Norgestimate and ethinyl estradiol is the generic equivalent of the brand-name drug Estarylla, Tri-Estarylla, Tri-Lo- Estarylla. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Norgestimate and ethinyl estradiol through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Tri-Lo-Estarylla (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-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ].
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…
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 norgestimate and ethinyl estradiol. 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 e…
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-Lo-Estarylla Tri-Lo-Estarylla is dispensed in a blister pack [see HOW SUPPLIED/STORAGE AND HANDLING (16) ]. Tri-Lo-Estarylla 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 o…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instruction for Use) . Counsel patients about the following information: • Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ]. • Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see WARNINGS AND PRECAUTIONS (5.1) ]. • Tri-Lo-Estarylla does no…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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