Spironolactone 25mg W/hctz 25mg Tab

Hydrochlorothiazide inhibits the reabsorption of sodium and chloride in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water. Spironolactone is a competitive antagonist of aldosterone at the mineralocorticoid receptors in the distal renal tubules and collecting ducts, leading to increased excretion of sodium and water, and retention of potassium and hydrogen ions.

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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, such as:
+ Mood changes or 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 changes in urine production
+ Dry mouth or dry eyes
+ Severe upset stomach or vomiting
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Unable to pass urine
+ Changes in urine production
+ Blood in the urine
+ Sudden weight gain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Changes in balance
Fever, chills, or sore throat
Burning, numbness, or tingling sensations that are not normal
Shortness of breath
Unexplained bruising or bleeding
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
Liver problems, which can be rare but potentially life-threatening. If you experience any of the following symptoms, contact your doctor immediately:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Rarely, skin cancer has been reported in people taking hydrochlorothiazide. To minimize your risk, protect your skin from the sun and follow your doctor's recommendations 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 Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Stomach cramps
Dizziness
Drowsiness
Fatigue
Weakness
Headache
* Restlessness

This is not an exhaustive list of possible 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.

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 symptoms you experienced.
A known sulfa allergy.
Certain health conditions, including:
+ Addison's disease
+ High calcium levels (hypercalcemia)
+ High potassium levels (hyperkalemia)
+ Kidney disease
+ Liver disease
If you have difficulty urinating or are unable to pass urine.
Current or planned use of the following medications:
+ Abiraterone
+ Amiloride
+ Dofetilide
+ Eplerenone
+ Triamterene
Use of lithium.
* If you are breastfeeding or plan to breastfeed.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

Important Warnings and Cautions

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

Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Monitoring Your Condition
If you have diabetes (high blood sugar), closely monitor your blood sugar levels and report any signs of high blood sugar to your doctor, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. Regularly check your blood pressure as instructed by your doctor. Additionally, have your blood work checked as directed by your doctor and discuss the results with them.

Interactions with Lab Tests and Other Substances
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. If you are on a low-salt or salt-free diet, consult with your doctor. Be aware that this medication may increase potassium levels in the blood, which can be life-threatening if left untreated, especially in individuals with diabetes, kidney disease, severe illness, or older adults. Your doctor will closely monitor your condition and adjust the dosage as needed. If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor.

Potential Side Effects
Be aware of the risk of gout attacks and high cholesterol and triglyceride levels, and discuss these with your doctor. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, which can lead to low blood pressure, inform your doctor promptly.

Special Considerations
If you have lupus, this medication can cause your condition to become active or worsen; report any new or worsening symptoms to your doctor immediately. This medication can also increase your risk of sunburn; take precautions when exposed to the sun and inform your doctor if you experience easy sunburning. Additionally, this medication can cause eye problems, which can lead to permanent vision loss if left untreated. If you experience changes in vision or eye pain, typically within hours to weeks of starting this medication, seek medical attention immediately.

Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), which can be life-threatening. Seek medical help immediately if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.

• Potassium supplements
• Other potassium-sparing diuretics (e.g., amiloride, triamterene)
• Eplerenone
• Strong CYP3A4 inhibitors (with spironolactone, though less critical for this combination)

• ACE inhibitors (e.g., lisinopril, enalapril) - increased risk of hyperkalemia
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan) - increased risk of hyperkalemia
• NSAIDs (e.g., ibuprofen, naproxen) - reduced diuretic/antihypertensive effect, increased risk of renal impairment and hyperkalemia
• Lithium - reduced renal clearance of lithium, leading to increased lithium toxicity
• Digoxin - spironolactone may interfere with digoxin assays and potentially increase digoxin half-life
• Trimethoprim/sulfamethoxazole - increased risk of hyperkalemia

• Corticosteroids, ACTH - enhanced electrolyte depletion (hypokalemia)
• Non-depolarizing muscle relaxants (e.g., tubocurarine) - enhanced effect of muscle relaxants
• Cholestyramine, Colestipol - reduced absorption of hydrochlorothiazide
• Alcohol, barbiturates, narcotics - may potentiate orthostatic hypotension
• Antidiabetic agents (oral agents and insulin) - may require dosage adjustment due to hydrochlorothiazide's hyperglycemic effect
• Pressor amines (e.g., norepinephrine) - decreased arterial responsiveness to pressor amines

• Allopurinol - increased risk of hypersensitivity reactions to allopurinol
• Amantadine - increased risk of amantadine toxicity

• Signs of hyperkalemia (muscle weakness, fatigue, bradycardia, irregular heartbeat)
• Signs of hypokalemia (muscle cramps, weakness, constipation, irregular heartbeat)
• Signs of hyponatremia (nausea, headache, confusion, seizures)
• Signs of dehydration (dry mouth, thirst, decreased urination, dizziness)
• Orthostatic hypotension (dizziness upon standing)
• Gout flares (joint pain, swelling)
• Gynecomastia (in males, with spironolactone)
• Menstrual irregularities (in females, with spironolactone)

Generally not recommended during pregnancy unless the benefits outweigh the risks. Both hydrochlorothiazide and spironolactone cross the placenta. Hydrochlorothiazide may cause fetal or neonatal jaundice, thrombocytopenia, and other adverse reactions. Spironolactone may cause feminization of male fetuses based on animal data.

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

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

Use with caution in elderly patients due to increased susceptibility to electrolyte imbalances (especially hyperkalemia and hyponatremia), dehydration, and renal impairment. Initiate at the lower end of the dosing range and monitor closely.

• This combination is particularly useful for patients who develop hypokalemia with thiazide diuretics alone, as spironolactone helps to conserve potassium.
• Always monitor serum potassium, sodium, and renal function closely, especially during initiation, dose changes, and in patients with impaired renal function or those on interacting medications (e.g., ACE inhibitors, ARBs).
• Advise patients to avoid potassium-rich foods, potassium supplements, and salt substitutes unless specifically instructed by their physician.
• Educate patients about the signs and symptoms of hyperkalemia and hyponatremia.
• Administer in the morning to prevent nocturia.
• Spironolactone can cause gynecomastia in males and menstrual irregularities/hirsutism in females; these effects are usually dose-related and reversible upon discontinuation.

• Other classes of antihypertensives (e.g., ACE inhibitors, ARBs, Calcium Channel Blockers, Beta-blockers)
• Loop diuretics (e.g., furosemide, torsemide) for more potent diuresis
• Spironolactone monotherapy (for primary aldosteronism, heart failure with reduced ejection fraction)
• Hydrochlorothiazide monotherapy

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 details. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.