Cryselle Generic Name & Formulations
Legal Class
Rx
General Description
Norgestrel 0.3mg, ethinyl estradiol 30mcg (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—6
Manufacturer
Cryselle Indications
Indications
Oral contraception.
Cryselle Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Cryselle Contraindications
Contraindications
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).
Cryselle Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Cryselle Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events (eg, MI, stroke, VTE). Smokers >35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
Cryselle Pharmacokinetics
See Literature
Cryselle Interactions
Interactions
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels.
Cryselle Adverse Reactions
Adverse Reactions
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.
Cryselle Clinical Trials
See Literature
Cryselle Note
Not Applicable
Cryselle Patient Counseling
See Literature