Monopril HCT

DRUG DESCRIPTION

Fosinopril sodium is a white to off-white crystalline powder, soluble ( > 100 mg/mL) in water, in ethanol, and in methanol, and slightly soluble in hexane. Fosinopril sodium is designated chemically as L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-; its structural formula is:

Fosinopril sodium Structural Formula Illustration

Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65.

Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Fosinopril is converted to fosinoprilat by hepatic cleavage of the ester group.

Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is designated chemically as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:

Its empirical formula is C7H8ClN3O4S2, and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic.

MONOPRIL®-HCT (fosinopril sodium-hydrochlorothiazide tablets) is a combination of fosinopril sodium and hydrochlorothiazide, USP. It is available for oral use in two tablet strengths: MONOPRIL-HCT 10/12.5, containing 10 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP; and MONOPRIL-HCT 20/12.5, containing 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP. The inactive ingredients of the tablets include lactose, croscarmellose sodium, povidone, sodium stearyl fumarate, and iron oxide.

What are the possible side effects of hydrochlorothiazide and fosinopril (Monopril HCT)?

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:

  • 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,...

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

What are the precautions when taking fosinopril sodium-hydrochlorothiazide tablets (Monopril HCT)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either fosinopril or hydrochlorothiazide; or to other ACE inhibitors (such as captopril, lisinopril); or to other thiazides (such as chlorothiazide); 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: a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), an inability to make urine (anuria).

Before using this medication, tell your doctor or pharmacist your medical history,...

Read All Potential Precautions of Monopril HCT »


Monopril HCT Consumer (continued)

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.

The hydrochlorothiazide in this product may cause too much body water and salts to be lost (dehydration). Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration: very dry mouth, extreme thirst, muscle cramps/weakness, fast heartbeat, severe dizziness, confusion, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: irregular heartbeat, toe/joint pain, decrease in vision, eye pain.

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.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either fosinopril or hydrochlorothiazide; or to other ACE inhibitors (such as captopril, lisinopril); or to other thiazides (such as chlorothiazide); 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: a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), an inability to make urine (anuria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease (such as renal artery stenosis), collagen vascular disease (such as lupus, scleroderma), gout, untreated salt imbalance (such as high calcium, high or low potassium, low magnesium), loss of too much body water (dehydration), blood filtering procedures (such as LDL apheresis, dialysis).

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 help prevent dizziness, drink plenty of fluids while taking this medication unless directed otherwise by your doctor. Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

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

This medication 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.

This product may increase or decrease your potassium levels, which could cause side effects. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination, or signs of low blood sugar such as nervousness, hunger, and shaking. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Older adults may be more sensitive to the side effects of this product, especially dizziness.

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

Fosinopril and hydrochlorothiazide pass into breast milk, and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.


Monopril HCT Patient Information Including Side Effects

Brand Names: Monopril HCT

Generic Name: hydrochlorothiazide and fosinopril (Pronunciation: hye droe klor oh THY a zide and foe SIN oh pril)

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

What is hydrochlorothiazide and fosinopril (Monopril HCT)?

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

Fosinopril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Fosinopril lowers blood pressure and also relieves symptoms of fluid retention.

The combination of hydrochlorothiazide and fosinopril is used to treat hypertension (high blood pressure) or congestive heart failure.

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

What are the possible side effects of hydrochlorothiazide and fosinopril (Monopril HCT)?

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:

  • 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.

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

Do not use this medication if you are unable to urinate.

You should not use this medication if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

Before taking hydrochlorothiazide and fosinopril, tell your doctor if you have kidney disease (or are on dialysis), liver disease, gout, lupus, diabetes, or an allergy to sulfa drugs.

Fosinopril can cause birth defects in the baby if you take the medication during pregnancy. Do not use hydrochlorothiazide and fosinopril without telling your doctor if you are pregnant or planning a pregnancy.

Avoid the regular use of salt substitutes in your diet, and do not take potassium supplements while taking hydrochlorothiazide and fosinopril, unless your doctor has told you to.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking other diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and fosinopril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

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