Dilatrend 6.25mg Roche treat hypertension, coronary artery disease, chronic heart failure (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Carvedilol
Ingredient
| Composition information | Content |
| Carvedilol | 6.25mg |
Uses
Indications
Dilatrend 6.25mg is indicated in the following cases:
dilatrend is indicated in the treatment of primary hypertension. The drug can be used alone or in combination with other antihypertensive drugs (for example, calcium channel blockers, diuretics).
Carvedilol is clinically effective in the treatment of coronary artery disease. Preliminary data has shown that the drug is effective and safe when used for patients with unstable angina and myocardial ischemia without symptoms.
Unless there is contraindications, Carvedilol is indicated in combination with standard treatment (including transferred inhibitors and diuretics, with or not accompanied by digitalis) to treat all patients with stable, symptomatic chronic heart failure, mild, medium to severe, due to severe or non -local anemia.
After suffering from myocardial infarction with left ventricular failure (LVEF) ≤ 40% or the index of constraints into ventricular ≤ 1,3), it is necessary to treat long -term treatment for patients after cardiac infarction with Carvedilol in combination with transferred inhibitors and other treatments.
Pharmacokology
Mechanism of action
Carvedilol is a multi -effect Adrenergic receptor inhibitor with adrenergic receptor inhibitors α1, β1 and β2. Carvedilol also has a tissue protection effect. Carvedilol is a potential antioxidant and is a reduction of reaction oxygen roots.
Carvedilol is a radical substance, and both R (+) and S (-) have the same properties of α-adrenergic receptors and antioxidant properties. Carvedilol has the effect of anti -proliferation of smooth muscle cells in humans.
The effect of reducing the oxidative reaction agents known in clinical studies by measuring different indicators in patients treated with long -term carvedilol.
Carvedilol's β-commenergic receptor blockers are not selective for receptors β1 and β2 adrenergic and are related to the S (-).
.Carvedilol does not have the same intertwined neurological effect and (like Propraprol) it has features that stabilize membrane. Carvedilol inhibits the Aldosterone-Anotensin-Renin system through β blockers, which will reduce the thread of renin, so it will rarely see the water retention in the body.
Carvedilol reduces peripheral blood vessel resistance through selective blocking the adrenoceptor-α1. Carvedilol reduces hypertension caused by phenylephrine - an adrenoceptor -α1 antagonist, but it does not work if caused by angiotensine II.
Carvedilol does not change the lipid indicators. The normal ratio of lipoprotein has a high density/low density lipoprotein (HDL/LDL).
Research on clinical effectiveness
Clinical studies have shown the following treatment effects of Carvedilol:
Hypertension
Carvedilol lowers blood pressure in patients with hypertension by a combination of β blockers and vasodilation through intermediaries α1. Some of the traditional limitations of beta blockers do not seem to appear in some β blockers that have vasodilation effects, like Carvedilol. The low -voltage effect of Carvedilol does not accompany the entire peripheral resistance as often as common in the mere β inhibitors. Slight reduction heart rate. The blood flow through the kidneys and renal function is still maintained in patients with hypertension. Carvedilol has the effect of maintaining the volume of systolic and reduces the entire peripheral resistance. Carvedilol does not hinder blood supply to separate tissues and artery networks including kidney, musculoskeletal, forearm, legs, skin, brain, or carotid arteries. Carvedilol also reduces the rate of cases of cold limbs and fatigue early when physical activity. The long -term effect of Carvedilol on hypertension is shown in some verified double blind tests.
kidney failure
Many open studies have shown that Carvedilol effectively with patients with hypertension due to renal artery stenosis. This is also true in patients with chronic renal impairment or dialysis or post -kidney transplant. Carvedilol gradually reduces blood pressure both days of dialysis and no dialysis, and the effect of hypotension can be compared to patients with normal renal function.
On the basis of efficiency achieved from comparative trials in artificial dialysis patients, Carvedilol shows that it is more effective than calcium channel blockers and drug tolerances.
coronary artery disease
In patients with coronary artery disease, carvedilol has anti -anemia effects (exertion time, time until the ST segment is different and angina time is improved). The anti -angina effect of the drug is maintained during long -term treatment. Acute hemodynamic studies have shown that Carvedilol significantly reduces the oxygen needs of the heart muscle and sympathetic activities. The drug also reduces the money burden of the heart muscle (pulmonary artery pressure and pulmonary capillary pressure) and post -burden (all peripheral resistance).
Chronic heart failure
Carvedilol significantly reduces mortality and hospitalization due to cardiovascular disease. Carvedilol also improves the symptoms and left ventricular failure in patients with chronic heart failure with or without ischemic. The impact of carvedilol depends on the dose.
kidney failure
Carvedilol reduces the incidence of disease and mortality in patients with dialysis with expanding heart disease. An analysis of placebo control clinical trials includes a large number of patients (> 4000) with mild to medium chronic kidney disease to support that Carvedilol's treatment in patients with left ventricular dysfunction includes or no symptoms that reduce the mortality rate as well as events related to heart failure.
left ventricular failure after acute myocardial infarction
In a dual blind study conducted in 1959 new patients with myocardial infarction and a number of left ventricle expansion ≤ 40% or the index of ventricular contractions ≤ 1.3 (with or without heart failure with symptoms), it is found that Carvedilol does not reduce statistically significance if the overall death rate is caused by all causes of Cardiac. Pharmaceutical, P = 0.297); But if considering alone, it significantly reduces the mortality rate for all causes by 23% (P = 0.031), reducing the mortality rate due to all causes or myocardial infarction does not cause death to 29% (P = 0.002), reducing the death rate due to cardiovascular causes of up to 25% (P = 0.024) and reducing hospitalization rates to treat non -death heart infarction to 41%). In addition, later analysis also shows that Carvedilol significantly reduces death or hospitalization mainly due to cardiovascular disease by 17% (P = 0.019).
pharmacokinetics
absorption
In healthy objects after taking a 25mg capsule, Carvedilol was quickly absorbed and reached the cmax peak concentration of 21mg/l after about 1.5 hours (TMAX). The peak concentration values are linearly to the dose. After drinking, Carvedilol is fully metabolized in the initial comprehensive biochemistry to absolutely 25% in healthy male objects. Carvedilol is an optical and isomer S-(-)-which is faster than the isomers R-(+)-, absolutely used orally is 15% compared to 31% of the isomers R-(+)-. The maximum plasma concentration of R-carvedilol is about 2 times higher than the S-Carvedilol.
studies, in the laboratory, showed that Carvedilol is the substrate of P-Glycoprotein transport protein. The role of P-Glycoprotein in the distribution of Carvedilol has also been confirmed on healthy subjects.
Distribution
Carvedilol is a high fat -loving compound, showing the ratio of cohesion to plasma proteins about 95%. The distribution volume ranges from 1.5 to 2l/kg.
Metabolism
In humans, Carvedilol is metabolized mostly in the liver with oxidation and combined into different metabolites that are mostly eliminated through biliary tract. In animals, people have seen the phenomenon of the bowel circulation of the original substance.
Methyl and hydroxy reducing reactions in the phenol round produces three metabolites with beta-adrenergic collection activity. According to preclinical studies, 4’-hydroxyphenol metabolites are 13 times stronger than Carvedilol. Three active metabolites have weaker vasodilation effect than Carvedilol. In humans, the concentration of these three metabolites is about 10 times lower than the concentration of the original substance. Two metabolites Hydroxy-Carbazole of Carvedilol have a very strong antioxidant effect, 30 to 80 times higher than Carvedilol.
Human pharmacokinetic studies have shown that Carvedilol's oxidation metabolism is stereoscopic selection. The results of a suggested laboratory study but the isenzyme of Cytochrome P450 may be related to the oxidation and hydrolysis process including CYP2D6, CYP3A4, CYP2E1, CYP2C9 as well as CYP1A2.
Studies on healthy volunteers and patients show that the r isomers are mainly metabolized by CYP2D6. H isomers are metabolized mainly by CYP2D6 and CYP2C9.
polymorphic genotypes
The results of clinical pharmacokinetic studies in humans showed that CYP2D6 plays an important role in the metabolism R and S-Carvedilol. As a result, the plasma concentration of R and S-Carvedilol increases in slow metabolic CYP2D6. The importance of the genotype of CYP2D6 in the pharmacokinetics of R and S-Carvedilol has been confirmed in pharmacokinetic studies, while other studies do not confirm this result. In short, the multi -phenotype gene type of CYP2D6 may have a limited clinical significance.
Elimination
After taking 1 dose of 50mg of carvedilol, about 60% is excreted through the bile and is discharged in feces in the form of metabolites for 11 days. After taking the single dose, only about 16% is excreted in the urine in the form of Carvedilol or its metabolites. The excretion through the urine of the drug in the form does not change lower than 2%.
After an intravenous injection of 12.5mg for healthy volunteers, the plasma clearance of Carvedilol reaches about 600ml/minute and the sale time is about 2.5 hours. The sale time of a 50mg capsule is observed on those people is 6.5 hours corresponding to the time of reabsorption from capsules. After drinking, the total clearance of the entire body of the S-Carvedilol is approximately 2 times higher than the R-Carvedilol.
pharmacokinetics in special subjects
Research in children shows that the clearance has been adjusted according to weight in children significantly bigger than adults.
Carvedilol pharmacokinetics in hypertension patients are not affected by age.
In patients with hypertension and renal failure, the area under the curve indicates plasma concentration over time, the sale time and the concentration of plasma peaks does not change much. The excretion of the kidneys of the drug in a constant form is reduced in patients with renal failure; However, changes in pharmacokinetic parameters are only moderate.
Carvedilol is not eliminated during hemolysis because it does not pass through the filter, maybe because it is strongly connected to plasma proteins.
See the contraindications and use in special subjects/Hepatic failure
In a study of 24 Japanese patients with heart failure, Carvedilol's clearance is significantly lower than the previous prediction in healthy volunteers. These results suggest that the pharmacokinetics of Carvedilol are shaped like R and S are changed by heart failure.
Before taking Dilatrend 6.25mg Roche treat hypertension, coronary artery disease, chronic heart failure (3 blisters x 10 tablets)
How to use
Take the 6.25mg dilatrend pills with a full glass of water.
Treatment time
Carvedilol treatment is a long -term treatment. As well as all β blockers, do not stop treating suddenly but should reduce the dose slowly weekly. This is especially important in the case of patients with coronary artery disease.
Dosage
The starting dose is recommended for 12.5mg, once a day, in the first two days. After that, the recommended dose is 25mg, once a day. If necessary, at least two weeks later, it may increase the dose to the maximum daily dose recommended by 50mg, once or twice daily.
The starting dose is recommended for 12.5mg, twice daily, in the first two days. Then the recommended dose is 25mg, twice daily. If necessary, at least two weeks later, it can increase the dose to the maximum daily dose recommended by 100mg, divided twice daily.
Doctors must do the right dose for each patient and carefully monitor the dose during the dose process.
For patients being treated with digitalis, diuretics and dosage inhibitors of these drugs should be stable before starting treatment with carvedilol.
The starting dose is recommended by 3,125mg, twice a day, for two weeks. If this dose is tolerated, at least two weeks later, it may increase the dose to 6.25mg, 12.5mg and 25mg, use twice daily. The dose may increase to the highest level that the patient can tolerate. The maximum dose is recommended for 25mg, twice daily for all patients with severe heart failure and for patients with chronic heart failure from mild to medium weight weighing less than 85kg. For patients with mild or moderate kidney failure, weighing over 85kg, the maximum dose is recommended to be 50mg, twice daily.
Before each dose increases, the doctor needs to evaluate symptoms of vasodilation or more severe heart failure in the patient. The severe heart failure or water retention can be treated by increasing diuretics. Sometimes it is necessary to reduce the dose of Carvedilol, and in very rare cases, the suspension of carvedilol must be temporarily suspended.
If you have stopped using Carvedilol for more than a week, it should be started at a lower dose (use twice daily) and then detect the increasing dose to suit the recommended dose above. If you have stopped using Carvedilol for more than two weeks, it is recommended to start using the dose of 3,125mg to suit the recommended dose above.
Symptoms of vasodilation can be initially treated by reducing diuretics. If the symptoms still exist, the dose of enzyme inhibitors may be reduced (if used), then reduce the dose of carvedilol if necessary. In these cases, the carvedilol dose should not be increased until the control of heart failure is more severe or vasodilation.
Doctors must do the right dose for each patient and carefully monitor the dose during the dose process.
The treatment may be started for inpatient or outpatient patients when the patient has stable hemodynamic indicators and water retention in the body has been limited to the lowest level.
Before starting to use Carvedilol: Patients with stable hemodynamics indicators should be treated with enzyme inhibitors for at least 48 hours, with a dose of a constant constant for at least the first 24 hours. You can then start using Carvedilol around the period from 3 to 21 after myocardial infarction.
The first dose of Carvedilol: The starting dose is recommended to be 6.25mg. Patients must be monitored for at least 3 hours after the first dose. (See the general and general warning)
The next dose of Carvedilol: If the patient has the first dose (for example, heart rate> 50 beats/minute, systolic blood pressure> 80mm and no clinical signs, of the phenomenon of tolerance of drugs), the dose should be increased to 6.25mg, twice daily, and maintained for 3 to 10 days.
During this time, if the patient has signs of tolerance phenomenon, especially if you see a slow heartbeat
How to detect the next dose: If the dose is 6.25mg, twice daily is well tolerated, about 3 to 10 days away, should increase the dose up to 12.5mg, twice daily and then, increase to 25mg, twice daily. The maintenance dose is the maximum dose that the patient can tolerate. No matter how much the patient has a weight, the maximum dose is recommended for patients is only 25mg, twice a day.
Special dose instructions
Data on pharmacokinetics (see pharmacokinetics on special population) and clinical studies published (see the renal failure) in patients with different levels of renal failure suggested that there is no need to change the recommended dose of Carvedilol for patients with medium to severe renal impairment.
Contraindicated to use Carvedilol for patients with clinical manifestations of liver dysfunction (see contraindications)
There is no evidence to support the adjustment of the dose in this object.
Carvedilol's efficiency and safety in children and adolescents (
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 of overdose
In cases of overdose, there may be serious hypotension from heart rhythms, heart failure, cardiac shock and cardiac arrest.
There may be respiratory problems, bronchospasm, vomiting, consciousness disorders and total epilepsy.
Treatment of overdose
Patients should be monitored the aforementioned signs and symptoms and treatment under the treatment of the treating doctor and according to the treatment standards for patients with overdose of β blockers (such as atropine, glucagon, phosphodiesterase inhibitors such as amirone or millrinone, β sympathetic strength).
Important notes
In case of severe severe poisoning, it is necessary to treat continuously for a long time because it must anticipate that Carvedilol's disposal time will last and the re -distribution of Carvedilol from deeper compartments. The time of detoxification /support treatment will depend on the severity of the overdose. Therefore, supportive treatment should be conducted continuously until the patient's condition is stable.
What to do when you forget 1 dose?
Take Dilatrend 6.25mg as soon as you remember. However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using 6.25mg dilatrend, you may experience unwanted effects (ADR).
Unwanted effects according to the classification system according to the Meddra and CIMS frequency: very common ≥ 1/10; Common ≥ 1/100 and
Table 1 below lists unwanted effects that have been reported when using Carvedilol in important clinical trials with indications: congestive heart failure, left ventricular dysfunction after myocardial infarction, hypertension and long -term treatment of coronary artery disease.
Unwanted effects are observed from clinical trials:
Agency group
Unwanted reaction
Anemia Common Rare
leukopenia Very rare
heart failure
Very common
Common Common
Common Not common
Not common Reduction of vision Common Common Common
nausea
Common
diarrhea
Common
Common Common
Abdominal pain Common
Constipation Not common Rare
weakness
Very common
Common
Common
Increase ALT, AST and GGT Very rare
Hypersensitivity (allergic reaction) Very rare infection and parasitic infection pneumonia Common Bronchitis Common Common Urinary tract infections Common weight gain Common Common Common Common dizziness Very common headache Very common Common Not common Mental disorders Depression, boring mood Common Not common Kidney failure and kidney dysfunction in patients with spreading blood vessel disease and/or reduced renal functional impairment Common Rare Ocean function disorder Not common Difficulty breathing Common pulmonary edema Common Common Rare Skin reactions (such as allergic rash, dermatitis, urticaria, itching, psoriasis and flattened skin damage) Not common Hypotension Very common Common Common Hypertension Common Expenditure on adverse events does not depend on the dose of Carvedilol, except dizziness, abnormal vision and slow heart rate. Dizziness, fainting, headache and weakness are usually mild and common at the time of starting treatment. In patients with congested heart failure, more severe heart failure and fluid retention may occur during the increase in the dose of carvedilol to the target dose (see the warning and caution). Heart failure is a very common side effect in both groups of placebo patients (14.5%) and a group of patients treating Carvedilol (15.4%), in patients with left ventricular dysfunction after acute myocardial infarction. Recovery impaired renal function has been recorded when treating carvedilol in patients with congestive heart failure with low blood pressure, ischemia heart disease and spreading blood vessel disease and/or impaired renal function (see the warning and caution). After circulating drugs The following side effects are determined after circulating Carvedilol. Because these side effects are reported from an unknown sample size, it is not always reliable to evaluate their output and/ or set a causal relationship about the harmful effects of the drug. Disorders of chemical and nutrition: Due to the β blocker properties, the drug can also develop potential diabetes, worse diabetes and inhibit blood sugar regulatory systems. Skin and subcutaneous disorders: Hair loss Serious side effects of the skin organization (poisoned epithelial necrosis, Stevens-Johnson syndrome) (see the warning and caution). Renal and urinary disorders: Cases of individual beams in women have been reported, and these cases will be cured after stopping the drug. When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using Dilatrend 6.25mg, you need to read the instructions carefully and refer to the information below.
Contraindicated
Dilatrend 6.25mg contraindicated drug in the following cases:
Carvedilol is not used for patients:
Unstable/unstable heart failure.
Like other beta blockers, Carvedilol is not used for the following patients:
History of bronchospasm or asthma.
Precautions when using
In patients with congested heart failure, more severe heart failure or water retention may occur during the carvedilol dose. If these symptoms occur, diuretics should be increased and should not increase the dose of carvedilol until these symptoms are clinically stable. Sometimes, it may be necessary to reduce the dose of Carvedilol or, in a rare number of cases, the drug must be suspended.
These suspension stages do not hinder the later dose of increasing carvedilol. Be careful when using Carvedilol in combination with glycoside digitalis, because these two drugs slow down the atrial transmission (see the interaction with other drugs and other forms of interactions).
The recovery impaired impairment has been observed when used, carvedilol for patients with chronic heart failure with low blood pressure (systolic blood pressure
Before being treated with Carvedilol, patients must have a stable clinical condition and should be treated with enamel inhibitors for at least 48 hours, with a dose of constant constant for at least the first 24 hours. (See the dosage and usage).
Carvedilol may slow down the heart rate. If the patient's circuit drops less than 55 times a minute, the carvedilol dose should be reduced.
The drugs that have an unstable beta blocker can cause chest pain in patients with Prinzmetal angina. There is no clinical experience when using Carvedilol for these patients, although the α blocker of Carvedilol can help prevent these symptoms. However, caution should be used when taking carvedilol for patients suspected of suffering from Prinzmetal angina.
Be careful when using Carvedilol for patients with chronic obstructive pulmonary disease (COPD) with bronchial spasms without being treated with sprays or oral. Only carvedilol is used for these patients if the benefit of treatment is higher than possible risks.
In patients tend to have bronchospasm, respiratory failure can occur as a result of increasing airway hindrance. These patients should be closely monitored at the beginning of treatment and during the Carvedilol dose, and if any manifestation of bronchospasm occurs during the treatment, the carvedilol dose must be reduced.
Be careful when using Carvedilol for patients with diabetes, because the drug can worsen blood sugar control, or early signs and symptoms of acute hypoglycemia may be covered or reduced. (See the interaction with other drugs and other types of interactions and use in special population).
Carvedilol should be used carefully for patients with peripheral vascular disease (eg raynaud) because beta blockers can appear quickly or worsen the symptoms of artery failure.
Like other drugs with other beta blockers, Carvedilol can cover the symptoms of thyroid poisoning.
Chrome -preferred cells
So be cautious when taking carvedilol for patients suspected of having chromium cell tumors.
Be cautious when taking Carvedilol for patients with a history of severe hypersensitivity reactions and patients being treated with induction, because β blockers may increase both sensitive to antigens and severe severity of hypersensitivity reactions.
Very rare serious adverse reactions such as epidermal necrosis (Ten) and Stevens-Johnson syndrome (SJS) have been reported during the treatment process with Carvedilol [see the next part of circulation (unwanted effect)]. Carvedilol should be stopped permanently in patients who have had serious adverse reactions in the skin due to Carvedilol.
Patients with a history of psoriasis are related to treatment with β blockers should only take Carvedilol after careful consideration between the risk and benefits of drug use.
There are many important interactions on pharmacokinetics and pharmacokinetic energy with other drugs (for example, digoxin, cyclosporin, rifampicin, anesthetic, anti -arrhythmic drugs), see more details in the interaction with other drugs and other types of interactions.
Person wearing contact lenses should pay attention to the ability to reduce the tears of the drug.
Do not stop treating carvedilol suddenly, especially in patients with ischemic heart disease. Carvedilol should be stopped slowly (for a period of two weeks).
No content.
No content
The ability to drive and operate machinery
There are no studies on the effects of Dilatrend 6.25mg on machinery.
Due to the reaction of each person different (for example dizziness, fatigue), the ability to drive, operate machines or work without support may be impaired. This usually happens at first treatment, after increasing the dose, changing drugs, or taking medicine with alcohol.
pregnancy and lactation
Animal studies have shown toxicity on the reproductive system (see section 3.3 Pre -clinical safety). The potential risks to humans are unknown.
Beta blockers reduce each other's circulation, which can cause fetal death and miscarriage or premature birth. In addition, side effects (especially reducing blood glucose and slow heart rate) can occur to the fetus and infants. The risk of heart and lung complications in newborns may increase during postpartum period. Animal studies have shown that there is no evidence of Carvedilol's monster effects.
There is no clinical experience in using Carvedilol for pregnant women.
Do not use carvedilol for pregnant women unless the benefits of treatment are much higher than those that may occur.
labor and birth: No content
Lactating mothers: Animal studies have shown that carvedilol and/or its metabolites are excreted into mother mouse milk. Carvedilol's excretion in breast milk has not been proven. However, most beta blockers, with special -soluble compounds, will go into breast milk with different degrees. So breastfeeding is not recommended when using Carvedilol.
Drug interaction
The influence of carvedilol on pharmacokinetics of other drugs
Carvedilol is a substrate and also a inhibitor of p-glycoprotein. Therefore, the bioavailability of drugs transported by p-glycoprotein may be increased when used simultaneously with Carvedilol. Moreover, the bioavailability of Carvedilol may be changed due to induction substances or p-Glycoprotein inhibitors.
digoxin: Some studies on healthy individuals and on heart failure patients showed an increase in Digoxin exposure by 20%. Significantly greater effects in male patients than female patients. Therefore, it is necessary to monitor the concentration of digoxin when starting, adjusting the dose and stopping carvedilol (see the warning and general caution). Carvedilol does not affect the intravenous digoxin.
Cyclosporin: Two studies on kidney transplant patients and cardiac transplant are using cyclosporin have shown that cyclosporin levels in plasma increases after starting to use carvedilol. It seems that Carvedilol increases the exposure of oral cyclosporine by 10-20%. In order to maintain the concentration of cyclosporin treatment, it is necessary to reduce the average dosage of cyclosporin 10 - 20%. The metabolism of the interactive substance is unknown, but the inhibition of Carvedilol on the plycoprotein is related. Because the dose adjustment requirements in each patient are very different, it is recommended that cyclosporin levels should be strictly controlled after starting treatment with carvedilol and the dose of cyclosporin should be adjusted appropriately. In the case of cyclosporin using intravenously, there is no interaction with carvedilol.
The effect of other drugs on the pharmacokinetics of Carvedilol
Inhibitors as well as CYP2D6 and CYP2C9 increase substances can change the process of body metabolism and/or initially selective stereoscopy of carvedilol, resulting in increased or decreased carvedilol-R and S serum concentrations (see metabolic parts). Some examples see in patients or healthy objects listed below but the list is incomplete.
Amiodarone: A laboratory study with human liver microorganisms shows that Amiodarone and Desethylamiodarone inhibit the oxidation of Carvedilol R and S. The bottom concentration of Carvedilol-R and S significantly increased by 2.2 times in patients with Carvedilol treated heart failure in combination with amiodilarone compared to carved canares. The effect on Carvedilol S is due to Desethyamiodarone, a metabolic substance of Amiodarone, a strong CYP2C9 inhibitor. It is necessary to monitor the sympathetic beta inhibition activity in patients with Carvedilol and Amiodarone combination treatments.
Rifampicin: In a study of 12 healthy people, the Carvedilol absorbing man decreased by about 60% during the simultaneous treatment with the diltiazem and recorded a decrease in the effect of carvedilol on systolic blood pressure. The mechanism of interaction is unknown but may be due to rifampicin that increases the effects of plycoprotein P Glycoprotein, which should be monitored tightly in inhibition of beta in patients with simultaneous treatment of Carvedilol and Rifampicin.
Fluoxetine and paroxetine: In a randomized diagonal study in 10 patients with heart failure, the use in combination with fluoxetine, a strong CYP2D6 inhibitor, causes selective inhibition of Carvedilol metabolism that increases the average AUC value of the R-image R (+), and the increase in statistical significance of 35% AUC of Figure S () compared to the place of Si Si. However, no side effects, blood pressure or heart rate are recorded in treatment groups. The effect of the single dose of paroxetine, strong inhibitor CYP2D6, on the pharmacokinetics of Carvedilol has been studied on 12 healthy subjects after taking the only dose. Despite the significant increase in absorption of Carvedilol-R and S, there is no clinical impact recorded on healthy objects.
insulin or oral hypoglycemic drugs: drugs with beta blockers can increase the hypoglycemia of insulin and oral hypoglycemic drugs. Symptoms of hypoglycemia may be covered or unclear (especially tachycardia). Therefore, in patients who are taking insulin or oral hypoglycemic drugs, should monitor blood sugar regularly (see the warning and cautious part).
Medications that reduce Catecholamine reserves: Patients with β blockers along with catecholamines (eg Reserpine and monoamine oxidpine inhibitors) should be closely monitored by signs of lowering blood pressure and/or gravity.
Digoxin: Using combination of beta and digoxin blockers can increase the extension of the atrial transmission time.
Calcium channel blockers are not dihydropyridines, amiodarone or anti -arrhythmia: used in combination with carvedilol may increase the risk of atrial transmission disorder. Some cases of separate conduction disorders (rarely affected hemodynamic) have been recorded when using Carvedilol combined with diltiazem. Like other beta inhibitors, if Carvedilol oral oral inhibitor inhibits Calcium channel does not DHP Verapamil or Deltiazem, Amiodarone or other arrhythmic medications, it is recommended to monitor ECG and blood pressure.
Clonidine: The effect of reducing the heart rate and hypotension of clonidine may increase when used with drugs with beta blockers. When stopping treating these two drugs, the β blockers should be stopped first. Clonidine can be stopped after a few days by slowly reducing the dose.
Antid for hypertension: Like other drugs with other β blockers, when shared, Carvedilol can enhance the effects of drugs that treat hypertension (eg α1-reador antagonists) or unwanted drugs are lowering blood pressure.
Anesthesia: It should be paid special attention to the resonance between negative muscle contraction effects and hypotension effects of carvedilol and anesthetic drugs during anesthesia.
NSAIDS: Concomitance the use of non -steroid anti -inflammatory drugs (NSAIDs) and beta sympathetic blockers can increase blood pressure and reduce blood pressure control.
Beta bronchodilators: Beta blockers are not selected on the heart against the bronchodilator effects of beta bronchodilators, need to carefully monitor these patients.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children.
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