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MICRONOR
Overview
What is MICRONOR?
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn
starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate,
and povidone.
What does MICRONOR look like?
What are the available doses of MICRONOR?
Sorry No records found.
What should I talk to my health care provider before I take MICRONOR?
Sorry No records found
How should I use MICRONOR?
Progestin-only oral contraceptives are indicated for the
prevention of pregnancy.
If used perfectly, the first-year failure rate for progestin-only
oral contraceptives is 0.5%. However, the typical failure rate is estimated to
be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates
for users of all major methods of contraception.
Adapted from Hatcher et al, 1998, Ref. # 1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after
unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactational Amenorrhea Method: LAM is highly effective, temporary method of
contraception.
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart
F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth
Revised Edition. New York NY: Irvington Publishers, 1998.
To achieve maximum contraceptive effectiveness, ORTHO
MICRONOR must be taken exactly as directed. One tablet
is taken every day, at the same time. Administration is continuous, with no
interruption between pill packs. See for detailed instruction.
What interacts with MICRONOR?
- Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
- Known or suspected pregnancy
- Known or suspected carcinoma of the breast
- Undiagnosed abnormal genital bleeding
- Hypersensitivity to any component of this product
- Benign or malignant liver tumors
- Acute liver disease
What are the warnings of MICRONOR?
The possibility of exacerbation or activation of systemic lupus erythematosus
has been reported.
Cigarette smoking increases the risk of serious cardiovascular
disease. Women who use oral contraceptives should be strongly advised not to
smoke.
ORTHO MICRONOR does not contain estrogen and,
therefore, this insert does not discuss the serious health risks that have been
associated with the estrogen component of combined oral contraceptives (COCs).
The healthcare professional is referred to the prescribing information of
combined oral contraceptives for a discussion of those risks. The relationship
between progestin-only oral contraceptives and these risks is not fully defined.
The healthcare professional should remain alert to the earliest manifestation of
symptoms of any serious disease and discontinue oral contraceptive therapy when
appropriate.
The incidence of ectopic pregnancies for progestin-only oral
contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported
in clinical studies of progestin-only oral contraceptive users are extrauterine.
Although symptoms of ectopic pregnancy should be watched for, a history of
ectopic pregnancy need not be considered a contraindication to use of this
contraceptive method. Healthcare professionals should be alert to the
possibility of an ectopic pregnancy in women who become pregnant or complain of
lower abdominal pain while on progestin-only oral contraceptives.
If follicular development occurs, atresia of the follicle is
sometimes delayed and the follicle may continue to grow beyond the size it would
attain in a normal cycle. Generally these enlarged follicles disappear
spontaneously. Often they are asymptomatic; in some cases they are associated
with mild abdominal pain. Rarely they may twist or rupture, requiring surgical
intervention.
Irregular menstrual patterns are common among women using
progestin-only oral contraceptives. If genital bleeding is suggestive of
infection, malignancy or other abnormal conditions, such nonpharmacologic causes
should be ruled out. If prolonged amenorrhea occurs, the possibility of
pregnancy should be evaluated.
Some epidemiological studies of oral contraceptive users have
reported an increased relative risk of developing breast cancer, particularly at
a younger age and apparently related to duration of use. These studies have
predominantly involved combined oral contraceptives and there is insufficient
data to determine whether the use of POPs similarly increases the risk.
A meta-analysis of 54 studies found a small increase in the frequency of
having breast cancer diagnosed for women who were currently using combined oral
contraceptives or had used them within the past ten years.
This increase in the frequency of breast cancer diagnosis, within ten years
of stopping use, was generally accounted for by cancers localized to the breast.
There was no increase in the frequency of having breast cancer diagnosed ten or
more years after cessation of use.
Women with breast cancer should not use oral contraceptives because the role
of female hormones in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an
increase in the risk of cervical intraepithelial neoplasia 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.
There is insufficient data to determine whether the use of POPs increases the
risk of developing cervical intraepithelial neoplasia.
Benign hepatic adenomas are associated with combined oral
contraceptive use, although the incidence of benign tumors is rare in the United
States. Rupture of benign, hepatic adenomas may cause death through
intraabdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma
in combined oral contraceptive users. However, these cancers are rare in the
U.S. There is insufficient data to determine whether POPs increase the risk of
developing hepatic neoplasia.
What are the precautions of MICRONOR?
Patients should be counseled that this product does not protect
against HIV infection (AIDS) and other sexually transmitted diseases.
It is considered good medical practice for sexually active women
using oral contraceptives to have annual history and physical examinations. The
physical examination may be deferred until after initiation of oral
contraceptives if requested by the woman and judged appropriate by the
healthcare professional.
Some users may experience slight deterioration in glucose
tolerance, with increases in plasma insulin but women with diabetes mellitus who
use progestin-only oral contraceptives do not generally experience changes in
their insulin requirements. Nonetheless, prediabetic and diabetic women in
particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and
apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased.
There is usually no effect on total cholesterol, HDL ,
LDL, or VLDL.
The effectiveness of progestin-only pills is reduced by hepatic
enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and
barbiturates, and the antituberculosis drug rifampin. No significant interaction
has been found with broad-spectrum antibiotics.
The following endocrine tests may be affected by progestin-only
oral contraceptive use:
See
section.
Many studies have found no effects on fetal development
associated with long-term use of contraceptive doses of oral progestins. The few
studies of infant growth and development that have been conducted have not
demonstrated significant adverse effects. It is nonetheless prudent to rule out
suspected pregnancy before initiating any hormonal contraceptive use.
In general, no adverse effects have been found on breastfeeding
performance or on the health, growth or development of the infant. However,
isolated post-marketing cases of decreased milk production have been reported.
Small amounts of progestins pass into the breast milk of nursing mothers,
resulting in detectable steroid levels in infant plasma.
Safety and efficacy of ORTHO MICRONOR
Tablets have been established in women of reproductive age. Safety and efficacy
are expected to be the same for postpubertal adolescents under the age of 16 and
for users 16 years and older. Use of this product before menarche is not
indicated.
The limited available data indicate a rapid return of normal
ovulation and fertility following discontinuation of progestin-only oral
contraceptives.
The following points should be discussed with prospective users
before prescribing progestin-only oral contraceptives:
What are the side effects of MICRONOR?
Adverse reactions reported with the use of POPs include:
- Menstrual irregularity is the most frequently reported side effect.
- Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.
- Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.
- Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.
What should I look out for while using MICRONOR?
Progestin-only oral contraceptives (POPs) should not be used by
women who currently have the following conditions:
Cigarette smoking increases the risk of serious cardiovascular
disease. Women who use oral contraceptives should be strongly advised not to
smoke.
ORTHO MICRONOR does not contain estrogen and,
therefore, this insert does not discuss the serious health risks that have been
associated with the estrogen component of combined oral contraceptives (COCs).
The healthcare professional is referred to the prescribing information of
combined oral contraceptives for a discussion of those risks. The relationship
between progestin-only oral contraceptives and these risks is not fully defined.
The healthcare professional should remain alert to the earliest manifestation of
symptoms of any serious disease and discontinue oral contraceptive therapy when
appropriate.
The incidence of ectopic pregnancies for progestin-only oral
contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported
in clinical studies of progestin-only oral contraceptive users are extrauterine.
Although symptoms of ectopic pregnancy should be watched for, a history of
ectopic pregnancy need not be considered a contraindication to use of this
contraceptive method. Healthcare professionals should be alert to the
possibility of an ectopic pregnancy in women who become pregnant or complain of
lower abdominal pain while on progestin-only oral contraceptives.
If follicular development occurs, atresia of the follicle is
sometimes delayed and the follicle may continue to grow beyond the size it would
attain in a normal cycle. Generally these enlarged follicles disappear
spontaneously. Often they are asymptomatic; in some cases they are associated
with mild abdominal pain. Rarely they may twist or rupture, requiring surgical
intervention.
Irregular menstrual patterns are common among women using
progestin-only oral contraceptives. If genital bleeding is suggestive of
infection, malignancy or other abnormal conditions, such nonpharmacologic causes
should be ruled out. If prolonged amenorrhea occurs, the possibility of
pregnancy should be evaluated.
Some epidemiological studies of oral contraceptive users have
reported an increased relative risk of developing breast cancer, particularly at
a younger age and apparently related to duration of use. These studies have
predominantly involved combined oral contraceptives and there is insufficient
data to determine whether the use of POPs similarly increases the risk.
A meta-analysis of 54 studies found a small increase in the frequency of
having breast cancer diagnosed for women who were currently using combined oral
contraceptives or had used them within the past ten years.
This increase in the frequency of breast cancer diagnosis, within ten years
of stopping use, was generally accounted for by cancers localized to the breast.
There was no increase in the frequency of having breast cancer diagnosed ten or
more years after cessation of use.
Women with breast cancer should not use oral contraceptives because the role
of female hormones in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an
increase in the risk of cervical intraepithelial neoplasia 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.
There is insufficient data to determine whether the use of POPs increases the
risk of developing cervical intraepithelial neoplasia.
Benign hepatic adenomas are associated with combined oral
contraceptive use, although the incidence of benign tumors is rare in the United
States. Rupture of benign, hepatic adenomas may cause death through
intraabdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma
in combined oral contraceptive users. However, these cancers are rare in the
U.S. There is insufficient data to determine whether POPs increase the risk of
developing hepatic neoplasia.
What might happen if I take too much MICRONOR?
There have been no reports of serious ill effects from
overdosage, including ingestion by children.
How should I store and handle MICRONOR?
Store the oral suspension between 20°-25°C (68°-77°F). [See USP]. Dispense in a tight container. Protect from heat.ORTHO MICRONOR (0.35 mg norethindrone) Tablets are available in a DIALPAK Tablet Dispenser(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).Keep out of reach of children.Relabeling of "Additional" barcode label by:ORTHO MICRONOR (0.35 mg norethindrone) Tablets are available in a DIALPAK Tablet Dispenser(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).Keep out of reach of children.Relabeling of "Additional" barcode label by:ORTHO MICRONOR (0.35 mg norethindrone) Tablets are available in a DIALPAK Tablet Dispenser(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).Keep out of reach of children.Relabeling of "Additional" barcode label by:ORTHO MICRONOR (0.35 mg norethindrone) Tablets are available in a DIALPAK Tablet Dispenser(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).Keep out of reach of children.Relabeling of "Additional" barcode label by:ORTHO MICRONOR (0.35 mg norethindrone) Tablets are available in a DIALPAK Tablet Dispenser(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).Keep out of reach of children.Relabeling of "Additional" barcode label by:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ORTHO MICRONOR progestin-only oral
contraceptives prevent conception by suppressing ovulation in approximately half
of users, thickening the cervical mucus to inhibit sperm penetration, lowering
the midcycle LH and FSH peaks, slowing the movement of the ovum through the
fallopian tubes, and altering the endometrium.
Serum progestin levels peak about two hours after oral
administration, followed by rapid distribution and elimination. By 24 hours
after drug ingestion, serum levels are near baseline, making efficacy dependent
upon rigid adherence to the dosing schedule. There are large variations in serum
levels among individual users. Progestin-only administration results in lower
steady-state serum progestin levels and a shorter elimination half-life than
concomitant administration with estrogens.
Non-Clinical Toxicology
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
ORTHO MICRONOR does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.
If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.
Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.
Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk.
A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.
This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.
Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia 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. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.
Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.
Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with metoprolol tartrate plus a catecholamine depletor should therefore be closely observed for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Risk of Anaphylactic Reaction
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL , LDL, or VLDL.
The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.
The following endocrine tests may be affected by progestin-only oral contraceptive use:
See section.
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
In general, no adverse effects have been found on breastfeeding performance or on the health, growth or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.
Safety and efficacy of ORTHO MICRONOR Tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.
The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:
Adverse reactions reported with the use of POPs include:
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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