Amlodipine Besylate 10mg Tablets

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This action is selective for vascular smooth muscle, resulting in peripheral arterial vasodilation and reduction in peripheral vascular resistance, leading to a decrease in blood pressure. In angina, it reduces total peripheral resistance (afterload) and dilates coronary arteries and arterioles, increasing myocardial oxygen delivery.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Fast or abnormal heartbeat
Swelling
Stiff muscles, shakiness, or abnormal muscle movements

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Upset stomach
Stomach pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Regularly monitor your blood pressure as instructed by your healthcare provider. Be aware that this medication may rarely cause new or worsening chest pain, which can increase the risk of a heart attack, particularly in individuals with severe heart blood vessel disease. If you experience any chest pain, consult your doctor promptly.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

It is also important to discuss alcohol consumption with your doctor before drinking while taking this medication. Additionally, be aware that liver problems have occurred with this medication, sometimes requiring hospital treatment. Inform your doctor about any concerns.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor.

Specific Instructions for Chest Pain

Do not use this medication to treat sudden chest pain, as it will not provide relief. Instead, consult your doctor for appropriate treatment.

• Simvastatin (increased simvastatin exposure, risk of myopathy/rhabdomyolysis)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure

• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure
• Sildenafil and other PDE5 inhibitors (additive hypotensive effects)
• Tacrolimus (increased tacrolimus blood levels)
• Cyclosporine (increased cyclosporine blood levels)

• Grapefruit juice (may increase amlodipine exposure, but generally not clinically significant with usual consumption)

• Dizziness
• Headache
• Flushing
• Palpitations
• Fatigue
• Nausea
• Abdominal pain
• Somnolence

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown reproductive toxicity at high doses. Limited human data suggest no increased risk of major birth defects.

Amlodipine is present in human milk. The effect of amlodipine on the breastfed infant or on milk production is unknown. Monitor breastfed infants for hypotension, bradycardia, and somnolence. Use with caution.

Safety and effectiveness for hypertension have been established in pediatric patients 6-17 years of age. Dosing is lower than adults. Not recommended for children younger than 6 years or for angina in pediatric patients.

Clearance of amlodipine is decreased in elderly patients, resulting in increased AUC and elimination half-life. A lower starting dose (2.5 mg once daily) is recommended for elderly patients.

• Amlodipine has a long half-life, allowing for once-daily dosing.
• Peripheral edema is a common dose-dependent side effect, often managed by reducing the dose or adding an ACE inhibitor/ARB.
• It is generally well-tolerated and can be used in patients with asthma, diabetes, and peripheral vascular disease.
• Unlike some other CCBs, amlodipine has minimal effect on cardiac conduction and contractility at therapeutic doses.
• Titrate dose slowly, especially in elderly patients or those with hepatic impairment, due to its long half-life.

• Other Dihydropyridine Calcium Channel Blockers (e.g., Felodipine, Nifedipine, Nicardipine)
• Thiazide Diuretics (e.g., Hydrochlorothiazide)
• ACE Inhibitors (e.g., Lisinopril, Enalapril)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
• Beta-blockers (e.g., Metoprolol, Atenolol)
• Other Antianginal Agents (e.g., Nitrates, Ranolazine)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.