Amlodipine

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Uses

Amlodipine, valsartan and hydrochlorothiazide tablets 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, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets.

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 1 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 (e.g., 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.

This fixed combination drug is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].

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Other Information

Amlodipine, valsartan, and hydrochlorothiazide tablets are fixed combination of amlodipine, valsartan and hydrochlorothiazide.

Amlodipine, valsartan and hydrochlorothiazide tablets contain the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl] -4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is:

Its empirical formula is C20H25ClN2O5•C6H6O3S and its molecular weight is 567.1.

Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan, USP is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4 -yl]methyl]-L-valine; its structural formula is:

Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.

Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is:

Amlodipine, valsartan and hydrochlorothiazide film-coated tablets are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan, and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 5/160/25 mg, 10/160/12.5 mg, 10/160/25 mg, and 10/320/25 mg amlodipine/ valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, the 5/160/25 mg, 10/160/12.5 mg, 10/160/25 mg and 10/320/25 mg strengths contain ferric oxide yellow.

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Amlodipine Manufacturers

Torrent Pharmaceuticals Limited

Amlodipine | Torrent Pharmaceuticals Limited

2.1 General Considerations
Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of amlodipine, valsartan and hydrochlorothiazide tablets, USP. The maximum recommended dose of amlodipine, valsartan and hydrochlorothiazide tablets, USP is 10/320/25 mg.
2.2 Add-on / Switch Therapy
Amlodipine, valsartan and hydrochlorothiazide tablets, USP may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of amlodipine, valsartan and hydrochlorothiazide tablets, USP may be switched to amlodipine, valsartan and hydrochlorothiazide tablets, USP containing a lower dose of that component to achieve similar blood pressure reductions.
2.3 Replacement Therapy
Amlodipine, valsartan and hydrochlorothiazide tablets, USP may be substituted for the individually titrated components.
2.4 Use with Other Antihypertensive Drugs
Amlodipine, valsartan and hydrochlorothiazide tablets, USP may be administered with other antihypertensive agents.

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Par Pharmaceutical Inc.

Amlodipine | Par Pharmaceutical Inc.

2.1 General Considerations
Dose once-daily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Amlodipine/ Valsartan /Hydrochlorothiazide. The maximum recommended dose of Amlodipine/Valsartan/Hydrochlorothiazide is 10/320/25 mg.
2.2 Add-on / Switch Therapy
Amlodipine/Valsartan/Hydrochlorothiazide may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Amlodipine/Valsartan/Hydrochlorothiazide may be switched to Amlodipine/Valsartan/Hydrochlorothiazide containing a lower dose of that component to achieve similar blood pressure reductions.
2.3 Replacement Therapy
Amlodipine/Valsartan/Hydrochlorothiazide may be substituted for the individually titrated components.

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Sandoz Inc

Amlodipine | Peaceful Mountain, Inc.

Apply daily to neck, chest, abdomen, inner arms or inner thighs. Begin with two metered pumps morning and evening: adjust dose for your personal needs and comfort.

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Teva Pharmaceuticals Usa Inc

Amlodipine | Wg Critical Care, Llc

NOTE: Contact of undiluted teniposide with plastic equipment or devices used to prepare solutions for infusion may result in softening or cracking and possible drug product leakage. This effect has not been reported with diluted solutions of teniposide.
In order to prevent extraction of the plasticizer DEHP [di(2-ethylhexyl) phthalate], solutions of teniposide should be prepared in non-DEHP containing large volume parenteral (LVP) containers such as glass or polyolefin plastic bags or containers.
Teniposide solutions should be administered with non-DEHP containing intravenous administration sets.
In one study, childhood ALL patients failing induction therapy with a cytarabine-containing regimen were treated with the combination of teniposide 165 mg/m2 and cytarabine 300 mg/m2 intravenously, twice weekly for 8 to 9 doses. In another study, patients with childhood ALL refractory to vincristine/prednisone-containing regimens were treated with the combination of teniposide 250 mg/m2 and vincristine 1.5 mg/m2 intravenously, weekly for 4 to 8 weeks and prednisone 40 mg/m2 orally for 28 days.
Adequate data in patients with hepatic insufficiency and/or renal insufficiency are lacking, but dose adjustments may be necessary for patients with significant renal or hepatic impairment.
Preparation and Administration Precautions
Caution should be exercised in handling and preparing the solution of teniposide. Several guidelines on proper handling and disposal of anticancer drugs have been published.1-4 Skin reactions associated with accidental exposure to teniposide may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling ampules containing teniposide. If teniposide solution contacts the skin, immediately wash the skin thoroughly with soap and water. If teniposide contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Preparation for Intravenous Administration
Teniposide Injection must be diluted with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, to give final teniposide concentrations of 0.1 mg/mL, 0.2 mg/mL, 0.4 mg/mL, or 1.0 mg/mL. Solutions prepared in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP at teniposide concentrations of 0.1 mg/mL, 0.2 mg/mL, or 0.4 mg/mL are stable at room temperature for up to 24 hours after preparation. Teniposide solutions prepared at a final teniposide concentration of 1.0 mg/mL should be administered within 4 hours of preparation to reduce the potential for precipitation. Refrigeration of teniposide solutions is not recommended. Stability and use times are identical in glass and plastic parenteral solution containers.
Although solutions are chemically stable under the conditions indicated, precipitation of teniposide may occur at the recommended concentrations, especially if the diluted solution is subjected to more agitation than is recommended to prepare the drug solution for parenteral administration. In addition, storage time prior to administration should be minimized and care should be taken to avoid contact of the diluted solution with other drugs or fluids. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Precipitation has been reported during 24-hour infusions of teniposide diluted to teniposide concentrations of 0.1 to 0.2 mg/mL, resulting in occlusion of central venous access catheters in several patients. Heparin solution can cause precipitation of teniposide, therefore, the administration apparatus should be flushed thoroughly with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP before and after administration of teniposide.
Hypotension has been reported following rapid intravenous administration; it is recommended that the teniposide solution be administered over at least a 30- to 60-minute period. Teniposide should not be given by rapid intravenous injection.
In a 24-hour study under simulated conditions of actual use of the product relative to dilution strength, diluent and administration rates, dilutions at 0.1 to 1.0 mg/mL were chemically stable for at least 24 hours. Data collected for the presence of the extractable DEHP [di(2-ethylhexyl) phthalate] from PVC containers show that levels increased with time and concentration of the solutions. The data appeared similar for 0.9% Sodium Chloride Injection, USP, and 5% Dextrose Injection, USP. Consequently, the use of PVC containers is not recommended.
Similarly, the use of non-DEHP intravenous administration sets is recommended. Lipid administration sets or low DEHP-containing nitroglycerin sets will keep patient’s exposure to DEHP at low levels and are suitable for use. The diluted solutions are chemically and physically compatible with the recommended intravenous administration sets and LVP containers for up to 24 hours at ambient room temperature and lighting conditions. Because of the potential for precipitation, compatibility with other drugs, infusion materials, or intravenous pumps cannot be assured.
Stability
Unopened ampules of Teniposide Injection are stable until the date indicated on the package when stored under refrigeration 2° to 8°C (36° to 46°F) in the original package. Freezing does not adversely affect the product.

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Caraco Pharmaceutical Laboratories, Ltd.

Amlodipine | Caraco Pharmaceutical Laboratories, Ltd.

Adults
The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy.
Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
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. See ADVERSE REACTIONS section for information related to dosage and side effects.
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 (see CLINICAL PHARMACOLOGY, Clinical Studies).
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. See CLINICAL PHARMACOLOGY.
Coadministration with Other Antihypertensive and/or Antianginal Drugs
Amlodipine has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.

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Remedyrepack Inc.

Amlodipine | Remedyrepack Inc.

Adults
The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy.
Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently. 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. See ADVERSE REACTIONSsection for information related to dosage and side effects.

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. (See CLINICAL PHARMACOLOGY).

Coadministration with Other Antihypertensive and/or AntianginalDrugs
Amlodipine has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.

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Macleods Pharmaceuticals Limited

Amlodipine | Macleods Pharmaceuticals Limited

2.1 Adults
The usual initial antihypertensive oral dose of amlodipine besylate tablets USP is 5 mg once daily, and the maximum dose of 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 besylate USP to other antihypertensive therapy.

Adjust dosage according to blood pressure goals. In general, Wait 7 to 14 days between titration steps. Titration may proceed 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 [see Adverse Reactions (6)].

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 [see Clinical Studies (14.4)].
2.2 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 [see Clinical Pharmacology ( 12.4 ), Clinical Studies ( 14.1 )].

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State Of Florida Doh Central Pharmacy

Amlodipine | State Of Florida Doh Central Pharmacy

Adults
The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy.
Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
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. See ADVERSE REACTIONS section for information related to dosage and side effects.
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 (see CLINICAL PHARMACOLOGY, Clinical Studies).
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. See CLINICAL PHARMACOLOGY.
Coadministration with Other Antihypertensive and/or Antianginal Drugs
Amlodipine has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.

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