Sprintec

Generic name:

Norgestimate and Ethinyl estradiol

Drug class:

Combination oral contraceptive (estrogen/progestin)

Dosage form:

Oral tablets (21 active tablets + 7 inert tablets per pack)

Route of administration:

Oral

Dose:

• One tablet daily at the same time each day
• 21/7 dosing regimen: 21 active tablets followed by 7 inert tablets
• Active tablets sequence:
  • Days 1–7: 0.18 mg norgestimate / 35 mcg ethinyl estradiol
  • Days 8–14: 0.215 mg norgestimate / 35 mcg ethinyl estradiol
  • Days 15–21: 0.25 mg norgestimate / 35 mcg ethinyl estradiol

Mechanism of action:

Suppresses ovulation via negative feedback on the hypothalamic-pituitary-ovarian axis, thickens cervical mucus to impede sperm penetration, and alters endometrial lining to prevent implantation.

Drug usage cases:

• Prevention of pregnancy (primary indication)
• Acne vulgaris in women seeking oral contraception (off-label)
• Regulation of menstrual cycles and management of dysmenorrhea
• Treatment of premenstrual dysphoric disorder (PMDD)
• Management of menstrual-related migraine (off-label)

Drug contraindications:

• Known or suspected pregnancy
• History of thromboembolic disorders (e.g., deep vein thrombosis, pulmonary embolism)
• Active or history of stroke or myocardial infarction
• Known thrombophilic disorders (e.g., Factor V Leiden)
• Uncontrolled hypertension (≥160/100 mm Hg)
• Current or history of estrogen-dependent neoplasia (e.g., breast cancer, endometrial cancer)
• Severe hepatic impairment or liver tumors
• Migraine with focal aura at any age
• Smokers aged ≥35 years (increased cardiovascular risk)
• Undiagnosed abnormal uterine bleeding
• Known hypersensitivity to any component of the formulation

Side effects:

• Nausea and vomiting
• Headache and migraine
• Breast tenderness or enlargement
• Weight changes (gain or loss)
• Irregular uterine bleeding or spotting
• Amenorrhea
• Mood changes, depression, or irritability
• Fluid retention and edema
• Hypertension
• Increased risk of venous thromboembolism (DVT, PE)
• Increased risk of arterial thromboembolism (MI, stroke)
• Gallbladder disease, cholestatic jaundice
• Altered glucose tolerance and lipid metabolism
• Contact lens intolerance
• Skin changes (melasma, chloasma)

Warnings:

• Increased risk of thromboembolic events; caution in patients with risk factors
• Monitor blood pressure periodically
• Discontinue if prolonged immobilization or major surgery increases thrombosis risk
• Avoid use in patients with severe hepatic dysfunction or cholestatic jaundice
• May exacerbate hypertension, diabetes, and gallbladder disease
• Potential for drug interactions reducing contraceptive efficacy (e.g., certain anticonvulsants, antibiotics, herbal supplements like St. John’s wort)
• Risk of hepatic adenomas and rarely hepatic carcinoma with long-term use
• May cause fluid retention; caution in heart disease or renal impairment
• Monitor for signs of depression and mood disorders
• Smoking increases serious cardiovascular risks; discontinue in women ≥35 who smoke

Use during pregnancy or breastfeeding:

Pregnancy: Contraindicated. If pregnancy occurs, discontinue immediately. No benefit in established pregnancy and potential risk of fetal exposure.

Breastfeeding: Excreted in breast milk; may reduce milk volume. Use only if benefits outweigh risks to the infant. Consider timing of dose relative to nursing.