Adult Dosing
Contraception, Menorrhagia
- 1 tab PO qd; initiate on day 1 of menstrual cycle
- Start with 0 mg/3 mg (2 tabs), then 2 mg/2 mg (5 tabs), and 3 mg/2 mg (17 tabs), followed by 0 mg/1 mg (2 tabs) and 2 inert tabs
- After taking 28 tabs, start a new course the day after taking the last inert tablet
Notes:- Instruct patients to use a non-hormonal back-up method of contraception for the first 9 days
- Tablets should be taken at the same time each day; tablets must be taken as recommended
- Do not skip or delay intake by >12 hrs
- Discontinue use at least 4 weeks before and through 2 weeks after major surgery
- May be started 4-6 wks postpartum in women who elect not to breastfeed
- On development of severe vomiting or diarrhea, undertake additional contraceptive measures. If vomiting or diarrhea occurs within 3-4 hrs after taking a colored tablet, consider it as a missed dose
Pediatric Dosing
Contraception, Menorrhagia (Postpubertal females)
- 1 tab PO qd; initiate on day 1 of menstrual cycle
- Start with 0 mg/3 mg (2 tabs), then 2 mg/2 mg (5 tabs), and 3 mg/2 mg (17 tabs), followed by 0 mg/1 mg (2 tabs) and 2 inert tabs
- After taking 28 tabs, start a new course the day after taking the last inert tablet
Notes:- Not indicated before menarche
- Instruct patients to use a non-hormonal back-up method of contraception for the first 9 days
- Tablets should be taken at the same time each day; tablets must be taken as recommended
- Do not skip or delay intake by >12 hrs
- Discontinue use at least 4 weeks before and through 2 weeks after major surgery
- May be started 4-6 wks postpartum in women who elect not to breastfeed
- On development of severe vomiting or diarrhea, undertake additional contraceptive measures. If vomiting or diarrhea occurs within 3-4 hrs after taking a colored tablet, consider it as a missed dose
[Outline]
See Supplemental Patient Information
- Cigarette smokers are more prone to the risk of serious cardiovascular side effects from combination 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
- Oral contraceptives may potentiate the effects of well-known risk factors such as hypertension, diabetes, hyperlipidemias, age and obesity; these risk factors have been associated with an increased risk of heart disease. Use cautiously in women with cardiovascular disease risk factors
- Increased risk of thromboembolic and thrombotic disease has been reported with the use of OCP; risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives. 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; initiate use not earlier than 4 weeks after delivery in women electing not to breastfeed
- Combination 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
- COCs 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
- Combination oral contraceptives may increase the risk of breast and cervical cancer. Discontinuation of OCP decreases this risk. Avoid use in females with known or suspected carcinoma of the breast or personal history of breast cancer
- Discontinue therapy on development of jaundice. It is essential to discontinue therapy 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
- Long-term use increases the risk of hepatocellular carcinoma. Women with a history of pregnancy-related cholestasis are prone to contraceptive-related cholestasis and the condition may recur with subsequent COC use
- Hypertension may occur during therapy. Monitor blood pressure in women with well-controlled hypertension and cease therapy on significant rise in blood pressure. Avoid usage in women with uncontrolled hypertension or hypertension with vascular disease. Use of therapy for prolonged duration and increased age is associated with increase in blood pressure. Increased concentration of progestin results in increased incidence of hypertension
- Small increased relative risk of developing gallbladder disease exists among COC users
- Carefully monitor prediabetic and diabetic women while taking COCs, as they may decrease glucose tolerance in a dose-related fashion. Alternative contraception should be considered for women with uncontrolled dyslipidemia. COCs may increase the risk of pancreatitis in women with hypertriglyceridemia or a family history thereof
- 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 COC 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. If such causes are excluded, bleeding irregularities may resolve over time or with a change to a different COC. Amenorrhea may occur in women who are not pregnant and using this drug. Rule out pregnancy in the event of amenorrhea occurring in two or more consecutive cycles. Amenorrhea or oligomenorrhea may occur after stopping COCs, especially when such a condition was pre-existent
- Discontinue use on detection of pregnancy. Avoid using oral contraceptives as a test for pregnancy
- Closely monitor women with a history of depression; discontinue use if depression recurs to a serious degree
- This drug is associated with alterations in the results of certain lab tests, including coagulation factors, lipids, glucose tolerance, and binding proteins. Increased doses of thyroid hormone may be essential in women on thyroid hormone replacement therapy
- Advise women using this drug to have a yearly visit with her healthcare provider for monitoring blood pressure and for other indicated healthcare
- Avoid concomitant use of this combination drug with medications that are strong CYP3A4 inducers and for at least 28 days after discontinuation of these inducers due to the possibility of decreased contraceptive efficacy
- Exogenous estrogens may induce or exacerbate symptoms of angioedema in women with hereditary angioedema. Advise women having a tendency for chloasma to avoid exposure to the sun or ultraviolet radiation while taking COCs
Cautions: Use cautiously in
- Hepatic impairment
- Renal disease
- Diabetes mellitus
- Hypertension
- Hyperlipidemia
- History of depression
- Sensitive to fluid retention
- Vomiting or diarrhea
- Obesity
- Breastfeeding 6 wks-6 months postpartum
- Inflammatory bowel disease
- Hereditary angioedema
Supplemental Patient Information
- If patients are switched from a combination hormonal method such as another pill, vaginal ring, or patch, advise users to take the first dark yellow pill on the first day of her withdrawal bleed. Instruct them to avoid taking the pills from her previous birth control pack. If a woman does not have a withdrawal bleed, rule out pregnancy before initiation of this combination oral contraceptives
- If a woman is using a vaginal ring or transdermal patch, advise her to initiate this combination contraceptives on the day the ring or patch is removed
- If the patient is switching from a progestin-only method such as progestin-only pill, implant, intrauterine system, or injection, instruct her to use the first dark yellow pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection
Pregnancy Category:X
Breastfeeding: Dienogest is only available in the US in a combination oral contraceptive product that also contains estradiol valerate. Estradiol valerate has not been evaluated during breastfeeding. Based on the available evidence, nonhormonal methods are preferred during breastfeeding and progestin-only contraceptives are preferred over combined oral contraceptives in breastfeeding women, especially during the first 4 weeks postpartum. 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. 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 9 August 2011). Manufacturer advises the nursing mother to avoid using combination oral contraceptives and to use other forms of contraception until she has completely weaned her child.
US Trade Name(s)
US Availability
Natazia (dienogest/estradiol valerate)
- TABS (28-day pack):
- 0 mg/3 mg (2 dark yellow tablets)
- 2 mg/2 mg (5 medium red tablets)
- 3 mg/2 mg (17 light yellow tablets)
- 0 mg/1 mg (2 dark red tablets)
- 0 mg/0 mg (2 white inert tablets)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Qlaira (dienogest/estradiol valerate)
- TABS (28-day pack):
- 0 mg/3 mg (2 dark yellow tablets)
- 2 mg/2 mg (5 medium red tablets)
- 3 mg/2 mg (17 light yellow tablets)
- 0 mg/1 mg (2 dark red tablets)
- 0 mg/0 mg (2 white inert tablets)
Australian Trade Name(s)
Australian Availability
Qlaira (dienogest/oestradiol valerate)
- TABS (28-day pack):
- 0 mg/3 mg (2 dark yellow tablets)
- 2 mg/2 mg (5 medium red tablets)
- 3 mg/2 mg (17 light yellow tablets)
- 0 mg/1 mg (2 dark red tablets)
- 0 mg/0 mg (2 white inert tablets)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Natazia 3/2-2/2-3/1 MG TABS [Disp Pack] (BAYER HEALTHCARE PHARMA)
28 mg = $93.07
84 mg = $251.83
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.
Drug Name: Natazia 28 Day Pack
Ingredient(s): Dienogest mixture with Estradiol and Inert Ingredients
Imprint: DT
Color(s): White
Shape: Round
Size (mm): 6.00
Score: 1
Inactive Ingredient(s): hypromellose / lactose monohydrate / polyethylene glycol 6000 / magnesium stearate / starch, corn / povidone k25 / talc / titanium dioxide
Drug Label Author:
Bayer HealthCare Pharmaceuticals Inc.
DEA Schedule:
Non-Scheduled
15 cigarettes/day) and is quite marked in women over 35 years of age