Tri-Vylibra
Generic name:norgestimate and ethinyl estradiol
Dosage form: tablets
Drug class:Contraceptives
Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4)].
Indications and Usage for Tri-Vylibra
Oral Contraceptive
Tri-Vylibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
Acne
Tri-Vylibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Vylibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)].
DOSAGE AND ADMINISTRATION
How to Start Tri-Vylibra
Tri-Vylibra is available in blister pack [see How Supplied/Storage and Handling (16)]. Tri-Vylibra 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.
