Peruzi tablets 12.5mg Davipharm treat hypertension, angina (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Carvedilol
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Carvedilol | 12.5mg |
Uses
Indications
Peruzi - 12.5 drugs are indicated in the following cases:
Clinical research has shown when using a combination of receptor blockers Alpha1 and beta, causing the heart frequency to decrease or not change when resting, maintaining blood and blood flow in the kidney and peripheral.
pharmacokinetic
absorption
Carvedilol is not completely absorbed in the digestive tract and is strongly metabolized for the first time through the liver, so the bioavailability absolutely fluctuates in about 20-25%. The peak concentration in plasma is achieved after drinking about 1-2 hours. The concentration in plasma increases linearly with the dose, within the recommended dose range.
The food that lasts for a long time to reach the peak concentration in the serum but does not affect the bioavailability and peak concentration in the serum of Carvedilol.
Distribution
Carvedilol has high oil body properties. In the blood of the drug attached to plasma protein about 98 - 99%. The distribution volume is about 2 l/ kg, increased in cirrhosis patients.
Metabolism
Research in humans and some animals shows that carvedilol is strongly metabolized in the liver into different metabolites, these substances are then excreted into bile. The first metabolic effect through the liver after drinking is about 60 - 75%. Seeing the diverse cycle of the mother in animals.
Carvedilol is strongly metabolized in the liver, glucuronid is one of the main reactions. Demethylation and hydroxylation in the phenol round generate 3 metabolites with beta receptor blockers.
Based on preclinical studies, the beta receptor blocker of metabolites 4- hydroxyphenol is approximately 13 times higher than the carvedilol. 3 Active metabolites have weaker vasodilation effect than Carvedilol.
In humans, the concentration of these substances is about 10 times lower than the mother. 2 of the carbazol -hydroxy metabolites are strong antioxidants, 30-80 times the carvedilol.
Elimination
Carvedilol's sale time is 6 - 10 hours after drinking. Plasma clearance is about 500 - 700 ml/ min. The drug is excreted mainly on bile and excreted mainly in feces.
Only about 15% of oral dose is eliminated through the kidneys. Therefore, there is no need to adjust the carvedilol dose in kidney failure.
pharmacokinetics on special subjects
Patients with renal failure
Some patients with hypertension suffer from medium to severe to severe renal failure (CLCR
No dose adjustment in patients with medium to severe renal failure.
Patients with liver failure
In cirrhosis patients, Carvedilol's systemic uses 80% increased due to the first decrease in metabolism through the liver. Therefore, contraindicated use of carvedilol for patients with liver failure clinically manifested.
Elderly
Age has statistically significant effects on carvedilol pharmacokinetics parameters in hypertension patients. Research in hypertension patients is an elderly show that there is no difference in unwanted effects in this age group compared to young patients. Another study including elderly people with coronary artery disease shows that there is no difference in unwanted effects that are reported compared to young people.
Children
Information about pharmacokinetics in this age group is limited.
Patients with diabetes
In patients with hypertension with type 2 diabetes, no effect of carvedilol on blood glucose (at full or hungry) and glycosylate hemoglobin A1, no need to change the dose of diabetes treatment drugs.
In patients with type 2 diabetes, Carvedilol has no statistical significance for glucose tolerance tests.
In patients with hypertension without diabetes with changing insulin sensitivity (X syndrome), carvedilol increases insulin sensitivity. The same results were reported in hypertension patients with diabetes Type 2.
Patients with heart failure
In a study of 24 patients with heart failure, the clearance of R-and S-carvedilol is significantly lower than in healthy volunteers. This result shows that the pharmacokinetics of R-and S-Carvedilol changes significantly in heart failure patients.
Before taking Peruzi tablets 12.5mg Davipharm treat hypertension, angina (3 blisters x 10 tablets)
How to use
Peruzi medicine for oral use.
To limit the risk of decreased vertical blood pressure, Carvedilol is recommended to drink with food. In addition, vasodilation manifestations in patients with the patient simultaneously inhibit the transferred enzyme inhibitors can be reduced by taking carvedilol 2 hours before taking the enzyme inhibitors.
The drug is only 12.5 mg, so it is not suitable for the indications for the dose of 3,125 mg and 6.25 mg, recommendation to choose another form of preparation.
Dosage
Hypertension
Carvedilol may be used for treatment in hypertension or in combination with other hypertension medications, especially diuretics. It is recommended to take 1 time/day, however, the maximum dosage recommends is 25 mg and the maximum daily dose is 50 mg.
Adults
The recommended starting dose is 12.5 mg x 1 time/day. After 2 days increased to 25 mg x 1 time/day. If necessary, can increase the dose with minerals at least 2 weeks.
Elderly
The recommended starting dose is 12.5 mg x 1 time/day and can also be fully effective when continuing treatment.
However, if the response is incomplete, it can gradually increase the dose with minerals at least 2 weeks.
Chronic stable angina
Recommendation of oral dosage is 2 times/day.
Adults
The recommended starting dose is 12.5 mg 2 times/day, taken for 2 days. Then continue treatment at a dose of 25 mg x 2 times/day. If necessary, the dose may increase gradually after each distance of at least 2 weeks to the recommended dose of up to 100 mg/day, divided 2 times/day.
Elderly
The recommended starting dose is 12.5 mg 2 times/day. After that, continue treatment with the maximum daily dosage recommended as 25 mg x 2 times/day.
heart failure
Carvedilol is used to support the basic basic treatment with diuretics, ACE inhibitors, Digitalis, and/or vasodilators. Patients need to be clinically stable (do not change the NYHA group, not hospitalized due to heart failure) and basic therapy must be stable at least 4 weeks before treatment. In addition, patients need a decrease in left ventricular blood and heart rate> 50 beats/ minute and systolic blood pressure> 85 mmHg.
The recommended starting dose is 3,125 mg x 2 times/day for 2 weeks. After that, the dose may increase, if tolerated, up to 6.25 mg x 2 times/day. The dose may increase if it is possible to tolerate the drug, apart at least 2 weeks the maximum dose is recommended 25 mg twice a day, for patients weighing less than 85 kg or 50 mg x 2 times/day, for people weighing over 85 kg or mild or medium heart failure.
Increasing the dose to 50 mg x 2 times/day should be done carefully under the supervision of a specialist.
Symptoms of severe heart failure can occur at the beginning of treatment or when increasing the dose, especially in patients with severe heart failure and/or taking high dosage, often without stopping treatment but should not increase the dose. Patients should be monitored within 2 hours after starting treatment or increasing dose. Before each dose increasing, the risk of severe heart failure should be tested or excessive vasodilation symptoms (such as kidney function, weight, heart rate).
Add heart failure or fluid retention is treated by increasing diuretic, and should not increase the dose of carvedilol until the patient is stable. If the heart rate is slow or prolonged the atrial - ventricular transmission, first need to monitor the concentration of digoxin. Sometimes it is possible to reduce the dose of carvedilol or temporarily stop treatment. Even in these cases, the adjustment of the carvedilol dose can often be successful.
Kidney, platelet and glucose function (in case of diabetes patients with insulin and/or non -dependent insulin) should be monitored regularly when adjusting the dose. However, after adjusting the dose, the frequency of monitoring may decrease.
If Carvedilol has been discontinued for more than 2 weeks, it is advisable to initiate treatment with a dose of 3,125 mg twice a day and gradually increase the dose as recommended above.
Dosage for special subjects
Renal function impairment
It is advisable to determine the dosage depending on the patient, but based on the pharmacokinetic parameters, there is no evidence that the adjustment of the carvedilol dose for patients with impaired renal function is not necessary.
Average liver dysfunction
No dose adjustment.
Children (
It is not recommended to use Carvedilol for children under 18 years old due to the information about the safety and effectiveness of Carvedilol in this group of patients.
Elderly
Elderly people may be more sensitive to the effects of Carvedilol and should be carefully monitored. Like other beta blockers, especially in patients with coronary artery disease, the stopping of carvedilol should be done slowly.
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 and signs
In case of overdose, severe hypotension, heart rate slow, heart failure, cardiac shock and cardiac arrest. Respiratory problems may also occur, bronchospasm, vomiting, consciousness disorders and total seizures.
Treatment
In addition to general supportive treatment, it is necessary to monitor and adjust important parameters, if necessary, in special care conditions, Atropin can be used when the heart rate is too slow, while, to support ventricular function, recommendations to use intravenous glucagon or sympathetic medications (Dobutamin, Isoprenalin).
If the vascular stimulation is needed, it is recommended to consider using phosphodiesterase inhibitors (PDE). If the peripheral vasodilation effect dominates, Norfenephrin or Noradrenalin should be used with continuous circulatory tracking. In case of slow heart rate that does not respond to the drug, the use of a pacemaker should be started.
In case of bronchospasm, sympathetic beta should be used (aerosol or intravenous), or aminophyllin intravenously or intravenously or infusion.
In case of convulsions, the intravenous intravenous recommendation is Diazepam or Clonazepam.
Carvedilol attaches strong plasma proteins. Therefore, the drug cannot be removed by hematoma.
In case of severe overdose with shock symptoms, it is necessary to continue treatment for long periods of time, for example: until the patient's condition is stable, because there may be a prolonged sale and re -distribution time of Carvedilol from deeper compartments.
What to do when forgetting a 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 Peruzi - 12.5, you may experience unwanted effects (ADR).
Very common, ADR ≥ 1/10
Common, (≥ 1/100 and
Describe some unwanted effects
can minimize the risk of slow heart rate and other undesirable effects by starting treatment at low doses, then gradually increasing the dose, careful monitoring of diastolic blood pressure and heart frequency and drinking carvedilol with food.
Needs to reduce the dose if the circuit frequency drops below 55 beats/minute. Avoid stopping the drug suddenly. Patients must avoid standing up suddenly or standing still for a long time, need to rest if they see dizziness or dizziness and recommend the patient to consult a doctor about the dose reduction.
The drug can cause other unwanted effects. Need to closely monitor and recommend the patient to notify the doctor unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Peruzi - 12.5 contraindications in the following cases:
Unstable/unstable heart failure.
Symptomatic liver disease, liver function impairment. The drug is used carefully in the following cases: No research has been conducted on the influence of Carvedilol on the ability to drive or operate machinery. Due to the different reactions between individuals (such as dizziness, fatigue), the ability to drive, operate machinery, or work, high concentration may be impaired. These effects are often encountered at the beginning of treatment, after increasing the dose, when changing the preparation and when using simultaneously alcohol. There is no adequate information about the use of Carvedilol in pregnant women. Animal research shows reproductive toxicity. The risk is unknown. Beta blockers reduce the perfusion of the placenta, which can lead to incomplete fetal deaths, development and premature birth. In addition, unwanted effects (especially hypoglycemia, hypotension, heartbeat, respiratory failure and body heat) can occur in fetus and babies. There is an increase in the risk of complications on the heart and lungs in newborns during postpartum period. Carvedilol should not be used during pregnancy unless it is really necessary (the benefits of treatment for mothers are superior to the risk of fetal/ infant). The treatment should be stopped 2-3 days before the expected birth date. If not, must monitor babies in the first 2-3 days after birth. Carvedilol is an oil body and based on the results from studies in nursing animals, carvedilol and its metabolites are excreted into milk. Therefore, do not breastfeed while taking the drug. pharmacokinetic interaction Carvedilol is a substrate and also a p-glycoprotein inhibitor. Therefore, the bioavailability of drugs transported by P-Glycoprotein may increase when used simultaneously Carvedilol. In addition, carvedilol's bioavailability may be affected by p-Glycoprotein inhibitors or induction. CYP2D6 and CYP2C9 inhibitors or touches can change the metabolism before and during the circulation of the selected stereoscopic Carvedilol, resulting in an increase or decrease of plasma concentrations R and S-carvedilol. Patients taking induction drugs (such as rifampicin, carbamazepin and barbiturat) or inhibitor (such as paroxetin, fluoxetin, quinidin, cinacalcet, bupropion, amiodaron and fluconazol) these CYP enzymes must be closely monitored when treated simultaneously with Carvedilol. Some cases have been recorded in patients or healthy people: digoxin Digoxin concentration increases by about 15% when using Carvedilol simultaneously. Both Digoxin and Carvedilol cause atrial -ventricular time. Enhance monitoring Digoxin levels at the beginning of treatment, dose adjustment and at the end of treatment with Carvedilol. rifampicin and cimetidine In one study, Rifampicin reduces carvedilol plasma levels about 70%, most likely due to the P-Glycoprotein sensor reducing the absorption of carvedilol in the intestine. Cimetidine increases about 30% but does not change CMAX. Caution should be used in patients who are taking induction drugs Oxydase enzymes with mixed functions such as rifampicin, as the serum concentration of carvedilol may decrease, or inhibitors of mixed oxydase enzymes such as cimetidine, because the serum concentration of carvedilol may increase. However, based on the relatively small impact of cimetidine for the poisonedilol, the ability to interact with small clinical significance. cyclosporin There has been a report on increased cyclosporin levels after the beginning of treatment with carvedilol in kidney transplant and heart transplant. About 30% of patients must reduce the dosage of cyclosporin to maintain cyclosporin levels within treatment, the remaining group of patients does not need to reduce the dose. On average, Cyclosporin dose decreased by about 20% in these patients. Due to the adjustment of the dose needed a lot of changes among individuals, it is recommended to closely monitor cyclosporin levels after the beginning of treatment with carvedilol and adjust the dosage of cyclosporin accordingly. amiodaron In patients with heart failure, Amiodaron reduces S-carvedilol clearance, may be due to CYP2C9 inhibitors. The average R-Carvedilol plasma plasma concentration does not change. Therefore, there may be a risk of increased beta closing block due to increased S-carvedilol concentration. fluoxetin and paroxetin In a random cross study in 10 patients with heart failure, simultaneously using fluoxetin, a strong CYP2D6 inhibitor, causing selective inhibition of stereoscopic in carvedilol metabolism, increasing 77% of the average AUC of the isomer R (+). However, there is no difference in unwanted effects, blood pressure or heart rate recorded among treatment groups. The effect of the repeated dose of paroxetin, a strong CYP2D6 inhibitor, on the dynamic of the single dose of Carvedilol has been studied over 12 healthy volunteers. R-carvedilol concentration increased by about 150% and s-carvedilol about 90% after simultaneous use of paroxetin. Pharmacological interaction digoxin Combining Beta and Digoxin blockers can cause a long -lasting bronze and ventricular time. Clonidin Simultaneous use of clonidin with drugs with beta blockers can increase the effect of lowering blood pressure and reducing heart rate. In case of discontinuing treatment simultaneously drugs with beta and clonidin blockers, beta blockers should be stopped a few days before gradually stop clonidin. Anti -arrhythmia and calcium channel blockers Using Carvedilol combination with these drugs may increase the risk and then the atrial - ventricular disorder. There has been a report on conduction disorders (rarely hemodynamic effects) when taking carvedilol and verapamil/ diltiazem and/ or amiodaron. Like other beta blockers, it is advisable to closely monitor the patient's electrocardiogram and blood pressure when using Carvedilol simultaneously with Calci -type channel blockers of Verapamil or Diltiazem due to the risk of atrial - ventricular or heart failure disorders (synergistic effects). Verapamil intravenous injection in patients being treated with beta blockers can cause severe blood pressure and atrial - ventricular block. closely monitor when used in combination with carvedilol and oral amiodaron or anti -arrhythmic drugs group I. Slow heart rate, cardiac arrest and ventricular vibration have been reported immediately after the beginning of treatment with beta blockers in patients taking amiodaron. Hypertension treatment As other beta blockers, Carvedilol can increase the effects of other hypertension medications used simultaneously (for example, alpha1 blockers) or drugs also have antihypertensive effects such as barbiturat, phenothiazine, three -ring anti -depressive drugs, vasodilators and alcohol. Anesthesia Be cautious when anesthesia due to the effect of synergies, inhibit myocardial and hypotension of Carvedilol and some anesthetic. insulin or medications for oral diabetes Medicines with beta blockers can enhance the hypoglycemia of insulin blood glucose and oral diabetes treatment drugs. Signs of hypoglycemia can fill or reduce. Regular monitoring of blood glucose levels in diabetic patients is necessary. Medications reduce catecholamine Patients take the drugs simultaneously active in beta and a drug that can reduce catecholamine (such as reserpin and Monoamin oxydase inhibitors) should be closely monitored by signs of lowering blood pressure and/ or severe heart rate. Beta bronchodilators Unstolant beta blockers on the heart antagonistic bronchodilator effects of bronchial bronchodilators beta. Recommended patient monitoring. The common interactions of beta blockers Epinephrin There are 10 severe and slow heart rate drop reports in patients treated with unsatisfactory beta blockers (including pindolol and propranolol) with epinephrin (adrenalin). These clinical reports have been confirmed in healthy studies. Epinephrin is thought to be a substance that supports local anesthesia that can cause these reactions when intravenous injection. This risk should be reduced by using selective beta blockers on the heart. phenylpropanolamine Phenylpropanolamine (norephedrin) single dose of 50 mg may cause diastolic hypertension to the level of health in healthy people. Propranolol often inhibits hypertension caused by phenylpropanolamine. However, beta blockers can cause paradoxical hypertension reactions in patients who are taking high doses of phenylpropanolamine. In some cases, hypertension has been reported when only phenylpropanolamine is taken. NSAIDs Anticonodus drugs inhibit the hypotension effect of beta blockers. Mainly research with indomethacin. This interaction does not seem to occur with Sindac. There is no similar interaction set in a study related to Diclofenac. There is no clinical experience in using Carvedilol combination with NSAIDs. Preparations of Barbituric Acid Avoid using in combination with Barbituric acid preparations. nitrate Increased hypotension effect. ergotamine Increase vasoconstriction. Neurological - muscle blockers Neuro -muscle Block. Precautions when using
The ability to drive and operate machinery
Pregnancy
Breastfeeding period
Drug interaction
Storage
In a dry place, avoiding light, the temperature does not exceed 30 ° C.
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