Hydrochlorothiazide 12.5mg Capsules

Manufacturer UNICHEM Active Ingredient Hydrochlorothiazide(hye droe klor oh THYE a zide) Pronunciation hye droe klor oh THYE a zide
It is used to treat high blood pressure.It is used to get rid of extra fluid.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
Thiazide Diuretic
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Pregnancy Category
C
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FDA Approved
Mar 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrochlorothiazide is a 'water pill' (diuretic) that helps your body get rid of extra salt and water. This helps to lower your blood pressure and reduce swelling (edema). It works by making your kidneys remove more salt and water from your blood.
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How to Use This Medicine

Taking Your Medication Correctly

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. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Important Administration Instructions

All products: This medication may increase your urine production, so try to avoid taking it too close to bedtime to minimize sleep disturbances.
Oral suspension: You can take this medication with or without food. Before using, shake the suspension well to ensure the ingredients are mixed properly. Measure your liquid dose carefully using the measuring device provided with the medication. If a device is not included, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store all products at room temperature, protected from light and moisture. Keep the medication in a dry place, away from the bathroom.
Keep the lid tightly closed to maintain the medication's potency.

What to Do If You Miss 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 the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning to avoid nighttime urination.
  • Do not stop taking this medication without consulting your doctor, even if you feel well.
  • Maintain a balanced diet, potentially including potassium-rich foods if advised by your doctor (e.g., bananas, oranges, potatoes), but avoid excessive potassium supplementation unless directed.
  • Limit alcohol intake, as it can increase the risk of dizziness and low blood pressure.
  • Avoid excessive sun exposure and use sunscreen, as this medication can increase sensitivity to sunlight.
  • Stay hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake unless advised for specific conditions.
  • Regularly monitor your blood pressure at home if advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 12.5 mg to 50 mg orally once daily
Dose Range: 12.5 - 50 mg

Condition-Specific Dosing:

hypertension: 12.5 mg to 50 mg orally once daily; doses above 25 mg generally do not provide additional benefit and increase risk of adverse effects.
edema: 25 mg to 100 mg orally once daily or intermittently (e.g., every other day or 3-5 days per week).
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all)
Infant: 1 to 2 mg/kg/day orally in 1 or 2 divided doses (max 37.5 mg/day)
Child: 1 to 2 mg/kg/day orally in 1 or 2 divided doses (max 100 mg/day)
Adolescent: 1 to 2 mg/kg/day orally in 1 or 2 divided doses (max 100 mg/day or 50 mg/day for hypertension)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically needed (CrCl > 50 mL/min)
Moderate: Use with caution; consider lower starting doses (CrCl 30-50 mL/min). May be less effective.
Severe: Contraindicated or not recommended (CrCl < 30 mL/min or anuria) due to lack of efficacy and potential for accumulation.
Dialysis: Not effective in patients with severe renal impairment or anuria; not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment, but use with caution.
Moderate: Use with caution; fluid and electrolyte disturbances may precipitate hepatic coma.
Severe: Use with caution; fluid and electrolyte disturbances may precipitate hepatic coma. Avoid if possible.

Pharmacology

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Mechanism of Action

Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule of the nephron. This action leads to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. It also decreases calcium excretion. The antihypertensive effect is initially due to reduced plasma volume and cardiac output, and later involves a reduction in peripheral vascular resistance.
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Pharmacokinetics

Absorption:

Bioavailability: 65-75%
Tmax: 1-2.5 hours
FoodEffect: Food may increase the extent of absorption but does not significantly affect the rate of absorption.

Distribution:

Vd: 0.8-1.7 L/kg
ProteinBinding: 40-68%
CnssPenetration: Limited

Elimination:

HalfLife: 5.6-14.8 hours (mean 6-15 hours)
Clearance: Approximately 300 mL/min (renal clearance)
ExcretionRoute: Renal (primarily unchanged)
Unchanged: Approximately 50-70%
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Pharmacodynamics

OnsetOfAction: Approximately 2 hours
PeakEffect: Approximately 4 hours
DurationOfAction: 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, irregular heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of pancreatitis (pancreas problems): severe abdominal pain, severe back pain, or severe nausea and vomiting.
Signs of kidney problems: difficulty urinating, changes in urine output, blood in the urine, or sudden weight gain. Additionally, dark urine or yellowing of the skin and eyes may occur.
Fever, chills, or sore throat; unexplained bruising or bleeding; or feeling extremely tired or weak.
Abnormal sensations such as burning, numbness, or tingling.
Shortness of breath.
Restlessness.
Difficulty achieving or maintaining an erection.

Eye Problems:

This medication can cause certain eye problems, which may lead to permanent vision loss if left untreated. If you experience eye problems, symptoms such as changes in vision or eye pain typically occur within hours to weeks of starting the medication. Contact your doctor immediately if you notice any of these signs.

Skin Cancer Risk:

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize this risk, protect your skin from the sun and follow your doctor's instructions for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor right away.

Other Side Effects:

Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not resolve on their own:

Constipation, diarrhea, upset stomach, vomiting, or decreased appetite.
Stomach cramps.
Dizziness, fatigue, or weakness.
Headache.

Reporting Side Effects:

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. 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 dehydration: severe thirst, dry mouth, muscle cramps, weakness, dizziness, lightheadedness, confusion.
  • Signs of electrolyte imbalance: irregular heartbeat, severe muscle weakness, numbness or tingling, seizures.
  • Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • Signs of gout: sudden, severe joint pain, swelling, warmth, and redness (often in the big toe).
  • Unusual tiredness or weakness.
  • Yellowing of the skin or eyes (jaundice).
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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, including any symptoms that occurred.
A known sulfa allergy.
If you have difficulty urinating or are unable to pass urine.
If you are currently taking dofetilide or lithium.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Safety Precautions

To avoid accidents, do not drive or perform tasks that require alertness until you know how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

Monitoring Your Health

Your doctor will schedule regular blood tests and other laboratory exams to monitor your health while taking this medication. It is essential to keep these appointments to ensure that any potential issues are identified and addressed promptly.

Potential Side Effects

High cholesterol and triglyceride levels have been reported in people taking this medication. If you have a history of high cholesterol or triglycerides, discuss this with your doctor. Additionally, if you have diabetes, you will need to closely monitor your blood sugar levels.

Blood Pressure Monitoring

Regularly check your blood pressure as directed by your doctor. This medication may affect the results of certain laboratory tests, so it is essential to inform all of your healthcare providers and laboratory personnel that you are taking this medication.

Interactions with Other Medications

If you have high blood pressure, consult with your doctor before taking 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.

Diuretic Effects

This medication is a potent diuretic, which means it can cause your body to lose excess water and electrolytes (such as potassium). In some cases, this can lead to severe health problems. Your doctor will closely monitor your condition and adjust your dosage as needed to minimize this risk.

Dietary Considerations

If you are on a low-salt or salt-free diet, discuss this with your doctor. You should also talk to your doctor before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or OTC medications that may cause drowsiness.

Dehydration and Low Blood Pressure

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

Interactions with Other Medications

If you take cholestyramine or colestipol, consult with your pharmacist about how to take these medications with this drug. You should also be aware of the potential for gout attacks.

Lupus and Sun Sensitivity

If you have lupus, this medication may cause your condition to worsen or become active. Inform your doctor immediately if you experience any new or worsening symptoms. Additionally, this medication may increase your risk of sunburn, so take precautions when spending time outdoors and inform your doctor if you experience any unusual sun sensitivity.

Age-Related Considerations

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

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication with you and help you make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Dehydration
  • Electrolyte depletion (hypokalemia, hyponatremia, hypochloremia)
  • Hypotension (low blood pressure)
  • Dizziness
  • Weakness
  • Nausea
  • Vomiting
  • Lethargy
  • Confusion
  • Cardiac arrhythmias (due to electrolyte imbalance)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive, focusing on correcting fluid and electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Anuria
  • Hypersensitivity to hydrochlorothiazide or sulfonamide-derived drugs
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Major Interactions

  • Lithium (increased lithium toxicity due to decreased renal clearance)
  • Corticosteroids, ACTH (enhanced electrolyte depletion, particularly hypokalemia)
  • Digoxin (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (may reduce diuretic, natriuretic, and antihypertensive effects; risk of renal impairment)
  • Cholestyramine, Colestipol (may reduce absorption of hydrochlorothiazide)
  • Diazoxide (enhanced hyperglycemic and hypotensive effects)
  • Neuromuscular blocking agents (e.g., tubocurarine) (enhanced effect due to hypokalemia)
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Moderate Interactions

  • Alcohol, Barbiturates, Narcotics (additive orthostatic hypotension)
  • Antidiabetic agents (oral agents and insulin) (may require dosage adjustment due to increased blood glucose)
  • Pressor amines (e.g., norepinephrine) (possible decreased arterial responsiveness)
  • Other antihypertensive drugs (additive hypotensive effect)
  • Amphotericin B (parenteral), Corticosteroids, ACTH (increased risk of hypokalemia)
  • Allopurinol (increased incidence of hypersensitivity reactions to allopurinol)
  • Calcium salts (increased serum calcium due to decreased excretion)
  • Cyclosporine (increased risk of hyperuricemia and gouty complications)
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Minor Interactions

  • Methenamine (may decrease hydrochlorothiazide effectiveness)
  • Probenecid, Sulfinpyrazone (may require dosage adjustment of uricosuric agent)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To establish baseline and assess efficacy.

Timing: Before initiation

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To establish baseline and identify pre-existing imbalances.

Timing: Before initiation

Renal Function (BUN, Serum Creatinine)

Rationale: To assess kidney function and guide dosing.

Timing: Before initiation

Uric Acid

Rationale: To establish baseline, as HCTZ can increase uric acid levels.

Timing: Before initiation

Blood Glucose

Rationale: To establish baseline, as HCTZ can affect glucose metabolism.

Timing: Before initiation

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Routine Monitoring

Blood Pressure

Frequency: Regularly (e.g., weekly initially, then monthly or quarterly)

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent elevation above target; consider dose adjustment or add-on therapy.

Serum Potassium

Frequency: Initially 1-2 weeks after initiation/dose change, then every 1-3 months or as clinically indicated.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L (consider potassium supplementation, potassium-sparing diuretic, or dose reduction); >5.0 mEq/L (rare, but investigate).

Serum Sodium

Frequency: Initially 1-2 weeks after initiation/dose change, then every 1-3 months or as clinically indicated.

Target: 135-145 mEq/L

Action Threshold: <130 mEq/L (consider dose reduction, fluid restriction, or discontinuation).

Renal Function (BUN, Serum Creatinine)

Frequency: Initially 1-2 weeks after initiation/dose change, then every 3-6 months or as clinically indicated.

Target: Stable within patient's baseline

Action Threshold: Significant increase (e.g., >20-30% from baseline); investigate, consider dose adjustment or discontinuation.

Uric Acid

Frequency: Every 6-12 months or if symptoms of gout develop.

Target: Within normal limits (or patient's baseline)

Action Threshold: Significant elevation or symptoms of gout; consider allopurinol or alternative antihypertensive.

Blood Glucose

Frequency: Every 6-12 months, more frequently in diabetic patients.

Target: Within target for patient

Action Threshold: Significant increase; consider adjustment of antidiabetic therapy or alternative antihypertensive.

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Symptom Monitoring

  • Signs of dehydration (e.g., excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness)
  • Symptoms of electrolyte imbalance (e.g., muscle weakness, cramps, irregular heartbeat, nausea, vomiting, confusion, fatigue)
  • Signs of gout (e.g., sudden joint pain, swelling, redness)
  • Symptoms of hyperglycemia (e.g., increased thirst, frequent urination, fatigue)
  • Skin rash or photosensitivity

Special Patient Groups

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Pregnancy

Generally not recommended as first-line therapy for hypertension in pregnancy. May be used for edema not associated with preeclampsia. Thiazides cross the placental barrier and can cause fetal or neonatal jaundice, thrombocytopenia, and other adverse reactions. Use only if clearly needed and potential benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Generally avoided unless compelling indication; potential for fetal harm is low but other agents preferred.
Second Trimester: Use with caution; risk of fetal/neonatal jaundice, thrombocytopenia, and other adverse effects.
Third Trimester: Use with caution; risk of fetal/neonatal jaundice, thrombocytopenia, and other adverse effects. May decrease plasma volume and placental perfusion.
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Lactation

Excreted in breast milk. May suppress lactation. Use with caution. The American Academy of Pediatrics considers it compatible with breastfeeding, but monitor infant for dehydration and electrolyte imbalance.

Infant Risk: Low to moderate risk. Potential for dehydration, electrolyte imbalance (hypokalemia, hyponatremia), and jaundice in the infant. May decrease milk supply.
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Pediatric Use

Dosing is established for children, but careful monitoring of fluid and electrolyte balance is crucial due to higher risk of imbalances. Not recommended for infants under 6 months.

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Geriatric Use

Increased sensitivity to the hypotensive and electrolyte-depleting effects (especially hypokalemia and hyponatremia). Renal function often declines with age, increasing risk of accumulation and adverse effects. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Take in the morning to avoid nocturia (nighttime urination).
  • Monitor electrolytes (especially potassium, sodium) regularly, particularly in the first few weeks of therapy or after dose changes.
  • Educate patients on symptoms of dehydration and electrolyte imbalance.
  • Can cause photosensitivity; advise patients to use sunscreen and protective clothing.
  • May increase blood glucose and uric acid levels; monitor in diabetic and gout-prone patients.
  • Less effective in patients with severe renal impairment (CrCl < 30 mL/min).
  • Often used in combination with ACE inhibitors or ARBs to enhance blood pressure lowering and mitigate potassium loss.
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Alternative Therapies

  • Loop diuretics (e.g., Furosemide, Torsemide) for more potent diuresis or severe renal impairment.
  • Potassium-sparing diuretics (e.g., Spironolactone, Amiloride, Triamterene).
  • Other classes of antihypertensives (e.g., ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers).
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Cost & Coverage

Average Cost: $10 - $30 per 30 capsules (12.5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.