LORYNA
Drospirenone and Ethinyl Estradiol Tablets · KIT · Xiromed, LLC.
LORYNA is a kit containing drospirenone and ethinyl estradiol tablets. Manufactured by Xiromed, LLC..
Key Facts
- Brand Name
- LORYNA
- Generic Name
- Drospirenone and Ethinyl Estradiol Tablets
- NDC Code (Product)
70700-114- Manufacturer
- Xiromed, LLC.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA079221
- Marketing Start
- 06/09/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Loryna (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for women 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 Loryna (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Loryna is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Loryna 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 include decreased interest in usual activities, difficulty concentrating, lack of ene…
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 Loryna (drospirenone and ethinyl estradiol tablets) 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, drospirenone and ethinyl estradiol tablets 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 Loryna (drospirenone and ethinyl estradiol tablets) Instruct the patient to begin taking Loryna tablets 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 Loryna tablets use, instruct the patient to take one peach drospirenone and ethinyl estradiol tablet daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one peach Loryna tablet daily for 24 consecutive days, followed by one white inert tabl…
Contraindications
4 CONTRAINDICATIONS Loryna 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 ) ] Undiag…
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 …
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 ) ] Adverse reactions commonly reported by COC users are: •Irregular uterine bleeding •Nausea •Breast tenderness •Headache 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 Xiromed, LLC. At 1-844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under wi…
Frequently Asked Questions
What is LORYNA used for?
LORYNA contains Drospirenone and Ethinyl Estradiol Tablets. It is a kit taken as directed. Consult your doctor for specific uses.
Is LORYNA a controlled substance?
LORYNA is not classified as a controlled substance by the DEA.
What is the generic name for LORYNA?
The generic name for LORYNA is Drospirenone and Ethinyl Estradiol Tablets. There are no other listed brand versions of Drospirenone and Ethinyl Estradiol Tablets.
What is the NDC code for LORYNA ?
The NDC (National Drug Code) for LORYNA is 70700-114, listed by Xiromed, LLC..
Other LORYNA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)