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Loestrin 24 Fe
Overview
What is Loestrin 24 Fe?
Loestrin 24 Fe provides a dosage regimen
consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown
ferrous fumarate (placebo) tablets.
Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl
estradiol.Each white tablet also contains the following inactive
ingredients: acacia, lactose, magnesium stearate, starch, confectioner’s sugar,
and talc.
Each brown tablet contains ferrous fumarate, microcrystalline cellulose,
magnesium stearate, povidone, sodium starch glycolate, and compressible sugar.
The ferrous fumarate tablets do not serve any therapeutic purpose.
Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]
Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]
What does Loestrin 24 Fe look like?
What are the available doses of Loestrin 24 Fe?
Sorry No records found.
What should I talk to my health care provider before I take Loestrin 24 Fe?
Sorry No records found
How should I use Loestrin 24 Fe?
Loestrin 24 Fe is indicated for the prevention of pregnancy in
women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 2 lists the typical unplanned
pregnancy rates for users of combination oral contraceptives and other methods
of contraception. The efficacy of these contraceptive methods, except
sterilization, the IUD, and the Norplant system, depends
upon the reliability with which they are used. Correct and consistent use of
methods can result in lower failure rates.
In a clinical study, 743 women, 18 to 45 years of age, were
treated with Loestrin 24 Fe for up to six 28-day cycles providing a total of
3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of
treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment
cycles during which no backup contraception was used. The Pearl Index for
Loestrin 24 Fe was 1.82.
To achieve maximum contraceptive effectiveness, Loestrin 24 Fe
should be taken exactly as directed and at intervals not exceeding 24 hours.
Loestrin 24 Fe tablets may be administered without regard to meals.
Loestrin 24 Fe provides a regimen consisting of 24 white active tablets of
Loestrin 24 Fe and 4 brown non-hormonal (placebo) tablets of ferrous fumarate.
The ferrous fumarate tablets do not serve any therapeutic purpose.
During the first cycle of use:
The possibility of ovulation and conception prior to initiation of medication
should be considered. The patient is instructed to begin taking Loestrin 24 Fe
on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the
onset of menstruation (Sunday Start). If menstruation begins on a Sunday, the
first tablet (white) is taken that day. One white tablet should be taken daily
for 24 consecutive days followed by one brown tablet daily for 4 consecutive
days. Withdrawal bleeding should usually occur within three days following
discontinuation of white tablets and may not have finished before the next pack
is started. During the first cycle with a Sunday start, contraceptive reliance
should not be placed on Loestrin 24 Fe until a white tablet has been taken daily
for 7 consecutive days and a non-hormonal back-up method of birth control (such
as condoms or spermicide) should be used during those 7 days.
The patient begins her next and all subsequent 28-day courses of tablets on
the same day of the week on which she began her first course, following the same
schedule: 24 days on white tablets—4 days on brown tablets. If in any cycle the
patient starts tablets later than the proper day, she should protect herself
against pregnancy by using a non-hormonal back-up method of birth control until
she has taken a white tablet daily for 7 consecutive days.
Switching from another hormonal method of
contraception:
When the patient is switching to Loestrin 24 Fe after completing a 21-day
regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring,
she should wait 7 days after her last tablet, patch, or ring before she starts
Loestrin 24 Fe. 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 to Loestrin 24 Fe after completing a
28-day regimen of oral contraceptive tablets, she should start her first pack of
Loestrin 24 Fe 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 Loestrin 24 Fe the next day. If switching from an implant or
injection, the patient should start Loestrin 24 Fe on the day of implant removal
or, if using an injection, the day the next injection would be due.
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 healthcare
provider. Although pregnancy is unlikely if Loestrin 24 Fe is 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. If the
patient has adhered to the prescribed regimen and misses two consecutive
periods, pregnancy should be ruled out. Hormonal contraceptives should be
discontinued if pregnancy is confirmed.
For additional patient instructions regarding missed
pills:
See the “WHAT TO DO IF YOU MISS PILLS” section in the . Any time the patient misses two or more white
tablets, she should also use another method of non-hormonal back-up
contraception until she has taken a white tablet daily for seven consecutive
days. If the patient misses one or more brown tablets, she is still protected
against pregnancy she begins taking the active
white tablets again on the proper day. If breakthrough bleeding occurs following
missed white tablets, it will usually be transient and of no consequence. The
possibility of ovulation increases with each successive day that scheduled white
tablets are missed. Therefore, the risk of pregnancy increases with each active
(white) tablet missed.
Use after pregnancy, abortion or miscarriage:
Loestrin 24 Fe should be initiated no earlier than 28 days postpartum in the
nonlactating mother due to the increased risk for thromboembolism. When the
tablets are administered in the postpartum period, the increased risk of
thromboembolic disease associated with the postpartum period must be considered
(see ,
,
and
concerning thromboembolic disease). The patient should be advised to use a
non-hormonal back-up method for the first 7 days of tablet taking. However, if
intercourse has already occurred, the possibility of ovulation and conception
prior to initiation of medication should be considered.
Loestrin 24 Fe may be initiated after a first-trimester abortion or
miscarriage; if the patient starts Loestrin 24 Fe immediately, additional
contraceptive measures are not needed.
For additional patient instructions regarding complete dosing instructions,
see the “HOW TO TAKE THE PILL” section in the .
What interacts with Loestrin 24 Fe?
- 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
- Cerebrovascular or coronary artery disease (current or history)
- Valvular heart disease with thrombogenic complications
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast or personal history of breast cancer
- 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
- Known or suspected pregnancy
- Hypersensitivity to any component of this product
What are the warnings of Loestrin 24 Fe?
Azathioprine tabletshave been reported to cause temporary depression in spermatogenesis and reduction in sperm viability and sperm count in mice at doses 10 times the human therapeutic dose; a reduced percentage of fertile matings occurred when animals received 5 mg/kg.
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 risk
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 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 principally based 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 a disease, namely, a
of the incidence of a disease among oral
contraceptive users to that among nonusers. 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 nonusers. 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.
An increased risk of myocardial infarction has been attributed to
oral contraceptive use. 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. The relative risk of heart
attack for current oral contraceptive users has been estimated to be two to six.
The risk is very low under the age of 30.
FIGURE 3. CIRCULATORY DISEASE MORTALITY RATES FOR
100,000 WOMEN-YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE
Layde PM, Beral V. 1981;1:541-546.
Oral contraceptives may compound the effects of well-known risk factors, such
as hypertension, diabetes, hyperlipidemias, age, and obesity. In particular,
some progestogens are known to decrease HDL cholesterol and cause glucose
intolerance, while estrogens may create a state of hyperinsulinism. Oral
contraceptives have been shown to increase blood pressure among users (see
section in
).
Such increases in risk factors have been associated with an increased risk of
heart disease and the risk increases with the number of risk factors present.
Oral contraceptives must be used with caution in women with cardiovascular
disease risk factors.
An increased risk of thromboembolic and thrombotic disease
associated with the use of oral contraceptives is well established. Case control
studies have found the relative risk of users compared to non-users to be 3 for
the first episode of superficial venous thrombosis, 4 to 11 for deep vein
thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing
conditions for venous thromboembolic disease. Cohort studies have shown the
relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new
cases requiring hospitalization. The risk of thromboembolic disease due to oral
contraceptives is not related to length of use and disappears after pill use is
stopped.
A two- to four-fold increase in relative risk of postoperative thromboembolic
complications has been reported with the use of oral contraceptives. The
relative risk of venous thrombosis in women who have predisposing conditions is
twice that of women without such medical conditions. If feasible, oral
contraceptives should be discontinued at least four weeks prior to and for two
weeks after elective surgery of a type associated with an increase in risk of
thromboembolism and during and following prolonged immobilization. Since the
immediate postpartum period is also associated with an increased risk of
thromboembolism, oral contraceptives should be started no earlier than four to
six weeks after delivery in women who elect not to breastfeed.
Oral contraceptives have been shown to increase both the relative
and attributable risk of cerebrovascular events (thrombotic and hemorrhagic
strokes) although, in general, the risk is greatest among older (>35 years),
hypertensive women who also smoke. Hypertension was found to be a risk factor
for both users and nonusers, for both types of strokes, while smoking interacted
to increase the risk for hemorrhagic strokes.
In a large study, the relative risk of thrombotic strokes has been shown to
range from 3 for normotensive users to 14 for users with severe hypertension.
The relative risk of hemorrhagic stroke is reported to be 1.2 for nonsmokers who
used oral contraceptives, 2.6 for smokers who did not use oral contraceptives,
7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and
25.7 for users with severe hypertension. The attributable risk is also greater
in older women. Oral contraceptives also increase the risk for stroke in women
with other underlying risk factors such as certain inherited or acquired
thrombophilias, hyperlipidemias, and obesity. Women with migraine (particularly
migraine with aura) who take combination oral contraceptives may be at an
increased risk of stroke.
A positive association has been observed between the amount of
estrogen and progestogen in oral contraceptives and the risk of vascular
disease. A decline in serum high-density lipoproteins (HDL) has been reported
with many progestational agents. A decline in serum high-density lipoproteins
has been associated with an increased incidence of ischemic heart disease.
Because estrogens increase HDL cholesterol, the net effect of an oral
contraceptive depends on a balance achieved between doses of estrogen and
progestogen and the nature and absolute amount of progestogens used in the
contraceptive. The amount of both hormones should be considered in the choice of
an oral contraceptive.
Minimizing exposure to estrogen and progestogen is in keeping with good
principles of therapeutics. For any particular estrogen/progestogen combination,
the dosage regimen prescribed should be one which contains the least amount of
estrogen and progestogen that is compatible with a low failure rate and the
needs of the individual patient. New acceptors of oral contraceptive agents
should be started on preparations containing the lowest estrogen content which
is judged appropriate for the individual patient.
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 persisted for at least 9 years for women 40 to 49 years old 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.
What are the precautions of Loestrin 24 Fe?
Patients should be counseled that this product
does not protect against HIV infection (AIDS) and other sexually transmitted
diseases.
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 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.
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 ).
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.
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.
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.
Women with a history of depression should be carefully observed
and the drug discontinued if depression recurs to a serious degree. 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.
Contact lens wearers who develop visual changes or changes in
lens tolerance should be assessed by an ophthalmologist.
Changes in contraceptive effectiveness
associated with co-administration of other products:
Contraceptive effectiveness may be reduced when hormonal
contraceptives are co-administered with antibiotics, anticonvulsants, and other
drugs that increase the metabolism of contraceptive steroids. This could result
in unintended pregnancy or breakthrough bleeding. Examples include rifampin,
barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate,
oxcarbazepine, topiramate, and griseofulvin.
Several of the anti-HIV protease inhibitors have been studied
with co-administration of oral combination hormonal contraceptives; significant
changes (increase and decrease) in the plasma levels of the estrogen and
progestin have been noted in some cases. The safety and efficacy of combination
oral contraceptive products may be affected with co-administration of anti-HIV
protease inhibitors. Healthcare providers should refer to the label of the
individual anti-HIV protease inhibitors for further drug-drug interaction
information.
Herbal products containing St. John’s Wort (hypericum perforatum)
may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and
may reduce the effectiveness of contraceptive steroids. This may also result in
breakthrough bleeding.
Increase in plasma levels of estradiol associated with
co-administered drugs:
Co-administration of atorvastatin and certain combination oral contraceptives
containing ethinyl estradiol increase AUC values for ethinyl estradiol by
approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl
estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such
as itraconazole or ketoconazole may increase plasma hormone levels.
Changes in plasma levels of co-administered drugs:
Combination hormonal contraceptives containing some synthetic estrogens
(e.g., ethinyl estradiol) may inhibit the metabolism of other compounds.
Increased plasma concentrations of cyclosporine, prednisolone, and theophylline
have been reported with concomitant administration of combination oral
contraceptives. Decreased plasma concentrations of acetaminophen and increased
clearance of temazepam, salicylic acid, morphine and clofibric acid, due to
induction of conjugation have been noted when these drugs were administered with
combination oral contraceptives.
Certain endocrine and liver function tests and blood components
may be affected by oral contraceptives:
See section.
Pregnancy Category X. See and
sections.
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.
Safety and efficacy of Loestrin 24 Fe have been established in
women of reproductive age. Safety and efficacy are expected to be the same in
postpubertal adolescents under the age of 16 years and in users age 16 years and
older. Use of this product before menarche is not indicated.
This product has not been studied in women over 65 years of age
and is not indicated in this population.
- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
- Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T by column or by radioimmunoassay. Free T resin uptake is decreased, reflecting the elevated TBG, free T concentration is unaltered.
- Other binding proteins may be elevated in serum.
- Sex hormone binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
- Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
- Glucose tolerance may be decreased.
- 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.
What are the side effects of Loestrin 24 Fe?
The most common adverse events reported by 2 - 6% of the 743
women using Loestrin 24 Fe were the following, in order of decreasing
incidence: headache, vaginal candidiasis, upper respiratory infection, nausea,
menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal
cervical smear, acne, urinary tract infection, mood swings, weight gain,
vomiting, and metrorrhagia.
Among the 743 women using Loestrin 24 Fe, 46 women (6.2%) withdrew because of
an adverse event. Adverse events occurring in 3 or more subjects leading to
discontinuation of treatment were, in decreasing order: abnormal bleeding
(0.9%), nausea (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%),
and irregular bleeding (0.4%).
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 a causal association has been neither confirmed nor
refuted:
What should I look out for while using Loestrin 24 Fe?
Oral contraceptives should not be used in women who currently
have the following conditions:
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 risk
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 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 principally based 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 a disease, namely, a
of the incidence of a disease among oral
contraceptive users to that among nonusers. 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 nonusers. 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.
An increased risk of myocardial infarction has been attributed to
oral contraceptive use. 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. The relative risk of heart
attack for current oral contraceptive users has been estimated to be two to six.
The risk is very low under the age of 30.
FIGURE 3. CIRCULATORY DISEASE MORTALITY RATES FOR
100,000 WOMEN-YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE
Layde PM, Beral V. 1981;1:541-546.
Oral contraceptives may compound the effects of well-known risk factors, such
as hypertension, diabetes, hyperlipidemias, age, and obesity. In particular,
some progestogens are known to decrease HDL cholesterol and cause glucose
intolerance, while estrogens may create a state of hyperinsulinism. Oral
contraceptives have been shown to increase blood pressure among users (see
section in
).
Such increases in risk factors have been associated with an increased risk of
heart disease and the risk increases with the number of risk factors present.
Oral contraceptives must be used with caution in women with cardiovascular
disease risk factors.
An increased risk of thromboembolic and thrombotic disease
associated with the use of oral contraceptives is well established. Case control
studies have found the relative risk of users compared to non-users to be 3 for
the first episode of superficial venous thrombosis, 4 to 11 for deep vein
thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing
conditions for venous thromboembolic disease. Cohort studies have shown the
relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new
cases requiring hospitalization. The risk of thromboembolic disease due to oral
contraceptives is not related to length of use and disappears after pill use is
stopped.
A two- to four-fold increase in relative risk of postoperative thromboembolic
complications has been reported with the use of oral contraceptives. The
relative risk of venous thrombosis in women who have predisposing conditions is
twice that of women without such medical conditions. If feasible, oral
contraceptives should be discontinued at least four weeks prior to and for two
weeks after elective surgery of a type associated with an increase in risk of
thromboembolism and during and following prolonged immobilization. Since the
immediate postpartum period is also associated with an increased risk of
thromboembolism, oral contraceptives should be started no earlier than four to
six weeks after delivery in women who elect not to breastfeed.
Oral contraceptives have been shown to increase both the relative
and attributable risk of cerebrovascular events (thrombotic and hemorrhagic
strokes) although, in general, the risk is greatest among older (>35 years),
hypertensive women who also smoke. Hypertension was found to be a risk factor
for both users and nonusers, for both types of strokes, while smoking interacted
to increase the risk for hemorrhagic strokes.
In a large study, the relative risk of thrombotic strokes has been shown to
range from 3 for normotensive users to 14 for users with severe hypertension.
The relative risk of hemorrhagic stroke is reported to be 1.2 for nonsmokers who
used oral contraceptives, 2.6 for smokers who did not use oral contraceptives,
7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and
25.7 for users with severe hypertension. The attributable risk is also greater
in older women. Oral contraceptives also increase the risk for stroke in women
with other underlying risk factors such as certain inherited or acquired
thrombophilias, hyperlipidemias, and obesity. Women with migraine (particularly
migraine with aura) who take combination oral contraceptives may be at an
increased risk of stroke.
A positive association has been observed between the amount of
estrogen and progestogen in oral contraceptives and the risk of vascular
disease. A decline in serum high-density lipoproteins (HDL) has been reported
with many progestational agents. A decline in serum high-density lipoproteins
has been associated with an increased incidence of ischemic heart disease.
Because estrogens increase HDL cholesterol, the net effect of an oral
contraceptive depends on a balance achieved between doses of estrogen and
progestogen and the nature and absolute amount of progestogens used in the
contraceptive. The amount of both hormones should be considered in the choice of
an oral contraceptive.
Minimizing exposure to estrogen and progestogen is in keeping with good
principles of therapeutics. For any particular estrogen/progestogen combination,
the dosage regimen prescribed should be one which contains the least amount of
estrogen and progestogen that is compatible with a low failure rate and the
needs of the individual patient. New acceptors of oral contraceptive agents
should be started on preparations containing the lowest estrogen content which
is judged appropriate for the individual patient.
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 persisted for at least 9 years for women 40 to 49 years old 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.
What might happen if I take too much Loestrin 24 Fe?
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 Loestrin 24 Fe?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Loestrin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate.NDC 54868-6100-0 - blister cards Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F) [see USP Controlled Room Temperature].References are available upon request.Loestrin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate.NDC 54868-6100-0 - blister cards Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F) [see USP Controlled Room Temperature].References are available upon request.Loestrin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate.NDC 54868-6100-0 - blister cards Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F) [see USP Controlled Room Temperature].References are available upon request.Loestrin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate.NDC 54868-6100-0 - blister cards Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F) [see USP Controlled Room Temperature].References are available upon request.Loestrin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate.NDC 54868-6100-0 - blister cards Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F) [see USP Controlled Room Temperature].References are available upon request.
Clinical Information
Chemical Structure
No Image foundClinical 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
Oral contraceptives should not be used in women who currently have the following conditions: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 risk 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 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 principally based 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 a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. 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 nonusers. 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.
An increased risk of myocardial infarction has been attributed to oral contraceptive use. 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. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30.
FIGURE 3. CIRCULATORY DISEASE MORTALITY RATES FOR 100,000 WOMEN-YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE
Layde PM, Beral V. 1981;1:541-546.
Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age, and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. Oral contraceptives have been shown to increase blood pressure among users (see section in ). Such increases in risk factors have been associated with an increased risk of heart disease and the risk increases with the number of risk factors present. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped.
A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed.
Oral contraceptives have been shown to increase both the relative and attributable risk of cerebrovascular events (thrombotic and hemorrhagic strokes) although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes.
In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension. The relative risk of hemorrhagic stroke is reported to be 1.2 for nonsmokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women. Oral contraceptives also increase the risk for stroke in women with other underlying risk factors such as certain inherited or acquired thrombophilias, hyperlipidemias, and obesity. Women with migraine (particularly migraine with aura) who take combination oral contraceptives may be at an increased risk of stroke.
A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. A decline in serum high-density lipoproteins (HDL) has been reported with many progestational agents. A decline in serum high-density lipoproteins has been associated with an increased incidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptive. The amount of both hormones should be considered in the choice of an oral contraceptive.
Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing the lowest estrogen content which is judged appropriate for the individual patient.
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 persisted for at least 9 years for women 40 to 49 years old 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.
Use with Allopurinol
One of the pathways for inactivation of azathioprine is inhibited by allopurinol. Patients receiving azathioprine tablets and allopurinol concomitantly should have a dose reduction of azathioprine tablets, to approximately ⅓ to ¼ the usual dose. It is recommended that a further dose reduction or alternative therapies be considered for patients with low or absent TPMT activity receiving azathioprine tablets and allopurinol because both TPMT and XO inactivation pathways are affected (see and sections).
Use with Aminosalicylates
Use with Other Agents Affecting Myelopoesis
Drugs which may affect leukocyte production, including co-trimoxazole, may lead to exaggerated leukopenia, especially in renal transplant recipients.
Use with Angiotensin-Converting Enzyme Inhibitors
The use of angiotensin-converting enzyme inhibitors to control hypertension in patients on azathioprine has been reported to induce anemia and severe leukopenia.
Use with Warfarin
Azathioprine tablets may inhibit the anticoagulant effect of warfarin.
Carcinogenesis, Mutagenesis, Impairment of Fertility
See section.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
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 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.
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 ).
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.
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.
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.
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. 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.
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
Changes in contraceptive effectiveness associated with co-administration of other products:
Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.
Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of combination oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
Herbal products containing St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Increase in plasma levels of estradiol associated with co-administered drugs:
Co-administration of atorvastatin and certain combination oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Changes in plasma levels of co-administered drugs:
Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of combination oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation have been noted when these drugs were administered with combination oral contraceptives.
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
See section.
Pregnancy Category X. See and sections.
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.
Safety and efficacy of Loestrin 24 Fe have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 16 years and in users age 16 years and older. Use of this product before menarche is not indicated.
This product has not been studied in women over 65 years of age and is not indicated in this population.
The most common adverse events reported by 2 - 6% of the 743 women using Loestrin 24 Fe were the following, in order of decreasing incidence: headache, vaginal candidiasis, upper respiratory infection, nausea, menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal cervical smear, acne, urinary tract infection, mood swings, weight gain, vomiting, and metrorrhagia.
Among the 743 women using Loestrin 24 Fe, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).
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 a causal 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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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).