Rx Item-Minastrin 24 Fe 1Mg/20Mcg Chewable 5X28 By Actavis Pharma

MINASTRIN 24 FE- norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets
Allergan, Inc.

WARNING: CIGARETTE SMOKING AND SERIOUS
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 should not be used by women who are over 35 years of age and smoke [ see Contraindications (4) ].

1 INDICATIONS AND USAGE



Minastrin 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies (14)].

The efficacy of Minastrin 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

2 DOSAGE AND ADMINISTRATION

2.1 How to Take Minastrin 24 Fe
​ To achieve maximum contraceptive effectiveness, Minastrin 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [ see FDA-approved patient labeling]. Minastrin 24 Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Minastrin 24 Fe
Instruct the patient to begin taking Minastrin 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start
During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Minastrin 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start
During the first cycle of Minastrin 24 Fe use, instruct the patient to take one white Minastrin 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Minastrin 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Minastrin 24 Fe should be taken in the order directed on the package at the same time each day. Minastrin 24 Fe should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Minastrin 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white Minastrin 24 Fe tablets on the next day after ingestion of the last brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Minastrin 24 Fe is started later than the day following administration of the last brown tablet, the patient should use another method of contraception until she has taken a white Minastrin 24 Fe tablet daily for 7 consecutive days.

For postpartum women who do not breastfeed or after a second trimester abortion, start Minastrin 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Minastrin 24 Fe postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Minastrin 24 Fe for 7 consecutive days.

Minastrin 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Minastrin 24 Fe immediately, additional contraceptive measures are not needed.

RX ITEM-Minastrin 24 Fe 1Mg/20Mcg Chewab
NDC 00430-0540-50 UPC/GTIN No.3-04300-54050-2 Mfg.Part No.54050 WC, 535 or 624 chewable tablet , multi-colored , round round 24 white (side 1: WC; side 2: 535), 4 brown (side 1: WC; side 2: 624)

Minastrin 24 Fe 1Mg/20Mcg Chewable 5X28
BRAND: MINASTRIN NDC: 00430-0540-50,430054050 UPC: 3-04300-54050-2,304300540502 Actavis Pharma

NORETHINDRONE-E.ESTRADIOL
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