Quartette

— THERAPEUTIC CATEGORIES —
  • Contraception

Quartette Generic Name & Formulations

General Description

Levonorgestrel 0.15mg, ethinyl estradiol 20micrograms (42 light pink tabs); levonorgestrel 0.15mg, ethinyl estradiol 25micrograms (21 pink tabs); levonorgestrel 0.15mg, ethinyl estradiol 30micrograms (21 purple tabs); ethinyl estradiol 10micrograms (7 yellow tabs).

Pharmacological Class

Progestin + estrogen.

How Supplied

Dispenser (13-week supply)—2

Manufacturer

Quartette Indications

Indications

Oral contraception.

Quartette Dosage and Administration

Adult

1 tab daily for 91 days; repeat. Use Sunday-start regimen. Take pills in order (42 light pink tabs, then 21 pink tabs, then 21 purple tabs, then 7 yellow tabs).

Children

Premenarchal: not recommended.

Quartette Contraindications

Contraindications

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, hypertension with vascular disease, diabetes with hypertension or with vascular disease or other end-organ damage, diabetes of >20 years duration, headaches with focal neurologic symptoms). Breast cancer, which may be hormone sensitive. Hepatic tumors, acute viral hepatitis, or severe cirrhosis. Undiagnosed abnormal uterine bleeding. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Quartette Boxed Warnings

Boxed Warning

Cigarette smoking increases risk of serious cardiovascular events.

Quartette Warnings/Precautions

Warnings/Precautions

Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Discontinue and evaluate if new headaches develop that are recurrent, persistent, or severe. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Obesity. Gallbladder disease. Pregnancy-related cholestasis. Hereditary angioedema. History of depression; monitor and discontinue if serious depression recurs. Evaluate if bleeding irregularities, amenorrhea, or oligomenorrhea occurs. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Postmenopausal women or nursing mothers: not recommended.

Quartette Pharmacokinetics

See Literature

Quartette Interactions

Interactions

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Quartette prior to starting HCV regimen and restart 2wks after completion. May be antagonized by aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort; use backup contraception. May be potentiated by atorvastatin, rosuvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May be affected by certain HIV protease inhibitors (eg, nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (eg, boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine). Concomitant colesevelam; give 4hrs apart. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid, lamotrigine. May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May need dose adjustment of thyroid hormones. May affect lab tests (eg, coagulation factors, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, serum folate).

Quartette Adverse Reactions

Adverse Reactions

Headache/migraine, nausea, vomiting, breast issues, abdominal pain/distension, menstrual disorders, mood disorders, acne, vulvovaginal infection, weight increased, fatigue; hypertension, chloasma, serious thromboembolic events, liver disease.

Quartette Clinical Trials

See Literature

Quartette Note

Not Applicable

Quartette Patient Counseling

See Literature

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