Amlodipine besylate

Description

Amlodipine Besylate Tablets USP are available in three strengths: 2.5 mg, 5 mg, and 10 mg. Each strength is supplied in a bottle containing 90 tablets. The product is designated for prescription use only. The National Drug Codes (NDC) for the respective strengths are as follows: 65841-620-16 for the 2.5 mg tablets, 65841-621-16 for the 5 mg tablets, and 65841-622-16 for the 10 mg tablets.

Uses and Indications

Amlodipine Besylate is indicated for the treatment of hypertension. Additionally, this drug is indicated for the management of coronary artery disease (CAD).

There are no specific teratogenic or nonteratogenic effects associated with Amlodipine Besylate as per the available data.

Dosage and Administration

Amlodipine Besylate is administered orally in tablet form. The available strengths are 2.5 mg, 5 mg, and 10 mg.

For adult patients, the recommended starting dose is 2.5 mg once daily. Depending on the patient's response and tolerability, the dose may be titrated to 5 mg or 10 mg once daily. The maximum recommended dose is 10 mg per day.

Tablets should be taken with or without food, and patients should be advised to swallow the tablets whole with a sufficient amount of water. It is important to ensure that the dosing regimen is individualized based on the patient's clinical condition and response to therapy. Regular monitoring of blood pressure and heart rate is recommended to assess the effectiveness of the treatment and to make any necessary adjustments.

Contraindications

Amlodipine is contraindicated in patients with known hypersensitivity to amlodipine or any of its components. Additionally, the use of amlodipine is contraindicated in patients with severe aortic stenosis due to the potential for exacerbating the condition.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests are required or suggested for safe use. Healthcare professionals should remain vigilant and monitor patients as necessary, although no specific monitoring parameters have been outlined.

In the absence of detailed instructions regarding emergency medical help or directives to discontinue use and consult a physician, it is advisable for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this medication.

Side Effects

Patients may experience a range of adverse reactions while receiving treatment. Common adverse reactions include edema, fatigue, dizziness, palpitations, flushing, abdominal pain, and nausea. Among these, peripheral edema has been noted to be dose-related.

Serious adverse reactions can occur, including hypotension, angina, myocardial infarction, heart failure, and severe allergic reactions such as anaphylaxis. These serious events necessitate careful monitoring and management.

In addition to the reactions observed in clinical trials, postmarketing experience has revealed further adverse reactions, including hepatic enzyme elevations, thrombocytopenia, rash, gynecomastia, and increased urination. It is important to note that rare cases of severe skin reactions have also been reported.

Caution is advised in patients with severe aortic stenosis due to the potential for exacerbation of their condition.

Drug Interactions

Amlodipine has several notable drug interactions that may impact its efficacy and safety profile.

Pharmacodynamic Interactions Amlodipine may interact with other antihypertensive agents, leading to an additive effect that can result in hypotension. Therefore, careful monitoring of blood pressure is recommended when Amlodipine is co-administered with these medications.

Additionally, caution is advised when Amlodipine is used in conjunction with drugs that affect heart rate or rhythm, such as beta-blockers and digoxin. Monitoring for bradycardia or other cardiac effects is warranted in these cases.

Pharmacokinetic Interactions Amlodipine is subject to interactions with CYP3A4 inhibitors and inducers. Co-administration with CYP3A4 inhibitors, such as ketoconazole, itraconazole, or ritonavir, may lead to increased plasma concentrations of Amlodipine, necessitating dosage adjustments and close monitoring for adverse effects. Conversely, the effectiveness of Amlodipine may be diminished when used with CYP3A4 inducers, including rifampin and St. John's Wort.

Laboratory Test Interactions Amlodipine may also interfere with certain laboratory tests, potentially affecting the accuracy of results related to blood pressure or heart function assessments. It is advisable to inform laboratory personnel of Amlodipine use prior to testing.

Packaging & NDC

The table below lists all NDC Code configurations of Amlodipine Besylate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness of amlodipine in pediatric patients have not been established. Amlodipine is not recommended for use in children under 6 years of age. For children aged 6 to 17 years, the safety and efficacy of amlodipine remain unverified; therefore, it should be used with caution in this age group.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of amlodipine. Therefore, caution should be exercised when administering this medication to geriatric patients, especially those with reduced kidney function.

While there are no specific dosage adjustments recommended for elderly patients, healthcare providers should closely monitor this population for any adverse effects and consider individual patient factors when determining the appropriateness of treatment.

Pregnancy

Amlodipine besylate is contraindicated in pregnancy due to the associated risks to the fetus. The use of amlodipine during pregnancy poses potential risks, and it is recommended that pregnant patients avoid this medication unless the potential benefits outweigh the risks to the fetus. Healthcare professionals should carefully evaluate the necessity of amlodipine in pregnant patients and consider alternative treatments when appropriate.

Lactation

There are no specific warnings or considerations regarding the use of Amlodipine Besylate in lactating mothers. The available data does not indicate any known effects on breastfed infants. Healthcare professionals may consider the use of Amlodipine Besylate in nursing mothers, as no adverse effects have been documented in the context of lactation.

Renal Impairment

Amlodipine is not significantly eliminated by the kidneys; therefore, no dosage adjustment is necessary in patients with renal impairment. However, patients with severe renal impairment, defined as a creatinine clearance of less than 10 mL/min, may experience increased plasma concentrations of amlodipine. Caution should be exercised in these patients. Additionally, renal function tests should be considered in patients with renal impairment to monitor for potential adverse effects.

Hepatic Impairment

Patients with hepatic impairment may experience increased exposure to amlodipine due to its primary metabolism by the liver. Consequently, dosage adjustments may be necessary for those with mild to moderate hepatic impairment to avoid potential adverse effects. Amlodipine is not recommended for use in patients with severe hepatic impairment, as the risks may outweigh the benefits in this population.

It is essential to monitor liver function tests in patients with hepatic impairment to ensure safe and effective use of amlodipine. Regular assessment of liver function will aid in determining the appropriateness of therapy and any necessary dosage modifications.

Overdosage

In cases of overdosage, patients may exhibit excessive peripheral vasodilation, which can result in hypotension. Clinicians should be vigilant for symptoms such as dizziness, lightheadedness, and fainting, which may indicate the severity of the overdosage.

Management of amlodipine overdosage requires a symptomatic and supportive approach, as there is no specific antidote available. It is essential for healthcare professionals to closely monitor the patient’s condition, particularly blood pressure and heart rate, and to implement appropriate measures to stabilize these vital signs. Continuous assessment and supportive care are critical in ensuring patient safety during the management of overdosage.

Nonclinical Toxicology

In animal studies, no teratogenic effects were observed with amlodipine. However, adverse developmental outcomes were noted at doses that are not considered clinically relevant. Additionally, studies have demonstrated that amlodipine can cause fetal harm when administered to pregnant animals at doses significantly higher than the maximum recommended human dose.

In terms of carcinogenic potential, amlodipine did not show any evidence of carcinogenicity in animal studies.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable reactions include peripheral edema, fatigue, and palpitations. Additional adverse reactions reported include dizziness, flushing, and abdominal pain.

Serious adverse reactions have also been documented, including hypotension and exacerbation of angina. Furthermore, cases of liver enzyme elevations have been noted in postmarketing reports. Rare instances of hypersensitivity reactions, such as angioedema, have been recorded.

Patient Counseling

Patients should be advised to take Amlodipine Besylate tablets once daily, with or without food. It is important for patients to be informed that they may experience side effects, which can include swelling of the hands, feet, or ankles, flushing, or palpitations.

Patients should be counseled to report any signs of allergic reactions, such as rash, itching, or difficulty breathing, to their healthcare provider promptly. Additionally, patients should be advised to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding, as this information is crucial for safe treatment management.

Healthcare providers should instruct patients to keep this medication out of the reach of children and to never share their medicine with others, emphasizing the importance of personal medication safety. Finally, patients should be encouraged to consult their healthcare provider if they have any questions or concerns regarding their treatment with Amlodipine Besylate, ensuring they feel supported and informed throughout their therapy.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its efficacy. Additionally, the container must be kept tightly closed to prevent contamination and preserve the quality of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Amlodipine Besylate as submitted by Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)