Amlodipine

Common Side Effects of Norvasc

The most common side effect of Norvasc is edema, or swelling of the hands, feet, ankles, or lower legs. You are more likely to experience edema with higher doses of Norvasc. Other common side effects of Norvascinclude:

• Headache
• Abdominal pain
• Nausea
• Dizziness
• Drowsiness and fatigue
• Flushing (feeling of warmth)

Severe Side Effects of Norvasc

Taking Norvasc can result in several serious side effects. Seek medical help immediately if you experience:

• More frequent or severe chest pain
• Palpitations (rapid, strong, or irregular heartbeats)
• Fainting

Rare Side Effects of Norvasc

In clinical trials, Norvasc has been associated with numerous rare side effects, which affect less than one percent of people. These include, but are not limited to:

• Muscle cramps
• Diarrhea, vomiting, and weight changes
• Abnormal vision
• Depression and anxiety
• Itchiness and rashes
• Difficulty breathing

Contact your doctor if you experience any severe side effects.

Norvasc comes in three tablet sizes, which should be taken once a day, with or without food: 2.5 mg, 5 mg, and 10 mg.

Adults typically start out with a 5 mg dose, with a maximum dose of 10 mg. Adults who are small, fragile, elderly, or have liver problems may be started on a 2.5 mg dose.

Children ages 6 to 17 may be given doses of 2.5 to 5 mg — a daily dose of over 5 mg has not been studied in children. The effect of Norvasc on children under 6 years old is unknown.

Norvasc Overdose

Norvasc overdose can result in rapid heartbeat and severe hypotension, possibly resulting in dizziness and fainting.

If you believe you or someone else has overdosed, call your local poison control center, or go to the nearest hospital emergency room immediately.

If someone taking Norvasc has collapsed or is not breathing, call 911.

Missed Dose of Norvasc

Take your dose of Norvasc at the same time every day.

If you miss a dose of Norvasc, take it as soon as you remember.

If has been more than 12 hours since your missed dose, wait and take your next dose at your normal time.

Chest pain or heart pain (angina) occurs because of insufficient oxygen delivered to the heart muscles. Insufficient oxygen may be a result of coronary artery blockage or spasm, or because of exertion which increases the need of the heart for oxygen in patients with coronary artery narrowing (coronary artery disease or atherosclerosis). Amlodipine is used for the treatment and prevention of angina resulting from coronary spasm as well as from exertion. Amlodipine also is used in the treatment of high blood pressure.

• Combining amlodipine with sildenafil (Viagra) and similar drugs used for treating erectile dysfunction may lead to excessive reductions in blood pressure with complications, particularly fainting upon standing (orthostatic hypotension).
• Amlodipine significantly increases blood levels of simvastatin (Zocor). The dose of simvastatin should be limited to 20 mg daily by patients taking amlodipine.
• Ketoconazole (Nizoral, Extina, Xolegel, Kuric), itraconazole (Sporanox), ritonavir (Norvir) and other drugs that are strong inhibitors of amlodipine inactivation in the liver increase blood levels of amlodipine, resulting in excessive blood pressure reduction.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how amlodipine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have your blood pressure checked often. Talk with your doctor.
• It is rare, but worse chest pain and heart attack can happen after this medicine is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. Talk with the doctor.
• If you are taking amlodipine and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Talk with your doctor before you drink alcohol.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Liver problems have happened with amlodipine. Sometimes, liver problems have needed to be treated in the hospital. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using amlodipine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Feeling tired or weak.
• Flushing.
• Upset stomach.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Amlodipine Besylate Tablets USP 10 mg, 90s Label Text

NDC 0093-7168-98

Amlodipine

Besylate

Tablets USP

10 mg*

PHARMACIST: PLEASE DISPENSE WITH
ATTACHED PATIENT INFORMATION LEAFLET

Rx only

90 TABLETS

TEVA

AUC may increase ~40% to 60%.

Coronary artery disease (CAD) (chronic stable angina, vasospastic angina, angiographically documented CAD [without heart failure or ejection fraction <40%]): Oral: 5 to 10 mg once daily

Hypertension: Oral: Initial: 5 mg once daily or 2.5 mg once daily in small or frail patients, or when adding amlodipine to other antihypertensive therapy; maximum dose: 10 mg once daily. In general, titrate every 7 to 14 days. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Usual dosage range (ASH/ISH [Weber 2014]): 5 to 10 mg once daily. Target dose (JNC8 [James 2013]): 10 mg once daily.

Store at 15°C to 30°C (59°F to 86°F).

Heart rate, blood pressure

Tell your doctor about all your current medicines and any you start or stop using, especially:

• nitroglycerin;

• simvastatin (Zocor, Simcor, Vytorin); or

• any other heart or blood pressure medications.

This list is not complete. Other drugs may interact with amlodipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Commonly reported side effects of amlodipine include: edema. Other side effects include: fatigue, palpitations, and flushing. See below for a comprehensive list of adverse effects.

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments:
-In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
-The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

Uses:
-Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
-Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
-To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Amlodipine may be used for the treatment of angina or to lower blood pressure but can cause edema in the feet.

Dosage Forms & Strengths

tablet

• 2.5mg (Norvasc, generic)
• 5mg (Norvasc, generic)
• 10mg (Norvasc, generic)

oral suspension

• 1mg/mL (Katerzia)

Hypertension

Indicated for hypertension, to lower blood pressure

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions

5 mg/day PO initially; may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day maintenance: 5-10 mg/day

Adjust dosage according to blood pressure goals

Angina & Coronary Artery Disease

Treatment of chronic stable angina, vasospastic angina (Prinzmetal or variant angina), and angiographically documented CAD in patients without heart failure or EF

>10%

Edema (1.8-10.8%)

1-10%

Headache (7.3%)

Fatigue (4.5%)

Palpitations (0.7-4.5%)

Dizziness (1.1-3.4%)

Nausea (2.9%)

Flushing (0.7-2.6%)

Abdominal pain (1.6%)

Somnolence (1.4%)

Asthenia (1-2%)

Pruritus (1-2%)

Skin rash (1-2%)

Muscle cramps (1-2%)

Male sexual dysfunction (1-2%)

Contraindications

Hypersensitivity

Cautions

Symptomatic hypotension is possible, particularly with severe aortic stenosis; owing to gradual onset of action, acute hypotension unlikely

Worsening of angina and acute myocardial infarction (MI) can develop after dose is started or increased, particularly with severe obstructive CAD

Extensively metabolized by the liver and plasma elimination half-life is 56 hr in patients with hepatic impairment; titrate slowly when treating patients with severe hepatic impairment

Drug interaction overview

• Sildenafil: Monitor for hypotension when sildenafil is coadministered with amlodipine
• CYP3A4 Inhibitors
  • Coadministration with moderate or strong CYP3A inhibitors may increase systemic exposure to amlodipine and may require dose reduction
  • Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
• CYP3A4 inducers
  • No information available on the quantitative effects of CYP3A4 inducers on amlodipine
  • Closely monitor blood pressure when amlodipine is coadministered with CYP3A4 inducers
• Simvastatin
  • Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin
  • Limit simvastatin dose in patients on amlodipine 20 mg/day
• Immunosuppressants
  • Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when coadministered
  • Frequent monitoring trough blood levels of cyclosporine and tacrolimus and adjust dose when appropriate

Pregnancy

Limited available data based on postmarketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy

Clinical considerations

• Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
• Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death
• Carefully monitor pregnant women with hypertension and manage accordingly

Lactation

Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose

No adverse effects of amlodipine on breastfed infant reported

There is no available information on effects of amlodipine on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.