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Sprintec

"Nov. 20, 2012 -- Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).

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Sprintec

Sprintec

SIDE EFFECTS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS section).

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

  • Nausea.
  • Vomiting.
  • Gastrointestinal symptoms (such as abdominal cramps and bloating).
  • Breakthrough bleeding.
  • Spotting.
  • Change in menstrual flow.
  • Amenorrhea.
  • Temporary infertility after discontinuation of treatment.
  • Edema.
  • Melasma which may persist.
  • Breast changes: tenderness, enlargement, secretion.
  • Change in weight (increase or decrease).
  • Change in cervical erosion and secretion.
  • Diminution in lactation when given immediately postpartum.
  • Cholestatic jaundice.
  • Migraine.
  • Rash (allergic).
  • Mental depression.
  • Reduced tolerance to carbohydrates.
  • Vaginal candidiasis.
  • Change in corneal curvature (steepening).
  • Intolerance to contact lenses.

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

Read the Sprintec (norgestimate and ethinyl estradiol tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine, and possibly with griseofulvin, ampicillin and tetracyclines.72

Interactions with Laboratory Tests

Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

  1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggrega-bility.
  2. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
  3. Other binding proteins may be elevated in serum.
  4. Sex hormone binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged.
  5. High-density lipoprotein (HDL-C) and total cholesterol (Total-C) may be increased, low-density lipoprotein (LDL-C) may be increased or decreased, while LDL-C/HDL-C ratio may be decreased and triglycerides may be unchanged.
  6. Glucose tolerance may be decreased.
  7. 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.

REFERENCES

72. Stockley I. Interactions with oral contraceptives. J Pharm 1976; 216:140-143.

Read the Sprintec Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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