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Drospirenone and ethinyl estradiol
Overview
What is Gianvi?
Gianvi (drospirenone/ethinyl estradiol tablets) provides an oral contraceptive regimen consisting of 24 light pink active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol stabilized by betadex as a clathrate (molecular inclusion complex) and 4 white inert film coated tablets.
The inactive ingredients in the light pink tablets are lactose monohydrate NF, corn starch NF, magnesium stearate NF, hypromellose USP, talc USP, titanium dioxide USP, ferric oxide pigment, red NF. The white inert film-coated tablets contain lactose monohydrate NF, microcrystalline cellulose NF, magnesium stearate NF, hypromellose USP, talc USP, titanium dioxide USP.
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 C24H30O3.
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 C20H24O2.
The structural formulas are as follows:
What does Gianvi look like?
What are the available doses of Gianvi?
Gianvi (drospirenone/ethinyl estradiol tablets) is available in blister packs.
Each blister pack (28 film-coated tablets) contains in the following order:
What should I talk to my health care provider before I take Gianvi?
Nursing Mothers: Not recommended; can decrease milk production. ()
How should I use Gianvi?
Gianvi 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, Gianvi 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 Gianvi?
Sorry No Records found
What are the warnings of Gianvi?
Sorry No Records found
What are the precautions of Gianvi?
Sorry No Records found
What are the side effects of Gianvi?
Sorry No records found
What should I look out for while using Gianvi?
Do not prescribe Gianvi to women who are known to have the following:
What might happen if I take too much Gianvi?
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 Gianvi?
Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK Zafirlukast tablets 10 mg Zafirlukast tablets 20 mg STORAGEStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in the original air-tight container. Rx Only Manufactured for:AvKARE, Inc. Pulaski, TN 38478Mfg. Iss. 1010AV 09/17 (P) AvPAK
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 Gianvi to women who are known to have the following:In a drug interaction study in 16 healthy male volunteers, coadministration of multiple doses of zafirlukast (160 mg/day) to steady-state with a single 25 mg dose of warfarin resulted in a significant increase in the mean AUC (+ 63%) and half-life (+36%) of S-warfarin. The mean prothrombin time (PT) increased by approximately 35%. This interaction is probably due to an inhibition by zafirlukast of the cytochrome P450 2C9 isoenzyme system. Patients on oral warfarin anticoagulant therapy and zafirlukast should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see ). No formal drug-drug interaction studies with zafirlukast and other drugs known to be metabolized by the cytochrome P450 2C9 isoenzyme (eg, tolbutamide, phenytoin, carbamazepine) have been conducted; however, care should be exercised when zafirlukast is coadministered with these drugs.
In a drug interaction study in 11 asthmatic patients, coadministration of a single dose of zafirlukast (40 mg) with erythromycin (500 mg three times daily for 5 days) to steady-state resulted in decreased mean plasma levels of zafirlukast by approximately 40% due to a decrease in zafirlukast bioavailability.
Coadministration of zafirlukast (20 mg/day) or placebo at steady-state with a single dose of sustained release theophylline preparation (16 mg/kg) in 16 healthy boys and girls (6 through 11 years of age) resulted in no significant differences in the pharmacokinetic parameters of theophylline.
Coadministration of zafirlukast (80 mg/day) at steady-state with a single dose of a liquid theophylline preparation (6 mg/kg) in 13 asthmatic patients, 18 to 44 years of age, resulted in decreased mean plasma levels of zafirlukast by approximately 30%, but no effect on plasma theophylline levels was observed.
Rare cases of patients experiencing increased theophylline levels with or without clinical signs or symptoms of theophylline toxicity after the addition of zafirlukast to an existing theophylline regimen have been reported. The mechanism of the interaction between zafirlukast and theophylline in these patients is unknown (see ).
Coadministration of zafirlukast (40 mg/day) with aspirin (650 mg four times daily) resulted in mean increased plasma levels of zafirlukast by approximately 45%.
In a single-blind, parallel-group, 3-week study in 39 healthy female subjects taking oral contraceptives, 40 mg twice daily of zafirlukast had no significant effect on ethinyl estradiol plasma concentrations or contraceptive efficacy.
No formal drug-drug interaction studies between zafirlukast and marketed drugs known to be metabolized by the P450 3A4 (CYP3A4) isoenzyme (eg, dihydropyridine calcium-channel blockers, cyclosporin, cisapride) have been conducted. As zafirlukast is known to be an inhibitor of CYP3A4 , it is reasonable to employ appropriate clinical monitoring when these drugs are coadministered with zafirlukast.
Stop Gianvi 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 Gianvi 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
† 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
If feasible, stop Gianvi at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Gianvi 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 Gianvi 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/"
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