Dosage of Amlodipino Combix in details
Adults
The usual initial antihypertensive oral dose of Amlodipino Combix 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 Amlodipino Combix 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 "Amlodipino Combix" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Amlodipino Combix" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Amlodipino Combix" on one side and "10" on the other
Storage And Handling
2.5 mg Tablets
Amlodipino Combix – 2.5 mg Tablets (Amlodipino Combix besylate equivalent to 2.5 mg of Amlodipino Combix per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Amlodipino Combix" on one side and "2.5" on the other side and supplied as follows:
NDC 0069-1520-68 Bottle of 90
5 mg Tablets
Amlodipino Combix – 5 mg Tablets (Amlodipino Combix besylate equivalent to 5 mg of Amlodipino Combix per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Amlodipino Combix" 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
Amlodipino Combix – 10 mg Tablets (Amlodipino Combix besylate equivalent to 10 mg of Amlodipino Combix per tablet) are white, round, flat-faced, beveled edged engraved with both "Amlodipino Combix" 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 Amlodipino Combix?
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 Amlodipino Combix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
See also:
Amlodipino Combix drug interactions (in more detail)
Amlodipino Combix interactions
Amlodipino Combix 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 Amlodipino Combix has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).
Simvastatin: Co-administration of multiple doses of 10 mg Amlodipino Combix 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 Amlodipino Combix to 20 mg daily.
Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Amlodipino Combix in 20 healthy volunteers had no significant effect on the pharmacokinetics of Amlodipino Combix. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Amlodipino Combix; therefore, administration of Amlodipino Combix 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 Amlodipino Combix in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Amlodipino Combix systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Amlodipino Combix 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 Amlodipino Combix to a greater extent than diltiazem. Amlodipino Combix 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 Amlodipino Combix. Close observation of patients is recommended when Amlodipino Combix is co-administered with clarithromycin.
CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Amlodipino Combix. Concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericum perforatum) may decrease the plasma concentrations of Amlodipino Combix. Amlodipino Combix should be used with caution when administered with CYP3A4 inducers.
In the following studies, there were no significant changes in the pharmacokinetics of either Amlodipino Combix or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Amlodipino Combix: Cimetidine: Co-administration of Amlodipino Combix with cimetidine did not alter the pharmacokinetics of Amlodipino Combix.
Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Amlodipino Combix had no significant effect on the pharmacokinetics of Amlodipino Combix.
Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Amlodipino Combix. When Amlodipino Combix and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Special Studies: Effect of Amlodipino Combix on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Amlodipino Combix with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Digoxin: Co-administration of Amlodipino Combix with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of Amlodipino Combix had no significant effect on the pharmacokinetics of ethanol.
Warfarin: Co-administration of Amlodipino Combix with warfarin did not change the warfarin prothrombin response time.
Cyclosporin: Pharmacokinetic studies with cyclosporin have demonstrated that Amlodipino Combix does not significantly alter the pharmacokinetics of cyclosporin.
Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Amlodipino Combix. In order to avoid toxicity of tacrolimus, administration of Amlodipino Combix 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 Amlodipino Combix 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 Amlodipino Combix. 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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
