Topol XL Dosage
Generic name: Topol XL SUCCINATE 25mg
Dosage form: capsule, extended release
Medically reviewed on June 19, 2018.
Adults: The usual initial dosage is 25 mg to 100 mg once daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. Dosages above 400 mg per day have not been studied.
Pediatric Hypertensive Patients 6 Years of age or older: The recommended starting dose of Topol XL is 1 mg/kg once daily, the maximum initial dose should not exceed 50 mg once daily. Adjust dosage according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients.
Topol XL has not been studied in pediatric patients less than 6 years of age.
Individualize the dosage of Topol XL. The usual initial dosage is 100 mg once daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 to 2 weeks.
Prior to initiation of Topol XL, stabilize the dose of other heart failure drug therapy and ensure that the patient is not fluid overloaded. The recommended starting dose of Topol XL is 25 mg once daily for two weeks. Topol XL is not suitable for initial therapy in patients who are expected to require a starting dose less than 25 mg daily. Dosage must be individualized and closely monitored during up-titration. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of Topol XL. If a patient experiences symptomatic bradycardia, reduce the dose of Topol XL. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of Topol XL or temporarily discontinuing it. The dose of Topol XL should not be increased until symptoms of worsening heart failure have been stabilized. Initial difficulty with titration should not preclude later attempts to introduce Topol XL.
For patients who are taking Topol XL succinate extended-release tablets at a dose of 25 mg to 200 mg once daily, substitute Topol XL for Topol XL succinate extended-release tablets, using the same total daily dose of Topol XL succinate.
Topol XL should be swallowed whole. For patients unable to swallow an intact capsule, alternative administration options are available.
Directions for use with soft food (applesauce, pudding, or yogurt)
For patients with swallowing difficulty, Topol XL can be opened and contents can be sprinkled over soft food. The contents of the capsules should be swallowed along with a small amount (teaspoonful) of soft food (such as applesauce, pudding, or yogurt). The drug/food mixture should be swallowed within 60 minutes and not stored for future use.
Nasogastric tube administration
Open and add contents of capsule to an all plastic oral tip syringe and add 15 mL of water. Gently shake the syringe for approximately 10 seconds. Promptly deliver through a 12 French or larger nasogastric tube. Ensure no granules are left in the syringe. Rinse with additional water if needed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Other brands: Topol XL Tartrate, Topol XL Succinate ER, Lopressor, Toprol-XL
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Topol XL, especially:
an antidepressant - bupropion, clomipramine, desipramine, duloxetine, fluoxetine, fluvoxamine, paroxetine, sertraline;
an ergot medicine - dihydroergotamine, ergonovine, ergotamine, methylergonovine;
heart or blood pressure medications - amlodipine, clonidine, digoxin, diltiazem, dipyridamole, hydralazine, methyldopa, nifedipine, quinidine, reserpine, verapamil, and others;
a MAO inhibitor - isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine; or
medicine to treat mental illness - chlorpromazine, fluphenazine haloperidol, thioridazine.
This list is not complete. Other drugs may interact with Topol XL, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Topol XL is a CYP2D6 substrate. Drugs that inhibit CYP2D6 can have an effect on the plasma concentration of Topol XL. Examples of drugs that inhibit CYP2D6 are quinidine, terbinafine, paroxetine, fluoxetine, sertraline, celecoxib, propafenon and diphenhydramine. When treatment with these drugs are initiated, the dose of Topol XL might have to be reduced for patients treated with Topol XL.
The Following Combinations with Topol XL Should be Avoided: Barbituric Acid Derivatives: Barbiturates (investigated for pentobarbital) induce the metabolism of Topol XL by enzyme induction.
Propafenone: Upon administration of propafenone to 4 patients on Topol XL therapy, the plasma concentrations of Topol XL increased by 2-5 fold and 2 patients experienced side effects typical of Topol XL. The interaction was confirmed in 8 healthy volunteers. The interaction is probably explained by the fact that propafenone, similarly to quinidine, inhibits the metabolism of Topol XL via cytochrome P450 2D6. The combination is probably difficult to handle since propafenone also has beta-receptor blocking properties.
Verapamil: In combination with beta-receptor blocking drugs (described for atenolol, propranolol and pindolol), verapamil may cause bradycardia and fall in blood pressure.
Verapamil and beta-blockers have additive inhibitory effects on AV-conduction and sinusnode function.
The Following Combinations with Topol XL may require Modified Drug Dosage:
Dosage:Amiodarone: A case report suggests that patients treated with amiodarone may developed pronounced sinus bradycardia when treated simultaneously with Topol XL. Amiodarone has extremely long half-life (around 50 days), which implies that interactions can occur for a long time after withdrawal of the drug.
Antiarrhythmics, Class I: Class I antiarrhythmics and beta-receptor blocking drugs have additive negative inotropic effects which may result in serious haemodynamic side effects in patients with impaired left ventricular function. The combination should also be avoided in "sick sinus syndrome" and pathological AV-conduction. The interaction is best documented for disopyramide.
Nonsteroidal Anti-Inflammatory/Antirheumatic Drugs (NSAIDs): NSAID-antiphlogistics have been shown to counteract the antihypertensive effect of beta-receptor blocking drugs. Primarily, indomethacin has been studied. This interaction probably does not occur with sulindac. A negative interaction study on diclofenac has been performed.
Diphenhydramine: Diphenhydramine decreases (2.5 times) clearance of Topol XL to alpha-hydroximetoprolol via CYP2D6 in fast hydroxylating persons. The effects of Topol XL are enhanced. Diphenhydramine may probably inhibit the metabolism of other CYP2D6 substrates.
Digitalis Glycosides: Digitalis glycosides in association with beta-blockers, may increase AV conduction time and may induce bradycardia.
Diltiazem: Diltiazem and beta-receptor blockers have additive inhibitory effects on the AV-conduction and sinusnode function. Pronounced bradycardia has been observed (case reports) during combination treatment with diltiazem.
Epinephrine: There are about 10 reports on patients treated with nonselective beta-receptor blockers (including pindolol and propranolol) that developed pronounced hypertension and bradycardia after administration of epinephrine (adrenaline). These clinical observations have been confirmed in studies in healthy volunteers. It has also been suggested that epinephrine in local anaesthetics may provoke these reactions upon intravasal administration. The risk is probably less with cardioselective beta-receptor blockers.
Phenylpropanolamine: Phenylpropanolamine (norephedrine) in single doses of 50 mg may increase the diastolic blood pressure to pathological values in healthy volunteers. Propranolol generally counteracts the rise in blood pressure induced by phenylpropanolamine. However, beta-receptor blockers may provoke paradoxical hypertensive reactions in patients who take high doses of phenylpropranolamine. Hypertensive crisis during treatment with only phenylpropanolamine have been described in a couple of cases.
Quinidine: Quinidine inhibits the metabolism of Topol XL in so-called rapid hydroxylators (>90% in Sweden) with markedly elevated plasma levels and enhanced beta-blockade as a result. A corresponding interaction might occur with other beta-blockers metabolised by the same enzyme (cytochrome P450 2D6).
Clonidine: The hypertensive reaction when clonidine is suddenly withdrawn may be potentiated by beta-blockers. If concomitant treatment with clonidine is to be discontinued, the beta-blocker medication should be withdrawn several days before clonidine.
Rifampicin: Rifampicin may induce the metabolism of Topol XL resulting in decreased plasma levels.
Patients receiving concomitant treatment with other beta-blockers (ie, eye drops) or MAO Inhibitors should be kept under close surveillance. In patients receiving beta-receptor blocker therapy, inhalation anaesthetics enhance the cardio-depressant effect. The dosages of oral antidiabetics may have to be readjusted in patients receiving beta-blockers. The plasma concentration of Topol XL can increase when cimetidine or hydralazine are administered simultaneously.
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Information checked by Dr. Sachin Kumar, MD Pharmacology