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Monopril HCT

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Monopril HCT

Monopril HCT Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Monopril-HCT (fosinopril sodium-hydrochlorothiazide) is a combination ACE (angiotensin converting enzyme) inhibitor and diuretic used to treat hypertension (high blood pressure) or congestive heart failure. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include dizziness, lightheadedness, or tiredness as your body adjusts to the medication. Dry cough may also occur.

Fosinopril is an effective treatment of hypertension in once-daily doses of 10-80 mg, while hydrochlorothiazide is effective in doses of 12.5-50 mg per day. Monopril-HCT may interact with other diuretics or blood pressure medications, gold injections to treat arthritis, lithium, steroids, NSAIDs (nonsteroidal anti-inflammatory drugs), or insulin or oral diabetes medicines. Tell your doctor all medications and supplements you use. Monopril-HCT is not recommended for use during pregnancy. It may harm a fetus. Both fosinopril and hydrochlorothiazide pass into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Monopril-HCT (fosinopril sodium-hydrochlorothiazide) 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.

Monopril 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.

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);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • dry mouth, thirst, nausea, vomiting;
  • feeling weak, drowsy, restless, or light-headed;
  • jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • swelling, weight gain, feeling short of breath; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • cough;
  • dizziness, headache, tired feeling;
  • joint or muscle pain;
  • diarrhea, constipation; 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 Monopril HCT (Fosinopril Sodium-Hydrochlorothiazide Tablets) »

What is Patient Information Overview?

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

Monopril HCT Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Monopril HCT (Fosinopril Sodium-Hydrochlorothiazide Tablets)»

What is Prescribing information?

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

Monopril HCT FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

MONOPRIL-HCT (fosinopril sodium-hydrochlorothiazide tablets) has been evaluated for safety in over 660 patients with hypertension; approximately 137 of these patients were treated for more than one year. The observed adverse events were generally mild, transient, and similar to those seen with fosinopril and hydrochlorothiazide taken separately. There was no relationship between the incidence of side effects and age.

In placebo-controlled clinical trials of MONOPRIL-HCT, the usual duration of therapy was two months. Adverse clinical or laboratory events led to discontinuation of therapy by 4.3% of 368 placebo-treated patients and by 3.5% of 660 MONOPRIL-HCT-treated patients.

The most common reasons for discontinuation of therapy with MONOPRIL-HCT in U.S. studies were headache (0.3%), cough (0.3%; see PRECAUTIONS), and fatigue (0.2%).

The side effects considered probably or possibly related to study drug that occurred in placebo-controlled trials in more than 2% of patients treated with MONOPRIL-HCT are shown in the table below.

Reactions Possibly or Probably Drug-Related (Incidence in Placebo-Controlled Studies)

  MONOPRIL-HCT
(N=660)
%
Placebo
(N=368)
%
Headache 7.0 12.8
Cough 5.6 1.1
Fatigue 3.9 2.4
Dizziness 3.2 2.2
Upper Respiratory Infection 2.3 2.7
Musculoskeletal Pain 2.0 1.9

Other side effects considered possibly or probably related to study drug that occurred in controlled trials in 0.5% to < 2.0% of patients treated with MONOPRIL-HCT, and rarer but clinically significant events regardless of causal relationship were:

General: Chest pain, weakness, fever, viral infection.

Cardiovascular: Orthostatic hypotension (seen in 1.8% of MONOPRIL-HCT patients and 0.3% of placebo patients; no patients discontinued therapy due to orthostatic hypotension), edema, flushing, rhythm disturbance, syncope.

Dermatologic: Pruritus, rash.

Endocrine/Metabolic: Sexual dysfunction, change in libido, breast mass.

Gastrointestinal: Nausea/vomiting, diarrhea, dyspepsia/heartburn, abdominal pain, gastritis/esophagitis.

Immunologic: Angioedema (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).

Musculoskeletal: Myalgia/muscle cramps.

Neurologic/Psychiatric: Somnolence, depression, numbness/paresthesia.

Respiratory: Sinus congestion, pharyngitis, rhinitis.

Special Senses: Tinnitus.

Urogenital: Urinary tract infection, urinary frequency, dysuria.

Laboratory Test Abnormalities: Serum electrolytes, uric acid, glucose, magnesium, cholesterol, triglycerides, and calcium (see PRECAUTIONS). Neutropenia.

Fetal/Neonatal Morbidity and Mortality

See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

Antihypertensive monotherapy with fosinopril has been evaluated for safety in more than 1500 patients, of whom approximately 450 patients were treated for a year or more. The observed adverse events included events similar to those seen with MONOPRIL-HCT; in addition, the following others have also been reported with fosinopril:

Cardiovascular: Angina, myocardial infarction, cerebrovascular accident, hypertensive crisis, hypotension, claudication.

Dermatologic: Urticaria, photosensitivity.

Endocrine/Metabolic: Gout.

Gastrointestinal: Pancreatitis, hepatitis, dysphagia, abdominal distention, flatulence, appetite/weight change, dry mouth.

Hematologic: Lymphadenopathy.

Musculoskeletal: Arthralgia.

Neurologic/Psychiatric: Memory disturbance, tremor, confusion, mood change, sleep disturbance.

Respiratory: Bronchospasm, laryngitis/hoarseness, epistaxis, and (in two patients) a symptom-complex of cough, bronchospasm, and eosinophilia.

Special Senses: Vision disturbance, taste disturbance, eye irritation.

Urogenital: Renal insufficiency.

Laboratory Test Abnormalities: Elevations (usually transient and minor) of BUN and creatinine have been observed, but these have not been more frequent than in parallel patients treated with placebo. The hemoglobin in fosinopril-treated patients generally decreases by an average of 0.1 g/dL, but this nonprogressive change has never been symptomatic. Leukopenia and eosinophilia have also been reported.

Serum levels of liver function tests (transaminases, LDH, alkaline phosphatase and serum bilirubin) have occasionally been found to be elevated, and these elevations have lead to discontinuation of therapy in 0.7% of patients. Other risk factors for liver dysfunction have often been present in these cases; in any event the elevations generally have resolved after discontinuation of therapy with fosinopril.

Other Adverse Events Reported with ACE Inhibitors

Other adverse effects reported with ACE inhibitors include cardiac arrest; pancytopenia, hemolytic anemia; aplastic anemia; thrombocytopenia; bullous pemphigus, exfoliative dermatitis; and a syndrome that may include one or more of arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermopathy, positive ANA titer, leukocytosis, eosinophilia, and elevated ESR.

Hydrochlorothiazide has now 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.

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

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

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

Immunologic: Necrotizing angiitis, Stevens-Johnson syndrome, respiratory distress (including pneumonitis and pulmonary edema), anaphylactic reactions, purpura, urticaria, rash, and photosensitivity.

Metabolic: Hyperglycemia, glycosuria, and hyperuricemia.

Musculoskeletal: Muscle spasm.

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

Read the entire FDA prescribing information for Monopril HCT (Fosinopril Sodium-Hydrochlorothiazide Tablets) »

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Monopril HCT - User Reviews

Monopril HCT User Reviews

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Here is a collection of user reviews for the medication Monopril 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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