Carvedol 6.25 United medicine for hypertension, coronary artery disease (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Carvedilol
Ingredient Korea United Pharm Joint Stock Company

Ingredient

Composition information	Content
Carvedilol	6.25mg

Uses

indications

Carvedol 6.25 drug indications for treatment in the following cases:

Hypertension

Carvedilol 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).

coronary artery disease

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.

Chronic heart failure

Unless there is contraindicated, Carvedilol is indicated in combination with standard treatment (including transferred and diuretical inhibitors, with or without Digitalis) to treat all patients with stable chronic heart failure, symptoms, mild, medium to severe, or non -medium anemia.

Left ventricular failure after acute myocardial infarction

After suffering from myocardial infarction with left ventricular failure [LVEF) ≤ 40% or index of ventricular contractions ≤ 1.3], long -term treatment for patients after cardiac infarction with Carvedilol combined with enzyme inhibitors and other therapy.

Pharmacology

Pharmacological group: Alpha and beta blockers.

ATC code: C07Ag02.

Carvedilol is an unsatisfactory beta blocker, reducing peripheral blood vessels by selecting Alpha1 receptors and inhibiting the renin-anidensin system through unsatisfied beta blockers. Renin activity in plasma decreases and sometimes causes fluid.

Carvedilol has no intrinsic sympathetic activity (ISA). Like Propranolol, Carvedilol has membrane stability.

Carvedilol is a racemic mixture of two stereopedomatic isomers. Both forms found to have alpha-adrenergic clogging activity in animal model. Carvedilol inhibits the Beta1 and Beta2 receptors mainly due to the effects of isomers s (-).

Carvedilol's antioxidant properties and its metabolites have been shown in in vitro and in vivo studies on animal and in vitro on some types of human cells.

In patients with hypertension, the hypotension effect of Carvedilol is not related to the increase in the overall pulse of beta blockers. Sleeping heart rate when taking the drug.

The volume of the squeeze does not change. The blood flow through the kidneys, the kidney function and peripheral blood flow are not changed, so it is very rare for cold symptoms to be unwanted effects commonly found in beta blockers. In hypertension patients, carvedilol increases plasma norepinephrin levels.

In long -term treatment in patients with angina, Carvedilol has shown to have anti -anemia and angina. Hemodynamic studies show that Carvedilol reduces the load and post -load of the ventricular. In patients with left ventricular dysfunction or congestive heart failure, Carvedilol has a positive impact on hemodynamics, blood emulation and left ventricular volume.

Carvedilol does not negatively affect serum and electrolyte lipid. HDL ratio (high density lipoprotein) and LDL (low -density lipoprotein) are still normal.

Pharmacokinetics

absorption

After drinking, Carvedilol is quickly absorbed. In healthy people, the peak concentration in plasma is about 1 hour after drinking. Carvedilol's absolute bioavailability is about 25%. There is a linear relationship between the dose and carvedilol levels in plasma. Using drugs with food does not affect the bioavailability or peak concentration in plasma, although the time needed to reach the peak concentration in the plasma is prolonged.

Distribution

Carvedilol is a high -fat -loving compound. Carvedilol binds to plasma proteins about 98 to 99%. The distribution volume is about 2 l/kg and increases in cirrhosis patients.

Metabolism

In humans and animals, Carvedilol is widely converted into different metabolites that mostly eliminated in the bile. The efficiency of the first metabolic step after drinking is 60 - 75%. In animals, the phenomenon of intestinal circulation of the original active ingredient.

Carvedilol is metabolized mainly in the liver, one of the metabolic paths is mainly glucuronid. Methyl and hydroxylation reducing reactions in the phenol round produces three metabolites with beta-adrenegic receptor blockers.

According to preclinical studies, 4-hydroxyphenol metabolites have a 13 times stronger receptor receptor blocker than Carvedilol. Three active metabolites have weaker vasodilation effect than Carvedilol. In humans, the concentration of three metabolites is about 10 times lower than the active ingredient concentration. Two metabolites Hydroxy -Carbazol of carvedilol have a very strong antioxidant effect, 30-80 times higher than Carvedilol.

Elimination

The average selling time of Carvedilol is about 6 hours. Plasma clearance is about 500 - 700 ml/min. Carvedilol is excreted mainly in bile and excreted mainly in feces. A small part is eliminated through the kidneys in the form of different metabolites.

pharmacokinetics in some special clinical subjects

Patients with renal failure

In some patients with hypertension accompanied by a severe to severe renal failure (creatinine clearance

In patients with average to severe renal impairment, no need to adjust the dose of Carvedilol.

Patients with liver failure

In cirrhosis patients, Carvedilol's systemic bioavailability increases by about 80% due to reduced metabolism for the first time. Therefore, contraindicated use of carvedilol for patients with clinical manifestations of liver dysfunction.

Elderly

Age has a significant impact on carvedilol pharmacokinetics parameters in hypertension patients. A study in elderly people with hypertension shows that there is no difference in adverse reactions between the elderly and young people. Another study related to elderly patients with coronary artery disease shows that there is no difference in adverse reactions reported compared to adverse reactions reported in young patients.

Children

Dynamic data in children under 18 years of age is limited.

Patients with diabetes

In patients with hypertension with type 2 diabetes, there is no influence of carvedilol on blood sugar levels (when hungry and after eating) and glycosylated haemoglobin A1, no need to change the dose of hypoglycemic drugs on these objects.

In patients with type 2 diabetes, Carvedilol does not have a significant effect on glucose tolerance. In patients with hypertension without diabetes that change insulin sensitivity (syndrome X), carvedilol increases insulin sensitivity. The same result is also observed in patients with hypertension with type 2 diabetes.

heart failure

In a study in 24 patients with heart failure, the clearance of R-and S-Carvedilol is significantly lower than in healthy volunteers. These results show that the pharmacokinetics of R-and S-Carvedilol changed significantly due to heart failure.

Before taking Carvedol 6.25 United medicine for hypertension, coronary artery disease (10 blisters x 10 tablets)

How to use

Carvedol 6.25 oral medicine, must be swallowed with enough 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

Hypertension

The starting dose is recommended for 12.5 mg, once a day, in the first two days. After that, the recommended dose is 25 mg, once a day. If necessary, at least two weeks later, it can increase the dose to the maximum daily dose recommended by 50 mg, once used once or twice daily.

coronary artery disease

The starting dose is recommended by 12.5 mg, twice daily, in the first two days. Then the recommended dose is 25 mg, twice daily. If necessary, at least two weeks later, it can increase the dose to the maximum daily dose recommended by 100 mg, divided twice daily.

Chronic heart failure

Doctors must do the appropriate dose for each patient and carefully monitor the dose during the dose process.

For patients being treated with digitalis, diuretics and enzyme inhibitors, the dose of these drugs should be stable before starting treatment with Carvedilol.

The starting dose is recommended by 3,125 mg, twice a day, for two weeks. If this dose is tolerated, at least two weeks later, it may increase the dose to 6.25 mg, 12.5 mg and 25 mg, use twice daily. The dose may increase to the highest level that the patient can tolerate. The maximum dose is recommended for 25 mg, twice daily for all patients with severe heart failure and for patients with chronic heart failure from mild to medium weight weighing less than 85 kg. For patients with mild or moderate heart failure, weighing over 85 kg, the maximum dose recommended is 50 mg, 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 is recommended to start using a lower dose (use twice daily) and then gradually 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 3,125 mg dose 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.

Left ventricular failure after acute myocardial infarction

Doctors must do the appropriate 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 6.25 mg. Patients must be monitored at least 3 hours after the first dose (see caution).

The next dose of Carvedilol: If the patient is tolerated with the first dose (for example, a heart rate> 50 beats/minute, systolic blood pressure> 80 mmHg and there are no clinical signs of the phenomenon of tolerance of drugs), so the dose is up to 6.25 mg, twice daily, and maintained for 3 to 10 days.

During this time, if the patient has signs of drug intolerant, especially if you see a slow heart rate

How to detect the next dose: If the dose is 6.25 mg, twice daily is well tolerated, about 3 to 10 days away, should increase the dose to 12.5 mg, twice daily and then, increase to 25 mg, 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 25 mg, twice daily.

Special dose instructions

kidney failure

Dynamic data and clinical studies published 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.

Hepatic failure

Contraindicated to use Carvedilol for patients with clinical manifestations of liver dysfunction (see contraindications).

Older people

There is no evidence to support the dose adjustments in this object.

Children

The effectiveness and safety of Carvedilol 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?

Signs and symptoms

In case of overdose, it may cause serious hypotension, heart rate, heart failure, shock, cardiac arrest. It may also occur in respiratory problems, bronchospasm, vomiting, cognitive disorders and total epilepsy.

How to handle

General support treatment, monitoring and treatment of survival signs. If necessary, apply measures in positive care conditions.

Use atropine if the heart rate is very slow, supporting the ventricular function by venous glucagon or using sympathetic drugs (dobutamin, isoprenalin). If you need to use spasms, you should consider using phosphodiesterase inhibitors (PDE). In the event of a toxic peripheral vasodilation, Norfenephrin or Noradrenalin should be used with continuous monitoring of circulatory status. In case of slow heart rate resistance to therapy, it is advisable to start treatment with a pacemaker.

For bronchospasm, use sympathetic drugs ß (aerosol or intravenous), or intravenous injection of slow venous infusion aminophylin. Diazepam or Clonazepam slow intravenous injection when epilepsy occurs.

Carvedilol is strongly linked to plasma proteins. Therefore, it cannot be excluded by the method of appraisal.

In case of severe overdose with shock symptoms, it is necessary to maintain long -term support treatment until the patient's condition is stable because it can extend the time of selling or re -distributing carvedilol into the deeper compartments of the body.

What to do when forgetting 1 dose? 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 the drug, there are common unwanted effects (ADR) such as:

(A) Safety records

The frequency of unwanted effects does not depend on the dosage, except for dizziness, abnormal vision and slow heart rate.

(b) List unwanted effects

The risk of most unwanted effects related to Carvedilol is similar on all indications.

Special cases are described in (C).

The types of frequency are as follows:

Very common (≥ 1/10); Common (≥ 1/100 and

Infections and parasites

Common: bronchitis, pneumonia, upper respiratory tract infections, urinary tract infections.

Common: Anemia

Very rare: hypersensitivity (allergic reaction).

Common: weight gain, hypercholesterol, difficulty controlling blood sugar (hyperglycemia, hypoglycemia) in patients with diabetes before.

Mental disorders

Common: depression, feeling of depression.

Very common: dizziness, headache.

Common: vision impairment, tearing reduction (dry eyes), eye irritation.

Heart disorders

Very common: heart failure.

Very common: Hypotension.

Common: Difficulty breathing, pulmonary edema, asthma attacks in patients with asthma.

Common: Nausea, diarrhea, vomiting, indigestion, abdominal pain.

Rare: dry mouth.

Very rare: Increased concentration of alanin-aminotransferase (ALT), aspartate-aminotransferase (AST) and gamma-glutamyltransferase (GGT).

Uncommon: skin reactions (such as allergies, dermatitis, urticaria, itching, psoriasis and flat lids such as skin damage and increased sweating), hair loss. Conclusion

Common: pain in the heads.

Common: Kidney failure and renal function abnormalities in patients with spreading blood vessel disease and/or impaired renal function, urination disorders.

Uncommon: erectile dysfunction.

Very common: weakness (fatigue).

Common: Pain.

Dizziness, fainting, headache and weakness are often mild and more likely to occur at the beginning of treatment.

In patients with congestive heart failure, worse heart failure and fluid retention may occur during the increase in the dose of the carvedilol dose.

Heart failure is an unwanted reaction that is often reported in both groups of patients treated with placebo or a group of patients treated with Carvedilol (respectively, 14.5% and 15.4%) in patients with left ventricular dysfunction after acute myocardial infarction.

The recovery impairment has been observed when treated with carvedilol in patients with chronic heart failure with low blood pressure, ischemia heart disease and spreading blood vessel disease and/ or hidden kidney failure.

As in the same group, Beta-adrenergic receptor blockers can make diabetes more clearly manifest, symptoms of diabetes will become worse, and inhibit blood glucose regulatory processes.

Carvedilol can cause incontinence in women and this unwanted effect can be removed after stopping the medication.

Notify the doctor with 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

Carvedol 6.25 drug contraindicated in the following cases:

Hypersensitivity to Carvedilol or any excipients of the drug. Management. Prinzmetal chest.

Be cautious when using

Special warnings in patients with heart failure

In patients with chronic heart failure, Carvedilol is mainly used with diuretics, Angiotensin (ACE), Digitalis and/or Palmic inhibitors. The beginning of treatment should be supervised by a specialist. The drug should only be used when the patient has stabilized with standard treatment for at least 4 weeks. Patients with severe heart failure, salt loss and water, the elderly or low blood pressure patients should be monitored for the first 2 hours after the first dose or after the dose increasing stage because there may be hypotension. Excessive blood pressure drop due to initially treated vasodilation by reducing diuretics. If the symptoms are still there, it is possible to reduce the dose of any enzyme inhibitors in the form of angiotensin. At the beginning of the treatment or increasing the dose of carvedilol, water retention may occur or worsen heart failure. In these cases, diuretics should be increased. However, in some cases, it may be necessary to reduce the dose or stop using Carvedilol. Carvedilol dose should not be increased before controlling the symptoms caused by more severe heart failure or hypotension due to vasodilation.

The risk of reduced renal function has been observed during treatment with Carvedilol in patients with low blood pressure (systolic blood pressure

Use cautious carvedilol in patients with chronic heart failure treatment with digitalis, because digitalis and carvedilol can extend the atrial transmission time.

Other warnings for Carvedilol and Beta receptor blockers

Unstolant beta receptor blockers can cause chest pain in patients with chest pain Prinzmetal. Although Carvedilol's alpha blockers can prevent this effect, there is no clinical experience of using Carvedilol in Prinzmetal angina. Be careful when using Carvedilol for patients suspected of suffering from Prinzmetal angina.

Patients with chronic pulmonary obstruction tend to have bronchospasm without oral medical treatment or aerosol should only be treated with Carvedilol if the benefits are larger than possible risks. Patients should be closely monitored at the beginning of treatment and during the carvedilol dose, and if any manifestation of bronchospasm occurs during treatment, the carvedilol dose must be reduced.

Carvedilol can cover the signs and symptoms of acute hypoglycemia. In patients with diabetes accompanied by heart failure, Carvedilol can make it more difficult to control blood sugar. Therefore, it is necessary to closely monitor blood sugar in patients with diabetes using carvedilol by regular measurement of blood sugar, especially during the dose adjustment, adjusting drugs to treat diabetes when necessary. Blood sugar concentration should also be closely monitored after a long hunger.

Carvedilol can cover the characteristics (signs and symptoms) of thyroid poisoning. Carvedilol can slow down the heart rate. If the heart rate drops below 55 beats/minute and the symptoms are related to the heart rate, it is advisable to reduce the dose of carvedilol.

When using Carvedilol simultaneously with calcium channel blockers such as Verapamil and Diltiazem or with other treatments for arrhythmia, especially amiodaron, should monitor the patient's blood pressure and electrocardiogram. It is necessary to avoid coordinating with these drugs when using intravenous sugar.

Be cautious when using cimetidine simultaneously because it can increase the effects of carvedilol.

Patients wearing contact lenses must be warned about the ability to reduce the tears of the drug.

Be cautious when taking Carvedilol for patients with a history of severe hypersensitivity reactions and patients who are in the hypersensitive therapy, because beta blockers can increase the sensitivity of the original allergies as well as increase the severity of the anaphylactic reactions. Be careful when prescribing beta blockers for psoriasis patients because the skin reactions may be worse.

Be cautious when using Carvedilol for patients with peripheral vascular disease, because beta blockers can worsen the symptoms of the disease. The same thing applies to people with Raynaud's syndrome, as there may be more severe symptoms.

closely monitor patients with poor metabolism Debrisoquin.

Because clinical experience is limited, carvedilol should not be used in secondary hypertension patients, unstable hypertension, vertical hypotension, acute heart disease, heart valve hemodynamic obstruction or output flow of the heart, end -stage peripheral artery disease, simultaneously used with alpha receptor antagonists, or Alpha2 receptor owner.

In patients with adrenal marrow tumors, it is recommended to treat Alpha receptor blockers before starting treatment with beta receptor blockers. Although Carvedilol shows the impact of both Alpha and Beta receptors, because of lack of experience, should not be used in these patients.

Due to the negative dromotropic impact, should be cautious when taking carvedilol for patients with cardiac block.

Beta receptor blockers reduce the risk of arrhythmia due to anesthesia but the risk of hypotension may increase. Be careful in patients using anesthetic. However, recent studies have shown the benefits of beta receptor blockers in the prevention of heart disease when conducting surgery and cardiovascular complications.

As well as other beta receptors, it is not advisable to stop using the sudden carvedilol, especially in people with ischemic heart disease. The stopping of carvedilol must be done gradually for 2 weeks, for example: reducing half a daily dose for 3 days. If necessary, may start other alternative treatments to prevent the severity of angina.

Use drugs for women during pregnancy and lactation

Pregnant women

There is no complete research on the use of Carvedilol in pregnant women. Animal studies have shown reproductive toxicity. The potential risks on people are not known.

Beta blockers reduce the perfusion of the placenta, which can lead to pregnancy and miscarriage or premature birth. In addition, unwanted effects (especially hypoglycemia, hypotension, slow heart rate, respiratory inhibition and hypothermia) can occur in fetus and infant.

The drug increases the risk of cardiovascular and pulmonary complications in newborns during postpartum. Carvedilol should not be used during pregnancy unless the benefits of treatment are clear (that is, if the benefit to the mother outperforms the risk of fetal/infant). Treatment should be stopped for 2-3 days before the expected birth date. If the drug is not done, the infant must be monitored for the first 2-3 days after birth.

breastfeeding women

Carvedilol is a fat -loving substance and according to the results of studies on dairy animals showing that Carvedilol and its metabolites are excreted in breast milk, which should not be used for carvedilol in nursing women.

The effect of the drug on the ability to drive and operate machinery

The drug has a slight effect on the ability to drive and operate machinery. Some patients may reduce alertness, especially when starting to use and after adjusting the dose.

Interactive drug

anti -arrhyths

Separate cases of transmission disorders (rarely decreased hemodynamic impairment) have been reported when using Carvedilol simultaneously with Diltiazem, Verapamil and/or Amiodaron. Like other beta receptor blockers, it is necessary to closely monitor the electrocardiogram and blood pressure when used simultaneously with calcium channel blockers such as Verapamil and Diltiazem due to the risk of atrial and heart failure disorders (copper effect). Closely monitoring cases of simultaneous use of carvedilol with amiodaron (oral) or anti -arrhythmic drugs Group I. Slow heart rate, cardiac arrest and ventricular vibration have been reported immediately after starting the use of beta receptor blockers in patients using amiodaron. The risk of heart failure increases when used simultaneously with anti -arrhythmic drugs group IA or intravenous infusion IC.

Simultaneous treatment with reserpin, guanethidin, methyldopa, guanfacin and monoamine inhibitors (except Mao-B inhibitors) can slow down the heart rate and lower blood pressure. Recommendation to monitor survival parameters during treatment.

dihydropyridine

Simultaneous use of Dihydropyridine and Carvedilol should be performed under close monitoring due to reporting cases such as heart failure and serious hypotension when using these two drugs simultaneously.

nitrate

Increases the effect of hypotension.

heart glycosides

Increases the concentration in the stable state of digoxin about 16% and of Digitoxin about 13% in patients with hypertension used simultaneously carvedilol and digoxin. It is recommended to monitor plasma digoxin concentrations at the beginning, adjust the dose or stop using carvedilol.

Other medications for hypertension

Carvedilol increases the effectiveness of other hypertension medications (such as α1 receptor antagonists) and adverse drugs that lower blood pressure such as barbiturat, phenothiazine, three -ring antidepressants, vasodilators and alcohol.

cyclosporin

Increase the average bottom concentration of cyclosporin has been recorded after starting treatment with carvedilol in 21 patients with kidney transplant with chronic vascular transplant. About 30% of patients must reduce the dosage of cyclosporin to maintain cyclosporin levels during treatment, the remaining patients do not need to adjust. On average, Cyclosporin dose has been reduced by about 20% in these patients. Due to the difference between individuals in adjusting the dose, it is necessary to closely monitor cyclosporin concentration after the beginning of treatment with carvedilol and adjust the doses of cyclosporin accordingly.

Diabetes treatment includes insulin

Carvedilol may increase the hypoglycemic effect of oral diabetes treatment, including insulin. Carvedilol can hide signs of hypoglycemia. Need to regularly monitor blood sugar in patients with diabetes.

Clonidin

In the event of a combination of carvedilol and clonidin treatment, it is gradually stopped using carvedilol a few days before stopping clonidin.

Respiratory anesthesia

Caution should be careful in case of anesthesia due to the effects of synergies, negative heart muscle spasms and hypotension of Carvedilol and some anesthetic drugs.

Non -steroid anti -inflammatory drugs (NSAIDs), estrogen and corticosteroid

Reduce the effectiveness of Carvedilol's hypertension due to sodium and water holding effect.

Cytochrom P450 inhibitors or induction drugs

Patients with simultaneous use of induction drugs (rifampicin, barbiturat) or inhibition (cimetidin, ketoconazole, fluoxetin, haloperidol, verapamil, erythromycin) enzyme cytochrom P450 should be carefully monitored during Carvedilol because of the carvedilol level by the server. The drug causes induction and increased by enzyme inhibitors.

Rifampicin reduces about 70% of plasma carvedilol levels. Cimetidine increases AUC value by about 30% but does not change C ... Caution should be careful for patients who are taking drugs that cause oxidation enzymes with mixed functions for example rifampicin, because the serum concentration of carvedilol may decrease, or oxidant enzyme inhibitors with a mixture of Cimetidine example, because the serum concentration can increase. However, the effects of cimetidine on carvedilol levels are relatively weak, so it is less likely to cause clinical influence.

Sympathetic nerve stimulants have the same effects as alpha and beta

The risk of hypertension and heart is too slow.

ergotamine

increased vascular contraction.

Neurotic blockers

Increase the risk of neuromuscular blockers.

Storage

In closed packaging, in a dry place, avoid light, temperature below 30 ° C.

Other drugs

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