Slinda Drug Interactions

Influence of other medicinal products on Slinda: Interactions can occur between Slinda and other medicinal products that induce microsomal enzymes. This can result in increased clearance of sex hormones and may lead to breakthrough bleeding and/or contraceptive failure.
Management: Enzyme induction can already be observed after a few days of treatment. Maximum enzyme induction is generally seen within a few weeks. After drug therapy is discontinued, enzyme induction may be sustained for about 4 weeks.
Short-term treatment: Women on treatment with enzyme inducing drugs should temporarily use a barrier method or another method of contraception in addition to the POP. The barrier method must be used during the whole time of the concomitant drug therapy and for 28 days after its discontinuation.
If the drug therapy runs beyond the end of the active tablets in the POP pack, the placebo tablets must be discarded, and the next POP pack should be started right away.
Long-term treatment: In women on long-term treatment with enzyme-inducing active substances, another reliable, nonhormonal, method of contraception is recommended.
The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only pills).
Substances increasing the clearance of contraceptive hormones (diminished contraceptive efficacy by enzyme induction) e.g.: Barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, and HIV medication ritonavir, nevirapine and efavirenz and possibly also felbamate, griseofulvin, oxcarbazepine, topiramate and products containing the herbal remedy St. John's Wort (Hypericum perforatum).
Substances with variable effects on the clearance of contraceptive hormones: When co-administered with sex hormones, many combinations of HIV protease inhibitors (e.g. ritonavir, nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine, efavirenz) and/or combinations with Hepatitis C virus (HCV) medicinal products (e.g. boceprevir, telaprevir), can increase or decrease plasma concentrations of progestins. The net effect of these changes may be clinically relevant in some cases.
Therefore, the prescribing information of concomitant HIV/HCV medications should be consulted to identify potential interactions and any related recommendations. In case of any doubt, an additional barrier contraceptive method should be used by women on protease inhibitor or non-nucleoside reverse transcriptase inhibitor therapy.
Substances decreasing the clearance of contraceptive hormones (enzyme inhibitors): The clinical relevance of potential interactions with enzyme inhibitors remains unknown.
Concomitant administration of strong or moderate CYP3A4 inhibitors such as azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the progestogen.
In a multiple dose study evaluating the daily (10 days) co-administration of the strong CYP3A4 inhibitor ketoconazole with two drospirenone-containing hormone preparations (drospirenone 3 mg + estradiol 1.5 mg and drospirenone 3 mg + ethinylestradiol 0.02 mg) the AUC (024h) of drospirenone was increased 2.30-fold and 2.7-fold, respectively.
Influence of Slinda on other medicinal products: Hormonal contraceptives may affect the metabolism of certain other active substances. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).
Based on in vitro studies and in vivo interaction studies in female volunteers using omeprazole, simvastatin and midazolam as marker substrate, a clinically relevant interaction of drospirenone with the cytochrome P450 mediated metabolism of other active substances is unlikely.
Pharmacodynamic interactions: Published data did not show a significant effect on serum potassium following the concomitant use of drospirenone and ACE-inhibitors or NSAIDs in patients without renal insufficiency. The concomitant use of Slinda with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, serum potassium should be tested during the first treatment cycle (see Precautions).