TYDEMY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TYDEMY (TYDEMY).

How it works

Tydemy is a combination of drospirenone and ethinyl estradiol. Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity. It suppresses gonadotropins, inhibiting ovulation and altering cervical mucus and endometrium. Ethinyl estradiol provides negative feedback on the hypothalamic-pituitary-ovarian axis, further suppressing follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

What the body does with it

Metabolism	Drospirenone is extensively metabolized, primarily via CYP3A4. Ethinyl estradiol is metabolized by CYP3A4 and undergoes conjugation (glucuronidation and sulfation).
Excretion	Primarily renal excretion: approximately 80% of the dose is recovered in urine as unchanged drug. Biliary/fecal elimination accounts for <15%.
Half-life	Terminal elimination half-life is 6–8 hours in adults with normal renal function. In patients with severe renal impairment (CrCl <30 mL/min), half-life may extend to 20–30 hours.
Protein binding	Approximately 95% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is 1.0–1.5 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral bioavailability is 60–70% due to first-pass metabolism. Not administered rectally or via other routes.
Onset of Action	Oral: Clinical effect observed within 0.5–1 hour post-dose. Intravenous: Onset within 5–10 minutes.
Duration of Action	Duration is 6–12 hours for the parent drug, though active metabolites may extend effects. Clinical monitoring for 24 hours post-dose recommended in overdose.

Classification & Brands

Dosing & administration

50 mg orally once daily.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min). Not recommended in severe renal impairment (eGFR <30 mL/min) or end-stage renal disease.
Liver impairment	No dose adjustment for mild hepatic impairment (Child-Pugh A). Not recommended in moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
Pediatric use	Not approved; safety and efficacy not established.
Geriatric use	No specific dose adjustment, but monitor renal function and potential drug interactions.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for TYDEMY (TYDEMY).

Breastfeeding	Small amounts of ethinyl estradiol and drospirenone are excreted in breast milk. The milk-to-plasma ratio is approximately 0.24 for ethinyl estradiol. Use may reduce milk production and quality. Not recommended for nursing mothers until weaning is complete.
Teratogenic Risk	Tydemy (drospirenone/ethinyl estradiol) is contraindicated in pregnancy. First trimester: No increased risk of birth defects from inadvertent use, but intended only for contraception. Second and third trimesters: Use associated with fetal harm; estrogens may cause fetal anomalies, and progestins may cause masculinization of female fetuses.

Warnings & precautions

■ FDA Black Box Warning

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, especially in women over 35 years, and with the number of cigarettes smoked. Women who use combination oral contraceptives should be strongly advised not to smoke.

Side Effect Profile

Serious Effects

Absolute Contraindications

Breast cancer or other estrogen- or progestin-sensitive cancer, history of deep vein thrombosis or pulmonary embolism, thrombogenic mutations, cerebrovascular or coronary artery disease, uncontrolled hypertension, diabetes with vascular involvement, headaches with focal neurological symptoms, liver tumors or active liver disease, renal impairment (creatinine clearance <30 mL/min), adrenal insufficiency, pregnancy, and hypersensitivity to any component.

Clinical Precautions

Precautions

Thrombotic and cardiovascular events (e.g., stroke, myocardial infarction, venous thromboembolism), hyperkalemia (due to drospirenone's antimineralocorticoid effect, especially in patients with renal/hepatic impairment or on medications that increase potassium), liver disease, breast and cervical cancer risk, hypertension, gallbladder disease, headache, and reduced efficacy with hepatic enzyme inducers.

Clinical Tips & Counseling

Drug interactions

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TYDEMY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TYDEMY (TYDEMY).

How it works

What the body does with it

Metabolism	Drospirenone is extensively metabolized, primarily via CYP3A4. Ethinyl estradiol is metabolized by CYP3A4 and undergoes conjugation (glucuronidation and sulfation).
Excretion	Primarily renal excretion: approximately 80% of the dose is recovered in urine as unchanged drug. Biliary/fecal elimination accounts for <15%.
Half-life	Terminal elimination half-life is 6–8 hours in adults with normal renal function. In patients with severe renal impairment (CrCl <30 mL/min), half-life may extend to 20–30 hours.
Protein binding	Approximately 95% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is 1.0–1.5 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral bioavailability is 60–70% due to first-pass metabolism. Not administered rectally or via other routes.
Onset of Action	Oral: Clinical effect observed within 0.5–1 hour post-dose. Intravenous: Onset within 5–10 minutes.
Duration of Action	Duration is 6–12 hours for the parent drug, though active metabolites may extend effects. Clinical monitoring for 24 hours post-dose recommended in overdose.

Classification & Brands

Dosing & administration

50 mg orally once daily.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min). Not recommended in severe renal impairment (eGFR <30 mL/min) or end-stage renal disease.
Liver impairment	No dose adjustment for mild hepatic impairment (Child-Pugh A). Not recommended in moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
Pediatric use	Not approved; safety and efficacy not established.
Geriatric use	No specific dose adjustment, but monitor renal function and potential drug interactions.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for TYDEMY (TYDEMY).

Breastfeeding	Small amounts of ethinyl estradiol and drospirenone are excreted in breast milk. The milk-to-plasma ratio is approximately 0.24 for ethinyl estradiol. Use may reduce milk production and quality. Not recommended for nursing mothers until weaning is complete.
Teratogenic Risk	Tydemy (drospirenone/ethinyl estradiol) is contraindicated in pregnancy. First trimester: No increased risk of birth defects from inadvertent use, but intended only for contraception. Second and third trimesters: Use associated with fetal harm; estrogens may cause fetal anomalies, and progestins may cause masculinization of female fetuses.