Amiloride 5mg / HCTZ 50mg Tabs

Manufacturer TEVA Active Ingredient Amiloride and Hydrochlorothiazide(a MIL oh ride & hye droe klor oh THYE a zide) Pronunciation a MIL oh ride & hye droe klor oh THYE a zide
WARNING: Sometimes, this drug may raise potassium levels in the blood. This can be deadly if it is not treated. The risk is highest in people with diabetes, kidney disease, severe illness, and in older adults. Your doctor will follow you closely to change the dose if needed. @ COMMON USES: It is used to treat high blood pressure.It is used to treat heart failure (weak heart).It is used to raise potassium in the body.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Diuretic
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Pharmacologic Class
Potassium-sparing diuretic and Thiazide diuretic combination
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Pregnancy Category
Category D
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FDA Approved
Aug 1973
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a 'water pill' (diuretic) that helps your body get rid of extra salt and water, which can lower your blood pressure and reduce swelling. It's a combination of two different types of water pills, one of which helps prevent your body from losing too much potassium, an important mineral.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

It's common for this medication to increase urine production, which may disrupt your sleep if taken too close to bedtime. To minimize this effect, try to take your medication earlier in the day.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, away from direct light and moisture. Keep it in a dry place, such as a closet or cupboard, and avoid storing it in the bathroom. Always keep your medication out of the reach of children and pets.

When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually once daily in the morning to avoid waking up at night to urinate.
  • Do not take potassium supplements or use salt substitutes containing potassium unless specifically instructed by your doctor.
  • Follow a low-sodium diet as advised by your healthcare provider.
  • Limit alcohol intake, as it can increase the risk of dizziness or lightheadedness.
  • Avoid excessive sun exposure and use sunscreen, as hydrochlorothiazide can increase sensitivity to the sun.
  • Stay hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake unless directed by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet (Amiloride 5mg / HCTZ 50mg) orally once daily
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

hypertension: Initial: 1 tablet daily; Max: 2 tablets daily (Amiloride 10mg / HCTZ 100mg)
edema: Initial: 1 tablet daily; Max: 2 tablets daily (Amiloride 10mg / HCTZ 100mg)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, monitor electrolytes and renal function.
Moderate: Use with caution (CrCl 30-50 mL/min), monitor closely. Consider lower doses.
Severe: Contraindicated (CrCl < 30 mL/min) due to risk of hyperkalemia and azotemia.
Dialysis: Contraindicated. Not effectively removed by dialysis.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; risk of hepatic encephalopathy with HCTZ component.
Severe: Use with caution; risk of hepatic encephalopathy with HCTZ component.

Pharmacology

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Mechanism of Action

Amiloride is a potassium-sparing diuretic that acts on the distal convoluted tubule and collecting duct to inhibit sodium reabsorption and potassium excretion by blocking epithelial sodium channels (ENaC). Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. The combination provides additive diuretic and antihypertensive effects while minimizing potassium loss.
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Pharmacokinetics

Absorption:

Bioavailability: Amiloride: Approximately 50%; HCTZ: 65-75%
Tmax: Amiloride: 3-6 hours; HCTZ: 1-2.5 hours
FoodEffect: Amiloride: Food may decrease absorption but not significantly alter therapeutic effect; HCTZ: Food may increase absorption slightly.

Distribution:

Vd: Amiloride: 350-380 L; HCTZ: 0.8-1.7 L/kg
ProteinBinding: Amiloride: 23%; HCTZ: 40-68%
CnssPenetration: Limited for both

Elimination:

HalfLife: Amiloride: 6-9 hours (can extend to 20 hours in renal impairment); HCTZ: 5.6-14.8 hours
Clearance: Amiloride: Renal clearance; HCTZ: Renal clearance
ExcretionRoute: Amiloride: Urine (primarily unchanged), feces; HCTZ: Urine (primarily unchanged)
Unchanged: Amiloride: 50% in urine; HCTZ: >95% in urine
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Pharmacodynamics

OnsetOfAction: Amiloride: 2 hours; HCTZ: 2 hours
PeakEffect: Amiloride: 6-10 hours; HCTZ: 4 hours
DurationOfAction: Amiloride: 24 hours; HCTZ: 6-12 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or throwing up
Signs of too much acid in the blood (acidosis), including:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ A heartbeat that does not feel normal
+ Very bad stomach pain, upset stomach, or throwing up
+ Feeling very sleepy
+ Shortness of breath
+ Feeling very tired or weak
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ A big weight gain
Eye problems, which can lead to lasting eyesight loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:
+ Change in eyesight
+ Eye pain (usually occurs within hours to weeks of starting this medication)
Rarely, certain types of skin cancer have been reported in people taking hydrochlorothiazide. To minimize your risk:
+ Protect your skin from the sun
+ Have your skin checked as advised by your doctor
+ Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

Feeling dizzy, tired, or weak
Headache
Decreased appetite
Upset stomach
Stomach pain
* Gas

If any of these side effects or any others bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of electrolyte imbalance: unusual weakness, tiredness, muscle cramps or pain, nausea, vomiting, irregular heartbeat, excessive thirst, dry mouth.
  • Signs of dehydration: severe dizziness, lightheadedness, fainting.
  • Signs of high potassium: muscle weakness, slow or irregular heartbeat.
  • Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • Signs of gout flare: sudden, severe joint pain, redness, swelling (especially in the big toe).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Certain health conditions, including:
+ Diabetes
+ High potassium levels
+ Kidney disease
+ Urination problems
If you are unable to urinate.
Your diet, particularly if it is rich in potassium.
Any medications you are taking, including:
+ Spironolactone
+ Triamterene
+ Potassium-containing drugs
+ Salt substitutes
+ Dofetilide
+ Lithium

Please note that this is not an exhaustive list of potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

If you have diabetes, closely monitor your blood sugar levels as directed by your healthcare provider. Regularly check your blood pressure as advised, and have blood tests done as recommended by your doctor. Discuss any concerns or questions with your doctor.

Be aware that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

This medication may increase your risk of sunburn. Take precautions when exposed to the sun, and notify your doctor if you experience excessive sunburn.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may cause drowsiness, discuss the potential risks with your doctor.

If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.

If you are on a low-sodium or sodium-free diet, consult your doctor for guidance. If you take cholestyramine or colestipol, consult your pharmacist about the best way to take these medications with this drug, and be aware of the potential for gout attacks.

If you have lupus, this medication may cause your condition to become active or worsen. Immediately report any new or worsening symptoms to your doctor. Additionally, this medication may cause elevated cholesterol and triglyceride levels; discuss this risk with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Dehydration
  • Electrolyte imbalance (especially hyperkalemia or severe hypokalemia, hyponatremia)
  • Hypotension (low blood pressure)
  • Dizziness
  • Weakness
  • Nausea
  • Vomiting
  • Cardiac arrhythmias (due to electrolyte imbalance)

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and symptomatic, focusing on correcting fluid and electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Potassium supplements
  • Other potassium-sparing diuretics (e.g., spironolactone, triamterene)
  • Anuria
  • Acute renal failure
  • Hyperkalemia
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Major Interactions

  • ACE inhibitors (e.g., lisinopril, enalapril) - increased risk of hyperkalemia
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan) - increased risk of hyperkalemia
  • NSAIDs (e.g., ibuprofen, naproxen) - reduced diuretic/antihypertensive effect, increased risk of renal dysfunction
  • Lithium - reduced renal clearance of lithium, increased risk of lithium toxicity
  • Digoxin - HCTZ-induced hypokalemia can increase digoxin toxicity
  • Corticosteroids - enhanced potassium loss
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Moderate Interactions

  • Antidiabetic agents (insulin, oral hypoglycemics) - HCTZ may decrease glucose tolerance, requiring dose adjustment
  • Cholestyramine, Colestipol - reduced absorption of HCTZ
  • Neuromuscular blocking agents (e.g., tubocurarine) - prolonged effect due to HCTZ-induced electrolyte imbalance
  • Pressor amines (e.g., norepinephrine) - decreased arterial responsiveness
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Minor Interactions

  • Alcohol, Barbiturates, Narcotics - additive orthostatic hypotensive effects

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To assess baseline hypertension and guide therapy.

Timing: Prior to initiation

Serum Electrolytes (Sodium, Potassium, Chloride, Magnesium, Calcium)

Rationale: To establish baseline electrolyte status and identify pre-existing imbalances; Amiloride can cause hyperkalemia, HCTZ can cause hypo- or hypernatremia, hypokalemia, hypomagnesemia, hypercalcemia.

Timing: Prior to initiation

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline renal function, as both drugs are renally cleared and renal impairment increases risk of hyperkalemia and reduced efficacy.

Timing: Prior to initiation

Blood Glucose

Rationale: HCTZ can impair glucose tolerance.

Timing: Prior to initiation

Serum Uric Acid

Rationale: HCTZ can increase uric acid levels and precipitate gout.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

Frequency: Regularly, e.g., weekly initially, then monthly, then every 3-6 months once stable.

Target: <130/80 mmHg or individualized target

Action Threshold: Persistently elevated BP despite therapy, or symptomatic hypotension.

Serum Potassium

Frequency: Weekly for first month, then monthly for 2-3 months, then every 3-6 months, or as clinically indicated (e.g., with dose changes, new interacting drugs, or symptoms).

Target: 3.5-5.0 mEq/L

Action Threshold: K+ > 5.5 mEq/L (consider dose reduction/discontinuation), K+ < 3.5 mEq/L (investigate cause, consider supplementation if HCTZ effect predominates).

Serum Sodium

Frequency: Same as potassium.

Target: 135-145 mEq/L

Action Threshold: Na+ < 130 mEq/L (symptomatic hyponatremia requires intervention).

Renal Function (BUN, Serum Creatinine)

Frequency: Same as potassium.

Target: Stable within patient's baseline range

Action Threshold: Significant increase in BUN/Cr (>20-30% from baseline) or decrease in eGFR (<30 mL/min) requires dose adjustment or discontinuation.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized glycemic targets

Action Threshold: Persistent hyperglycemia.

Serum Uric Acid

Frequency: Periodically, especially in patients with history of gout.

Target: Normal range (e.g., 3.5-7.2 mg/dL)

Action Threshold: Elevated levels or symptoms of gout.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Weakness
  • Muscle cramps or pain
  • Irregular heartbeat (palpitations)
  • Excessive thirst
  • Dry mouth
  • Nausea or vomiting
  • Unusual fatigue
  • Swelling in ankles or feet (if edema persists)

Special Patient Groups

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Pregnancy

Category D. Not recommended for routine use in pregnancy. Hydrochlorothiazide can cross the placental barrier and may cause fetal or neonatal jaundice, thrombocytopenia, and other adverse reactions. Amiloride is Category B, but the combination is rated based on the higher risk component.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided due to potential for fetal harm with HCTZ.
Second Trimester: Risk of fetal/neonatal jaundice, thrombocytopenia, and electrolyte disturbances (HCTZ).
Third Trimester: Increased risk of fetal/neonatal jaundice, thrombocytopenia, and electrolyte disturbances (HCTZ). May also reduce plasma volume and placental perfusion.
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Lactation

Both amiloride and hydrochlorothiazide are excreted into breast milk. Hydrochlorothiazide can suppress lactation. Due to the potential for serious adverse effects in the nursing infant (e.g., electrolyte disturbances, jaundice), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Risk of electrolyte imbalance, jaundice, and potential for suppression of lactation. Monitor infant for signs of dehydration or electrolyte disturbances.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

Elderly patients may be more sensitive to the effects of diuretics and are at increased risk for electrolyte imbalances (especially hyperkalemia with amiloride and hyponatremia/hypokalemia with HCTZ), dehydration, and renal impairment. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Always check serum potassium levels before initiating therapy and regularly thereafter, especially in patients with renal impairment or those on ACE inhibitors/ARBs.
  • Advise patients to avoid potassium-rich foods and potassium supplements unless specifically instructed by their physician.
  • Take the medication in the morning to prevent nocturia (frequent urination at night).
  • Hydrochlorothiazide can cause photosensitivity; advise patients to use sunscreen and protective clothing.
  • May exacerbate or precipitate gout due to HCTZ-induced hyperuricemia.
  • Monitor blood glucose levels in diabetic patients, as HCTZ can impair glucose tolerance.
  • This combination is particularly useful for patients who experience hypokalemia with thiazide monotherapy.
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Alternative Therapies

  • Other classes of antihypertensives (e.g., ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers)
  • Loop diuretics (e.g., furosemide, torsemide) for more potent diuresis
  • Other potassium-sparing diuretics (e.g., spironolactone, eplerenone) as monotherapy or with other diuretics
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.