Amiloride and hydrochlorothiazide

Name: Amiloride and hydrochlorothiazide

Amiloride and Hydrochlorothiazide Drug Class

Amiloride and Hydrochlorothiazide is part of the drug class:

  • Low ceiling diuretics and potassium sparing agents

Amiloride and Hydrochlorothiazide Food Interactions

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. 

Inform MD

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. 

Other Requirements

  • 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. 

What are some other side effects of Amiloride and Hydrochlorothiazide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Headache.
  • Not hungry.
  • Upset stomach.
  • Stomach pain.
  • Gas.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take amiloride and hydrochlorothiazide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to amiloride and hydrochlorothiazide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Warnings

Hyperkalemia

Like other potassium-conserving diuretic combinations, Amiloride and Hydrochlorothiazide may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter). In patients without renal impairment or diabetes mellitus, the risk of hyperkalemia with this combination product is about 1 to 2 percent. This risk is higher in patients with renal impairment or diabetes mellitus (even without recognized diabetic nephropathy). Since hyperkalemia, if uncorrected, is potentially fatal, it is essential to monitor serum potassium levels carefully in any patient receiving amiloride hydrochloride and hydrochlorothiazide, particularly when it is first introduced, at the time of dosage adjustments, and during any illness that could affect renal function.

The risk of hyperkalemia may be increased when potassium-conserving agents, including amiloride hydrochloride and hydrochlorothiazide, are administered concomitantly with an angiotensin-converting enzyme inhibitor, cylosporine or tacrolimus (see PRECAUTIONS, Drug Interactions). Warning signs or symptoms of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, shock, and ECG abnormalities. Monitoring of the serum potassium level is essential because mild hyperkalemia is not usually associated with an abnormal ECG.

When abnormal, the ECG in hyperkalemia is characterized primarily by tall, peaked T waves or elevations from previous tracings. There may also be lowering of the R wave and increased depth of the S wave, widening and even disappearance of the P wave, progressive widening of the QRS complex, prolongation of the PR interval, and ST depression.

Treatment of Hyperkalemia

If hyperkalemia occurs in patients taking Amiloride and Hydrochlorothiazide, the drug should be discontinued immediately. If the serum potassium level exceeds 6.5 mEq per liter, active measures should be taken to reduce it. Such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. If needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. Patients with persistent hyperkalemia may require dialysis.

Diabetes Mellitus

In diabetic patients, hyperkalemia has been reported with the use of all potassium-conserving diuretics, including amiloride HCl, even in patients without evidence of diabetic nephropathy. Therefore, Amiloride and Hydrochlorothiazide should be avoided, if possible, in diabetic patients and, if it is used, serum electrolytes and renal function must be monitored frequently.

Amiloride and Hydrochlorothiazide should be discontinued at least three days before glucose tolerance testing.

Metabolic or Respiratory Acidosis

Antikaliuretic therapy should be instituted only with caution in severely ill patients in whom respiratory or metabolic acidosis may occur, such as patients with cardiopulmonary disease or poorly controlled diabetes. If Amiloride and Hydrochlorothiazide is given to these patients, frequent monitoring of acid-base balance is necessary. Shifts in acid-base balance alter the ratio of extracellular/intracellular potassium, and the development of acidosis may be associated with rapid increases in serum potassium levels.

How is Amiloride and Hydrochlorothiazide Supplied

Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP are available as:

5 mg/50 mg:

Light yellow, round, scored, biconvex tablet. Debossed with 555 over 483 on the scored side and stylized barr on the other side. Each tablet contains 5 mg of anhydrous amiloride HCl and 50 mg of hydrochlorothiazide.

100 Tablets NDC 0555-0483-02

1000 Tablets NDC 0555-0483-05

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. A 3/2016

Pharmacologic Category

  • Antihypertensive
  • Diuretic, Combination

Administration

Oral: Administer with food.

  • High Blood Pressure (Hypertension) Medications
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