Valsartan + Hydrochlorothiazide


Concise Prescribing Info
Indications/Uses
HTN.
Dosage/Direction for Use
Adult : PO Per tab contains valsartan (mg)/hydrochlorothiazide (mg): 80/12.5; 160/12.5; 160/25; 320/12.5; 320/25: Initial: 80/12.5 mg once daily, up to 320/25 mg if needed.
Dosage Details
Oral
Hypertension
Adult: Per combination tablet contains valsartan/hydrochlorothiazide: 80/12.5 mg; 160/12.5 mg; 160/25 mg; 320/12.5 mg; 320/25 mg: Initially, 80/12.5 mg once daily, titrate dose gradually according to response, up to 320/25 mg.
Renal Impairment
CrClDosage
<30Not recommended.
Contraindications
Hypersensitivity to valsartan, hydrochlorothiazide or sulphonamides. Severe hepatic impairment, creatinine clearance <30ml/min, anuria, cirrhosis, biliary obstruction, conditions where there is increased potassium loss (e.g. salt losing nephropathies and pre-renal impairment of kidney function), refractory hypokalaemia, hyponatraemia, hypercalcaemia, hyperuricaemia, history of gout and uric acid stones, untreated Addison's disease. Pregnancy and lactation.
Special Precautions
DM, postsympathectomy patients. May exacerbate SLE. Monitor serum potassium regularly. Observe for signs of fluid or electrolyte imbalance. Discontinue before testing for parathyroid function. May affect ability to drive or operate machinery. Elderly.
Adverse Reactions
Headache, asthenia, fatigue, dizziness, somnolence, insomnia, orthostatic hypotension, paraesthesia, nasopharyngitis, tachycardia, palpitations, tinnitus, vertigo, dyspepsia, diarrhoea, flatulence, dry mouth, nausea, vomiting, abdominal pain, peripheral oedema, pyrexia, increased BUN, elevated LFT, anxiety, erectile dysfunction, glucose intolerance, increased serum cholesterol, triglycerides, uric acid. Electrolyte imbalances e.g. hypomagnesaemia, hypercalcaemia, hyponatraemia, hypochloraemic alkalosis.
Overdosage
Symptoms: Hypotension, tachycardia, bradycardia, circulatory collapse, electrolyte abnormalities (e.g. hypokalaemia, hypochloremia, hyponatremia, dehydration). Management: Treatment is symptomatic and supportive. Effectiveness of haemodialysis is unknown.
Drug Interactions
Increased antihypertensive effect with other antihypertensive drugs. Monitor potassium frequently if used with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or drugs that may affect potassium levels (e.g. heparin, ciclosporin, drospirenone, amphotericin, corticosteroids, carbenoxolone). Reduced antihypertensive effect of valsartan and increased risk of renal impairment with NSAIDs. May reduce renal clearance of cytotoxic drugs (e.g. cyclophosphamide, methotrexate). Increased serum calcium with vitamin D or calcium salts.
Potentially Fatal: Increased lithium levels with valsartan, monitor lithium levels. Increased risk of cardiac arrhythmia with dofetilide, avoid use.
Lab Interference
Thiazides may decrease serum protein bound iodine levels.
Action
Description: Valsartan is an angiotensin II receptor antagonist and reduces blood pressure by blocking the vasoconstrictive and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide is a thiazide diuretic.
Onset: Hyopotensive effect of valsartan: 2hr. Diuresis effect of hydrochlorothiazide: 2 hr.
Duration: Hypotensive effect of valsartan: 24 hr. Diuresis effect of hydrochlorothiazide: 6-12 hr.
Pharmacokinetics:
Absorption: Valsartan: Rapidly absorbed, bioavailability 23%, peak plasma concentration occur 2-4 hr. Hydrochlorothiazide: Rapidly absorbed, bioavailability: 65-70%.
Distribution: Valsartan: Protein binding 94-97%, mainly to serum albumin, volume of distribution: 17 L. Hydrochlorothiazide: Preferentially bound to red blood cells, crosses placenta and excreted into breast milk.
Metabolism: Valsartan: Not significantly metabolised.
Excretion: Valsartan: Excreted mainly as unchanged drug in faeces (70%) and urine (30%), terminal half life 5-9 hr. Hydrochlorthiazide: Excreted mainly unchanged in urine, plasma half life 5-15 hr.
Storage
Store between 15-30°C.
Disclaimer: This information is independently developed by MIMS based on Valsartan + 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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