Colixtan Drug Interactions

Interaction with other medicinal products and other forms of interaction. No drug interaction studies have been conducted with Fixed-dose combination of Losartan and Amlodipine and other drugs, although studies have been conducted with the individual Losartan and Amlodipine components, as described as follows.
Losartan: In clinical pharmacokinetic trials, no drug interactions of clinical significance have been identified with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, and erythromycin. Rifampin and fluconazole have been reported to reduce levels of active metabolite.
As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium, or other drugs that may increase serum potassium (e.g., trimethoprim-containing products) may lead to increases in serum potassium. As with other drugs which affect the excretion of sodium, lithium excretion may be reduced. Non-steroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) may reduce the effect of diuretics and other antihypertensive drugs. Therefore, the antihypertensive effect of angiotensin II receptor antagonists or ACE inhibitors may be attenuated by NSAIDs including selective COX-2 inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on Fixed-dose combination of Losartan and Amlodipine and other agents that affect the RAAS. Do not co-administer aliskiren with Losartan and Amlodipine in patients with diabetes. Avoid use of aliskiren with Fixed-dose combination of Losartan and Amlodipine in patients with renal impairment (GFR <60 mL/min).
Amlodipine: CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 1.6-fold increase in amlodipine systemic exposure. Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Amlodipine to a greater extent. Monitor for symptoms of hypotension and edema when Amlodipine is coadministered with CYP3A4 inhibitors.
CYP3A4 Inducers: Patients should be monitored for adequate clinical effect when Amlodipine is co-administered with CYP3A4 inducers.