Olmesartan + Hydrochlorothiazide


Concise Prescribing Info
Indications/Uses
Hypertension.
Dosage/Direction for Use
Adult : PO Each tab contains olmesartan (mg)/hydrochlorothiazide (mg): 20/12.5, 40/12.5, 20/25, 40/25: 1 tab once daily. Dosage is individualised and may be titrated according to patient condition. Max: Olmesartan 40 mg and hydrochlorothiazide 25 mg.
Dosage Details
Oral
Hypertension
Adult: Available preparations:
Olmesartan 20 mg and hydrochlorothiazide 12.5 mg
Olmesartan 40 mg and hydrochlorothiazide 12.5 mg
Olmesartan 20 mg and hydrochlorothiazide 25 mg
Olmesartan 40 mg and hydrochlorothiazide 25 mg

1 tab once daily. Dosage is individualised and may be titrated according to patient condition. Max: Olmesartan 40 mg and hydrochlorothiazide 25 mg.
Renal Impairment
CrCl (mL/min) Dosage
<30 Contraindicated.
30-60 Max dose of olmesartan 20 mg once daily.
Hepatic Impairment
Moderate: Initially, olmesartan 10 mg once daily. Max: olmesartan 20 mg daily. Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to olmesartan, hydrochlorothiazide, or sulphonamide-derived drugs, anuria, cholestasis, biliary obstruction, refractory hypokalaemia, hypercalcaemia, hyponatremia, and symptomatic hyperuricaemia. Severe hepatic and severe renal impairment (CrCl <30 mL/min) impairment. Pregnancy and lactation. Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal (GFR <30 mL/min) impairment.
Special Precautions
Patient with aortic/mitral stenosis, obstructive hypertrophic cardiomyopathy, diabetes mellitus, diabetic nephropathy, hypercalcaemia, hypercholesterolaemia, parathyroid disease, renal artery stenosis, SLE, intravascular volume depletion, primary aldosteronism. Mild to moderate hepatic or renal impairment.
Adverse Reactions
Significant: Angioedema, electrolyte disturbance, sprue-like enteropathy, gout, hypotension, acute transient myopia, acute angle-closure glaucoma, photosensitivity, renal function deterioration, hypersensitivity.
Blood and lymphatic system disorders: Aplastic anaemia, bone marrow depression, leukopenia, thrombocytopenia.
Cardiac disorders:
Palpitations.
Gastrointestinal disorders: Nausea, diarrhoea, dyspepsia, abdominal pain, vomiting.
General disorders and administration site conditions: Asthenia, chest pain, fatigue, malaise, peripheral oedema, weakness.
Infections and infestations: Sialadenitis.
Investigations:
Increased creatinine phosphokinase, increased SGOT/SGPT.
Metabolism and nutrition disorders: Hypercholesterolaemia, hypertriglyceridaemia, hyperuricaemia.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, muscle spasm, myalgia, pain in extremity.
Nervous system disorders: Dizziness, headache, somnolence, postural dizziness, syncope, vertigo.
Renal and urinary disorders: Haematuria.
Reproductive system and breast disorders: Erectile dysfunction.
Respiratory, thoracic and mediastinal disorders: Upper respiratory infection, cough.
Skin and subcutaneous tissue disorders: Angioneurotic oedema, eczema, rash, urticaria.
Vascular disorders: Orthostatic hypotension.
Patient Counseling Information
This drug may cause dizziness or fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood pressure, serum electrolytes, BUN, creatinine.
Drug Interactions
May increase serum lithium levels and toxicity. Reduced antihypertensive effect with NSAIDs. Enhanced hypotensive effect with other antihypertensive agents and barbiturates, narcotics or antidepressants. Increased risk of hyperkalaemia with K-sparing diuretics, K supplements, or K-containing salt substitutes. Increased risk of symptomatic hyponatremia with carbamazepine.
Olmesartan: May decrease serum concentration with colesevelam. Decreased serum concentration with antacid.
Hydrochlorothiazide: Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia. May potentiate the effect of nondepolarising skeletal muscle relaxants (e.g. tubocurarine). May enhance the hypercalcaemic effect of fat-soluble vitamin, folate, and Fe. May increase electrolyte depletion, particularly hypokalaemia, when used with corticosteroids and ACTH, laxatives. May reduce the excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects. Decreased therapeutic effect of pressor amines e.g. noradrenaline. May enhance the hyperglycaemic effect of β-blockers and diazoxide. Increased bioavailability of thiazides with anticholinergic agents (e.g. atropine, biperiden). Induced risk of lactic acidosis with metformin. May increase serum uric acid level with uricosuric medicinal products (e.g. probenecid, sulfinpyrazone, allopurinol). Increased risk of adverse effects with amantadine. Risk of haemolytic anaemia with methyldopa. Increased risk of hyperuricaemia and gout-type complications with ciclosporin. Increased risk of tetracycline-induced increase in urea with tetracycline. 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 with aliskiren especially in patients with diabetes mellitus or renal impairment.
Food Interaction
Diminished antihypertensive effect with yohimbine. Potentiated orthostatic hypotensive effect with alcohol.
Lab Interference
Hydrochlorothiazide: May cause false-positive analytic result with anti-doping test. May interfere with parathyroid function test and decrease serum iodine without signs of thyroid disturbances. May cause false-negative aldosterone/renin ratio (ARR).
Action
Description: Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to AT1 receptors.
Hydrochlorothiazide is a diuretic acting mainly in 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.
Onset: Hydrochlorothiazide: Approx 2 hours.
Duration: Hydrochlorothiazide: 6-12 hours.
Pharmacokinetics:
Absorption: Olmesartan: Absolute bioavailability: Approx 26%. Time to peak plasma concentration: Approx 1-2 hours.
Hydrochlorothiazide: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 65-70%. Time to peak plasma concentration: Within 2-5 hours.
Distribution: Olmesartan: Volume of distribution: Approx 17 L. Plasma protein binding: 99%.
Hydrochlorothiazide: Crosses placenta and enters breast milk. Volume of distribution: 3.6-7.8L/kg. Plasma protein binding: Approx 40-68%.
Metabolism: Olmesartan: Undergoes rapid ester hydrolysis of olmesartan medoxomil to olmesartan.
Excretion: Olmesartan: Via urine (35-50%); faeces (50-65%) both as unchanged drug. Terminal elimination half-life: Approx 13 hours.
Hydrochlorothiazide: Mainly via urine (approx 70% as unchanged drug). Terminal elimination half-life: 5-15 hours.
Chemical Structure

Chemical Structure Image
Olmesartan

Source: National Center for Biotechnology Information. PubChem Database. Olmesartan, CID=158781, https://pubchem.ncbi.nlm.nih.gov/compound/Olmesartan (accessed on Jan. 22, 2020)


Chemical Structure Image
Hydrochlorothiazide

Source: National Center for Biotechnology Information. PubChem Database. Hydrochlorothiazide, CID=3639, https://pubchem.ncbi.nlm.nih.gov/compound/Hydrochlorothiazide (accessed on Jan. 20, 2020)

Storage
Store between 20-25°C.
ATC Classification
C09DA08 - olmesartan medoxomil and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
References
Anon. Hydrochlorothiazide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2018.

Anon. Olmesartan Medoxomil and Hydrochlorothiazide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2018.

Anon. Olmesartan. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com/. Accessed 06/06/2018.

Anon. Olmesartan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2018.

Buckingham R (ed). Hydrochlorothiazide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2018.

Buckingham R (ed). Olmesartan Medoxomil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2018.

Joint Formulary Committee. Olmesartan with Hydrochlorothiazide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2018.

Olmesartan Medoxomil and Hydrochlorothiazide Tablet (Torrent Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/06/2018.

Disclaimer: This information is independently developed by MIMS based on Olmesartan + 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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