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Drospirenone and Ethinyl Estradiol
Overview
What is Vestura?
Vestura (drospirenone/ethinyl estradiol tablets USP) provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets.
The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized starch, magnesium stearate, and FD&C red #40. The peach inert uncoated tablets contain lactose monohydrate, microcrystalline cellulose, FD&C yellow #6, and magnesium stearate.
Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of CHO.
Ethinyl Estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of CHO.
The structural formulas are as follows:
What does Vestura look like?
What are the available doses of Vestura?
Vestura consist of 28 uncoated, flat-face bevel edge tablets in the following order (:
What should I talk to my health care provider before I take Vestura?
Nursing Mothers: Not recommended; can decrease milk production. ()
How should I use Vestura?
Vestura is indicated for use by women to prevent pregnancy.
Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.
To achieve maximum contraceptive and PMDD effectiveness, Vestura must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
What interacts with Vestura?
Sorry No Records found
What are the warnings of Vestura?
Sorry No Records found
What are the precautions of Vestura?
Sorry No Records found
What are the side effects of Vestura?
Sorry No records found
What should I look out for while using Vestura?
Do not prescribe Vestura to women who are known to have the following:
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke .
What might happen if I take too much Vestura?
There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
DRSP is a spironolactone analogue which has anti-mineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.
How should I store and handle Vestura?
JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures 1000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/171000mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "H/104" on one side and plain on the other side. NDC 66267-553-30 BOTTLES OF 30StorageStore at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.]Dispense in tight, light-resistant containers with child-resistant closure.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901. DRUG(3784)Made in India Iss. 07/17
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and the endometrial changes that reduce the likelihood of implantation.
Non-Clinical Toxicology
Do not prescribe Vestura to women who are known to have the following:Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke .
(Clinical Evaluation of Drug Interactions Conducted with metformin hydrochloride tablets)
Glyburide—In a single-dose interaction study in type 2 diabetes patients, coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and C were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain (see ).
Furosemide
Nifedipine
Drugs that reduce metformin clearance
Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Alcohol
Stop Vestura if an arterial or venous thrombotic (VTE) event occurs.
Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin*), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of Vestura in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs .
A number of studies have compared the risk of VTE for users of Yasmin* (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel. Those that were required or sponsored by regulatory agencies are summarized in Table 1.
Table 1: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin*
Compared to Users of Oral Contraceptives that Contain Other Progestins
In addition to these “regulatory studies,” other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 1): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007]. An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 1), and two from Denmark [Lidegaard 2009, Lidegaard 2011]. There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010]. There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011]. The results of all of these studies are presented in Figure 1.
Figure 1: VTE Risk with Yasmin* Relative to LNG-Containing COCs (adjusted risk)
Risk ratios displayed on logarithmic scale; risk ratio < 1 indicates a lower risk of VTE for DRSP, > 1 indicates an increased risk of VTE for DRSP.
*Comparator “Other COCs”, including LNG- containing COCs
† LASS is an extension of the EURAS study
#Some adjustment factors are indicated by superscript letters: a) Current heavy smoking, b) hypertension, c) obesity, d) family history, e) age, f) BMI, g) duration of use, h) VTE history, i) period of inclusion, j) calendar year, k) education, l) length of use, m) parity, n) chronic disease, o) concomitant medication, p) smoking, q) duration of exposure, r) site
(References: Ingenix [Seeger 2007], EURAS (European Active Surveillance Study) [Dinger 2007], LASS (Long-Term Active Surveillance Study) [Dinger, unpublished document on file], FDA-funded study [Sidney 2011], Danish [Lidegaard 2009], Danish re-analysis [ Lidegaard 2011], MEGA study [van Hylckama Vlieg 2009], German Case-Control study [Dinger 2010], PharMetrics [Jick 2011], GPRD study [Parkin 2011])
Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2). The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.
The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
Figure 2 shows the risk of developing a VTE for women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, for pregnant women, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE.
Figure 2: Likelihood of Developing a VTE
* Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY.
If feasible, stop Vestura at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Vestura no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (greater than 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.
Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Stop Vestura if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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