Ortho Tri-Cyclen

Ortho Tri-Cyclen Information

Other Common Names: Cilest, Ortho-Cyclen, Evra Patch

Indication:

Ortho-Cyclen and Ortho Tri-Cyclen Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Ortho Tri-Cyclen is also indicated for the treatment of moderate acne vulgaris in females, aged 15 and above, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications.

In simple terms:

Oral contraceptives, also known as "birth control pills" or "the pill," are taken to prevent pregnancy. Tri-Cyclen Tablets may also be taken to treat moderate acne in females who are able to use the pill. When taken correctly to prevent pregnancy, oral contraceptives have a failure rate of less than 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.

How Does Ortho Tri-Cyclen Work?

Oral Contraception

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus(which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate, the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity.Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin(SHBG), resulting in lower serumtestosterone.

Acne

Acne is a condition with a multifactorial etiology. The combination of ethinyl estradiol and norgestimate may increase sex hormone binding globulin (SHBG) and decrease free testosterone resulting in a decrease in the severity of facial acne in otherwise healthy women with this skin condition.

Ortho Tri-Cyclen Ingredients and Composition

How To Take Ortho Tri-Cyclen and Ortho Tri-Cyclen Dosage and Administration

To achieve maximum contraceptive effectiveness, Ortho Tri-Cyclen Tablets and Ortho-Cyclen Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Ortho Tri-Cyclen and Ortho-Cyclen are available in the DIALPAK Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.

21-Day Regimen (Sunday Start)

When taking Ortho Tri-Cyclen 21 and Ortho-Cyclen 21, the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet is taken on that day. One tablet is taken daily for 21 days. For subsequent cycles, no tablets are taken for 7 days, then a tablet is taken the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

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

21-Day Regimen (Day 1 Start)

The dosage of Ortho Tri-Cyclen 21 and Ortho-Cyclen 21, for the initial cycle of therapy is one tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1." For subsequent cycles, no tablets are taken for 7 days, then a new course is started of one tablet a day for 21 days. The dosage regimen then continues with 7 days of no medication, followed by 21 days of medication, instituting a three-weeks-on, one-week-off dosage regimen.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing Ortho Tri-Cyclen pills.

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

28-Day Regimen (Sunday Start)

When taking Ortho Tri-Cyclen 28 and Ortho-Cyclen 28 the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one green tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of Ortho Tri-Cyclen administration.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing Ortho Tri-Cyclen pills.

28-Day Regimen (Day 1 Start)

The dosage of Ortho Tri-Cyclen 28 and Ortho-Cyclen 28, for the initial cycle of therapy is one active tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one green tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

The use of Ortho Tri-Cyclen and Ortho-Cyclen for contraception may be initiated 4 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.

Dosage of Ortho Tri-Ciclen for Acne Treatment

The timing of initiation of dosing with OOrtho Tri-Cyclen for acne should follow the guidelines for use of OOrtho Tri-Cyclen as an oral contraceptive. The dosage regimen for Ortho Tri-Cyclen for treatment of facial acne, as available in a DIALPAK Tablet Dispenser, utilizes a 21-day active and a 7-day placebo schedule. Take one active tablet daily for 21 days followed by one green tablet for 7 days. After 28 tablets have been taken, a new course is started the next day.

If you suspect a Ortho Tri-Cyclen Overdose

Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health care provider or pharmacist.

If You Miss a Dose of Ortho Tri-Cyclen

Ortho Tri-Cyclen:

If you miss 1 white, light blue, or blue "active" pill:

Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.

You do not need to use a back-up birth control method if you have sex.

If you miss 2 white or light blue "active" pills in a row in week 1 or week 2 of your pack:

Take 2 pills on the day you remember and 2 pills the next day.

Then take 1 pill a day until you finish the pack.
You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 2 blue "active" pills in a row in the 3rd week:

If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.

You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 3 OR MORE white, light blue, or blue "active" pills in a row (during the first 3 weeks):

If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.

You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

Ortho Tri-Cyclen:

If you miss 1 blue "active" pill:

Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.

You do not need to use a back-up birth control method if you have sex.

If you miss 2 blue "active" pills in a row in week 1 OR week 2 of your pack:

Take 2 pills on the day you remember and 2 pills the next day.

Then take 1 pill a day until you finish the pack.
You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 2 blue "active" pills in a row in THE 3RD week:

If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.

You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 3 OR MORE blue "active" pills in a row (during the first 3 weeks):

If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.

You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

Contraindications to Ortho Tri-Cyclen

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
Known or suspected carcinoma of the breast
Carcinoma of the endometrium or other known or suspected estrogendependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Hepatic adenomas or carcinomas
Known or suspected pregnancy

Ortho Tri-Cyclen Side Effects

Ortho Tri-Cyclen Precautions and Contraindications

Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physi-cal examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. Your pharmacist should have given you the detailed patient information labeling which gives you further information which you should read and discuss with your health care provider.

If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:

Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
Pain in the calf (indicating a possible clot in the leg)
Crushing chest pain or heaviness in the chest (indicating a possible heart attack)
Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
Sudden partial or complete loss of vision (indicating a possible clot in the eye)
Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care provider to show you how to examine your breasts)
Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)

Ortho Tri-Cyclen Drug Interactions

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine, and possibly with griseofulvin, ampicillin and tetracyclines.

Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital), anticonvulsants such as carbamazepine (Tegretol is one brand of this drug), phenytoin (Dilantin is one brand of this drug), phenylbutazone (Butazolidin is one brand) and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective.

Ortho Tri-Cyclen Experiences and Results

Oral contraceptives are highly effective. The table below 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use

Method	Lowest Expected	Typical
No Contraceptive	85	85
Oral contraceptives	3
combined	0.1	N/ A
progestin only	0.5	N/ A
Diaphragm with spermicidal cream or jelly	6	18
Spermicides alone (foams, creams, gels, jellies, vaginal suppositories, and vaginal film)	6	21
Vaginal sponge nulliparous	9	18
parous	20	36
Implant	0.09	0.09
Injection: depot medroxyprogesterone acetate	0.3	0.3
IUD progesterone	1.5	2.0
copper T 380A	0.6	0.8
Condom without spermicides female	5	21
male	3	12
Cervical Cap with spermicidal cream or jelly nulliparous	9	18
parous	26	36
Periodic abstinence (all methods)	1- 9	20
Female sterilization	0.4	0.4
Male sterilization	0.10	0.15

Ortho Tri-Cyclen Clinical Trials and Studies

Oral Contraceptives and Smoking

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Taking Ortho Tri-Cyclen during Pregnancy or Breast-feeding

If you are breast feeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breast feeding. You should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely.

Additional Notes

Ortho Tri-Cyclen Tablets Ortho-Cyclen Tablets (norgestimate/ethinyl estradiol) Prescribing Information Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.