Telmisartan

Telmisartan tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors ( 1.2 ) 1.1 Hypertension Telmisartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …

• May be administered with or without food When used for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary Indication Starting Dose Dose Range Hypertension 40 mg once daily 40 to 80 mg once daily Cardiovascular Risk Reduction 80 mg once daily 80 mg once daily Hypertension Dosage must be individualized
• The usual starting dose of telmisartan tablets is 40 mg once a day
• Blood pressure response is dose-related over the range of 20 to 80 mg [see Clinical Studies ]
• Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks
• No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis
• Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored
• Telmisartan tablets may be administered with other antihypertensive agents
• Telmisartan tablets may be administered with or without food
• Cardiovascular Risk Reduction The recommended dose of telmisartan tablets is 80 mg once a day and can be administered with or without food
• It is not known whether doses lower than 80 mg of telmisartan are effective in reducing the risk of cardiovascular morbidity and mortality. …

80 mg, white to off-white, uncoated oval shaped tablets, biconvex with beveled edges, plain on one side and debossed “038” on other side. Tablets: 80mg ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established [see Clinical Pharmacology ]
• Neonates with a history of in utero exposure to telmisartan If oliguria or hypotension occurs, support blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function

Of the total number of patients receiving telmisartan in hypertension clinical studies, 551 (19%) were 65 to 74 years of age and 130 (4%) were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals c …

• Advise the patient to read the FDA-approved patient labeling (Patient Information) Pregnancy Advise female patients of childbearing age about the consequences of exposure to telmisartan during pregnancy
• Discuss treatment options with women planning to become pregnant
• Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions and Use in Specific Populations ]
• Lactation Advise nursing women not to breastfeed during treatment with telmisartan [see Use in Specific Populations ] . …

• Telmisartan is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions ]
• Do not co-administer aliskiren with telmisartan in patients with diabetes. [see Drug interactions ]
• Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product Do not co-administer aliskiren with telmisartan in patients with diabetes

Aliskiren: Do not co-administer aliskiren with telmisartan in patients with diabetes. Avoid use of aliskiren with telmisartan in patients with renal impairment (GFR

Avoid fetal or neonatal exposure ( 5.1 ) Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension ( 5.2 ) Monitor carefully in patients with impaired hepatic ( 5.4 ) or renal function ( 5.5 ) Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker ( 5.6) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. …

The following adverse reaction is described elsewhere in labeling: Renal dysfunction upon use with ramipril [see Warnings and Precautions (5.6) ] Hypertension: The most common adverse events (≥1%) reported in hypertension trials are back pain, sinusitis, and diarrhea ( 6.1 ) Cardiovascular risk reduction: The serious adverse events (≥1%) reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Telmisartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations ). …

Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.