Telmisartan and Hydrochlorothiazide

Name: Telmisartan and Hydrochlorothiazide

telmisartan and hydrochlorothiazide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • confusion
  • convulsions
  • decreased urine
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • sudden sweating
  • unusual tiredness or weakness
Less common or rare
  • Chills
  • cold sweats
Rare
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Body aches or pain
  • cough
  • difficulty breathing
  • dizziness
  • ear congestion
  • fever
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
Less common
  • Abdominal or stomach pain
  • acid or sour stomach
  • back pain
  • belching
  • cough producing mucus
  • diarrhea
  • heartburn
  • hoarseness
  • indigestion
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • pain or tenderness around the eyes and cheekbones
  • rash
  • shivering
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble sleeping
  • trouble swallowing
  • voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Uses of Telmisartan and Hydrochlorothiazide

  • It is used to treat high blood pressure.
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take Telmisartan and Hydrochlorothiazide?

  • Tell all of your health care providers that you take telmisartan and hydrochlorothiazide. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take telmisartan and hydrochlorothiazide.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • If you take cholestyramine or colestipol, talk with your pharmacist about how to take them with this medicine.
  • Watch for gout attacks.
  • If you have lupus, telmisartan and hydrochlorothiazide can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.

How is this medicine (Telmisartan and Hydrochlorothiazide) best taken?

Use telmisartan and hydrochlorothiazide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • This medicine may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.
  • Take telmisartan and hydrochlorothiazide at the same time of day.
  • Some brands of this medicine come in a blister pack. If telmisartan and hydrochlorothiazide comes in a blister pack, take out the tablet right before use. Do not push the tablet out of the foil when opening.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Indications and Usage for Telmisartan and Hydrochlorothiazide

Telmisartan and Hydrochlorothiazide 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Telmisartan and Hydrochlorothiazide tablets, USP.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)].

Telmisartan and Hydrochlorothiazide tablets, USP are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)].

Telmisartan and Hydrochlorothiazide tablets, USP may be used alone or in combination with other antihypertensive agents.

Warnings and Precautions

Fetal Toxicity

Pregnancy Category D

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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmisartan and Hydrochlorothiazide tablets as soon as possible.

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations (8.1)].

Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with Telmisartan and Hydrochlorothiazide tablets. Correct volume or salt depletion prior to administration of Telmisartan and Hydrochlorothiazide tablets.

Impaired Renal Function

Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the rennin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure on Telmisartan and Hydrochlorothiazide tablets. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Telmisartan and Hydrochlorothiazide tablets.

Electrolytes and Metabolic Disorders

Drugs, including telmisartan, that inhibit the renin-angiotensin system can cause hyperkalemia, particularly in patients with renal insufficiency, diabetes, or combination use with other angiotensin receptor blockers or ACE inhibitors and the concomitant use of other drugs that raise serum potassium levels [see Drug Interactions (7.1,7.4)].

Hydrochlorothiazide can cause hypokalemia and hyponatremia. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

In controlled trials using the telmisartan/hydrochlorothiazide combination treatment, no patient administered 40 mg/12.5 mg, 80 mg/12.5 mg, or 80 mg/25 mg experienced a decrease in potassium ≥1.4 mEq/L, and no patient experienced hyperkalemia.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Because telmisartan decreases uric acid, telmisartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia.

Hypersensitivity Reaction

Hydrochlorothiazide

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history [see Contraindications (4)].

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Postsympathectomy Patients

The antihypertensive effects of hydrochlorothiazide may be enhanced in the postsympathectomy patient.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral:

Micardis HCT:

40/12.5: Telmisartan 40 mg and hydrochlorothiazide 12.5 mg

80/12.5: Telmisartan 80 mg and hydrochlorothiazide 12.5 mg

80/25: Telmisartan 80 mg and hydrochlorothiazide 25 mg

Generic:

40/12.5: Telmisartan 40 mg and hydrochlorothiazide 12.5 mg

80/12.5: Telmisartan 80 mg and hydrochlorothiazide 12.5 mg

80/25: Telmisartan 80 mg and hydrochlorothiazide 25 mg

Adverse Reactions

The following reactions have been reported with the combination product. Also see individual agents.

2% to 10%:

Central nervous system: Dizziness (5%), fatigue (3%)

Gastrointestinal: Diarrhea (3%), nausea (2%)

Renal: Increased blood urea nitrogen (3%)

Respiratory: Upper respiratory tract infection (8%), sinusitis (4%), flu-like symptoms (2%)

<2% (Limited to important or life-threatening): Abdominal pain, back pain, bronchitis, decreased hematocrit, decreased hemoglobin, dyspepsia, hypokalemia, increased liver enzymes, increased serum bilirubin, increased serum creatinine, orthostatic hypotension, pharyngitis, skin rash, tachycardia, vomiting

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