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Ortho Cyclen Birth Control
A prescription is required for this product.
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Product Code: Z9236
Purchase:
| 3 months - 21 Tablets | - | $61.00 | BUY | | 3 months - 28 Tablets | - | $61.00 | BUY |
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Description
Pharmacology
The primary mechanism of action 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.
Indications
Conception control.
Contraindications
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.
Warnings
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, non-smoking 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.
Discontinue medication at the earliest manifestation of:
Thromboembolic and cardiovascular disorders such as: thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis.
Conditions that predispose to venous stasis and to vascular thrombosis (e.g., immobilization after accidents or confinement to bed during long-term illness). Other non-hormonal methods of contraception should be used until regular activities are resumed. For use of oral contraceptives when surgery is contemplated, see Precautions.
Visual defects, partial or complete.
Papilledema, or ophthalmic vascular lesions.
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 follow-up visit should be 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 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 requires discontinuance 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 alternative 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.
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—Post-surgery: 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 Table 1 and Table 2). 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, including herbal preparations/remedies, before oral contraceptives are prescribed.
The metabolism of oral contraceptives may be influenced by various drugs and herbal preparations including St. John's wort. Of potential clinical importance are drugs and herbal supplements that are known to affect the induction of enzymes that are responsible for the degradation of contraceptive steroid hormones (e.g., St. John's wort). Decreased effectiveness of the estrogenic component of oral contraceptives may result in spotting, breakthrough bleeding and possible pill failure. It is possible that induction of these enzymes may lead to reductions in the circulating levels of the progestational component of Cyclen tablets. In actual practice, reduced efficacy has been associated with concomitant use of St. John's wort.
Some drugs, such as cholestyramine, may impair the enterohepatic circulation of estrogens, and may result in hastened elimination and impaired effectiveness.
Some data has indicated a decrease in the serum levels of the estrogenic component of oral contraceptives in conjunction with topiramate. Therefore, the efficacy of low-dose oral contraceptives may be reduced with concomitant use. Patients should be encouraged to report any change in bleeding patterns.
Some protease inhibitors and some antiretroviral agents have been found to either increase (e.g., indinavir) or decrease (e.g., ritonavir) circulating levels of combination hormonal contraceptives.
Adverse Effects
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.
Treatment
In case of overdosage 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
Information for the Patient on How to Take the Birth Control Pill:
Read these directions:
before you start taking your pills, and
any time you are not sure what to do.
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).
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 back-up in case pills are forgotten while you are getting used to taking them.
When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
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.
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.
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.
Always be sure you have ready:
another kind of birth control (such as latex condoms and spermicidal foam or gel) to use as a back-up in case you miss pills, and
an extra, full pack of pills.
If you experience vomiting or diarrhea, or if you take certain medicines, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
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.
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.
Directions for 21-Day and 28-Day Pill Packs:
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.
If you are using a:
21-Day Pill Pack: With this type of birth control pill, you are on pills for 21 days and off pills for 7 days. You must not be off the pills for more than 7 days in a row.
Take 1 pill at approximately the same time every day for 21 days; do not take a pill 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.)
28-Day Pill Pack: With this type of birth control pill, you take 21 pills that contain hormones and 7 pills that contain no hormones.
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 Discreet package for both 21-day and 28-day packs. Follow these instructions carefully.
For Day 1 start: Label the Discreet Package by selecting the day label that starts with Day 1 of your menstrual period (the first day of menstruation is Day 1). For example, if your first day of menstruation is Tuesday, attach the day label that begins with TUE in the space provided.
or
For Day 5 start: Label the Discreet Package by selecting the day label that starts with the day that is 5 days after your period begins. (Count 5 days including the first day of menstruation.) For example, if your first day of menstruation is Saturday, place the day label that starts with WED in the space provided.
or
For Sunday start: No day label is required. The Discreet Package is printed for a Sunday start. (The first Sunday after your period begins, or, if your period starts on Sunday, start that same day.)
Place the day label in the space where you see the words “Place day label here”. Having the Discreet Package labelled with the days of the week will help remind you to take your pill every day.
To begin taking your pills, start with the pill inside the red circle (where you see the word START). This pill should correspond to the day of the week that you are taking your first pill. To remove the pill, push through the back of the Discreet Package.
On the following day, take the next pill in the same row, always proceeding from left to right (→). Each row will always begin on the same day of the week.
What to do during the month:
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 such as 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.
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.
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