Spironolactone (Aldactone) 100mg

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Description

Product Description

Spironolactone (Aldactone) 100mg is a potassium-sparing diuretic (water tablet) used in the treatment of edema (fluid overload) due to heart failure, liver disease, or kidney disease. It is also used as an adjunct to treat hypertension (high blood pressure) when other medications have not worked. It has helped reduce the need for hospitalization among heart failure patients and risk of stroke and heart attack among hypertensive patients. Furthermore, it has also been used to diagnose and treat hyperaldosteronism, a condition in which the adrenal gland produces too much hormone called aldosterone.

Spironolactone Aldactone 100mg

What does Spironolactone (Aldactone) 100mg contain?


Its active ingredient is spironolactone, an FDA-approved drug, for the treatment of heart failure with reduced ejection fraction, hypertension that is resistant to medications, hyperaldosteronism, edema, and hypokalemia (low levels of potassium). 

Off-label, non-FDA approved uses of this drug include the treatment of acne and hirsutism (condition in women that results in excessive hair growth in a male pattern). It has been considered as a possible alternative for the management of patients with moderate to severe acne who have long been on oral antibiotics. Spironolactone’s role in reducing testosterone production has been significant in treating hirsutism among women.

How does Spironolactone (Aldactone) 100mg work?


It belongs to a class of drugs called aldosterone receptor antagonists. It helps the kidneys remove excess and prevent reabsorption of water and salt, or electrolytes, while conserving potassium ions in the body. By reducing the heart’s workload and making it more efficient in pumping blood throughout the body, it relieves edema. By excreting excess fluids onto the urine, it lowers blood pressure. In treating hypertension, it is used in combination with other medicines to achieve maximum benefit.

Who cannot take Spironolactone (Aldactone) 100mg?


Although most adults can use it, it is not suitable for everyone. Inform your doctor if you:

  • Allergic to spironolactone or similar drugs
  • Breastfeeding
  • Are using other potassium-sparing drugs, like eplerenone, or potassium supplements
  • Addison’s disease
  • Have high levels of potassium in your body (hyperkalemia)
  • Have significant kidney problem (e.g. acute kidney failure, anuria or not able to produce urine)

How should you take Spironolactone (Aldactone) 100mg?


Take this medicine as advised by your doctor. Dose will vary depending on your condition and tolerability. Your dose may need to be changed a few times before you find the dose that is right for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. You may view Additional Information tab for recommended doses.

Because it can make you pass more urine, it is best to take it during the day in order to avoid the frequent urge to urinate while you are asleep. Aldactone should be taken consistently with food. Swallow tablets whole; do not chew or crush them. 

Depending on the reason you’re taking the drug, you may have to take it for a long time, possibly for life. Talk to your doctor if you want to stop taking the drug. If you abruptly stop the medication, your symptoms may get worse.

What if you miss a dose?


If you miss a dose, take it as soon as you remember it unless it’s after 6pm. In this case, skip the missed dose and take your next dose at the usual time the next day. Do not take two doses to make up for a missed dose.

What if you take too much?


Taking too much of the drug can cause symptoms, such as peeing more than usual, increased thirst, dizziness, confusion, and vomiting.

Overdose of this drug can increase your body’s potassium to dangerous levels, especially if you have a kidney problem. Signs of high potassium level include:

  • Chest pain
  • Slow or irregular heartbeat
  • Shortness of breath
  • Tingling feeling
  • Muscle weakness
  • Abdominal pain and vomiting

What are the side effects of Spironolactone (Aldactone) 100mg?


Like other medicines, Aldactone can cause side effects, but not everyone gets them. You may experience these side effects when you first start taking the drug, but they get better as soon as your body adjusts to the medicine. Talk to your doctor if they persist or bother you. 

Common side effects include:

  • Low blood pressure (hypotension)
  • Dizziness
  • Muscle cramps
  • Tiredness or fatigue
  • Breast pain and breast enlargement (in males)
  • Menstrual irregularities

Serious side effects can happen but are rare. Tell your doctor right away if you experience:

  • A serious allergic reaction to the drug
  • Irregular heartbeat, tingling feeling, numbness, weakness, shortness of breath (signs of hyperkalemia)
  • Dizziness, drowsiness, confusion increased thirst, peeing less than usual, diarrhea (signs of loss of kidney function)

What other precautions should be taken?


Children

Safety and efficacy in this population have not been established.

Elderly

Caution is needed when using this drug among the elderly. This drug is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, your doctor will need to monitor renal function more frequently.

Pregnancy 

Due to the risks to the mother and fetus with heart failure and poorly controlled hypertension during the pregnancy, this drug can be given during pregnancy. However, because of its potential risks to the male fetus due to the anti-androgenic properties of spironolactone, it is advised to avoid taking this drug during pregnancy. If it cannot be avoided, the mother should be warned of the risks. 

Talk to your doctor if you are trying to get pregnant or if you get pregnant while on this medication. Do not stop taking this drug without talking to your doctor.

Breastfeeding

This drug should be avoided by breastfeeding women.

Fertility

For women, your menstrual cycle may be affected. Your periods and fertility should go back to normal 2 months after you stop using it.

For men, there is insufficient evidence that this drug affects fertility.

Drug-Disease Interactions

Caution must be exercised by patients who have the following conditions. Dose adjustments and more frequent monitoring are needed. Inform your doctor if you have:

    • Kidney disease
    • Liver disease
    • Porphyria

Drug-Drug Interactions

Intake of this drug should be avoided if you are using other potassium-sparing drugs, like eplerenone, and potassium supplements.

Some  medicines affect how spironolactone works and vice versa. Inform your doctor if you are taking any of these medications:

    • Other diuretics, like amiloride
    • Other anti-hypertensive medications, like ACE inhibitors (enalapril, captopril, lisinopril) and angiotensin II antagonists (losartan, telmisartan, candesartan)
    • Digoxin (for irregular heartbeat)
    • Painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs), like naproxen, ibuprofen, diclofenac, and aspirin
    • Lithium (for bipolar disorder/depression)
    • Heparin (for bleeding)
    • Metformin (for diabetes)
    • Cotrimoxazole (for bacterial infections)

Do not take supplements that are high in potassium due to increased risk of hyperkalemia.

Alcohol

Consumption of alcohol is not recommended while you are taking this medicine. It may increase the risk of dizziness and fainting.

Driving

Dizziness, lightheadedness, or fainting may also occur, especially when you get up suddenly from a lying or sitting position. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Diet and Lifestyle

  • Avoid potassium-rich food and drinks (e.g. potatoes, banana).
  • Avoid low-sodium salt or salt substitutes because they contain a lot of potassium. 
  • Regular physical activity improves blood flow.
  • Avoid refined food (bread, pasta, sugar) and food rich in trans fatty acids (processed baked pastries, fried food).
  • Elevate your legs or swollen area on a chair or pillows to minimize edema.
  • Quit smoking and alcohol use.
  • Avoid standing or sitting for prolonged periods.

How should you store Spironolactone (Aldactone) 100mg?


Store the medicine at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children and pets. Do not keep expired medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Quick Tips


It is very important that your doctor checks your progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it.

Blood and urine tests may be routinely done to check your electrolyte, blood sugar, and uric acid levels and kidney function.

What company produces Spironolactone (Aldactone) 100mg?


RPG Life Sciences Ltd.Managing Director: Yugal Sikri
Founded: 1993
Headquarters: Mumbai India
Number of employees: 1,001 to 5,000
Subsidiaries:
Website:https://www.rpglifesciences.com/website/index.php

 

Additional information

Additional Information

Dosage

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. Recommended doses are as follows. If your dose is different, do not change it unless your doctor tells you to do so.

Edema:
Adult – Initially 100mg daily, may be adjusted according to response for maintenance

Congestive Heart Failure with Edema
Adult – Initially 100mg daily, may be adjusted up to 25-200mg daily according to response for maintenance

Nephrotic Syndrome (condition caused by the kidneys)
Adult – 100-200mg (if glucocorticoids are not sufficient)
Elderly – Start at lowest dose possible then titrate upwards if needed

Hypertension:
Adults – Initially 25-100mg daily as a single dose or in divided doses (if not adequately controlled by other medications). Dosage may adjusted at 2-week intervals depending on response and tolerability

Diagnosis of Primary Hyperaldosteronism (high aldosterone levels):
Adult
Long test – 400mg daily for 3-4 weeks
Short test – 400mg daily for 4 days

Treatment of Hyperaldosteronism
Adult
Patients undergoing surgery: 100-400mg daily
Patients not suitable for surgery: Use lowest effective dose

Side Effects

Common side effects:
– Low blood pressure (hypotension)
– Dizziness
– Muscle cramps
– Tiredness or fatigue
– Breast pain and breast enlargement (males)
Menstrual irregularities

Rare but serious side effects:
– Serious allergic reaction
– Hyperkalemia (irregular heartbeat, tingling feeling, numbness, weakness, shortness of breath)
– Loss of kidney function (dizziness, drowsiness, confusion increased thirst, peeing less than usual, diarrhea)

Contraindications

– Hyperkalemia (high potassium levels)
– Addison’s disease (disease of adrenal glands)
– Severe kidney problem (e.g. acute kidney failure, anuria or not able to produce urine)
– Diabetic nephropathy
– Breastfeeding women
– Concomitant use of eplerenone or other potassium-sparing diuretics and potassium supplements

Pack Size

30 Pills, 60 Pills, 90 Pills

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