Telamlo 40/5mg

Product Information

TELAMLO

TelAmlo®  (Telmisartan + Amlodipine)

Presentation

TelAmlo 40/5 tablet: Pink, shield shaped, scored on one side,    logo on other side; each tablet contains Telmisartan USP 40mg &

Amlodipine Besilate BP equivalent to Amlodipine 5mg.

TelAmlo 80/5 tablet: Pink, diamond shaped, scored on one side,   logo on other side; each tablet contains Telmisartan USP 80mg &

Amlodipine Besilate BP equivalent to Amlodipine 5mg.

Indications

TelAmlo is indicated for the treatment of hypertension alone or with other antihypertensive agents. TelAmlo tablets are indicated

as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Dosage and Administration

Initial therapy: The usual starting dose is TelAmlo 40/5 mg once daily. Patients requiring larger blood pressure reductions may be

started on TelAmlo 80/5 mg once daily. Initial therapy with TelAmlo is not recommended in patients =75 years old or with hepatic

impairment. Correct imbalances of intravascular volume or salt-depletion, before initiating therapy with TelAmlo tablets. Dosage

must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks

and maximal reduction is generally attained after 4 weeks.

Replacement therapy: Patients receiving Amlodipine and Telmisartan from separate tablets may instead receive TelAmlo tablets

containing the same component doses once daily.

Add-on therapy: TelAmlo tablet may be used to provide additional blood pressure lowering for patients not adequately controlled

with Amlodipine alone or with Telmisartan alone. Patients treated with 10 mg Amlodipine who experience any dose-limiting adverse

reactions such as edema, may be switched to TelAmlo 40/5 mg tablets once daily, reducing the dose of Amlodipine without reducing

the overall expected antihypertensive response.

Renal impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in

patients with severe renal impairment.

Hepatic impairment: In most patients, initiate Amlodipine therapy at 2.5 mg. Titrate slowly in patients with hepatic impairment.

Patients 75 years of age and older: In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients 75 years

of age and older.

TelAmlo may be taken with or without food.

Contraindications, warnings etc.

Contraindication: Hypersensitivity to Telmisartan, Amlodipine, dihydropyridine derivatives or to any of the excipients of TelAmlo.

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to

pregnant women. When pregnancy is detected, discontinue TelAmlo tablets as soon as possible. In patients with an activated renin-

angiotensin system, such as volume or salt- depleted patients, symptomatic hypotension may occur after initiation of therapy with

TelAmlo tablets. Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart

failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt

substitutes or other drugs that increase potassium levels. Initial therapy with TelAmlo tablets is not recommended in hepatically

impaired patients. Uncommonly, patients, particularly those with severe obstructive coronary artery disease, have developed

documented increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker

therapy or at the time of dosage increase. Closely monitor patients with heart failure. Safety and effectiveness of TelAmlo in

pediatric patients have not been established.

Warnings: Avoid fetal or neonatal exposure. Hypotension: Correct any volume or salt depletion before initiating therapy. Observe

for signs and symptoms of hypotension. Titrate slowly in patients with hepatic or severe renal impairment. Heart failure: Monitor

for worsening. Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker. Myocardial infarction: Uncommonly,

initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased

angina.

Drug Interactions: The pharmacokinetics of Amlodipine and Telmisartan are not altered when the drugs are co-administered. No drug

interaction studies have been conducted with TelAmlo tablets and other drugs.

Use in pregnancy and lactation: Pregnancy categories C (first trimester) and D (second and third trimesters). It is not known

whether Telmisartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant,

decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Adverse reactions: In the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy were

peripheral edema, dizziness, and hypotension, each leading to discontinuation of =0.5% of patients. Adverse reactions that

occurred at a =2% higher incidence on Telmisartan/Amlodipine tablets than placebo were peripheral edema (4.8% vs 0%), dizziness

(3.0% vs 2.2%), clinically meaningful orthostatic hypotension (6.3% vs 4.3%), and back pain (2.2% vs 0%).

Overdosage: Limited data are available with regard to overdosage in humans. The most likely manifestations of overdosage with

telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic stimulation. If

symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Overdosage with Amlodipine might be expected to cause excessive peripheral vasodilation with marked hypotension. In humans,

experience with intentional overdosage of Amlodipine is limited. If massive overdose should occur, active cardiac and respiratory

monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular

support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension

remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered

with attention to circulating volume and urine output. Intravenous calcium gluconate may help to reverse the effects of calcium

entry blockade. As Amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

Pharmaceutical Precautions

Store below 30°C in dry place, protected from light. Keep out of children’s reach.

Packaging Quantity

TelAmlo 40/5 tablet: Each pack contains 30 tablets in Alu-Alu blister pack.

TelAmlo 80/5 tablet: Each pack contains 30 tablets in Alu-Alu blister pack.