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Telarb CCB

Telarb CCB

telmisartan + amlodipine

Manufacturer:

Evertogen

Distributor:

Cathay YSS
Concise Prescribing Info
Contents
Per 40 mg/5 mg tab Telmisartan 40 mg, amlodipine besilate 5 mg. Per 40 mg/10 mg tab Telmisartan 40 mg, amlodipine besilate 10 mg. Per 80 mg/5 mg tab Telmisartan 80 mg, amlodipine besilate 5 mg. Per 80 mg/10 mg tab Telmisartan 80 mg, amlodipine besilate 10 mg
Indications/Uses
HTN, as monotherapy or in combination w/ other antihypertensive agents.
Dosage/Direction for Use
Dose may be individualized & increased after at least 2 wk of initial therapy. Max: 80/10 mg once daily. Replacement therapy for separate tab Same component doses once daily. Add-on therapy when HTN is not adequately controlled on antihypertensive monotherapy Initially 40/5 mg once daily. Patient requiring larger BP reductions may be started on 80/5 mg once daily. Elderly ≥75 yr Initiate amlodipine at 2.5 mg. Slowly titrate dose. Patient w/ severe renal impairment Slowly titrate dose. Patient w/ hepatic impairment Initiate amlodipine at 2.5 mg. Slowly titrate dose.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Risk of symptomatic hypotension in patients w/ activated renin-angiotensin system (eg, vol- or salt-depleted patient). Correct intravascular vol- or salt-depletion before initiating therapy. Initial therapy w/ telmisartan + amlodipine is not recommended in patients ≥75 yr or w/ hepatic impairment. Discontinue therapy as soon as possible when pregnancy is detected. Closely observe infants w/ histories of in utero exposure to telmisartan + amlodipine for hypotension, oliguria, & hyperkalemia. Recommended to discontinue nursing during therapy. Telmisartan: Risk of hyperkalemia, particularly in patients w/ advanced renal impairment, heart failure on renal replacement, or on K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels; changes in renal function in susceptible individuals; dual blockade of the renin-angiotensin-aldosterone system w/ ACE inhibitor. Amlodipine: Closely observe patients w/ severe aortic stenosis or heart failure. Risk of angina or acute MI, particularly in patients w/ severe obstructive CAD.
Adverse Reactions
Telmisartan + amlodipine: Peripheral edema, dizziness, back pain; edema (other than peripheral edema), hypotension, syncope. Telmisartan: URTI, back pain, sinusitis, diarrhea, pharyngitis. Amlodipine: Headache, edema; dizziness, flushing, palpitations; fatigue, nausea, abdominal pain, somnolence.
Drug Interactions
Telmisartan: Increased peak plasma & trough conc of digoxin. Reversible increases in serum lithium conc & toxicity. Risk of renal function deterioration w/ NSAIDs (including selective COX-2 inhibitors), in patients who are elderly, vol-depleted, or w/ compromised renal function. Antihypertensive effect may be attenuated w/ NSAIDs including selective COX-2 inhibitors. Possible additive pharmacodynamic effect w/ ramipril/ramiprilat. Possible inhibition of metabolism of CYP2C19 substrates. Amlodipine: Increased exposure of simvastatin.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
C09DB04 - telmisartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Telarb CCB 40 mg/10 mg tab
Packing/Price
30's
Form
Telarb CCB 40 mg/5 mg tab
Packing/Price
30's
Form
Telarb CCB 80 mg/10 mg tab
Packing/Price
30's
Form
Telarb CCB 80 mg/5 mg tab
Packing/Price
30's
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