Hailey 24 Fe (Page 6 of 6)

13 NONCLINICAL TOXICOLOGY

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13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions (5.2, 5.11) and Use in Specific Populations (8.1).]

14 CLINICAL STUDIES

In an active-controlled clinical trial, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, for up to six 28-day cycles. The racial demographic of women randomized to norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets was: 69.5% Caucasian, 15.5% African-American, 10.4% Hispanic, 2.3% Asian and 2.3% Native American/Other. Women with body mass index (BMI) greater than 35 mg/m2 were excluded from the study. The weight range for those women treated was 90 to 260 pounds, with a mean weight of 147 pounds. Among the women in the study randomized to norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, 38.9% had not used hormonal contraception immediately prior to enrolling in this study.

A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies among women aged 18 to 45 years in 3,565 treatment cycles during which no back-up contraception was used. The Pearl Index for norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets was 1.82 (95% confidence interval 0.59 to 4.25).

16 HOW SUPPLIED/STORAGE AND HANDLING

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How Supplied

HaileyTM 24 Fe (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) is available in blister card dispensers containing 28 tablets:

NDC 68462-731-29 Cartons of 3 blister cards of 28 tablets.

Each blister card (28 tablets) contains in the following order:

24 white, round (active) tablets imprinted with ‘16’ on one side and ‘G’ on other side and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.
4 brown, round (non-hormonal placebo) tablets imprinted with ‘17’ on one side and ‘G’ on other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

Storage Conditions

Store at 20º to 25ºC (68ºF to 77º F); excursions permitted from 15ºC to 30ºC (59ºF to 86º F) [see USP Controlled Room Temperature].
Protect from light.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling (Patient Information and Instructions for Use).

Counsel patients about the following information:

Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning].
Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1)].
Hailey 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Hailey 24 Fe is not to be used during pregnancy; if pregnancy occurs during use of Hailey 24 Fe instruct the patient to stop further use [see Warnings and Precautions (5.9)].
Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed [see Dosage and Administration (2.2)].
Use a back-up or alternative method of contraception when enzyme inducers are used with Hailey 24 Fe [see Drug Interactions (7.1)].
COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.3)].
Women who start COCs postpartum, and who has not yet had a period, must use an additional method of contraception until she has taken a white tablet for 7 consecutive days [see Dosage and Administration (2.2)].
Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions (5.8)].

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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HAILEY 24 FE
norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-731
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-731-29 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (68462-731-29)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 24
Part 2 4
Part 1 of 2
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TALC
SUCROSE
Product Characteristics
Color WHITE (to off white) Score no score
Shape ROUND (flat faced, beveled edge) Size 6mm
Flavor Imprint Code 16;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204847 11/17/2017
Part 2 of 2
INERT
ferrous fumarate tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FERROUS FUMARATE 75 mg
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
Product Characteristics
Color BROWN (to dark brown) Score no score
Shape ROUND (flat faced, beveled edge) Size 6mm
Flavor Imprint Code 17;G
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204847 11/17/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204847 11/17/2017
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-731), MANUFACTURE (68462-731)

Revised: 11/2017 Glenmark Pharmaceuticals Inc., USA

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