Melodetta 24 Fe

MELODETTA 24 FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate
Amneal Pharmaceuticals LLC

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

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

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

The efficacy of Melodetta 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 Melodetta 24 Fe

To achieve maximum contraceptive effectiveness, Melodetta 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]. Melodetta 24 Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Melodetta 24 Fe

Instruct the patient to begin taking Melodetta 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 Melodetta 24 Fe use, instruct the patient to take one white Melodetta 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 Melodetta 24 Fe tablet daily for 24 consecutive days, followed by one brown ferrous fumarate tablet daily on days 25 through 28. Melodetta 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 Melodetta 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 Melodetta 24 Fe use, instruct the patient to take one white Melodetta 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Melodetta 24 Fe tablet daily for 24 consecutive days, followed by one brown ferrous fumarate tablet daily on days 25 through 28. Melodetta 24 Fe should be taken in the order directed on the package at the same time each day. Melodetta 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 Melodetta 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 Melodetta 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 Melodetta 24 Fe is started later than the day following administration of the last brown ferrous fumarate tablet, the patient should use another method of contraception until she has taken a white Melodetta 24 Fe tablet daily for 7 consecutive days.

For postpartum women who do not breastfeed or after a second trimester abortion, start Melodetta 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Melodetta 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 Melodetta 24 Fe for 7 consecutive days.

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

2.3 Switching from another Hormonal Method of Contraception

If the patient is switching from a combination hormonal method such as:

  • Another pill
  • Vaginal ring
  • Patch
  • Instruct her to take the first white Melodetta 24 Fe tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Melodetta 24 Fe.
  • If she previously used a vaginal ring or transdermal patch, she should start using Melodetta 24 Fe on the day she would have resumed the previous product.

If the patient is switching from a progestin-only method such as a:

  • Progestin-only pill
  • Implant
  • Intrauterine system
  • Injection
  • She may switch any day from a progestin-only pill; instruct her to take the first white Melodetta 24 Fe tablet on the day she would have taken her next progestin-only pill. She should use a non-hormonal method of contraception for 7 consecutive days.
  • If switching from an implant or injection, start the first white Melodetta 24 Fe tablet on the day her next injection would have been due or on the day of removal of her implant.
  • If switching from an IUD, depending on the timing of removal, back-up contraception may be needed.

2.4 Advice in Case of Gastrointestinal Disturbances

If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white Melodetta 24 Fe tablet), she should follow the instructions in the “What to Do if You Miss Tablets ” section [see FDA-approved patient labeling].

3 DOSAGE FORMS AND STRENGTHS

Melodetta 24 Fe is available in blister packs.

Each blister pack contains 28 tablets in the following order:

  • 24 white, round, (active) chewable tablets debossed with “AN” on one side and “30” on the other side, and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.
  • 4 brown, round (non-hormonal placebo) tablets debossed with “AN” on one side and “364” on the other side, and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Do not prescribe Melodetta 24 Fe to women who are known to have the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
  • Have cerebrovascular disease [see Warnings and Precautions (5.1)]
  • Have coronary artery disease [see Warnings and Precautions (5.1)]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
  • Have uncontrolled hypertension [see Warnings and Precautions (5.3)]
  • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5)]
  • Have headaches with focal neurological symptoms or have migraine headaches with aura
  • All women over age 35 with migraine headache [see Warnings and Precautions (5.6)]
  • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
  • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7)]
  • Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)]
  • Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.10)]
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

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