Amiloride and Hydrochlorothiazide

Amiloride and hydrochlorothiazide is a prescription medication used to treat high blood pressure. Amiloride and hydrochlorothiazide can also be used in patients with heart failure who develop low amounts of potassium in their blood or in whom maintenance of normal potassium levels is considered to be important. 

It is a single product containing 2 medications: amiloride and hydrochlorothiazide. Amiloride belongs to a group of drugs called diuretics ("water pills"). Specifically, it is a "potassium-sparing" diuretic which means that it works by helping the body get rid of excess fluid by increasing the amount of salt and water the kidneys remove from the blood, while still keeping potassium in the body. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

This medication comes in tablet form and is typically given once daily with food.

Common side effects of amiloride and hydrochlorothiazide include headache, weakness, and nausea.

Amiloride and hydrochlorothiazide can also cause dizziness and tiredness (fatigue). Do not drive or operate heavy machinery until you know how this mediaction affects you. 

Amiloride and hydrochlorothiazide is a prescription medication used to treat high blood pressure. Amiloride and hydrochlorothiazide can also be used in patients with heart failure who develop low amounts of potassium in their blood or in whom maintenance of normal potassium levels is considered to be important. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Amiloride and Hydrochlorothiazide may be found in some form under the following brand names:

• Moduretic

Serious side effects have been reported with amiloride and hydrochlorothiazide. See the "Amiloride and hydrochlorothiazide Precautions" section. 

Common side effects of amiloride and hydrochlorothiazide include the following:

• headache
• weakness
• tiredness (fatigue)
• nausea
• an eating disorder associated with low body weight (anorexia)
• diarrhea
• stomach pain (abdominal and gastrointestinal pain)
• leg ache
• dizziness
• difficulty breathing (dyspnea)
• skin reactions such as rash and itching

This is not a complete list of amiloride and hydrochlorothiazide side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking:

• nonsteroidal anti-inflammatory drugs (NSAIDS) such as naproxen (Aleve) and ibuprofen (Advil)
• other medicines that lower blood pressure such as guanethidine (Ismelin), methyldopa (Aldomet), beta-blockers like bisoprolol (Zebeta) , vasodilators like hydralazine (Apresoline), calcium channel blockers like amlodipine (Norvasc), angiotensin-­converting enzyme (ACE) inhibitors like enalapril (Vasotec, Vaseretic), angiotensin receptor II blockers (ARBs) like valsartan (Diovan) and direct renin inhibitors (DRIs) like aliskiren (Tekturna)
• cyclosporine (Sandimmune) and tacrolimus (Prograf, Hecoria)
• alcohol, a class of drugs called barbiturates, or a type of pain medications called narcotics
• diabetic medications
• cholestyramine (Questran) and colestipol (Colestid)
• medicines that provide relief for inflamed areas of the body (corticosteroids) such as methylprednisolone (Medrol) and dexamethasone (Decadron)
• substances that raise blood pressure (pressor amines) such as norepinephrine (Levophed)
• medicines that relax skeletal muscles such as cyclobenzaprine (Flexeril) and carisoprodol (Soma)
• lithium (Lithobid)

This is not a complete list of amiloride and hydrochlorothiazide drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with amiloride and hydrochlorothiazide or its ingredients including the following:

• abnormal heart rhythms (arrhythmia)
• increases in a substance in the blood called urea nitrogen (increases in BUN) and imbalances in the levels of salts and fluids in your body (electrolyte and fluid imbalance). Amiloride and hydrochlorothiazide is especially known to cause elevated potassium levels. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • dry mouth
  • thirst
  • weakness
  • drowsiness
  • restlessness
  • muscle pains or cramps
  • low blood pressure
  • low output of urine
  • fast heart rate
  • nausea
  • vomiting
• acid-base imbalance. Use amiloride and hydrochlorothiazide with caution in patients who are severely ill and at risk for respiratory and metabolic acidosis. 

Amiloride and hydrochlorothiazide can cause dizziness and tiredness (fatigue). Do not drive or operate heavy machinery until you know how this medication affects you.

Do not take amiloride and hydrochlorothiazide if you:

• are allergic to amiloride and hydrochlorothiazide or any of its ingredients or to other sulfonamide-derived drugs
• have high levels of potassium in your blood
• have kidney problems
• you are taking potassium-conserving agents (i.e. spironolactone or triamterene) or potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet. [Except in severe and/or refractory cases of low potassium levels (hypokalemia)]

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of amiloride and hydrochlorothiazide, salt substitutes containing potassium should be avoided. 

Before taking amiloride and hydrochlorothiazide, tell your doctor about all of your medical conditions. Especially tell your doctor if:

• are allergic to amiloride and hydrochlorothiazide or any of its ingredients or to other sulfonamide-derived drugs
• have high levels of potassium in your blood
• have kidney problems
• you are taking potassium-conserving agents (i.e. spironolactone or triamterene) or potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet. [Except in severe and/or refractory cases of low potassium levels (hypokalemia)]
• you have diabetes
• you are breastfeeding or plan to breastfeed
• you are pregnant or plan to become pregnant

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amiloride and hydrochlorothiazide falls into category B. There are no well-done studies that have been done in humans with amiloride and hydrochlorothiazide. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if amiloride is excreted in human breast milk. Hydrochlorothiazide has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from amiloride and hydrochlorothiazide, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. 

• Take amiloride and hydrochlorothiazide exactly as prescribed.
• The daily dose of amiloride and hydrochlorothiazide is usually given as a single dose with food but may be given in divided doses.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of amiloride and hydrochlorothiazide at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your blood pressure
• previous medications used
• other medications you are taking
• how you respond to this medication

The recommended starting dose of amiloride and hydrochlorothiazide to treat high blood pressure and to maintain normal blood levels of potassium in heart failure patients is one 5/50 mg tablet by mouth once daily with food. The dosage may be increased to two 5/50 mg tablets once a day with food, if necessary. More than two tablets a day is usually not needed. 

If you take too much amiloride and hydrochlorothiazide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store at room temperature, 68º to 77ºF (20º to 25ºC). 
• Protect from light.
• Dispense in a tight, light-resistant container.
• Keep this and all medications out of the reach of children. 

WARNING: HYPERKALEMIA

Amiloride and hydrochlorothiazide may cause hyperkalemia (serum potassium levels greater than 5.5 mEq/L). In patients without renal impairment or diabetes mellitus, the risk of hyperkalemia with this combination product is about 1% to 2%. This risk is higher in patients with renal impairment or diabetes mellitus (even without recognized diabetic neuropathy). Because hyperkalemia, if uncorrected, is potentially fatal, it is essential to monitor serum potassium levels carefully in any patient receiving amiloride/hydrochlorothiazide, particularly when it is first introduced, at the time of dosage adjustments, and during any illness that could affect renal function.