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Norgestrel and Ethinyl Estradiol
Overview
What is Cryselle?
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
CHOMW: 312.45
Ethinyl Estradiol, USP
CHOMW: 296.40
What does Cryselle look like?
What are the available doses of Cryselle?
Sorry No records found.
What should I talk to my health care provider before I take Cryselle?
Sorry No records found
How should I use Cryselle?
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.
What interacts with Cryselle?
- Do not prescribe Cryselle to women who are known to have any of the following conditions:
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- 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 , Risk of liver enzyme elevations with concomitant hepatitis c treatment).
What are the warnings of Cryselle?
1. Thromboembolic Disorders and Other Vascular Problems
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2. Liver Disease
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Do not use Cryselle in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver . 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.
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Cryselle is contraindicated in women with benign and malignant liver tumors . 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.
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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 ]. Cryselle can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
3. High Blood Pressure
Cryselle is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease . For women with well-controlled hypertension, monitor blood pressure and stop Cryselle if blood pressure rises significantly.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing quantities of progestin.
4. Gallbladder Disease
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.
5. Carbohydrate and Lipid Metabolic Effects
Carefully monitor prediabetic and diabetic women who take Cryselle. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
6. Headache
If a woman taking Cryselle develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Cryselle if indicated.
Consider discontinuation of Cryselle in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
7. Bleeding Irregularities and Amenorrhea
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Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product.
In 1,287 patients (pooled data from a number of studies), unscheduled bleeding was recorded in 15% of first cycles and by Cycle 12 was 5%. In total, 23% of subjects reported spotting, 20% reported unscheduled bleeding, and 2% reported change in menstrual flow at some point in the studies.
In the studies, 1.2% discontinued use of the product due to breakthrough bleeding and 1% discontinued due to spotting.
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Women who use Cryselle may experience amenorrhea. A total of 9% of subjects in the studies reported amenorrhea in one or more cycles.
Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
8. Depression
Carefully observe women with a history of depression and discontinue Cryselle if depression recurs to a serious degree.
What are the precautions of Cryselle?
1. Carcinoma of the Breast and Cervix
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2. Effect on Binding Globulins
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
3. Hereditary Angioedema
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
4. Chloasma
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Cryselle.
5. Drug Interactions
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation:
Do not coadminister Cryselle with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see , Risk of liver enzyme elevations with concomitant hepatitis c treatment).
Effects of Other Drugs on Combined Oral Contraceptives
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Colesevelam:
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Effects of Combined Oral Contraceptives on Other Drugs
COCs containing EE may inhibit the metabolism of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in the plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.
6. Interference with Laboratory Tests
The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
7. Carcinogenesis
See and .
8. Pregnancy
There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.
Discontinue Cryselle use if pregnancy is confirmed.
Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.
9. 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.
10. Pediatric Use
Safety and efficacy of Cryselle tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of Cryselle before menarche is not indicated.
11. Geriatric Use
Cryselle has not been studied in postmenopausal women and is not indicated in this population.
12. Information for the Patient
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see Boxed Warning
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See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information:
What are the side effects of Cryselle?
An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:
Adverse reactions commonly reported by COC users are:
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):
A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression.
Postmarketing Experience
The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Cryselle. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Arterial Events:
Eye Disorder:
Gastrointestinal Disorders:
Hepatobiliary Disorders:
Immune System Disorders:
Metabolism and Nutrition Disorders:
Neoplasms, Benign, Malignant, and Unspecified:
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Psychiatric Disorders:
Reproductive System and Breast Disorders:
Skin and Subcutaneous Tissue Disorders:
Vascular Events:
OVERDOSAGE
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Cryselle (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Cryselle is one white tablet daily for 21 consecutive days, followed by one light-green colored inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Cryselle tablets be taken by mouth at the same time each day.
How to Start Cryselle
Consider the possibility of ovulation and conception prior to initiation of medication.
Instruct the patient to begin taking Cryselle on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. The patient should take one white tablet daily for 21 consecutive days followed by one light-green colored inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Cryselle for contraception until a white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days.
After the first cycle of use
The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of white tablets, followed by 7 days of light-green colored inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.
Switching from another hormonal method of contraception
Use after pregnancy, abortion, or miscarriage
If spotting or breakthrough bleeding occurs
If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult her healthcare provider if the bleeding is persistent or prolonged.
Missed Tablets
The possibility of ovulation and pregnancy increases with each successive day that scheduled white tablets are missed. If withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (if she missed one or more tablets or started taking them on a day later than she should have), consider the probability of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
For additional patient instructions regarding missed tablets, see the section in below.
Advice in Case of Gastrointestinal Disturbances
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet .
What should I look out for while using Cryselle?
Do not prescribe Cryselle to women who are known to have any of the following conditions:
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 , Risk of liver enzyme elevations with concomitant hepatitis c treatment).
What might happen if I take too much Cryselle?
Sorry No Records found
How should I store and handle Cryselle?
JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures Cryselle (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331.Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.Rev. C 12/2017Cryselle (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331.Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.Rev. C 12/2017Cryselle (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331.Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.Rev. C 12/2017Cryselle (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331.Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.Rev. C 12/2017Cryselle (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331.Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.Rev. C 12/2017
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
Do not prescribe Cryselle to women who are known to have any of the following conditions: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 , Risk of liver enzyme elevations with concomitant hepatitis c treatment).
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.
An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:
Adverse reactions commonly reported by COC users are:
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):
A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression.
Postmarketing Experience
The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Cryselle. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Arterial Events:
Eye Disorder:
Gastrointestinal Disorders:
Hepatobiliary Disorders:
Immune System Disorders:
Metabolism and Nutrition Disorders:
Neoplasms, Benign, Malignant, and Unspecified:
,
Psychiatric Disorders:
Reproductive System and Breast Disorders:
Skin and Subcutaneous Tissue Disorders:
Vascular Events:
OVERDOSAGE
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Cryselle (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Cryselle is one white tablet daily for 21 consecutive days, followed by one light-green colored inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Cryselle tablets be taken by mouth at the same time each day.
How to Start Cryselle
Consider the possibility of ovulation and conception prior to initiation of medication.
Instruct the patient to begin taking Cryselle on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. The patient should take one white tablet daily for 21 consecutive days followed by one light-green colored inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Cryselle for contraception until a white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days.
After the first cycle of use
The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of white tablets, followed by 7 days of light-green colored inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.
Switching from another hormonal method of contraception
Use after pregnancy, abortion, or miscarriage
If spotting or breakthrough bleeding occurs
If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult her healthcare provider if the bleeding is persistent or prolonged.
Missed Tablets
The possibility of ovulation and pregnancy increases with each successive day that scheduled white tablets are missed. If withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (if she missed one or more tablets or started taking them on a day later than she should have), consider the probability of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
For additional patient instructions regarding missed tablets, see the section in below.
Advice in Case of Gastrointestinal Disturbances
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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