Generic Name and Formulations:
Levonorgestrel 0.15mg, ethinyl estradiol 20mcg (42 light pink tabs); levonorgestrel 0.15mg, ethinyl estradiol 25mcg (21 pink tabs); levonorgestrel 0.15mg, ethinyl estradiol 30mcg (21 purple tabs); ethinyl estradiol 10mcg (7 yellow tabs).
Company:
Teva Pharmaceuticals
RECENT UPDATES
10/07/13
Monograph added.
Indications for QUARTETTE:
Oral contraception.
Adult Dose for QUARTETTE:
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's Dose for QUARTETTE:
Premenarchal: not recommended.
Pharmacological Class:
Progestin + estrogen.
Contraindications:
High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or pulmonary embolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive cancer. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy.
Warnings/Precautions:
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. Cardiovascular disease. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias; consider alternative contraception. Hypertriglyceridemia. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Monitor blood pressure. Do regular complete physical exams. Nursing mothers: not recommended.
Interactions:
May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampicin, St. John’s wort, topiramate); use backup contraception. May be potentiated by atorvastatin, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May be affected by protease inhibitors, NNRTIs. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.
Adverse Reactions:
Headaches, heavy/irregular vaginal bleeding, nausea, vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain, migraines; angioedema, chloasma, others (see full labeling).
How Supplied:
Dispenser (13-week supply)—1, 2
新一代口服避孕药Quartette新药申请被批准
2013年3月29日，美国制药企业之一的梯瓦（Teva）集团旗下的梯瓦女性健康公司（Teva Women‘s Health）宣布，FDA已接受审查其女性口服避孕药Quartette（左炔诺孕酮/乙炔雌二醇片剂及乙炔雌二醇片剂）的新药申请（NDA）。
Quartette的特殊性在于，它是第一种设计为递增剂量的长效口服避孕药，其设计旨在尽可能减少2个规律月经周期之间的突破性出血（BTB），极有可能成为下一代缓释口服避孕药的代表性药物。
Quartette并不是传统意义上的需要长时间服用的片剂，它是一种独特的91天口服药物。女性朋友们在前84天中服用左炔诺孕酮，旨在月经周期的3个时间点增加雌激素剂量，并使孕酮水平保持稳定，后7天则服用10 μg的乙炔雌二醇。
之所以Quartette会获得FDA的认可，是基于其1、2和3期临床试验的安全性和有效性结果。在招募了3，000多名女性的3期临床试验中，Quartette被证明具有高达97%的避孕有效率。这项临床试验还评估了BTB的发生率，结果显示不规律月经的分布范围在连续91天疗程中缩小。
另外，Quartette的研究的数据还表明，该药最常见不良反应为头痛、严重/不规则阴道出血、恶心/呕吐、痤疮、痛经、体重增加、情绪改变、焦虑/惊恐发作、乳房疼痛和偏头痛。
Quartette的研发人员指出，年龄大于35岁和吸烟的女性不可使用该产品，吸烟还可增加该药的心血管不良反应，女性患者应该注意。
介于Quartette的主要突破点事减少BTB的发生率。
突破性出血（BTB）会发生在少数服用避孕药的妇女身上，是女性服用避孕药时易发的一种副作用，特别是在服药的最初几个月，不规则的突破性出血量可能会增加。而突破性出血是很多女性不再使用长效避孕药的原因之一。