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estradiol valerate and estradiol valerate/dienogest

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Overview

What is Estradiol Valerate and Estradiol Valerate/Dienogest?

Estradiol Valerate and Estradiol Valerate/Dienogest tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets:

Estradiol Valerate and Estradiol Valerate/Dienogest also contains the excipients lactose monohydrate, maize starch, maize starch pre-gelatinized, povidone 25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide, and ferric oxide pigment, yellow, or ferric oxide pigment, red.

The empirical formula of estradiol valerate is C H Oand the chemical structure is:

Estradiol Valerate

The chemical name of estradiol valerate is Estra-1,3,5(10)-triene-3,17-diol(17ß)-,17-pentanoate.

The empirical formula of dienogest is C H NO and the chemical structure is:

Dienogest

The chemical name of dienogest is (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile.



What does Estradiol Valerate and Estradiol Valerate/Dienogest look like?



What are the available doses of Estradiol Valerate and Estradiol Valerate/Dienogest?

Estradiol Valerate and Estradiol Valerate/Dienogest consists of 28 film-coated, unscored tablets in the following order ():

What should I talk to my health care provider before I take Estradiol Valerate and Estradiol Valerate/Dienogest?

How should I use Estradiol Valerate and Estradiol Valerate/Dienogest?

Estradiol Valerate and Estradiol Valerate/Dienogest is indicated for use by women to prevent pregnancy.

The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in women with a body mass index (BMI) of > 30 kg/m has not been evaluated.

To achieve maximum contraceptive effectiveness, Estradiol Valerate and Estradiol Valerate/Dienogest must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.


What interacts with Estradiol Valerate and Estradiol Valerate/Dienogest?

Sorry No Records found


What are the warnings of Estradiol Valerate and Estradiol Valerate/Dienogest?

Sorry No Records found


What are the precautions of Estradiol Valerate and Estradiol Valerate/Dienogest?

Sorry No Records found


What are the side effects of Estradiol Valerate and Estradiol Valerate/Dienogest?

Sorry No records found


What should I look out for while using Estradiol Valerate and Estradiol Valerate/Dienogest?

Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following:

Catecholamine-depleting Drugs:

Digitalis Glycosides and Beta-blockers:

Calcium Channel Blockers:

CYP2D6 Inhibitors:

Hydralazine:

Alpha-adrenergic Agents:

Ergot Alkaloid:

Dipyridamole:


What might happen if I take too much Estradiol Valerate and Estradiol Valerate/Dienogest?

There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.


How should I store and handle Estradiol Valerate and Estradiol Valerate/Dienogest?

Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320Metoprolol Tartrate Tablets, USP are available as follows: Tablets 100 mg Bottles of 30         NDC 63187-532-30Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90Bottles of 120       NDC 63187-532-72Bottles of 180       NDC 63187-532-78Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and heat.Dispense To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchCitron Pharma LLCRepackaged by:Proficient Rx LPThousand Oaks, CA 91320


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Non-Clinical Toxicology
Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following:

Array

Stop Estradiol Valerate and Estradiol Valerate/Dienogest if an arterial or venous thrombotic event (VTE) occurs.

The use of COCs increases the risk of venous thromboembolism. However, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.

Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

If feasible, stop Estradiol Valerate and Estradiol Valerate/Dienogest at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Estradiol Valerate and Estradiol Valerate/Dienogest no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Estradiol Valerate and Estradiol Valerate/Dienogest if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

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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.

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Professional

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).