Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 21 February 2017

Indication(s)

INDICATIONS & USAGE CAZIANT® (desogestrel/ethinyl estradiol) Tablets 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 II lists the typical unintended 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 these methods can result in lower failure rates.

TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR, UNITED STATES. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4)

Chance4 85 85

Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal6 2 Post-Ovulation 1 Withdrawal 19 4 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Condom8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75 % 9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell J, Stewart F

Contraceptive Efficacy.

In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal 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 percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception 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 pre-ovulatory and basal body temperature in the post-ovulatory phases.

7 With spermicidal cream or jelly.

8 Without spermicides.

9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose.

The Food and Drug Administration 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 2 light orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills) 10 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 six months of age

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Advisory information

contraindications

CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular or coronary artery disease (current or history) Valvular heart disease with thrombogenic complications Severe hypertension Diabetes with vascular involvement Headaches with focal neurological symptoms Major surgery with prolonged immobilization Known or suspected carcinoma of the breast (or personal history of breast cancer) Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use Hepatic tumors (benign or malignant) or

active liver disease Known or suspected pregnancy Heavy smoking (?15 cigarettes per day) and over age 35 Hypersensitivity to any of the components of CAZIANT®

Special warnings and precautions

PRECAUTIONS 1.

SEXUALLY TRANSMITTED DISEASES Patients should be counseled that this product does not protect against HIV infection (AIDS)and other sexually transmitted diseases.

2.

PHYSICAL EXAMINATION AND FOLLOW UP It is good medical practice for all women to have an annual history and physical examinations, including women using oral contraceptives.

The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.

The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests.

In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy.

Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

3.

LIPID DISORDERS Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives.

Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.

4.

LIVER FUNCTION If jaundice develops in any woman receiving oral contraceptives, the medication should be discontinued.

The hormones in CAZIANT®Tablets may be poorly metabolized in patients with impaired liver function.

5.

FLUID RETENTION Oral contraceptives may cause some degree of fluid retention.

They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

6.

EMOTIONAL DISORDERS Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related.

7.

CONTACT LENSES Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

8.

DRUG INTERACTIONS Changes in contraceptive effectiveness associated with co-administration of other drugs:

a. Anti-infective agents and anticonvulsants Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with some antibiotics, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids.

This could result in unintended pregnancy or breakthrough bleeding.

Examples include barbiturates, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.

Since desogestrel is mainly metabolized by the cytochrome P450 2C9 enzyme (CYP 2C9) to form etonogestrel, the active progestin, there is a possibility of interaction with CYP 2C9 substrates or inhibitors (such as: ibuprofen, piroxicam, naproxen, phenytoin, fluconazole, diclofenac, tolbutamide, glipizide, celecoxib, sulfamethoxazole, isoniazid, torsemide, irbesartan, losartan, and valsartan).

The clinical relevance of these interactions is unknown.

b. Anti-HIV protease inhibitors Several of the anti-HIV protease inhibitors have been studied with co-administration 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 efficacy and safety of these oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors.

Health care providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

c. Herbal products Herbal products containing St. John 's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

This may also result in breakthrough bleeding.

Increase in plasma hormone levels associated with co-administered drugs: Co-administration of atorvastatin and certain ethinyl estradiol containing oral contraceptives increased AUC values for ethinyl estradiol by approximately 20 %.

Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation.

CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

Changes in plasma levels of co-administered drugs: Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds.

Increased plasma concentrations of cyclosporine, prednisolone, 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 have been noted when these drugs were administered with oral contraceptives.

No formal drug-drug interaction studies were conducted with desogestrel and ethinyl estradiol tablets.

9.

INTERACTIONS WITH LABORATORY TESTS Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

a. Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.

b. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay.

Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.

c.

Other binding proteins may be elevated in serum.

d. Sex hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged.

e. Triglycerides may be increased, and levels of various other lipids and lipoproteins may be affected.

f. Glucose tolerance may be decreased.

g.

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.

10.

CARCINOGENESIS See WARNINGS section.

11.

PREGNANCY Pregnancy Category X (see CONTRAINDICATIONS and WARNINGS sections).

12.

NURSING MOTHERS Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement.

In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk.

If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

13.

PEDIATRIC USE Safety and efficacy of desogestrel and ethinyl estradiol tablets have been established in women of reproductive age.

Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older.

Use of this product before menarche is not indicated.

14.

GERIATRIC USE This product has not been studied in women over 65 years of age and is not indicated in this population.

Adverse reactions

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis and venous thrombosis with or without embolism Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives: Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow

Amenorrhea Temporary infertility after discontinuation of treatment Edema/fluid retention Melasma/chloasma which may persist Breast changes: tenderness, pain, enlargement, and secretion Decrease in serum folate levels Exacerbation of porphyria Aggravation of varicose veins Change in weight or appetite (increase or decrease) Change in cervical erosion and secretion Possible diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine headache Rash (allergic) Mood changes, including depression Vaginitis, including candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses Exacerbation of systemic lupus erythematosus Exacerbation of chorea Anaphylactic/anaphylactoid reactions, including urticaria, angioedema

and severe reactions with respiratory and circulatory symptoms The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Dysmenorrhea Pancreatitis Erythema nodosum

Hemorrhagic eruption

Impaired renal function Hemolytic uremic syndrome Acne Changes in libido Colitis Budd-Chiari Syndrome Optic neuritis, which may lead to partial or complete loss of vision

Usage information

Dosing and administration

DOSAGE & ADMINISTRATION To achieve maximum contraceptive effectiveness, CAZIANT® Tablets must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours.

CAZIANT® Tablets may be initiated using either a Sunday start or a Day 1 start.

NOTE: Each tablet dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen.

Six different “day label strips” are provided with each tablet dispenser in order to accommodate a Day 1 start regimen.

In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days.

DURING THE FIRST CYCLE OF USE: IMPORTANT: The possibility of ovulation and conception prior to initiation of use of CAZIANT® Tablets should be considered.

A woman can begin to take CAZIANT® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1

Start).

When switching from another oral contraceptive, CAZIANT® should be started on the same day that a new pack of the previous oral contraceptive would have been started.

SUNDAY START When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used until after the first 7 consecutive days of taking CAZIANT®. Using a Sunday start, tablets are taken daily without interruption as follows:

The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day).

Tablets are then taken sequentially following the arrows marked on the dispenser.

One white tablet is taken daily for 7 days, followed by 1 light blue tablet daily for 7 days, 1 blue tablet daily for 7 days, and then 1 green (inactive) tablet daily for 7 days.

For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green tablet.

[If switching from a Sunday Start oral contraceptive, the first CAZIANT® tablet should be taken on the second Sunday after the last tablet of a 21 day oral contraceptive regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]

If a patient misses one active tablet in Weeks 1, 2 or 3, she should take the missed tablet as soon as she remembers.

If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack.

The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after missing pills.

If the patient misses 2 consecutive blue (active) tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should keep taking 1 active tablet daily until the next Sunday.

On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack the same day.

The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling (" How to Take the Pill " section).

DAY 1 START Counting the first day of menstruation as “Day 1”, the first white tablet should be taken on the first day of menstrual bleeding.

Tablets are then taken sequentially without interruption as follows:

One white tablet daily for 7 days, then 1 light blue tablet daily for 7 days, followed by 1 blue tablet daily for 7 days and then 1 green (inactive) tablet daily for 7 days.

For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green tablet.

[If switching directly from another oral contraceptive, the first white tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]

If a patient misses 1 active tablet in Weeks 1, 2 or 3, she should take the missed tablet as soon as she remembers.

If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack.

The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills.

If the patient misses 2 consecutive blue tablets in the third week or if the patient misses 3 or more active tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day.

The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after she restarts her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling (" How to Take the Pill " section).

ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS If Spotting or Breakthrough Bleeding Occurs Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives.

In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered.

In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy.

If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem.

Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of CAZIANT® in the E vent of a M issed M enstrual P eriod: If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and CAZIANT® use should be discontinued if pregnancy is confirmed.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

CAZIANT® should be discontinued if pregnancy is confirmed.

Use of CAZIANT® Postpartum The use of CAZIANT® for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast feed.

When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease.

See also PRECAUTIONS for “Nursing Mothers”).

If the patient starts on

CAZIANT® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 consecutive days.

More information

Category Value
Authorisation number ANDA077182
Orphan designation No
Product NDC 61786-385
Date Last Revised 28-07-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 748797
Marketing authorisation holder REMEDYREPACK INC.