Micardis HCT

What Is Micardis HCT?

Micardis HCT (telmisartan and hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist and a thiazide diuretic (water pill) used to treat high blood pressure (hypertension).

What Are Side Effects of Micardis HCT?

Common side effects of Micardis HCT include:

• dizziness,
• lightheadedness, and
• blurred vision as your body adjusts to the medication.

Other side effects of Micardis HCT include:

• tiredness,
• flu symptoms,
• nausea,
• diarrhea, or
• cold symptoms such as stuffy nose, sneezing, and sore throat.

Micardis HCT may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor if you have any symptoms of dehydration including extreme thirst, very dry mouth, muscle cramps or weakness, fast/slow/irregular heartbeat, confusion, or decreased urination. Tell your doctor if you have serious side effects of Micardis HCT including:

• fainting,
• unusual changes in the amount of urine (not including the normal increase in urine when you first start this drug),
• toe or joint pain,
• symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
• decrease in vision, or
• eye pain.

Dosage for Micardis HCT

The dosage of Micardis HCT is based on your medical condition and response to treatment.

What Drugs, Substances, or Supplements Interact with Micardis HCT?

Micardis HCT may interact with other blood pressure medications, digoxin, blood thinners, steroids, lithium, cholestyramine, colestipol, insulin or diabetes medications you take by mouth, barbiturates, other diuretics, aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs), muscle relaxers, or narcotics. Tell your doctor all medications you are taking.

Micardis HCT During Pregnancy and Breastfeeding

Micardis HCT is not recommended for use during pregnancy due to the risk for harm to the fetus. This medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Micardis HCT Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Micardis HCT Consumer Information

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

In rare cases, this medicine 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 unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

• eye pain, vision problems;
• a light-headed feeling, like you might pass out;
• jaundice (yellowing of the skin or eyes);
• swelling in your hands or feet, unusual weight gain;
• easy bruising, unusual bleeding; or
• signs of an electrolyte imbalance--dry mouth, increased thirst, drowsiness, confusion, feeling restless, vomiting, muscle pain or weakness, lack of energy, fast heartbeats, little or no urine, or a seizure.

Common side effects may include:

• dizziness, feeling tired;
• nausea, diarrhea;
• back pain; or
• cold or flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Micardis HCT (Telmisartan and Hydrochlorothiazide Tablets)

 

Micardis HCT Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in labeling:

• Hypotension [see WARNINGS AND PRECAUTIONS]
• Renal Impairment [see WARNINGS AND PRECAUTIONS]
• Electrolytes and Metabolic Disorders [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

MICARDIS HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.

Adverse reactions occurring at an incidence of ≥ 2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies].

Table 1 : Adverse Reactions Occurring at an Incidence of ≥ 2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo*

	Telmisartan/ Hydrochlorothiazide (n = 414)	Placebo (n = 74)	Telmisartan (n = 209)	Hydrochlorothiazide (n = 121)
Body as a whole
Fatigue	3%	1%	3%	3%
Influenza-like symptoms	2%	1%	2%	3%
Central/Peripheral nervous system
Dizziness	5%	1%	4%	6%
Gastrointestinal system
Diarrhea	3%	0%	5%	2%
Nausea	2%	0%	1%	2%
Respiratory system disorder
Sinusitis	4%	3%	3%	6%
Upper respiratory tract infection	8%	7%	7%	10%
* includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof

Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis.

Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.

Telmisartan

Other adverse events that have been reported with telmisartan are listed below:

Autonomic Nervous System: impotence, increased sweating, flushing

Body as a Whole: allergy, fever, leg pain, chest pain

Cardiovascular: palpitation, angina pectoris, abnormal ECG, hypertension, peripheral edema

Central Nervous System: insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoesthesia

Gastrointestinal: flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache

Hepato-biliary: elevations of liver enzymes or serum bilirubin

Metabolic: gout, hypercholesterolemia, diabetes mellitus

Musculoskeletal: arthritis, arthralgia, leg cramps, myalgia

Psychiatric: anxiety, depression, nervousness

Resistance Mechanism: infection, abscess, otitis media

Respiratory: asthma, rhinitis, dyspnea, epistaxis

Skin: dermatitis, eczema, pruritus

Urinary: micturition frequency, cystitis

Vascular: cerebrovascular disorder

Special Senses: abnormal vision, conjunctivitis, tinnitus, earache

Hydrochlorothiazide

Other adverse events that have been reported with hydrochlorothiazide are listed below:

Body as a Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Metabolic: hyperglycemia, glycosuria

Musculoskeletal: muscle spasm

Nervous System/Psychiatric: restlessness

Renal: interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: transient blurred vision, xanthopsia

Clinical Laboratory Findings

Creatinine, Blood Urea Nitrogen (BUN): Increases in BUN ( ≥ 11.2 mg/dL) and serum creatinine ( ≥ 0.5 mg/dL) were observed in 2.8% and 1.4%, respectively, of patients with essential hypertension treated with MICARDIS HCT tablets in controlled trials. No patient discontinued treatment with MICARDIS HCT tablets because of an increase in BUN or creatinine [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MICARDIS HCT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: eosinophilia

Cardiac Disorders: atrial fibrillation, congestive heart failure, myocardial infarction, tachycardia, bradycardia

Ear and Labyrinth Disorders: vertigo

General Disorders and Administration Site Conditions: asthenia, edema

Hepato-biliary: Abnormal hepatic function / liver disorder

Immune System Disorders: anaphylactic reaction

Infections and Infestations: urinary tract infection

Investigations: increased CPK

Metabolism and Nutrition Disorders: hypoglycemia (in diabetic patients)

Musculoskeletal and Connective Tissue Disorders: tendon pain (including tendonitis, tenosynovitis), rhabdomyolysis

Nervous System Disorders: syncope

Renal and Urinary Disorders: renal failure, renal impairment including acute renal failure

Reproductive System and Breast Disorders: erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders: coughing

Skin and Subcutaneous Tissue Disorders: drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), angioedema (with fatal outcome)

Vascular Disorder: orthostatic hypotension

Read the entire FDA prescribing information for Micardis HCT (Telmisartan and Hydrochlorothiazide Tablets)