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levonorgestrel and ethinyl estradiol

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Overview

What is Balcoltra?

Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets.

The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

Levonorgestrel has the empirical formula of CHO and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of CHO and the molecular weight of 296.4.

The molecular structures are provided below:



What does Balcoltra look like?



What are the available doses of Balcoltra?

Balcoltra consists of 28 tablets in the following order ():

What should I talk to my health care provider before I take Balcoltra?

Balcoltra can decrease milk production. ()

How should I use Balcoltra?

Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.

Balcoltra is dispensed in a blister card . Balcoltra may be started using either a Day 1 start or a Sunday start (see ). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.


What interacts with Balcoltra?

Sorry No Records found


What are the warnings of Balcoltra?

Sorry No Records found


What are the precautions of Balcoltra?

Sorry No Records found


What are the side effects of Balcoltra?

Sorry No records found


What should I look out for while using Balcoltra?

Do not prescribe Balcoltra to women who are known to have the following conditions:

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Drug Interactions:


What might happen if I take too much Balcoltra?

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


How should I store and handle Balcoltra?

ArrayDivalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-533-30Bottles of 60                                                                           NDC 55111-533-60Unit dose package of 100 (10 x 10)                                       NDC 55111-533-78Recommended StorageStore tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-533-30Bottles of 60                                                                           NDC 55111-533-60Unit dose package of 100 (10 x 10)                                       NDC 55111-533-78Recommended StorageStore tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-533-30Bottles of 60                                                                           NDC 55111-533-60Unit dose package of 100 (10 x 10)                                       NDC 55111-533-78Recommended StorageStore tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-533-30Bottles of 60                                                                           NDC 55111-533-60Unit dose package of 100 (10 x 10)                                       NDC 55111-533-78Recommended StorageStore tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-533-30Bottles of 60                                                                           NDC 55111-533-60Unit dose package of 100 (10 x 10)                                       NDC 55111-533-78Recommended StorageStore tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-533-30Bottles of 60                                                                           NDC 55111-533-60Unit dose package of 100 (10 x 10)                                       NDC 55111-533-78Recommended StorageStore tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].


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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 Balcoltra to women who are known to have the following conditions:

Array

Thrombotic Disorders and Other Vascular Problems

Liver disease

High blood pressure:

Carbohydrate and lipid metabolic effects:

Headache:

Bleeding Irregularities and Amenorrhea:

•

5.9

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

Adverse reactions commonly reported by COC users:

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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

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