Telsan tablets

Telsan

  • Active Ingredient: Telmisartan
  • 80 mg, 40 mg, 20 mg
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What is Telsan?

The active ingredient of Telsan brand is telmisartan. Telmisartan is an angiotensin II receptor antagonist. Telmisartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Used for

Telsan is used to treat diseases such as: Cardiovascular Risk Reduction, High Blood Pressure, Prevention of Cardiovascular Disease.

Side Effect

Possible side effects of Telsan include: dilated neck veins; sore throat; swelling in the hands, lower legs, and feet; muscle aching; stomach discomfort or upset; weakness; muscle pain or spasm; extreme fatigue.

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Pharmacodynamics

In normal volunteers, a dose of Telsan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours.

Plasma concentration of angiotensin II and plasma renin activity (PRA) increased in a dose-dependent manner after single administration of Telsan to healthy subjects and repeated administration to hypertensive patients. The once-daily administration of up to 80 mg Telsan to healthy subjects did not influence plasma aldosterone concentrations. In multiple dose studies with hypertensive patients, there were no clinically significant changes in electrolytes (serum potassium or sodium), or in metabolic function (including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric acid).

In 30 hypertensive patients with normal renal function treated for 8 weeks with Telsan 80 mg or Telsan 80 mg in combination with hydrochlorothiazide 12.5 mg, there were no clinically significant changes from baseline in renal blood flow, glomerular filtration rate, filtration fraction, renovascular resistance, or creatinine clearance.

Forms and strengths

Generic: Telsan

  • Form: Oral tablet
  • Strengths: 20 mg, 40 mg, 80 mg

Brand: Micardis

  • Form: Oral tablet
  • Strengths: 20 mg, 40 mg, 80 mg

Dosage to reduce the risk of a heart attack, stroke, or death from heart disease

Adult dosage (ages 55 years and older)

  • For people 55 years and older who cannot take angiotensin-converting enzyme (ACE) inhibitors, the typical dose is 80 mg, taken by mouth, once daily.

Adult dosage (ages 18–55 years)

Telsan is not used in this age group for this indication.

Child dosage (ages 0–17 years)

This medication hasn’t been studied in children and shouldn’t be used in children under the age of 18 years.

Senior dosage (ages 65 years and older)

There are no specific recommendations for senior dosing. Older adults may process drugs more slowly. A normal adult dose may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dose or a different schedule.

Warning

  • Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking Telsan, call your doctor right away.

Serious side effects

Call your doctor right away if you have any of these serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

  • Low blood pressure. Symptoms include:
    • faintness
    • dizziness
  • swelling in your feet, ankles, or hands
  • unexplained weight gain
  • swelling of your face, tongue, or throat
  • trouble breathing
  • skin rash
  • Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Telsan oral tablet can interact with other medications, herbs, or vitamins you might be taking. An interaction is when a substance changes the way a drug works. This can be harmful or cause the drugs that you take to not work as well. To help prevent interactions, your doctor should manage all of your medications carefully. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    Examples of drugs that can cause interactions with Telsan are listed below.

    In patients with hepatic insufficiency, plasma concentrations of Telsan are increased, and absolute bioavailability approaches 100% .

    A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% Telsan patients compared with 0.3% placebo patients. One Telsan-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

    Study cohort

    Within the base-cohort defined above, we assembled a study cohort of all patients newly prescribed an ARB on or after 1 January 2000, the year Telsan entered the UK market, through 31 December 2008. Study cohort entry was defined by the date of the first ARB prescription. Thus, patients with a history of ARB use before study cohort entry and those with a previous history of cancer (other than nonmelanoma skin cancer) at any time before study cohort entry were excluded. Finally, all cohort members were required to have at least 1 year of follow-up after entering the study cohort, necessary for latency purposes as short duration exposures are unlikely to be associated with cancer incidence. Thus, follow-up started the year after study cohort entry, until an incident diagnosis of cancer (other than nonmelanoma skin cancer), death from any cause, end of registration with the general practice, or end of study period; 31 December 2010, whichever came first.

    What Is Amlodipine-Telsan?

    Amlodipine is a calcium channel blocker that relaxes (widens) blood vessels and improves blood flow.

    Telsan is an angiotensin II receptor antagonist that keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

    Amlodipine and Telsan is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

    Amlodipine and Telsan may also be used for purposes not listed in this medication guide.

    Do not use this medicine if you are pregnant, and tell your doctor right away if you become pregnant. This medicine can harm an unborn baby.

    If you have diabetes, do not use amlodipine and Telsan together with any medication that contains aliskiren (a blood pressure medicine).

    You should not use this medicine if you are allergic to amlodipine (Norvasc) or Telsan (Micardis).

    If you have diabetes, do not use amlodipine and Telsan together with any medication that contains aliskiren (a blood pressure medicine).

    You may also need to avoid taking amlodipine and Telsan with aliskiren if you have kidney disease.

    Tell your doctor if you have ever had:

    • kidney disease (or if you are on dialysis);
    • liver disease;
    • heart disease;
    • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
    • if you are on a low-salt diet.

    Do not use if you are pregnant, and tell your doctor right away if you become pregnant. Amlodipine and Telsan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

    You should not breast-feed while you are using this medicine.

    This medicine is not approved for use by anyone younger than 18 years old.

    Telsan

    In a prospective randomized trial of Telsan in 77 children with hypertension, 42% had adverse events such as headache (n = 10), dizziness (n = 7), and cough (n = 4) . Two children taking Telsan withdrew, one with syncope and increased blood urea nitrogen and serum creatinine concentrations due to an incorrect dosage calculation, and the other with dizziness, weakness, and headache. Adverse events mirrored those seen in adults.

    Electrolyte balance A 75-year-old man with diabetes, hypertension, and hyperthyroidism who was taking Telsan 40 mg/day developed hyperkalemia after taking etoricoxib 90 mg/day for 3 days . The potassium concentration had previously been stable despite the use of a “low salt” dietary substitute containing potassium chloride (3.5 g/day). The authors suggested that etoricoxib, by inhibiting prostaglandins, caused an acute renal insult, precipitating hyperkalemia, which was exacerbated by the use of “low salt” and treatment with Telsan.

    What should I avoid while taking Telsan?

    Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

    Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

    Where can I get more information (Micardis)?

    Your pharmacist can provide more information about Telsan.

    No dosage adjustment is necessary in patients with decreased renal function. Telsan is not removed from blood by hemofiltration .

    Precautions

    Before taking Telsan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, bile duct blockage, high blood levels of potassium in the blood (hyperkalemia), loss of too much body water and/or minerals (dehydration).

    This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

    Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

    This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

    It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

    Indications and clinical uses

    In dogs, clinical experience with Telsan and other ARB drugs is limited. Ordinarily ACE inhibitors are used first (e.g., enalapril, benazepril). However, in experimental dogs, Telsan (1 mg/kg) was more effective than enalapril. If it is necessary to directly block the angiotensin receptor, Telsan and other drugs in this class may be indicated. A related drug, irbesartan (30 mg/kg q12h), has also been shown to block angiotensin II receptors in dogs. Another ARB, losartan, has been used in dogs, but it is less potent because it relies mostly on an active metabolite that dogs do not produce (see section on Losartan in this book for more details). There are no well-controlled clinical trials testing the effectiveness of Telsan or other ARB drugs in dogs. The use is based on studies in experimental animals and anecdotal experience.

    What is the dosage for Telsan?

    The recommended dose for treating hypertension is 20-80 mg daily. The recommended dose for cardiovascular risk reduction is 80 mg daily.

    More common side effects

    The more common side effects that occur with Telsan include:

    • sinus pain and congestion
    • back pain
    • diarrhea
    • sore throat
    • flu-like symptoms, such as fever and body aches
    • upset stomach
    • muscle pain
    • headache
    • dizziness
    • fatigue
    • nausea

    If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

    Telsan should be stored at room temperature, 15 C - 30 C (59 F - 86 F). The tablets should be kept in their blister-pack packaging until they are used.

    Other ARBs

    in clinical use include candesartan, eprosartan, irbesartan, Telsan , valsartan and olmesartan. Some of these may be marginally more effective than losartan at lowering blood pressure, but few if any comparisons have been performed at maximal dose of each drug. Losartan is generally used in combination with hydrochlorothiazide. In a landmark study this combination was 25% more effective than atenolol plus hydrochlorothiazide in preventing stroke. 15

    This class of drug is very well tolerated; in clinical trials the side-effect profiles are indistinguishable or even better than those of placebo. Unlike the ACE inhibitors they do not produce cough, and are a valuable alternative for the 10–15% of patients who thereby discontinue their ACE inhibitor. ARBs are used to treat hypertension, left ventricular (LV) failure after MI and established heart failure. With the possible exception of chronic heart failure, they do not appear to be superior to ACE inhibitors.

    The cautions listed for the use of ACE inhibitors (above) apply also to AT1-receptor blockers.

    Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; AHT, antihypertensive treatment; ARB, angiotensin receptor blocker; CCB, calcium channel blocker; NSAIDs, nonsteroidal anti-inflammatory drug; PSA, prostate-specific antigen.

    a Percentages calculated among males.

    b Percentages calculated among females.

    Baseline characteristics of Telsan and other angiotensin receptor blockers users

    Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; AHT, antihypertensive treatment; ARB, angiotensin receptor blocker; CCB, calcium channel blocker; NSAIDs, nonsteroidal anti-inflammatory drug; PSA, prostate-specific antigen.

    a Percentages calculated among males.

    b Percentages calculated among females.

    Table 2 presents the results of the primary and secondary analyses for all cancers combined. Compared with other ARBs, the use of Telsan was not associated with an increased risk of any cancer (16.3 vs. 15.0 per 1,000 person-years, respectively; adjusted HR: 0.93, 95% CI: 0.81–1.06). Similarly, there was no evidence of a duration- or dose-relationship between Telsan use and the incidence of all cancers combined.

    Crude and adjusted HRs of all cancers associated with Telsan use compared with other ARBs


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