Tri-Estarylla

norgestimate and ethinyl estradiol · KIT · Xiromed, LLC.

No Recall History

Plain English

Tri-Estarylla is a kit containing norgestimate and ethinyl estradiol. Manufactured by Xiromed, LLC..

Key Facts

Brand Name: Tri-Estarylla
Generic Name: norgestimate and ethinyl estradiol
NDC Code (Product): 70700-121
Manufacturer: Xiromed, LLC.
Dosage Form: KIT
Marketing Status
Application #: ANDA090793
Marketing Start: 09/01/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Estarylla 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-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Estarylla (norgestimate and ethinyl estradiol) Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14 )] . 1.2 Acne Tri-Estarylla 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-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES ( 14 )].

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) Do not skip or delay tablet intake. ( 2.1 ) 2.1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Tri-Estarylla. Table 1: Instructions for Administration of Tri-Estarylla 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-Estarylla active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). Tri-Estarylla have green inactive tablets (Day 22 to Day 28). Day 1 Start: Take first active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. Begin each subsequent blister pack on the same day of …

Contraindications

4 CONTRAINDICATIONS Tri-Estarylla 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 hyper coagulopathies [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 PRECAUTIONS ( 5.7 )] Liver tumo…

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 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 hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between h…

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 ANDPRECAUTIONS ( 5.1 )] Vascular events [see WARNINGS ANDPRECAUTIONS ( 5.1 )] Liver disease [see WARNINGS ANDPRECAUTIONS ( 5.2 )] The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC. at 1- (844-947-6633) XIROMED 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 norgestimate and ethiny…

Frequently Asked Questions

What is Tri-Estarylla used for?

Tri-Estarylla contains norgestimate and ethinyl estradiol. It is a kit taken as directed. Consult your doctor for specific uses.

Is Tri-Estarylla a controlled substance?

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

What is the generic name for Tri-Estarylla?

The generic name for Tri-Estarylla is norgestimate and ethinyl estradiol. There are 12 other brand versions of norgestimate and ethinyl estradiol.

What is the NDC code for Tri-Estarylla ?

The NDC (National Drug Code) for Tri-Estarylla is 70700-121, listed by Xiromed, LLC..

Product NDC

70700-121

Package NDC

70700-121-85

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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)