DRUGS & SUPPLEMENTS
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 induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as Sunolut.
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.
Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions
Effect of Food
The effect of food administration on the pharmacokinetics of Sunolut has not been studied.
Sunolut is 36% bound to sex hormone-binding globulin and 61% bound to albumin. Volume of distribution of Sunolut is about 4 L/kg.
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.
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.
The effect of age on the pharmacokinetics of Sunolut after Sunolut administration has not been evaluated.
The effect of race on the disposition of Sunolut after Sunolut administration has not been evaluated.
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.
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.
No pharmacokinetic drug interaction studies investigating any drug-drug interactions with Sunolut have been conducted.
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.
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:
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.
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.
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.
Sunolut tablets are not indicated in children.
See WARNINGS and PRECAUTIONS .
The following adverse reactions have been observed in women taking progestins:
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.
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.
Sunolut® (norethindrone acetate tablets USP) is available as:
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
(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)?
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:
What are the risks associated with Sunolut?
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.
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.
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
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
Other side effects include
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?
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
ORALLY ACTIVE PROGESTIN
PHARMACIST: PLEASE DISPENSE WITH
ATTACHED PATIENT INFORMATION LEAFLET.
TEVA WOMEN’S HEALTH
Sunolut 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.
Sunolut 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.
Sunolut 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.
Sunolut 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.
Sunolut 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.
Frequently asked QuestionsCan 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.
ReviewsDrugs.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.
One visitor reported price estimatesWhat 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.
Two visitors reported frequency of useHow 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.
Eight visitors reported dosesWhat 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.
Four visitors reported time for resultsWhat 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.
Five visitors reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology