Tri-Lo-Sprintec (Page 6 of 8)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions (5.2, 5.11) and Use in Specific Populations (8.1).]

14 CLINICAL STUDIES

In an active controlled clinical trial lasting 12 months, 1,673 women, 18 to 45 years old completed 11,003 cycles of Tri-Lo-Sprintec use and a total of 20 pregnancies were reported in Tri-Lo-Sprintec users. The racial demographic of those treated with Tri-Lo-Sprintec was: Caucasian (86%), African-American (6%), Asian (2%), and Other (6%). There were no exclusions on the basis of weight; the weight range for women treated was 90 to 240 lbs, with a mean weight of about 142 lbs. The pregnancy rate in women aged 18 to 35 years was approximately 2.6 pregnancies per 100 woman-years of use.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tri-Lo-Sprintec® 28 (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of three blister cards (NDC: 0093-2140-62). Each of the 7 gray tablets contains 0.18 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 451 on the other side; Each of the 7 light blue tablets contains 0.215 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 452 on the other side; Each of the 7 blue tablets contains 0.25 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 453 on the other side. The 7 placebo tablets are white, round, biconvex, unscored, placebo tablets, debossed with stylized b on one side and 208 on the other side.

16.2 Storage Conditions

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

PROTECT FROM LIGHT.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions 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-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections.
  • Tri-Lo-Sprintec is not to be used during pregnancy; if pregnancy occurs during use of Tri-Lo-Sprintec instruct the patient to stop further use [see Warnings and Precautions (5.9)].
  • Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed [see Dosage and Administration (2.2)].
  • Use a back-up or alternative method of contraception when enzyme inducers are used with Tri-Lo-Sprintec [see Drug Interactions (7.1)].
  • COCs may reduce breast milk production, this is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.3)].
  • Women who start COCs postpartum; and who have not yet had a period, should use an additional method of contraception until they have taken a gray tablet for 7 consecutive days [see Dosage and Administration (2.2)].
  • Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions (5.8)].

Teva Pharmacueticals USA, Inc.

North Wales, PA 19454

Rev. F 12/2021

Patient Information

Tri-Lo-Sprintec [trī-lō-sprin-tek]

(norgestimate and ethinyl estradiol tablets)

What is the most important information I should know about Tri-Lo-Sprintec?

Do not use Tri-Lo-Sprintec if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

What is Tri-Lo-Sprintec?

Tri-Lo-Sprintec is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Tri-Lo-Sprintec work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results from the clinical study, about 3 out of 100 women may get pregnant during the first year they use Tri-Lo-Sprintec.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Chart
(click image for full-size original)

Who should not take Tri-Lo-Sprintec?

Do not take Tri-Lo-Sprintec if you:

  • smoke and are over 35 years of age
  • had blood clots in your arms, legs, lungs, or eyes
  • had a problem with your blood that makes it clot more than normal
  • have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
  • had a stroke
  • had a heart attack
  • have high blood pressure that cannot be controlled by medicine
  • have diabetes with kidney, eye, nerve, or blood vessel damage
  • have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
  • have liver problems, including liver tumors
  • take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
  • have any unexplained vaginal bleeding
  • are pregnant
  • had breast cancer or any cancer that is sensitive to female hormones

If any of these conditions happen while you are taking Tri-Lo-Sprintec, stop taking Tri-Lo-Sprintec right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Tri-Lo-Sprintec.

What should I tell my healthcare provider before taking Tri-Lo-Sprintec?

Tell your healthcare provider if you:

  • are pregnant or think you may be pregnant
  • are depressed now or have been depressed in the past
  • had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
  • are breastfeeding or plan to breastfeed. Tri-Lo-Sprintec may decrease the amount of breast milk you make. A small amount of the hormones in Tri-Lo-Sprintec may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Tri-Lo-Sprintec may affect the way other medicines work, and other medicines may affect how well Tri-Lo-Sprintec works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Tri-Lo-Sprintec?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of Tri-Lo-Sprintec?

  • Like pregnancy, Tri-Lo-Sprintec may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:

  • first start taking birth control pills
  • restart the same or different birth control pills after not using them for a month or more

Call your healthcare provider or go to a hospital emergency room right away if you have:

  • leg pain that will not go away
  • a sudden, severe headache unlike your usual headaches
  • sudden severe shortness of breath
  • weakness or numbness in your arm or leg
  • sudden change in vision or blindness
  • trouble speaking
  • chest pain

Other serious side effects include:

  • liver problems, including:
    • rare liver tumors
    • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
  • high blood pressure. You should see your healthcare provider for a yearly check of your blood pressure.
  • gallbladder problems
  • changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
  • new or worsening headaches including migraine headaches
  • irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Tri-Lo-Sprintec.
  • depression
  • possible cancer in your breast and cervix
  • swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.
  • dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking Tri-Lo-Sprintec. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Tri-Lo-Sprintec?

  • headache (including migraine)
  • pain with your periods (menstrual cycle)
  • nausea and vomiting
  • mood changes, including depression
  • breast problems
  • acne
  • tenderness, pain and discomfort
  • vaginal infections
  • enlargement and swelling
  • bloating
  • discharge
  • weight gain
  • nipple pain
  • fatigue
  • stomach pain

These are not all the possible side effects of Tri-Lo-Sprintec. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Tri-Lo-Sprintec?

  • If you are scheduled for any lab tests, tell your healthcare provider you are taking Tri-Lo-Sprintec. Certain blood tests may be affected by Tri-Lo-Sprintec.
  • Tri-Lo-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Tri-Lo-Sprintec?

  • Store Tri-Lo-Sprintec at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Tri-Lo-Sprintec and all medicines out of the reach of children.
  • Store away from light.

General information about the safe and effective use of Tri-Lo-Sprintec.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tri-Lo-Sprintec for a condition for which it was not prescribed. Do not give Tri-Lo-Sprintec to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about Tri-Lo-Sprintec. You can ask your pharmacist or healthcare provider for information about Tri-Lo-Sprintec that is written for health professionals.

For more information, call 1-888-838-2872.

Does hormonal birth control cause cancer?

It is not known if hormonal birth control pills causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Tri-Lo-Sprintec?

Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Tri-Lo-Sprintec, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What are the ingredients in Tri-Lo-Sprintec?

Active ingredients: Each gray, light blue, and blue pill contains norgestimate and ethinyl estradiol.

Inactive ingredients:

Gray pills: anhydrous lactose, black iron oxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Light blue pills: anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Blue pills: anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

White pills: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. F 12/2021

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