Tri-Estarylla (Page 2 of 9)

2.3 Missed Tablets

Table 2: Instructions for Missed Tri-Estarylla™ Tablets

If one active tablet is missed in Weeks 1, 2, or 3

Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.

If two active tablets are missed in Week 1 or Week 2

Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.

If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3

Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.

2.4 Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

2.5 Tri-Estarylla™ Use for Acne

The timing of initiation of dosing with Tri-Estarylla™ for acne should follow the guidelines for use of Tri-Estarylla™ as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions

3 DOSAGE FORMS AND STRENGTHS

Tri-Estarylla™ Tablets are available in blister cards. Each blister pack contains

28 tablets in the following order:

7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol.
7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol.
7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol.
7 green (inert) tablets are round, debossed with SZ on one side and J1 on the other side.

4 CONTRAINDICATIONS

Do not prescribe norgestimate and ethinyl estradiol to women who are known to have 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)]
1.
Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS ( 5.7)]
Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS (5.2)]
Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS ( 5.8)]
Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS ( 5.9) and USE IN SPECIFIC POPULATIONS ( 8.1)]
Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.11)]
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS AND PRECAUTIONS ( 5.3)]

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic Disorders and Other Vascular Problems

Stop norgestimate and ethinyl estradiol if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop norgestimate and ethinyl estradiol if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see ADVERSE REACTIONS (6.2)].
If feasible, stop norgestimate and ethinyl estradiol at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.
Start norgestimate and ethinyl estradiol no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
Use COCs with caution in women with cardiovascular disease risk factors.

5.2 Liver Disease

Impaired Liver Function

Do not use norgestimate and ethinyl estradiol in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see CONTRAINDICATIONS (4)]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue norgestimate and ethinyl estradiol if jaundice develops.

Liver Tumors

Norgestimate and ethinyl estradiol is contraindicated in women with benign and malignant liver tumors [see CONTRAINDICATIONS (4)]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.

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