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Norethindrone acetate, 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, USP. It is a white, or creamy white, crystalline powder.
Norethindrone acetate tablets, USP contain the following inactive ingredients: lactose, magnesium stearate, and microcrystalline cellulose.
What does Norethindrone Acetate look like?
What are the available doses of Norethindrone Acetate?
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What should I talk to my health care provider before I take Norethindrone Acetate?
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How should I use 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.
Therapy with norethindrone acetate tablets, USP 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:
Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing norethindrone acetate, USP therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate tablets, USP.
Endometriosis:
What interacts with Norethindrone Acetate?
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What are the warnings of Norethindrone Acetate?
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What are the precautions of Norethindrone Acetate?
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What are the side effects of Norethindrone Acetate?
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What should I look out for while using Norethindrone Acetate?
1. 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.
2. 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.
What might happen if I take too much Norethindrone Acetate?
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How should I store and handle Norethindrone Acetate?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Norethindrone acetate tablets, USP,
are supplied as white to off-white oval, biconvex tablets debossed with “AN” bisect “475” on one side and plain on the other side.
They are available as follows:Bottles of 90: NDC 42291-650-90Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Norethindrone acetate tablets, USP,
are supplied as white to off-white oval, biconvex tablets debossed with “AN” bisect “475” on one side and plain on the other side.
They are available as follows:Bottles of 90: NDC 42291-650-90Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Norethindrone acetate tablets, USP,
are supplied as white to off-white oval, biconvex tablets debossed with “AN” bisect “475” on one side and plain on the other side.
They are available as follows:Bottles of 90: NDC 42291-650-90Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Norethindrone acetate tablets, USP,
are supplied as white to off-white oval, biconvex tablets debossed with “AN” bisect “475” on one side and plain on the other side.
They are available as follows:Bottles of 90: NDC 42291-650-90Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
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Clinical Information
Chemical Structure
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Clinical Pharmacology
Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone.
Pharmacokinetics
Absorption
Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate is rapidly absorbed from 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 norethindrone acetate 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 norethindrone acetate has not been studied.
Distribution
Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) 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 norethindrone acetate is approximately 9 hours.
Special Populations
Geriatrics
The effect of age on the pharmacokinetics of norethindrone after norethindrone acetate administration has not been evaluated.
Race
The effect of race on the disposition of norethindrone after norethindrone acetate administration has not been evaluated.
Renal Insufficiency
The effect of renal disease on the disposition of norethindrone after norethindrone acetate 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 norethindrone acetate administration has not been evaluated. However, 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 norethindrone acetate have been conducted.
Non-Clinical Toxicology
1. 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.
2. 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.
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
General Precautions
Information for the Patient
Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe norethindrone acetate.
Drug/Laboratory Test Interactions
The following laboratory test results may be altered by the use of estrogen/progestin combination drugs:
Carcinogenesis, Mutagenesis, 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
Pregnancy Category X
Norethindrone 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
Norethindrone acetate tablets are not indicated in children.
See
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The following adverse reactions have been observed in women taking progestins:
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Clonazepam Description
Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake.
Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:
C15H10ClN3O3 M.W. 315.72
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib).
228 major drug interactions (854 brand and generic names)
210 moderate drug interactions (691 brand and generic names)
2 minor drug interactions (4 brand and generic names)
Show all medications in the database that may interact with Imbruvica (ibrutinib).
