Micardis HCT

DRUG DESCRIPTION

MICARDIS HCT tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.

Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1Hbenzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:

Telmisartan Structural Formula Illustration

Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.

Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is:

MICARDIS HCT tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, sodium starch glycolate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Micardis® HCT (telmisartan and hydrochlorothiazide) tablets are hygroscopic and require protection from moisture.

What are the possible side effects of hydrochlorothiazide and telmisartan (Micardis HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Stop using this medication and call...

Read All Potential Side Effects and See Pictures of Micardis HCT »

What are the precautions when taking telmisartan, hydrochlorothiazide (Micardis HCT)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to telmisartan or hydrochlorothiazide; or to ACE inhibitors (e.g., captopril, lisinopril); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through too much sweating/vomiting/diarrhea), mineral/electrolyte problems (e.g.,...

Read All Potential Precautions of Micardis HCT »


Micardis HCT Consumer (continued)

SIDE EFFECTS: See also How to Use section.

You may experience dizziness, lightheadedness, and blurred vision as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of loss of too much body water and minerals (e.g., unusual thirst, muscle cramps, weakness, confusion, fast/irregular heartbeat, fainting, seizures), decreased sexual ability, decrease in vision, eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), unusual tiredness, easy bruising/bleeding, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, muscle pain/tenderness/weakness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to telmisartan or hydrochlorothiazide; or to ACE inhibitors (e.g., captopril, lisinopril); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through too much sweating/vomiting/diarrhea), mineral/electrolyte problems (e.g., imbalance of sodium/potassium/magnesium/calcium), gout, lupus, high levels of fats in the blood (high cholesterol or triglycerides), asthma.

If you have diabetes, this medication may affect your blood sugar levels. Your doctor may need to adjust the dosage of your medications used to treat diabetes (e.g., insulin, glipizide). Monitor your blood sugar levels as instructed and tell your doctor immediately if you develop signs of high blood sugar (e.g., increased thirst, unusual tiredness, vision changes, fruity breath odor).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Hydrochlorothiazide may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness while using this drug.

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

This medication passes into breast milk. Consult your doctor before breast-feeding.


Micardis HCT Patient Information Including Side Effects

Brand Names: Micardis HCT

Generic Name: hydrochlorothiazide and telmisartan (Pronunciation: hye droe klor oh THYE a zide and TEL mi SAR tan)

  • What is hydrochlorothiazide and telmisartan (Micardis HCT)?
  • What are the possible side effects of hydrochlorothiazide and telmisartan (Micardis HCT)?
  • What is the most important information I should know about hydrochlorothiazide and telmisartan (Micardis HCT)?
  • What should I discuss with my healthcare provider before taking hydrochlorothiazide and telmisartan (Micardis HCT)?
  • How should I take hydrochlorothiazide and telmisartan (Micardis HCT)?
  • What happens if I miss a dose (Micardis HCT)?
  • What happens if I overdose (Micardis HCT)?
  • What should I avoid while taking hydrochlorothiazide and telmisartan (Micardis HCT)?
  • What other drugs will affect hydrochlorothiazide and telmisartan (Micardis HCT)?
  • Where can I get more information?

What is hydrochlorothiazide and telmisartan (Micardis HCT)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Telmisartan is in a group of drugs called angiotensin II receptor antagonists. Telmisartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of hydrochlorothiazide and telmisartan is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and telmisartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and telmisartan (Micardis HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Stop using this medication and call your doctor at once if you have any other serious side effects, such as:

  • feeling light-headed, fainting;
  • swelling, rapid weight gain;
  • fast or pounding heartbeats;
  • urinating less than usual, or not at all;
  • jaundice (yellowing of the skin or eyes); or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).

Less serious side effects may include:

  • stomach pain, diarrhea;
  • back pain;
  • headache, tired feeling, dizziness;
  • skin rash;
  • stuffy nose, sore throat; or
  • dry cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydrochlorothiazide and telmisartan (Micardis HCT)?

Do not use this medication if you are allergic to hydrochlorothiazide or telmisartan, or if you are unable to urinate.

Do not use this medication without telling your doctor if you are pregnant. Telmisartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Before using hydrochlorothiazide and telmisartan, tell your doctor if you have congestive heart failure, kidney or liver disease, asthma, low or high blood levels of potassium, gout, lupus, diabetes, or an allergy to sulfa drugs.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of hydrochlorothiazide and telmisartan.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and telmisartan, unless your doctor has told you to.

In rare cases, hydrochlorothiazide and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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