Data from FDA - Curated by EPG Health - Last updated 20 December 2016
CONTRAINDICATIONS Telmisartan and hydrochlorothiazide tablets, USP are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, hydrochlorothiazide, or any other component of this product (see
Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Do not co-administer aliskiren with telmisartan and hydrochlorothiazide tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions).
PRECAUTIONS Serum Electrolytes Telmisartan and Hydrochlorothiazide In
Hydrochlorothiazide Periodic determinations of serum electrolytes to detect possible electrolyte
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte
Warning signs or symptoms of fluid and electrolyte
Hypokalemia may cause cardiac arrhythmia and may also sensitize or
Dilutional hyponatremia may occur in edematous patients in hot weather;
Hyperuricemia may occur or
Hyperglycemia may occur with thiazide diuretics.
Thus latent diabetes mellitus may become manifest during thiazide therapy.
Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism.
Telmisartan and hydrochlorothiazide tablets should therefore be used with
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g.,
Similar results may be anticipated in patients treated with telmisartan.
In studies of
There has been
Hydrochlorothiazide Thiazides should be used with
In patients with renal disease, thiazides may precipitate azotemia.
Dual Blockade of the Renin-angiotensin-aldosterone
Dual blockade of the renin-angiotensin-aldosterone system (e.g., by adding an ACE-inhibitor to an angiotensin II receptor
The ONTARGET trial enrolled 25,620 patients >55 years old with atherosclerotic disease or diabetes with end-organ damage, randomized them to telmisartan only, ramipril only, or the combination, and followed them for a median of 56 months.
Patients receiving the combination of telmisartan and ramipril did not obtain any additional
Concomitant use of telmisartan and
Information for Patients Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to telmisartan and hydrochlorothiazide during pregnancy.
Discuss treatment options with women planning to become pregnant.
Patients should be asked to report pregnancies to their physicians as soon as
Symptomatic Hypotension: A patient receiving
The patients should be told that if syncope occurs,
Potassium Supplements: A patient receiving telmisartan and hydrochlorothiazide tablets should be told not to use potassium supplements or salt substitutes that contain potassium
Drug Interactions Telmisartan Aliskiren: Do not co-administer aliskiren with telmisartan and hydrochlorothiazide tablets in patients with diabetes.
Digoxin: When telmisartan was co-administered with digoxin, median
It is, therefore,
Cases have also been reported with angiotensin II receptor
Because lithium should not be used with diuretics, the use of lithium with telmisartan and
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor
These effects are usually reversible.
Monitor renal function periodically in patients receiving telmisartan and
The antihypertensive effect of angiotensin II receptor
Ramipril and Ramiprilat: Co-administration of telmisartan 80 mg once daily and ramipril 10 mg once daily to
When co-administering telmisartan and ramipril,
Warfarin: Telmisartan administered for
Co-administration of telmisartan did not result in a clinically
Telmisartan is not metabolized by the cytochrome P450 system and had
Telmisartan is not expected to interact with
Hydrochlorothiazide When administered concurrently, the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or
Antidiabetic drugs (oral agents and insulin):
Other antihypertensive drugs: Additive effect or potentiation.
Cholestyramine and colestipol resins:
Corticosteroids, ACTH: Intensified electrolyte
Pressor amines (e.g., norepinephrine): Possible decreased response to pressor amines but not
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible
Lithium: Should not generally be given with diuretics.
Diuretic agents reduce the renal clearance of lithium and add a
Refer to the package insert for lithium preparations before use of such preparations with telmisartan and hydrochlorothiazide tablets.
Non-steroidal anti-inflammatory drugs: In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.
Therefore, when telmisartan and hydrochlorothiazide tablets and non-steroidal anti-inflammatory agents are used concomitantly,
Telmisartan There was
These same doses have been shown to provide
Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level.
These assays included bacterial mutagenicity tests with Salmonella and E. coli (Ames), a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse micronucleus test.
This dose in the
Hydrochlorothiazide Two-year feeding studies in mice and
Program (NTP) uncovered
The NTP, however, found
Hydrochlorothiazide was not genotoxic in_vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal
Nursing Mothers It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating
Thiazides appear in human milk.
Because of the
Pediatric Use Neonates with a history of in utero exposure to telmisartan and hydrochlorothiazide:If oliguria or hypotension occurs, direct attention toward support of
Geriatric Use In the
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but
In clinical trials with telmisartan and hydrochlorothiazide tablets,
The overall incidence of
2 % of Telmisartan/Hydrochlorothiazide (HCTZ) Patients
* Telm/HCTZ (N=414) (%) Placebo (N=74) (%) Telm (N=209) (%) HCTZ (N=121) (%) Body as a whole
Finally, the following
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory
Because these reactions are reported voluntarily from
Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1)
The most frequently spontaneously reported events include:
anaphylactic reaction, and tendon
Clinical Laboratory Findings In
Hemoglobin and Hematocrit:
Creatinine, Blood Urea Nitrogen (BUN):
0.5 mg/dL) were observed in 2.8 % and 1.4 %, respectively, of patients with essential hypertension treated with telmisartan and hydrochlorothiazide tablets in
Liver Function Tests: Occasional elevations of liver enzymes and/or serum bilirubin have occurred.
Serum Electrolytes: See PRECAUTIONS.
DOSAGE AND ADMINISTRATION The usual starting dose of telmisartan is 40 mg once a day;
To minimize dose-independent side effects,
The side effects (see WARNINGS) of
Therapy with any combination of telmisartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
Telmisartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.
Telmisartan and hydrochlorothiazide tablets may be administered with or without food.
Replacement Therapy The combination may be substituted for the titrated components.
A patient whose
A patient whose
The clinical response to telmisartan and hydrochlorothiazide tablets should be subsequently evaluated and if
Those patients controlled by 25 mg hydrochlorothiazide but who experience hypokalemia with this regimen, may be switched to telmisartan 80 mg/hydrochlorothiazide 12.5 mg tablets once daily, reducing the dose of hydrochlorothiazide
|Agency product number||U5SYW473RQ|
|Date Last Revised||14-03-2014|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Alembic Pharmaceuticals Limited|
|Warnings||WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity).|