norgestrel

(nor jess' trel)

Ovrette

Pregnancy Category X

Drug classes
Hormone
Progestin
Hormonal contraceptive

Therapeutic actions
Progestational agent; the endogenous female progestin, progesterone, transforms
proliferative endometrium into secretory endometrium; inhibits the secretion of pituitary
gonadotropins, which prevents follicular maturation and ovulation; and inhibits
spontaneous uterine contractions. The primary mechanism by which norgestrel prevents
conception is not known, but progestin-only hormonal contraceptives alter the cervical
mucus, exert a progestional effect on the endometrium that interferes with implantation,
and in some patients, suppress ovulation.

Indication
• Prevention of pregnancy using hormonal contraceptives; somewhat less
efficacious (3 pregnancies per 100 woman years) than the combined
estrogen/progestin hormonal contraceptives (about 1 pregnancy per 100 woman
years, depending on formulation)

Contraindications and cautions

• Contraindicated with allergy to progestins, tartrazine; thrombophlebitis,
thromboembolic disorders, cerebral hemorrhage, or history of these conditions;
CAD; hepatic disease, carcinoma of the breast or genital organs, undiagnosed
vaginal bleeding, missed abortion; as a diagnostic test for pregnancy; pregnancy
(fetal abnormalities—masculinization of the female fetus, congenital heart
defects, and limb reduction defects); lactation.
• Use cautiously with epilepsy, migraine, asthma, cardiac or renal dysfunction.

Available forms
Tablets—0.075 mg

Dosages
ADULTS
Administer daily, starting on the first day of menstruation. Take 1 tablet, PO, at the same
time each day, every day of the year. Missed dose: 1 tablet—take as soon as remembered,
then take the next tablet at regular time; 2 consecutive tablets—take 1 of the missed
tablets, discard the other, and take daily tablet at usual time; 3 consecutive tablets—
discontinue immediately and use additional form of birth control until menses or
pregnancy is ruled out.
Pharmacokinetics
Route Onset
Oral Varies

Metabolism: Hepatic; T1/2: Unknown

Distribution: Crosses placenta; enters breast milk
Excretion: Urine

Adverse effects
• CNS: Neuro-ocular lesions, mental depression, migraine, changes in corneal
curvature, contact lens intolerance
• CV: Thrombophlebitis, thrombosis, pulmonary embolism, coronary thrombosis,
MI, cerebral thrombosis, Raynaud's disease, arterial thromboembolism, renal
artery thrombosis, cerebral hemorrhage, hypertension
• Dermatologic: Rash with or without pruritus, acne, melasma
• GI: Gallbladder disease, liver tumors, hepatic lesions, nausea, vomiting,
abdominal cramps, bloating, cholestatic jaundice
• GU: Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea,
changes in cervical erosion and cervical secretions, endocervical hyperplasia,
vaginal candidiasis
• Other: Breast tenderness and secretion, enlargement; fluid retention, edema,
increase or decrease in weight

Interactions
Drug-drug
• Decreased effectiveness of hormonal contraceptives with barbiturates, hydantoins,
carbamazepine, rifampin, griseofulvin, penicillins, tetracyclines; use alternate
form of birth control if these drugs are needed
Drug-alternative therapy
• Decreased effectiveness if taken with St. John's wort

Nursing considerations
Assessment
• History: Allergy to progestins, tartrazine; thrombophlebitis, thromboembolic
disorders, cerebral hemorrhage; CAD; hepatic disease, carcinoma of the breast or
genital organs, undiagnosed vaginal bleeding, missed abortion; epilepsy,
migraine, asthma, cardiac or renal dysfunction; pregnancy; lactation
• Physical: Skin color, lesions, turgor; hair; breasts; pelvic exam; orientation,
affect; ophthalmologic exam; P, auscultation, peripheral perfusion, edema; R,
adventitious sounds; liver evaluation; liver and renal function tests, glucose
tolerance, Pap smear, pregnancy test

Interventions
• Arrange for pretreatment and periodic (at least annual) history and physical,
including BP, breasts, abdomen, pelvic organs, and a Pap smear.
• Start no earlier than 4 wk postpartum for postpartum use.
 • Discontinue drug and consult physician if sudden partial or complete loss of
vision occurs; if papilledema or retinal vascular lesions are present on exam,
discontinue.
• Discontinue drug and consult physician at any sign of thromboembolic disease—
leg pain, swelling, peripheral perfusion changes, shortness of breath.

Teaching points
• Take exactly as prescribed at intervals not exceeding 24 hr. Take at bedtime or
with a meal to establish a routine; medication must be taken daily for prevention
of pregnancy; if you miss 1 tablet, take as soon as remembered, then take the next
tablet at regular time. If you miss 2 consecutive tablets, take 1 of the missed
tablets, discard the other, and take daily tablet at usual time. If you miss 3
consecutive tablets, discontinue immediately, and use another method of birth
control until your cycle starts again. It is a good idea to use an additional method
of birth control if any tablets are missed.
• Discontinue drug and consult your health care provider if you decide to become
pregnant. It may be suggested that you use a nonhormonal form of birth control
for a few months before becoming pregnant.
• Do not take this drug during pregnancy; serious fetal abnormalities have been
reported. If you think that you are pregnant consult physician immediately.
• Tell your nurse, physician, or dentist that you take this drug. If other medications
are prescribed, they may decrease the effectiveness of hormonal contraceptives
and an additional method of birth control may be needed.
• These side effects may occur: Sensitivity to light (avoid exposure to the sun; use
sunscreen and protective clothing); dizziness, sleeplessness, depression (use
caution driving or performing tasks that require alertness); rash, skin color
changes, loss of hair; fever; nausea; breakthrough bleeding or spotting (transient);
intolerance to contact lenses due to corneal changes.
• Report pain or swelling and warmth in the calves, acute chest pain or shortness of
breath, sudden severe headache or vomiting, dizziness or fainting, visual
disturbances, numbness or tingling in the arm or leg, breakthrough bleeding or
spotting that lasts into the second month of therapy.

Adverse effects in Italic are most common; those in Bold are life-threatening.