Estradiol .1 mg/d
Estradiol · PATCH, EXTENDED RELEASE · Zydus Lifesciences Limited
Estradiol is a patch, extended release containing estradiol at .1 mg/d, taken transdermal. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Estradiol
- Generic Name
- Estradiol
- NDC Code (Product)
70771-1567- Manufacturer
- Zydus Lifesciences Limited
- Strength
- .1 mg/d
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- ANDA206241
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 04/13/2023
Recall History
Teva Pharmaceuticals USA, Inc
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Clinical Specialties Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Noven Pharmaceuticals, Inc.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Mylan Pharmaceuticals Inc.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
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 Sprintec ® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )].
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) Do not skip or delay tablet intake. ( 2.1 ) 2.1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Sprintec. Table 1: Instructions for Administration of Sprintec Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Sprintec active tablets are blue (Day 1 to Day 21). Sprintec has white inactive tablets (Day 22 to Day 28). Day 1 Start: Take first active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one white inactive tablet daily for 7 days and at the same time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet…
Contraindications
4 CONTRAINDICATIONS Sprintec 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 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings and Precautions ( 5.4 )] Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.6 )] Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions ( 5.7 )] Women over age 35 with any migraine headaches [see Warnings and Precautions ( 5.7 )] Liver tumors, be…
Drug Interactions
7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Sprintec. Drugs or herbal products that induce certain enzymes including 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 decreasing the plasma concentrations of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish 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, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and o…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in 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 reported during clinical trials (≥2%) were: Sprintec: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of norgestimate and ethinyl estradiol was evaluated in 1,647 healthy women of child-bearing potential …
Frequently Asked Questions
What is Estradiol used for?
Estradiol contains Estradiol. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.
Is Estradiol a controlled substance?
Estradiol is not classified as a controlled substance by the DEA.
What is the generic name for Estradiol?
The generic name for Estradiol is Estradiol. There are 8 other brand versions of Estradiol.
What is the NDC code for Estradiol .1 mg/d?
The NDC (National Drug Code) for Estradiol .1 mg/d is 70771-1567, listed by Zydus Lifesciences Limited.