Telmisartan + Hydrochlorothiazide


Concise Prescribing Info
Indications/Uses
HTN.
Dosage/Direction for Use
Adult : PO Each tab contains telmisartan (mg)/hydrochlorothiazide (mg): 40/12.5, 80/12.5 or 80/25: In patients w/ inadequate response to monotherapy w/ telmisartan 40 mg: 40/12.5 mg once daily. In patients w/ inadequate response to monotherapy w/ telmisartan 80 mg or hydrochlorothiazide 25 mg: 80/12.5 mg once daily, may titrate up to 80/25 mg or 160/25 mg once daily according to response.
Dosage Details
Oral
Hypertension
Adult: Each tab contains telmisartan (mg)/hydrochlorothiazide (mg): 40/12.5, 80/12.5, or 80/25: In patients w/ inadequate response to monotherapy w/ telmisartan 40 mg: 40/12.5 mg once daily. In patients w/ inadequate response to monotherapy w/ telmisartan 80 mg or hydrochlorothiazide 25 mg: 80/12.5 mg once daily, may titrate up to 80/25 mg once daily if BP is inadequately controlled or up to 160 mg/25 mg daily if BP remains uncontrolled after 2-4 wk.
Renal Impairment
CrCl (mL/min) Dosage
≤30
Contraindicated.
Hepatic Impairment
Mild to moderate: Max: 40 mg/12.5 mg once daily. Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to telmisartan, hydrochlorthiazide, or sulphonamide-derived drugs, cholestasis and biliary obstructive disorder, anuria, refractory hypokalaemia, hypercalcaemia. Severe hepatic and renal (<30 mL/min) impairment. Pregnancy and lactation. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal (GFR <60 mL/min) impairment.
Special Precautions
Patient w/ intravascular hypovolaemia, severe CHF, renal artery stenosis, primary aldosteronism, aortic and mitral stenosis, obstructive hypertrophic cardiomyopathy, DM, hypercholesterolaemia, parathyroid disease, SLE, history of bronchial asthma or gout. Mild to moderate hepatic and renal impairment.
Adverse Reactions
Significant: Electrolyte distrubances (e.g. hyper- or hypokalaemia, hypochloraemic alkalosis, hypomagnesaemia, hyponatraemia, hypercalcaemia), renovascular HTN, hypotension, increased cholesterol and triglyceride levels, hyperuricaemia, gout, acute transient myopia, angle-closure glaucoma, photosensitivity, SLE activation or exacerbation, renal function deterioration, hypersensitivity reactions.
Nervous: Drowsiness, dizziness, fatigue, flu-like symptoms, insomnia, headache, migraine, anxiety, depression, syncope, paraesthesia.
CV: Chest pain, tachycardia, flushing, arrhythmia.
GI: Diarrhoea, dry mouth, nausea, taste disturbances, flatulence, abdominal pain, constipation, dyspepsia, vomiting, gastritis.
Resp: Upper resp tract infection, sinusitis, pharyngitis, cough, bronchitis, dyspnoea.
Hepatic: Jaundince, abnormal liver function.
Genitourinary: Increased BUN and serum creatinine.
Endocrine: Dyslipidaemia, impotence, hyperglycaemia, glycosuria.
Musculoskeletal: Back pain, muscle pain and cramps, increased creatine phosphokinase.
Ophthalmologic: Blurred vision.
Dermatologic: Urticaria, erythema, pruritus, rash, hyperhidrosis.
Potentially Fatal: Rarely, angioedema.
Patient Counseling Information
This drug may cause dizziness or drowsiness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor BP, serum electrolytes, BUN, creatinine, wt, input and output, and renal function. Monitor for signs of angioedema.
Overdosage
Symptoms: Hypotension, tachycardia, dizziness, bradycardia, vomiting, increased serum creatinine, acute renal failure, electrolyte depletion (e.g. hypokalaemia, hypochloraemia), hypovolaemia, nausea, somnolence. Management: Symptomatic and supportive treatment. Employ gastric lavage and induce emesis. Admin of activated charcoal may be useful. Treat hypotension w/ salt and volume replacements. Monitor serum electrolytes and creatinine levels frequently.
Drug Interactions
May increase serum lithium levels and toxicity. Increased risk of hyperkalaemia w/ K-sparing diuretics, K supplements, K-containing salt substitutes, ACE inhibitors, and cyclosporin. May decrease effect of pressor amines. Reduced antihypertensive effect w/ NSAIDs. Telmisartan may increase the hypotensive effect of other antihypertensive agents. Telmisartan may increase peak plasma and trough concentrations of digoxin. Potentiated hypokalaemic effect of hydrochlorothiazide when concomitantly used w/ corticosteroids, ACTH, amphotericin, carbenoxolone, salicylic acid derivatives, and other kaliuretic diuretics. Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia. Impaired absorption of hydrochlorothiazide in the presence of anionic exchange resins (e.g. cholestyramine, colestipol). Hydrochlorothiazide may potentiate the effect of nondepolarising skeletal muscle relaxant (e.g. tubocurarine). Thiazides may enhance the hyperglycaemic effect of β-blockers and diazoxide. May increase the risk of adverse effects of amantadine. Thiazides may reduce the excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects. Increased bioavailability of thiazides w/ anticholinergic agents (e.g. atropine, biperiden). Hydrochlorthiazide enhances hypercalcaemic effect of Ca-containing medicinal products.
Potentially Fatal: Increased risk of hypotension, hyperkalaemia, and decreased renal function (e.g. acute renal failure) when concomitantly used w/ aliskiren esp in patients w/ DM or renal impairment.
Food Interaction
Diminished antihypertensive effect w/ yohimbine. Potentiated orthostatic hypotensive effect w/ alcohol.
Lab Interference
May cause false-negative aldosterone/renin ratio (ARR) and may also cause false-positive analytic result w/ anti-doping test. Hydrochlorothiazide may interfere w/ parathyroid function test and decrease serum iodine w/out signs of thyroid disturbances.
Action
Description: Telmisartan is a nonpeptide benzimidazole derivative that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to AT1 receptors. Hydrochlorothiazide is a diuretic acting mainly at the beginning of the distal tubules. It increases the excretion of Na and Cl ions, and consequently of water, by reducing electrolyte reabsorption from the renal tubules.
Pharmacokinetics:
Absorption: Telmisartan: Rapidly absorbed from the GI tract. Bioavailability: 42% (40 mg); 58% (160 mg). Time to peak plasma concentration: 0.5-1 hr. Hydrochlorothiazide: Well absorbed from the GI tract. Bioavailability: 65-75%. Time to peak plasma concentration: Approx 1-5 hr.
Distribution: Telmisartan: Volume of distribution: 500 L. Plasma protein binding: >99.5%, primarily to albumin and α1-acid glycoprotein. Hydrochlorothiazide: Crosses the placenta and enters breast milk. Volume of distribution: 0.83-1.14 L/kg. Plasma protein-binding: Approx 40-68%.
Metabolism: Telmisartan: Metabolised in the liver via conjugation to the inactive metabolites, acyl glucuronide.
Excretion: Telmisartan: Via faeces, 97% mainly as unchanged drug. Terminal elimination half-life: 24 hr. Hydrochlorothiazide: Via urine, ≥61% as unchanged drug. Elimination half-life: Approx 6-15 hr.
Chemical Structure

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Click on icon to see table/diagram/image
Storage
Store between 20-25°C. Protect from moisture.
ATC Classification
C09DA07 - telmisartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Disclaimer: This information is independently developed by MIMS based on Telmisartan + Hydrochlorothiazide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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