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Amlodipine Besylate And Benazepril Hydrochloride (Amlodipine Besylate And Benazepril Hydrochloride)

Trade Name : Amlodipine Besylate and Benazepril Hydrochloride

Aidarex Pharmaceuticals LLC

CAPSULE

Strength 520 mg/1mg/1

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amlodipine Besylate And Benazepril Hydrochloride (Amlodipine Besylate And Benazepril Hydrochloride) which is also known as Amlodipine Besylate and Benazepril Hydrochloride and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 5; 20 mg/1; mg/1 per ml. Read more

Amlodipine Besylate And Benazepril Hydrochloride (Amlodipine Besylate And Benazepril Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Boxed Warning: Fetal Toxicity u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2012Dosage and Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2012u00a0Contraindicationsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2012Warnings and Precautions: Fetal Toxicityu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2012
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  • Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
  • Amlodipine besylate and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. n
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  • Dose once-daily.
  • May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor. n
  • Patients who experience edema with amlodipine may be switched to amlodipine besylate and benazepril hydrochloride capsules containing a lower dose of amlodipine. n
  • Start amlodipine besylate and benazepril hydrochloride capsules at 2.5 mg/10 mg in patients u2265 75 years old or in patients with hepatic impairment. n
  • Amlodipine besylate and benazepril hydrochloride capsules are available as follows:n 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg.
  • Capsules (amlodipine and benazepril): 2.5 mg/10 mg, 5 mg/10 mg,u00a05 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. n
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  • Do not co-administer aliskiren with ARBs or ACEIs, including amlodipine besylate and benazepril hydrochloride capsules in patients with diabetes. n
  • Amlodipine besylate and benazepril hydrochloride capsulesare contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine. n
  • No data
  • Watch for anaphylactoid reactions, including angioedema (head, neck or intestinal).u00a0n
  • Warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina. n
  • Assess for hypotension and hyperkalemia. ( and )
  • Avoid fetal or neonatal exposure. n
  • Titrate slowly in patients with impaired hepatic or severely impaired renal function.
  • Discontinuation because of adverse reactions occurred in 4% of amlodipine besylate and benazepril hydrochloride-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with amlodipine besylate and benazepril hydrochloride were cough and edema. n n n
  • No data
  • Potassium supplements/Potassium-sparing diuretics: Risk of hyperkalemia. n
  • Lithium: Increased serum lithium levels; toxicity symptoms. n
  • Injectable gold: Facial flushing, nausea, vomiting, or hypotension may occur. n
  • NSAID: Risk of renal dysfunction, loss of antihypertensive effect. n
  • If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin. n
  • Dual inhibition of the rennin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. n
  • Nursing Mothers:
  • (8.3)
  • Only a few cases of human overdose with amlodipine have been reported. One patient was asymptomatic after a 250 mg ingestion; another, who combined 70 mg of amlodipine with an unknown large quantity of a benzodiazepine, developed refractory shock and died.n Human overdoses with any combination of amlodipine and benazepril have not been reported. In scattered reports of human overdoses with benazepril and other ACE inhibitors, there are no reports of death.n Patients should be admitted to hospital and, generally, should be managed in an intensive care setting, with continuous monitoring of cardiac function, blood gases, and blood biochemistry. Emergency supportive measures such as artificial ventilation or cardiac pacing should be instituted if appropriate.n In the event of a potentially life-threatening oral overdose, use induction of vomiting or gastric lavage and/or activated charcoal to remove the drug from the gastrointestinal tract (only if presented within 1 hour after ingestion of amlodipine besylate and benazepril hydrochloride).n Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care.n To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physiciansu2019 Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.n The most likely effect of overdose with amlodipine besylate and benazepril hydrochloride is vasodilation, with consequent hypotension and tachycardia. Simple repletion of central fluid volume (Trendelenburg positioning, infusion of crystalloids) may be sufficient therapy, but pressor agents (norepinephrine or high-dose dopamine) may be required. With abrupt return of peripheral vascular tone, overdoses of other dihydropyridine calcium channel blockers have sometimes progressed to pulmonary edema, and patients must be monitored for this complication.n Analyses of bodily fluids for concentrations of amlodipine, benazepril, or their metabolites are not widely available. Such analyses are, in any event, not known to be of value in therapy or prognosis.n No data are available to suggest physiologic maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of amlodipine, benazepril, or their metabolites. Benazeprilat is only slightly dialyzable; attempted clearance of amlodipine by hemodialysis or hemo-perfusion has not been reported, but amlodipineu2019s high protein binding makes it unlikely that these interventions will be of value.n Angiotensin II could presumably serve as a specific antagonist-antidote to benazepril, but angiotensin II is essentially unavailable outside of scattered research laboratories.
  • Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride.u00a0Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochlorideu2019s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula isu00a0
  • Its molecular formula is CHNOu2022HCl, and its molecular weight is 460.96.u00a0Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.u00a0Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4u00ad-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is
  • Its molecular formula is CHClNOu2022CHOS, and its molecular weight is 567.1.u00a0Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.u00a0Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent tou00a02.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg.u00a0The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac.
  • No data
  • No data
  • Over 950 patients received amlodipine besylate and benazepril hydrochloride once daily in six double-blind, placebo-controlled studies. The antihypertensive effect of a single dose persisted for 24 hours, with peak reductions achieved 2 to 8 hours after dosing.u00a0Once-daily doses of benazepril and amlodipine using benazepril doses of 10 to 20 mg and amlodipine doses of 2.5 to 10 mg decreased seated pressure (systolic/diastolic) 24 hours after dosing by about 10 to 25/6 to 13 mmHg.u00a0In two studies in patients not adequately controlled on either benazepril 40 mg alone (n=329) or amlodipine 10 mg alone (n=812) once daily doses of amlodipine besylate and benazepril hydrochloride 10 mg/40 mg further decreased seated blood pressure compared to the respective monotherapy alone.u00a0Combination therapy was effective in blacks and nonblacks. Both components contributed to the antihypertensive efficacy in nonblacks, but virtually all of the antihypertensive effect in blacks could be attributed to the amlodipine component. Among nonblack patients in placebo-controlled trials comparing amlodipine besylate and benazepril hydrochloride to the individual components, the blood pressure lowering effects of the combination were shown to be additive and in some cases synergistic.u00a0During chronic therapy with amlodipine besylate and benazepril hydrochloride, the maximum reduction in blood pressure with any given dose is generally achieved after 1 to 2 weeks. The antihypertensive effects of amlodipine besylate and benazepril hydrochloride have continued during therapy for at least 1 year. Abrupt withdrawal of amlodipine besylate and benazepril hydrochloride has not been associated with a rapid increase in blood pressure.
  • Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 5 mg of amlodipine, with 20 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/20 mg. They are available as follows:n n are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size u201c0u201d of pink cap and pink body imprinted with u2018Iu2019 on pink cap and u201898u2019 on pink body with black edible ink.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles ofu00a030u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0982-30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles ofu00a060u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0982-60u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles ofu00a090u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0982-90
  • Arrayn- Store at
  • Information for Patients
  • Female patients of childbearing age should be told about the consequences of exposure to amlodipine besylate and benazepril hydrochloride during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.n Maalox is a registered trademark of Physicians Total Care, Inc.n Manufactured for:n 2400 Route 130 NorthDayton, NJ 08810 n Manufactured by:n n Unit-VII (SEZ)Mahaboob Nagar (Dt)AP-509302, INDIA n Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • Revised: 11/2012
  • No data
  • No data

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