Co-flumactone (hydroflumethiazide and spironolactone) oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of co-flumactone.
Drugs List
Therapeutic Indications
Uses
Congestive cardiac failure
Dosage
Adults
An initial dose of 100mg spironolactone once daily is required in most cases. The dose can then be adjusted to suit the individual and can range from 25mg to 200mg once daily.
Elderly
Treatment should be started with the lowest dose and titrated upwards as required.
Children
1.5mg/kg to 3mg/kg of spironolactone given daily in divided doses.
Contraindications
Acute porphyria
Acute renal failure
Addison's disease
Anuria
Breastfeeding
Hyperkalaemia
Hyponatraemia
Pregnancy
Progressive renal disorder
Refractory hypokalaemia
Severe hypercalcaemia
Severe renal impairment
Symptomatic hyperuricaemia
Precautions and Warnings
Elderly
General anaesthesia
Risk factors for skin cancer
Acute hepatic disorder
Diabetes mellitus
Gout
Hepatic cirrhosis
History of skin cancer
Hyperaldosteronism
Hyperlipidaemia
Malnutrition
Nephrotic syndrome
Renal impairment
Severe hepatic impairment
Systemic lupus erythematosus
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Monitor blood / urinary glucose in patients suspected of latent diabetes
Monitor for signs of cutaneous basal cell carcinoma
Monitor for signs of cutaneous squamous cell carcinoma
Monitor periodically for signs of fluid or electrolyte imbalance
Periodic monitoring of blood urea and serum potassium recommended
Advise patient of increased risk of non-melanoma skin cancer
Excess consumption of liquorice may increase the risk of hypokalaemia
Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
May precipitate diabetes mellitus
May precipitate gout
May affect results of some laboratory tests
Discontinue if hyperkalaemia occurs
Discontinue if patient develops decreased visual acuity +/or ocular pain
Additional calcium/vitamin D under strict medical supervision only
Advise patient not to take NSAIDs unless advised by clinician
Advise on problems of salt substitutes/high intake of potassium-rich food
Caution should be shown when treating the elderly, especially in the presence of severe hepatic or renal impairment.
Treatment with co-flumactone can result in choroidal effusion, acute myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain, if untreated acute angle-closure glaucoma can lead to permanent vision loss. If symptoms occur, discontinue and consider prompt medical or surgical treatment if intraocular pressure remains uncontrolled.
Pregnancy and Lactation
Pregnancy
Co-flumactone is contraindicated during pregnancy.
The effects of using co-flumactone during pregnancy is unknown. Use is not recommended by the manufacturer.
Known effects of spironolactone during pregnancy:
Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Known effects of hydroflumethiazide during pregnancy:
At the time of writing there is limited published information regarding the use of hydroflumethiazide during pregnancy. Potential risks are unknown, however hydroflumethiazide is known to cross the placenta. Based on the pharmacological mechanism of action of thiazides, exposure may compromise placental perfusion, increase uterine inertia, inhibit labour, cause icterus and thrombocytopenia and disturb electrolyte balance. Hydroflumethiazide should not be used for essential hypertension in pregnant women or for gestational oedema, gestational hypertension or preeclampsia due to the risk of reduced plasma volume and placental hypoperfusion.
Lactation
Co-flumactone is contraindicated during breastfeeding.
The effects of using co-flumactone when breastfeeding is unknown. Breastfeeding is contraindicated by the manufacturer.
Known effects of spironolactone during breastfeeding:
Available data indicates spironolactone is expressed in human breast milk, but the quantity is unknown. Effects on exposed infants are unknown.
Known effects of hydroflumethiazide during breastfeeding:
Hydroflumethiazide is present in human breast milk in small amounts. High doses of hydroflumethiazide can cause diuresis and inhibit milk production.
Side Effects
Abdominal pain
Abnormal liver function
Acidosis
Acute kidney injury
Acute myopia
Acute renal failure
Agranulocytosis
Alopecia
Anaphylactoid reaction
Aplastic anaemia
Asthenia
Basal cell carcinoma
Blood disorders
Breast enlargement
Breast neoplasm
Breast pain
Changes in libido
Choroidal effusion
Confusion
Dermatitis
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Electrolyte disturbances
Erectile dysfunction
Gastro-intestinal disturbances
Glaucoma (closed angle)
Glycosuria
Gynaecomastia
Headache
Hypercalcaemia
Hyperchloraemia
Hyperglycaemia
Hyperkalaemia
Hypertrichosis
Hypokalaemia
Hyponatraemia
Insomnia
Interstitial nephritis
Jaundice
Leukopenia
Malaise
Menstrual disturbances
Muscle spasm
Nausea
Necrotising vasculitis
Orthostatic hypotension
Pancreatitis
Paraesthesia
Photosensitivity
Pruritus
Pulmonary oedema
Purpura
Pyrexia
Rash
Restlessness
Rise in blood lipids
Sialadenitis
Squamous cell carcinoma
Stevens-Johnson syndrome
Systemic lupus erythematosus
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vertigo
Visual field defects
Vomiting
Xanthopsia
Effects on Laboratory Tests
Spironolactone has been reported to interfere with certain digoxin assays. Patients who are receiving spironolactone should have their serum digoxin concentrations measured by means other than serum digoxin concentrations, unless the digoxin assay has been proven not to be affected by spironolactone therapy.
In fluorometric assays, spironolactone may interfere with the estimation of compounds with similar fluorescence characteristics.
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: February 2020
Reference Sources
Summary of Product Characteristics: Aldactide 25mg Tablets. Pfizer Ltd. Revised July 2020.
Summary of Product Characteristics: Aldactide 50mg Tablets. Pfizer Ltd. Revised July 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 February 2020
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last accessed: 19 February 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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