Tri-Sprintec
TRI-SPRINTEC- norgestimate and ethinyl estradiol
REMEDYREPACK INC.
WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4)] .
1 INDICATIONS AND USAGE
1.1 Oral Contraceptive
Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14)] .
1.2 Acne
Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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-Sprintec ® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies ( 14)] .
2 DOSAGE AND ADMINISTRATION
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-Sprintec ® (norgestimate and ethinyl estradiol tablets).
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:
| Day 1 Start:
|
Sunday Start:
| |
Switching to Tri-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 Tri-Sprintec ® | Start Tri-Sprintec ®: |
|
|
|
|
|
|
|
|
|
|
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. |
Starting Tri-Sprintec ® after Abortion or Miscarriage
First-trimester
- After a first-trimester abortion or miscarriage, Tri-Sprintec ® may be started immediately. An additional method of contraception is not needed if Tri-Sprintec ® is started immediately.
- If Tri-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 Tri-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 Tri-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 Tri-Sprintec ® [see Contraindications ( 4) and Warnings and Precautions ( 5.1)].
Starting Tri-Sprintec ® after Childbirth
- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Sprintec ® following the instructions in Table 1 for women not currently using hormonal contraception.
- Tri-Sprintec ® is not recommended for use in lactating women [see Use in Specific Populations ( 8.2)] .
- If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-Sprintec ® [see Contraindications ( 4), Warnings and Precautions ( 5.1), and Use in Specific Populations ( 8.1, and 8.2)].
2.2 Recommendations Regarding Missed Doses
Contraceptive failure may occur when active tablets are missed. Table 2 describes instructions for Tri-Sprintec ® dosing and use of additional non-hormonal contraception (such as condoms) when active tablets are missed.
| Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. |
| 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. |
| 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. |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.