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AA-ATENIDONE is a brand name for Atenolol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AA-ATENIDONE (atenolol and chlorthalidone tablets) is indicated for: • Treatment of hypertension for patients for whom combination therapy with atenolol and chlorthalidone is required. This fixed combination is not indicated for initial therapy of hypertension. See 4.2 Recommended Dose and Dosage Adjustment. 1.1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Dosage must be determined for individual patients by titration of each component separately. Where the fixed combination in AA-ATENIDONE (atenolol/chlorthalidone) supplies the dosage so determined, the combination product may be used for maintenance therapy.
• For further adjustment of dosage, however, it is best to use the individual drugs again. The treatment of hypertension is not static, but must be re-evaluated as conditions in each patient warrant. 2 Recommended Dose and Dosage Adjustment One AA-ATENIDONE tablet once daily can be used to administer up to 100 mg of atenolol and AA-ATENIDONE (Atenolol and Chlorthalidone) Page 6 of 50 25 mg of chlorthalidone.
If further lowering of the blood pressure is required, another antihypertensive agent may be added to the regimen. In patients with renal impairment, the dose of the components should be carefully individualized. Recommendations for dosage adjustments for atenolol and chlorthalidone in renal disease are found in the Atenolol prescribing information and Chlorthalidone prescribing information.
If dosage adjustment is necessary during maintenance therapy, it is advisable to use the individual drugs. Pediatrics Health Canada has not authorized an indication for pediatric use. 3 Pediatrics. 4 Administration AA-ATENIDONE tablets should be taken whole with a glass of water at the same time each day.
5 Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule. Do not double dose.
1 Adverse Reaction Overview Adverse reactions that have been reported with the individual components are listed below: The most serious adverse reactions encountered with atenolol are congestive heart failure, A-V block and bronchospasm.
Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints. The most common adverse reactions reported in clinical trials with atenolol in 2500 patients are bradycardia (3%), dizziness (3%), vertigo (2%), fatigue (3%), diarrhea (2%) and nausea (3%).
Serious adverse reactions reported with chlorthalidone include cardiac arrhythmia, dyspnea, aplastic anemia and agranulocytosis. Most frequent adverse reactions (≥10%) include hypokalemia, hyperuricemia, and hyperlipidemia.
Chlorthalidone:
The following adverse reactions have been reported: Blood and lymphatic system disorders: Rare: Leukopenia, thrombocytopenia and eosinophilia.
Not known:
Agranulocytosis, aplastic anemia.
Eye disorders:
Rare: disturbance of vision.
Not known:
Choroidal effusion, acute myopia and acute angle-closure glaucoma (Cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics), xanthopsia.
Gastrointestinal disorders:
Common: minor gastrointestinal distress. Rare: mild nausea, vomiting, diarrhea, constipation, gastric pain.
Very rare:
Pancreatitis.
5 Ethnic Origin 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
6 5 OVERDOSAGE............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS ...................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Not known:
Gastric irritation, cramping.
General disorders and administration site conditions:
Not known: Weakness.
Hepatobiliary disorders:
AA-ATENIDONE (Atenolol and Chlorthalidone) Page 17 of 50 Rare: intrahepatic cholestasis or jaundice.
Immune system disorders:
Very rare: Necrotizing angiitis (vasculitis) (cutaneous vasculitis).
Not known:
Lyell’s syndrome (toxic epidermal necrolysis).
Investigations:
Common: decrease reaction time.
Metabolism and nutrition disorders:
Common: Anorexia, hypomagnesemia, hyperglycemia, hyponatremia and loss of appetite. Uncommon: gout. Rare: hypercalcemia, worsening of diabetic metabolic state. Very rare: hypochloremic alkalosis.
Not known:
Hypokalemia.
Musculoskeletal and connective tissue disorders:
Not known: Muscle spasm.
Nervous system disorders:
Common: Dizziness, slow mentation.
Rare:
Paresthesias, headache.
Not known:
Vertigo, restlessness Renal and urinary disorders: Rare: Glycosuria, allergic interstitial nephritis.
Reproductive system and breast disorders:
Common: Impotence.
Respiratory, thoracic and mediastinal disorders:
Rare: idiosyncratic pulmonary edema (respiratory disorders) Skin and subcutaneous tissue disorders: Common: urticaria, and other forms of skin rash.
Rare:
Photosensitivity.
Not known:
Purpura.
Vascular disorders:
Common: postural hypotension, which may be aggravated by alcohol, anesthetics or sedatives. Very rare: vasculitis AA-ATENIDONE (Atenolol and Chlorthalidone) Page 18 of 50 Potential adverse reactions The following adverse reactions have occurred with other beta-blockers but have not been reported with atenolol: Blood and lymphatic system disorders: Agranulocytosis.
Cardiac disorders:
Pulmonary edema, cardiac enlargement, and sinus arrest.
Eye disorders:
Blurred vision, burning, and grittiness.
Gastrointestinal disorders:
Mesenteric arterial thrombosis and ischemic colitis.
Nervous system disorders:
Short term memory loss.
Psychiatric disorders:
Aggressiveness, anxiety, emotional lability with slightly clouded sensorium.
Respiratory, thoracic, and mediastinal disorders:
Laryngospasm, status asthmaticus, and fever combined with aching and sore throat.
Skin and subcutaneous tissue disorders:
Exfoliative dermatitis.
Vascular disorders:
Hot flushes. 2 Clinical Trial Adverse Reactions No information is available. 3 Less Common Clinical Trial Adverse Reactions Atenolol: Adverse reactions, occurring with an incidence of less than 1%, grouped by system, are as follows: Blood and lymphatic system disorders: Thrombocytopenia Cardiac disorders: Heart failure deterioration (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular) Heart block, Palpitations, Chest pain, Lightheadedness Eye disorders: Visual disturbances, Ichy and/or dry eyes.
Gastrointestinal disorders:
Abdominal discomfort, Indigestion, Constipation.
General disorders and administration site conditions:
Edema, Tiredness, Flushes, General body aches, Decreased exercise tolerance.
Investigations:
Lengthening of P-R interval. AA-ATENIDONE (Atenolol and Chlorthalidone) Page 19 of 50 Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders:
Leg pain.
Nervous System disorders:
Faintness, Ataxia, Drowsiness, Vivid dreams, Paresthesia, Headache, Tinnitus Psychiatric disorders: Lethargy, Nervousness, Depression, Insomnia, Mood changes, Psychoses and hallucinations Reproductive system and breast disorders: Impotence, Decreased libido.
Respiratory, thoracic, and mediastinal disorders:
Dyspnea, Wheeziness, Cough, Bronchospasm, Epistaxis.
Skin and subcutaneous tissue disorders:
Skin rash, Psoriasiform skin reactions, Exacerbation of psoriasis, Alopecia, Sweating, Purpura Vascular disorders: Postural hypotension which may be associated with syncope, Raynaud’s phenomenon, Intermittent claudication, or worsening of pre-existing intermittent claudication, cold extremities.
5 Post-Market Adverse Reactions During post-marketing experience with atenolol, cold extremeties, gastrointestinal disturbances and fatigue were commonly reported. 2%).
The following have been reported in temporal relationship to the use of the drug:
Blood and lymphatic system disorders: Thrombocytopenia.
Eye disorders:
Choroidal effusion, acute myopia, acute angle-closure glaucoma (frequency unknown).
Investigations:
Elevated liver enzymes and/or bilirubin.
Nervous system disorders:
Headache, confusion.
Psychiatric disorders:
Nightmares, impotence. […]
1 Special Populations................................................................................................ 1 Pregnant Women ............................................................................................... 2 Breast-feeding ...................................................................................................
3 Pediatrics ........................................................................................................... 4 Geriatrics ...........................................................................................................
5 Ethnic Origin ...................................................................................................... 16 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ......................................................
5 Post-Market Adverse Reactions ............................................................................ 19 9 DRUG INTERACTIONS ................................................................................................. 3 Drug-Behavioural Interactions...............................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 27 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 29 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 31 PART II: SCIENTIFIC INFORMATION ........................................................................................
32 13 PHARMACEUTICAL INFORMATION ............................................................................. 32 14 CLINICAL TRIALS .........................................................................................................
2 Comparative Bioavailability Studies ................................................................... 33 15 MICROBIOLOGY ......................................................................................................... 35 16 NON-CLINICAL TOXICOLOGY ......................................................................................
35 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 39 PATIENT MEDICATION INFORMATION ................................................................................... 40 AA-ATENIDONE […]