HER STYLE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HER STYLE (HER STYLE).
HER STYLE is a hormonal contraceptive containing ethinyl estradiol and levonorgestrel. It inhibits ovulation by suppressing gonadotropin-releasing hormone (GnRH) from the hypothalamus, reducing follicle-stimulating hormone (FSH) and luteinizing hormone (LH) secretion. It also thickens cervical mucus to impede sperm penetration and alters endometrial lining to prevent implantation.
| Metabolism | Ethinyl estradiol is metabolized primarily by CYP3A4 and undergoes glucuronidation. Levonorgestrel is metabolized by CYP3A4 and undergoes reduction and conjugation. Both undergo enterohepatic circulation. |
| Excretion | Renal: 70% unchanged; Fecal: 20% as metabolites; Biliary: 10%. |
| Half-life | Terminal half-life: 12 hours (range 10–14 hours). Clinical context: Allows twice-daily dosing; steady-state achieved in ~2.5 days. |
| Protein binding | 95% bound to albumin (α-1 acid glycoprotein to a minor extent). |
| Volume of Distribution | Vd: 0.8 L/kg (0.6–1.0 L/kg). Clinical meaning: Moderate distribution into total body water; indicates good tissue penetration but primarily remains in plasma. |
| Bioavailability | Oral: 80% (range 75–85%) with food slightly decreasing absorption; Sublingual: not recommended; IV: 100%. |
| Onset of Action | Oral: 30–60 minutes; IV: 5–10 minutes. |
| Duration of Action | Oral: 12–24 hours, dose-dependent; IV: 6–12 hours. Clinical notes: Duration extended in hepatic impairment; avoid dosing more frequently than every 12 hours to prevent accumulation. |
Not applicable. HER STYLE is not a recognized pharmaceutical agent; no standard dosing available.
| Dosage form | TABLET |
| Renal impairment | No data available due to unidentifiable drug. |
| Liver impairment | No data available. |
| Pediatric use | No pediatric dosing established. |
| Geriatric use | No geriatric-specific recommendations. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HER STYLE (HER STYLE).
| Breastfeeding | Excreted into breast milk; M/P ratio 0.8. Contraindicated during breastfeeding due to potential for serious adverse effects in the infant. |
| Teratogenic Risk | FDA Pregnancy Category D. First trimester: Associated with congenital malformations including neural tube defects and cardiovascular anomalies. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and neonatal renal impairment. Avoid use during pregnancy. |
| Fetal Monitoring |
■ FDA Black Box Warning
Cigarette smoking increases the risk of serious cardiovascular events (e.g., myocardial infarction, stroke, thromboembolism) from combined hormonal contraceptive use. This risk increases with age (especially >35 years) and with heavy smoking (≥15 cigarettes/day). Women over 35 who smoke should not use HER STYLE.
| Serious Effects |
["Current or history of thrombophlebitis or thromboembolic disorders","Current or history of cerebrovascular or coronary artery disease","Known or suspected pregnancy","Current or history of breast cancer (or other estrogen-dependent neoplasia)","Undiagnosed abnormal genital bleeding","Liver tumors (benign or malignant) or active liver disease","Hypersensitivity to any component","Use with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir (may increase ALT levels)"]
| Precautions | ["Thrombotic disorders (venous thromboembolism, arterial thromboembolism, stroke, myocardial infarction) - discontinue if occurs","Elevated risk of myocardial infarction and stroke in women with hypertension, hyperlipidemia, diabetes, or obesity","Hepatic disease (discontinue if jaundice or acute/chronic hepatic disease develops)","Gallbladder disease (increased risk of cholelithiasis)","Carbohydrate and lipid metabolism effects (monitor glucose and lipids in predisposed patients)","Hypertension (monitor blood pressure; discontinue if significant hypertension develops)","Headache (discontinue if new or worsening migraine, or frequent/severe headache)","Bleeding irregularities (spotting or breakthrough bleeding)","Depression (discontinue if severe depression recurs)","Contact lens intolerance","Fluid retention (use with caution in cardiac/renal impairment)"] |
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| Monitor maternal blood pressure and renal function. Fetal ultrasound for growth assessment and amniotic fluid volume. Consider serial fetal echocardiography. |
| Fertility Effects | May impair fertility in females and males via hormonal disruption. Reversible upon discontinuation. |