Cryselle
Norgestrel and Ethinyl Estradiol · KIT · A-S Medication Solutions
Cryselle is a kit containing norgestrel and ethinyl estradiol. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Cryselle
- Generic Name
- Norgestrel and Ethinyl Estradiol
- NDC Code (Product)
50090-2183- Manufacturer
- A-S Medication Solutions
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA075840
- Marketing Start
- 07/24/2002
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
Warnings
WARNINGS 1. Thromboembolic Disorders and Other Vascular Problems • Stop Cryselle if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. • Stop Cryselle if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. • If feasible, stop Cryselle at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. • Start Cryselle no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. • The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is d…
Contraindications
CONTRAINDICATIONS Cryselle 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: o Smoke, if over age 35 o Have deep-vein thrombosis or pulmonary embolism, now or in the past o Have inherited or acquired coagulopathies o Have cerebrovascular disease o Have coronary artery disease o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) o Have uncontrolled hypertension o Have diabetes mellitus with vascular disease o Headaches with focal neurological symptoms or migraine headaches with aura o Women over age 35 with any migraine headaches • Liver tumors, benign or malignant, or liver disease • Undiagnosed abnormal uterine bleeding • Pregnancy, because there is no reason to use COCs during pregnancy • Current diagnosis or history of breast cancer, which may be hormone sensitive • Hypersensitivity to any of the components of Cryselle Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without …
Drug Interactions
8. Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.
Adverse Reactions
ADVERSE REACTIONS An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives: • Serious cardiovascular events and stroke [see Boxed Warning ] • Vascular events • Liver disease Adverse reactions commonly reported by COC users are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache 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 clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Cryselle was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Cryselle for contraception. Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure. Subjects ranged in age from 15 to 40 years. Demographics were 69% Caucasian, 28% Black, and 3% other. Common Adverse Reactions (≥ 2% of women): • Weight increase (11%) • Cervical erosion (9%) • Weight decre…
Frequently Asked Questions
What is Cryselle used for?
Cryselle contains Norgestrel and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Cryselle a controlled substance?
Cryselle is not classified as a controlled substance by the DEA.
What is the generic name for Cryselle?
The generic name for Cryselle is Norgestrel and Ethinyl Estradiol. There are 4 other brand versions of Norgestrel and Ethinyl Estradiol.
What is the NDC code for Cryselle ?
The NDC (National Drug Code) for Cryselle is 50090-2183, listed by A-S Medication Solutions.