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TEVA-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 Teva-Telmisartan is indicated for the treatment of mild to moderate essential hypertension in adults. Teva-Telmisartan may be used alone or in combination with thiazide diuretics. The concurrent use with angiotensin converting enzyme inhibitors is not recommended. 1.1 Pediatrics…
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 Teva-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). When initiating telmisartan therapy at 80 mg dose, monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Drug discontinuation Teva-Telmisartan Page 6 of 38 If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, Teva- Telmisartan should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears.
When pregnancy is detected, Teva-Telmisartan should be discontinued as soon as possible. 4 Administration Teva-Telmisartan are for once-daily oral administration and should be swallowed whole with liquid. Teva-Telmisartan can be taken with or without food.
5 Missed Dose Teva-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 Teva-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 Teva-Telmisartan Page 12 of 38 Clinical trials are conducted under very specific conditions. The adverse reaction 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 drug reaction information from clinical trials is 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 adverse drug reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports. All Clinical Trials The adverse drug events listed below have been accumulated from 27 clinical trials including 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 Teva-Telmisartan Page 13 of 38 Central and Peripheral Nervous System: Very Common: Headache.
08/2023 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 .....................................................................................................
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 .................................................................................................................
08/2023 7 WARNINGS AND PRECAUTIONS 08/2023 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 .....................................................................................................
4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Telmisartan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
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 (including cystits) Not known: Sepsis including fatal outcome.
Investigations:
Uncommon: Blood creatinine increased.
Rare:
Blood uric acid increased, hepatic enzymes 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.
Teva-Telmisartan Page 14 of 38 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 treatment with telmisartan than with placebo.
9%) in controlled clinical trials. 7 Oedema […]
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 6 7 WARNINGS AND PRECAUTIONS...................................................................................... 1 Special Populations .........................................................................................................
1 Pregnant Women: ........................................................................................................ 2 Breast-feeding..............................................................................................................
3 Pediatrics...................................................................................................................... 4 Geriatrics ......................................................................................................................
11 8 ADVERSE REACTIONS..................................................................................................... 1Adverse 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 ................................................................................... 18 9 DRUG INTERACTIONS ....................................................................................................
1 Serious Drug Interactions ............................................................................................. 4 Drug-Drug Interactions .................................................................................................
5 Drug-Food Interactions ................................................................................................ 6 Drug-Herb Interactions .................................................................................................
7 Drug-Laboratory Test Interactions ............................................................................... 21 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action.................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 23 11 STORAGE, STABILITY AND DISPOSAL ..............................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS................................................................................ 25 PART II: SCIENTIFIC INFORMATION........................................................................................
26 13 PHARMACEUTICAL INFORMATION................................................................................. 26 14 CLINICAL TRIALS ............................................................................................................
1 Clinical Trials by Indication ......................................................................................... 2 Comparative Bioavailability Studies ...........................................................................
29 15 MICROBIOLOGY............................................................................................................. 30 16 NON-CLINICAL TOXICOLOGY ..........................................................................................
30 17 SUPPORTING PRODUCT MONOGRAPHS […]