TELMISARTAN

(tel'' mi sar' tan)

PCI  : Contraindicated in pregnancy

LCI  : Contraindicated in lactation

Molecule Info

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 WARNING

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Telmisartan as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Indication(s) & Dosage

HYPERTENSION Adult: Initially, 40 mg orally once daily. Max: 80 mg/day. 
Renal impairment: Severe impairment/ Haemodialysis: Initial dose 20 mg/day.
Hepatic impairment: Mild to moderate: Max 40 mg/day. Severe: Contra-indicated

Special Populations: Renal impairment: Lower doses should be considered.

Administration

May be taken with or without food.

Overdosage

Hypotension, dizziness, tachycardia or bradycardia. Supportive treatment to be instituted. Not removed by haemodialysis.

Contraindications

Severe hepatic impairment, biliary obstructive disorders. Pregnancy. Lactation.

Special Precautions

Hepatic insufficiency, biliary obstruction, renal impairment, renaly artery stenosis. Correct volume depletion before initiating treatment. Monitor serum potassium levels regularly, especially in elderly and renally-impaired patients.

Adverse Drug Reaction(s)

URTI, dizziness, back pain, sinusitis, pharyngitis and diarrhoea. Slight elevations in liver enzymes.
Potentially Fatal: Rarely angioedema, rash, pruritus and urticaria.

Drug Interactions

Concurrent use increases digoxin concentration; increases risk of lithium toxicity; increases risk of hyperkalaemia with potassium sparing diuretics, heparin.

Food Interaction

Food slightly reduces the bioavailability.

Pregnancy Category (FDA)

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk .

Storage

Oral: Store at 15-30°C.

Pharmacology

Telmisartan is a nonpeptide AT1 angiotensin II receptor antagonist. Exerts antihypertensive activity by preventing angiotensin II from binding to AT1receptors thus inhibiting the vasoconstriction and aldosterone-secreting effects of angiotensin II.
Absorption: Rapidly absorbed. Dose dependent bioavailability 42% ; 58% . Peak plasma concentrations: 0.5-1hr.
Distribution: Protien binding: 99%.
Metabolism: Undergoes conjugation with glucuronic acid to form inactive metabolites.
Excretion: Excreted almost entirely as unchanged drug in faeces via bile. <1% excreted via urine. Terminal elimination half-life: 24 hr.

ATC Classification

C09CA07 - telmisartan; Belongs to the class of angiotensin II antagonists. Used in the treatment of cardiovascular disease.

Brand/Product Info


Total Products : 1 
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
MITOSAN Sandoz/Novartis Telmisartan INN 40mg & 80mg 40mg x 30's: MRP 390.00; 80mg x 30's: MRP 630.00

Gen. MedInfo

IMPORTANT WARNING:

Tell your doctor if you are pregnant or plan to become pregnant. Do not take telmisartan if you are pregnant. If you become pregnant while you are taking telmisartan, stop taking telmisartan and call your doctor immediately. Telmisartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

 

Why is this medication prescribed?

Telmisartan is used alone or in combination with other medications to treat high blood pressure. Telmisartan is also used to decrease the chance of heart attack, stroke, or death in people 55 years of age or older who are at high risk for cardiovascular disease. Telmisartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

How should this medicine be used?

Telmisartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take telmisartan, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take telmisartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Telmisartan tablets come in individual blister packs that can be opened by peeling back the paper layer from the foil and pushing the tablet through the foil. Do not open a blister pack until you are ready to swallow the tablet it contains.

Your doctor may start you on a low dose of telmisartan and gradually increase your dose.

Telmisartan controls high blood pressure but does not cure it. Your blood pressure may decrease during the first 2 weeks of your treatment, but it may take 4 weeks for you to notice the full benefit of telmisartan. Continue to take telmisartan even if you feel well. Do not stop taking telmisartan without talking to your doctor.

Ask your doctor for a copy of the manufacturer's information for the patient. 

Other uses for this medicine

Telmisartan is also used sometimes to treat congestive heart failure  and diabetic nephropathy . Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor for more information.

What special precautions should I follow?

Before taking telmisartan,

·         tell your doctor if you are allergic to telmisartan, any other medications, or any of the ingredients in telmisartan tablets. Ask your pharmacist for a list of the ingredients.

·         tell your doctor if you have diabetes  and you are taking aliskiren . Your doctor will probably tell you not to take telmisartan if you have diabetes and you are also taking aliskiren.

·         tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin-converting enzyme  inhibitors such as benazepril , captopril , enalapril , fosinopril , lisinopril , moexipril , perindopril , quinapril , ramipril , and trandolapril ; aspirin and other nonsteroidal anti-inflammatory medications  such as ibuprofen  and naproxen , and selective COX-2 inhibitor such as celecoxib ; digoxin ; diuretics  including spironolactone ; lithium and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

·         tell your doctor if you have or have ever had heart failure; blockage of the bile duct ; or kidney or liver disease.

·         tell your doctor if you are breast-feeding.

·         you should know that telmisartan may cause drowsiness, dizziness, lightheadedness, or fainting. Do not drive a car or operate machinery until you know how this medication affects you.

·         you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

What special dietary instructions should I follow?

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Telmisartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

·         back pain

·         sinus pain and congestion

·         diarrhea

Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

·         swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

·         hoarseness

·         difficulty breathing or swallowing

·         pain and cramping in the lower leg that comes and goes during walking or exercise

·         blistering of the skin or rash

Telmisartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

In case of emergency/overdose:

In case of overdose, if the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include:

·         dizziness

·         fainting

·         fast or slow heartbeat

Telmisartan may cause other side effects.  Consult your doctor if you have any unusual problems while taking this.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: U.S. Natl. Library of Medicine


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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