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PRZ-SPIRONOLACTONE is a brand name for Spironolactone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ". The concurrent administration of potassium supplements, a diet rich in potassium, or other potassium-sparing diuretics is not recommended as this may induce hyperkalemia. Carcinogenesis and Genotoxicity Tumorigenicity: Spironolactone, in chronic toxicity studies, has been shown to be a tumorigenic in rats. Breast…
Verbatim from this product's HC label. Tap a section to expand.
4 Drug-Drug Interactions) 3. Serious Warnings and Precautions Box 4.
Dosage and Administration Note:
PRZ-PIRONOLACTONE is only available in the 100 mg tablet strength. , bananas, prunes, raisins and orange juice). Low-salt or low-sodium diet and daily exercise program are recommended. 2 Recommended Dose and Dosage Adjustment 1. Diagnosis and Treatment of Primary Hyperaldosteronism As an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets: Long Test: Administer PRZ-SPIRONOLACTONE at a daily dosage of 400 mg for 3-4 weeks.
Correction of hypokalemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short Test:
Administer PRZ-SPIRONOLACTONE at a daily dosage of 400 mg x 4 days. If serum potassium increases or urinary potassium decreases during PRZ-SPIRONOLACTONE administration, but reverts when PRZ-SPIRONOLACTONE is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of primary hyperaldosteronism has been established by more definitive testing procedures, PRZ-SPIRONOLACTONE may be administered in doses of 75 mg to 400 mg daily in preparation for surgery. For those unsuitable for surgery, spironolactone may be employed for long term maintenance therapy at the lowest effective dosage determined for the individual.
2. Edematous Disorders Associated with Congestive Heart Failure, Cirrhosis and the Nephrotic Syndrome When given as sole agent for diuresis, continue administration for at least 5 days. If an adequate response has been achieved within 5 days, continue dosage at the same level (or in selected patients, at a reduced dosage) in either single or divided daily doses.
Some may respond adequately to a dosage of only 75 mg daily. If adequate diuresis is not obtained within 5 days, a second diuretic also should be given for additive effect. Occasionally for severe resistant edema, one may add a potent glucocorticoid to this combined therapy.
Normally, an initial daily dosage of 100 mg (but may range from 25 mg to 200 mg daily) of spironolactone tablets administered in either single or divided doses is recommended.
Spironolactone and its metabolites do cross the placental barrier. There are no studies in pregnant women. PRZ-SPIRONOLACTONE should not be administered to patients who are pregnant. Females of reproductive potential who undergo treatment with PRZ- SPIRONOLACTONE should be informed of the potential hazard to the fetus and should be advised to avoid becoming pregnant prior to or during treatment.
Spironolactone was devoid of teratogenic effects in mice. Rabbits receiving spironolactone showed reduced conception rate, increased resorption rate, and lower number of live births. No embryotoxic effects were seen in rats administered high dosages, but limited, dose -related hypoprolactinemia and decreased ventral prostate and seminal vesicle weights in males, and increased luteinizing hormone secretion and ovarian and uterine weights in females were reported.
Feminization of the external genitalia of male fetuses was reported in another rat study. 2 Breastfeeding See 2 CONTRAINDICATIONS Canrenone, a major (and active) metabolite of spironolactone, appears in human breast milk. Because of the unknown potential for adverse events on the breast-feeding infant, a decision should be made whether to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.
3 Pediatrics: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of spironolactone in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
8. 1 Adverse Reaction Overview The following adverse reactions have been reported in association with spironolactone: Blood and lymphatic system disorders: Leukopenia (including agranulocytosis), thrombocytopenia, anemia.
Gastrointestinal disorders:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dosage in Children (<18 years of age):
The initial daily dosage should provide approximately 3 mg/kg of body weight administered in either single or divided doses. This dose should be reduced to 1-2 mg/kg for maintenance therapy or combination use with other diuretics. 1 Pediatrics) 3.
Essential Hypertension Usually in combination with other drugs, PRZ-SPIRONOLACTONE is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate. PRZ-SPIRONOLACTONE has mild to moderate antihypertensive activity.
For adults an initial daily dosage of 50 mg/day to 100 mg/day (in either single or divided doses) of PRZ-SPIRONOLACTONE is recommended. PRZ-SPIRONOLACTONE may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive PRZ-SPIRONOLACTONE (spironolactone) Page 7 of 35 agents.
Since a stabilized response may not occur before 2 weeks, continue treatment in either single or divided daily doses for that duration of time. Subsequently, adjust dosage in response to patient's needs. Most patients will respond to doses not exceeding 200 mg/day.
4. Hypokalemia Spironolactone tablets in dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic induced hypokalemia, when oral potassium supplements or other potassium sparing regimens are inappropriate. See also Table 1 for a summary of dosage recommendations.
Table 1 - PRZ-SPIRONOLACTONE Dosage* In Single or Divided Daily Doses CONDITION TYPE OF TEST INITIAL DOSAGE MAXIMUM DOSAGE Primary Hyperaldosteronism Long Test: 400 mg/day x 3-4 weeks - Short Test: 400 mg/day x 4 days - In Preparation for Surgery: 100-400 mg/day 400 mg/day Edematous Disorders: Congestive Heart Failure Cirrhosis Nephrotic Syndrome - Urinary: Na+ / K+ ratio >1 Na+ / K+ ratio <1 - 100 mg/day 100 mg/day 200-400 mg/day 100 mg/day 200 mg/day 100 mg/day 400 mg/day 200 mg/day Essential Hypertension - 50-100 mg/day 200 mg/day Hypokalemia - 25-100 mg/day 100 mg/day * Maintenance dosage should be individually determined, and may be lower than the recommended initial dose.
5 Missed Dose Take the missed dose as soon as you remember it. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take a double dose to make up for a missed one. 5.
Overdosage Symptoms:
There have been no reports of fatal overdose in man (except indirectly through hyperkalemia). Nausea and vomiting occur, and (much more rarely) drowsiness, dizziness, mental confusion, diarrhea, or a maculopapular or erythematous rash.
These manifestations disappear promptly on discontinuation of medication. Hyperkalemia may be exacerbated.
Treatment:
No specific antidote. No persistent toxicity has occurred or is expected. Inducing vomiting and evacuating the stomach by lavage could be considered. Spironolactone use should be discontinued and potassium intake (including dietary sources) restricted.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1- 844 POISON-X (1-844-764-7669). PRZ-SPIRONOLACTONE (spironolactone) Page 8 of 35 6.
Dosage Forms, Strengths, Composition and […]
Diarrhea and cramping, gastric bleeding, gastritis, nausea, ulceration, vomiting.
General disorders and administration site conditions:
Malaise, ataxia.
Hepatobiliary disorders:
Abnormal hepatic function. A few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
Immune system disorders:
Drug fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis, pruritus, rash.
Metabolism and nutrition disorders:
Electrolyte disturbances, hyperkalemia.
Musculoskeletal and connective tissue disorders:
Leg cramps, muscle spasms, rhabdomyolysis, myalgia, weakness Nervous system/psychiatric disorders: Mental confusion, ataxia, headache, drowsiness, lethargy, dizziness, change in libido.
Renal and urinary disorders:
Renal dysfunction (including acute renal failure). Reproductive system and breast disorders: gynecomastia* (see 7 WARNINGS and PRECAUTIONS, Carcinogenesis and Mutagenesis), erectile dysfunction (inability to achieve or maintain erection), abnormal semen (decreased motility and sperm count), irregular menses or amenorrhea, postmenopausal bleeding, benign breast neoplasm, breast pain, breast carcinoma (including male patients) Respiratory, thoracic and mediastinal disorders: Dysphonia, dyspnea.
Skin and subcutaneous tissue disorders:
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, hypertrichosis. *Gynecomastia may develop with the use of spironolactone, and physicians should be advised of its possible occurrence.
Development of gynecomastia is related to both dose and duration of therapy. If gynecomastia develops, discontinue the drug. Gynecomastia is usually reversible when spironolactone is discontinued, although in rare instances some breast enlargement may persist.
Adverse reactions are usually reversible upon discontinuation of the drug. 01%) Blood and lymphatic system disorders Disseminated intravascular coagulation, Bone marrow failure, Lymphadenopathy Neutropenia Pancytopenia, Lymphopenia, Splenomegaly, Coagulopathy Eosinophilia Cardiac disorders Cardiac arrest, Cardio-respiratory/Sinus arrest, Torsade de pointes, Atrioventricular block (1st/2nd degree, complete), Bundle branch block (left), Sinoatrial block, Myocardial infarction, Myocardial ischaemia, Defect conduction intraventricular, Ventricular/Supraventricular tachycardia, Ventricular/Supraventricular extrasystoles, Cardiomegaly, Cardiomyopathy Cardiogenic shock, Sick sinus syndrome, Cardiac failure, Ventricular fibrillation, Atrial fibrillation/flutter, Tachycardia, Coronary artery disease, Cardiovascular disorder, Sinus bradycardia, Angina unstable, Angina pectoris, Tricuspid valve incompetence, Mitral valve incompetence, Palpitations, Arrhythmia, Pericardial effusion, Cyanosis, Coronary artery occlusion Ear and labyrinth disorders Deafness, Hypoacusis, Vertigo, Ear disorder, Ear pain, Tinnitus Endocrine disorders Hyperthyroidism, Hypothyroidism, Inappropriate antidiuretic hormone secretion Eye disorders Diabetic retinopathy, Cataract, Vision blurred, Visual impairment Gastrointestinal disorders Pancreatitis, GI haemorrhage, Varices oesophageal, Intestinal obstruction, Large intestine polyp, Diverticulum, Hiatus hernia, Ileus paralytic, Melaena, Coeliac disease, Gastrooesophageal reflux disease, Haemorrhoids, Duodenitis, Retching, Gastric disorder, Gastrointestinal disorder, Abdominal distension, Dyspepsia, Dysphagia, Constipation General disorders and administration site conditions Sudden death, Multi-organ failure, Hypothermia, Peripheral swelling, Face oedema, Chest pain/discomfort, General physical health deterioration, Gait disturbance, Swelling, Chills, Pain, Asthenia, Fatigue Hepatobiliary disorders Hepatitis, Hepatic […]