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CARVEDEXXON 12.5

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CARVEDEXXON

Cardiovascular System

Heart Reactants, Arrhythmias and Cardiac Failure

ACTIVE INGREDIENTS

= Additional active ingredients

Carvedilol.

CARVEDILOL

PRESENTATION AND DOSSAGE

TABS: 30 x 6.25 mg.

TABS: 30 x 12.5 mg.

RELATED INFORMATION



TAKE WITH FOOD

INDICATIONS

Treatment of symptomatic congestive heart failure. May be used as an adjuct to standard therapy, but may also be used in those patients unable to tolerate an ACE inhibitor, or those who are not receiving digitalis, hydralazine or nitrate therapy.


CONTRA-INDICATIONS

Carvedilol is contra-indicated in patients with marked fluid retention or overload requiring intravenous inotropic support. Patients with obstructive airways disease, liver dysfunction, hypersensitivity to carvedilol or any other constituents of the tablets. As with other beta-blocking agents: History of bronchospasm or asthma, 2nd and 3rd degree A-V heart block, severe bradycardia (< 50 bpm), cardiogenic shock, sick sinus syndrome (including sino-atrial block), severe hypotension (systolic blood pressure < 85mmHg), metabolic acidosis and phaeochromocytoma (unless adequately controlled by alpha blockade).


SPECIAL PRECAUTIONS

Monitor renal and cardiac function in patients with SBP < 100 mmHg when increasing dose. Ischemic heart disease, diffuse vascular disease or renal insufficiency when titrating dose. Unstable angina. Withdraw gradually in ischemic heart disease. Hyperthyroidism, diabetes.

For full details see prescribing information.


SIDE EFFECTS

Postural hypotension, bradycardia, dizziness, oedema, headache, GI upset, visual disturbances, dry eyes. Reduced peripheral circulation, angina, A-V block. For full details see prescribing information.


DRUG INTERACTIONS

As with other agents with beta-blocking activity, Carvedilol may potentiate the effect of other concomitantly administered drugs that are anti-hypertensive in action (e.g. alpha1-receptor antagonists) or have hypotension as part of their adverse effect profile. Isolated cases of conduction disturbance (rarely with haemodynamic disruption) have been observed when Carvedilol and diltiazem were given concomitantly. Therefore, as with other drugs with beta-blocking activity, careful monitoring of ECG and blood pressure should be undertaken when co-administering calcium channel blockers of the verapamil or diltiazem type, or class I anti-arrhythmic drugs. These types of drugs should not be co-administered intravenously in patients receiving Carvedilol. The effects of insulin or oral hypoglycaemics may be intensified. Regular monitoring of blood glucose is therefore recommended. Trough plasma digoxin levels may be increased by approximately 16% in hypertensive patients co-administered Carvedilol and digoxin. Increased monitoring of digoxin levels is recommended when initiating, adjusting or discontinuing Carvedilol. Concomitant administration of Carvedilol and cardiac glycosides may prolong AV conduction time. When treatment with Carvedilol and clonidine together is to be terminated, Carvedilol should be withdrawn first, several days before gradually decreasing the dosage of clonidine. Care may be required in those receiving inducers of mixed function oxidases e.g. rifampicin, as serum levels of carvedilol may be reduced or inhibitors of mixed function oxidases e.g. cimetidine, as serum levels may be increased. During general anaesthesia, attention should be paid to the potential synergistic negative inotropic effects of carvedilol and anaesthetic drugs. For full details see prescribing information.


DOSAGE

The recommended dose for the initiation therapy is 3.125mg twice a day for two weeks. If this dose is tolerated, the dosage should be increased subsequently, at intervals of not less than two weeks, to 6.25mg twice daily, followed by 12.5mg twice daily and thereafter 25mg twice daily. Dosing should be increased to the highest level tolerated by the patient. The recommended maximum daily dose is 25mg given twice daily in patients weighing less than 85kg and 50mg twice daily in patient weighing more than 85kg. Prior to each dose increase, the patient should be examined by a physician with regard to any symptoms relating to deteriorating heart failure and/or vascular dilation. Occasional deterioration of heart failure or increased fluid retention should be treated with increased dosage of diuretics. Under these circumstances, the dose of Carvedexxon should not be increased until symptoms of worsening heart failure or vasodilatation have been established. Sometimes it may become necessary to decrease the dose of Carvedilol or temporally discontinue Carvedilol treatment. If Carvedilol is discontinued for more than two weeks, therapy should be recommenced at 3.125 mg twice daily and up-titrated in line with the above dosing recommendation.

Elderly: As for adults.

Children: Safety and efficacy in children (under 18 years) has not been established. 2 Patients with co-existing hepatic disease Carvedilol is contra-indicated in patients with hepatic dysfunction. Patients with co-existing renal dysfunction No dose adjustment is anticipated as long as systolic blood pressure is above 100mmHg.

Patients with co-existing hepatic disease: Carvedilol is contra-indicated in patients with hepatic dysfunction.

Patients with co-existing renal dysfunction: No dose adjustment is anticipated as long as systolic blood pressure is above 100mmHg.

For full details see prescribing information.


OVERDOSE

Symptoms and signs :Profound cardiovascular effects such as hypotension and bradycardia would be expected after massive overdose. Heart failure, cardiogenic shock and cardiac arrest may follow. There may

also be respiratory problems, bronchospasm, vomiting, disturbed consciousness and generalised seizures.

Treatment :Gastric lavage or induced emesis may be useful in the first few hours after ingestion. In addition to general procedures, vital signs must be monitored and corrected, if necessary under intensive care conditions. Patients should be placed in the supine position. Atropine, 0.5mg to 2mg i.v. and/or glucagon 1 to 10mg i.v. (followed by a slow i.v. infusion of 2 to 5mg/hour if necessary) may be given when bradycardia is present. Pacemaker therapy may be necessary. For excessive hypotension, intravenous fluids may be administered. In addition, norepinephrine may be given, either 5 to 10 micrograms i.v., repeated according to blood pressure response, or 5 micrograms per minute by infusion titrated to blood pressure. Bronchospasm may be treated using salbutamol or other beta2-agonists given as aerosol or, if necessary, by the intravenous route. In the event of seizures, slow i.v. injection of diazepam or clonazepam is recommended. In cases of severe overdose with symptoms of shock, supportive treatment as described should be continued for a sufficiently long period of time, i.e. until the patient stabilises, since prolonged elimination half life and redistribution of carvedilol from deeper compartments can be expected.


PREGNANCY & LACTATION

There is no adequate experience with Carvedilol in pregnant women. Carvedilol should not be used in pregnancy or in breast feeding mothers unless the anticipated benefits outweigh the potential risks. There is no evidence from animal studies that carvedilol has any teratogenic effects. Embryotoxicity was observed only after large doses in rabbits. The relevance of these findings for humans is uncertain. Beta blockers reduce placental perfusion which may result in intrauterine foetal death and immature and premature deliveries. In addition, animal studies have shown that carvedilol crosses the placental barrier and is excreted in breast milk and therefore the possible consequences of alpha and beta blockade in the human foetus and neonate should also be borne in mind. With other alpha and beta blocking agents, effects have included perinatal and neonatal distress (bradycardia, hypotension, respiratory depression, hypoglycaemia, hypothermia). There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.


MANUFACTURER & DISTRIBUTER:

Manufacturer: Dexcel Ltd.

License Holder: Dexxon

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