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APO-AMLODIPINE is a brand name for Amlodipine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-AMLODIPINE (amlodipine besylate tablets) is indicated for: • Hypertension APO-AMLODIPINE is indicated in the treatment of mild to moderate essential hypertension. Combination of amlodipine besylate tablets with a diuretic, a beta-blocking agent, or an angiotensin converting enzyme inhibitor has been found to be…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 09/2023 7 WARNINGS AND PRECAUTIONS, Cardiovascular 09/2023 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 09/2023 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.................................................................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment................................................... 4 Administration ................................................................................................... 5 Missed Dose ......................................................................................................
6 5 OVERDOSAGE ........................................................................................................... 6
1 Adverse Reaction Overview The most serious adverse reaction associated with the APO-AMLODIPINE is hypotension especially under gross overdose (see 5 OVERDOSAGE). 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Amlodipine besylate tablets has been administered to 1,714 patients (805 hypertensive and 909 angina patients) in controlled clinical trials (vs placebo alone and with active comparative agents). Most adverse reactions reported during therapy were of mild to moderate severity.
9% of patients. 3%). 7%). 5%). 5%). 5%). 5%). 5%). 4%). 7%). 6% of patients. 8%). 9%). 6%). 9%). 9%). 0%). 0%). 7%). 1%). 8%). 6%). 3 Less Common Clinical Trial Adverse Reactions Amlodipine besylate tablets has been evaluated for safety in about 11,000 patients with hypertension and angina.
1% of patients in comparative clinical trials (double-blind comparative vs placebo or active agents; n = 2,615) or under conditions of open trials or marketing experience where a causal relationship is uncertain. APO-AMLODIPINE (amlodipine besylate tablets) Page 12 of 40 Autonomic Nervous System: dry mouth, hyperhidrosis.
Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, myocardial infarction, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis, chest pain.
Central and Peripheral Nervous System: hypoaesthesia/paraesthesia, neuropathy peripheral, tremor, vertigo. Gastrointestinal: anorexia, constipation, dysphagia, vomiting, gingival hyperplasia, change in bowel habits, dyspepsia General: allergic reaction, asthenia+, back pain, pain, hot flushes, malaise, rigors, and weight increased/weight decreased.
, Cardiovascular 09/2023 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 09/2023 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..................................................................................................
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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Hemopoietic: leukopenia, purpura, thrombocytopenia. Metabolic and Nutritional: hyperglycaemia, thirst. Musculoskeletal System: arthralgia, arthrosis, myalgia, muscle cramps. Psychiatric: sexual dysfunction (male+ and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization, mood altered.
Reproductive system and breast disorders: gynecomastia, erectile dysfunction. Respiratory System: dyspnoea, epistaxis. Skin and Appendages: pruritus, rash erythematous, rash maculopapular, erythema multiforme. Special Senses: conjunctivitis, diplopia, eye pain, visual impairment, tinnitus.
Urinary System: pollakiuria, micturition disorder, nocturia. +These events occurred in less than 1% in placebo controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies. 1% of patients: cardiac failure, skin discoloration*, urticaria*, skin dryness, Stevens-Johnson syndrome, alopecia*, twitching, ataxia, hypertonia*, migraine, apathy, amnesia, gastritis*, pancreatitis*, increased appetite, coughing*, rhinitis*, parosmia, taste perversion*, and xerophthalmia.
* these events were observed in marketing experience as well. APO-AMLODIPINE (amlodipine besylate tablets) Page 13 of 40 Isolated cases of angioedema have been reported. Angioedema may be accompanied by breathing difficulty. 5 Post-Market Adverse Reactions In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis […]
1 Special Populations............................................................................................ 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
3 Pediatrics ........................................................................................................... 4 Geriatrics ...........................................................................................................
9 8 ADVERSE REACTIONS ................................................................................................ 1 Adverse Reaction Overview ............................................................................. 2 Clinical Trial Adverse Reactions .......................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................ 5 Post-Market Adverse Reactions....................................................................... 13 9 DRUG INTERACTIONS ................................................................................................
1 Serious Drug Interaction .................................................................................. 2 Drug Interactions Overview ............................................................................. 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions...................................................................
19 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics .........................................................................................
3 Pharmacokinetics ............................................................................................ 20 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 22 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
22 PART II: SCIENTIFIC INFORMATION ....................................................................................... 23 13 PHARMACEUTICAL INFORMATION ............................................................................
23 14 CLINICAL TRIALS ........................................................................................................ 3 Comparative Bioavailability Studies................................................................. 23 15 MICROBIOLOGY.........................................................................................................
24 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 24 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 33 PATIENT MEDICATION INFORMATION ..................................................................................
34 APO-AMLODIPINE (amlodipine besylate tablets) Page 4 of 40 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-AMLODIPINE (amlodipine besylate tablets) is indicated for: • Hypertension APO-AMLODIPINE is indicated in the treatment of mild to moderate essential hypertension.
Combination of amlodipine besylate tablets with a diuretic, a beta-blocking agent, or an angiotensin […]
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