Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Overview
What is Safyral?
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below:
The inactive ingredients in the orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose USP, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF, ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF. The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF and ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF.
Drospirenone (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 (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.
Levomefolate calcium (N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid, calcium salt) is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B and has a molecular weight of 497.5 and a molecular formula of CHCaNO
The structural formulas are as follows:
What does Safyral look like?
What are the available doses of Safyral?
Safyral consists of 28 film-coated, biconvex tablets in the following order ():
What should I talk to my health care provider before I take Safyral?
How should I use Safyral?
Safyral 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 effectiveness, Safyral must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
What interacts with Safyral?
Sorry No Records found
What are the warnings of Safyral?
Sorry No Records found
What are the precautions of Safyral?
Sorry No Records found
What are the side effects of Safyral?
Sorry No records found
What should I look out for while using Safyral?
Do not prescribe Safyral to women who are known to have the following:
What might happen if I take too much Safyral?
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.
Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of Safyral) were well tolerated after long-term treatment up to 12 weeks.
How should I store and handle Safyral?
Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016These solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USAThese solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USAThese solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USAThese solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USAThese solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USAThese solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USAThese solutions are not for spinal anesthesia.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]MARCAINERevised: 10/2011 Printed in USA EN-2916 Hospira, Inc., Lake Forest, IL 60045 USA
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 endometrial changes that reduce the likelihood of implantation.
Non-Clinical Toxicology
Do not prescribe Safyral to women who are known to have the following:Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.
Stop Safyral 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 Safyral 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.
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
†
#
(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
If feasible, stop Safyral at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Safyral 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 (>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 Safyral 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.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
514Total User Reviews
User Reviews
Learn about
User Reviews
Professional
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
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).