Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

1 INDICATIONS AND USAGE Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1) Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1) Telmisartan and hydrochlorothiazide tablets, are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.

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Advisory information

contraindications
4 CONTRAINDICATIONS Hypersensitivity to telmisartan or any component (4) Anuria (4). Co-Administration with aliskiren in patients with diabetes (4) Telmisartan and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.5)]. In patients with anuria. For co-administration with aliskiren in patients with diabetes [see Drug Interactions (7.4)].
Adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1- 800-912-9561, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The following adverse reactions are discussed elsewhere in labeling: Hypotension [see Warnings and Precautions (5.2)] Renal Impairment [see Warnings and Precautions (5.3)] Electrolytes and Metabolic Disorders [see Warnings and Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Telmisartan and hydrochlorothiazide tablets have been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide. Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies (14)]. Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo* * includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof Telmisartan/ Hydrochlorothiazide (n = 414) Placebo (n = 74) Telmisartan (n = 209) Hydrochlorothiazide (n = 121) Body as a whole Fatigue 3% 1% 3% 3% Influenza-like symptoms 2% 1% 2% 3% Central/peripheral nervous system Dizziness 5% 1% 4% 6% Gastrointestinal system Diarrhea 3% 0% 5% 2 % Nausea 2% 0% 1% 2% Respiratory system disorder Sinusitis 4% 3% 3% 6% Upper respiratory tract infection 8% 7% 7% 10% Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis. Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients. Telmisartan Other adverse events that have been reported with telmisartan are listed below: Autonomic Nervous System: impotence, increased sweating, flushing Body as a Whole: allergy, fever, leg pain, chest pain Cardiovascular: palpitation, angina pectoris, abnormal ECG, hypertension, peripheral edema Central Nervous System: insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoesthesia Gastrointestinal: flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache Hepato-biliary: elevations of liver enzymes or serum bilirubin Metabolic: gout, hypercholesterolemia, diabetes mellitus Musculoskeletal: arthritis, arthralgia, leg cramps, myalgia Psychiatric: anxiety, depression, nervousness Resistance Mechanism: infection, abscess, otitis media Respiratory: asthma, rhinitis, dyspnea, epistaxis Skin: dermatitis, eczema, pruritus Urinary: micturition frequency, cystitis Vascular: cerebrovascular disorder Special Senses: abnormal vision, conjunctivitis, tinnitus, earache Hydrochlorothiazide Other adverse events that have been reported with hydrochlorothiazide are listed below: Body as a Whole: weakness Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions Metabolic: hyperglycemia, glycosuria Musculoskeletal: muscle spasm Nervous System/Psychiatric: restlessness Renal: interstitial nephritis Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis Special Senses: transient blurred vision, xanthopsia Clinical Laboratory Findings Creatinine, Blood Urea Nitrogen (BUN): Increases in BUN (≥11.2 mg/dL) and serum creatinine (≥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 controlled trials. No patient discontinued treatment with telmisartan and hydrochlorothiazide tablets because of an increase in BUN or creatinine [see Warnings and Precautions (5.3)]. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of telmisartan and hydrochlorothiazide tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: eosinophilia Cardiac Disorders: atrial fibrillation, congestive heart failure, myocardial infarction, tachycardia, bradycardia Ear and Labyrinth Disorders: vertigo General Disorders and Administration Site Conditions: asthenia, edema Hepatobiliary: Abnormal hepatic function / liver disorder Immune System Disorders: anaphylactic reaction Infections and Infestations: urinary tract infection Investigations: increased CPK Metabolism and Nutrition Disorders: hypoglycemia (in diabetic patients) Musculoskeletal and Connective Tissue Disorders: tendon pain (including tendonitis, tenosynovitis), rhabdomyolysis Nervous System Disorders: syncope, headache Renal and Urinary Disorders: renal failure, renal impairment including acute renal failure Reproductive System and Breast Disorders: erectile dysfunction Respiratory, Thoracic and Mediastinal Disorders: coughing Skin and Subcutaneous Tissue Disorders: drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), angioedema (with fatal outcome) Vascular Disorder: orthostatic hypotension

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Usual starting dose is 80 mg/12.5 mg once daily (2.1) Titrate up to 160 mg/25 mg as needed (2.1) Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg (2.2) 2.1 Dosing Information Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on telmisartan and hydrochlorothiazide tablets, 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on telmisartan and hydrochlorothiazide tablets 80 mg / 12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of telmisartan and hydrochlorothiazide tablets. Telmisartan and hydrochlorothiazide tablets may be administered with other antihypertensive drugs. 2.2 Dose Adjustment for Hepatic Impairment Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. Telmisartan and hydrochlorothiazide tablets are not recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)]. 2.3 Important Administration Instructions Telmisartan and hydrochlorothiazide tablets should not be removed from blisters until immediately before administration.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Lactation: Do not breastfeed during treatment with telmisartan and hydrochlorothiazide tablets (8.2) Severe Hepatic Impairment: Use not recommended (8.6) Severe Renal Impairment: Use not recommended (8.7) 8.1 Pregnancy Risk Summary Telmisartan and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations). Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the rennin-angiotensin system from other antihypertensive agents. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data). When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide tablets as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions Telmisartan Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking telmisartan and hydrochlorothiazide tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue telmisartan and hydrochlorothiazide tablets, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to telmisartan and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function [see Use in Specific Populations (8.4)]. Hydrochlorothiazide Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possible other adverse reactions that have occurred in adults. Data Animal Data Telmisartan and hydrochlorothiazide tablets A developmental toxicity study was performed in rats with telmisartan/hydrochlorothiazide doses of 3.2/1.0, 15/4.7, 50/15.6, and 0/15.6 mg/kg/day. Although the two higher dose combinations appeared to be more toxic (significant decrease in body weight gain) to the dams than either drug alone, there did not appear to be an increase in toxicity to the developing embryos. Telmisartan No teratogenic effects were observed when telmisartan was administered to pregnant rats at oral doses of up to 50 mg/kg/day and to pregnant rabbits at oral doses of up to 45 mg/kg/day. In rabbits, embryo lethality associated with maternal toxicity (reduced body weight gain and food consumption) was observed at 45 mg/kg/day (approximately 12 times the maximum recommended human dose [MRHD] of 80 mg on a mg/m2 basis). In rats, maternally toxic (reduced body weight gain and food consumption) telmisartan doses of 15 mg/kg/day (approximately 1.9 times the MRHD on a mg/m2 basis), administered during late gestation and lactation, were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain. The no-observed effect doses for developmental toxicity in rats and rabbits, 5 and 15 mg/kg/day, respectively, are approximately 0.64 and 3.7 times, respectively, on a mg/m2 basis, the MRHD of telmisartan (80 mg/day). Hydrochlorothiazide Studies in which hydrochlorothiazide was administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD), provided no evidence of harm to the fetus. Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times that in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of EPH (Edema, Proteinuria, Hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women. The use of hydrochlorothiazide for other indications (e.g., heart disease) in pregnancy should be avoided. 8.2 Lactation Risk Summary There is no information regarding the presence of telmisartan and hydrochlorothiazide or telmisartan in human milk, the effects on the breastfed infant or the effects on milk production. Limited published studies report that hydrochlorothiazide is present in human milk. However, there is insufficient information to determine the effects of hydrochlorothiazide on the breastfed infant or the effects of hydrochlorothiazide on milk production. Telmisartan is present in the milk of lactating rats. (see Data). Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan and hydrochlorothiazide tablets. Data Telmisartan was present in the milk of lactating rats at concentrations 1.5 to 2 times those found in plasma from 4 to 8 hours after administration. 8.4 Pediatric Use Safety and effectiveness of telmisartan and hydrochlorothiazide tablets in pediatric patients have not been established. Neonates with a history of in utero exposure to Telmisartan and Hydrochlorothiazide tablets: If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. 8.5 Geriatric Use In the controlled clinical trials (n=1017), approximately 20% of patients treated with telmisartan/hydrochlorothiazide were 65 years of age or older, and 5% were 75 years of age or older. No overall differences in effectiveness and safety of telmisartan/hydrochlorothiazide were observed in these patients compared to younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy. 8.6 Use in Patients with Hepatic Impairment Patients with biliary obstructive disorders or hepatic insufficiency should initiate treatment under close medical supervision using the 40 mg/12.5 mg combination. Telmisartan As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance and higher blood levels. Hydrochlorothiazide Minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease. 8.7 Use in Patients with Renal Impairment Safety and effectiveness of telmisartan and hydrochlorothiazide tablets in patients with severe renal impairment (CrCl ≤30 mL/min) have not been established. In patients with severe renal impairment, telmisartan and hydrochlorothiazide tablets are not recommended. No dose adjustment is required in patients with mild (CrCl 60 to 90 mL/min) or moderate (CrCl 30 to 60 mL/min) renal impairment.
Pregnancy and lactation
8.2 Lactation Risk Summary There is no information regarding the presence of telmisartan and hydrochlorothiazide or telmisartan in human milk, the effects on the breastfed infant or the effects on milk production. Limited published studies report that hydrochlorothiazide is present in human milk. However, there is insufficient information to determine the effects of hydrochlorothiazide on the breastfed infant or the effects of hydrochlorothiazide on milk production. Telmisartan is present in the milk of lactating rats. (see Data). Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan and hydrochlorothiazide tablets. Data Telmisartan was present in the milk of lactating rats at concentrations 1.5 to 2 times those found in plasma from 4 to 8 hours after administration.

Interactions

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity (7.2) Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; increased risk of renal impairment (7.3) Dual blockade of renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7.4) Antidiabetic drugs: Dosage adjustment may be required (7.6) Cholestyramine and colestipol: Reduced absorption of thiazides (7.7) 7.1 Agents Increasing Serum Potassium Co-administration of telmisartan with other drugs that raise serum potassium levels may result hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving telmisartan and hydrochlorothiazide tablets and lithium. 7.3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors Telmisartan 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 ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. The antihypertensive effect of ARBs may be attenuated by NSAIDs. Therefore, monitor renal function and blood pressure periodically in patients receiving telmisartan and hydrochlorothiazide tablets and NSAIDs. Hydrochlorothiazide Administration of a non-steroidal anti-inflammatory agent, including a selective COX-2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Therefore, when telmisartan and hydrochlorothiazide and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained. 7.4 Dual Blockade of the Renin-Aldosterone System and Changes in Renal Function Dual blockade of the renin-angiotensin-aldosterone system (RAS) with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and renal impairment. The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan (ARB) only, ramipril (ACE inhibitor) only, or the combination, and followed them for a median of 56 months. Patients who received the combination of ARB and ACE inhibitor did not obtain any additional benefit (no additional reduction of risk of cardiovascular death, myocardial infarction, stroke, or hospitalization from heart failure) compared to ARB monotherapy or ACE inhibitor monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with monotherapy groups. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on telmisartan and hydrochlorothiazide and other agents that affect the RAS. Do not co-administer aliskiren with telmisartan and hydrochlorothiazide tablets in patients with diabetes. Avoid concomitant use of aliskiren with telmisartan and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/min/1.73 m2). 7.5 Digoxin When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Monitor digoxin levels in patients taking concomitant telmisartan and hydrochlorothiazide and digoxin. 7.6 Antidiabetic Drugs (Oral Agents and Insulin) Dosage adjustment of antidiabetic drugs may be required when coadministered with hydrochlorothiazide. 7.7 Cholestyramine and Colestipol Resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

More information

Category Value
Authorisation number ANDA201192
Agency product number U5SYW473RQ
Orphan designation No
Product NDC 13668-161,13668-159,13668-160
Date Last Revised 03-04-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 477130
Marketing authorisation holder Torrent Pharmaceuticals Limited
Warnings W ARN ING: FETAL TOXICITY S e e full prescribing information for complete boxed warning . W h e n pregnancy is detected, discontinue telmisartan and hydrochlorothiazide tablets as soon as possible. (5.1, 8.1) D r u g s that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1) WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide tablets as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].