Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
RIDAQ-12,5 is contraindicated in:
RIDAQ-12,5 should be used with caution in patients with impaired hepatic function or progressive liver disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma and increases the risk of hepatic encephalopathy.
Patients with hepatic cirrhosis are particularly at risk of hypokalaemia.
RIDAQ-12,5 should be given with caution in renal function impairment since it can further reduce renal function (see section 4.3).
In patients with renal disease, RIDAQ-12,5 may precipitate azotaemia and oliguria. Cumulative effects of the medicine may develop in patients with impaired renal function. RIDAQ-12,5 is ineffective at creatinine clearance values of 30 mL/min or below (i.e. moderate or severe renal insufficiency). If progressive renal impairment becomes evident, as indicated by rising non-protein nitrogen, careful reappraisal of therapy is necessary, with consideration given to discontinuing diuretic therapy.
RIDAQ-12,5 may cause hyperglycaemia and aggravate or unmask diabetes mellitus. Blood-glucose concentrations should be monitored in patients taking antidiabetic medicines, including insulin and oral hypoglycaemic medicines, since requirements may change.
All patients should be carefully observed for signs of fluid and electrolyte imbalance namely, hyponatremia, hyperchloremic alkalosis, and hypokalaemia; serum and urine electrolyte determinations are particularly important especially in the presence of vomiting or during parenteral fluid therapy. Elderly patients are particularly susceptible to electrolyte imbalance.
Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals.
Hypokalaemia may develop, especially with brisk diuresis, in patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) also known as corticotropin, or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalaemia. Hypokalaemia may cause cardiac dysrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g. increased ventricular irritability). Hypokalaemia may be avoided or treated by use of potassium sparing diuretics or potassium supplements such as foods with a high potassium content.
Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.
Dilutional hyponatremia may occur in oedematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Hyperuricaemia may occur, or acute gout may be precipitated in certain patients receiving RIDAQ-12,5.
RIDAQ-12,5 have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesaemia. Hypercalcaemia RIDAQ-12,5 may decrease urinary calcium excretion. RIDAQ-12,5 may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. RIDAQ-12,5 should be discontinued before carrying out tests for parathyroid function.
Increases in cholesterol and triglyceride levels may be associated with RIDAQ-12,5 therapy.
There is a possibility that RIDAQ-12,5 may exacerbate or activate systemic lupus erythematosus in susceptible patients.
RIDAQ-12,5 may add to or potentiate the action of other antihypertensive medicines.
Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
Lithium generally should not be given with diuretics (see section 4.5).
RIDAQ-12,5, a sulphonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of medicine initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue RIDAQ-12,5 as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulphonamide or penicillin allergy.
Sulfonamide or sulfonamide derivative medicines, such as hydrochlorothiazide, as in RIDAQ-12,5, can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of medicine initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue medicines intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
An increased risk of non-melanoma skin cancer (NMSC) (basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)) with increasing cumulative dose of hydrochlorothiazide (HCTZ), as in RIDAQ-12,5, exposure has been observed in two epidemiological studies. Photosensitising actions of RIDAQ-12,5 could act as a possible mechanism for NMSC.
Patients taking RIDAQ-12,5 should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients to minimise the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. RIDAQ-12,5 should not be used by patients who have had previous and/or current basal cell carcinomas and/or squamous cell carcinomas of the skin and/or lip (see section 4.3).
The antihypertensive effects of the medicine may be enhanced in the post-sympathectomy patient.
RIDAQ-12,5 could produce a positive analytical result in an anti-doping test.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption should not take this medicine.
RIDAQ-12,5 may intensify electrolyte imbalance, particularly hypokalaemia.
Dosage adjustment of the antidiabetic medicines may be necessary.
Increased serum calcium levels due to decreased excretion may occur when administered concurrently with RIDAQ-12,5.
The presence of anionic exchange resins may delay or decrease absorption of RIDAQ-12,5. Sulphonamide diuretics should be taken at least one hour before or four to six hours after these medicines.
RIDAQ-12,5 may enhance the toxicity of digitalis glycosides by depleting serum-potassium concentrations.
RIDAQ-12,5 may enhance the neuromuscular blocking action of competitive muscle relaxants, such as tubocurarine.
RIDAQ-12,5 may enhance or potentiate the effect of other antihypertensive medicines, while postural hypotension associated with this therapy may be enhanced by concomitant ingestion of alcohol, barbiturates, or opioids.
The potassium-depleting effect of RIDAQ-12,5 may be enhanced by corticosteroids, ACTH or corticotropin and beta2- agonists such as salbutamol.
RIDAQ-12,5 has been reported to diminish the response to pressor amines, such as noradrenaline, but the clinical significance of this effect is uncertain.
Concomitant administration of RIDAQ-12,5 and lithium is not generally recommended since RIDAQ-12,5 may reduce the renal clearance of lithium and may lead to toxic blood concentrations of lithium (see section 4.4).
In some patients, the administration of NSAIDs can reduce the diuretic, natriuretic and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when RIDAQ-12,5 and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Due to the risk of hypokalaemia, caution should be used when RIDAQ-12,5 is co-administered with medicines associated with torsades de pointes, e.g. anti-dysrhythmics, antipsychotics and other medicines known to induce Torsades de pointes.
RIDAQ-12,5 should be discontinued before carrying out tests for parathyroid function (see section 4.3).
RIDAQ-12,5 may cause diagnostic interference of the bentiromide test. RIDAQ-12,5 may decrease serum Protein Bound Iodine (PBI) levels without signs of thyroid disturbance.
The safety of RIDAQ-12,5 in pregnancy and lactation has not been established (see section 4.3).
There is limited experience with RIDAQ-12,5 during pregnancy, especially during the first trimester. RIDAQ-12,5 crosses the placenta and there have been reports of neonatal jaundice, thrombocytopenia, icterus and electrolyte imbalances following maternal treatment and is not recommended for use in pregnancy. Reductions in maternal blood volume could also adversely affect placental perfusion.
RIDAQ-12,5 should not be used for gestational oedema, gestational hypertension or pre-eclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
RIDAQ-12,5 should not be used for essential hypertension in pregnant women.
RIDAQ-12,5 is distributed into breast milk, and is not recommended for use in lactation. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue RIDAQ-12,5, considering the importance of the medicine to the mother. RIDAQ-12,5 in high doses causing intense diuresis can inhibit the milk production.
There is no data available.
RIDAQ 12,5 mg has moderate influence on the ability to drive and use machines. Since adverse reactions such as somnolence, dizziness and blurred vision have been reported in patients receiving RIDAQ 12, 5 mg, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that RIDAQ 12,5 mg does not adversely affect their ability to do so (see section 4.8).
| System organ class | Frequent | Less frequent | Frequency unknown (cannot be estimated from the available data) |
|---|---|---|---|
| Infections and infestations | Sialadenitis | ||
| Neoplasm benign, malignant and unspecified (including cysts and polyps) | Non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) | ||
| Blood and the lymphatic system disorders | Blood dyscrasias, thrombocytopenia, granulocytopenia, leukopenia, aplastic anaemia, haemolytic anaemia | Agranulocytosis, neutropenia, bone marrow depression | |
| Immune system disorders | Hypersensitivity reactions | Anaphylactic reactions, purpura | |
| Metabolism and nutrition disorders | Electrolyte imbalances, hypochloraemic alkalosis, hyponatraemia (may occur in patients with severe heart failure who are very oedematous, particularly with large doses in conjunction with restricted salt in the diet), and hypokalaemia (intensifies the effect of digitalis on cardiac muscle and administration of digitalis or its glycosides may have to be temporarily suspended) | Metabolic disturbances especially at high doses, hyperglycaemia in diabetic and other susceptible patients, hyperuricaemia and precipitate attacks of gout in some patients, hypomagnesaemia, anorexia | |
| Psychiatric disorders | Restlessness | Depression, sleep disturbances | |
| Nervous system disorders | Lethargy, drowsiness, seizures | Headache, dizziness, paraesthesia | Light-headedness |
| Eye disorders | Yellow vision (xanthopsia) | Transient blurred vision, choroidal effusion | |
| Ear and labyrinth disorders | Vertigo | ||
| Cardiac disorders | Cardiac dysrhythmias | ||
| Vascular disorders | Postural hypotension (aggravated by barbiturates, alcohol or narcotics) | Necrotising angiitis (vasculitis, cutaneous vasculitis) | |
| Respiratory, thoracic and mediastinal disorders | Pulmonary oedema, pneumonitis | Respiratory distress | |
| Gastrointestinal disorders | Gastrointestinal disturbances, dry mouth | Gastric irritation, nausea, vomiting, constipation, diarrhoea, intestinal ulceration has occurred following the administration of tablets containing thiazides with an enteric-coated core of potassium chloride, pancreatitis, cramping | |
| Hepato-biliary disorders | Cholestatic jaundice | ||
| Skin and subcutaneous tissue disorders | Photosensitivity reactions, skin rashes | Erythema multiforme including Stevens- Johnson Syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, urticaria | |
| Musculoskeletal and connective tissue disorders | Muscle pain and cramps | Muscle spasm | |
| Renal and urinary disorders | Oliguria | Glycosuria, urinary excretion of calcium is reduced | Renal failure, renal dysfunction, interstitial nephritis |
| Reproductive system and breast disorders | Impotence | ||
| General disorders and administrative site conditions | Thirst, weakness | Fever | |
| Investigations | Adverse changes in plasma lipids have been noted but their clinical significance is unclear. | Increases in cholesterol and triglycerides |
Eye disorders: Cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to:
SAHPRA: https://www.sahpra.org.za/Publications/Index/8
Aspen Pharmacare:
E-mail: Drugsafety@aspenpharma.com
Tel: 0800 118 088
Not applicable.
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