Aldactone 25 mg
Aldactone 25 mg
50 tabletsActive ingredient: Spironolactone
Applications of Aldactone
- The drug is a drug which increases the excretion of urine (diuretic). Thus, it can an increased accumulation of water to flush out the fabric.
- The drug is used in:
primary aldosteronism (a condition with increased secretion of the hormone aldosterone by a tumor in the adrenal gland), unless an operation is indicated
Fluid retention (edema) and / or in the abdomen (ascites) in diseases associated with a secondary hyperaldosteronism (increased secretion of the hormone aldosterone from the adrenal gland).
Absolute contraindications of Aldactone
The drug should not be taken
if you are allergic (hypersensitive) to the active substance spironolactone or to any of the excipients.
in the absence of diuresis (anuria).
with acute renal failure.
with severe renal impairment (severe renal failure with strongly reduced urine output [oliguria] or lack of diuresis [anuria]; creatinine clearance below 30 ml / min or serum creatinine greater than 1.8 mg / dl).
at elevated potassium levels (hyperkalemia).
at reduced sodium content in the blood (hyponatremia).
during pregnancy.
during lactation.
patients notice
- Take special care with taking the drug is necessary
if you suffer from renal impairment lighter degree (creatinine clearance between 30 and 60 ml / min or serum creatinine between 1.2 and 1.8 mg / dl).
tend in patients as a result of their underlying disease to blood acidity (acidosis) and / or elevated potassium levels in the blood (hyperkalemia), such as Patients with diabetes (diabetes mellitus)
if you have a strong low blood pressure (hypotension) have.
with reduced circulating blood volume (hypovolemia) or dehydration (dehydration).
- Concomitant administration of the drug with potassium-sparing diuretic drugs (diuretics, such as triamterene, amiloride), potassium-containing agents (as potassium chloride) or ACE inhibitors may cause a life-threatening increase in the potassium content in the blood (hyperkalemia). The combination of the aforementioned drugs with the drug is not recommended.
- In severe renal impairment (Glomerulumfiltrat below 30 ml / min and / or serum creatinine greater than 1.8 mg / dl), the drug is ineffective and even harmful.
- When renal function (serum creatinine levels-between 1.2 and 1.8 mg / dl and with creatinine clearance 60-30 ml / min) and with concomitant use of drugs that lead to an increase of potassium in the blood can, treatment with spironolactone should only with frequent monitoring of potassium in the blood.
- Certain blood values, particularly potassium, sodium, calcium, bicarbonate, creatinine, urea and uric acid, and the acid-base status should be monitored periodically during treatment with the drug.
- The effects caused by increased urinary excretion weight loss should be independent of the degree of urine not exceed 1 kg per day.
- With chronic abuse of diuretics (diuretic abuse) may occur a pseudo-Bartter syndrome, with the result of fluid retention in the body tissues (edema). This water retention (edema) are an expression of an increase of the enzyme renin, with the consequence of a secondary hyperaldosteronism (increased secretion of the hormone aldosterone from the adrenal gland).
- Spironolactone, a disorder of certain diagnostic tests cause (for example, RIA determination of serum digoxin concentration).
- During treatment with the drug, patients should ensure adequate fluid intake.
- Children: children should be administered spironolactone not longer than 30 days.
- Elderly: In elderly people pay attention to a possible renal impairment. The elderly are at increased risk of developing serious side effects, eg. As electrolyte imbalance (for example potassium and / or sodium depletion in the blood), dehydration (dehydration), blood pressure when changing position from lying to standing (orthostatic reactions), thrombosis.
- Testing: The use of this product may in doping controls lead to positive results.
- This medicine can alter the responsiveness of so far even with correct applications that, the ability to travel on the road, to operate machinery or to engage in potentially hazardous is impaired. This applies even more at the start of treatment, dose escalation and preparations change as well as in combination with alcohol.
- Store drug out of reach of children.
pregnancy Note
- Ask before taking / using any medicine your doctor or pharmacist for advice
- pregnancy
If you are pregnant, you should not take the medicines used, since there is evidence that spironolactone may lead to disturbances in the hormonal system in male and female offspring.
- Lactation
If you are breastfeeding, you should not take the drug as the active ingredient of the drug or its metabolite is excreted in human milk. When an application of the drug is still required, you must stop breast-feeding.
Dose of Aldactone
- The dosage should be individualized by the physician - to be determined - depending on the severity and extent of disease.
- Unless otherwise prescribed by your doctor, the usual dose
adult
For adults, the initial dose of 1 to 2 times daily is 100-200 mg spironolactone / day for 3 - 6 days.
In case of insufficient effectiveness of the daily dose can be increased to a maximum of 400 mg spironolactone / day.
As a maintenance dose are generally 50-100 mg spironolactone) to a maximum of 100-200 mg spironolactone) is sufficient.
The maintenance dose can - as needed - be administered daily, every second or every 3rd day
children
For children, the recommended starting dose is 3 mg spironolactone / kg body weight daily for 5 days.
If necessary, the dose up to 9 mg spironolactone / kg body weight can be increased each day until the onset of clinical effect.
For further treatment, the dose should be reduced to give the effect as much as possible.
- The duration of intake decided by the treating physician. They should be limited to the shortest possible period. The need for treatment over a longer period should be checked regularly.
- Children should not be given more than 30 days the drug.
- Please talk to your doctor or pharmacist if you have the impression that the effect of the drug is too strong or too weak.
- In case of suspected overdose with larger amounts of drug immediately a doctor / emergency physician must be informed. This may decide on the measures that may be necessary according to the severity of the overdose. In case of severe symptoms immediate medical treatment is required.
- Symptoms of overdose
The symptoms of acute or chronic overdose of the extent of water and electrolyte loss dependent. Overdose can lead to reduced blood pressure (hypotension), cause circulatory problems when changing from lying to standing (orthostatic dysregulation) and electrolyte disorders (hyperkalemia or hypokalemia, hyponatremia).
For heavier fluid and sodium losses can lead to "dehydration" and as a result of a reduction in the circulating blood volume (hypovolemia) to lethargy and confusion, cardiac dysrhythmia, circulatory collapse, thickening of the blood (hemoconcentration) come with thrombosis and acute renal failure. In rapid water and electrolyte losses confusion (delirium state images) may occur.
Too high blood potassium levels (hyperkalemia) may cause cardiac arrhythmia (for example, AV block, atrial fibrillation, ventricular fibrillation) lead, cardiac arrest, ECG changes, hypotension with circulatory collapse and neurological disorders (flaccid paralysis, apathy [apathy], confusion).
- Therapy of overdose:
In case of overdose or signs of reduced circulating blood volume (hypovolemia) (reduced blood pressure [hypotension] or circulation problems when changing from lying to standing [orthostatic dysregulation]), treatment with the drug should be discontinued immediately.
In only a short time ago and revenue can be attempted to reduce the further uptake of the active ingredient by measures such as vomiting, gastric lavage or administration of activated charcoal. Keep a pack of the drug prepared so that the doctor can inform the captured agent.
In severe cases must ICU setting the vital parameters monitored and repeatedly carried out inspections of the water and electrolyte balance, the acid-base balance and the urinary metabolites and deviations are corrected, if necessary.
A specific antidote spironolactone is not known.
- Even if you have taken once too little or miss a dose, take the next time rather than a double dose, but check the intake as in the dosage instructions described or as prescribed by the doctor continued.
- If you have further questions on the use of this product, ask your doctor or pharmacist.
side effects
- The frequency of possible side effects listed below are defined as:
Very common: more than 1 user in 10
Common: affects 1 to 10 of 100
Uncommon: affects 1 to 10 of 1000
Rare: affects 1 to 10 10 000
Very rare: less than 1 10 000, including isolated reports
Frequency not known: frequency can not be estimated from the available data
- If you are affected by one of the following side effects, you take the medicine a not and look as soon as possible to your doctor.
- Heart / circulatory disorders
Frequency not known: Due to excessive diuresis (diuresis) may result in decreased circulating blood volume (hypovolemia) headache, dizziness, blurred vision, dry mouth and thirst, and circulatory disorders with reduced blood pressure when changing from lying to standing (orthostatic dysregulation) or hypotension up come to circulatory collapse.
Exposure to very strong (excessive) diuresis can lead to "drainage" (dehydration) and as a result of a reduction in the circulating blood volume (hypovolemia) to thickening of the blood (hemoconcentration) come. As a result of hemoconcentration can - especially in the elderly - an increased tendency to thrombosis and embolism occur.
- Blood and lymphatic system disorders
Uncommon: decreases in the number of platelets (thrombocytopenia by spironolactoninduzierte antibodies)
Rare:
- Proliferation of certain white blood cells (eosinophilia) in patients with cirrhosis.
- Severe reduction in certain white blood cells with tendency to infection and severe general symptoms (agranulocytosis). Evidence of agranulocytosis may be fever with chills, mucosal lesions and sore throat.
- Disorders of the nervous system
Uncommon: headache, drowsiness, confusion, disorders of movements (ataxia), weakness, dizziness.
- Respiratory, thoracic and mediastinal space
Rare: The drug can in women lead to a deepening of the voice pitch in men to an increase in voice pitch. Voice changes can also occur in the form of hoarseness. A change in the tone of voice goes in some patients do not return even after discontinuation of the drug. Therefore, the need for treatment against this risk must be balanced, particularly in individuals with occupations where the voice has a special meaning (for example, theater, apprenticeships).
- Diseases of the gastrointestinal tract
Uncommon: dry mouth, gastrointestinal complaints (for example, upper abdominal pain, nausea, vomiting, diarrhea, gastrointestinal spasms), bleeding of the stomach lining, gastrointestinal ulcers (with bleeding [gastrointestinal ulcers]).
- Renal and urinary disorders
Frequency not known: Under the drug may cause a temporary to an increase of substances that are excreted via the kidneys (creatinine, urea), come in the blood.
- Skin and subcutaneous tissue
Uncommon: rash, itching, rash, hives (urticaria).
Very rare: Erythema Annulare (inflammatory redness), lichen-ruber-planus-like lesions (flat lichen), hair loss and hair (alopecia), lupus erythematosus-like syndrome.
Frequency not known: Increased hair from the male type (hirsutism) in women.
- Musculoskeletal and connective tissue disorders
Uncommon: muscle spasms (cramps).
Very rare: bone softening (osteomalacia).
- Metabolism and nutrition disorders
Under the administration of the drug occurs - particularly in patients with impaired renal function - often a life-threatening increase in the potassium content in the blood (hyperkalemia), which can lead to onset of muscle paralysis and cardiac arrhythmias. The addition of potassium, another potassium-sparing diuretic drugs (diuretics) or a potassium-rich diet should therefore be avoided.
In the treatment with the drug, it may - especially in renal impairment - as a result of increased fluid and electrolyte excretion disturbances in fluid and electrolyte balance coming (u a sodium and magnesium deficiency in the blood and increased chloride and calcium content in the blood..).
As a result of excessive diuresis (diuresis) may lead to a reduction in the circulating blood volume (hypovolemia) and a sodium deficiency (hyponatremia). A sodium deficiency (hyponatremia) can occur, especially after extensive water supply under the drug.
As a result of electrolyte imbalance in the blood can lead to loss of appetite, dry mouth, thirst, vomiting, headache or head pressure, weakness, dizziness, drowsiness, fatigue, blurred vision, lethargy (apathy), confusional states, generalized muscle weakness, muscle spasms (eg calf cramps) and cardiac arrhythmia and circulatory disorders come. Therefore, it is important to balance unwanted fluid losses (as in vomiting, diarrhea, excessive sweating).
Infrequent pulse, fatigue or muscle weakness (as in the legs) must be specifically aimed at the possibility of high blood potassium levels (hyperkalemia). After high doses extreme sleepiness (lethargy) and confusion were observed.
Therefore, regular monitoring of serum electrolytes (especially potassium, sodium and calcium) are displayed.
At the start of treatment and prolonged use of the drug, in particular of blood potassium levels should be checked regularly to prevent the occurrence of excessively elevated blood potassium levels.
Disturbances in acid-base balance are possible.
The drug may induce or exacerbate an acidification of the blood (metabolic acidosis hyperchloraemic).
Occasionally there may be a return setting (reversible) increase nitrogen uric substances (urea and creatinine).
It often occurs during treatment with the drug to increased uric acid levels in the blood (hyperuricemia). This may in susceptible patients lead to gout. Therefore, should the concentrations of urea, creatinine and uric acid in the blood and the acid-base status be monitored regularly during treatment with the drug in addition to the serum electrolytes (potassium, sodium, calcium, chloride, magnesium).
Immune system disorders
Uncommon: Allergic reactions. This may occur as skin and mucosal reactions.
- Hepatobiliary disorders
Very rare:
Pathological changes in the liver (hepatotoxicity) with rise in liver enzymes.
By histological examination demonstrated liver inflammation (hepatitis).
- Sex organs and breast disorders
Frequently:
In men: Most back walking (reversible) increase in size of the breasts (gynecomastia)
For men and women: Increased sensitivity to touch the nipple and breast tenderness.
In women: menstrual disorders, in rare cases: Painful swelling of the breasts (mastalgia), irregular bleeding and absence of menstruation (amenorrhea).
Uncommon: erectile dysfunction.
- Countermeasures
If you observe the above-mentioned side effects occurs, contact your doctor so that he can decide on the severity and any necessary further action. If a side effect occurs suddenly or developed strongly, tell a doctor immediately, because certain drug side effects (for example, an elevated blood level of potassium [hyperkalemia], blood disorders such as agranulocytosis) can be life threatening. The doctor will determine what action to take and whether the treatment is continued. Do not take in such cases the drug without medical advice on.
At the first signs of a hypersensitivity reaction, the drug should not be used again.
- Please also inform your doctor or pharmacist if you notice any side effects not listed.
interactions
When multiple drugs are used concomitantly, there may be interactions. Effects and side effects of drugs may be altered. Whether an interaction occurs, depends on various factors.
therefore Always speak with your doctor or pharmacist to determine whether an interaction you actually plays a role. Doctor or pharmacist Only assess your individual risk factors for interaction. If necessary to devise appropriate measures doctor or pharmacist. Put the doctor prescribed medicines without talking with your doctor or pharmacist from.
Aldactone should not be administered concomitantly with medicines containing the following active ingredients:
eplerenone
There is a great risk of severe, possibly even life-threatening interaction.
Please speak to your doctor immediately.
In addition, further interaction between "Aldactone" and other medicinal products are known. If you still are taking other medicines, ask your pharmacist to clarify whether it can possibly be interactions with "Aldactone".
Storing
Store. Medicines out of reach of children
Disposal
For the disposal of drugs, there are regional differences in recommendations. Ask. In the pharmacy according to current regulations in your region
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