Ortho-Cept (Desogestrel / Ethinyl Estradiol)

ORTHO-CEPT®

Janssen-Ortho

Desogestrel – Ethinyl Estradiol

Oral Contraceptive

Action And Clinical Pharmacology: The primary mechanism of action of Ortho-Cept tablets is an inhibition of ovulation. Additionally, other effects caused by the treatment (e.g., alteration of the endometrium and the thickening of the cervical mucus), appear to interfere with implantation and conception. tag_IndicationsIndications

Indications And Clinical Uses: Conception control.

Contra-Indications: History of/or actual thrombophlebitis or thromboembolic disorders. History of/or actual cerebrovascular disorders. History of/or actual myocardial infarction or coronary arterial disease. Active liver disease or history of/or actual benign or malignant liver tumors. Known or suspected carcinoma of the breast. Known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal vaginal bleeding. Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields. When pregnancy is suspected or diagnosed.

Manufacturers’ Warnings In Clinical States: Predisposing Factors for Coronary Artery Disease: Cigarette smoking increases the risk of serious cardiovascular side effects and mortality. Birth control pills increase this risk, especially with increasing age. Convincing data are available to support an upper age limit of 35 years for oral contraceptive use by women who smoke.

Other women who are independently at high risk for cardiovascular disease include those with diabetes, hypertension, abnormal lipid profile, or a family history of these. Whether oral contraceptives accentuate this risk is unclear.

In low-risk, nonsmoking women of any age, the benefits of oral contraceptive use outweigh the possible cardiovascular risks associated with low dose formulations. Consequently, oral contraceptives may be prescribed for these women up to the age of menopause.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in oral contraceptive users over 35 years of age. Women should be counselled not to smoke.

Thromboembolic and Thrombotic Disease: An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Data from case control and cohort studies report that oral contraceptives containing desogestrel (Ortho-Cept Tablets contain desogestrel) are associated with a 2-fold increase in the risk of venous thromboembolic disease as compared with other low-dose (containing less than 50 µg of estrogen) pills containing other progestins. According to these studies, this 2-fold risk increases the yearly occurrence of venous thromboembolic disease by about 10 to 15 cases per 100 000 women.

Earlier case control studies on older formulations have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep venous thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. The risk of thromboembolic disease associated with oral contraceptives is not related to length of use and disappears after pill use is stopped.

Discontinue medication at the earliest manifestation of:

A. Thromboembolic and cardiovascular disorders such as: thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis.

B. Conditions which predispose to venous stasis and to vascular thrombosis, (e.g., immobilization after accidents or confinement to bed during long-term illness). Other nonhormonal methods of contraception should be used until regular activities are resumed. For use of oral contraceptives when surgery is contemplated, see Precautions.

C. Visual defects, partial or complete.

D. Papilledema, or ophthalmic vascular lesions.

E. Severe headache of unknown etiology or worsening of pre-existing migraine headache.

Precautions: Physical Examination and Follow-up: Before oral contraceptives are used, a thorough history and physical examination should be performed, including a blood pressure determination. Breasts, liver, extremities and pelvic organs should be examined. A Papanicolaou smear should be taken if the patient has been sexually active.

The first followup visit should be done 3 months after oral contraceptives are prescribed. Thereafter, examinations should be performed at least once a year, or more frequently if indicated. At each annual visit, examination should include those procedures that were done at the initial visit as outlined above or per recommendations of the Canadian Workshop on Screening for Cancer of the Cervix. Their suggestion was that, for women who had 2 consecutive negative Pap smears, screening could be continued every 3 years up to the age of 69.

Pregnancy: Oral contraceptives should not be taken by pregnant women. However, if conception accidentally occurs while taking the pill, there is no conclusive evidence that the estrogen and progestin contained in the oral contraceptive will damage the developing child.

Lactation: In breast-feeding women, the use of oral contraceptives results in the hormonal components being excreted in breast milk and may reduce its quantity and quality. If the use of oral contraceptives is initiated after the establishment of lactation, there does not appear to be any effect on the quantity and quality of the milk. There is no evidence that low dose oral contraceptives are harmful to the nursing infant.

Hepatic Function: Patients who have had jaundice, including a history of cholestatic jaundice during pregnancy, should be given oral contraceptives with great care and under close observation.

The development of severe generalized pruritus or icterus requires that the medication be withdrawn until the problem is resolved.

If a patient develops jaundice that proves to be cholestatic in type, the use of oral contraceptives should not be resumed. In patients taking oral contraceptives, changes in the composition of the bile may occur and an increased incidence of gallstones has been reported.

Hepatic nodules (adenoma and focal nodular hyperplasia) have been reported, particularly in long-term users of oral contraceptives. Although these lesions are extremely rare, they have caused fatal intra-abdominal hemorrhage and should be considered in women with an abdominal mass, acute abdominal pain or evidence of intra-abdominal bleeding.

Hypertension: Patients with essential hypertension whose blood pressure is well controlled may be given oral contraceptives but only under close supervision. If a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during the administration of the drug, cessation of medication is necessary.

Migraine and Headache: The onset or exacerbation of migraine or the development of headache of a new pattern, that is recurrent, persistent or severe, requires discontinuation of oral contraceptives and evaluation of the cause.

Diabetes: Current low dose oral contraceptives exert minimal impact on glucose metabolism. Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any worsening of carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given oral contraceptives. Young diabetic patients whose disease is of recent origin, well-controlled and not associated with hypertension or other signs of vascular disease such as ocular fundal changes, should be monitored more frequently while using oral contraceptives.

Ocular Disease: Patients who are pregnant or are taking oral contraceptives may experience corneal edema that may cause visual disturbances and changes in tolerance to contact lenses, especially of the rigid type. Soft contact lenses usually do not cause disturbances. If visual changes or alterations in tolerance to contact lenses occur, temporary or permanent cessation of wear may be advised.

Breasts: Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, nulliparity and late age at first full-term pregnancy. The identified groups of women that may be at increased risk of developing breast cancer before menopause are long-term users of oral contraceptives (more than 8 years) and starters at an early age. In a few women, the use of oral contraceptives may accelerate the growth of an existing but undiagnosed breast cancer. Since any potential increased risk related to oral contraceptive use is small, there is no reason to change prescribing habits at present.

Women receiving oral contraceptives should be instructed in self-examination of their breasts. Their physicians should be notified whenever any masses are detected. A yearly clinical breast examination is also recommended because, if a breast cancer should develop, estrogen-containing drugs may cause a rapid progression.

Vaginal Bleeding: Persistent irregular vaginal bleeding requires assessment to exclude underlying pathology.

Fibroids: Patients with fibroids (leiomyomata) should be carefully observed. Sudden enlargement, pain or tenderness require discontinuation of the use of oral contraceptives.

Emotional Disorders: Patients with a history of emotional disturbances, especially the depressive type, may be more prone to have a recurrence of depression while taking oral contraceptives. In cases of a serious recurrence, a trial of an alternate method of contraception should be made which may help to clarify the possible relationship. Women with premenstrual syndrome (PMS) may have a varied response to oral contraceptives, ranging from symptomatic improvement to worsening of the condition.

Laboratory Tests: Results of laboratory tests should be interpreted in light of the fact that the patient is on oral contraceptives. The following laboratory tests are modified.

A. Liver Function Tests: Bromsulphthalein Retention Test (BSP): moderate increase; AST and GGT: minor increase; alkaline phosphatase: variable increase; serum bilirubin: increased, particularly in conditions predisposing to or associated with hyperbilirubinemia.

B. Coagulation Tests: Factors II, VII, IX, X, XII and XIII: increased; Factor VIII: mild increase; platelet aggregation and adhesiveness: mild increase in response to common aggregating agents; fibrinogen: increased; plasminogen: mild increase; antithrombin III: mild decrease; prothrombin time: increased.

C. Thyroid Function Tests: Protein-bound Iodine (PBI): increased; Total Serum Thyroxine (T4): increased; Thyroid Stimulating Hormone (TSH): unchanged.

D. Adrenocortical Function Tests: plasma cortisol: increased.

E. Miscellaneous Tests: serum folate: occasionally decreased; glucose tolerance test: variable increase with return to normal after 6 to 12 months; insulin response: mild to moderate increase; c-Peptide response: mild to moderate increase.

Tissue Specimens: Pathologists should be advised of oral contraceptive therapy when specimens obtained from surgical procedures and Pap smears are submitted for examination.

Return to Fertility: After discontinuing oral contraceptive therapy, the patient should delay pregnancy until at least 1 normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative contraceptive method should be used during this time.

Amenorrhea: Women having a history of oligomenorrhea, secondary amenorrhea or irregular cycles may remain anovulatory or become amenorrheic following discontinuation of estrogen-progestin combination therapy.

Amenorrhea, especially if associated with breast secretion, that continues for 6 months or more after withdrawal, warrants a careful assessment of hypothalamic-pituitary function.

Thromboembolic Complications – Postsurgery: There is an increased risk of thromboembolic complications in oral contraceptive users after major surgery. If feasible, oral contraceptives should be discontinued and an alternative method substituted at least 1 month prior to major elective surgery. Oral contraceptive use should not be resumed until the first menstrual period after hospital discharge following surgery.

Drug Interactions: The concurrent administration of oral contraceptives with other drugs may result in an altered response to either agent (see Tables I and II). Reduced effectiveness of the oral contraceptive, should it occur, is more likely with the low-dose formulations. It is important to ascertain all drugs that a patient is taking, both prescription and nonprescription, before oral contraceptives are prescribed.

Refer to Oral Contraceptives 1994 (Chapter 8), Health Canada, for possible drug interactions with OCs.

Non-contraceptive Benefits of Oral Contraceptives: Several health advantages other than contraception have been reported.

1. Combination oral contraceptives reduce the incidence of cancer of the endometrium and ovaries.

2. Oral contraceptives reduce the likelihood of developing benign breast disease and, as a result, decrease the incidence of breast biopsies.

3. Oral contraceptives reduce the likelihood of development of functional ovarian cysts.

4. Pill-users have less menstrual blood loss and have more regular cycles, thereby reducing the chance of developing iron-deficiency anemia.

5. The use of oral contraceptives may decrease the severity of dysmenorrhea and premenstrual syndrome, and may improve acne vulgaris, hirsutism and other androgen-mediated disorders.

6. Oral contraceptives decrease the incidence of acute pelvic inflammatory disease and, thereby, reduce as well the incidence of ectopic pregnancy.

7. Oral contraceptives have potential beneficial effects on endometriosis.

Oral contraceptives do not protect against sexually transmitted diseases (STDs) including HIV/AIDS. For protection against STDs, it is advisable to use latex condoms in combination with oral contraceptives.

Adverse Reactions: An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives: thrombophlebitis, pulmonary embolism, mesenteric thrombosis, neuro-ocular lesions, (e.g., retinal thrombosis), myocardial infarction, cerebral thrombosis, cerebral hemorrhage, hypertension, benign hepatic tumors, gallbladder disease.

The following adverse reactions also have been reported in patients receiving oral contraceptives: Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or less of patients during the first cycle. Other reactions, as a general rule, are seen less frequently or only occasionally, as follows: gastrointestinal symptoms (such as abdominal cramps and bloating), breakthrough bleeding, spotting, change in menstrual flow, dysmenorrhea, amenorrhea during and after treatment, temporary infertility after discontinuance of treatment, edema, chloasma or melasma which may persist, breast changes (tenderness, enlargement and secretion), change in weight (increase or decrease), endocervical hyperplasias, possible diminution in lactation when given immediately postpartum, cholestatic jaundice, migraine, increase in size of uterine leiomyomata, rash (allergic), depression, reduced tolerance to carbohydrates, vaginal candidiasis, premenstrual-like syndrome, intolerance to contact lenses, change in corneal curvature (steepening), cataracts, optic neuritis, retinal thrombosis, changes in libido, chorea, changes in appetite, cystitis-like syndrome, rhinitis, headache, nervousness, dizziness, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, vaginitis, porphyria, impaired renal function, Raynaud’s phenomenon, auditory disturbances, hemolytic uremic syndrome, pancreatitis.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: In case of overdose or accidental ingestion by children, the physician should observe the patient closely although generally no treatment is required. Gastric lavage may be utilized if considered necessary.

Dosage And Administration: Information for the Patient on How to Take the Birth Control Pill:

1. Read these directions:

before you start taking your pills, and

any time you are not sure what to do.

2. Look at your pill pack to see if it has 21 or 28 pills:

21-Pill Pack: 21 active pills (with hormones) taken daily for 3 weeks, and then take no pills for 1 week or

28-Pill Pack: 21 active pills (with hormones) taken daily for 3 weeks, and then 7 “reminder” pills (no hormones) taken daily for 1 week.

Also check the pill pack for instructions on (1) where to start and (2) directions to take pills (see package insert for illustrations).

3. You may wish to use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use. This will provide a backup in case pills are forgotten while you are getting used to taking them.

4. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.

5. Many women have spotting or light bleeding or may feel sick to their stomach during the first 3 months on the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

6. Missing pills also can cause some spotting or light bleeding, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take 2 pills to make up for missed pills.

7. If you miss pills at any time, you could get pregnant. The greatest risks for pregnancy are:

when you start a pack late, or

when you miss pills at the beginning or at the very end of the pack.

8. Always be sure you have ready:

another kind of birth control (such as latex condoms and spermicidal foam or gel) to use as a backup in case you miss pills, and

an extra, full pack of pills.

9. If you experience vomiting or diarrhea, or if you take certain medicines, such as antibiotics, your pills may not work as well. Use a backup method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

10. If you forget more than 1 pill 2 months in a row, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.

11. If your questions are not answered here, call your doctor or clinic.

When to start the first pack of pills: Be sure to read these instructions:

before you start taking your pills, and

any time you are not sure what to do.

Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills. Your pills may be either a 21-day or a 28-day type.

A. 21-Day Combination: With this type of birth control pill, you are 21 days on pills with 7 days off pills. You must not be off the pills for more than 7 days in a row.

1. The first day of your menstrual period (bleeding) is Day 1 of your cycle. The pills may be started up to Day 6 of your cycle. Your starting day will be chosen in discussion with your doctor. You will always begin taking your pill on this day of the week. Your doctor may advise you to start taking the pills on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.

2. Take 1 pill at approximately the same time every day for 21 days. Then take no pills for 7 days. Start a new pack on the 8th day. You will probably have a period during the 7 days off the pill. (This bleeding may be lighter and shorter than your usual period.)

Instructions for Using Your DIALPAK Tablet Dispenser: Follow these instructions carefully: 21-Day Regimen: (see package insert for illustrations): If you have a refill ring of Ortho-Cept Tablets, you should insert it into your DIALPAK Tablet Dispenser. You do this by removing the empty foil ring and snapping in your new foil ring such that the tab on the side of the foil fits in the notch in the ribbed outer ring of the plastic. You are now ready to align your package.

Note: Be sure that the foil ring is secure in the package before proceeding further.

Please make sure that your DIALPAK Tablet Dispenser is aligned such that the Black Day Arrow in the centre of the plastic points to the Black Day Arrow at the top of the package (towards the cover) as shown in the diagram. To align the Black Day Arrows, turn the ribbed outer ring to the right.

Your starting day will be chosen in discussion with your doctor. You should always begin taking your tablets on this day of the week. To set the package to the day you and your doctor selected, a calendar label is enclosed. To put the label in place, identify your correct starting day, locate that day on the label, line that day up with the pill to which the Black Day Arrow is pointing, remove the label from the backing and press the label over the printed calendar on the centre of the plastic. The first orange pill you will take is indicated by the Black Day Arrows. Push down on your first orange tablet with your thumb or forefinger. The tablet will come out through a hole in the back of the package. To take your second and subsequent tablets, turn the ribbed outer ring to the right. Take 1 tablet every day for 21 days, completing all orange tablets. After you have taken all of your tablets, insert your new refill ring as per the above instructions, wait 7 days and begin your next package on your chosen starting day, whether you have finished menstruating or not. Always remember to set the starting day of each new package to the day chosen by you and your doctor.

B. 28-Day Combination: With this type of birth control pill, you take 21 pills which contain hormones and 7 pills which contain no hormones.

1. The first day of your menstrual period (bleeding) is Day 1 of your cycle. The pills may be started up to Day 6 of your cycle. Your starting day will be chosen in discussion with your doctor. You will always begin taking your pill on this day of the week. Your doctor may advise you to start taking the pills on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.

2. Take 1 pill at approximately the same time every day for 28 days. Begin a new pack the next day, not missing any days on the pills. Your period should occur during the last 7 days of using that pill pack.

Instructions for Using Your DIALPAK Tablet Dispenser: Follow these instructions carefully: 28-Day Regimen: (see package insert for illustrations): Always complete the orange tablets before taking the green tablets.

If you have a refill ring of Ortho-Cept Tablets, you should insert it into your DIALPAK Tablet Dispenser. You do this by removing the empty foil ring and snapping in your new foil ring such that the tab on the side of the foil fits in the notch in the ribbed outer ring of the plastic. You are now ready to align your package.

Note: Be sure that the foil ring is secure in the package before proceeding further.

Please make sure that your DIALPAK Tablet Dispenser is aligned such that the Black Day Arrow in the center of the plastic points to the Black Day Arrow at the top of the package (towards the cover) as shown in the diagram. To align the Black Day Arrows, turn the ribbed outer ring to the right. The Black Day Arrows should be pointing at the first orange tablet to the left of the green tablets.

Your starting day will be chosen in discussion with your doctor. You should always begin taking your tablets on this day of the week. To set the package to the day you and your doctor selected, a calendar label is enclosed. To put the label in place, identify your correct starting day, locate that day on the label, line that day up with the pill to which the Black Day Arrow is pointing, remove the label from the backing and press the label over the printed calendar on the center of the plastic. The first orange tablet you will take is to the left of the green tablets and between the Black Day Arrows. Push down on your first orange tablet with your thumb or forefinger. The tablet will come out through a hole in the back of the package. To take your second and subsequent tablets, turn the ribbed outer ring to the right. Take 1 tablet every day, first completing all 21 orange tablets, and finally the 7 green tablets. After you have taken all of your tablets, insert your new refill ring as per the above instructions. Begin your next package the very next day, your chosen starting day, whether you have finished menstruating or not. Always remember to set the starting day of each new package to the day chosen by you and your doctor.

What to do during the month:

1. Take a pill at approximately the same time every day until the pack is empty.

Try to associate taking your pill with some regular activity like eating a meal or going to bed.

Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).

Do not skip pills even if you do not have sex very often.

2. When you finish a pack:

21 pills: Wait 7 days to start the next pack. You will have your period during that week.

28 pills: Start the next pack on the next day. Take 1 pill every day. Do not wait any days between packs.

What to do if you miss pills: Table III outlines the actions you should take if you miss 1 or more of your birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack.

Note: 28-Day Pack: If you forgot any of the 7 “reminder” pills (without hormones) in Week 4, just safely dispose of the pills you missed. Then keep taking 1 pill each day until the pack is empty. You do not need to use a backup method.

Always be sure you have on hand:

a backup method of birth control (such as latex condoms and spermicidal foam or gel) in case you miss pills, and

•an extra, full pack of pills.

If you forget more than 1 pill 2 months in a row, talk to your doctor or clinic about ways to make pill-taking easier or about using another method of birth control.

Availability And Storage: Each orange tablet, unscored with D 150 engraved on each side, contains: desogestrel 0.15 mg and ethinyl estradiol 0.03 mg. In the 28-day regimen, the green tablet, engraved with ORTHO P on each side, contains: inert ingredients. Nonmedicinal ingredients: Orange tablets: colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxide (red and yellow), lactose, polyethylene glycol, povidone, starch, stearic acid, talc, titanium dioxide and vitamin E; Green tablets: hydroxypropyl methylcellulose, indigotin blue or FD&C Blue No. 1, iron oxide (red and yellow), lactose, magnesium stearate, polyethylene glycol, starch, talc and titanium dioxide. DIALPAK Tablet Dispenser Units and Refill Packages 21-day (21 active tablets) and 28 days (21 active and 7 inert tablets). Store between 15 and 30°C. Leave contents in protective packaging until time of use.

ORTHO-CEPT® Janssen-Ortho Desogestrel – Ethinyl Estradiol Oral Contraceptive

Connected Diseases :

Pregnancy / Birth Control

General Information Description: Pregnancy (Latin – graviditas) is a special condition of a woman’s body, at which her developing reproductive organs contain a developing embryo…