Normetec Drug Interactions




Zuellig Pharma
Full Prescribing Info
Drug Interactions
Potential Interactions Related to the Normetec Combination: To be taken into account with concomitant use of other antihypertensive agents: The blood pressure lowering effect of Normetec can be increased by concomitant use of other antihypertensive medicinal products (eg, α-blockers, diuretics).
Potential Interactions Related to the Olmesartan Medoxomil Component of Normetec: Concomitant use not recommended.
Medicinal Products Affecting Potassium Levels: Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (eg, heparin, ACE inhibitors) may lead to increases in serum potassium (see Precautions). If medicinal products which affect potassium levels are to be prescribed in combination with Normetec, monitoring of serum potassium levels is recommended.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors and, rarely, with angiotensin II antagonists. Therefore concomitant use of Normetec and lithium is not recommended (see Precautions). If concomitant use of Normetec and lithium proves necessary, careful monitoring of serum lithium levels is recommended.
Concomitant Use Requiring Caution: Nonsteroidal anti-inflammatory medicinal products (NSAIDs) including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day) and nonselective NSAIDs: When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may increase the risk of worsening of renal function and may lead to an increase in serum potassium. Therefore, monitoring of renal function at the beginning of such concomitant therapy is recommended, as well as adequate hydration of the patient.
Additional Information: After treatment with antacid (aluminium magnesium hydroxide), a modest reduction in bioavailability of olmesartan was observed.
Olmesartan medoxomil had no significant effect on the pharmacokinetics or pharmacodynamics of warfarin or the pharmacokinetics of digoxin. Co-administration of olmesartan medoxomil with pravastatin had no clinically relevant effects on the pharmacokinetics of either component in healthy subjects.
Olmesartan had no clinically relevant inhibitory effects on human CYP450 enzymes 1A1/2, 2A6, 2C8/9, 2C19, 2D6, 2E1 and 3A4 in vitro, and had no or minimal inducing effects on rat CYP450 activities. No clinically relevant interactions between olmesartan and medicinal products metabolised by the previously mentioned CYP450 enzymes are expected.
Potential Interactions Related to the Amlodipine Component of Normetec: Concomitant use requiring caution.
CYP3A4 Inhibitors: A study in elderly patients showed that diltiazem inhibits the metabolism of amlodipine, probably via CYP3A4, since plasma concentrations of amlodipine increased by approximately 50% and its effect was increased. The possibility that more potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine to a greater extent than diltiazem cannot be excluded.
CYP3A4 Inducers [anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, hypericum perforatum]: Concomitant administration may decrease the plasma concentration of amlodipine. Clinical monitoring is indicated, with possible adjustment of amlodipine dosage during treatment with the CYP3A4 inducer and after its withdrawal.
Sildenafil: When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Additional Information: Concomitant administration of grapefruit juice 240 mL with a single oral dose of amlodipine 10 mg in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of amlodipine.
Co-administration of amlodipine with cimetidine had no significant effect on the pharmacokinetics of amlodipine.
Co-administration of amlodipine with atorvastatin, digoxin, warfarin or cyclosporin had no significant effect on the pharmacokinetics or pharmacodynamics of these agents.
Incompatibilities: Not applicable.
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