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INTRODUCTION
ALDACTONE contain Spironolactone which belongs to a group of medicine called potassium sparing diuretics, which help you lose excess fluid from your body. It is used to treat primary aldosteronism, congestive heart failure, low potassium levels and fluid retention (oedema) caused due to various kidney and liver conditions.
ALDACTONE works by blocking aldosterone activity. Aldosterone is a chemical made by the body that can cause water retention. This makes certain heart, kidney, and liver condition worse. By blocking aldosterone, your body will not retain fluid. This process also stops potassium from being excreted by your body. It may lower your blood pressure by blocking aldosterone’s effect on your blood vessels.
Always take ALDACTONE exactly as your doctor has told you. This medicine must be taken with food. Do not drive or operate any machine while taking this medicine it may cause dizziness or drowsiness. Before taking this medicine tell your doctor if you have ever had kidney disease, heart disease, liver problems. Pregnant and breastfeeding women should consult their doctor before taking this medicine.
USES OF ALDACTONE
- Primary aldosteronism
- Congestive heart failure
- Low potassium levels
- Fluid retention (Oedema) caused due to various kidney and liver conditions
HOW ALDACTONE WORKS
ALDACTONE works by blocking aldosterone activity. Aldosterone is a chemical made by the body that can cause water retention which make certain heart, kidney, and liver condition worse. By blocking aldosterone, your body will not retain fluid. This process also stops potassium from being excreted by your body. It may also lower your blood pressure by its aldosterone blocking effect.
DIRECTIONS FOR USE
Always take ALDACTONE exactly as your doctor has told you. This medicine must be taken with food. Try to take this medicine at the same time each day. It should be swallowed whole with water. Do not crush or chew the medicine.
SIDE EFFECTS OF ALDACTONE
SERIOUS
- high blood level of potassium (muscle twitching or weakness, irregular heartbeat, unusual tiredness or weakness, paralysis with or without loss of muscle tone, circulatory failure), especially if you have impaired kidney functions or a diet high in potassium
- an allergic reaction (hypersensitivity) such as swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, shock, collapse, skin rash or itching
- severe form of skin rash with flushing, fever, blister, or ulcer (Stevens-Johnson syndrome)
- severe rash involving reddening, peeling, and swelling of the skin that resemble severe burn (toxic epidermal necrolysis)
- drug reaction with eosinophilia and systemic symptom (DRESS). DRESS appear initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood test and an increase in a type of white blood cell (eosinophilia)
COMMON
- increased bruising, nosebleeds, sore throats, or infection
- low blood level of sodium, changes in the level of chemical in the body
- lack of muscle control or coordination, drowsiness, dizziness, headache, clumsiness, tiredness, confusion
- impaired liver function, a poisonous effect on the liver
- stomach upset, inflammation of the stomach lining, bleeding in the stomach, stomach or intestinal ulcers, stomach cramps, diarrhoea, nausea, or vomiting
- skin rashes including pale or red irregular raised patches with severe itching (hives), hair loss, excessive hair growth, itching, rash, pemphigoid (condition presenting with fluid-filled blisters on the skin)
- bone softening due to vitamin D deficiency, leg cramp
- acute kidney failure particularly in those who already have impaired kidney functions
- enlarged breast in men, change in voice pitch, reduced sexual potency in men, change in sexual ability/drive, breast tenderness, breast lump and increased hair growth in female, irregular periods, sweating
- feeling of general discomfort and illness
HOW TO MANAGE SIDE EFFECTS
Dizziness:
Get up and move around to feel awake, take small naps to edge off the sleepiness. Give your eyes a break to avoid fatigue and eat a healthy food to boost energy.
Headache:
Apply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.
Diarrhoea:
Drink lot of fluid such as water or squash, to avoid dehydration. Do not take any other medicines without talking to a doctor.
Nausea or vomiting:
Try taking this medicine with, or just after, a meal or snack and stick to simple meals and do not eat rich or spicy food.
WARNING & PRECAUTIONS
PREGNANCY
ALDACTONE should be used with caution in pregnant women. Consult your doctor before taking this medicine.
BREASTFEEDING
ALDACTONE is not recommended for use in breastfeeding women unless necessary. Discuss the risks and benefits with your doctor.
DRIVING AND USING MACHINES
Do not drive or operate any machine while taking this medicine it may cause dizziness or drowsiness.
ALCOHOL
Consumption of alcohol is not recommended during treatment with ALDACTONE.
KIDNEY
ALDACTONE is not recommended in patients with active kidney diseases. Before taking, this medicine consult your doctor.
LIVER
ALDACTONE should be used with caution in patients suffering from liver function impairment or active liver diseases. Consult your doctor for advice.
ALLERGY
Do not take ALDACTONE if you are allergic (hypersensitive) to spironolactone or any other ingredients in this medicine.
HEART DISEASE
ALDACTONE should be used with caution in patients suffering from active heart diseases. Consult your doctor for advice.
OTHERS
Tell your doctor, if you have:
- Addison’s disease (weakness, loss of energy, low blood pressure and dark pigmentation of the skin)
- high blood levels of potassium
- been passing small amounts or not passing urine
- a severe illness
- ever had too much acid in the body
- an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and nervous system disorders (porphyria)
- abnormal periods or swollen breasts
INTERACTIONS
Talk to your doctor if you are taking,
- blood pressure lowering medicine (antihypertensive) such as ACE inhibitors (e.g. captopril or enalapril) and angiotensin-II receptor antagonist such as valsartan or losartan)
- chlorpropamide (used to treat diabetes)
- digoxin (used to treat some heart conditions)
- ciclosporin or tacrolimus (used to prevent organ transplant rejection, treat rheumatoid arthritis, eczema, or psoriasis)
- corticosteroid such as fludrocortisone
- warfarin (used to thin the blood)
- other potassium-sparing diuretics (water tablets)
- lithium (used for some mental illnesses)
- non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin, mefenamic acid
- aspirin (used to reduce pain, inflammation, and high temperature)
- potassium supplements (potassium salts)
- noradrenaline (used for low blood pressure or heart problem)
- an anaesthetic
- ulcer healing drug such as carbenoxolone
- trimethoprim and trimethoprim-sulfamethoxazole combination
SYNOPSIS
| Drug | : | Spironolactone |
| Pharmacological Category | : | Antihypertensive, Diuretic, Potassium-Sparing, Mineralocorticoid (Aldosterone) Receptor Antagonists |
| Therapeutic Indication | : | Primary aldosteronism, Congestive heart failure, Low potassium levels, Fluid retention (Oedema) caused due to various kidney and liver conditions |
| Dosage Forms | : | Tablet |
MORE INFORMATION
Store below 20-25°C and keep out of reach of children.
FAQs ABOUT ALDACTONE
Can I use ALDACTONE for weight control?
No, it should not be used for weight control. It is not helpful in weight management. If you have weight related concern, please consult a doctor who will let you know the best therapy for weight control.
Can I take ALDACTONE during kidney disease?
No, it is not recommended in patients with active kidney diseases. Before taking this medicine consult your doctor.
Can I take ALDACTONE during liver disease?
It should be used with caution in patients suffering from liver function impairment or active liver diseases.
REFERENCES
1. Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. Page - 3575-3576.
2. B Pitt 1, F Zannad, W J Remme, R Cody, A Castaigne, A Perez, J Palensky, J Wittes. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov.2 Sep 1999. [Accessed 24 Dec 2020] https://pubmed.ncbi.nlm.nih.gov/10471456/
3. Accord; Electronic Medicines Compendium (EMC); [Revised on Jan 2020] [Accessed 24 Dec 2020] https://www.medicines.org.uk/emc/files/pil.5919.pdf
USEFUL DIAGNOSTIC TESTS
- Kidney function test
- Potassium
- Sodium
- Urine potassium
PRODUCT DETAILS
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