Generic Levora (Levonorgestrel ethinyl estradiol 0.1mg + 0.02/0.15mg + 0.03mg)
CONTRACEPTIVE PRODUCTS
Indications
Contraceptive: For the prevention of pregnancy. Start new patients on preparations containing
Emergency contraception: For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain efficacy, the first dose should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
Acne vulgaris (Ortho Tri-Cyclen only): For the treatment of moderate acne vulgaris in females > 15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
Administration and Dosage
Product choice: Only low-dose pills should be routinely used now; there is rarely a need for > 50 mcg estrogen component tablets.
Sunday-Stan packaging: If the instructions recommend starting the regimen on Sunday, take the first tablet on the first Sunday after menstruation begins. If menstruation begins on Sunday, take the first tablet on that day.
21-Day regimen: Day 1 of the cycle is the first day of menstrual bleeding. Take 1 tablet daily for 21 days, beginning on day 5 of cycle. No tablets are taken for 7 days; whether bleeding has stopped or not, start a new course of 21 days.
28-Day regimen: To eliminate the need to count the days between cycles, some products contain 7 inert or iron-containing tablets to permit continuous daily dosage during the entire 28-day cycle. Take the 7 tablets on the last 7 days of the cycle.
Biphasic and triphasic OCs: Follow instructions on the dispensers or packs. As with the monophasic OCs, 1 tablet is taken each day; however, as the color of the tablet changes, the strength of the tablet also changes (i.e., the estrogen/progestin ratio varies).
Missed dose:
One tablet - Take it as soon as remembered, or take 2 tablets the next day; alternatively take 1 tablet, discard the other missed tablet, continue as scheduled and use another form of contraception for the 7 days after the pills missed, preferably for the remainder of the cycle.
Two consecutive tablets - Take 2 tablets as soon as remembered with the next pill at the usual time or take 2 tablets/day for the next 2 days, then resume the regular schedule. Use an additional form of contraception for the 7 days after pills are missed, preferably for the remainder of the cycle.
Three consecutive tablets - Begin a new compact of tablets, starting on day 1 of the cycle after the last pill was taken or starting 7 days after the last tablet was taken. Emergency contraception: If a positive pregnancy result is obtained, advise the patient not to take the pills in the kit.
Take the initial 1 (Plan B) or 2 (Preven) pills as soon as possible but within 72 hours of unprotected intercourse. This is followed by the second dose of 1 (Plan B) or 2 (Preven) pills 12 hours later. Emergency contraception can be used at any time during the menstrual cycle. If the user vomits
Contraception:
Progestin-only - One tablet every day at the same time. Administration is continuous, with no interruption between pill packs. Every time a pill is taken late, especially if a pill is missed, pregnancy is more likely.
Missed dose: If the patient is > 3 hours late or misses > 1 tablet, she should take a missed pill as soon as remembered, then go back to taking progestin-only pills (POPs) at the regular time, but be sure to use a backup method (such as a condom or spermicide) every time she has sexual intercourse for the next 48 hours.
Acne: The timing of dosing with Ortho Tri-Cyclen for acne should follow the guidelines for use of Ortho Tri-Cyclen as an ОС. The dosage regimen for treatment of facial acne uses a 21-day active and a 7-day inert schedule. Take 1 active tablet daily for 21 days followed by 1 inert for 7 days. After 28 tablets have been taken, a new course is started the next day.
Postpartum administration: Postpartum administration in non-nursing mothers may begin at the first postpartum examination (4>to 6 weeks), regardless of whether spontaneous menstruation has occurred. Also, start no earlier than 4 to 6 weeks after a mid-trimester pregnancy termination.
Switching pills: If switching from the combined pills to POPs, take the first POP the day after the last active combined pill is finished. Do not take any of the 7 inactive pills from the combined pill pack. Many women have irregular periods after switching to POPs; this is normal and to be expected. If switching from POPs to the combined pills, take the first active combined pill on the first day of menses, even if the POP pack is not finished. If switching to another brand of POPs, start the new brand any time. If breastfeeding, switch to another method of birth control at any time, except do not switch to the combined pills until breastfeeding is stopped or until > 6 months after delivery.
Dosage adjustments:
Progestin-only products: Administer daily, starting on the first day of menstruation. Take 1 tablet at the same time each day, every day of the year.
Postpartum administration ~ May be initiated no earlier than 4 weeks postpartum; however, consider the increased risk of thromboembolic disease associated with the postpartum period. Missed dose -
One tablet: Take as soon as remembered, then take next tablet at regular time. Two consecutive tablets: Do not take the missed tablets; discard and take the next tablet at the regular time (Micronor and Nor-Q.D.), or take 1 of the missed tablets, discard the other and take daily tablet at usual time (Ovrette).
Three consecutive tablets: Discontinue immediately. Use an additional method of contraception if > 2 tablets are missed until menses appears or pregnancy is ruled out. If menses does not occur within 45 days, regardless of circumstances, discontinue drug, use a non-hormonal method of contraception, and rule out pregnancy. Because of the slightly higher failure rate of the progestin-only products, a more conservative approach is to discontinue the regimen if only 1 tablet is missed and use other non-hormonal contraceptive methods until menses occurs or pregnancy is ruled out.
Patch:
Use - This system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 days total). Week 4 is patch-free. Withdrawal bleeding is expected to begin during this time.
Apply every new patch on the same day of the week. This day is known as the "Patch Change Day."
On the day after week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7 day patch-free interval between dosing cycles. If there are > 7 patch-free days, the woman may not be protected from pregnancy and back-up contraception (e.g., condoms, spermicide, diaphragm) must be used for 7 days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If intercourse has occurred during such an extended patch-free interval, consider the possibility of fertilization.
The patient must choose 1 option:
First day start - For first day start, the woman should apply her first patch during the first 24 hours of her menstrual period.
If therapy starts after day 1 of the menstrual cycle, a non-hormonal back-up contraceptive (e.g., condoms, spermicide, diaphragm) should be used concurrently for the first 7 consecutive days of the first treatment cycle.
Sunday start - For Sunday start, the woman should apply her first patch on the first Sunday after her menstrual period starts. She must use back-up contraception for the first week of her first cycle.
If the menstrual period begins on a Sunday, the first patch should be applied on that day and no back-up contraception is needed.
Application - Apply the patch to clean, dry, intact, healthy skin on the buttock, abdomen, upper outer arm, or upper torso in a place where it will not be tubbed by tight clothing. The patch should not be placed on skin that is red, irritated, or cut, nor should it be placed on the breasts.
To prevent interference with the adhesive properties of the patch, no topical products should be applied to the skin area where the patch is or will be placed.
Patch changes may occur at any time on the change day. Apply each new patch to a new spot on the skin to help avoid irritation, although they may be kept within the same anatomic area.
If a patch is partially or completely detached -
For
For > 1 day (> 24 hours) or if the woman is not sure how long the patch has been detached: The woman may not be protected from pregnancy. She should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. There is now a new "day 1" and a new "patch change day." Back-up contraception (e.g., condoms, spermicide, diaphragm) must be used for the first week of the new cycle. Do not reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has previously become loose or fallen off. If a patch cannot be reapplied, a new patch should be applied immediately. Do not use supplemental adhesives or wraps to hold the patch in place.
If the woman forgets to change her patch -
At the start of any patch cycle (week 1/day 1): She may not be protected from pregnancy. She should apply the first patch of her new cycle as soon as she remembers. There is now a new "patch change day" and a new "day 1." The woman must use back-up contraception (e.g., condoms, spermicide, diaphragm) for the first week of the new cycle.
In the middle of the patch cycle (week 2/day 8 or week 3/day 15):
For I or 2 days (up to 48 hours) - She should apply a new patch immediately. The next patch should be applied on the usual "patch change day." No back-up contraception is needed.
For > 2 days (> 48 hours) - She may not be protected from pregnancy. She should stop the current contraceptive cycle and start a new 4-week cycle immediately by putting on a new patch. There is now a new "patch change day" and a new "day 1." The woman must use back-up contraception for 1 week.
At the end of the patch cycle (week 4/day 22): If the woman forgets to remove her patch, she should take it off as soon as she remembers. The next cycle should be started on the usual "patch change day," which is the day after day 28. No back-up contraception is needed.
Change day adjustment - If the woman wishes to change her patch change day, she should complete her current cycle, removing the third patch on the correct day. During the patch-free week, she may select an earlier patch change day by applying a new patch on the desired day. In no case should there be > 7 consecutive patch-free days.
Switching from an oral contraceptive - Treatment with the norelgestromin/ethinyl estradiol transdermal patch should begin on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If therapy starts later than the first day of withdrawal bleeding, a non-hormonal contraceptive should be used concurrently for 7 days. If > 7 days elapse after taking the last active oral contraceptive tablet, consider the possibility of ovulation and conception.
Use after childbirth - Women who elect not to breastfeed should start contraceptive therapy with the norelgestromin/ethinyl estradiol transdermal patch no sooner than 4 weeks after childbirth. If a woman begins using the patch postpartum and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of the patch, and instruct her to use an additional method of contraception (e.g., condoms, spermicide, diaphragm) for the first 7 days.
Use after abortion or miscarriage - After an abortion or miscarriage that occurs in the first trimester, the patch may be started immediately. An additional method of contraception is not needed if the patch is started immediately. If use of the patch is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting the patch for the first time. In the meantime, advise her to use a non-hormonal contraceptive method. Ovulation may occur within 10 days after an abortion or miscarriage.
Do not start the patch any earlier than 4 weeks after a second trimester abortion or miscarriage. When the patch is used postpartum or post-abortion, the increased risk of thromboembolic disease must be considered.
Breakthrough bleeding or spotting - In the event of breakthrough bleeding or spotting (bleeding that occurs on the days that the patch is worn), continue treatment. If breakthrough bleeding persists longer than a few cycles, consider a cause other than the patch.
In the event of no withdrawal bleeding (bleeding that should occur during the patch-free week), resume treatment on the next scheduled change day. If the patch has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, consider the possibility of pregnancy, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. Discontinue the patch if pregnancy is confirmed.
Skin irritation - If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next change day. Only 1 patch should be worn at a time.
Missed menstrual period - If the woman has not adhered to the prescribed schedule, consider the possibility of pregnancy at the time of the first missed period. Discontinue hormonal contraceptive use if pregnancy is confirmed.
If the woman has adhered to the prescribed regimen and misses 1 period, she should continue using her contraceptive patches.
If the woman has adhered to the prescribed regimen and misses 2 consecutive periods, rule out pregnancy. Discontinue use of the patch if pregnancy is confirmed.
Pharmacology: Oral contraceptives (OCs) include estrogen-progestin combinations and progestin-only products.
Progestin-only - Progestin-only oral contraceptives prevent conception by suppressing ovulation in 50% of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle luteinizing hormone (LH) and follicle-stimulating hormone (FSH) peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Combination OCs - Combination OCs inhibit ovulation by suppressing the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Additionally, alterations in the genital tract, including cervical mucus (which inhibits sperm penetration) and the endometrium (which reduces the likelihood of implantation), may contribute to contraceptive effectiveness.
Contraceptive efficacy - If 100 women used emergency contraceptive pills (ECPs) correctly in 1 month, 2 women would become pregnant after a single act of intercourse. The use of ECPs results in a 75% reduction in the number of pregnancies expected if no ECPs were used after unprotected intercourse. Some clinical trials have shown that efficacy was greatest when ECPs were taken within 24 hours of unprotected intercourse, decreasing somewhat during each subsequent 24-hour period.
ECPs are not as effective as some other forms of contraception.
There are 3 types of combination OCs: Monophasic, biphasic, and triphasic. The biphasic and triphasic OCs are intended to deliver hormones in a fashion similar to physiologic processes.
Monophasic - Fixed dosage of estrogen to progestin throughout the cycle. Biphasic - Amount of estrogen remains the same for the first 21 days of the cycle. Decreased progestin : estrogen ratio in first half of cycle allows endometrial proliferation. Increased ratio in second half provides adequate secretory development.
Triphasic - Estrogen amount remains the same or varies throughout cycle. Progestin amount varies.
Pharmacokinetics:
Estrogens - Ethinyl estradiol is rapidly absorbed with peak concentrations attained in 1 to 2 hours. It undergoes considerable first-pass elimination. Mestranol is demethylated to ethinyl estradiol. Ethinyl estradiol is about 97% to 98% bound to plasma albumin. Half-life varies from 6 to 20 hours. It is excreted in bile and urine as conjugates, and undergoes some enterohepatic recirculation.
Progestins - Peak concentrations of norethindrone occur 0.5 to 4 hours after oral administration; it undergoes first-pass metabolism with an overall bioavailability around 65%. Levonorgestrel reaches peak concentrations between 0.5 to 2 hours, does not undergo a first-pass effect and is completely bioavailable. Desogestrel is rapidly and completely absorbed and converted into 3-keto-desogestrel, the biologically active metabolite. Relative bioavailability is about 84%. Maximum concentrations of the metabolite are reached at 1.4 ± 0.8 hours. Norgestimate is well absorbed; peak scrum concentrations are observed within 2 hours followed by a rapid decline to levels generally below assay within 5 hours. However, a major metabolite, 17-deacetyl norgestimate, appears rapidly in serum with concentrations greatly exceeding that of the parent. Both norethynodrel and ethynodiol diacetate are converted to norethindrone. Terminal half-life of the progestins are as follows: Norethindrone, 5 to 14 hours; levonorgestrel, 11 to 45 hours; desogestrel (metabolite), 38 ± 20 hours; norgestimate (metabolite), 12 to 30 hours. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.
Patch - Norelgestromin is the active progestin largely responsible for the progestational activity that occurs in women following application of norelgestromin/ethinyl estradiol transdermal patch. Following application of the product, norelgestromin and ethinyl estradiol rapidly appear in the serum, reach a plateau by 48 hours, and are maintained at an approximate steady state throughout the wear period. Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins. Because the patch is applied transdermally, first-pass metabolism (via the GI tract or liver) of norelgestromin and ethinyl estradiol that would be expected with oral administration is avoided. Following removal of patches, the elimination kinetics of norelgestromin and ethinyl estradiol were consistent for all studies with half-life values of 28 hours and 17 hours, respectively. The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways. For norelgestromin and ethinyl estradiol, increasing age, body weight, and body surface area each were associated with slight decreases in C5S and AUC values.
Contraindications
Thrombophlebitis; thromboembolic disorders; history of deep-vein thrombophlebitis; cerebral vascular disease; myocardial infarction; coronary artery disease; valvular heart disease with complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected breast carcinoma or estrogen-dependent neoplasia; carcinoma of endometrium or other; acute or chronic hepatocellular disease with abnormal liver function; hepatic adenomas/carcinomas; undiagnosed abnormal genital bleeding; known or suspected pregnancy; cholestatic jaundice of pregnancy/jaundice with prior pill use; hypersensitivity to any component of the product; acute liver disease.
Warnings
Cigarette smoking: Cigarette smoking increases the risk of cardiovascular side effects from OCs. This risk increases with age and with heavy smoking (> 15 cigarettes/day) and is quite marked in women > 35 years of age. Women who use OCs should not smoke.
Hyperkalemia: Yasmin contains the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. Yasmin should not be used in patients with conditions that predispose to hyperkalemia (e.g., renal insufficiency, hepatic dysfunction, adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium level checked during the first treatment cycle. Drugs that may increase serum potassium include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone antagonists, and NSAIDs.
Risks of ОС use: The use of OCs is associated with increased risk of thromboembolism, stroke, MI, hypertension, hepatic neoplasia, and gallbladder disease, although risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.
Mortality: Mortality associated with all methods of birth control is low and below that associated with childbirth, with the exception of ОС use in women > 35 who smoke and > 40 who do not smoke. However, the Fertility and Maternal Health Drugs Advisory Committee recommended that the benefits of low-dose ОС use by healthy non-smoking women > 40 years of age may outweigh the possible risks.
Thromboembolism: Be alert to the earliest symptoms of thromboembolic and thrombotic disorders. Should any of these occur or be suspected, discontinue the drug immediately.
MI - MI risk associated with ОС use is increased. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.
Long-term use - Data suggest that the increased risk of MI persists after discontinuation of long-term ОС use; the highest risk group includes women 40 to 49 years of age who used OCs for > 5 years.
Smoking-Smoking in combination with ОС use has been shown to contribute substantially to the incidence of MIs in women in their mid-30s or older, with smoking accounting for the majority of excess cases. Mortality rates associated with circulatory disease have been shown to increase substantially in smokers, especially in those > 35 years of age who use OCs.
Cerebrovascular diseases - OCs increase the risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest in hypertensive women > 35 years of age who also smoke. The attributable risk is also greater in older women.
Vascular disease - A positive association is observed between the amount of estrogen and progestin in OCs and the risk of vascular disease. A decline in serum high density lipoproteins (HDL) has occurred with progestins. Because estrogens increase HDL cholesterol, the net effect depends on a balance achieved between doses of estrogen and progestin and the androgenic activity of the progestin.
Age - The risk of cerebrovascular and circulatory disease in ОС users is substantially increased in women > 35 years of age with other risk factors (e.g., smoking, uncontrolled hypertension, hypercholesterolemia [LDL 190], obesity, diabetes).
Postsurgical thromboembolism - Risk is increased 2- to 4-fold. If possible, discontinue OCs > 4 weeks before and 2 weeks after surgery and during and following prolonged immobilization because OCs are associated with an increased risk of thromboembolism.
Subarachnoid hemorrhage - Subarachnoid hemorrhage has been increased by ОС use.
Dose-related risk - A positive association has been observed between the amount of estrogen and progestin in hormonal contraceptives and the risk of vascular disease.
Persistence of risk - There are 2 studies that have shown persistence of risk of vascular disease for ever-users of combination hormonal contraceptives.
Ocular lesions: Ocular lesions such as optic neuritis or retinal thrombosis have been associated with the use of OCs.
Risks of use before or during early pregnancy: Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.
Gallbladder disease: Combination hormonal contraceptives such as norelgestromin/ethi-nyl estradiol transdermal patch may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women.
Carcinoma: While there are conflicting reports, the overall evidence in the literature suggests that use of OCs is not associated with an increase in the risk of developing any cancer, regardless of age and parity of first use.
Women with breast cancer should not use OCs because the role of female hormones in breast cancer has not been fully determined.
ОС-users appear about half as likely to develop ovarian and endometrial cancer as women who have never used OCs. The protective effect from endometrial cancer lasts up to 15 years after the pills are stopped.
Hepatic lesions (adenomas, focal nodular hyperplasia, hepatocellular carcinoma, etc): Benign and malignant hepatic adenomas have been associated with the use of OCs. Severe abdominal pain, shock, or death may be due to rupture and hemorrhage of a liver tumor.
Pregnancy test: Do not administer progestin-only products or progestin-estrogen combinations to induce withdrawal bleeding as a test for pregnancy.
Carbohydrate metabolism: Glucose tolerance may decrease, which is directly related to estrogen dose.
Lipid profile: Triglycerides may increase. Some progestins decrease HDL, while some estrogens increase HDL.
Elevated blood pressure: Elevated blood pressure and hypertension may occur within a few months of beginning use. The prevalence increases with the duration of use and age. Incidence of hypertension may directly correlate with increasing dosages of progestin. Discontinue the ОС if elevated blood pressure occurs.
Headaches: Onset or exacerbation of migraine or development of headache with focal neurological symptoms of a new pattern which is recurrent, persistent, or severe, requires ОС discontinuation and evaluation.
Bleeding irregularities: Breakthrough bleeding (BTB), spotting, and amenorrhea are frequent reasons for discontinuing OCs. Progestin-only products are more likely to cause an alteration in menstrual patterns.
Progestin-only products - Episodes of irregular, unpredictable spotting, and BTB within the first year are the most frequently encountered side effects and are the major reasons why women discontinue ОС use.
Menopause: Treatment with OCs may mask the onset of the climacteric.
Fertility impairment: Fertility impairment may occur in women discontinuing OCs; however, impairment diminishes with time.
Pregnancy: Category X. Rule out pregnancy before initiating or continuing the OCs, and always consider it if withdrawal bleeding does not occur.
Lactation: Oral contraceptives may interfere with lactation, decreasing both the quantity and the quality of breast milk. Furthermore, a small fraction of the hormones in OCs are excreted in breast milk. A few adverse effects on the nursing infant have been reported, including jaundice and breast enlargement.
If fully breastfeeding (not giving baby any food or formula), start pills 6 weeks after delivery. If partially breastfeeding (giving baby some food or formula), start taking pills by 3 weeks after delivery.
Children; Safety and efficacy are expected to be the same for post-pubertal adolescents
Precautions
Monitoring: Pretreatment and annual exams should include blood pressure, breasts, abdomen and pelvic organs, including Papanicolaou smear.
Lipid disorders: HDL-C and total cholesterol may be increased, LDL-C may be increased or decreased, while LDL-C/HDL-C ratio may be decreased and triglycerides may be unchanged.
Uterine fibroids: Preexisting uterine leiomyomata (uterine fibroids) may increase in size. However, there is no evidence of this with low-dose OCs.
Pyridoxins deficiency: ОС users may have relative pyridoxine deficiency.
Depression: The incidence of depression in ОС users ranges from
Hepatic function: Patients with a history of jaundice during pregnancy have an increased risk of recurrence of jaundice.
Contact lenses: Contact lens wearers who develop changes in vision or lens tolerance should be assessed by an ophthalmologist; consider temporary or permanent cessation of wear.
Serum folate levels: Serum folate levels may be depressed by therapy.
Acute intermittent porphyria: Estrogens have been reported to precipitate attacks of acute intermittent porphyria.
Vomiting/Diarrhea: Several cases of ОС failure have been reported in association with vomiting or diarrhea. If significant GI disturbance occurs, a back-up method of contraception for the remainder of the cycle is recommended.
Sexually transmitted diseases (STDs): Advise patients that OCs do not protect against HIV infection and other STDs.
Photosensitivity: Photosensitization (photoallergy or phototoxicity) may occur.
Drug Interactions
Drugs that may affect oral contraceptives include acetaminophen, antibiotics, ascorbic acid, atorvastatin, barbiturates, carbamazepine, CYP3A4 inhibitors (e.g., itraconazole, ketoconazole) felbamate, griscofulvin, hydantoins, oxcarbazepine, phenylbutazone, phenytoin, primidone, protease inhibitors, rifampin, St. John's wort, and topiramate. Drugs that may be affected by oral contraceptives include acetaminophen, anticoagulants, benzodiazepines, beta blockers, caffeine, clofibrate, corticosteroids, cyclosporine, morphine, prednisolone, salicylates, theophyllines, and tricyclic antidepressants.
Drug/Lab test interactions: Estrogen-containing OCs may cause the following alterations in serum, plasma or blood, unless specified otherwise.
Increased - Factors I (prothrombin), VII, VIII, IX, X; fibrinogen; norepinephrine-induced platelet aggregation; thyroid binding globulin (TBG), leading to increased total thyroid hormone (as measured by protein bound iodine or T4 by column or radioimmunoassay); corticosteroid levels; triglycerides and phospholipids; aldosterone; amylase; gamma-glutamyltranspeptidase; iron binding capacity; sex-hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids (combination); corticoids; transferrin; prolactin; renin activity; vitamin A.
Decreased - Antithrombin III; free T, resin uptake; response to metyrapone test; folate; glucose tolerance; albumin; cholinesterase; haptoglobin; zinc; vitamin B12; sex-hormone-binding globulin, thyroxine due to decrease in thyroid-binding globulin (progestin-only).
Adverse Reactions
Serious adverse reactions that may occur include thrombophlebitis and venous thrombosis with or without embolism; pulmonary embolism; coronary thrombosis; MI; cerebral thrombosis; arterial thromboembolism; cerebral hemorrhage; hypertension; gallbladder disease; hepatic adenomas or benign liver tumors; mesenteric thrombosis. Other adverse reactions that may occur include nausea and vomiting (10% to 30% of patients during the first cycle, less common with low doses, and majority resolve in 3 months); abdominal cramps; bloating; breakthrough bleeding (majority, > 80%, resolve in 3 months); spotting; change in menstrual flow; amenorrhea during and after treatment; change in cervical erosion and cervical secretions; vaginal candidiasis; temporary infertility after discontinuation; breast changes; melasma (may persist); rash (allergic); migraine; mental depression; headache; dizziness; contact lens intolerance; edema; weight change (increase or decrease); changes in corneal curvature (steepening); neuro-ocular lesions (e.g., retinal thrombosis, optic neuritis).
Emergency contraceptives: The most common adverse events in the clinical trial for women receiving emergency contraceptives include nausea; abdominal pain/cramps; fatigue; headache; menstrual irregularities; dizziness; breast tenderness; vomiting; diarrhea.
WOMEN’S HEALTH
GETTING PREGNANT: ABOUT MENSTRUAL CYCLE AND BASAL BODY TEMPERATURE
To get pregnant, you must have sexual intercourse near the time you ovulate. Ovulation is when an ovary releases one or more eggs into a fallopian tube. The timing of ovulation can vary from menstrual cycle to menstrual cycle. You can try to determine when you ovulate and increase your chances of conceiving by charting your body's monthly changes and your sexual activity. Charting involves:
- Noting the first day of your menstrual period.
- Taking your basal body temperature.
- Examining your cervical mucus.
- Noting when you had sexual intercourse.
Menstrual Cycle
During every menstrual cycle, your uterus builds up an internal lining of tissue called endometrium in preparation for ovulation. If an egg becomes fertilized, it implants in the tissue and begins to grow into a fetus. An unfertilized egg doesn't implant, and the tissue sloughs off in a process called menstruation.
Noting the first day of each menstrual period gives you an obvious starting date for each menstrual cycle. After you've recorded the starting day for a few months, you can see how long your menstrual cycle usually lasts, which is a first step toward predicting ovulation.
Basal Body Temperature (BBT)
Your basal body temperature is the temperature of your body at rest. Your BBT probably ranges from 97.2°F to about 97.7°F before ovulation. When you ovulate, your BBT rises 0.5°F to 1°F and remains elevated for several days (usually until your next period). If you conceive, your temperature stays elevated throughout your pregnancy.
Charting your BBT over a few months helps you see whether there's a pattern to your cycle. The information can help you pinpoint when you ovulated, because a sustained increase in your BBT shows that ovulation has occurred. You may note your BBT spiking on other days, but unless it stays elevated, you probably haven't yet ovulated.
Use a basal thermometer (available at drugstores) to take your BBT. A basal thermometer shows the incremental temperature changes that a regular thermometer can't. To get an accurate reading, take your BBT upon waking each morning, and try to wake up at the same time. Any activity raises your BBT, so take your BBT before you get out of bed, brush your teeth, get dressed, or otherwise start your day. If you don't take your BBT at a regular time and upon waking, any pattern you find may be inaccurate.
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WOMEN’S HEALTH
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Q. Can you tell me if I should be taking Generic Levora ( Levonorgestrel ethinyl estradiol 0.1mg + 0.02/0.15mg + 0.03mg ) ? Or, will it work for me?
A. We cannot advise you in any capacity in this matter. You should not take any medication without consulting a physician first.
Q. What is your returns policy?
A. By law, we regret that we are unable to accept returned pharmaceuticals. If your purchase is defective in any way, we will be pleased to replace it at no cost to you.
Q. What about importing of Generic Levora ( Levonorgestrel ethinyl estradiol 0.1mg + 0.02/0.15mg + 0.03mg ) to my country ?
A. Importation of prescription medication is legal in most countries (including the US, UK, France, Spain, Hong Kong, Japan and S. Korea) provided the medication is for personal use and is not a controlled substance. If you are in doubt about the situation in your country, check with your local Post Office.
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