Franilax medicine 50mg/20mg Davipharm prevents water accumulation in the body (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Spironolactone, Furosemid
Ingredient
| Composition information | Content |
| Spironolactone | 50mg |
| Furosemid | 20mg |
Uses
Indications
Franilax contains a short -effective diuretics and an anti -Aldosteron anti -antacids. Indicated for anti -drug treatment related to secondary Aldosteron; Conditions include chronic congestive heart failure and cirrhosis.
Franilax should be used when treated with a dosage at the usual doses ineffective.
This fixed dose combination should only be used when adjusting the dose with separate components that show this form of combination appropriately.
The use of Franilax in the treatment of basic hypertension should be limited in patients with Aldosteron power. At the same time in these patients, it is recommended to use only the form of coordination when adjusting the dose with separate components that show this form of combination appropriately.
Pharmacokology
Code ATC: C03E801
Pharmacological group: diuretics, diuretics and potassium diuretics.
spironolacton:
Spironolacton is a corticoid structure like aldosteron (adrenal gland hormone), which is an unsatisfactory mineralocorticoid receptor and is also an Androgen and progesterone antagonist.
Spironolactone is acting through inhibition of competition with aldosteron and other mineralocorticoids, mainly in the distance, resulting in increased excretion of sodium and water. Spironolacton reduces the excretion of potassium, ammonium ions (NH4+) and hydrogen.
Both diuretic and anti -hypertension effects are even through that mechanism. Spironolacton started to work relatively slowly, it takes 2 or 3 days to achieve the maximum effect and the drug reduces the slow effect for 2-3 days when thiazid diuretics and straps (Furosemid) will be reduced when used simultaneously with spironolacton.
Spironolacton and its main metabolites (7-alpha-thiomethyl-spironolacton and canrenone) have anti-mineralocorticoid effects.
Spironolacton reduces both systolic and diastolic blood pressure, the maximum hypotension effect is achieved after 2 weeks of treatment. Because Spironolacton is an antagonist competing with aldosteron, the necessary dose is adjusted according to the treatment response.
Spironolacton is used in the case of rare hyperlink hyperplation, secondary increase in secondary aldosteron occurs in secondary edema due to cirrhosis, kidney damage syndrome and prolonged congestion and after treatment and after treatment with conventional diuretic. The diuretic effect is enhanced when used in combination with conventional diuretics, spironolacton does not cause hyperuricemia or hyperglycemia, as happened when using high -dose thiazid diuretics.
Furosemid:
Furosemid is a diuretics that conducts sulfonamid diuretic belonging to a strong, fast, dosage -dependent effect group. The drug acts in the branches of the Henle straps, so it is classified as diuretics.
The main mechanism of action of Furosemid is to inhibit the system of sodium-2clo co-transport system, in the thick section of the branch on the Henle straps, increase potassium excretion in the distance and can work directly on the nearby tube.
Furosemid does not inhibit carbon dioxide and non -antagonistic with aldosteron. Furosemid increases the elimination of calcium, magnesium hydrogen, ammonium, bicarbonate and can be phosphate through the kidneys. Losing a lot of potassium, hydrogen and chlorine can cause metabolic inflammation. Due to reducing plasma volume, it can cause hypotension but usually only mitigate.
Furosemid has the effect of renal vasodilation, reducing the impact in the kidney and blood flow through the tank after taking the drug.
In patients with congestion heart failure with acute myocardial infarction, after furosemid intravenous injection, temporary but significant increase in glomerular filtration, while reducing the resistance of peripheral vessels and increasing peripheral vein.
When taking high doses in patients with chronic renal impairment, the filtration rate of the glomeruli may increase temporarily. If excessive excretion is due to drugs that reduce plasma volume, blood flow may occur and reduces the rate of glomerular filtration.
Furosemid has less impact on blood glucose levels than thiazid, but can increase blood glucose, urine glucose and change glucose tolerance, which can be the result of hypotension.
pharmacokinetic
absorption
spironolacton:
Spironolacton is absorbed through the gastrointestinal tract depending on the preparation, reaching the maximum concentration in the blood after 1 hour, but still with the concentration that can be measured at least 6 hours after 1 dose. Food increases drug absorption, but does not mean clinical significance. Relative bioavailability of over 90% compared to the bioavailability of Spironolacton solution in Polyethylene Glycol 400, the best absorption.
Furosemid:
Furosemid is quickly absorbed through the gastrointestinal tract, bioavailability is about 60 - 70% but absorbed and erratic, affected by drugs, disease processes and the presence of food. However, whether taking medicine when full or hungry, responding to diuretic is similar. In patients with furosemid absorption heart failure.
Biochemical can be reduced to 10% in kidney disease, increasing in liver disease. When taking diuretic effects appear quickly after 1/2 hours, reach the maximum effect after 1-2 hours, maintain the effect from 6 - 8 hours, the maximum reduction effect may not be clear until a few days after the initial use of the drug. It is unknown the concentration of the drug needed in the serum to achieve maximum diuretic effects, usually the level of response is not correlated with the peak concentration or the average concentration of the drug in the serum. In people with severe renal failure, the diuretic response can be extended.
distribution
spironolacton:
Over 90% of Spironolacton is linked to plasma proteins. Spironolacton and its metabolites can be through the placenta fence, carenon is distributed into milk but in very small amounts.
Furosemid:
up to 99% of blood furosemids with plasma albumin. The free (non -mounted) Furosemid part is higher in people with heart disease, kidney failure and cirrhosis. Furosemid passed the placenta fence and into breast milk.
transformation
spironolacton:
Spironolacton metabolizes strongly and quickly into several metabolites including Carenon and 7α-Taomethyl Spironolactone, both have pharmacological activity but many zinc compared to the mother medicine. Previously Carenon was considered the main metabolite, but recent studies showed that 7α-tiomethyl spironolactone was the main metabolite, at least after the single dose of the drug.
Furosemid:
Furosemid is less metabolized.
Elimination
spironolacton:
After taking a single dose in healthy people, the spineolacton waste time is about 1.5 hours, the sale time of 7α -tiomethyl spironolactone is about 9 - 12 hours, of Carenon 10 - 35 hours. Spironolacton and metabolites excreted mainly through urine, partly through bile and waste.
Furosemid:
Furosemid is excreted mainly in urine, mostly in the form of non -metabolic. Furosemid's waste time is from 30 minutes to 120 minutes in normal people, prolonged in infants and the elderly, patients with liver and kidney failure. Completely eliminated drugs for 24 hours.
Before taking Franilax medicine 50mg/20mg Davipharm prevents water accumulation in the body (3 blisters x 10 tablets)
How to use
oral drugs. Swallowing whole tablets with water.
It is best to take medicine for breakfast and/or lunch with lots of water. It is not recommended for patients to take medicine in the evening, especially when the beginning of treatment, because it can increase the number of patients' urination at night.
Dosage
Adults: 1 - 4 capsules/day.
Children: This preparation is not suitable for children.
Elderly (≥ 65 years old): Furosemid and Spironolacton eliminate slower in the elderly.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? Symptoms of these disorders include severe hypotension (progressing to shock), acute renal failure , thrombosis, delirium, soft paralysis, indifference and confusion. Therefore, conducting treatment is to replace the epidemic and adjust the electrolyte imbalance. Along with the prophylaxis and treatment of serious complications due to the above disorders and other effects on the body (such as hyperboly.
There is no specific antidote for Furosemid overdose. If you only take medicine, you can take measures to limit the absorption of drugs such as gastric wash or drink substances that reduce absorption (such as activated carbon).
Signs to note and recommend: Do not use the prescribed overdose.
What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Franilax medicine, you may experience unwanted effects (ADR).
Overall, Furosemid is well tolerated.
Furosemid
The unwanted effect mainly occurs during high doses, the most common is water and electrolyte imbalance, especially in people with liver failure, kidney failure, after high doses, prolonged. The signs of electrolyte imbalance include: headache, hypotension, dizziness, dizziness, visual disorders, cramps, dry mouth, thirst, weak, tired, sleepy, sleepy, unable to sleep, small urination, arrhythmia and digestive disorders. Reducing blood volume and dehydration can occur especially in the elderly. Because of the shorter acting time, the risk of hypokalemia of Furosemid may be less than thiazid diuretic. Unlike thiazid, Furosemid increases excretion of calcium in urine and renal calcium infection that has been notified in children.
Very common, ADR ≥ 1/10
Unwanted effects depend on the dose and treatment time. The most common unwanted effect is hyperkalemia, breeding system disorders and mammary glands, including female mammary glands. Female mammary glands occur related to both dose and treatment time and often recover when stopped treatment. Other common unwanted effects include headache, digestive system disorders, diarrhea, fatigue and drowsiness.
Very common, ADR ≥ 1/10
Rare, 1/1000
Instructions on how to handle ADR
Hypoglycatrological reduction is often manifested: dry mouth, thirst, fatigue, drowsiness. This is often considered carefully, especially when used in combination with other diuretics. Sodium hypoglycemia occurs most often in advanced cirrhosis patients and can be prevented by limiting drinking water. Need to adjust the dose and periodically check the electrolyte. Patients should use Spironolacton 2-3 days before coordinating Thiazid to prevent potassium deficiency and cause liver coma.
Potassium supplements when patients are at high risk of hypoglycemia.
Dose reduction or stop treatment if ADR is medium or severe.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Franilax medicine is contraindicated in the following cases:
Be cautious when using
Spironolacton may cause voice changes. Be cautious about determining whether or not to start treatment in patients whose voice is important for their work (for example, actors, singers, teachers ...)
The amount of urine must be guaranteed. Patients with partial clogged urine paths, for example, patients with prostate hypertrophy or urinary decrease, increased the risk of acute fluid retention and should be carefully monitored.
It is necessary to take steps to adjust the condition of hypotension or reduce blood volume before starting treatment.
Need to be careful carefully when:
Patients with hypotension.
Patients are at risk of reducing blood pressure.
Patient patients with hidden diabetes can develop or insulin demand in patients with diabetes increases.
Patients with gout.
Patients with cirrhosis along with renal function.
Patients with hypotension, for example, a combination of nephrotic syndrome (Furosemid's effects may be reduced and increased toxicity on the ear). Be careful when adjusting the dose for these patients.
Symptomic hypotension leads to dizziness, fainting or loss of consciousness that may occur in patients treated with Furosemid, especially in the elderly, patients taking other drugs that cause hypotension and patients suffering from conditions that lead to other risk of hypotension.
Avoid using Franilax in patients with serum hyperpassia. It is not recommended for simultaneous use of triamteren, amilorid, preparations containing potassium or nonsteroidal anti -inflammatory drugs due to hyperkalemia.
Be careful when taking the drug for patients with electrolyte deficit. Periodically monitor sodium, potassium, creatinine and serum glucose is often recommended during treatment; Especially closely monitoring in patients at high risk of electrolyte imbalance or in case of significant additional loss of fluid. Must adjust the decrease of blood volume or dehydration as well as electrolyte disorders and acid-base significantly, may temporarily stop using Franilax.
Using drugs that cause hyperkalemia simultaneously with Spironolacton can cause severe hyperkalemia.
kidney failure
Periodically check the serum potassium level in patients with impaired renal function and creatinine clearance below 60 ml/min/1.73m2 of the body surface area as well as in the case of Franilax simultaneously with some other drugs that can increase potassium concentration.
Patients with high risk of kidney disease due to contrast drugs, do not recommend using Furosemid to diuretic as part of the measures to prevent renal disease due to contrast drugs.
There is a risk of exacerbations or systems of lupus erythematosus when using Franilax.
simultaneously used with risperidon
There is an increase in the death rate in patients who are dementia when using simultaneously Risperidon and Furosemid compared to when using only Risperidon or Furosemid. Simultaneous use of Risperidon with other diuretics (mainly low -dose thiazid diuretic) is not related to the same results.
Be careful and consider the risk benefits of this combination or of a combination with other strong diuretics before deciding to use.
Caution is related to Spironolacton
Severe liver failure
Be cautious when taking medication for patients with liver dysfunction due to the risk of liver coma.
Cancer risk
Animal research shows that high -dose, prolonged spironolacton spironolacton can cause tumor growth. Clinically clinical results are unknown. However, it is necessary to consider the benefits of treatment compared to the long -term risk that may be encountered before the beginning of prolonged treatment with Spironolacton in young people.
Diuretics generally contraindicated in pregnancy, unless heart disease , because the drug is not defensive and does not cure the pH due to the toxicity of the pregnancy and the drug also reduces the perfusion of the placenta.
Spironolacton is considered unsafe for patients with porphyrin metabolic disorders.
Some clinical houses are considered contraindicated use of spironolacton when serum or nitrogen -blood creatinine concentration is higher than normal.
Caution related to Furosemid
Monitor regularly in the first months of treatment and periodic treatment.
Change values in subclinical tests.
Increase creatinine and serum urea during treatment.
Cholesterol and serum triglycerides may increase but often return to normal when starting treatment with Furosemid.
Stop treatment with Furosemid before conducting glucose tolerance tests.
Be cautious for patients with prostate hypertrophy or urination because it can promote urinary retention. Using Furosemid is considered unsafe in patients with porphyrin metabolism disorders, because it is often accompanied by an exacerbation.
In patients with parathyroid hygiene, using Furosemid may cause muscle spasms (tetani) due to hypocalcemia.
Caution related to excipients
Franilax contains cellactose (containing lactose), patients with rare genetic disorders in galactose tolerance, lactase deficiency or glucose-galactose absorption disorders should not use this drug.
Franilax contains Polysorbate 80 that can cause allergies and castor oils that can cause nausea, vomiting, abdominal pain, diarrhea.
To be out of reach of children.
The ability to drive and operate machinery
The drug can affect the ability to drive and operate machinery due to reducing alertness. Should be cautious, especially in the first stage of treatment with the drug.
Pregnancy
Animal research does not see the toxicity of Furosemid during pregnancy. There is clinical evidence of the safety of the drug in the last three months of pregnancy in humans. However, Furosemid passed the placenta.
Spironolacton or its metabolites can pass through the placenta. Animal studies show that the toxicity causes female genital organs of the fetus and males. Androgenic resistance has been reported in humans with an unclear non -genital risk in male infants.
Therefore, only Franilax is used in pregnant women when they are really necessary. Need to monitor the growth of the fetus when taking drugs for pregnant women.
Breastfeeding period
Furosemid goes into breast milk and can inhibit milk secretion. Caneron, a metabolite of Spironolacton, was found in breast milk. Therefore, do not use Franilax for women who are breastfeeding.
Drug interaction
The effect of other drugs on Franilax
Food
Increase Spironolacton absorption if the drug is used with food. Unknown influence on clinical.
Coordination causes hypokalemia
When using Franilax with potassium salts, drugs that reduce potassium excretion, nonsteroidal anti-inflammatory drugs (NSAID) or double-an Antin-Anotensin-Aldosteron (RAAS) system with a combination of Angiotensin (ACE) enzyme inhibitors (ACE) and an Angiotensin II antagonistic antagonist, increased serum level of serum and hyperlemm.
Combining ACE and Spironolacton inhibitors can cause hyperburgemia, especially in patients with impaired renal function. Need to be cautious and monitor patients closely electrolyte balance.
ciclosporin and spironolacton both increase serum potassium concentration and this interaction can be fatal. Should avoid using these two drugs simultaneously.
In addition to other drugs that cause hyperkalemia, simultaneous use of trimethoprim /sulfamethoxazol (co-trimoxazol) with spironolacton can lead to clinical hyperkalemia.
Combining hypokalemia
corticosteroid, carbenoxolon, licorice, high -dose B2 sympathetic drugs (such as Bambuterol, Femoterol, Salbutamol, Salmeterol and Terbutaline and prolonged laxatives, reboxetin and amphoticin can increase the risk of hypokalemia.
Increased risk of hypokalemia when combining amphotericin antifungal.
Increased diuretic effect when combining metolazon. The risk of hypokalemia increases when combining thiazid diuretics.
corticosteroid, acth
Increased risk of power outages, especially hypokalemia, can occur when used in combination of spironolacton.
Diuretics can decrease (due to corticoid sodium holding effects).
heparin , low density heparin
Simultaneous use of spironolacton and heparin or low density heparin can cause severe hypotension. There have been reports to increase diuretic effects when combining spironolacton and heparin.
Non -steroid anti -inflammatory drugs (NSAID)
NSAIDs (such as indometacin, acetylsalisylic acid) may reduce the effect of Franilax and can cause acute renal failure in cases of reduced blood volume or dehydration in advance.
Salicylic toxicity may increase by Franilax.
Renin inhibitors
Aliskiren reduces the plasma concentration of Furosemid.
Sucralfat
Do not use Franilax and sucralfat apart for less than 2 hours apart because sucralfate reduces the absorption of Furosemid from the intestine and thus reduces the effectiveness of the drug.
epilepsy treatment
Concentrated carbamazepine or aminoglutethimid may increase the risk of hypoglycet.
The effect of Franilax may be reduced when used with phenytoin.
estrogen and progestogen
Reduce the diuretic effect of Furosemid.
Systemic anesthesia
Systemic anesthesia increases the hypotension effect of Furosemid.
Furosemid may increase the effect of curare.
Other drugs
Probenecid, methotrexate and other drugs such as Furosemid, mostly eliminated through the renal tubules, can reduce the effect of Franilax. In contrast, Furosemid can reduce the excretion of these drugs. When using high doses (especially when both Furosemid and other drugs take high doses) can lead to increased serum concentration and increased risk of unwanted effects of Furosemid or simultaneous medications.
The influence of Franilax on other drugs
anticoagulants
Furosemid increases anticoagulant effects.
The anticoagulant effect of cooumarin, or indandion or heparin is reduced when used with spironolacton.
noradrenalin
Spironolacton reduces the shrinkage effect of Noradrenalin.
Hematoplasty drugs
Spironolacton increases the effects of antihypertensive drugs.
may need to adjust the dose of cardiac glycosides, diuretics, anti -hypertension drugs, or other drugs that are likely to lower blood pressure due to increased risk of hypotension when using simultaneously Franilax.
Hypotension and renal function may occur when ACE inhibitors or Angiotensin II receptor antagonists are added to Furosemid or dose increased. Franilax dose should be reduced or stopped at least three days before starting or increasing ACE inhibitors or Angiotensin II receptor antagonists.
Palmic drugs: Hypotension increases when coordinating Furosemid and moxisylyt (thymxamin) or hydralazin.
Furosemid combined with nitrate, levodopa, aldesleukin , Theophylllin or Prostaglandin (such as Alprostadin) increases the hypotension effect.
Hypotension effect increases when combining muscle relaxants such as Baclofen or tizanidine.
Central neurological inhibitors (Clopromaxin, diazepam , clonazepam, Halothan, ketamin ) increase the effect of lowering blood pressure.
Anxiety antidote, sleep
Furosemid combines anxiety antidote, causing sleep that increases the effect of lowering blood pressure. Cloral and triclofos can replace thyroid hormones at the link.
Simultaneous use of chlorine hydrates and furosemid causes blushing syndrome, tachycardia, hypertension, sweating.
lithium
Like other diuretics, serum lithium concentration may increase when used simultaneously with Franilax, increasing lithium toxicity, including increased risk of lithium toxicity and nerves. Therefore, it is recommended to carefully monitor lithium concentrations and adjust the dose of lithium if necessary.
Digoxin and cardiac glycosides
Digoxin's semi -discharged time and cardiac glycosides may increase, resulting in an increase in concentration and toxicity of cardiac glycosides when using simultaneous spironolacton. Therefore, if you have to be used simultaneously, it is necessary to monitor the patient carefully and the maintenance of the heart glycoside should be adjusted accordingly.
Hypotension and electrolyte disorders (including magnesium) because Furosemid may increase the risk of toxicity on the heart.
Alcohol, barbiturate, sleeping pills
Hypotension can occur when using the above drugs with Spironolacton. Alcohol increases the hypotension effect of Furosemid.
cholestyramin
Hyperbysical hyperkalemia may occur in the case of metabolic acidosis due to hypertension in patients who share Franilax with cholestyramine.
Anti -psychotic drugs
Furosemid causes hypoglycemia to increase the risk of toxicity on the heart. Avoid simultaneous use of pimozid. Increasing risk of ventricular arrhythmia when coordinating Furosemid with amisulprid or SERTINDOL and increasing the effect of lowering blood pressure when coordinating phenthiazin.
CNS stimulants
Hypotension can increase the risk of ventricular arrhythmia.
Anti -arrhythmia (Amiodaron, Disopyramid, Flecanaid and Sotalol).
Increased the risk of toxicity on the heart when coordinating Furosemid due to hypokalemia effects. The effects of lidocaine, tocainid or Mexilentin may be antagonistic by Furosemid.
The drug extends the range of qt
Heart toxicity increases due to hypotension and/or hypoglycemia of Furosemid/Spironolacton.
Kidney poison - Ear
Toxicity of kidney toxic drugs can increase when used with strong diuretics such as Furosemid.
The drug may increase the toxicity on the ears of aminoglycosides and other ear poisoning. Because this effect can lead to irreversible damage, so only use only when the benefits are superior to the risk.
The risk of toxicity on the ears shared with cisplatin and furosemid. In addition, the kidney toxicity of cisplatin may increase if it is not used in low doses (e.g. 40mg in patients with normal kidney function) and with positive fluid balance when used to achieve diuretic effects when using Cisplatin.
Periodic impairment may occur in patients using high -dose Furosemid and Cephalosporin. The toxicity on the kidneys and ears of cytotoxic poison (platinum compounds) increased when used simultaneously Furosemid.
Treatment of diabetes, insulin
Reduce the effect when coordinating Franilax. The insulin dose may be increased when used in combination.
levothyroxin
High doses of Furosemid can inhibit thyroid hormones with shipping proteins and thus lead to a glimpse of free thyroid hormones at the beginning of treatment, then reducing the entire total thyroid hormone. Should monitor thyroid hormone levels.
risperidon
Be careful, carefully consider the risks and benefits when coordinating or treating simultaneously with Furosemid or other strong diuretic medications before use. The death rate in patients is an elderly person who has increased dementia when using Risperidon and Furosemid.
spironolacton reduces the effect of beta/alpha quinidin.
antihistamine resistance
Hypotension can increase the risk of toxicity on the heart.
Other drugs
Concomitance use of cyclosporin and furosemid is associated with increased risk of gout arthritis.
Both Spironolacton and Carbenoloxon can reduce each other's effects. Spironolacton reduces carbenoxolon ulcer resistance. Using licorice in large quantities causing similar interaction with carbenoxolon.
Other interactions
ammonium chloride
Hemorrhagic metabolic acidosis, often accompanied by hyperkalemia, has been reported in patients with simultaneous use of spironolacton with ammonium chloride (such as liquoric).
Overdose of Liquoric increases the risk of furosemid.
Plasma cortisol levels
Spironolacton affects the matting -meter -meter -meter -meter -cumulative method to determine plasma cortisoll concentrations.
Storage
Keep medicine in the original of the manufacturer, closed.
Put the drug in a dry place, avoid light, the temperature does not exceed 30 ° C and out of the reach of children.
Do not use this medication after the expiry date on the packaging.
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