Norethindrone Acetate And Ethinyl Estradiol

Norethindrone Acetate And Ethinyl Estradiol Manufacturers

• Glenmark Pharmaceuticals Inc., Usa
  

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  Norethindrone Acetate And Ethinyl Estradiol | Glenmark Pharmaceuticals Inc., Usa

  

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  Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

  2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

  Norethindrone acetate and ethinyl estradiol tablets therapy consists of a single tablet to be taken orally once daily.

  2.2 Prevention of Postmenopausal Osteoporosis

  Norethindrone acetate and ethinyl estradiol tablets therapy consists of a single tablet taken orally once daily.  

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• Mylan Pharmaceuticals Inc.
  

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  Norethindrone Acetate And Ethinyl Estradiol | Fresenius Kabi Usa, Llc

  

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  CAUTION - RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (see WARNINGS and PRECAUTIONS).

  INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see WARNINGS).

  Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections. 

  A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient.

  Dosage

  HERPES SIMPLEX INFECTIONS

  MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 and HSV-2)

  INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

   

  HERPES SIMPLEX ENCEPHALITIS:
  

  Adults and Adolescents (12 years of age and older): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Pediatrics (3 months to 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.  In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

  
  

  VARICELLA-ZOSTER INFECTIONS

  ZOSTER IN IMMUNO­COMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older: 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Obese Patients

  Obese patients should be dosed at the recommended adult dose using Ideal Body Weight.

  PATIENTS WITH ACUTE OR CHRONIC RENAL IMPAIRMENT: Refer to DOSAGE AND ADMINISTRATION section for recommended doses, and adjust the dosing interval as indicated in Table 5.

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73 m2)

  Percent of

  Recommended Dose

  Dosing Interval

  (hours)

  >50

  25 to 50

  10 to 25

  0 to 10

  100%

  100%

  100%

  50%

  8

  12

  24

  24

  Hemodialysis

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a six-hour dialysis period.  Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis
  

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Administration

  The calculated dose should be further diluted in an appropriate intravenous solution at a volume selected for administration during each 1 hour infusion.  Infusion concentrations of approximately 7 mg/mL or lower are recommended.  In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose.  Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation.  Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Dosage

  HERPES SIMPLEX INFECTIONS

  MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 and HSV-2)

  INFECTIONS IN IMMUNOCOMPROMISED PATIENTS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS:
  

  Adults and Adolescents (12 years of age and older):

  5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days.

   

  HERPES SIMPLEX ENCEPHALITIS:
  

  Adults and Adolescents (12 years of age and older): 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Pediatrics (3 months to 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.

   

  Neonatal Herpes Simplex Virus Infections (Birth to 3 months):
  

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days.  In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused at a constant rate over 1 hour every 8 hours) have been used; the safety and efficacy of these doses are not known.

  
  

  VARICELLA-ZOSTER INFECTIONS

  ZOSTER IN IMMUNO­COMPROMISED PATIENTS:

  Adults and Adolescents (12 years of age and older: 

  10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

   

  Pediatrics (Under 12 years of age):
  

  20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days.

  Obese Patients

  Obese patients should be dosed at the recommended adult dose using Ideal Body Weight.

  PATIENTS WITH ACUTE OR CHRONIC RENAL IMPAIRMENT: Refer to DOSAGE AND ADMINISTRATION section for recommended doses, and adjust the dosing interval as indicated in Table 5.

  Table 5: Dosage Adjustments for Patients with Renal Impairment

  Creatinine Clearance

  (mL/min/1.73 m2)

  Percent of

  Recommended Dose

  Dosing Interval

  (hours)

  >50

  25 to 50

  10 to 25

  0 to 10

  100%

  100%

  100%

  50%

  8

  12

  24

  24

  Hemodialysis

  For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.  This results in a 60% decrease in plasma concentrations following a six-hour dialysis period.  Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

  Peritoneal Dialysis
  

  No supplemental dose appears to be necessary after adjustment of the dosing interval.

  Administration

  The calculated dose should be further diluted in an appropriate intravenous solution at a volume selected for administration during each 1 hour infusion.  Infusion concentrations of approximately 7 mg/mL or lower are recommended.  In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose.  Higher concentrations (e.g., 10 mg/mL) may produce phlebitis or inflammation at the injection site upon inadvertent extravasation.  Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) are not recommended.

  Once diluted for administration, each dose should be used within 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Mylan Pharmaceuticals Inc.
  

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  Norethindrone Acetate And Ethinyl Estradiol | Mylan Pharmaceuticals Inc.

  

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  The tablet blister pack has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet blister above the first row of tablets.

  Note: Each blister card has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days.

  Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

  The possibility of ovulation and conception prior to initiation of use should be considered.

  Dosage and Administration for 28-Day Dosage Regimen

  To achieve maximum contraceptive effectiveness, norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets should be taken exactly as directed and at intervals not exceeding 24 hours.

  Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets provides a continuous administration regimen consisting of 21 white to off-white tablets of norethindrone acetate and ethinyl estradiol tablets and 7 brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no "off-tablet days."

  A. Sunday-Start Regimen: The patient begins taking the first white to off-white tablet from the top row of the blister (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first white to off-white tablet is taken on the same day. The patient takes one white to off-white tablet daily for 21 days. The last white to off-white tablet in the blister pack will be taken on a Saturday. Upon completion of all 21 white to off-white tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday white to off-white tablet in the top row. Adhering to this regimen of one white to off-white tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday.

  B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the blister card. She starts taking one white to off-white tablet daily, beginning with the first white to off-white tablet in the top row. After the last white to off-white tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last white to off-white tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet blister. Following this regimen of 21 white to off-white tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course.

  Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

  Special Notes on Administration

  Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking white to off-white tablets, continue medication without interruption.

  If the patient forgets to take one or more white to off-white tablets, the following is suggested:

  One tablet is missed

  take tablet as soon as remembered take next tablet at the regular time

  Two consecutive tablets are missed (week 1 or week 2)

  take two tablets as soon as remembered take two tablets the next day use another birth control method for seven days following the missed tablets

  Two consecutive tablets are missed (week 3)

  Sunday-Start Regimen:

  take one tablet daily until Sunday discard remaining tablets start new pack of tablets immediately (Sunday) use another birth control method for seven days following the missed tablets

  Day-1 Start Regimen:

  discard remaining tablets start new pack of tablets that same day use another birth control method for seven days following the missed tablets

  Three (or more) consecutive tablets are missed

  Sunday-Start Regimen:

  take one tablet daily until Sunday discard remaining tablets start new pack of tablets immediately (Sunday) use another birth control method for seven days following the missed tablets

  Day-1 Start Regimen:

  discard remaining tablets start new pack of tablets that same day use another birth control method for seven days following the missed tablets

  The possibility of ovulation occurring increases with each successive day that scheduled white to off-white tablets are missed. While there is little likelihood of ovulation occurring if only one white to off-white tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive white to off-white tablets are missed.

  If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last white to off-white tablet was taken.

  In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet blister pack on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.

  Use of Oral Contraceptives in the Event of a Missed Menstrual Period

  If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

  After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

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