disposition of norethindrone after Evorel; EvorelConti administration has not been evaluated. In premenopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma norethindrone concentration was unchanged compared to concentrations in premenopausal women with normal renal function.

Hepatic Insufficiency

The effect of hepatic disease on the disposition of norethindrone after Evorel; EvorelConti (Norethindrone Acetate) administration has not been evaluated. However, Evorel; EvorelConti (Norethindrone Acetate) is contraindicated in markedly impaired liver function or liver disease.

Drug Interactions

No pharmacokinetic drug interaction studies investigating any drug-drug interactions with Evorel; EvorelConti (Norethindrone Acetate) have been conducted.

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INDICATIONS AND USAGE

Evorel; EvorelConti (Norethindrone Acetate) (norethindrone acetate tablets USP) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Evorel; EvorelConti (Norethindrone Acetate) (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

CONTRAINDICATIONS

  • Known or suspected pregnancy. There is no indication for Evorel; EvorelConti (Norethindrone Acetate) in pregnancy. (See PRECAUTIONS .)
  • Undiagnosed vaginal bleeding
  • Known, suspected or history of cancer of the breast
  • Active deep vein thrombosis, pulmonary embolism or history of these conditions
  • Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
  • Impaired liver function or liver disease
  • As a diagnostic test for pregnancy
  • Hypersensitivity to any of the drug components

WARNINGS

  • Cardiovascular Disorders

    Patients with 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.

  • Visual Abnormalities

    Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

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PRECAUTIONS

General

  • Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, require careful observation.
  • In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.
  • Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
  • Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism. The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy.
  • The pathologist should be advised of progestin therapy when relevant specimens are submitted.

Information for the Patient

Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Evorel; EvorelConti.

Drug/Laboratory Tests Interactions

The following laboratory test results may be altered by the use of estrogen/progestin combination drugs:

  • 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 antifactor 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), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 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 circulating corticosteroid and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
  • Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
  • Impaired glucose metabolism.
  • Reduced response to metyrapone test.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established.

Pregnancy

Category X

Evorel; EvorelConti is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses.

Nursing Mothers

Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman.

Pediatric Use

Evorel; EvorelConti (Norethindrone Acetate) tablets are not indicated in children.

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ADVERSE REACTIONS

See WARNINGS and PRECAUTIONS .

The following adverse reactions have been observed in women taking progestins:

  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Edema
  • Changes in weight (decreases, increases)
  • Changes in the cervical squamo-columnar junction and cervical secretions
  • Cholestatic jaundice
  • Rash (allergic) with and without pruritus
  • Melasma or chloasma
  • Clinical depression
  • Acne
  • Breast enlargement/tenderness
  • Headache/migraine
  • Urticaria
  • Abnormalities of liver tests (i.e., AST, ALT, Bilirubin)
  • Decreased HDL cholesterol and increased LDL/HDL ratio
  • Mood swings
  • Nausea
  • Insomnia
  • Anaphylactic/anaphylactoid reactions
  • Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism)
  • Optic neuritis (which may lead to partial or complete loss of vision)

DOSAGE AND ADMINISTRATION

Therapy with Evorel; EvorelConti must be adapted to the specific indications and therapeutic response of the individual patient.

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology

2.5 to 10 mg Evorel; EvorelConti (Norethindrone Acetate) may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Evorel; EvorelConti (Norethindrone Acetate) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Evorel; EvorelConti (Norethindrone Acetate).

Endometriosis

Initial daily dosage of 5 mg Evorel; EvorelConti (Norethindrone Acetate) for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Evorel; EvorelConti (Norethindrone Acetate) is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

HOW SUPPLIED

Evorel; EvorelConti (Norethindrone Acetate)® (norethindrone acetate tablets USP) is available as:


5 mg:


White, oval, flat-faced, beveled edge, tablet scored on one side. Debossed with 5 Evorel; EvorelConti (Norethindrone Acetate) on the unscored side and stylized b / 424 on the scored side. Available in bottles of 50 tablets (NDC 51285-424-10).


Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA WOMEN’S HEALTH, INC.

Subsidiary of TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. A 10/2015

PATIENT INFORMATION

Evorel; EvorelConti (Norethindrone Acetate)®

(norethindrone acetate tablets USP)

Read this PATIENT INFORMATION before you start taking Evorel; EvorelConti (Norethindrone Acetate) and read what you get each time you refill Evorel; EvorelConti (Norethindrone Acetate). There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition.

What is the most important information I should know about Evorel; EvorelConti (Norethindrone Acetate) (A Progestin Hormone)?

  • Do not use Evorel; EvorelConti (Norethindrone Acetate) if you are pregnant, breastfeeding or are trying to conceive.
  • Do not use Evorel; EvorelConti (Norethindrone Acetate) if you have had a previous blood clot, stroke, or heart attack.
  • Do not use Evorel; EvorelConti (Norethindrone Acetate) if you are postmenopausal.

What is Evorel; EvorelConti (Norethindrone Acetate)?

Evorel; EvorelConti (Norethindrone Acetate) is similar to the progesterone hormones naturally produced by the body. Your healthcare provider may provide Evorel; EvorelConti (Norethindrone Acetate) as individual tablets.

What are Evorel; EvorelConti (Norethindrone Acetate) used for?

Evorel; EvorelConti (Norethindrone Acetate) are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance.

Who should not take Evorel; EvorelConti (Norethindrone Acetate)?

You should not take Evorel; EvorelConti (Norethindrone Acetate) if you are postmenopausal, pregnant or breastfeeding.

You should not take Evorel; EvorelConti (Norethindrone Acetate) if you have the following conditions:

  • Known or suspected pregnancy. Evorel; EvorelConti (Norethindrone Acetate) are not indicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take Evorel; EvorelConti (Norethindrone Acetate) during the first 4 months of pregnancy (mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus). If you take Evorel; EvorelConti (Norethindrone Acetate) and later find out you were pregnant, talk with your healthcare provider right away.
  • History of blood clots in the legs, lungs, eyes, brain, or elsewhere, or a past history of these conditions
  • Liver impairment or disease
  • Known or suspected cancer of the breast. If you have or had cancer of the breast, talk with your healthcare provider about whether you should take Evorel; EvorelConti (Norethindrone Acetate).
  • Undiagnosed vaginal bleeding
  • Hypersensitivity to Evorel; EvorelConti (Norethindrone Acetate). See the end of this leaflet for a list of all of the ingredients in Evorel; EvorelConti (Norethindrone Acetate).

What are the risks associated with Evorel; EvorelConti (Norethindrone Acetate)?

  • Risk to the Fetus

Evorel; EvorelConti (Norethindrone Acetate) should not be used if you are pregnant. Evorel; EvorelConti (Norethindrone Acetate) are contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.

You should avoid using Evorel; EvorelConti (Norethindrone Acetate) during pregnancy. If you take Evorel; EvorelConti (Norethindrone Acetate) and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible.

  • Abnormal Blood Clotting

Use of progestational drugs, such as Evorel; EvorelConti (Norethindrone Acetate), has been associated with changes in the blood-clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems. Any of these conditions may cause death or serious long-term disability. Call your healthcare provider right away if you suspect you have any of these conditions. He or she may advise you to stop using the drug.

  • Eye Abnormalities

Discontinue Evorel; EvorelConti (Norethindrone Acetate) tablets and call your healthcare provider right away if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine.

These are some of the warning signs of serious side effects with progestin therapy

  • Breast lumps
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps/bloating
  • Nausea and vomiting
  • Hair loss

Other side effects include

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargements of benign tumors of the uterus (“fibroids”)
  • Vaginal yeast infections
  • Mental depression

These are not all the possible side effects of progestin and/or estrogen therapy. For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of getting a serious side effect with Evorel; EvorelConti (Norethindrone Acetate)?

  • Talk with your healthcare provider regularly about whether you should continue taking Evorel; EvorelConti (Norethindrone Acetate).
  • Have a breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart attacks.

General information about the safe and effective use of Evorel; EvorelConti (Norethindrone Acetate)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Evorel; EvorelConti (Norethindrone Acetate) for conditions for which it was not prescribed. Do not give Evorel; EvorelConti (Norethindrone Acetate) tablets to other people, even if they have the same symptoms you have. It may harm them.

Keep Evorel; EvorelConti (Norethindrone Acetate) out of the reach of children.

This leaflet provides a summary of the most important information about progestin and/or estrogen therapy. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Evorel; EvorelConti (Norethindrone Acetate) that is written for health professionals.

What are the ingredients in Evorel; EvorelConti (Norethindrone Acetate)?

Evorel; EvorelConti (Norethindrone Acetate) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

TEVA WOMEN’S HEALTH, INC.

Subsidiary of TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. A 10/2015

NDC 51285-424-10

Aygestin®

(norethindrone acetate

tablets USP)

ORALLY ACTIVE PROGESTIN

5 mg

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION LEAFLET.

Rx only

50 TABLETS

TEVA

TEVA WOMEN’S HEALTH

Evorel; EvorelConti pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Evorel; EvorelConti available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
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.


Evorel; EvorelConti destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Evorel; EvorelConti Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Evorel; EvorelConti pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."AYGESTIN (NORETHINDRONE ACETATE) TABLET [TEVA WOMEN'S HEALTH, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."NORETHINDRONE: 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/dailym... (accessed August 28, 2018).
  3. 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/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Evorel; EvorelConti?

Depending on the reaction of the Evorel; EvorelConti after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Evorel; EvorelConti not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Evorel; EvorelConti addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Evorel; EvorelConti, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Evorel; EvorelConti consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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