Cryselle

CRYSELLE- norgestrel and ethinyl estradiol
REMEDYREPACK INC.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications] .

DESCRIPTION

Cryselle ® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.

Norgestrel, USP

Norgestrel Strustural Formula
(click image for full-size original)

C 21 H 28 O 2 MW: 312.45

Ethinyl Estradiol, USP

Ethinyl Estradiol Structural Formula
(click image for full-size original)

C 20 H 24 O 2 MW: 296.40

CLINICAL PHARMACOLOGY

Mechanism of Action

Combined oral contraceptives (COCs) lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and the endometrial changes that reduce the likelihood of implantation.

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.

CONTRAINDICATIONS

Do not prescribe Cryselle to women who are known to have any of the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35
  • Have deep-vein thrombosis or pulmonary embolism, now or in the past
  • Have inherited or acquired coagulopathies
  • Have cerebrovascular disease
  • Have coronary artery disease
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation)
  • Have uncontrolled hypertension
  • Have diabetes mellitus with vascular disease
  • Headaches with focal neurological symptoms or migraine headaches with aura
  • 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
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • Hypersensitivity to any of the components of Cryselle

Combination oral contraceptives should not be used in women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , Risk of liver enzyme elevations with concomitant hepatitis c treatment).

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 discontinued.
  • Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
  • Use COCs with caution in women with cardiovascular disease risk factors.

2. Liver Disease

Impaired Liver Function

Do not use Cryselle in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications] . Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue Cryselle if jaundice develops.

Liver Tumors

Cryselle is contraindicated in women with benign and malignant liver tumors [see Contraindications] . Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However the risk of liver cancers in COC users approaches less than one case per million users.

Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue Cryselle prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications]. Cryselle can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.

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