The usual initial antihypertensive oral dose of Topdip is 5 mg once daily, and the maximum dose is 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Topdip to other antihypertensive therapy.
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
The recommended dose range for patients with coronary artery disease is 5–10 mg once daily. In clinical studies, the majority of patients required 10 mg.
The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
2.5 mg white, diamond, flat-faced, beveled edged, with "Topdip" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Topdip" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Topdip" on one side and "10" on the other
Topdip – 2.5 mg Tablets (Topdip besylate equivalent to 2.5 mg of Topdip per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Topdip" on one side and "2.5" on the other side and supplied as follows:
NDC 0069-1520-68 Bottle of 90
Topdip – 5 mg Tablets (Topdip besylate equivalent to 5 mg of Topdip per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Topdip" and "5" on one side and plain on the other side and supplied as follows:
NDC 0069-1530-68 Bottle of 90
NDC 0069-1530-41 Unit Dose package of 100
NDC 0069-1530-72 Bottle of 300
Topdip – 10 mg Tablets (Topdip besylate equivalent to 10 mg of Topdip per tablet) are white, round, flat-faced, beveled edged engraved with both "Topdip" and "10" on one side and plain on the other side and supplied as follows:
NDC 0069-1540-68 Bottle of 90
NDC 0069-1540-41 Unit Dose package of 100
Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, lightresistant containers (USP).
Manufactured by: Pfizer, Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: March 2015
Tell your doctor about all your other medicines, especially:
simvastatin (Zocor, Simcor, Vytorin); or
any other heart or blood pressure medications.
This list is not complete. Other drugs may affect Topdip, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Topdip drug interactions (in more detail)
Topdip has been safely administered with thiazide diuretics, α-blockers, β-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs.
In vitro data from studies with human plasma indicate that Topdip has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).
Simvastatin: Co-administration of multiple doses of 10 mg Topdip with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Topdip to 20 mg daily.
Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Topdip in 20 healthy volunteers had no significant effect on the pharmacokinetics of Topdip. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Topdip; therefore, administration of Topdip with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg Topdip in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Topdip systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Topdip systemic exposure [22% increase in area under the concentration versus time curve (AUC)]. Although the clinical relevance of these findings is uncertain, pharmacokinetic variations may be more pronounced in the elderly.
Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Topdip to a greater extent than diltiazem. Topdip should be used with caution when administered with CYP3A4 inhibitors.
Clarithromycin: Clarithromycin is an inhibitor of CYP3A4. There is an increased risk of hypotension in patients receiving clarithromycin with Topdip. Close observation of patients is recommended when Topdip is co-administered with clarithromycin.
CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Topdip. Concomitant use of CYP3A4 inducers (e.g., rifampicin, hypericum perforatum) may decrease the plasma concentrations of Topdip. Topdip should be used with caution when administered with CYP3A4 inducers.
In the following studies, there were no significant changes in the pharmacokinetics of either Topdip or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Topdip: Cimetidine: Co-administration of Topdip with cimetidine did not alter the pharmacokinetics of Topdip.
Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Topdip had no significant effect on the pharmacokinetics of Topdip.
Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Topdip. When Topdip and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Effect of Topdip on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Topdip with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Digoxin: Co-administration of Topdip with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of Topdip had no significant effect on the pharmacokinetics of ethanol.
Warfarin: Co-administration of Topdip with warfarin did not change the warfarin prothrombin response time.
Cyclosporin: No drug interaction studies have been conducted with cyclosporin and Topdip in healthy volunteers or other populations, with the exception of renal transplant patients. Various studies in renal transplant patients report that co-administration of Topdip with cyclosporin affects the trough concentrations of cyclosporin, from no change up to an average increase of 40%. Consideration should be given for monitoring cyclosporin levels in renal transplant patients on Topdip.
Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Topdip. In order to avoid toxicity of tacrolimus, administration of Topdip in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate. Drug/Laboratory Test Interactions:
Drug/Laboratory Test Interactions:None known.
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Information checked by Dr. Sachin Kumar, MD Pharmacology