Amlodipine 10 mg FDC Uses

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What is Amlodipine 10 mg FDC?

Amlodipine 10 mg FDC 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 10 mg FDC is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, Amlodipine 10 mg FDC relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Amlodipine 10 mg FDC is available only with your doctor's prescription.

Amlodipine 10 mg FDC indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Hypertension

Amlodipine 10 mg FDC is 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 10 mg FDC.

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 10 mg FDC may be used alone or in combination with other antihypertensive agents.

Coronary Artery Disease (CAD)

Chronic Stable Angina

Amlodipine 10 mg FDC is indicated for the symptomatic treatment of chronic stable angina. Amlodipine 10 mg FDC may be used alone or in combination with other antianginal agents.

Vasospastic Angina (Prinzmetal's or Variant Angina)

Amlodipine 10 mg FDC is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine 10 mg FDC 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 10 mg FDC is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.

How should I use Amlodipine 10 mg FDC?

Use Amlodipine 10 mg FDC as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Amlodipine 10 mg FDC.

Uses of Amlodipine 10 mg FDC in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used along with other treatment for certain blood vessel diseases (e.g., arteriosclerosis obliterans, Raynaud's disease, Buerger's disease, cerebrovascular insufficiency). It works by widening blood vessels to help increase blood flow (improve circulation) to certain parts of the body (e.g., hands/feet, brain). This effect may help to decrease symptoms such as cold hands and feet, numbness, tingling, and decreased memory or judgment.

How to use Amlodipine 10 mg FDC

This medication is taken by mouth with or without food, usually 3 to 4 times daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition persists or worsens.

Amlodipine 10 mg FDC description

Each 5-mg and 10-mg tablet contains Amlodipine besilate equivalent to Amlodipine 10 mg FDC 5 mg and 10 mg, respectively.

Amlodipine 10 mg FDC also contains the following excipients: Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, magnesium stearate, sodium starch glycollate.

Amlodipine 10 mg FDC besilate is the besilate salt of Amlodipine 10 mg FDC, a long-acting calcium-channel blocker. It is 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate. Its empirical formula is C20H25ClN2O5·C6H6O3S and has a molecular weight of 567.1.

Amlodipine 10 mg FDC besilate is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.

Amlodipine 10 mg FDC dosage

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Adults

The usual initial antihypertensive oral dose of Amlodipine 10 mg FDC 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 10 mg FDC 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 5–10 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 5–10 mg once daily. In clinical studies, the majority of patients required 10 mg.

Children

The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.

How supplied

Dosage Forms And Strengths

Tablets

2.5 mg white, diamond, flat-faced, beveled edged, with "Amlodipine 10 mg FDC" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Amlodipine 10 mg FDC" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Amlodipine 10 mg FDC" on one side and "10" on the other

Storage And Handling

2.5 mg Tablets

Amlodipine 10 mg FDC – 2.5 mg Tablets (Amlodipine 10 mg FDC besylate equivalent to 2.5 mg of Amlodipine 10 mg FDC per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Amlodipine 10 mg FDC" on one side and "2.5" on the other side and supplied as follows:

NDC 0069-1520-68 Bottle of 90

5 mg Tablets

Amlodipine 10 mg FDC – 5 mg Tablets (Amlodipine 10 mg FDC besylate equivalent to 5 mg of Amlodipine 10 mg FDC per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Amlodipine 10 mg FDC" and "5" on one side and plain on the other side and supplied as follows:

NDC 0069-1530-68 Bottle of 90

NDC 0069-1530-41 Unit Dose package of 100

NDC 0069-1530-72 Bottle of 300

10 mg Tablets

Amlodipine 10 mg FDC – 10 mg Tablets (Amlodipine 10 mg FDC besylate equivalent to 10 mg of Amlodipine 10 mg FDC per tablet) are white, round, flat-faced, beveled edged engraved with both "Amlodipine 10 mg FDC" and "10" on one side and plain on the other side and supplied as follows:

NDC 0069-1540-68 Bottle of 90

NDC 0069-1540-41 Unit Dose package of 100

Storage

Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, lightresistant containers (USP).

Manufactured by: Pfizer, Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: March 2015

Amlodipine 10 mg FDC interactions

See also:
What other drugs will affect Amlodipine 10 mg FDC?

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Amlodipine 10 mg FDC has been safely administered with thiazide diuretics, alpha-blockers, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

In vitro data from studies with human plasma indicate that Amlodipine 10 mg FDC has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).

Simvastatin: Co-administration of multiple doses of 10 mg Amlodipine 10 mg FDC with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Amlodipine 10 mg FDC to 20 mg daily.

Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Amlodipine 10 mg FDC in 20 healthy volunteers had no significant effect on the pharmacokinetics of Amlodipine 10 mg FDC. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Amlodipine 10 mg FDC; therefore, administration of Amlodipine 10 mg FDC with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.

CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg Amlodipine 10 mg FDC in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Amlodipine 10 mg FDC systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Amlodipine 10 mg FDC systemic exposure (22% increase in area under the concentration versus time curve [AUC]). Although the clinical relevance of these findings is uncertain, pharmacokinetic variations may be more pronounced in the elderly.

Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Amlodipine 10 mg FDC to a greater extent than diltiazem. Amlodipine 10 mg FDC should be used with caution when administered with CYP3A4 inhibitors.

Clarithromycin: Clarithromycin is an inhibitor of CYP3A4. There is an increased risk of hypotension in patients receiving clarithromycin with Amlodipine 10 mg FDC. Close observation of patients is recommended when Amlodipine 10 mg FDC is co-administered with clarithromycin.

CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Amlodipine 10 mg FDC. Concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericum perforatum) may decrease the plasma concentrations of Amlodipine 10 mg FDC. Amlodipine 10 mg FDC should be used with caution when administered with CYP3A4 inducers.

In the following studies, there were no significant changes in the pharmacokinetics of either Amlodipine 10 mg FDC or another drug within the study, when co-administered.

Special Studies: Effect of Other Agents on Amlodipine 10 mg FDC: Cimetidine: Co-administration of Amlodipine 10 mg FDC with cimetidine did not alter the pharmacokinetics of Amlodipine 10 mg FDC.

Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Amlodipine 10 mg FDC had no significant effect on the pharmacokinetics of Amlodipine 10 mg FDC.

Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Amlodipine 10 mg FDC. When Amlodipine 10 mg FDC and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.

Special Studies: Effect of Amlodipine 10 mg FDC on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Amlodipine 10 mg FDC with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

Digoxin: Co-administration of Amlodipine 10 mg FDC with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.

Ethanol (Alcohol): Single and multiple 10 mg doses of Amlodipine 10 mg FDC had no significant effect on the pharmacokinetics of ethanol.

Warfarin: Co-administration of Amlodipine 10 mg FDC with warfarin did not change the warfarin prothrombin response time.

Cyclosporin: Pharmacokinetic studies with cyclosporin have demonstrated that Amlodipine 10 mg FDC does not significantly alter the pharmacokinetics of cyclosporin.

Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Amlodipine 10 mg FDC. In order to avoid toxicity of tacrolimus, administration of Amlodipine 10 mg FDC in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.

Drug/Laboratory Test Interactions: None known.

Amlodipine 10 mg FDC side effects

See also:
What are the possible side effects of Amlodipine 10 mg FDC?

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 10 mg FDC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Amlodipine 10 mg FDC was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Amlodipine 10 mg FDC were of mild or moderate severity. In controlled clinical trials directly comparing Amlodipine 10 mg FDC (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Amlodipine 10 mg FDC 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:

2.5 mg Amlodipine 10 mg FDC 5 mg 10 mg Placebo
N=275 N=296 N=268 N=520
Edema 1.8 3.0 10.8 0.6
Dizziness 1.1 3.4 3.4 1.5
Flushing 0.7 1.4 2.6 0.0
Palpitation 0.7 1.4 4.5 0.6

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

Amlodipine 10 mg FDC (%)

(N=1730)

Placebo (%)

(N=1250)

Fatigue 4.5 2.8
Nausea 2.9 1.9
Abdominal Pain 1.6 0.3
Somnolence 1.4 0.6

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Amlodipine 10 mg FDC treatment as shown in the following table:

Amlodipine 10 mg FDC Placebo
Male=%

(N=1218)

Female=%

(N=512)

Male=%

(N=914)

Female=%

(N=336)

Edema 5.6 14.6 1.4 5.1
Flushing 1.5 4.5 0.3 0.9
Palpitations 1.4 3.3 0.9 0.9
Somnolence 1.3 1.6 0.8 0.3

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, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System

arthralgia, arthrosis, muscle cramps,These 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 10 mg FDC contraindications

See also:
What is the most important information I should know about Amlodipine 10 mg FDC?

Before taking Amlodipine 10 mg FDC, tell your doctor if you have congestive heart failure or liver disease.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Amlodipine 10 mg FDC.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Amlodipine 10 mg FDC is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Tell your doctor about all other heart or blood pressure medications you are taking.

Your chest pain may become worse when you first start taking Amlodipine 10 mg FDC or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Active ingredient matches for Amlodipine 10 mg FDC:

Amlodipine in United Kingdom.


List of Amlodipine 10 mg FDC substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Amlodipine Maleate 10 mg
Tablet; Oral; Amlodipine Maleate 5 mg
Tablet; Oral; Amlodipine Maleate 10 mg
Tablet; Oral; Amlodipine Maleate 5 mg
Tablet; Oral; Amlodipine 10 mg
Tablet; Oral; Amlodipine 5 mg

References

  1. PubChem. "amlodipine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "amlodipine". http://www.drugbank.ca/drugs/DB00381 (accessed September 17, 2018).
  3. MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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