Adult Dosing
Contraception
- drospirenone 3 mg/ethinyl estradiol 0.02 mg (24 tabs) + 4 inert tabs (Gianvi, Loryna, Vestura, Yaz):
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 24 days, followed by one inert tablet x 4 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
- drospirenone 3 mg/ethinyl estradiol 0.03 mg (21 tabs) + 7 inert tabs (Ocella, Syeda, Yasmin, Zarah):
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 21 days, followed by one inert tablet x 7 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
Acne vulgaris (Gianvi, Loryna, Vestura, Yaz)
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x24 days, then the inert tablets are taken x4 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
Premenstrual dysphoric disorder (Gianvi, Loryna, Vestura, Yaz)
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 24 days, followed by one inert tablet x 4 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
Notes:- Tablets should be taken at the same time each day, especially after the evening meal or at bedtime. Tablets must be taken as recommended and at intervals not exceeding 24 hrs
- For the first cycle of a Sunday start regimen, use another non-hormonal back-up method of contraception until after the first 7 consecutive days of starting the tablet
- When switching from another oral contraceptive, therapy should be started on the same day that a new pack of the previous oral contraceptive would have been started
- May be started 4 wks postpartum in women who elect not to breastfeed or >6 wks postpartum if breastfeeding
Pediatric Dosing
Contraception (postpubertal females)
- drospirenone 3 mg/ethinyl estradiol 0.02 mg (24 tabs) + 4 inert tabs (Gianvi, Loryna, Vestura, Yaz):
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 24 days, followed by one inert tablet x 4 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
- drospirenone 3 mg/ethinyl estradiol 0.03 mg (21 tabs) + 7 inert tabs (Ocella, Syeda, Yasmin, Zarah):
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 21 days, followed by one inert tablet x 7 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
Acne vulgaris (Gianvi, Loryna, Vestura, Yaz)
Postpubertal females
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x24 days, then the inert tablets are taken x4 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
Premenstrual dysphoric disorder (Gianvi, Loryna, Vestura, Yaz)
Postpubertal females
- 1 tab PO qd
- Start first active tablet on day 1 of menstrual cycle or 1st Sunday after onset of menses x 24 days, followed by one inert tablet x 4 days
- After taking 28 tabs, start a new course the day after taking last inert tablet
Notes:- Tablets should be taken at the same time each day, especially after the evening meal or at bedtime. Tablets must be taken as recommended and at intervals not exceeding 24 hrs
- For the first cycle of a Sunday start regimen, use another non-hormonal back-up method of contraception until after the first 7 consecutive days of starting the tablet
- When switching from another oral contraceptive, therapy should be started on the same day that a new pack of the previous oral contraceptive would have been started
- May be started 4 wks postpartum in women who elect not to breastfeed or >6 wks postpartum if breastfeeding
[Outline]
See Supplemental Patient Information
- Cigarette smokers are more prone to the risk of serious cardiovascular side effects from oral contraceptive use. Advise women who use contraceptives to avoid smoking [US Black Box Warning]
- Increased risk of several serious conditions such as MI, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease has been associated with the therapy. Risk of morbidity and mortality markedly increases in the presence of underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes
- Increased risk of thromboembolic and thrombotic disease has been reported with the use of COCs; risk of post-operative thromboembolic complications has been reported with the use of COCs. Discontinue use at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization
- Start therapy no earlier than 4 weeks after delivery in women who are not breastfeeding as the risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week
- Oral contraceptives may increase the risk of cerebrovascular events such as thrombotic and hemorrhagic strokes; this risk is greatest among older (>35 yrs) and hypertensive women who also smoke. Use therapy cautiously in women with cardiovascular disease risk factors
- Oral contraceptives may cause retinal thrombosis leading to partial or complete loss of vision. Discontinue the drug if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions and initiate appropriate diagnostic and therapeutic measures
- Avoid this therapy in patients with conditions that predispose to hyperkalemia such as renal or hepatic impairment and adrenal insufficiency. Examine serum potassium level during the first treatment cycle in women receiving long-term treatment for chronic conditions with medications that may increase serum potassium levels
- COCs may increase the risk of breast and cervical cancer; discontinuation of therapy decreases this risk
- Discontinue therapy if jaundice occurs; discontinue COC use if acute or chronic disturbances of liver function occurs until markers of liver function return to normal
- Rarely, fatal benign hepatic adenomas have been reported with COC use. Rupture of these benign, hepatic adenomas may cause intra-abdominal hemorrhage leading to death
- Hypertension may occur during therapy. Closely monitor hypertensive women electing to use oral contraceptives; discontinue use in women with significant elevation of blood pressure. Avoid this therapy in women with uncontrolled hypertension or hypertension with vascular disease
- Combination oral contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women
- COCs may decrease glucose intolerance in a dose-related manner; closely monitor prediabetic and diabetic women taking this therapy. Consider alternative contraception for women with uncontrolled dyslipidemia. Increased risk of pancreatitis may occur in women with family history of hypertriglyceridemia
- Discontinue therapy on onset or exacerbation of migraine, development of headache with a new pattern that is recurrent, persistent or severe
- Bleeding irregularities such as breakthrough bleeding and spotting may occur, especially during the first 3 months of combined oral contraceptive use. Consider non-hormonal causes and initiate adequate diagnostic measures to rule out malignancy/pregnancy in the event of breakthrough bleeding or any abnormal vaginal bleeding
- Closely monitor women with a history of depression; discontinue use if depression recurs to a serious degree
- Exogenous estrogens may induce or exacerbate symptoms of angioedema in women with hereditary angioedema
- Chloasma may rarely occur, particularly in women with a history of chloasma gravidarum; such individuals should avoid exposure to the sun or ultraviolet radiation while taking COCs
- Therapy may change the results of certain lab tests including coagulation factors, lipids, glucose tolerance, and binding proteins
- Increased doses of thyroid hormone may be needed in women on thyroid hormone replacement therapy as serum concentrations of thyroid-binding globulin increase with use of COCs. Therapy may cause an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity
- Do not use COCs during pregnancy to treat threatened or habitual abortion
- Counsel the patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Consider physical examination and follow up in relevance to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and perform relevant laboratory tests in all the women taking COCs
Caution: Use cautiously in
- Cardiovascular disease
- Fluid retention
- Vomiting or diarrhea
- Breastfeeding 6 wks-6 months postpartum
- Hereditary angioedema
- Inflammatory bowel disease
Supplemental Patient Information
- Inform patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Instruct patients to take pill exactly as directed and at intervals not exceeding 24 hrs
- Instruct patients that amenorrhea may occur during therapy; advise them to rule out pregnancy in the event of amenorrhea in two or more consecutive cycles
Pregnancy Category:X
Breastfeeding: Combination oral contraceptives probably do not affect the composition of milk substantially in healthy, well-nourished mothers and do not adversely affect long-term infant growth and development, but can transiently affect growth negatively during the first month after introduction. Rarely, reversible breast enlargement has been reported with higher doses of estrogen. Ethinyl estradiol in doses of 30 mcg daily or greater can suppress lactation leading to earlier discontinuation of breastfeeding than nonhormonal or progestin-only contraception. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum. As per US expert opinion, the risks of combination contraceptive products usually outweigh the benefits before 4 weeks postpartum. Between 4 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks. After 6 months postpartum, combination contraceptives can be used, but progestin-only methods are preferred if breastfeeding will be continued. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 July 2011). According to the manufacturer's data, nursing mothers should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.
US Trade Name(s)
- Gianvi
- Loryna
- Ocella
- Syeda
- Vestura
- Yasmin
- Yaz
- Zarah
US Availability
drospirenone/ethinyl estradiol (generic)
- TABS: 3 mg/0.03 mg (21 tabs), 7 inert tabs
- TABS: 3 mg/0.02 mg (24 tabs), 4 inert tabs
Gianvi, Vestura (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.02 mg (24 tabs), 4 inert tabs
Ocella, Yasmin, Zarah (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.03 mg (21 tabs), 7 inert tabs
Syeda (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.03 mg (21 tabs), 7 inert tabs
Loryna (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.02 mg (24 tabs), 4 inert tabs
Yaz (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.02 mg (24 tabs), 4 inert tabs
Canadian Trade Name(s)
Canadian Availability
Yasmin 21 (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.03 mg (21 tabs)
Yasmin 28 (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.03 mg (21 tabs), 7 inert tabs
Yaz (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.02 mg (24 tabs), 4 inert tabs
UK Trade Name(s)
UK Availability
Yasmin (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.03 mg (21 tabs)
Australian Trade Name(s)
Australian Availability
Yasmin (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.03 mg (21 tabs), 7 inert tabs
Yaz (drospirenone/ethinyl estradiol)
- TABS: 3 mg/0.02 mg (24 tabs), 4 inert tabs
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Ocella 3-0.03 MG TABS [Disp Pack] (TEVA PHARMACEUTICALS USA)
28 mg = $71.99
84 mg = $195.98 - YAZ 3-0.02 MG TABS [Disp Pack] (BAYER HEALTHCARE PHARMA)
28 mg = $92.99
84 mg = $252.97 - Zarah 3-0.03 MG TABS [Disp Pack] (WATSON LABS)
28 mg = $71.99
84 mg = $199.96 - Gianvi 3-0.02 MG TABS [Disp Pack] (TEVA PHARMACEUTICALS USA)
28 mg = $69.99
84 mg = $189.96 - Yasmin 28 3-0.03 MG TABS [Disp Pack] (BAYER HEALTHCARE PHARMA)
28 mg = $85.99
56 mg = $161.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
15 cigarettes/day) and is quite marked in women over 35 years of age