Amlodipine Uses

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• Amlodipine indications
• Uses of Amlodipine in details
• Amlodipine description
• Amlodipine dosage
• Amlodipine interactions
• Amlodipine side effects
• Amlodipine contraindications

What is Amlodipine?

Amlodipine is used alone or together with other medicines to treat angina (chest pain) and high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, Amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Amlodipine is available only with your doctor's prescription.

Amlodipine indications

Hypertension

Amlodipine tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Amlodipine.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Amlodipine may be used alone or in combination with other antihypertensive agents.

Coronary Artery Disease (CAD)

Chronic Stable Angina

Amlodipine tablets, USP are indicated for the symptomatic treatment of chronic stable angina. Amlodipine tablets, USP may be used alone or in combination with other antianginal agents.

Vasospastic Angina (Prinzmetal's or Variant Angina)

Amlodipine tablets, USP are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine tablets, USP may be used as monotherapy or in combination with other antianginal agents.

Angiographically Documented CAD

In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, Amlodipine tablets, USP are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.

How should I use Amlodipine?

Use Amlodipine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Amlodipine. Talk to your pharmacist if you have questions about this information.
• Take Amlodipine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Taking Amlodipine at the same time each day will help you remember to take it.
• Continue to take Amlodipine even if you feel well. Do not miss any doses.
• If you miss a dose of Amlodipine, take it as soon as possible. If it has been more than 12 hours since you missed your last dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amlodipine.

Uses of Amlodipine in details

Use: Labeled Indications

Angina: Treatment of symptomatic chronic stable angina; treatment of confirmed or suspected vasospastic angina (previously referred to as Prinzmetal or variant angina). May be used alone or in combination with other antianginal agents.

Hypertension: Management of hypertension in adults and children ≥6 years of age.

Off Label Uses

Raynaud phenomenon

Based on the European Society for Vascular Medicine guidelines for the diagnosis and management of Raynaud phenomenon, Amlodipine is a reasonable alternative to nifedipine for the management of this condition.

Amlodipine description

Amlodipine is a long-acting 1,4-dihydropyridine calcium channel blocker. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, Amlodipine prevents calcium-dependent myocyte contraction and vasoconstriction. A second proposed mechanism for the drug’s vasodilatory effects involves pH-dependent inhibition of calcium influx via inhibition of smooth muscle carbonic anhydrase. Some studies have shown that Amlodipine also exerts inhibitory effects on voltage-gated N-type calcium channels. N-type calcium channels located in the central nervous system may be involved in nociceptive signaling and pain sensation. Amlodipine is used to treat hypertension and chronic stable angina.

Amlodipine dosage

Adults

The usual initial antihypertensive oral dose of Amlodipine tablets 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 Amlodipine tablets 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 to 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 to 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 to 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.

Amlodipine interactions

See also:
What other drugs will affect Amlodipine?

Concurrent use of hydrocarbon inhalation anesthetics may produce additive hypotension.

NSAIDs, especially indomethacin may reduce the antihypertensive effects of Amlodipine.

Caution is recommended given the similarity of Amlodipine to nifedipine in which concurrent use of nifedipine with the β-adrenergic blocking agents may produce excessive hypotension and may increase the possibility of congestive heart failure in rare cases.

Estrogen-induced fluid retention may tend to increase blood pressure.

Caution is advised when high protein bound medications (eg, anticonvulsants, hydantoin, anticoagulants, coumarin- and indandione-derivatives, NSAIDs, quinine, salicylates, sulfinpyrazone) are used concurrently with Amlodipine since Amlodipine is highly protein bound.

Antihypertensive effects may be potentiated when Amlodipine is used concurrently with hypotension-producing medications.

Concurrent use of lithium with Amlodipine potentially may result in neurotoxicity.

Concurrent use of sympathomimetic drugs may reduce antihypertensive effects of Amlodipine.

Amlodipine side effects

See also:
What are the possible side effects of Amlodipine?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing Amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1% in placebo-controlled clinical trials include the following:

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Amlodipine treatment as shown in the following table:

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.

Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

General: allergic reaction, asthenia, 1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System: arthralgia, arthrosis, muscle cramps, 1 myalgia.

Psychiatric: sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Respiratory System: dyspnea, 1 epistaxis.

Skin and Appendages: angioedema, erythema multiforme, pruritus, 1 rash, 1 rash erythematous, rash maculopapular.

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.

Urinary System: micturition frequency, micturition disorder, nocturia.

Autonomic Nervous System: dry mouth, sweating increased.

Metabolic and Nutritional: hyperglycemia, thirst.

Hemopoietic: leukopenia, purpura, thrombocytopenia.

1These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.

In the CAMELOT and PREVENT studies, the adverse event profile was similar to that reported previously, with the most common adverse event being peripheral edema.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of Amlodipine.

Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and Amlodipine.

Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Amlodipine contraindications

See also:
What is the most important information I should know about Amlodipine?

Hypersensitivity to Amlodipine or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other dihydropyridines; severe hypotension (systolic blood pressure <90 mm Hg); breastfeeding; hereditary fructose intolerance (oral solution); hyperglycerolemia or glycerol kinase deficiency (oral solution).

Active ingredient matches for Amlodipine:

Amlodipine Besylate in Australia, Austria, Belize, Bosnia & Herzegowina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia (Hrvatska), Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Estonia, Finland, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey, United States, Venezuela.

Amoxicillin

Amlodipine in Romania.

References

1. DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "amoxicillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. PubChem. "amlodipine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology