Telsat AM Drug Interactions

No interactions between the two components of this fixed dose combinations have been observed.
Interactions common to the combination: No drugs interaction studies have been performed with TELSAT AM and other medicinal products.
Concomitant use to be taken into account: Other antihypertensive agents: The blood pressure lowering effect of TELSAT AM can be increased by concomitant use of other antihypertensive medicinal products.
Agents with blood pressure lowering potential: Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including TELSAT AM, e.g. baclofen, amifostine. Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants.
Corticosteroids (systemic route): Reduction of the antihypertensive effect.
Interactions linked to telmisartan: Concomitant use not recommended: Potassium sparing diuretics or potassium supplements: Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Potassium sparing diuretics e.g. spironolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Concomitant use requiring caution: Nonsteroidal anti-inflammatory medicinal products (NSAIDs): Nonsteroidal anti-inflammatory medicinal products/NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors, and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the coadministration of angiotensin II receptor antagonists and medicinal products that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with the caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Ramipril: The coadministration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC_0-24 and C_max of ramipril and ramiprilat. The clinical relevance of this observation is not known.
Interactions linked to amlodipine: Concomitant use requiring caution: Grapefruit and grapefruit juice: Administration of TELSAT AM with grapefruit or grapefruit juice is not recommended since bioavailability may be increased in certain patients resulting in increased blood pressure lowering effects.
CYP3A4 inhibitors: With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients respectively, the plasma concentration of amlodipine increased 22% and 50% respectively. However, the clinical relevance of this finding is uncertain. It cannot be ruled out that strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem. Amlodipine should be used with caution together with CYP3A4 inhibitors. However, no adverse events attributable to such interaction have been reported.
CYP3A4 inducers: There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma concentration of amlodipine.
Concomitant use to be taken into account: Simvastatin: Coadministration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in exposure to simvastatin up to 77% compared to simvastatin alone. Therefore, limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
Immunosuppressants: Amlodipine may increase the systemic exposure of ciclosporin or tacrolimus when coadministered. Frequent monitoring of trough blood levels of ciclosporin and tacrolimus and dose adjustment when appropriate is recommended.
Others: Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, antiacid-medicinal products (aluminium hydroxide, magnesium hydroxide, and simeticone), cimetidine, ciclosporin, antibiotics, and oral hypoglycemic medicinal products. When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Additional information: Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine in healthy volunteers did not show a significant effect on the pharmacokinetic properties of amlodipine.