|
| U.S. Brand
Names |
|
| Ovrette® |

|
|
| Generic
Available |
|
|
No |

|
|
| Pharmacological Index |
|
|
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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