Amlodipine

Amlodipine is a prescription medication that is used with or without other medications to treat high blood pressure. Lowering blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily.

Amlodipine is also used to prevent certain types of chest pain (angina). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor.

Amlodipine is available under the following different brand names: Norvasc.

Dosages of Amlodipine Should Be Given As Follows:

Adult and Pediatric Dosage Forms & Strengths

Tablets

• 2.5 mg
• 5 mg
• 10 mg

Dosage Considerations

Hypertension (High Blood Pressure)

Adult

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

Pediatric

• Children under 6 years: Safety and efficacy not established
• Children 6 years and older: 2.5-5 mg/day orally

Geriatric

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

Coronary Artery Disease

Treatment of chronic stable angina and vasospastic angina (Prinzmetal or variant angina) and angiographically documented coronary artery disease (CAD) in patients without heart failure or ejection fraction (EF) less than 40%

Adult

• 5-10 mg/day orally initially; maintenance: 10 mg/day orally

Geriatric

• 2.5-10 mg/day orally initially; maintenance: 10 mg/day orally

Angina

Adult

• 5-10 mg/day orally; maintenance: 10 mg/day orally

Geriatric

• 2.5-10 mg/day orally; maintenance: 10 mg/day

Dosage Modifications

• Hepatic insufficiency: Consider starting with 2.5 mg/day orally
• Severe hepatic impairment: Titrate slowly

Dosing Considerations

Also given in combination with benazepril (Lotrel), atorvastatin (Caduet), olmesartan (Azor), telmisartan (Twynsta), and valsartan (Exforge)

Geriatric

• Start dosing at the low end of the dosing range; elderly patients have a greater frequency of decreased renal, hepatic or cardiac function

Side effects of amlodipine include:

• Swelling (edema)
• Excess fluid in the lungs (pulmonary edema)
• Headache
• Fatigue
• Palpitations
• Dizziness
• Nausea
• Flushing
• Abdominal pain
• Sleepiness
• Male sexual disorder
• Drowsiness
• Itching
• Skin rash
• Muscle cramps
• Muscle weakness

Postmarketing side effects of amlodipine reported include:

• Extrapyramidal disorder (muscle spasms, restlessness, muscle rigidity, slow movement, tremor, and jerky movements)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of amlodipine include:

• dantrolene

Serious Interactions of amlodipine include:

• diltiazem
• idelalisib
• ivacaftor
• nefazodone
• simvastatin

Amlodipine moderate interactions with at leas 92 different drugs.

Amlodipine moderate interactions with at leas 100 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains amlodipine. Do not take Norvasc if you are allergic to amlodipine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Hypersensitivity

Effects of Drug Abuse

None

Short-term Effects

See "What Are Side Effects Associated with Using Amlodipine?"

Long-term Effects

See “What Are Side Effects Associated with Using Amlodipine?”

Cautions

Congestive heart failure (CHF).

Persistent progressive dermatologic reactions.

Symptomatic hypotension with or without syncope possible, particularly with severe aortic stenosis; because of 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.

Peripheral edema may develop within 2-3 weeks of starting therapy.

Use with caution in patients with hypertrophic cardiomyopathy; reduction in afterload may worsen symptoms associated with this condition.

May reduce coronary perfusion and result in ischemia in patients with severe aortic stenosis; use caution.

Extensively metabolized by liver; titrate dose slowly with severe hepatic impairment.

Initiate at lower dose in the elderly.

Titrate dose every 7-14 days on a given dose; peak antihypertensive effect is delayed.

Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction; monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.

Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when co-administered; frequent monitoring of trough blood levels of cyclosporine and tacrolimus recommended; adjust dose when appropriate

Pregnancy and Lactation

Use amlodipine with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

It is unknown whether amlodipine is excreted in milk; use of amlodipine while breastfeeding is not recommended.