Moduretic

DRUG DESCRIPTION

MODURETIC (Amiloride HCl-Hydrochlorothiazide) combines the potassium-conserving action of amiloride HCl with the natriuretic action of hydrochlorothiazide.

Amiloride HCl is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene)pyrazinecarboxamide monohydrochloride, dihydrate and has a molecular weight of 302.12. Its empirical formula is C6H8ClN7OH02H2O and its structural formula is:

Amiloride HCl structural formula illustration

Hydrochlorothiazide is designated chemically as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide  structural formula illustration

It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

MODURETIC (amiloride and hydrochlorothiazide) is available for oral use as tablets containing 5 mg of anhydrous amiloride HCl and 50 mg of hydrochlorothiazide. Each tablet contains the following inactive ingredients: calcium phosphate, FD&C Yellow 6, guar gum, lactose, magnesium stearate and starch.

What are the possible side effects of hydrochlorothiazide and amiloride (Moduretic 5-50)?

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • dry mouth,...

Read All Potential Side Effects and See Pictures of Moduretic

What are the precautions when taking amiloride and hydrochlorothiazide (Moduretic)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to amiloride or hydrochlorothiazide; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,...

Read All Potential Precautions of Moduretic


Moduretic Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, dizziness, nausea, vomiting, loss of appetite, stomach/abdominal pain, gas, or diarrhea may occur. If any of these effects persist or worsen, tell 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 immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast heartbeat, severe dizziness, confusion, unusual decrease in the amount of urine, fainting, seizures.

Tell your doctor immediately if this unlikely but serious side effect occurs: joint pain.

Tell your doctor immediately if any of these rare but serious side effects occur: yellowing eyes/skin, dark urine, persistent nausea/vomiting, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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: See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to amiloride or hydrochlorothiazide; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent these effects and dehydration. If you are on restricted fluid intake, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.

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.

If you have diabetes, this product may make it harder to control 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 and urination. Your anti-diabetic medication or diet may need to be adjusted.

This product may affect the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Hydrochlorothiazide passes into breast milk. It is unknown if amiloride passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Moduretic Patient Information Including Side Effects

Brand Names: Moduretic 5-50

Generic Name: hydrochlorothiazide and amiloride (Pronunciation: hy dro klor oh THI a zide and a MIL o ride)

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

What is hydrochlorothiazide and amiloride (Moduretic)?

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

Amiloride is a potassium sparing-diuretic that also prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

The combination of hydrochlorothiazide and amiloride is used to treat fluid retention (edema) and high blood pressure (hypertension).

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

What are the possible side effects of hydrochlorothiazide and amiloride (Moduretic)?

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • dry mouth, increased thirst, tiredness, nausea, vomiting;
  • shallow breathing;
  • tremors, confusion; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea or vomiting;
  • gas, stomach pain; or
  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydrochlorothiazide and amiloride (Moduretic)?

Do not use this medication if you have kidney disease, urination problems, diabetes, or high levels of potassium in your blood. Do not use potassium supplements while you are taking hydrochlorothiazide and amiloride.

Before using this medication, tell your doctor if you have heart disease, cirrhosis or other liver disease, a breathing disorder, gout, lupus, an allergy to sulfa drugs, or a pancreas disorder. Tell your doctor if you use steroids or other blood pressure medicines.

Avoid drinking alcohol, which can increase some of the side effects of hydrochlorothiazide and amiloride.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking hydrochlorothiazide and amiloride.

There are many other medicines that can interact with hydrochlorothiazide and amiloride. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

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