Inspra

Inspra Manufacturers

• Rebel Distributors Corp
  

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  Inspra | Rebel Distributors Corp

  

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  2.1 Congestive Heart Failure Post-Myocardial Infarction

  Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. INSPRA may be administered with or without food.

  Once treatment with INSPRA has begun, adjust the dose based on the serum potassium level as shown in Table 1.

  Table 1. Dose Adjustment in Congestive Heart Failure Post-MI Serum Potassium
  (mEq/L) Action Dose Adjustment < 5.0 Increase 25 mg every other day to 25 mg once daily
  25 mg once daily to 50 mg once daily 5.0–5.4 Maintain No adjustment 5.5–5.9 Decrease 50 mg once daily to 25 mg once daily
  25 mg once daily to 25 mg every other day
  25 mg every other day to withhold ≥ 6.0 Withhold Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L 2.2 Hypertension

  The recommended starting dose of INSPRA is 50 mg administered once daily. The full therapeutic effect of INSPRA is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of INSPRA should be increased to 50 mg twice daily. Higher dosages of INSPRA are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. [See CLINICAL STUDIES (14.2).]

  2.3 Recommended Monitoring

  Serum potassium should be measured before initiating INSPRA therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. [See WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2).] In the EPHESUS study [See CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.

  In all patients taking INSPRA who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3–7 days.

  2.4 Dose Modifications for Specific Populations

  For hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of INSPRA should be reduced to 25 mg once daily. [See DRUG INTERACTIONS (7.1).]

  No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. [See CLINICAL PHARMACOLOGY (12.3).]

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• G.d. Searle Llc Division Of Pfizer Inc
  

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  Inspra | Qualitest Pharmaceuticals

  

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  To achieve maximum contraceptive effectiveness, norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be taken exactly as directed and at intervals not exceeding 24 hours. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets may be administered without regard to meals.

  Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide a regimen consisting of 24 white active tablets of norethindrone acetate and ethinyl estradiol and 4 white-speckled brown non-hormonal (placebo) tablets of ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

  During the first cycle of use:

  The possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking norethindrone acetate and ethinyl estradiol tablets on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start). If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 24 consecutive days followed by one white-speckled brown tablet daily for 4 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on norethindrone acetate and ethinyl estradiol tablets until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days.

  The patient begins her next and all subsequent 28 day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 24 days on white tablets-4 days on white-speckled brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-­hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

  Switching from another hormonal method of contraception:

  When the patient is switching to norethindrone acetate and ethinyl estradiol tablets after completing a 21 day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts norethindrone acetate and ethinyl estradiol tablets. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21 day regimen. When the patient is switching to norethindrone acetate and ethinyl estradiol tablets after completing a 28 day regimen of oral contraceptive tablets, she should start her first pack of norethindrone acetate and ethinyl estradiol tablets on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin norethindrone acetate and ethinyl estradiol tablets the next day. If switching from an implant or injection, the patient should start norethindrone acetate and ethinyl estradiol tablets on the day of implant removal or, if using an injection, the day the next injection would be due.

  If spotting or breakthrough bleeding occurs:

  The patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if norethindrone acetate and ethinyl estradiol tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

  For additional patient instructions regarding missed pills: See the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more white-speckled brown tablets, she is still protected against pregnancy provided she begins taking the active white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. Therefore, the risk of pregnancy increases with each active (white) tablet missed.

  Use after pregnancy, abortion or miscarriage:

  Norethindrone acetate and ethinyl estradiol tablets should be initiated no earlier than 28 days postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking.  However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. 

  Norethindrone acetate and ethinyl estradiol tablets may be initiated after a first-trimester abortion or miscarriage; if the patient starts norethindrone acetate and ethinyl estradiol tablets immediately, additional contraceptive measures are not needed.

  For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

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