Dosing & Uses
Dosage Forms and Strengths
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
tablet, monophasic
- 0.1mg/0.02mcg (21 tabs) plus 36.5mg ferrous bisglycinate (7 tabs)
Oral Contraception
Indicated for use by females of reproductive potential to prevent pregnancy
Follow manufacturer's color-coding for sequence
1 active tab PO qDay for 21 days, then 1 Fe tab PO qDay on Days 22-28
Take tablets in the order directed on the blister pack
Also see Administration
Dosage Modifications
Drug interactions
- Drugs or herbal products that may decrease the effectiveness of hormonal contraceptives (eg, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, products containing St. John’s wort): Use an alternative method of contraception or a back-up method and continue backup contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability
- Coadministration with colesevelam: Separate doses by 4 hr
- Discontinue levonorgestrel oral/ethinylestradiol/ferrous bisglycinate prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; restart therapy ~2 weeks following completion of hepatitis C treatment (see Contraindications)
- Also see Warnings
Discontinue if these adverse reactions occurs
- Arterial thrombotic event or venous thromboembolic event occurs
- Unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions occurs
- Jaundice develops
Hepatic impairment
- Pharmacokinetics of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate have not been studied in women with hepatic impairment
- Steroid hormones may be poorly metabolized in patients with hepatic impairment
- See Contraindications and Warnings
Dosing Considerations
Switching to levonorgestrel oral/ethinylestradiol/ferrous bisglycinate from another contraceptive method
- Transdermal patch: Start levonorgestrel oral/ethinylestradiol/ferrous bisglycinate on the next scheduled application
- Vaginal ring: Start levonorgestrel oral/ethinylestradiol/ferrous bisglycinate on the day when next insertion would have been scheduled
- Injection: Start levonorgestrel oral/ethinylestradiol/ferrous bisglycinate on the day when next injection would have been scheduled
- Intrauterine contraceptive (IUD): Start levonorgestrel oral/ethinylestradiol/ferrous bisglycinate on the day of removal; if IUD is not removed on first day of the patient’s menstrual cycle, additional nonhormonal contraceptive (eg, condoms, spermicide) is needed for the first 7 days of the first cycle pack
- Implant: Start levonorgestrel oral/ethinylestradiol/ferrous bisglycinate on the day of removal
After abortion or miscarriage during first trimester
- After a first-trimester abortion or miscarriage, start levonorgestrel oral/ethinylestradiol/ferrous bisglycinate immediately
- Initiating within 5 days after pregnancy termination: No additional method of contraception is needed
- Initiating >5 days after termination of pregnancy: Additional nonhormonal contraception (eg, condoms, spermicide) required for the first 7 days of first cycle pack
- Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to increased risk of thromboembolic disease; start therapy following instructions for Day 1 or Sunday start, as desired; if using Sunday start, use additional non-hormonal contraception (such as condoms or spermicide) for first seven days of patient’s first cycle pack of contraceptive therapy
After childbirth
- Do not start until 4 weeks after delivery owing to increased risk of thromboembolic disease
- Start contraceptive therapy following instructions for women not currently using hormonal contraception
- If woman has not yet had a period postpartum, consider possibility of ovulation and conception occurring prior to use of contraceptive therapy
- CDC guidelines recommend waiting 3 weeks after delivery in postpartum women with no venous thromboembolism (VTE) risks and 3-6 weeks in postpartum women with additional VTE risks (Morbidity and Mortality Weekly; July 29, 2016)
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate, ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC). unknown mechanism. Contraindicated. ALT elevations >5x ULN (including some >20x ULN) observed in clinical trials when ethinyl estradiol was coadministered with ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Discontinue ethinyl estradiol-containing medications before initiating ombitasvir/paritaprevir/ritonavir, and/or dasabuvir. Restart ethinyl estradiol containing medication ~2 weeks after hepatitis C combination drug regimen completed.
Serious - Use Alternative (19)
- atazanavir
atazanavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- belzutifan
belzutifan will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of belzutifan with hormonal contraceptives may lead to contraceptive failure or increased breakthrough bleeding. Advise females of reproductive potential to use effective nonhormonal contraception. Based on animal studies, belzutifan can cause fetal harm.
- calaspargase pegol
calaspargase pegol, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. unknown mechanism. Avoid or Use Alternate Drug. Due to the potential for an indirect interaction between calaspargase pegol and oral contraceptives, concomitant use of these drugs is not recommended. Use another non-oral contraceptive method for females of childbearing potential.
- darunavir
darunavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- elagolix
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate decreases effects of elagolix by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action of elagolix, estrogen-containing contraceptives are expected to reduce elagolix efficacy. Effects of progestin-only contraceptives on the efficacy of elagolix is unknown. Advise women to use nonhormonal contraceptives during treatment with elagolix and for 1 week after discontinuing elagolix.
- encorafenib
encorafenib will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of encorafenib with hormonal contraceptives (CYP3A4 substrates) can result in decreased concentrations and loss of hormonal contraceptive efficacy. Encorafenib can cause fetal harm. Advise women of childbearing potential to use a highly effective nonhormonal contraceptive during treatment and for 2 weeks after final encorafenib dose.
- indinavir
indinavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- isavuconazonium sulfate
isavuconazonium sulfate will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lopinavir
lopinavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- mavacamten
mavacamten will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Progestin and ethinyl estradiol are CYP3A4 substrates. Mavacamten may decrease systemic exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) or add nonhormonal contraception (eg, condoms) during coadministration and for 4 months after last mavacamten dose.
- mobocertinib
mobocertinib will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of mobocertinib with hormonal contraceptives may lead to contraceptive failure or increased breakthrough bleeding. Advise females of reproductive potential to use effective non-hormonal contraception.
- nelfinavir
nelfinavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- nevirapine
nevirapine will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- omaveloxolone
omaveloxolone will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Omaveloxolone may reduce efficacy of hormonal contraceptives (eg, pill, patch, ring), implants, and progestin-only pills owing to weak CYP3A4 induction.
- pexidartinib
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- pretomanid
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- ritonavir
ritonavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- saquinavir
saquinavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
- tipranavir
tipranavir, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. Other (see comment). Avoid or Use Alternate Drug. Comment: Significant changes (increase or decrease) can occur in estrogen plasma levels. Efficacy of hormonal contraceptives may be reduced. Use of a nonhormonal contraceptive is recommended.
Monitor Closely (123)
- acetaminophen
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of acetaminophen by unknown mechanism. Use Caution/Monitor.
acetaminophen increases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by decreasing hepatic clearance. Use Caution/Monitor. Coadministration of ascorbic acid and certain combined hormonal contraceptives (CHCs) containing EE may increase plasma EE concentrations, possibly by inhibition of conjugation. - acetaminophen IV
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of acetaminophen IV by unknown mechanism. Use Caution/Monitor.
- acetaminophen rectal
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of acetaminophen rectal by unknown mechanism. Use Caution/Monitor.
- alprazolam
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of alprazolam by decreasing metabolism. Use Caution/Monitor. Ethinyl estradiol may inhibit the clearance of benzodiazepines that undergo oxidation, thereby increasing serum concentrations of concomitantly administered benzodiazepines.
- amobarbital
amobarbital will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- amoxicillin
amoxicillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- ampicillin
ampicillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- aprepitant
aprepitant will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- ascorbic acid
ascorbic acid increases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by decreasing hepatic clearance. Use Caution/Monitor. Coadministration of ascorbic acid and certain combined hormonal contraceptives (CHCs) containing EE may increase plasma EE concentrations, possibly by inhibition of conjugation.
- atorvastatin
atorvastatin increases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Coadministration of atorvastatin and certain combined hormonal contraceptives (CHCs) containing EE increase AUC values for EE by approximately 20-25%.
- bosentan
bosentan will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- brigatinib
brigatinib will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Brigatinib induces CYP3A4 in vitro. Coadministration of hormonal contraceptives with brigatinib can result in decreased concentrations and loss of efficacy. Brigatinib can cause fetal harm. Women should use an effective nonhormonal method of contraception during treatment and for at least 4 months after the last brigatinib dose.
- butabarbital
butabarbital will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- butalbital
butalbital will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- carbamazepine
carbamazepine will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- cefaclor
cefaclor will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefadroxil
cefadroxil will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefazolin
cefazolin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefdinir
cefdinir will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefepime
cefepime will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefixime
cefixime will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefotaxime
cefotaxime will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefprozil
cefprozil will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- ceftazidime
ceftazidime will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- ceftibuten
ceftibuten will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cefuroxime
cefuroxime will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- cenobamate
cenobamate will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Advise women to use additional or alternative non-hormonal birth control when concomitantly using cenobamate with oral contraceptives.
- cephalexin
cephalexin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- chloramphenicol
chloramphenicol will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- ciprofloxacin
ciprofloxacin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- clarithromycin
clarithromycin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
clarithromycin will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended. - clindamycin
clindamycin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- clonazepam
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of clonazepam by decreasing metabolism. Use Caution/Monitor. Ethinyl estradiol may inhibit the clearance of benzodiazepines that undergo oxidation, thereby increasing serum concentrations of concomitantly administered benzodiazepines.
- cobicistat
cobicistat will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- colesevelam
colesevelam decreases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by Other (see comment). Modify Therapy/Monitor Closely. Comment: Colesevelam, a bile acid sequestrant, given together with a combined hormonal contraceptives (CHCs), has been shown to significantly decrease the AUC of ethinyl estradiol (EE). Oral contraceptives containing ethinyl estradiol should be administered at least 4 hours before the colesevelam dose.
- conivaptan
conivaptan will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- cyclosporine
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate, cyclosporine. Either increases levels of the other by decreasing metabolism. Use Caution/Monitor. Combined oral contraceptives containing EE may inhibit the metabolism and increase plasma concentrations of cyclosporine.
- dabrafenib
dabrafenib will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- demeclocycline
demeclocycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- dexamethasone
dexamethasone will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- diazepam
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of diazepam by decreasing metabolism. Use Caution/Monitor. Ethinyl estradiol may inhibit the clearance of benzodiazepines that undergo oxidation, thereby increasing serum concentrations of concomitantly administered benzodiazepines.
- dicloxacillin
dicloxacillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- doxycycline
doxycycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- efavirenz
efavirenz will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- enzalutamide
enzalutamide will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- erythromycin base
erythromycin base will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- erythromycin lactobionate
erythromycin lactobionate will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- erythromycin stearate
erythromycin stearate will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- etravirine
etravirine will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- fosamprenavir
fosamprenavir will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- fosaprepitant
fosaprepitant will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- fosphenytoin
fosphenytoin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- gemifloxacin
gemifloxacin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- grapefruit
grapefruit will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- griseofulvin
griseofulvin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- idelalisib
idelalisib will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- imatinib
imatinib will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- isoniazid
isoniazid will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- itraconazole
itraconazole will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- ivosidenib
ivosidenib will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Coadministration of ivosidenib may decrease the concentrations of hormonal contraceptives, consider alternative methods of contraception in patients receiving ivosidenib.
- ketoconazole
ketoconazole will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- lamotrigine
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate decreases levels of lamotrigine by unspecified interaction mechanism. Use Caution/Monitor. Significant decrease in plasma concentration of lamotrigine when concomitantly used with combined hormonal contraceptives (CHCs) containing EE, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
- lesinurad
lesinurad will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- levofloxacin
levofloxacin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- levoketoconazole
levoketoconazole will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- levothyroxine
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of levothyroxine by unknown mechanism. Modify Therapy/Monitor Closely. The estrogen component of combined hormonal contraceptives (CHCs) may raise the serum concentrations of thyroxine-binding globulin. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone with use of CHCs.
- liothyronine
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of liothyronine by unknown mechanism. Modify Therapy/Monitor Closely. The estrogen component of combined hormonal contraceptives (CHCs) may raise the serum concentrations of thyroxine-binding globulin. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone with use of CHCs.
- liotrix
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of liotrix by unknown mechanism. Modify Therapy/Monitor Closely. The estrogen component of combined hormonal contraceptives (CHCs) may raise the serum concentrations of thyroxine-binding globulin. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone with use of CHCs.
- lixisenatide (DSC)
lixisenatide (DSC) will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. GLP1 agonists delay gastric emptying, which may affect absorption of concomitantly administered oral medications. Oral contraceptives should be taken at least 1 hr before lixisenatide administration or 11 hr after lixisenatide.
- lonapegsomatropin
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of lonapegsomatropin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- metronidazole
metronidazole will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- midazolam
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of midazolam by decreasing metabolism. Use Caution/Monitor. Ethinyl estradiol may inhibit the clearance of benzodiazepines that undergo oxidation, thereby increasing serum concentrations of concomitantly administered benzodiazepines.
- mineral oil
mineral oil decreases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely.
- minocycline
minocycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- mitotane
mitotane will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- morphine
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of morphine by unknown mechanism. Use Caution/Monitor.
- moxifloxacin
moxifloxacin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- nafcillin
nafcillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- nefazodone
nefazodone will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- neomycin PO
neomycin PO will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- nicardipine
nicardipine will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- nitrofurantoin
nitrofurantoin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- ofloxacin
ofloxacin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- paromomycin
paromomycin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- penicillin VK
penicillin VK will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- pentobarbital
pentobarbital will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- phenobarbital
phenobarbital will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- phenytoin
phenytoin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- pitolisant
pitolisant will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Pitolisant is a borderline/weak inducer of CYP3A4. Monitor sensitive CYP3A4 substrates for reduced effectiveness if coadministered.
- posaconazole
posaconazole will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended.
- prednisolone
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of prednisolone by decreasing metabolism. Use Caution/Monitor. Combined oral contraceptives containing EE may inhibit the metabolism and increase plasma concentrations of cyclosporine.
- primidone
primidone will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- rifabutin
rifabutin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- rifampin
rifampin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- rifapentine
rifapentine will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- rosuvastatin
rosuvastatin increases levels of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Coadministration of rosuvastatin and certain combined hormonal contraceptives (CHCs) containing EE increase AUC values for EE by approximately 20-25%.
- rufinamide
rufinamide will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- salicylic acid acne
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of salicylic acid acne by unknown mechanism. Use Caution/Monitor.
- secobarbital
secobarbital will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- somapacitan
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of somapacitan by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- somatrogon
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of somatrogon by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- somatropin
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of somatropin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- St John's Wort
St John's Wort will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- sulfadiazine
sulfadiazine will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- sulfamethoxazole
sulfamethoxazole will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- sulfisoxazole
sulfisoxazole will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- temazepam
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of temazepam by unknown mechanism. Use Caution/Monitor.
- tetracycline
tetracycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- theophylline
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of theophylline by decreasing metabolism. Use Caution/Monitor. Combined oral contraceptives containing EE may inhibit the metabolism and increase plasma concentrations of cyclosporine.
- thyroid desiccated
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of thyroid desiccated by unknown mechanism. Modify Therapy/Monitor Closely. The estrogen component of combined hormonal contraceptives (CHCs) may raise the serum concentrations of thyroxine-binding globulin. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone with use of CHCs.
- ticarcillin
ticarcillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- tigecycline
tigecycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- tizanidine
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of tizanidine by decreasing metabolism. Use Caution/Monitor. Combined oral contraceptives containing EE may inhibit the metabolism and increase plasma concentrations of cyclosporine.
- topiramate
topiramate will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. The efficacy of hormonal contraceptives may be reduced. Use an alternative method of contraception or a backup method when enzyme inducers are used with combined hormonal contraceptives (CHCs), and continue backup contraception for 28 days after discontinuing enzyme inducer to ensure contraceptive reliability.
- triazolam
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of triazolam by decreasing metabolism. Use Caution/Monitor. Ethinyl estradiol may inhibit the clearance of benzodiazepines that undergo oxidation, thereby increasing serum concentrations of concomitantly administered benzodiazepines.
- trimethoprim
trimethoprim will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- valoctocogene roxaparvovec
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate and valoctocogene roxaparvovec both increase Other (see comment). Use Caution/Monitor. Medications that may cause hepatotoxicity when combined with valoctogene roxaparvovec may potentiate the risk of elevated liver enzymes. Closely monitor these medications and consider alternative medications in case of potential drug interactions.
- voriconazole
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will increase the level or effect of voriconazole by decreasing metabolism. Use Caution/Monitor. Combined oral contraceptives containing EE may inhibit the metabolism and increase plasma concentrations of cyclosporine.
voriconazole will increase the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with CYP3A4 inhibitors may increase the plasma hormone concentrations. Use of a nonhormonal contraceptive is recommended. - warfarin
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
Minor (1)
- enasidenib
enasidenib, levonorgestrel oral/ethinylestradiol/ferrous bisglycinate. unknown mechanism. Minor/Significance Unknown. Coadministration of enasidenib may increase or decrease the concentrations of combined hormonal contraceptives. Clinical significance of this interaction is unknown.
Adverse Effects
>10%
Headache (14%)
1-10%
Metrorrhagia (8%)
Dysmenorrhea (7%)
Nausea (7%)
Abdominal pain (4%)
Breast pain (4%)
Emotional lability (3%)
Acne (3%)
Depression (2%)
Amenorrhea (2%)
Vaginal moniliasis (2%)
<1%
Hypertension
Hypercholesterolemia
Weight gain
Dysmenorrhea
Flatulence
Postmarketing Reports
Cardiac disorder: Chest pain, dyspnea, palpitations
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea
General disorders and administration site conditions: Chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia
Immune system disorders: Hypersensitivity reactions, including pruritus, rash, urticaria, erythema
Injury, poisoning, and procedural complications: Injury
Investigations: Decreased weight
Musculoskeletal and connective-tissue disorders: Pain in extremity, arthralgia, back pain, muscle spasm
Nervous system disorders: Headache, migraine, dizziness, hypoesthesia, paresthesia
Psychiatric disorders: Depression, insomnia, anxiety
Reproductive system and breast disorders: Metrorrhagia, menorrhagia, hot flush, vaginal hemorrhage
Respiratory, thoracic, and mediastinal disorders: Nasopharyngitis, cough
Sleep disorders and disturbances: Somnolence
Vascular disorders: Deep vein thrombosis, pulmonary embolism
Warnings
Black Box Warnings
Cigarette smoking & risk of cardiovascular disease
- Cigarette smoking increases risk of serious cardiovascular adverse effects from combination hormonal contraceptive use
- This risk increases with age (>35 years) and with heavy smoking (15 or more cigarettes/day)
- For this reason, combined hormonal contraceptives (CHCs) are contraindicated in women aged >35 years who smoke
Contraindications
Liver tumors, benign or malignant, or liver disease (acute viral hepatitis or severe, decompensated, cirrhosis of the liver)
Undiagnosed abnormal uterine bleeding
Pregnancy (no reason to use CHCs during pregnancy)
History or current breast cancer or other estrogen- or progestin-sensitive cancer
Hypersensitivity
Coadministration with ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
High risk of arterial or venous thrombotic disease
- Smoking, if older than 35 years (see Black Box Warnings)
- History or current deep vein thrombosis or pulmonary embolism
- Inherited or acquired hypercoagulopathies
- Cerebrovascular disease
- Coronary artery disease
- Thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, atrial fibrillation)
- Uncontrolled hypertension
- Diabetes mellitus with vascular disease
- Headaches with focal neurological symptoms or have migraine headaches with aura
- Women over age 35 with any migraine headaches
Cautions
Risk of postpartum VTE decreases after third postpartum week, whereas risk of ovulation increases after third postpartum week; start contraceptive therapy no earlier than 4 weeks after delivery, in women who are not breastfeeding
Acute or chronic disturbances of liver function may necessitate the discontinuation of CHCs use until liver function resolves to normal and CHC causation has been excluded
Hepatic adenomas are associated with CHCs use; studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) combined oral contraceptive (COC) users (see Contraindications)
Studies suggest a small increased relative risk of developing gallbladder disease among CHC users; use of CHCs may worsen existing gallbladder disease; past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use; women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis
CHCs may decrease glucose tolerance; carefully monitor in prediabetes and diabetes
Consider alternative contraception for women with uncontrolled dyslipidemia
Small proportion of women will have adverse lipid changes while on CHCs; women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using CHCs
If new headaches that are recurrent, persistent, or severe develop in women taking the drug, evaluate the cause and discontinue therapy if indicated (see Contraindications)
This product contains FD&C yellow no. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons
Carefully observe women with a history of depression, and discontinue therapy if depression recurs to a serious degree
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum; women with a tendency to chloasma should avoid exposure to the sun or ultraviolet light
Bleeding irregularities and amenorrhea
- Unscheduled (breakthrough or intracyclic) bleeding and spotting may occur, especially during the first 3 months of use; if bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy; if pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product
- If scheduled (withdrawal) bleeding does not occur, consider possibility of pregnancy; if patient has not adhered to prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider possibility of pregnancy at time of first missed period and take appropriate diagnostic measures; if patient has adhered to prescribed regimen and misses two consecutive periods, rule out pregnancy
- In clinical trial, 2.6% of the evaluable cycles were amenorrheic; women may experience amenorrhea or oligomenorrhea after discontinuation of CHCs, especially when such a condition was preexistent
Thrombotic disorders and other vascular problems
- Use of CHCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events
- CHCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes)
- If feasible, discontinue CHC at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE, as well as during the following prolonged immobilization
- An increase in blood pressure has been reported in women taking CHCs, and this increase is more likely in older women with extended duration of use (see Contraindications); incidence of hypertension increases with increasing concentrations of progestin; monitor blood pressure periodically; stop therapy in women with well-controlled hypertension if blood pressure rises significantly
Drug interactions overview
- During clinical trials with the hepatitis C combination drug regimen containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, incidences of elevated ALT >5x ULN, including some cases >20x ULN, were significantly more frequent in women using ethinyl estradiol (EE)-containing medications, such as CHCs (see Contraindications)
- Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding
- Coadministration of atorvastatin or rosuvastatin and certain CHCs containing EE increase AUC values for EE by approximately 20-25%
- Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation CYP3A4 inhibitors (eg, itraconazole, voriconazole, fluconazole, grapefruit juice, ketoconazole) may increase plasma hormone concentrations
- Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of coadministration with HIV/HCV protease inhibitors and nonnucleoside reverse-transcriptase inhibitors CHCs containing EE may inhibit the metabolism of other compounds (eg, cyclosporine, prednisolone, theophylline, tizanidine, voriconazole) and increase their plasma concentrations
- CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam, and lamotrigine; significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation
- Estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin; dose of replacement thyroid hormone or cortisol therapy may need to be increased
Pregnancy & Lactation
Pregnancy
Contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy (see Contraindications)
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy
Lactation
Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breastfed infants
CHCs, including levonorgestrel oral/ethinylestradiol/ferrous bisglycinate, can reduce milk production in breastfeeding females; reduction can occur at any time but is less likely to occur once breastfeeding
Advise nursing female to use other methods of contraception until she discontinues breastfeeding
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ethinyl Estradiol (EE): Reduces luteinizing hormone-releasing hormone release from hypothalamus; reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues
Levonorgestrel: Synthetic progestin; ovulation is inhibited from a negative feedback mechanism on hypothalamus, leading to reduced secretion of follicle-stimulating hormone and luteinizing hormone and LH
Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation
Absorption
AUC: 41.7 ng·hr/mL (levonorgestrel); 1167 pg·hr/mL (EE)
Peak plasma concentration: 4.4 ng/mL (levonorgestrel); 115 pg/mL (EE)
Bioavailability after first-pass metabolism: ~100% (levonorgestrel); 38-48% (EE)
Peak plasma time, single dose of two levonorgestrel and EE: 1 hr (levonorgestrel); 1.5 hr (EE)
Distribution
Protein bound (albumin): ~97% (EE)
Metabolism
Levonorgestrel
- Most important metabolic pathway occurs in the reduction of the delta, 4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation
- Most of the metabolites that circulate in the blood are sulfates of 3α, 5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides
- Some of the parent levonorgestrel also circulates as 17β-sulfate
Ethinyl estradiol
- CYP3A4 in the liver is responsible for the 2-hydroxylation that is the major oxidative reaction
- 2-Hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion
- CYP3A levels vary widely among individuals and can explain the variation in rates of EE 2-hydroxylation
- EE is excreted in the urine and feces as glucuronide and sulfate conjugates, and undergoes enterohepatic circulation
Elimination
Half-life: 34 hr (single dose levonorgestrel); 17 hr (EE)
Excretion: 40-68% (urine); 16-48% (feces)
Administration
Oral Administration
Starting CHCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)
Tablet color
- Active tablets: Orange (Day 1-21)
- Placebo tablet: Blue (Day 22-28)
Day 1 start
- Administer 1 tablet qDay at the same time each day
- Take 1 orange tablet on the first day of period; take subsequent orange tablets once daily for a total of 21 days
- Take 1 blue tablet daily for 7 days
- Begin each subsequent pack on the same day of the week as the first cycle pack (eg, on the day after taking the last blue placebo tablet)
Sunday start
- Administer 1 tablet qDay at the same time each day
- Take first orange tablet on the first Sunday after the onset of menses
- Owing to the potential risk of becoming pregnant, use additional nonhormonal contraception (eg, condoms or spermicide) for the first 7 days of the patient’s first cycle pack
- Take subsequent orange tablets once daily for a total of 21 days
- Take 1 blue tablet daily for the following 7 days
- Begin each subsequent pack on the same day of the week as the first cycle pack
Missed dose
- If one orange tablet is missed in Weeks 1, 2, or 3: Take orange tablet as soon as possible; continue taking 1 tablet qDay until the pack is finished
- If two orange tablets are missed in Week 1 or 2: Take 2 missed tablets as soon as possible and the next 2 orange tablets the next day; continue taking 1 tablet qDay until the pack is finished; additional nonhormonal contraception (eg, condoms or spermicide) should be used as backup if the patient has sex within 7 days after missing tablets
If two orange tablets are missed in Week 3 or ≥3 orange tablets are missed in a row in Weeks 1, 2, or 3
- Day 1 start: Throw out remaining pack and start a new pack that same day
- Sunday start: Continue taking 1 tablet qDay until Sunday, then throw out the remaining pack and start a new pack that same day; additional nonhormonal contraception (such as condoms or spermicide) should be used as backup if the patient has sex within 7 days after missing tablets
Gastrointestinal disturbances
- In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken
- If vomiting or diarrhea occurs within 3-4 hr after taking an orange tablet, handle this as a missed dose
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Protect from light
Keep out of the reach of children
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Balcoltra oral - | 0.1 mg-0.02 mg (21)/iron (7) tablet |  | |
| Balcoltra oral - | 0.1 mg-0.02 mg (21)/iron (7) tablet |  |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
