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SIMLIYA
Overview
What is SIMLIYA?
SIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 white to off-white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol USP (19-nor- 17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, lactose monohydrate, potato starch, povidone, stearic acid and vitamin E, followed by 2 inert green round tablets with the following inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. SIMLIYA also contains 5 light blue round tablets containing 0.01 mg ethinyl estradiol USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&C blue no. 1, lactose monohydrate, povidone, pregelatinized starch (maize), stearic acid and vitamin E. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows:
SIMLIYA meets USP Dissolution Test 2.
What does SIMLIYA look like?
What are the available doses of SIMLIYA?
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What should I talk to my health care provider before I take SIMLIYA?
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How should I use SIMLIYA?
SIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table II lists the typical 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 these methods can result in lower failure rates.
a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) Among couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly.h) Without spermicides.
To achieve maximum contraceptive effectiveness, SIMLIYA (desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. SIMLIYA may be initiated using either a Sunday start or a Day 1 start.
NOTE: Each blister pack is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different “day label strips” are provided with each blister pack in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days.
IMPORTANT: The possibility of ovulation and conception prior to initiation of use of SIMLIYA should be considered.
The use of SIMLIYA 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 (see and concerning thromboembolic disease. See also for Nursing mothers).
If the patient starts on SIMLIYA postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white to off-white tablet has been taken daily for 7 days.
When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.
Using a Sunday start, tablets are taken daily without interruption as follows: The first white to off-white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white to off-white tablet is taken on that day). One white to off-white tablet is taken daily for 21 days, followed by 1green (inert) tablet daily for 2 days and 1 light blue (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last light blue tablet. [If switching from a Sunday start oral contraceptive, the first SIMLIYA (desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) should be taken on the second Sunday after the last tablet of a 21 day regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]
If a patient misses 1 white to off-white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white to off-white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the blister pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white to off-white tablets in the third week or misses 3 or more white to off-white tablets in a row at any time during the cycle, the patient should keep taking 1 white to off-white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that blister pack and start a new blister pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.
Counting the first day of menstruation as “Day 1”, tablets are taken without interruption as follows: One white to off-white tablet daily for 21 days, one green (inert) tablet daily for 2 days followed by 1 light blue (ethinyl estradiol) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last light blue tablet. [If switching directly from another oral contraceptive, the first white to off-white tablet should be taken on the first day of menstruation which begins after the last ACTIVE tablet of the previous product.]
If a patient misses 1 white to off-white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white to off-white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the blister pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white to off-white tablets in the third week or if the patient misses 3 or more white to off-white tablets in a row at any time during the cycle, the patient should throw out the rest of that blister pack and start a new blister pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual period:
1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued until pregnancy is ruled out. 2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.
What interacts with SIMLIYA?
- 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 estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas
- Known or suspected pregnancy
- Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see , ).
What are the warnings of SIMLIYA?
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 should be strongly advised not to smoke.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among non-users. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author’s permission). For further information, the reader is referred to a text on epidemiologic methods.
1. Thromboembolic disorders and other vascular problems
2. Estimates of mortality from contraceptive use
One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table IV). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth.
The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970’s - but not reported until 1983 (35). However, current clinical practice involves the use of lower estrogen formulations combined with careful consideration of risk factors.
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed (100,101), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of low-dose oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
| Method of control and outcome | 15 to 19 | 20 to 24 | 25 to 29 | 30 to 34 | 35 to 39 | 40 to 44 | |||||||
| No fertility control methods | 7 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 | |||||||
| Oral contraceptives non-smoker | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 | |||||||
| Oral contraceptives Smoker | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 | |||||||
| IUD | 0.8 | 0.8 | 1 | 1 | 1.4 | 1.4 | |||||||
| Condom | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 | 0.4 | |||||||
| Diaphragm/spermicide | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 | |||||||
| Periodic abstinence | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 | |||||||
3. Carcinoma of the reproductive organs and breasts
Numerous epidemiologic studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. While there are conflicting reports, most studies suggest that the use of oral contraceptives is not associated with an overall increase in the risk of developing breast cancer. Some studies have reported an increased relative risk of developing breast cancer, particularly at a younger age. This increased relative risk appears to be related to duration of use (36 to 43, 79 to 89). Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intra-epithelial neoplasia in some populations of women (45 to 48). However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
4. Hepatic neoplasia
Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose (49). Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage (50,51).
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma (52 to 54) in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
5. Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue SIMLIYA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir . SIMLIYA can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
6. Ocular lesions
There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.
7. Oral contraceptive use before or during early pregnancy
Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy (55 to 57). Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned (55,56,58,59), when oral contraceptives are taken inadvertently during early pregnancy. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the first missed period. Oral contraceptive use should be discontinued until pregnancy is ruled out.
8. Gallbladder disease
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens (60,61). More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal (62 to 64). The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.
9. Carbohydrate and lipid metabolic effects
Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users (17). Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance (65). Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents (17,66). However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose (67). Because of these demonstrated effects, prediabetic and diabetic women should be carefully monitored while taking oral contraceptives. A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see 1.a. and 1.d.), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
10. Elevated blood pressure
An increase in blood pressure has been reported in women taking oral contraceptives (68) and this increase is more likely in older oral contraceptive users (69) and with continued use (61). Data from the Royal College of General Practitioners (12) and subsequent randomized trials have shown that the incidence of hypertension increases with increasing quantities of progestogens. Women with a history of hypertension or hypertension-related diseases, or renal disease (70) should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives (69), and there is no difference in the occurrence of hypertension between ever- and never-users (68,70,71).
11. Headache
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.
12. Bleeding irregularities
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.
13. Ectopic pregnancy
Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.
What are the precautions of SIMLIYA?
1. General
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical examination and follow up
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
3. Lipid disorders
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.
4. Liver function
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
5. Fluid retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
6. Emotional disorders
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
7. Contact lenses
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. 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 (72).
Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation
Do not co-administer SIMLIYA with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ,).
Consult the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
9. Interactions with laboratory tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
a. Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. b. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered. c. Other binding proteins may be elevated in serum. d. Sex hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged. e. High-density lipoprotein cholesterol (HDL-C) and triglycerides may be increased, while low-density lipoprotein cholesterol (LDL-C) and total cholesterol (Total-C) may be decreased or unchanged. f. Glucose tolerance may be decreased. g. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
10. Carcinogenesis
See section.
11. Pregnancy
Pregnancy Category X (see and sections).
12. Nursing mothers
Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.
13. Pediatric use
Safety and efficacy of SIMLIYA (desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
INFORMATION FOR THE PATIENT
See Patient Labeling Printed Below
What are the side effects of SIMLIYA?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
What should I look out for while using SIMLIYA?
Oral contraceptives should not be used in women who currently have the following conditions:
What might happen if I take too much SIMLIYA?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiologic studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol (73 to 78).
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
How should I store and handle SIMLIYA?
Store at SIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx onlySIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx onlySIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx onlySIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx onlySIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx onlySIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx onlySIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side.2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet.5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side.Carton of 6 Pouches NDC 65862-886-92Store atRx only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
SIMLIYA OVER A 28-DAY DOSING PERIOD IN THE THIRD CYCLE (n=17).
Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions: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 (72). Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Do not co-administer SIMLIYA with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ,).
Consult the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).