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Pronunciation |
|
(nor
JES
trel) |
|
|
U.S. Brand
Names |
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Ovrette® |
|
|
Generic
Available |
|
No |
|
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Pharmacological Index |
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Contraceptive |
|
|
Use |
|
Prevention of pregnancy; progestin only products have higher risk of
failure in contraceptive use |
|
|
Pregnancy Risk
Factor |
|
X |
|
|
Contraindications |
|
Known hypersensitivity to norgestrel; thromboembolic disorders, severe
hepatic disease, breast cancer, undiagnosed vaginal bleeding,
pregnancy |
|
|
Warnings/Precautions |
|
Discontinue if sudden loss of vision or if diplopia or proptosis occur; use
with caution in patients with a history of mental depression; use of any
progestin during the first 4 months of pregnancy is not
recommended |
|
|
Adverse
Reactions |
|
>10%:
Cardiovascular: Edema
Endocrine & metabolic: Breakthrough bleeding, spotting, changes in
menstrual flow, amenorrhea
Gastrointestinal: Anorexia
Neuromuscular & skeletal: Weakness
1% to 10%:
Cardiovascular: Embolism, central thrombosis
Central nervous system: Mental depression, fever, insomnia
Dermatologic: Melasma or chloasma, allergic rash with or without pruritus
Endocrine & metabolic: Changes in cervical erosion and secretions,
increased breast tenderness
Gastrointestinal: Weight gain or loss
Hepatic: Cholestatic jaundice
Local: Thrombophlebitis |
|
|
Overdosage/Toxicology |
|
Toxicity is unlikely following single exposures of excessive doses
Supportive treatment is adequate in most cases |
|
|
Drug
Interactions |
|
Decreased effect: Aminoglutethimide may decrease effects by increasing
hepatic metabolism |
|
|
Mechanism of
Action |
|
Inhibits secretion of pituitary gonadotropin (LH) which prevents follicular
maturation and ovulation |
|
|
Pharmacodynamics/Kinetics |
|
Absorption: Oral: Readily absorbed
Protein binding: >90%
Metabolism: Primarily hepatic
Half-life: ~20 hours |
|
|
Usual Dosage |
|
Administer daily, starting the first day of menstruation, take 1 tablet at
the same time each day, every day of the year. If one dose is missed, take as
soon as remembered, then next tablet at regular time; if two doses are missed,
take 1 tablet and discard the other, then take daily at usual time; if three
doses are missed, use an additional form of birth control until menses or
pregnancy is ruled out. |
|
|
Dietary
Considerations |
|
Should be administered with food at same time each day |
|
|
Test
Interactions |
|
Thyroid function tests, metyrapone test, liver function
tests |
|
|
Mental Health: Effects
on Mental Status |
|
May cause insomnia or depression |
|
|
Mental Health:
Effects on Psychiatric
Treatment |
|
None reported |
|
|
Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
|
|
Dental Health:
Effects on Dental Treatment |
|
Until we know more about the mechanism of interaction, caution is required in
prescribing antibiotics to female dental patients taking progestin-only oral
contraceptives |
|
|
Patient
Information |
|
Take this medicine only as directed; do not take more of it and do not take
it for a longer period of time; if you suspect you may have become pregnant,
stop taking this medicine; report any loss of vision or vision changes
immediately; avoid excessive exposure to sunlight |
|
|
Nursing
Implications |
|
Patients should receive a copy of the patient labeling |
|
|
Dosage Forms |
|
Tablet: 0.075 mg |
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