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Indapamide oral

Presentation

Oral formulations of indapamide.

Drugs List

  • ALKAPAMID XL 1.5mg prolonged release tablet
  • CARDIDE SR 1.5mg prolonged release tablet
  • indapamide 1.5mg modified release tablet
  • indapamide 2.5mg tablets
  • INDIPAM XL 1.5mg prolonged release tablet
  • LORVACS XL 1.5mg prolonged release tablet
  • NATRILIX 2.5mg tablets
  • NATRILIX SR 1.5mg prolonged release tablet
  • RAWEL XL 1.5mg prolonged release tablet
  • TENSAID XL 1.5mg prolonged release tablet
  • Therapeutic Indications

    Uses

    Treatment of essential hypertension

    Dosage

    Adults

    2.5mg standard release tablet once daily in the morning or 1.5mg modified release tablet once daily in the morning.

    Additional Dosage Information

    Higher doses are not recommended as the antihypertensive effect is not enhanced although diuretic effects may be increased.

    Contraindications

    Children under 18 years
    Addison's disease
    Anuria
    Breastfeeding
    Galactosaemia
    Hepatic encephalopathy
    Hypercalcaemia
    Hyponatraemia
    Long QT syndrome
    Porphyria
    Pregnancy
    Refractory hypokalaemia
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment
    Symptomatic hyperuricaemia
    Torsade de pointes

    Precautions and Warnings

    Allergic disposition
    Elderly
    Family history of long QT syndrome
    Predisposition to narrow angle glaucoma
    Asthma
    Cardiac failure
    Diabetes mellitus
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    Gout
    Hepatic cirrhosis
    History of torsade de pointes
    Hyperaldosteronism
    Hyperparathyroidism
    Hyperuricaemia
    Hypokalaemia
    Ischaemic heart disease
    Lactose intolerance
    Malnutrition
    Mild hepatic impairment
    Mild renal impairment
    Nephrotic syndrome
    Systemic lupus erythematosus

    Advise patient to protect skin if restarting following photosensitivity
    Correct electrolyte disorders before treatment
    May cause hepatic encephalopathy in patients with hepatic disease
    May exacerbate or activate systemic lupus erythematosus
    Advise ability to drive/operate machinery may be affected by side effects
    Some formulations contain lactose
    Correct hypokalaemia before or during treatment
    Monitor plasma sodium before and during treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Diabetic control may need adjustment
    Monitor fluid and electrolyte status
    Monitor glucose levels more closely in diabetics with low potassium
    Monitor renal function
    Monitor serum potassium regularly
    Excess consumption of liquorice may increase the risk of hypokalaemia
    May precipitate diabetes mellitus
    May precipitate gout
    Withdraw and consider hyperparathyroidism if frank hypercalcaemia develops
    Discontinue before parathyroid function tests
    Discontinue at once if hepatic encephalopathy occurs
    Discontinue if hypercalcaemia occurs in patients with hyperparathyroidism
    Discontinue if patient develops decreased visual acuity +/or ocular pain
    Discontinue if photosensitivity occurs
    Discontinue if renal function deteriorates
    Advise patient not to take NSAIDs unless advised by clinician

    Monitor serum potassium regularly. More frequent monitoring is required in the following: the elderly, malnourished and/or polymedicated, cirrhotic patients with oedema and ascites, coronary artery disease, cardiac failure, as they are at increased risk of arrhythmias. Individuals with long QT intervals, whether the origin is congenital or iatrogenic are also at risk. Bradycardia with hypokalaemia is a risk factor for severe arrhythmias including potentially fatal torsades de pointes. More frequent monitoring of plasma potassium levels is required in all of the above situations. The first measurement should be obtained during the first week after commencing therapy. Correct hypokalaemia if detected.

    An idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute closed angle glaucoma may occur. Symptoms including acute onset of decreased visual acuity or ocular pain may occur within hours to weeks of initiation of indapamide and can lead to permanent vision loss. If symptoms occur treatment should be discontinued and prompt medical or surgical treatments should be considered if the intraocular pressure remains uncontrolled.

    Pregnancy and Lactation

    Pregnancy

    Indapamide is contraindicated in pregnancy.

    Diuretics can reduce plasma volume and lead to a reduced perfusion of the placenta. Schaefer (2015) 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 indapamide is not an indication for interrupting pregnancy. Briggs (2015) 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.

    Lactation

    Indapamide is contraindicated in breastfeeding.

    At the time of writing, there is limited published experience concerning the use of indapamide during breastfeeding. Indapamide is excreted into human breast milk.

    Schaefer (2015) concludes that during breastfeeding, diuretics should not normally be prescribed for treating hypertension. However, when such a drug is urgently needed, moderately dosed treatment with hydrochlorothiazide can be undertaken, with attention to the side effects. Single doses of indapamide do not require limitation of breastfeeding, but therapy should be changed.

    Side Effects

    Abnormal liver function
    Agranulocytosis
    Angioedema
    Aplastic anaemia
    Arrhythmias
    Blurred vision
    Choroidal effusion
    Constipation
    Dehydration
    Dry mouth
    Erectile dysfunction
    Fatigue
    Gout
    Haemolytic anaemia
    Headache
    Hepatic encephalopathy
    Hepatic impairment
    Hepatitis
    Hypercalcaemia
    Hyperglycaemia
    Hypersensitivity reactions
    Hypokalaemia
    Hyponatraemia
    Hypotension
    Hypovolaemia
    Increases in hepatic enzymes
    Increases in plasma urate concentration
    Leucopenia
    Maculopapular rash
    Metabolic alkalosis
    Muscle spasm
    Muscle weakness
    Myalgia
    Myopia
    Narrow angle glaucoma
    Nausea
    Ocular pain
    Pancreatitis
    Paraesthesia
    Photosensitivity
    Prolongation of QT interval
    Purpura
    Renal failure
    Rhabdomyolysis
    Stevens-Johnson syndrome
    Syncope
    Thrombocytopenia
    Torsades de pointes
    Toxic epidermal necrolysis
    Urticaria
    Vertigo
    Visual disturbances
    Vomiting
    Worsening of lupus erythematosus

    Overdosage

    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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: March 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: ALKAPAMID XL 1.5 mg prolonged-release tablets. HBS Healthcare Ltd. Revised January 2016.

    Summary of Product Characteristics: Cardide SR 1.5mg prolonged release tablets. Teva UK Ltd. Revised June 2015.

    Summary of Product Characteristics: Indapamide 2.5mg tablets. Zenvita. Revised July 2018.

    Summary of Product Characteristics: Indipam XL 1.5mg prolonged release tablets. Actavis UK Ltd. Revised September 2020.

    Summary of Product Characteristics: Lorvacs XL 1.5mg prolonged release tablets. Torrent Pharma (UK) Ltd. Revised December 2018.

    Summary of Product Characteristics: Natrilix 2.5mg. Servier Laboratories Ltd. Revised October 2021.

    Summary of Product Characteristics: Natrilix SR. Servier Laboratories Ltd. Revised October 2021.

    Summary of Product Characteristics: Rawel XL. Consillient Health Ltd. Revised October 2014.

    Summary of Product Characteristics: Tensaid XL 1.5mg prolonged-release film-coated tablets. Generics (UK) Ltd. Revised October 2016.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 March 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Indapamide Last revised: 07 February 2019
    Last accessed: 21 March 2019

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