Dosage of Aldosion in details
Adults
The usual initial antihypertensive oral dose of Aldosion 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 Aldosion 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.
Angina
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.
Coronary Artery Disease
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.
Children
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.
How supplied
Dosage Forms And Strengths
Tablets
2.5 mg white, diamond, flat-faced, beveled edged, with "Aldosion" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Aldosion" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Aldosion" on one side and "10" on the other
Storage And Handling
2.5 mg Tablets
Aldosion – 2.5 mg Tablets (Aldosion besylate equivalent to 2.5 mg of Aldosion per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Aldosion" on one side and "2.5" on the other side and supplied as follows:
NDC 0069-1520-68 Bottle of 90
5 mg Tablets
Aldosion – 5 mg Tablets (Aldosion besylate equivalent to 5 mg of Aldosion per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Aldosion" 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
10 mg Tablets
Aldosion – 10 mg Tablets (Aldosion besylate equivalent to 10 mg of Aldosion per tablet) are white, round, flat-faced, beveled edged engraved with both "Aldosion" 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
Storage
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
What other drugs will affect Aldosion?
Tell your doctor about all your other medicines, especially:
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nitroglycerin;
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simvastatin (Zocor, Simcor, Vytorin); or
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any other heart or blood pressure medications.
This list is not complete. Other drugs may affect Aldosion, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
See also:
Aldosion drug interactions (in more detail)
Aldosion interactions
Aldosion has been safely administered with thiazide diuretics, alpha-blockers, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
In vitro data from studies with human plasma indicate that Aldosion has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).
Simvastatin: Co-administration of multiple doses of 10 mg Aldosion 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 Aldosion to 20 mg daily.
Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Aldosion in 20 healthy volunteers had no significant effect on the pharmacokinetics of Aldosion. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Aldosion; therefore, administration of Aldosion 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 Aldosion in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Aldosion systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Aldosion 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 Aldosion to a greater extent than diltiazem. Aldosion 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 Aldosion. Close observation of patients is recommended when Aldosion is co-administered with clarithromycin.
CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Aldosion. Concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericum perforatum) may decrease the plasma concentrations of Aldosion. Aldosion should be used with caution when administered with CYP3A4 inducers.
In the following studies, there were no significant changes in the pharmacokinetics of either Aldosion or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Aldosion: Cimetidine: Co-administration of Aldosion with cimetidine did not alter the pharmacokinetics of Aldosion.
Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Aldosion had no significant effect on the pharmacokinetics of Aldosion.
Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Aldosion. When Aldosion and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Special Studies: Effect of Aldosion on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Aldosion with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Digoxin: Co-administration of Aldosion with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of Aldosion had no significant effect on the pharmacokinetics of ethanol.
Warfarin: Co-administration of Aldosion with warfarin did not change the warfarin prothrombin response time.
Cyclosporin: Pharmacokinetic studies with cyclosporin have demonstrated that Aldosion does not significantly alter the pharmacokinetics of cyclosporin.
Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Aldosion. In order to avoid toxicity of tacrolimus, administration of Aldosion in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Drug/Laboratory Test Interactions: None known.
References
- MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "3,5-Pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- PubMed Health. "Norvasc: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Aldosion are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Aldosion. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported frequency of use
No survey data has been collected yetConsumer reported doses
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
