April 25, 2017
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Sprintec

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Sprintec




Indications
Dosage
How Supplied

INDICATIONS

Oral Contraceptive

Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductivepotential to prevent pregnancy [see Clinical Studies].

DOSAGE AND ADMINISTRATION

How To Start Sprintec

Sprintec is dispensed in a blister pack tablet dispenser [see HOW SUPPLIED/Storage and Handling]. Sprintec 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.

How To Take Sprintec

Table 1: Instructions for Administration of Sprintec

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:
  • Sprintec active tablets are blue (Day 1 to Day 21).
  • Sprintec has white 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 white inactive tablet daily for 7 days and at the same time of day that active tablets were taken.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet)
Sunday Start:
  • Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Sprintec.
  • Take subsequent active tablets once daily at the same time each day for a total of 21 days.
  • Take one white inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to Sprintec from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Sprintec Start Sprintec:
  • Trans dermal patch
  • On the day when next application would have been scheduled
  • Vaginal ring
  • On the day when next insertion would have been scheduled
  • Injection
  • On the day when next injection would have been scheduled
  • Intrauterine contraceptive
  • On the day of removal
  • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
  • Implant
  • On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

Starting Sprintec after Abortion or Miscarriage

First-trimester
  • After a first-trimester abortion or miscarriage, Sprintec may be started immediately. An additional method of contraception is not needed if Sprintec is started immediately.
  • If Sprintec is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Sprintec.
Second-trimester
  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Sprintec, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Sprintec. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and FDA Approved Patient Labeling.]
Starting Sprintec after Childbirth
  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Sprintec following the instructions in Table 1 for women not currently using hormonal contraception.
  • Sprintec is not recommended for use in lactating women [see Use in Specific Populations].
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Sprintec. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Specific Populations, and FDA-Approved Patient Labeling].

There are two ways to start taking birth-control pills, Sunday Start or Day 1 Start. Your healthcare professional will tell you which to use.

How to Use Blister Cards for the 28 Tablets
  1. Pick the Days of the Week Sticker that starts the first day of your period. (This is the day you begin bleeding or spotting, even if it is midnight when bleeding begins.) When you have picked the right sticker, throw away the others and place the sticker on the blister card over the preprinted days of the week and make sure it lines up with the pills.
  2. Your blister package consists of three parts, the foil pouch, wallet, and a blister pack containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. All 21 blue pills are “active” birth-control pills, and 7 white “reminder” pills. Refer to the sample of the blister card below:
  3. SPRINTEC® blister pack - Illustration

  4. After taking the last white pill, start a new blister card the very next day no matter when your period started. You will be taking a pill every day without interruption. Any time you start the pills later than directed, protect yourself by using another method of birth control until you have taken a pill a day for seven consecutive days. After taking the last white pill, start taking the first blue pill from the blister card the very next day.
  5. Take the pills in each new package as before. Start with the blue pill on row #1 and take one pill each day, left to right, until the last white pill has been taken.
Three Ways to Remember in What Order to Take the Pills
  1. Follow the sticker with the days of the week (placed above the pills).
  2. Always go from left to right.
  3. Always finish all your blue pills.
Missed Tablets

Table 2: Instructions for Missed Sprintec 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.

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].

HOW SUPPLIED

Dosage Forms And Strengths

Sprintec (norgestimate and ethinyl estradiol tablets USP) is available in blister cards. Each blister card contains 28 tablets in the following order:

21 blue, round, flat-faced, beveled-edge, unscored tablet debossed with stylized b on one side and 987 on the other side contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol

7 white, round, flat-faced, beveled-edge, unscored tablet (non-hormonal placebo) debossed with stylized b on one side and 143 on the other side contains inert ingredients

Storage And Handling

Sprintec® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of six blister cards. Each card contains 21 blue tablets and 7 white tablets containing inert ingredients. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 987 on the other side. Each white tablet contains inert ingredients and are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side. NDC: 0555-9016-58

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Storage Conditions
  • Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • Protect from light.

TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. Revised: Aug 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/8/2016

Indications
Dosage
How Supplied

Sprintec - User Reviews

Sprintec User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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