DRUGS & SUPPLEMENTS

Sunolut

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Sunolut uses


DESCRIPTION

Sunolut® (norethindrone acetate tablets USP) - 5 mg oral tablets.

Sunolut® (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 Sunolut. It is a white, or creamy white, crystalline powder. The structural formula is as follows:

C22H28O3 M.W. 340.46

Sunolut® (norethindrone acetate tablets USP) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

Sunolut Acetate structural formula

CLINICAL PHARMACOLOGY

Sunolut acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as Sunolut.

Pharmacokinetics

Absorption

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


Table 1

Pharmacokinetic Parameters after a Single Dose of

Sunolut® in Healthy Women


Sunolut® (n = 29) Arithmetic Mean ± SD


Sunolut (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 Sunolut has not been studied.

Distribution

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

Metabolism

Sunolut 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 Sunolut is approximately 0.4 L/hr/kg. Sunolut is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of Sunolut following a single dose administration of Sunolut is approximately 9 hours.

Special Populations

Geriatrics

The effect of age on the pharmacokinetics of Sunolut after Sunolut administration has not been evaluated.

Race

The effect of race on the disposition of Sunolut after Sunolut administration has not been evaluated.

Renal Insufficiency

The effect of renal disease on the disposition of Sunolut after Sunolut 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 Sunolut, plasma Sunolut concentration was unchanged compared to concentrations in premenopausal women with normal renal function.

Hepatic Insufficiency

The effect of hepatic disease on the disposition of Sunolut after Sunolut administration has not been evaluated. However, Sunolut is contraindicated in markedly impaired liver function or liver disease.

Drug Interactions

No pharmacokinetic drug interaction studies investigating any drug-drug interactions with Sunolut have been conducted.

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INDICATIONS AND USAGE

Sunolut (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. Sunolut (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 Sunolut 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 Sunolut.

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 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

Sunolut acetate 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

Sunolut 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)
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DOSAGE AND ADMINISTRATION

Therapy with Sunolut 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 Sunolut 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 Sunolut therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Sunolut.

Endometriosis

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

HOW SUPPLIED

Sunolut® (norethindrone acetate tablets USP) is available as:


5 mg:


White, oval, flat-faced, beveled edge, tablet scored on one side. Debossed with 5 Sunolut 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

Sunolut®

(norethindrone acetate tablets USP)

Read this PATIENT INFORMATION before you start taking Sunolut and read what you get each time you refill Sunolut. 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 Sunolut (A Progestin Hormone)?

  • Do not use Sunolut if you are pregnant, breastfeeding or are trying to conceive.
  • Do not use Sunolut if you have had a previous blood clot, stroke, or heart attack.
  • Do not use Sunolut if you are postmenopausal.

What is Sunolut?

Sunolut is similar to the progesterone hormones naturally produced by the body. Your healthcare provider may provide Sunolut as individual tablets.

What are Sunolut used for?

Sunolut 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 Sunolut?

You should not take Sunolut if you are postmenopausal, pregnant or breastfeeding.

You should not take Sunolut if you have the following conditions:

  • Known or suspected pregnancy. Sunolut 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 Sunolut 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 Sunolut 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 Sunolut.
  • Undiagnosed vaginal bleeding
  • Hypersensitivity to Sunolut. See the end of this leaflet for a list of all of the ingredients in Sunolut.

What are the risks associated with Sunolut?

  • Risk to the Fetus

Sunolut should not be used if you are pregnant. Sunolut 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 Sunolut during pregnancy. If you take Sunolut 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 Sunolut, 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 Sunolut 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 Sunolut?

  • Talk with your healthcare provider regularly about whether you should continue taking Sunolut.
  • 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 Sunolut

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

Keep Sunolut 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 Sunolut that is written for health professionals.

What are the ingredients in Sunolut?

Sunolut 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

Sunolut pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Sunolut available forms, composition, doses:

infoForm 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.


Sunolut destination | category:

infoDestination 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.


Sunolut Anatomical Therapeutic Chemical codes:

infoA 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.


Sunolut pharmaceutical companies:

infoPharmaceutical 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."SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]". 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. "norethindrone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Sunolut?

Depending on the reaction of the Sunolut after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sunolut 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 Sunolut 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 Sunolut, 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 Sunolut 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.

Visitor reports

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sDrugs.com website users shows the following figures about several people who felt the medicine Sunolut is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Not expensive1
100.0%

Two visitors reported frequency of use

How often in a day do you take the medicine?
Are you taking the Sunolut drug as prescribed by the doctor?

Few medications can be taken 3 times in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Sunolut is mentioned below.
Visitors%
3 times in a day1
50.0%
4 times in a day1
50.0%

Eight visitors reported doses

What is the dose of Sunolut drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg7
87.5%
6-10mg1
12.5%

Four visitors reported time for results

What is the time duration Sunolut drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sDrugs.com website users needed 2 weeks to notice the result from using Sunolut drug. The time needed to show improvement in health condition after using the medicine Sunolut need not be same for all the users. It varies based on other factors.
Visitors%
2 weeks2
50.0%
1 day1
25.0%
5 days1
25.0%

Five visitors reported age

Visitors%
16-294
80.0%
30-451
20.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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