Cryselle 28

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F,

Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth

Revised Edition. New York, NY: Irvington Publishers; 1998.

1 Among typical couples who initiate use of a method (not necessarily for the

first time), the percentage who experience an accidental pregnancy during the

first year if they do not stop use for any other reason.

2 Among couples who initiate use of a method (not necessarily for the first time)

and who use it perfectly (both consistently and correctly), the percentage who

experience an accidental pregnancy during the first year if they do not stop use

for any other reason.

3 Among couples attempting to avoid pregnancy, the percentage who

continue to use a method for one year.

4 The percents becoming pregnant in columns (2) and (3) are based on

data from populations where contraception is not used and from women

who cease using contra ception in order to become pregnant. Among such

populations, about 89% become pregnant within one year. This estimate was

lowered slightly (to 85%) to represent the percent who would become

pregnant within one year among women now relying on reversible methods of

contraception if they abandoned contraception altogether.

5 Foams, creams, gels, vaginal suppositories, and vaginal film.

6 Cervical mucus (ovulation) method supplemented by calendar in the preovulatory

and basal body temperature in the post-ovulatory phases.

7 With spermicidal cream or jelly.

8 Without spermicides.

9 However, to maintain effective protection against pregnancy, another method

of contraception must be used as soon as menstruation resumes, the frequency

or duration of breastfeeds is reduced, bottle feeds are introduced, or

the baby reaches 6 months of age.

10 The treatment schedule is one dose within 72 hours after unprotected intercourse,

and a second dose 12 hours after the first dose. The FDA has declared

the following brands of oral contraceptives to be safe and effective for emergency

contraception. Ovral (1 dose is 2 white pills). Alesse (1 dose is 5 pink

pills). Nordette or Levlen (1 dose is 4 yellow pills).

Cryselle 28 combination is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

Cryselle 28 will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Cryselle 28 is available only with your doctor's prescription.

To achieve maximum contraceptive effectiveness, Cryselle 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 inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed 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. One white tablet should be taken daily for 21 consecutive days followed by one light-green inert tablet daily for 7 consecutive days.

Withdrawal bleeding should usually occur within three days following discontinuation of white tablets. During the first cycle, contraceptive reliance should not be placed on Cryselle until a white tablet has been taken daily for 7 consecutive days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins 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 on white tablets – 7 days on light-green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white tablet daily for 7 consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Although the occurrence of pregnancy is highly unlikely if Cryselle is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below.

Any time the patient misses two or more white tablets, she should also use another method of contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more light-green tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.

In the nonlactating mother, Cryselle may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

See also:
What is the most important information I should know about Cryselle 28?

Combination oral contraceptives should not be used in women with any of the following conditions:

Use Lo/Ovral as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Lo/Ovral by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Begin taking Lo/Ovral on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Lo/Ovral on that day. Try to take Lo/Ovral at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
• Lo/Ovral works best if it is taken at the same time each day. Do not skip doses.
• If you miss 1 dose of Lo/Ovral, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Lo/Ovral, read the extra patient information leaflet that comes with Lo/Ovral or contact your doctor for instructions. If you miss 1 or more doses of Lo/Ovral, you must use a backup form of birth control for 7 days after you start to take it again. If you are not sure about how to handle miss doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use Lo/Ovral.

See also:
What other drugs will affect Cryselle 28?

Changes in contraceptive effectiveness associated with coadministration of other products:

Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil.

Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and other penicillins, and tetracyclines, possibly due to a decrease of enterohepatic recirculation of estrogens. However, clinical pharmacology studies investigating drug interactions between combined oral contraceptives and these antibiotics have reported inconsistent results. Enterohepatic recirculation of estrogens may also be decreased by substances that reduce gut transit time.

Several of the anti-HIV protease inhibitors have been studied with coadministration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Health-care professionals should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

Herbal products containing St. John's Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P 450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

During concomitant use of Ethinyl estradiol (Cryselle 28) containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back- up method of birth control be used in addition to the regular intake of Lo/Ovral. If the use of a substance which leads to decreased Ethinyl estradiol (Cryselle 28) plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.

After discontinuation of substances that may lead to decreased Ethinyl estradiol (Cryselle 28) plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased Ethinyl estradiol (Cryselle 28) concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.

Increase in plasma levels associated with coadministered drugs

Coadministration of atorvastatin and certain oral contraceptives containing Ethinyl estradiol (Cryselle 28) increase AUC values for Ethinyl estradiol (Cryselle 28) by approximately 20%. The mechanism of this interaction is unknown. Ascorbic acid and acetaminophen increase the bioavailability of Ethinyl estradiol (Cryselle 28) since these drugs act as competitive inhibitors for sulfation of Ethinyl estradiol (Cryselle 28) in the gastrointestinal wall, a known pathway of elimination for Ethinyl estradiol (Cryselle 28). CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole, and troleandomycin may increase plasma hormone levels. Troleandomycin may also increase the risk of intrahepatic cholestasis during coadministration with combination oral contraceptives.

Changes in plasma levels of coadministered drugs:

Combination hormonal contraceptives containing some synthetic estrogens (eg, Ethinyl estradiol (Cryselle 28)) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporin, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, due to induction of conjugation (particularly glucuronidation), have been noted when these drugs were administered with oral contraceptives.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

Interactions With Laboratory Tests

Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:

1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T concentration is unaltered.
3. Other binding proteins may be elevated in serum ie, corticosteroid binding globulin (CBG), sex hormone-binding globulins (SHBG) leading to increased levels of total circulating corticosteroids and sex steroids respectively. Free or biologically active hormone concentrations are unchanged.
4. Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
5. Glucose tolerance may be decreased.
6. Serum folate levels may be depressed by oral-contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

See also:
What are the possible side effects of Cryselle 28?

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives:

Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

Acne

Amenorrhea

Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with

respiratory and circulatory symptoms

Breakthrough bleeding

Breast changes: tenderness, pain, enlargement, secretion

Budd-Chiari syndrome

Cervical erosion and secretion, change in

Cholestatic jaundice

Chorea, exacerbation of

Colitis

Corneal curvature (steepening), change in

Diminution in lactation when given immediately postpartum

Dizziness

Edema/fluid retention

Erythema multiforme

Erythema nodosum

Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)

Hirsutism

Intolerance to contact lenses

Libido, changes in

Loss of scalp hair

Melasma/chloasma which may persist

Menstrual flow, change in

Mood changes, including depression

Nausea

Nervousness

Pancreatitis

Porphyria, exacerbation of

Rash (allergic)

Serum folate levels, decrease in

Spotting

Systemic lupus erythematosus, exacerbation of

Temporary infertility after discontinuation of treatment

Vaginitis, including candidiasis

Varicose veins, aggravation of

Vomiting

Weight or appetite (increase or decrease), change in

The following adverse reactions have been reported in users of oral contraceptives:

Cataracts

Cystitis-like syndrome

Dysmenorrhea

Hemolytic uremic syndrome

Hemorrhagic eruption

Optic neuritis, which may lead to partial or complete loss of vision

Porphyria

Premenstrual syndrome

Renal function, impaired