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DRUGS & SUPPLEMENTS
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Ethinyl Estradiol:
Indication: For treatment of moderate to severe vasomotor symptoms associated with the menopause, female hypogonadism, prostatic carcinoma-palliative therapy of advanced disease, breast cancer, as an oral contraceptive, and as emergency contraceptive.
Norethin 1 / 35E (Ethinyl Estradiol) is a synthetic derivative of the natural estrogen estradiol. It is one of two estrogens currently used in oral contraceptive pills. The other, mestranol, is converted to Norethin 1 / 35E (Ethinyl Estradiol) before it is biologically active. Norethin 1 / 35E (Ethinyl Estradiol) and norethindrone are used together as an oral contraceptive agent.
Norethindrone:
Norethin 1 / 35E (Norethindrone)® (norethindrone acetate tablets USP) - 5 mg oral tablets.
Norethin 1 / 35E (Norethindrone)® (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 Norethin 1 / 35E (Norethindrone). It is a white, or creamy white, crystalline powder. The structural formula is as follows:
C22H28O3 M.W. 340.46
Norethin 1 / 35E (Norethindrone)® (norethindrone acetate tablets USP) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.
Norethin 1 / 35E (Norethindrone) Acetate structural formula
Norethin 1 / 35E acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as Norethin 1 / 35E (Norethindrone).
Norethin 1 / 35E acetate is completely and rapidly deacetylated to Norethin 1 / 35E (Norethindrone) (NET) after oral administration, and the disposition of Norethin 1 / 35E (Norethindrone) acetate is indistinguishable from that of orally administered Norethin 1 / 35E (Norethindrone). Norethin 1 / 35E (Norethindrone) acetate is rapidly absorbed from Norethin 1 / 35E (Norethindrone) tablets, with maximum plasma concentration of Norethin 1 / 35E (Norethindrone) generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of Norethin 1 / 35E (Norethindrone) following single oral administration of Norethin 1 / 35E (Norethindrone) in 29 healthy female volunteers are summarized in Table 1.
Table 1 Pharmacokinetic Parameters after a Single Dose of Norethin 1 / 35E (Norethindrone)® in Healthy Women | |
Norethin 1 / 35E (Norethindrone)® (n = 29) Arithmetic Mean ± SD | |
Norethin 1 / 35E (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
The effect of food administration on the pharmacokinetics of Norethin 1 / 35E (Norethindrone) has not been studied.
Norethin 1 / 35E is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin. Volume of distribution of Norethin 1 / 35E (Norethindrone) is about 4 L/kg.
Norethin 1 / 35E (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.
Plasma clearance value for Norethin 1 / 35E is approximately 0.4 L/hr/kg. Norethin 1 / 35E (Norethindrone) is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of Norethin 1 / 35E (Norethindrone) following a single dose administration of Norethin 1 / 35E (Norethindrone) is approximately 9 hours.
The effect of age on the pharmacokinetics of Norethin 1 / 35E after Norethin 1 / 35E (Norethindrone) administration has not been evaluated.
The effect of race on the disposition of Norethin 1 / 35E (Norethindrone) after Norethin 1 / 35E (Norethindrone) administration has not been evaluated.
The effect of renal disease on the disposition of Norethin 1 / 35E after Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone), plasma Norethin 1 / 35E (Norethindrone) concentration was unchanged compared to concentrations in premenopausal women with normal renal function.
The effect of hepatic disease on the disposition of Norethin 1 / 35E (Norethindrone) after Norethin 1 / 35E (Norethindrone) administration has not been evaluated. However, Norethin 1 / 35E (Norethindrone) is contraindicated in markedly impaired liver function or liver disease.
No pharmacokinetic drug interaction studies investigating any drug-drug interactions with Norethin 1 / 35E (Norethindrone) have been conducted.
Norethin 1 / 35E (Norethindrone) (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. Norethin 1 / 35E (Norethindrone) (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
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.
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.
Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Norethin 1 / 35E.
The following laboratory test results may be altered by the use of estrogen/progestin combination drugs:
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.
Norethin 1 / 35E 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.
Norethin 1 / 35E (Norethindrone) tablets are not indicated in children.
See WARNINGS and PRECAUTIONS .
The following adverse reactions have been observed in women taking progestins:
Therapy with Norethin 1 / 35E must be adapted to the specific indications and therapeutic response of the individual patient.
2.5 to 10 mg Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Norethin 1 / 35E (Norethindrone).
Initial daily dosage of 5 mg Norethin 1 / 35E (Norethindrone) for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Norethin 1 / 35E (Norethindrone) is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
Norethin 1 / 35E (Norethindrone)® (norethindrone acetate tablets USP) is available as:
5 mg: | White, oval, flat-faced, beveled edge, tablet scored on one side. Debossed with 5 Norethin 1 / 35E (Norethindrone) 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
Norethin 1 / 35E (Norethindrone)®
(norethindrone acetate tablets USP)
Read this PATIENT INFORMATION before you start taking Norethin 1 / 35E (Norethindrone) and read what you get each time you refill Norethin 1 / 35E (Norethindrone). 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 Norethin 1 / 35E (Norethindrone) (A Progestin Hormone)?
What is Norethin 1 / 35E (Norethindrone)?
Norethin 1 / 35E (Norethindrone) is similar to the progesterone hormones naturally produced by the body. Your healthcare provider may provide Norethin 1 / 35E (Norethindrone) as individual tablets.
What are Norethin 1 / 35E (Norethindrone) used for?
Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone)?
You should not take Norethin 1 / 35E (Norethindrone) if you are postmenopausal, pregnant or breastfeeding.
You should not take Norethin 1 / 35E (Norethindrone) if you have the following conditions:
What are the risks associated with Norethin 1 / 35E (Norethindrone)?
Norethin 1 / 35E (Norethindrone) should not be used if you are pregnant. Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone) during pregnancy. If you take Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone), 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 Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone)?
General information about the safe and effective use of Norethin 1 / 35E (Norethindrone)
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Norethin 1 / 35E (Norethindrone) for conditions for which it was not prescribed. Do not give Norethin 1 / 35E (Norethindrone) tablets to other people, even if they have the same symptoms you have. It may harm them.
Keep Norethin 1 / 35E (Norethindrone) 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 Norethin 1 / 35E (Norethindrone) that is written for health professionals.
What are the ingredients in Norethin 1 / 35E (Norethindrone)?
Norethin 1 / 35E (Norethindrone) 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
Depending on the reaction of the Norethin 1 / 35E after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Norethin 1 / 35E 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 Norethin 1 / 35E 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology