levonorgestrel and ethinyl estradiol
levonorgestrel and ethinyl estradiol · KIT · Glenmark Pharmaceuticals Inc., USA
levonorgestrel and ethinyl estradiol is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by Glenmark Pharmaceuticals Inc., USA.
Key Facts
- Brand Name
- levonorgestrel and ethinyl estradiol
- Generic Name
- levonorgestrel and ethinyl estradiol
- NDC Code (Product)
68462-672- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA203164
- Marketing Start
- 06/12/2015
Recall History
Mylan Pharmaceuticals Inc.
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Sandoz Incorporated
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Teva Pharmaceuticals USA, Inc.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Watson Laboratories Inc
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Teva Pharmaceuticals USA
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Teva Pharmaceuticals USA, Inc.
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Xiromed LLC
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Start Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] . Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets may be started using either a Day 1 start or a Sunday start (see Table 1 ). 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. 2.2 How to Take Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets (orange active tablets and blue placebo tablets) are swallowed whole once a day Table 1: Instructions for Administration of Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Complete instructions to facilitate patient counseling on proper tablet usa…
Contraindications
4 CONTRAINDICATIONS Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic disease. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] . Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] . Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] . Have coronary artery disease [see Warnings and Precautions ( 5.1 )] . Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )] . Have uncontrolled hypertension [see Warnings and Precautions ( 5.4 )] . Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.6 )] . Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions ( 5.7 )] . Wome…
Drug Interactions
7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs.( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other d…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acella Pharmaceuticals, LLC at 1-800-541-4802 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a clinical trial with levonorgestrel 0.1 mg an…
Frequently Asked Questions
What is levonorgestrel and ethinyl estradiol used for?
levonorgestrel and ethinyl estradiol contains levonorgestrel and ethinyl estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is levonorgestrel and ethinyl estradiol a controlled substance?
levonorgestrel and ethinyl estradiol is not classified as a controlled substance by the DEA.
What is the generic name for levonorgestrel and ethinyl estradiol?
The generic name for levonorgestrel and ethinyl estradiol is levonorgestrel and ethinyl estradiol. There are 10 other brand versions of levonorgestrel and ethinyl estradiol.
What is the NDC code for levonorgestrel and ethinyl estradiol ?
The NDC (National Drug Code) for levonorgestrel and ethinyl estradiol is 68462-672, listed by Glenmark Pharmaceuticals Inc., USA.