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AG-TELMISARTAN is a brand name for Telmisartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of Essential Hypertension AG-Telmisartan (telmisartan) is indicated for the treatment of mild to moderate essential hypertension in adults. AG-Telmisartan may be used alone or in combination with thiazide diuretics. The concurrent use with angiotensin converting enzyme inhibitors is not recommended. Risk…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The antihypertensive effect is present within 2 weeks and maximal reduction is generally attained after four weeks. If additional blood pressure reduction is required, a thiazide diuretic may be added. 2 Recommended Dose and Dosage Adjustment Treatment of Essential Hypertension: The recommended dose of AG-Telmisartan (telmisartan) is 80 mg once daily.
Patients with renal Impairment No initial dosing adjustment is necessary for patients with renal impairment, but greater sensitivity in some older individuals cannot be ruled out. Markedly reduced telmisartan plasma levels were observed in patients on hemodialysis.
Patients with hepatic Impairment For patients with hepatic impairment a starting dose of 40 mg is recommended and should be administered with caution (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Risk Reduction of Cardiovascular Morbidity:
The recommended dose is 80 mg once daily in patients 55 years or older at high risk for a cardiovascular event. It is not known whether doses lower than 80 mg of telmisartan are effective in preventing cardiovascular morbidity. It can be administered with other antihypertensive agents except an ACEI.
When initiating telmisartan therapy at this dose, monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary. Drug discontinuation If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, AG- Telmisartan should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears.
Product Monograph AG-Telmisartan (telmisartan) Page 6 of 38 When pregnancy is detected, AG-Telmisartan should be discontinued as soon as possible. 4 Administration AG-Telmisartan tablets are for once-daily oral administration and should be swallowed whole with liquid.
AG-Telmisartan can be taken with or without food. 5 Missed Dose AG-Telmisartan should be taken at the same time each day, preferably in the morning. However, if a dose is missed during the day, the next dose should be continued at the usual time.
Do not double dose.
9%) in controlled clinical trials. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of telmisartan in patients treated for prevention of cardiovascular morbidity and mortality was consistent with that obtained in hypertensive patients.
2 Clinical Trial Adverse Drug Reactions Clinical trials are conducted under very specific conditions. The adverse re action rates observed in the clinical trials; therefore, 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. Telmisartan has been evaluated for safety in 27 clinical trials involving 7968 patients treated for hypertension.
Of these 7968 patients, 5788 patients were treated with telmisartan monotherapy including 1058 patients treated for ≥1 year and 1395 patients treated in placebo- controlled trials. 1% of placebo patients. The following potentially serious adverse events have been reported rarely with telmisartan in controlled clinical trials: syncope and hypotension.
1% in telmisartan - treated patients. The safety profile of telmisartan in patients treated for risk reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients. In this program, 11% of patients treated with telmisartan discontinued study medication due to adverse events.
The most common adverse events that led to discontinuation were dizziness, hypotension and headache. Product Monograph AG-Telmisartan (telmisartan) Page 12 of 38 The adverse drug reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports.
10/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 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 .......................................................... 5 Missed Dose ............................................................................................................
6 5 OVERDOSAGE ................................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 6 7 WARNINGS AND PRECAUTIONS ......................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women............................................................................................... 2 Breast-feeding ..................................................................................................
10/2023 7 WARNINGS AND PRECAUTIONS 10/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS .....................................................................................................
4
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The listing also takes into account serious adverse events and adverse events leading to discontinuation reported in three clinical long-term studies including 21642 patients treated with telmisartan for prevention of cardiovascular morbidity and mortality for up to six years.
All Clinical Trials The adverse drug events listed below have been accumulated from 27 clinical trials includi ng 5788 hypertensive patients treated with telmisartan. Adverse events have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (< 1/10000) Body as a Whole, General: Common: Chest pain, influenza-like symptoms, fatigue, conjunctivitis.
Uncommon:
Hyperhidrosis, asthenia (weakness).
Blood and Lymphatic System:
Uncommon: Anaemia.
Rare:
Thrombocytopenia.
Not known:
Eosinophilia.
Cardiovascular System:
Common: Edema, palpitation.
Uncommon:
Bradycardia, orthostatic hypotension, hypotension.
Rare:
Tachycardia.
Central and Peripheral Nervous System:
Very Common: Headache.
Common:
Dizziness, insomnia.
Uncommon:
Vertigo.
Eye Disorders:
Rare: Visual disturbance.
Gastro-Intestinal System:
Common: Abdominal pain, diarrhoea, dyspepsia, nausea, constipation, gastritis.
Uncommon:
Dry mouth, flatulence, vomiting.
Rare:
Abdominal discomfort.
Hepato-biliary Disorders:
Rare: Hepatic function abnormal/liver disorder*. *Most cases of hepatic function abnormal/ liver disorder from post-marketing experience with telmisartan occurred in patients in Japan, who are more likely to experience these adverse reactions Product Monograph AG-Telmisartan (telmisartan) Page 13 of 38 Immune System: Rare: Hypersensitivity.
Not known:
Anaphylactic reaction, angioedema.
Infections and Infestations:
Uncommon: Upper respiratory tract infections (including pharyngitis, sinusitis, bronchitis, rhinitis and coughing) and urinary tract infections, cystitis.
Not known:
Sepsis including fatal outcome.
Investigations:
Uncommon: Blood creatinine increased.
Rare:
Blood uric acid increased, hepatic enzyme increased, blood creatinine, phosphokinase increased, haemoglobin decreased.
Metabolism and Nutrition Disorders:
Uncommon: Hyperkalemia.
Rare:
Hypoglycemia (in diabetic patients).
Musculo-Skeletal System:
Common: Arthralgia, muscle spasms (cramps in legs) or pain in extremity (leg pain), myalgia, arthritis, arthrosis.
Uncommon:
Tendon pain (tendonitis like symptoms), back pain.
Nervous System:
Uncommon: Syncope (faint).
Psychiatric System:
Common: Anxiety, nervousness.
Uncommon:
Depression.
Renal and Urinary System:
Uncommon: Renal impairment (including acute kidney injury).
Respiratory System:
Common: Dyspnea.
Skin and Appendages System:
Common: Skin disorders like rash.
Uncommon:
Pruritus.
Rare:
Erythema, drug eruption, eczema, toxic skin eruption.
Not known:
Urticaria.
Hemoglobin:
Infrequently, a decrease in hemoglobin has been observed which occurs more often during Product Monograph AG-Telmisartan (telmisartan) Page 14 of 38 treatment with telmisartan than with placebo. 9%) in controlled clinical trials. Adverse events occurring in ≥1% of 1395 hypertensive patients treated with telmisartan monotherapy in placebo-controlled clinical trials, regardless of drug relationship, include the following: Table 2: Adverse Events Occurring in > 1% of Hypertensive Patients Treated with Telmisartan Monotherapy Adverse Event, by […]
3 Pediatrics ......................................................................................................... 14 Geriatrics .............................................................................................................
11 8 ADVERSE REACTIONS ..................................................................................................... 1 Adverse Reaction Overview ....................................................................................
2 Clinical Trial Adverse Drug Reactions ...................................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................ 4 Abnormal Laboratory Findings: Hematologic Clinical Chemistry and Other Quantitative Data ............................................................................................................................
5 Post-Market Adverse Reactions .............................................................................. 17 9. DRUG INTERACTIONS .....................................................................................................
1 Serious Drug Interactions ....................................................................................... 4 Drug-Drug Interactions ...........................................................................................
5 Drug-Food Interactions........................................................................................... 6 Drug-Herb Interactions ...........................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 20 10 CLINICAL PHARMACOLOGY ............................................................................................ 1 Mechanism of Action .........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics............................................................................................... 22 11 STORAGE, STABILITY AND DISPOSAL ..............................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 24 PART II: SCIENTIFIC INFORMATION .....................................................................................
25 13 PHARMACEUTICAL INFORMATION ................................................................................. 25 14 CLINICAL TRIALS.............................................................................................................
1 Clinical Trials by Indication..................................................................................................... 2 Comparative Bioavailability Studies......................................................................................
26 15 MICROBIOLOGY ............................................................................................................. 31 16 NON-CLINICAL TOXICOLOGY...........................................................................................
31 17 SUPPORTING PRODUCT MONOGRAPHS......................................................................... 32 PATIENT MEDICATION INFORMATION ................................................................................ 33 Product Monograph AG-Telmisartan (telmisartan) Page 4 of 38 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Treatment of Essential Hypertension AG-Telmisartan (telmisartan) is […]