Telmisartan

Do not co-administer with telmisartan in patients with diabetes. Avoid use in patients with renal impairment (GFR <60 mL/min).

Co-administration increases digoxin peak plasma concentration (49%) and trough concentration (20%). Monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan.

Reversible increases in serum lithium concentrations and toxicity reported with concomitant administration. Monitor serum lithium levels during concomitant use.

May result in deterioration of renal function including possible acute renal failure in elderly, volume-depleted, or renal-compromised patients. May attenuate antihypertensive effect.

NSAIDs with telmisartan may cause renal function deterioration, including acute renal failure, especially in elderly, volume-depleted, or renally compromised patients. Antihypertensive effect may be attenuated.

Concomitant use resulted in increased incidence of clinically important renal dysfunction including death, doubling of serum creatinine, and dialysis. Not recommended.

7 DRUG INTERACTIONS NSAIDS: Increased risk of renal impairment and loss of antihypertensive effect (7) If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin (7) Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes (7.2) 7.1 Drug Interactions with Telmisartan and Amlodipine Tablets The pharmacokinetics of amlodipine and telmisartan are not altered when the drugs are co-administered. No drug interaction studies have been conducted with telmisartan and amlodipine tablets and other drugs, although studies have been conducted with the individual amlodipine and telmisartan components of telmisartan and amlodipine tablets, as described below: 7.2 Drug Interactions with Telmisartan Aliskiren: Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes. Avoid use of aliskiren with telmisartan and amlodipine tablets in patients with renal impairment (GFR <60 mL/min).

Drug Interactions Telmisartan Aliskiren: Do not co-administer aliskiren with telmisartan and hydrochlorothiazide tablets in patients with diabetes. Avoid use of aliskiren with telmisartan and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/min). Digoxin : When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.

COX-2 inhibitors may deteriorate renal function and cause acute renal failure in elderly, volume-depleted, or renally compromised patients. May attenuate antihypertensive effect. Monitor renal function periodically.

7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. Prevention or Management Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil Examples Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation).

Induces glucuronidation, decreasing mycophenolic acid systemic exposure and potentially reducing Mycophenolate Mofetil efficacy. Monitor for alterations.

Patiromer binds telmisartan, potentially reducing systemic exposure and clinical efficacy. Separate dosing by at least 3 hours.

Co-administration with telmisartan increases ramiprilat Cmax and AUC 2.4- and 1.5-fold respectively with additive pharmacodynamic effects.

7 DRUG INTERACTIONS NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect ( 7.1 ) If simvastatin is co-administered with Widaplik, do not exceed doses greater than 20 mg daily of simvastatin ( 7.2 ) Do not co-administer aliskiren with Widaplik in patients with diabetes ( 7.1 ) 7.1 Drug Interactions with Telmisartan Aliskiren and other renin-angiotensin-aldosterone system (RAAS) inhibitors: Do not co-administer aliskiren with Widaplik in patients with diabetes. Digoxin: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Lithium: Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan.

Other Drugs: Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen.

Other Drugs: Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen.

Other Drugs: Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen.