Mononessa

Mononessa Manufacturers

• Watson Pharmaceuticals
  

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  Mononessa | Actavis Pharma, Inc

  

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  2.1 How to Start MonoNessa or TriNessa

  MonoNessa and TriNessa are dispensed in a VERIDATE Tablet Dispenser [see How Supplied/Storage and Handling (16)]. MonoNessa and TriNessa 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.

  2.2 How to Take MonoNessa or TriNessa Table 1: Instructions for Administration of MonoNessa or TriNessa Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. 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: MonoNessa active tablets are blue (Day 1 to Day 21). TriNessa active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21). MonoNessa and TriNessa both have dark 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 dark green 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 MonoNessa or TriNessa. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one dark green 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 MonoNessa or TriNessa 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 MonoNessa or TriNessa Start MonoNessa or TriNessa: Transdermal 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

  Starting MonoNessa or TriNessa after Abortion or Miscarriage

  First-trimester

  After a first-trimester abortion or miscarriage, MonoNessa or TriNessa may be started immediately. An additional method of contraception is not needed if MonoNessa or TriNessa is started immediately. If MonoNessa or TriNessa 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 MonoNessa or TriNessa.

  Second-trimester

  Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start MonoNessa or TriNessa, 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 MonoNessa or TriNessa. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

  Starting MonoNessa or TriNessa after Childbirth

  Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with MonoNessa or TriNessa following the instructions in Table 1 for women not currently using hormonal contraception. MonoNessa or TriNessa are not recommended for use in lactating women [see Use in Specific Populations (8.3)]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of MonoNessa or TriNessa. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

  VERIDATE® Tablet Dispenser

  Place the refill in the VERIDATE Tablet Dispenser so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under all the nibs (see illustration below). If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser.

  MonoNessa:

  If the patient will start pill-taking on "Day 1," choose a blue pill that corresponds with the day of the week the patient will take the first pill. Remove that blue pill by pressing the pill through the hole in the bottom of the dispenser.

  TriNessa:

  If the patient will start pill-taking on a day other than Sunday, a calendar label has been provided and should be placed over the calendar in the center of the VERIDATE. To place the label correctly, identify the correct starting day, locate that day printed in blue on the label, and line that day up with the first white pill directly under the V notch at the top of the dispenser. Remove the label from the backing. Press the center of the label down onto the center of the printed calendar. Remove that white pill by pressing the pill through the hole in the bottom of the dispenser. After all the dark green pills have been taken, insert a new refill into the VERIDATE. The patient should take the first pill on the next day, even if the patient's period is not over yet.

  To Insert New Refill (MonoNessa or TriNessa):

  Lift the empty refill out of the VERIDATE Tablet Dispenser. Insert the new refill so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under the nibs. 2.3 Missed Tablets Table 2: Instructions for Missed MonoNessa or TriNessa 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 TriNessa Use for Acne

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

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• Proficient Rx Lp
  

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  Mononessa | Proficient Rx Lp

  

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  Oral Contraception

  To achieve maximum contraceptive effectiveness, MonoNessa® must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. MonoNessa® is available in a blister card with a tablet dispenser which is preset for a Sunday Start. Day 1 Start is also provided.

  Sunday Start

  When taking MonoNessa®, the first blue "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one dark green inactive tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

  If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  Day 1 Start

  The dosage of MonoNessa® for the initial cycle of therapy is one blue "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one dark green inactive tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

  If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  The use of MonoNessa® for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers.) The possibility of ovulation and conception prior to initiation of medication should be considered.

  (See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

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