Jasmiel

Drospirenone and Ethinyl Estradiol · KIT · Afaxys Pharma, LLC

No Recall HistoryCurrently in Shortage

Plain English

Jasmiel is a kit containing drospirenone and ethinyl estradiol. Manufactured by Afaxys Pharma, LLC.

Key Facts

Brand Name: Jasmiel
Generic Name: Drospirenone and Ethinyl Estradiol
NDC Code (Product): 50102-240
Manufacturer: Afaxys Pharma, LLC
Dosage Form: KIT
Marketing Status
Application #: ANDA209632
Marketing Start: 02/27/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain1,717 reports

injury1,299 reports

cholecystitis chronic1,024 reports

anxiety784 reports

gallbladder disorder777 reports

pulmonary embolism761 reports

deep vein thrombosis715 reports

emotional distress688 reports

cholelithiasis672 reports

abdominal pain354 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Jasmiel is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) 1.1 Oral Contraceptive Jasmiel ® is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Jasmiel is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Jasmiel for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features inclu…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. (2.1) Tablets must be taken in the order directed on the blister pack. (2.1) 2.1 How to Take Jasmiel Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, Jasmiel must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 How to Start Jasmiel Instruct the patient to begin taking Jasmiel 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 Jasmiel use, instruct the patient to take one light pink to pink Jasmiel daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one light pink to pink Jasmiel daily for 24 consecutive days, followed by one green inert tablet daily on Days 25 through 28. Jasmiel should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at…

Contraindications

4 CONTRAINDICATIONS Jasmiel is contraindicated in females who are known to have or develop the following conditions: Renal impairment Adrenal insufficiency 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 (5.6) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.8) ] Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.9) ] Undiagnosed abnormal uterine bleeding [se…

Drug Interactions

7 DRUG INTERACTIONS Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. (7.1) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme in…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.4) ] The most frequent adverse reactions (≥ 2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and mood changes (2.2%). (6.1) The most frequent adverse reactions (≥ 2%) in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Afaxys Pharma, LLC at 1-855-888-2467 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinica…

Frequently Asked Questions

What is Jasmiel used for?

Jasmiel contains Drospirenone and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.

Is Jasmiel a controlled substance?

Jasmiel is not classified as a controlled substance by the DEA.

What is the generic name for Jasmiel?

The generic name for Jasmiel is Drospirenone and Ethinyl Estradiol. There are 11 other brand versions of Drospirenone and Ethinyl Estradiol.

What is the NDC code for Jasmiel ?

The NDC (National Drug Code) for Jasmiel is 50102-240, listed by Afaxys Pharma, LLC.

Product NDC

50102-240

Package NDC

50102-240-23

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)