Ermina

Ermina Drug Interactions

ethinylestradiol + drospirenone

Manufacturer:

Sun Pharma Industries

Distributor:

DKT

Marketer:

DKT
Full Prescribing Info
Drug Interactions
Effects of other medicaments on Drospirenone + Ethinylestradiol: Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of sex hormones and which may lead to breakthrough bleeding and/or contraceptive failure. Women on treatment with any of these drugs should temporarily use a barrier method in addition to the COC or choose another method of contraception. The barrier method should be used during the time of the concomitant drug administration and for 28 days after its discontinuation. If the period during which the barrier method is used runs beyond the end of tablets in the COC pack, the tablet-free phase should be omitted and the next COC pack should be started.
Substances increasing the clearance of COCs (diminished efficacy of COCs by enzyme-induction), e.g.: Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's Wort.
Substances with variable effects on the clearance of COCs, e.g.: When co-administered with COCs, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of estrogen or progestin. These changes may be clinically relevant in some cases.
Substances interfering with the metabolism of combined hormonal contraceptives (enzyme inhibitors): The main metabolites of drospirenone in human plasma are generated without involvement of the cytochrome P450 system. Inhibitors of this enzyme system are therefore unlikely to influence the metabolism of drospirenone.
Effects of COCs on other medicaments: Oral contraceptives may affect the metabolism of certain other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. ciclosporin) or decrease (e.g. lamotrigine).
Based on reported in vitro inhibition studies and reported in vivo interaction studies in female volunteers using omeprazole, simvastatin and midazolam as marker substrates, an interaction of drospirenone at doses of 3 mg with the metabolism of other drugs is unlikely.
Other forms of interactions: Serum Potassium: There is a theoretical potential for an increase in serum potassium in women taking drospirenone + ethinylestradiol with other drugs that may increase serum potassium levels. Such drugs include angiotensin-II-receptor antagonists, potassium-sparing diuretics, and aldosterone antagonists. However, in reported studies evaluating the interaction of drospirenone (combined with estradiol) with an ACE inhibitor or indomethacin, no clinically or statistically significant differences in serum potassium concentrations were observed.
Laboratory tests: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.
Drospirenone causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity.
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.