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Valsartan with hydrochlorothiazide oral


Oral formulations of valsartan with hydrochlorothiazide

Drugs List

  • CO-DIOVAN 160mg+12.5mg tablets
  • CO-DIOVAN 160mg+25mg tablets
  • CO-DIOVAN 80mg+12.5mg tablets
  • valsartan 160mg and hydrochlorothiazide 12.5mg tablets
  • valsartan 160mg and hydrochlorothiazide 25mg tablets
  • valsartan 80mg and hydrochlorothiazide 12.5mg tablets
  • Therapeutic Indications


    Hypertension-not adequately controlled by individual components



    Doses between 80 mg valsartan with 12.5 mg hydrochlorothiazide once daily and 160 mg valsartan with 25 mg hydrochlorothiazide once daily are recommended.

    The response to this medication should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of 320 mg valsartan with 25 mg hydrochlorothiazide.

    The peak anti-hypertensive effect is seen within 2 to 4 weeks from the initiation of therapy. However, in some patients 4 to 8 weeks of treatment may be necessary. This should be taken into account during dose titration.


    (See Dosage; Adult)

    Patients with Hepatic Impairment

    Mild to moderate hepatic impairment without cholestasis
    The dose of valsartan should not exceed 80 mg - use with caution in this population.

    Additional Dosage Information

    When clinically appropriate direct change from monotherapy to the fixed combination therapy may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.


    Children under 18 years
    Addison's disease
    Biliary cirrhosis
    Hepatic encephalopathy
    Refractory hypokalaemia
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe bilateral renal artery stenosis
    Severe hepatic impairment
    Severe unilateral stenosis of solitary functioning kidney

    Precautions and Warnings

    Aortic stenosis
    Bilateral renal artery stenosis
    Diabetes mellitus
    Electrolyte depletion
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    History of skin cancer
    Hypertrophic obstructive cardiomyopathy
    Lactose intolerance
    Mild hepatic impairment
    Mitral stenosis
    Nephrotic syndrome
    Peripheral vascular disease
    Renal impairment
    Renovascular disorder
    Severe congestive cardiac failure
    Severe generalised atherosclerosis
    Systemic lupus erythematosus
    Unilateral stenosis of solitary functioning kidney

    Advise patient to protect skin if restarting following photosensitivity
    Patients with primary aldosteronism may not benefit from this treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Afro-Caribbean or black patients may show reduced response
    Correct volume and/or salt depletion before initiating therapy
    Some formulations contain lactose
    Some products may contain soya or soya derivative
    Evaluate renal function before and during treatment
    Diabetic control may need adjustment
    Monitor periodically for signs of fluid or electrolyte imbalance
    Monitor serum potassium regularly
    Advise patient of increased risk of non-melanoma skin cancer
    Advise patient to monitor for and report any skin changes
    Excess consumption of liquorice may increase the risk of hypokalaemia
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    Increases in cholesterol and triglyceride levels may be seen
    May precipitate diabetes mellitus
    May precipitate gout
    Patient to report nausea, vomiting or situations leading to salt/water loss
    Withdraw and consider hyperparathyroidism if frank hypercalcaemia develops
    Discontinue before parathyroid function tests
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if angioedema occurs
    Discontinue if patient develops decreased visual acuity +/or ocular pain
    Discontinue if photosensitivity occurs
    Discontinue if symptoms of acute angle closure glaucoma occur
    Additional calcium/vitamin D under strict medical supervision only
    Advise patient not to take NSAIDs unless advised by clinician
    Hypotensive effects may be potentiated by alcohol
    Advise on problems of salt substitutes/high intake of potassium-rich food
    Female: Ensure adequate contraception during treatment
    Advise pt. to minimise exposure to sunlight & avoid sunlamps during therapy

    In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with ACE inhibitors has been associated with oliguria and/ or progressive azotaemia and in rare cases with acute renal failure and/ or death. As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of this medication may be associated with impairment of the renal function.

    Hydrochlorothiazide has been associated with an idiosyncratic reaction resulting in choroidal effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma. Symptoms can occur within hours to weeks of the drug initiation, these include acute onset of decreased visual activity or ocular pain.

    If intraocular pressure remains uncontrolled, consider prompt medical or surgical treatment. Risk factors for developing acute closure glaucoma may include a history of sulfonamide or penicillin allergy.

    Pregnancy and Lactation


    Valsartan with hydrochlorothiazide is contraindicated in pregnancy.

    Angiotensin II receptor antagonists may be associated with similar risks as ACE inhibitors. Angiotensin II receptor antagonist exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

    The MHRA states that the use of angiotensin II receptor antagonists in late pregnancy has been associated with adverse effects on the foetal kidney and other congenital anomalies, therefore angiotensin II receptor antagonists should not be used at any stage during of pregnancy unless absolutely necessary and only then after the potential risks and benefits have been discussed with the patient.

    Exposure to angiotensin II receptor antagonists during the first trimester has been inconclusive, however, a small increase in risk cannot be excluded and a detailed ultrasound is recommended.

    If pregnancy is detected during therapy, valsartan should be discontinued as soon as possible and alternative treatment should be offered. Guidelines advise that women who are taking angiotensin II receptor blockers are told that there is an increased risk of congenital abnormalities if these drugs are taken during pregnancy and other antihypertensive treatments should be discussed and offered.

    Diuretics can reduce plasma volume and lead to a reduced perfusion of the placenta. Schaefer (2007) comments that diuretics are no longer part of the standard therapy for hypertension and oedema during pregnancy; they should only be used for particular indications. In such cases hydrochlorothiazide is the diuretic of choice. Use of hydrochlorothiazide is not an indication for interrupting pregnancy. Briggs (2011) comments that in general, diuretics are not recommended in the treatment of gestational hypertension because of the maternal hypovolaemia characteristic of the disease.

    Thiazides and related diuretics may cause neonatal thrombocytopenia, bone marrow suppression, jaundice, electrolyte disturbance and hypoglycaemia. Stimulation of labour, uterine inertia and meconium staining have also been reported.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Valsartan with hydrochlorothiazide is contraindicated in breastfeeding.

    Schaefer (2007) suggests that accidental administration of a single dose does not require weaning, however, therapy should be changed to an antihypertensive which has been better studied in breastfeeding. The MHRA concludes that the use of angiotensin II receptor antagonists in breastfeeding mothers is not recommended. Alternative agents with more established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm baby.

    Hydrochlorothiazide is excreted in small quantities into breast milk. There have been reports of thrombocytopenia in the nursing infants of mothers receiving a thiazide diuretic, however, the risk is considered low by, Hale (2010) and Briggs (2011). Thiazide diuretics have been used in large quantities to suppress lactation. Overall, hydrochlorothiazide is considered safe while breastfeeding (Briggs, 2011, Schaefer, 2007 and Hale, 2010).

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Acute respiratory distress
    Altered glucose tolerance
    Blurred vision
    Bone marrow depression
    Cardiac arrhythmias
    Choroidal effusion
    Decrease in haematocrit
    Decreased appetite
    Electrolyte disturbances
    Elevated triglyceride levels
    Elevation of liver enzymes
    Exacerbation of systemic lupus erythematosus
    Glaucoma (closed angle)
    Haemoglobin decrease
    Haemolytic anaemia
    Hypersensitivity reactions
    Hypochloraemic alkalosis
    Impaired renal function
    Increase in blood urea nitrogen
    Increase in creatinine
    Increase in plasma cholesterol
    Increased uric acid level
    Intrahepatic cholestasis
    Lupus erythematosus-like syndrome
    Necrotising vasculitis
    Postural hypotension
    Pulmonary oedema
    Renal failure
    Serum bilirubin increased
    Serum sickness
    Sleep disturbances
    Thrombocytopenic purpura
    Toxic epidermal necrolysis
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Co-Diovan 80/12.5mg, 160/12.5mg, 160/25mg tablets. Novartis Pharmaceuticals UK Ltd. Revised August 2020.

    Summary of Product Characteristics: Valsartan/hydrochlorothiazide 80/12.5mg film-coated tablets. Actavis UK Ltd. Revised July 2012.
    Summary of Product Characteristics: Valsartan/hydrochlorothiazide 160/12.5mg film-coated tablets. Actavis UK Ltd. Revised July 2012.
    Summary of Product Characteristics: Valsartan/hydrochlorothiazide 160/25mg film-coated tablets. Actavis UK Ltd. Revised July 2012.

    MHRA Drug Safety Update: Volume 1, Issue 5 December 2007.
    Available at:
    Last accessed: August 6, 2013

    MHRA Drug Safety Update: Volume 2. Issue 10. May 2009.
    Last accessed: August 6, 2013

    MHRA Drug Safety Update November 2018
    Available at:
    Last accessed: 08 January 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Hydrochlorothiazide, Last revised: January 24, 2013.
    Last accessed: August 6, 2013.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Valsartan, Last revised: September 29, 2009.
    Last accessed: August 6, 2013.

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