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Lotensin Hct

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Lotensin Hct

Lotensin Hct Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide USP) is used to treat hypertension (high blood pressure). It is a combination of benazepril, an ACE (angiotensin converting enzyme) inhibitor, and hydrochlorothiazide, a thiazide diuretic (water pill). This medication is available in generic form. Common side effects include dizziness, light-headedness, drowsiness, headache, fatigue, blurred vision, dry cough, or vomiting as your body adjusts to the medication.

The recommended dosage of Lotensin HCT ranges between 5 mg/6.25 mg (benazepril/hydrochlorothiazide) and 20 mg/25 mg once a day. Dosage may be increased or decreased based on the patient's response. Lotensin HCT may interact with other diuretics (water pills) or blood pressure medications, gold injections for arthritis, lithium, digoxin, cholestyramine, colestipol, steroids, NSAIDs (non-steroidal anti-inflammatory drugs), or insulin or oral diabetes medicine. Tell your doctor all medications you use. Lotensin HCT is not recommended during pregnancy due to the risk for harm to a fetus. A small amount of this drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Our Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide USP) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lotensin Hct in Detail - Patient Information: Side Effects

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

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

  • eye pain, vision problems;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • urinating less than usual or not at all;
  • weakness, confusion, increased thirst, loss of appetite, vomiting, pounding heartbeats or fluttering in your chest;
  • swelling, weight gain, feeling short of breath;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale or yellowed skin, dark colored urine, fever, jaundice (yellowing of the skin or eyes);
  • wheezing, trouble breathing; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • cough;
  • headache;
  • dizziness, drowsiness, tired feeling;
  • nausea, constipation, upset stomach; or
  • mild skin rash, increased sweating.

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 Lotensin Hct (Benazepril HCl and HCTZ) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lotensin Hct Overview - Patient Information: Side Effects

SIDE EFFECTS: You may experience dizziness, light-headedness, drowsiness, headache, fatigue, blurred vision, dry cough, or vomiting 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.

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

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, decreased sexual ability, tingling or numbness of the hands/feet, decrease in vision, eye pain, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

Tell your doctor immediately if any of these highly unlikely 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), seizures, signs of infection (e.g., fever, chills, persistent sore throat).

This drug may rarely cause serious (possibly fatal) liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing eyes or skin, dark urine, stomach/abdominal pain, persistent fatigue, persistent nausea.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction 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.

Read the entire patient information overview for Lotensin Hct (Benazepril HCl and HCTZ)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lotensin Hct FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Lotensin HCT has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year.

The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 7% of U.S. patients treated with Lotensin HCT and in 4% of patients treated with placebo.

The most common reasons for discontinuation of therapy with Lotensin HCT in U.S. studies were cough (1.0%; see PRECAUTIONS), “dizziness” (1.0%), headache (0.6%), and fatigue (0.6%).

The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Lotensin HCT are shown in the table below.

Reactions Possibly or Probably Drug Related Patients in U.S. Placebo-Controlled Studies

  LOTENSIN HCT
N = 665
Placebo
N = 235
N % N %
“Dizziness”
41
6.3
8
3.4
Fatigue
34
5.2
6
2.6
Postural Dizziness
23
3.5
1
0.4
Headache
20
3.1
10
4.3
Cough
14
2.1
3
1.3
Hypertonia
10
1.5
3
1.3
Vertigo
10
1.5
2
0.9
Nausea
9
1.4
2
0.9
Impotence
8
1.2
0
0.0
Somnolence
8
1.2
1
0.4

Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in 0.3% to 1.0% of patients treated with Lotensin HCT were the following:

Angioedema: Edema of the lips or face without other manifestations of angioedema (0.3%). See WARNINGS, Angioedema.

Cardiovascular: Hypotension (seen in 0.6% of patients), postural hypotension (0.3%), palpitations, and flushing.

Gastrointestinal: Vomiting, diarrhea, dyspepsia, anorexia, and constipation.

Neurologic and Psychiatric: Insomnia, nervousness, paresthesia, libido decrease, dry mouth, taste perversion, and tinnitus.

Dermatologic: Rash and sweating.

Other: Gout, urinary frequency, arthralgia, myalgia, asthenia, and pain (including chest pain and abdominal pain).

Other adverse experiences reported in 0.3% or more of Lotensin HCT patients in U.S. controlled clinical trials, and rarer events seen in post-marketing experience, were the following; asterisked entries occurred in more than 1% of patients (in some, a causal relationship to Lotensin HCT is uncertain):

Angioedema: Edema of the lips or face without other manifestations of angioedema. See WARNINGS, Angioedema.

Cardiovascular: Syncope, peripheral vascular disorder, and tachycardia.

Body as a Whole: Infection, back pain*, flu syndrome*, fever, chills, and neck pain.

Dermatologic: Photosensitivity and pruritus.

Gastrointestinal: Gastroenteritis, flatulence, and tooth disorder.

Neurologic and Psychiatric: Hypesthesia, abnormal vision, abnormal dreams, and retinal disorder.

Respiratory: Upper respiratory infection*, epistaxis, bronchitis, rhinitis*, sinusitis*, and voice alteration.

Other: Conjunctivitis, arthritis, urinary tract infection, alopecia, and urinary frequency*.

Monotherapy with benazepril has been evaluated for safety in over 6000 patients. In clinical trials, the observed adverse reactions to benazepril were similar to those seen in trials of Lotensin HCT. In post-marketing experience with benazepril, there have been rare reports of Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, and thrombo-cytopenia. Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

Hydrochlorothiazide has been extensively prescribed for many years, but there has not been enough systematic collection of data to support an estimate of the frequency of the observed adverse reactions. Within organ-system groups, the reported reactions are listed here in decreasing order of severity, without regard to frequency.

Unknown frequency: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, neutropenia.

Cardiovascular: Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic) (see WARNINGS), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, and anorexia.

Neurologic: Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.

Musculoskeletal: Muscle spasm.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia.

Metabolic: Hyperglycemia, glycosuria, and hyperuricemia.

Hypersensitivity: Necrotizing angiitis, respiratory distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash, and photosensitivity.

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

Clinical Laboratory Test Findings

Serum Electrolytes: See PRECAUTIONS.

Creatinine: Minor reversible increases in serum creatinine were observed in patients with essential hypertension treated with Lotensin HCT. Such increases occurred most frequently in patients with renal artery stenosis (see PRECAUTIONS).

PBI and Tests of Parathyroid Function: See PRECAUTIONS.

Other (Causal Relationships Unknown): Other clinically important changes in standard laboratory tests were rarely associated with Lotensin HCT administration. Elevations in blood urea nitrogen, uric acid, glucose, SGOT, and SGPT have been reported (see WARNINGS). In the somewhat larger patient population exposed to benazepril monotherapy in U.S. trials, the same abnormalities were reported, together with scattered accounts of hyponatremia, melena, electrocardiographic changes, leukopenia, eosinophilia, and proteinuria.

Read the entire FDA prescribing information for Lotensin Hct (Benazepril HCl and HCTZ) »

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Lotensin Hct - User Reviews

Lotensin Hct User Reviews

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Here is a collection of user reviews for the medication Lotensin Hct sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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