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Levonorgestrel and Ethinyl Estradiol

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Overview

What is Portia?

Portia (levonorgestrel and ethinyl estradiol tablets USP) consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel, USP, (18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(−)-), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 white inert tablets. The inactive ingredients in the pink active tablets include anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The ingredients in the film-coating include FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. Each white inert tablet contains anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

The structural formulas are as follows:

Levonorgestrel, USP

CHO M.W. 312.45

Ethinyl Estradiol, USP

CHO M.W. 296.40



What does Portia look like?



What are the available doses of Portia?

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What should I talk to my health care provider before I take Portia?

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How should I use Portia?

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

To achieve maximum contraceptive effectiveness, Portia (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours.

The dosage of Portia is one pink tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to prescribed schedule.

It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed to begin taking Portia on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of pink tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Portia until a pink tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28 day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on pink tablets ─ 7 days on white inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a pink tablet daily for 7 consecutive days.

When the patient is switching from a 21 day regimen of tablets, she should wait 7 days after her last tablet before she starts Portia. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21 day regimen. When the patient is switching from a 28 day regimen of tablets, she should start her first pack of Portia on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Portia the next day. If switching from an implant or injection, the patient should start Portia on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Portia tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the “” section in the below.

Anytime the patient misses two or more pink tablets, she should also use another method of contraception until she has taken a pink tablet daily for seven consecutive days. If the patient misses one or more white tablets, she is still protected against pregnancy she begins taking pink tablets again on the proper day.

If breakthrough bleeding occurs following missed pink tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two pink tablets are missed, the possibility of ovulation increases with each successive day that scheduled pink tablets are missed.

Portia may be initiated no earlier than day 28 postpartum in the non-lactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see , , and concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first trimester abortion, if the patient starts Portia immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel (bromocriptine mesylate) has been used for the prevention of lactation.


What interacts with Portia?

Combination oral contraceptives should not be used in women with any of the following conditions:


Thrombophlebitis or thromboembolic disorders.


A past history of deep-vein thrombophlebitis or thromboembolic disorders.


Cerebral-vascular or coronary artery disease.


Thrombogenic valvulopathies.


Thrombogenic rhythm disorders.


Diabetes with vascular involvement.


Uncontrolled hypertension.


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, or active liver disease, as long as liver function has not returned to normal.


Known or suspected pregnancy.


Hypersensitivity to any of the components of Portia (levonorgestrel and ethinyl estradiol tablets).


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 Portia?

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Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) 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 venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, 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 certain inherited or acquired thrombophilias, 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 based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological 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 disease, namely, a ratio 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 difference 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. For further information, the reader is referred to a text on epidemiological methods.

1. Thromboembolic Disorders and Other Vascular Problems

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There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40 to 49 years who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small. However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.

2. Estimate 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 (). 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 less than 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. However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling.

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, 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 nonsmoking women (even with the newer low-dose formulations), there are 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 oral contraceptive use by healthy nonsmoking 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.

TABLE III: ANNUAL NUMBER OF BIRTH-RELATED OR METHOD RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY-CONTROL METHOD AND ACCORDING TO AGE
Method of control and outcome15 to 1920 to 2425 to 2930 to 3435 to 3940 to 44
No fertility-control methods 77.49.114.825.728.2
Oral contraceptives nonsmoker 0.30.50.91.913.831.6
Oral contraceptives smoker 2.23.46.613.551.1117.2
IUD 0.80.8111.41.4
Condom 1.11.60.70.20.30.4
Diaphragm/ spermicide 1.91.21.21.32.22.8
Periodic abstinence 2.51.61.61.72.93.6
Adapted from H.W. Ory, Family Planning Perspectives, .


3. Carcinoma of the Reproductive Organs

A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combination oral contraceptives compared to never-users. The increased risk gradually disappears during the course of the 10 years after cessation of combination oral contraceptive use. These studies do not provide evidence for causation. The observed pattern of increased risk of breast cancer diagnosis may be due to earlier detection of breast cancer in combination oral contraceptive users, the biological effects of combination oral contraceptives, or a combination of both. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent combination oral contraceptive users is small in relation to the lifetime risk of breast cancer. Breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established.

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. Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies from Britain have shown an increased risk of developing hepatocellular carcinoma 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 Portia prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see ). Portia 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 that may lead to partial or complete loss of vision. 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 epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy (see section).

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 time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.

8. Gallbladder Disease

Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. 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 glucose intolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.

A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see , 1a. and 1d.), 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, and this increase is more likely in older oral contraceptive users and with continued use. Data from the Royal College of General Practitioners 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, should be encouraged to use another method of contraception. If women with hypertension elect to use oral contraceptives, they should be monitored closely, and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued (see section). For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- and never-users.

11. Headache

The onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause (see , 1c.).

12. Bleeding Irregularities

Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. The type and dose of progestogen may be important. If bleeding persists or recurs, nonhormonal 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 if the oral contraceptive has not been taken according to directions prior to the first missed withdrawal bleed or if two consecutive withdrawal bleeds have been missed.

Some women may encounter post-pill amenorrhea or oligomenorrhea (possibly with anovulation), especially when such a condition was preexistent.


What are the precautions of Portia?

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

A periodic personal and family medical history and complete physical examination are appropriate for all women, 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 the 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 (see , 1d.).

In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.

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

Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug-related. 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. Gastrointestinal Motility

Diarrhea and/or vomiting may reduce hormone absorption.

9. Drug Interactions

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Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when coadministered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort.

Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens.

During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Portia (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.

After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.

Some substances may increase plasma ethinyl estradiol concentrations. These include:

Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Portia with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ).

10. Interactions with Laboratory Tests

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a.

b.

c.

d.

e.

f.

g.

Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:

11. Carcinogenesis

See section

12. Pregnancy

13. Nursing Mothers

Small amounts of oral contraceptive steroids and/or metabolites 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, combination 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 combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

14. Pediatric Use

Safety and efficacy of Portia (levonorgestrel 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 users 16 and older. Use of this product before menarche is not indicated.


What are the side effects of Portia?

An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:

Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

Nausea

Vomiting

Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)

Breakthrough bleeding

Spotting

Change in menstrual flow

Amenorrhea

Temporary infertility after discontinuation of treatment

Edema/fluid retention

Melasma/chloasma which may persist

Breast changes: tenderness, pain, enlargement, secretion

Change in weight or appetite (increase or decrease)

Change in cervical erosion and secretion

Diminution in lactation when given immediately postpartum

Cholestatic jaundice

Rash (allergic)

Mood changes, including depression

Vaginitis, including candidiasis

Change in corneal curvature (steepening)

Intolerance to contact lenses

Mesenteric thrombosis

Decrease in serum folate levels

Exacerbation of systemic lupus erythematosus

Exacerbation of porphyria

Exacerbation of chorea

Aggravation of varicose veins

Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:

Congenital anomalies

Premenstrual syndrome

Cataracts

Optic neuritis, which may lead to partial or complete loss of vision

Cystitis-like syndrome

Nervousness

Dizziness

Hirsutism

Loss of scalp hair

Erythema multiforme

Erythema nodosum

Hemorrhagic eruption

Impaired renal function

Hemolytic uremic syndrome

Budd-Chiari syndrome

Acne

Changes in libido

Colitis

Sickle-cell disease

Cerebral-vascular disease with mitral valve prolapse

Lupus-like syndromes

Pancreatitis

Dysmenorrhea


What should I look out for while using Portia?

Combination oral contraceptives should not be used in women with any of the following conditions:

Thrombophlebitis or thromboembolic disorders.

A past history of deep-vein thrombophlebitis or thromboembolic disorders.

Cerebral-vascular or coronary artery disease.

Thrombogenic valvulopathies.

Thrombogenic rhythm disorders.

Diabetes with vascular involvement.

Uncontrolled hypertension.

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, or active liver disease, as long as liver function has not returned to normal.

Known or suspected pregnancy.

Hypersensitivity to any of the components of Portia (levonorgestrel and ethinyl estradiol tablets).

Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see).


What might happen if I take too much Portia?

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.


How should I store and handle Portia?

Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017Portia (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58). Each card contains 21 pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized on one side and on the other side, and 7 white, round, biconvex, unscored inert tablets, debossed with stylized on one side and on the other side. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.REFERENCES AVAILABLE UPON REQUESTTEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. C 4/2017


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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

Non-Clinical Toxicology
Combination oral contraceptives should not be used in women with any of the following conditions:

Thrombophlebitis or thromboembolic disorders.

A past history of deep-vein thrombophlebitis or thromboembolic disorders.

Cerebral-vascular or coronary artery disease.

Thrombogenic valvulopathies.

Thrombogenic rhythm disorders.

Diabetes with vascular involvement.

Uncontrolled hypertension.

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, or active liver disease, as long as liver function has not returned to normal.

Known or suspected pregnancy.

Hypersensitivity to any of the components of Portia (levonorgestrel and ethinyl estradiol tablets).

Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see).

Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when coadministered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort.

Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens.

During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Portia (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.

After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.

Some substances may increase plasma ethinyl estradiol concentrations. These include:

Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Portia with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ).

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 (see section for additional information) has been associated with the use of oral contraceptives:

Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

Nausea

Vomiting

Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)

Breakthrough bleeding

Spotting

Change in menstrual flow

Amenorrhea

Temporary infertility after discontinuation of treatment

Edema/fluid retention

Melasma/chloasma which may persist

Breast changes: tenderness, pain, enlargement, secretion

Change in weight or appetite (increase or decrease)

Change in cervical erosion and secretion

Diminution in lactation when given immediately postpartum

Cholestatic jaundice

Rash (allergic)

Mood changes, including depression

Vaginitis, including candidiasis

Change in corneal curvature (steepening)

Intolerance to contact lenses

Mesenteric thrombosis

Decrease in serum folate levels

Exacerbation of systemic lupus erythematosus

Exacerbation of porphyria

Exacerbation of chorea

Aggravation of varicose veins

Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:

Congenital anomalies

Premenstrual syndrome

Cataracts

Optic neuritis, which may lead to partial or complete loss of vision

Cystitis-like syndrome

Nervousness

Dizziness

Hirsutism

Loss of scalp hair

Erythema multiforme

Erythema nodosum

Hemorrhagic eruption

Impaired renal function

Hemolytic uremic syndrome

Budd-Chiari syndrome

Acne

Changes in libido

Colitis

Sickle-cell disease

Cerebral-vascular disease with mitral valve prolapse

Lupus-like syndromes

Pancreatitis

Dysmenorrhea

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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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Professional

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. 315.72
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Tips

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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).