Telmisartan + Hydrochlorothiazide

Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Hypertension
Adult: Telmisartan 40 mg and hydrochlorothiazide 12.5 mg tab
Telmisartan 80 mg and hydrochlorothiazide 12.5 mg tab
Telmisartan 80 mg and hydrochlorothiazide 25 mg tab
In patients whose blood pressure is not adequately controlled on telmisartan or hydrochlorothiazide alone: 1 tab once daily. May titrate dose up to 160 mg/25 mg once daily if needed. Dosage is individualised and may be titrated according to the patient condition. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Initiate at the lower end of the dosing range.
Các sản phẩm có chứa hoạt chất Telmisartan + Hydrochlorothiazide tại Việt Nam?
Các thuốc khác
  • Actelsar HCT
  • Agimstan-H
  • Cilzec
  • Mibetel HCT
  • Micardis Plus
  • Telart
Suy thận
CrCl (mL/min) Dosage
<30 Contraindicated.
Suy gan
Mild to moderate: Initially, 40 mg/12.5 mg once daily. Severe: Contraindicated.
Cách dùng
May be taken with or without food.
Chống chỉ định
Hypersensitivity to telmisartan, hydrochlorothiazide or other sulfonamide-derived drugs. Anuria, refractory hypokalaemia, hypercalcaemia, cholestasis, biliary obstructive disorders. Severe renal and hepatic impairment. Pregnancy and lactation. Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).
Thận trọng
Patient with volume and/or Na depletion, significant aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, severe CHF, prediabetes or diabetes mellitus; history of allergy or bronchial asthma; hypercholesterolaemia, unstented unilateral or bilateral renal artery stenosis, parathyroid disease, SLE. Patients undergoing anaesthesia and surgery. Not recommended in patients with primary aldosteronism. Not indicated for initial therapy of hypertension. Black patients. Mild to moderate renal and hepatic impairment. Elderly.
Tác dụng không mong muốn
Significant: Hypersensitivity reactions; hyperkalaemia, hypochloraemic alkalosis, hypokalaemia, hypomagnesaemia, hyponatraemia; elevated serum Ca; increased serum cholesterol and triglyceride levels; altered glucose tolerance; symptomatic hypotension; renal function deterioration; exacerbation or activation of SLE; non-melanoma skin cancer (NMSC), squamous cell carcinoma (SCC); choroidal effusion with visual field defect, acute transient myopia, acute angle-closure glaucoma; hyperuricaemia, gout; photosensitivity. Rarely, severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS).
Cardiac disorders: Tachycardia, arrhythmia, chest pain.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dry mouth, flatulence.
Investigations: Increased blood BUN or serum creatinine.
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms, myalgia.
Nervous system disorders: Dizziness, syncope, paraesthesia.
Psychiatric disorders: Anxiety.
Reproductive system and breast disorders: Erectile dysfunction.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, bronchitis, sinusitis, pharyngitis, URTI.
Skin and subcutaneous tissue disorders: Erythema.
Vascular disorders: Orthostatic hypotension.
Thông tin tư vấn bệnh nhân
This drug may cause dizziness or drowsiness, if affected, do not drive or operate machinery. Avoid prolonged exposure to sunlight and UV rays, wear sunscreen or protective clothing when going outdoors.
Chỉ số theo dõi
Monitor blood pressure, serum electrolytes, BUN and creatinine.
Quá liều
Symptoms: Telmisartan: Hypotension, tachycardia, bradycardia, dizziness, vomiting, increased serum creatinine and acute renal failure. Hydrochlorothiazide: Electrolyte depletion (e.g. hypochloraemia, hypokalaemia) and hypovolaemia. Management: Symptomatic and supportive treatment. May induce emesis, perform gastric lavage or administer activated charcoal. Frequently monitor serum electrolytes and creatinine. Place the patient in a supine position with salt and volume replacement administered immediately in case of hypotension.
Tương tác
May increase serum concentration of lithium. Concomitant use with NSAIDs (including COX-2 inhibitors) may result in renal function deterioration and reduced antihypertensive effects. Enhanced hypotensive effects with amifostine, baclofen and other antihypertensive drugs. Enhanced orthostatic hypotensive effects with barbiturates, narcotics and antidepressants.
Telmisartan: May increase serum concentration of digoxin. Increased risk of hyperkalaemia with K-containing salt substitutes, K-sparing diuretics, K supplements, ciclosporin and heparin.
Hydrochlorothiazide: May increase the frequency of hypersensitivity reactions to allopurinol. Increased risk of hypercalcaemia with Ca salts. May enhance the hyperglycaemic effect of β-blockers and diazoxide. Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of hydrochlorothiazide. May increase the risk of adverse reactions caused by amantadine. May decrease the renal excretion and potentiate the myelosuppressive effects of cytotoxic agents (e.g. cyclophosphamide, methotrexate). May reduce the effect of oral antidiabetics, uric acid-lowering agents, norepinephrine and epinephrine. Increased risk of lactic acidosis with metformin. Impaired absorption with colestyramine and colestipol. Concomitant use with ACTH, amphotericin B, antiarrhythmics, benzylpenicillin, carbenoxolone, corticosteroids, laxatives, salicylates and other kaliuretic diuretics may result in increased K loss. May result in increased Na loss with antidepressants, antipsychotics and antiepileptics. May potentiate the effect of nondepolarising skeletal muscle relaxants. Increased risk of hyperuricaemia and gout-like complications with ciclosporin.
Potentially Fatal: Telmisartan: Increased risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure) with aliskiren or ACE inhibitors.
Tương tác với thức ăn
Enhanced orthostatic hypotensive effect with alcohol.
Ảnh hưởng đến kết quả xét nghiệm
May cause false-negative aldosterone/renin ratio (ARR).
Hydrochlorothiazide: May interfere with parathyroid function tests and may reduce serum iodine without signs of thyroid disturbance.
Tác dụng
Description:
Mechanism of Action: Telmisartan is a nonpeptide, benzimidazole-derivative angiotensin II type 1 (AT1) receptor antagonist. It blocks the binding of angiotensin II to AT1 receptors, therefore blocking the vasoconstriction and aldosterone secretion effects of angiotensin II.
Hydrochlorothiazide is a thiazide diuretic. It inhibits Na reabsorption in the distal tubules, thereby increasing the excretion of Na, water, K and hydrogen ions.
Onset: Telmisartan: 1-2 hours.
Hydrochlorothiazide: Diuresis: Approx 2 hours.
Duration: Telmisartan: Up to 24 hours.
Hydrochlorothiazide: 6-12 hours.
Pharmacokinetics:
Absorption: Telmisartan: Rapidly absorbed from the gastrointestinal tract. Bioavailability: 42-58%. Time to peak plasma concentration: 0.5-1 hour.
Hydrochlorothiazide: Rapidly and well absorbed from the gastrointestinal tract. Bioavailability: 65-75%. Time to peak plasma concentration: Approx 1-5 hours.
Distribution: Telmisartan: Volume of distribution: 500 L. Plasma protein binding: >99.5%, mainly to albumin and α1-acid glycoprotein.
Hydrochlorothiazide: Crosses the placenta and enters breast milk. Volume of distribution: 3.6-7.8 L/kg. Plasma protein binding: Approx 40-68%.
Metabolism: Telmisartan: Metabolised in the liver via conjugation to form inactive metabolites.
Excretion: Telmisartan: Via faeces (97% as unchanged drug). Terminal elimination half-life: Approx 24 hours.
Hydrochlorothiazide: Via urine (≥61% as unchanged drug). Elimination half-life: Approx 6-15 hours.
Đặc tính

Chemical Structure Image
Telmisartan

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 65999, Telmisartan. https://pubchem.ncbi.nlm.nih.gov/compound/Telmisartan. Accessed July 30, 2024.


Chemical Structure Image
Hydrochlorothiazide

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3639, Hydrochlorothiazide. https://pubchem.ncbi.nlm.nih.gov/compound/Hydrochlorothiazide. Accessed Oct. 24, 2023.

Bảo quản
Store between 15-30°C. Protect from light and moisture.
Phân loại MIMS
Thuốc đối kháng thụ thể angiotensin II / Thuốc lợi tiểu
Phân loại ATC
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.
Tài liệu tham khảo
Anon. Hydrochlorothiazide. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/06/2024.

Anon. Telmisartan. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/06/2024.

Brayfield A, Cadart C (eds). Hydrochlorothiazide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2024.

Brayfield A, Cadart C (eds). Telmisartan. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2024.

Hydrochlorothiazide. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/06/2024.

Micardis HCT Tablet (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/06/2024.

Micardis Plus (Boehringer Ingelheim [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/06/2024.

Telmisartan and Hydrochlorothiazide Crescent 40 mg/12.5 mg Tablets (Crescent Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/06/2024.

Telmisartan and Hydrochlorothiazide. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/06/2024.

Telmisartan. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/06/2024.

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