Introvale
Levonorgestrel and Ethinyl Estradiol · KIT · Xiromed, LLC.
Introvale is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by Xiromed, LLC..
Key Facts
- Brand Name
- Introvale
- Generic Name
- Levonorgestrel and Ethinyl Estradiol
- NDC Code (Product)
70700-117- Manufacturer
- Xiromed, LLC.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA079064
- Marketing Start
- 02/01/2018
Recall History
Sandoz Incorporated
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Introvale is indicated for use by females of reproductive potential to prevent pregnancy. Introvale is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days. ( 2.1 ) Take tablets in the order directed on the Extended-Cycle Blister Pack. ( 2.2 ) 2.1 How to Start and Take Introvale Introvale is dispensed in an Extended-Cycle Blister Pack [ see How Supplied/Storage and Handling (16) ]. Introvale should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 1: Instructions for Administration of Introvale Starting Introvale in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Introvale active tablets are white to off-white (Day 1 to Day 84). Introvale inactive tablets are green (Day 85 to Day 91). Sunday Start: For each 91-day course, take in the following order: Take the first white to off-white tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on …
Contraindications
4 CONTRAINDICATIONS Introvale is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] . Have current or history of deep vein thrombosis or pulmonary embolism [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 or hypertension with vascular disease [see Warnings and Precautions (5.4) ] . Have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.7) ] . Have headaches with focal neurological s…
Drug Interactions
7 DRUG INTERACTIONS The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets. Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol tablets or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of CO…
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 (5.2) ] The most common adverse reactions (≥2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol tablets was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least on…
Frequently Asked Questions
What is Introvale used for?
Introvale contains Levonorgestrel and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Introvale a controlled substance?
Introvale is not classified as a controlled substance by the DEA.
What is the generic name for Introvale?
The generic name for Introvale is Levonorgestrel and Ethinyl Estradiol. There are 12 other brand versions of Levonorgestrel and Ethinyl Estradiol.
What is the NDC code for Introvale ?
The NDC (National Drug Code) for Introvale is 70700-117, listed by Xiromed, LLC..