Tri-VyLibra Lo

Norgestimate and Ethinyl Estradiol · KIT · Afaxys Pharma, LLC

No Recall History

Plain English

Tri-VyLibra Lo is a kit containing norgestimate and ethinyl estradiol. Manufactured by Afaxys Pharma, LLC.

Key Facts

Brand Name: Tri-VyLibra Lo
Generic Name: Norgestimate and Ethinyl Estradiol
NDC Code (Product): 50102-231
Manufacturer: Afaxys Pharma, LLC
Dosage Form: KIT
Marketing Status
Application #: ANDA205762
Marketing Start: 11/04/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pregnancy on oral contraceptive56 reports

drug ineffective45 reports

nausea38 reports

maternal exposure during pregnancy37 reports

drug dose omission36 reports

no adverse event31 reports

drug interaction29 reports

headache29 reports

product quality issue29 reports

vomiting29 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] .

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister pack. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-VyLibra Lo (Norgestimate and Ethinyl Estradiol Tablets) Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is dispensed in a blister pack [see How Supplied/Storage and Handling (16) ] . Tri-VyLibra Lo (norgestimate and ethinyl estradiol 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 Tri-VyLibra Lo (Norgestimate and Ethinyl Estradiol Tablets) Table 1: Instructions for Administration of Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) active tablets are white to off whi…

Contraindications

4 CONTRAINDICATIONS Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. 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 migraine headaches with aura [see Warnings and Precautions (5.7) ] Women over age 35 with any migraine headaches [see Warnings and …

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. No drug-drug interaction studies were conducted with Tri-VyLibra Lo. 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 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 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 COCs include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant and products containing St. John’s wort. Interactions between COCs and other drugs may lead to breakthrou…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in 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 The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, nausea/vomiting, breast issues, abdominal pain, menstrual disorders, mood disorders, acne, vulvovaginal infection, abdominal distension, weight increased, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Afaxys Pharma, LLC at 1-855-888-2467 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. The safety of Tri-VyLibra Lo was evaluated in 1,723 subjec…

Frequently Asked Questions

What is Tri-VyLibra Lo used for?

Tri-VyLibra Lo contains Norgestimate and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.

Is Tri-VyLibra Lo a controlled substance?

Tri-VyLibra Lo is not classified as a controlled substance by the DEA.

What is the generic name for Tri-VyLibra Lo?

The generic name for Tri-VyLibra Lo is Norgestimate and Ethinyl Estradiol. There are 12 other brand versions of Norgestimate and Ethinyl Estradiol.

What is the NDC code for Tri-VyLibra Lo ?

The NDC (National Drug Code) for Tri-VyLibra Lo is 50102-231, listed by Afaxys Pharma, LLC.

Product NDC

50102-231

Package NDC

50102-231-13

Other Norgestimate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)