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Amlodipine Besylate And Benazepril Hydrochloride (Lotrel)

Trade Name : Lotrel

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 1020 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 (Lotrel) which is also known as Lotrel and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 10; 20 mg/1; mg/1 per ml. Read more

Amlodipine Besylate And Benazepril Hydrochloride (Lotrel) 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
  • When pregnancy is detected, discontinue Lotrel as soon as possible (5.1).
  • Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus (5.1).
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue Lotrel as soon as possible (). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ().
  • Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.u00a0u00a0
  • Lotrel is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. ()
  • No data
  • Usual starting dose is 2.5/10 mg. ()n
  • 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 Lotrel containing a lower dose of amlodipine. ()u00a0n
  • Lotrel (amlodipine/benazepril) capsules are available as follows:
  • 5/10 mg, 5/20 mg, 10/20 mg, and 10/40 mg.
  • Capsules (amlodipine/benazepril mg): 5/10, 5/20, 10/20, 10/40 ()
  • No data
  • Do not coadminister aliskiren with ACE inhibitors, including Lotrel, in patients with diabetes. ()
  • Lotrel is contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine. ()
  • Lotrel is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotrel within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan. ()
  • No data
  • Anaphylactoid reactions, including angioedema ()n
  • Myocardial infarction or increased angina in patients with obstructive coronary artery disease. ()
  • Assess for hypotension and hyperkalemia. (, )
  • Titrate slowly in patients with impaired hepatic or severely impaired renal function. (, )
  • Discontinuation because of adverse reactions occurred in 4% of Lotrel-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with Lotrel were cough and edema. ()
  • Amlodipine
  • Simvastatin:
  • CYP3A4 Inhibitors:
  • CYP3A4 Inducers:
  • Benazepril
  • Potassium Supplements and Potassium-Sparing Diuretics:
  • Lithium:
  • Gold:
  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
  • The antihypertensive effect of ACE inhibitors, including benazepril, may be attenuated by NSAIDs.
  • Antidiabetic Agents:
  • Mammalian Target of Rapamycin (mTOR) Inhibitors:
  • Dual Blockade of the Renin-Angiotensin System (RAS):
  • Do not coadminister aliskiren with Lotrel in patients with diabetes. Avoid use of aliskiren with Lotrel in patients with renal impairment [glomerular filtration rate (GFR) < 60 mL/min].
  • Neprilysin Inhibitor
  • [see Warnings and Precautions (5.1)]
  • Potassium supplements/potassium-sparing diuretics: hyperkalemia ()
  • Lithium: Increased serum lithium levels; toxicity symptoms ()
  • Injectable gold: facial flushing, nausea, vomiting, hypotension ()
  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect ()
  • Do not exceed doses greater than 20 mg daily of simvastatin ()
  • mTOR inhibitors: increased risk of angioedema ()
  • Dual inhibition of the RAS: Increased risk of renal impairment, hypotension, and hyperkalemia ()
  • Neprilysin inhibitors: increased risk of angioedema ()
  • No data
  • 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.
  • 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.
  • Treatment:
  • 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 Lotrel).
  • Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care.
  • 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.
  • The most likely effect of overdose with Lotrel 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.
  • 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.
  • 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.
  • Angiotensin II could presumably serve as a specific antagonist-antidote to benazepril, but angiotensin II is essentially unavailable outside of scattered research laboratories.
  • Lotrel is a combination of amlodipine besylate and benazepril hydrochloride.
  • Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 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 is:
  • nttu00a0u00a0u00a0u00a0u00a0ntu00a0u00a0n
  • Its empirical formula is CHNOu2022HCl, and its molecular weight is 460.96.
  • Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl ACE inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.
  • Amlodipine besylate is a white to pale yellow crystalline 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)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:
  • nttu00a0u00a0u00a0u00a0u00a0ntu00a0u00a0u00a0n
  • Its empirical formula is CHClNOu2022CHOS, and its molecular weight is 567.1.
  • Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.
  • Lotrel capsules are formulated in 4 different strengths for oral administration with a combination of amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine, with 10 mg, 20u00a0mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 5/10 mg, 5/20 mg, 10/20 mg and 10/40 mg.
  • The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 10/40 mg strength), iron oxides, lactose monohydrate, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.
  • No data
  • Carcinogenicity and mutagenicity studies have not been conducted with this combination. However, these studies have been conducted with amlodipine and benazepril alone (see below).u00a0No adverse effects on fertility occurred when the benazepril:amlodipine combination was given orally to rats of either sex at doses up to 15:7.5 mgu00a0(benazepril:amlodipine)/kg/day, prior to mating and throughout gestation.
  • Benazepril:
  • Amlodipine:
  • Over 950 patients received Lotrel once-daily in 6 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.
  • Once-daily doses of benazepril/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 10u201325/6u201313 mmHg.
  • In 2 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 Lotrel 10/40 mg further decreased seated blood pressure compared to the respective monotherapy alone.
  • Combination 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 Lotrel to the individual components, the blood pressure lowering effects of the combination were shown to be additive and in some cases synergistic.
  • During chronic therapy with Lotrel, the maximum reduction in blood pressure with any given dose is generally achieved after 1 to 2 weeks. The antihypertensive effects of Lotrel have continued during therapy for at least 1 year. Abrupt withdrawal of Lotrel has not been associated with a rapid increase in blood pressure.
  • Lotrel is available as capsules containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine, with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride providing for the following available combinations: 5/10 mg, 5/20 mg, 10/20 mg, and 10/40 mg. All strengths are packaged in bottles of 100 capsules.
  • Capsules are imprinted with u201cLotrelu201d and appropriate code.
  • Storage: Store at 20u00b0C - 25u00b0C (68u00b0F - 77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F). [See USP controlled room temperature]. Protect from moisture. Dispense in tight container (USP).
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Pregnancy:n- [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]
  • Symptomatic Hypotension:n- [see Warnings and Precautions (5.4)]
  • Hyperkalemia:n- [see Drug Interactions (7)]
  • T2020-19
  • Patient Information
  • LOTREL (low-TREL)
  • (amlodipine besylate/benazepril hydrochloride)
  • capsules
  • Read this Patient Information leaflet before you start taking LOTREL and each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor. If you have any questions, ask your doctor or pharmacist.
  • What is LOTREL?
  • LOTREL contains 2 prescription medicines that work together to lower blood pressure: amlodipine besylate, a calcium channel blocker, and benazepril hydrochloride, an ACE inhibitor. Your doctor will prescribe LOTREL only after other medicines havenu2019t worked.
  • High Blood Pressure (hypertension
  • LOTREL has not been studied in children.
  • Who should not take LOTREL?
  • Donu2019t take LOTREL if you are allergic to any of the ingredients.
  • What should I tell my Doctor before taking LOTREL?
  • Tell your doctor about all your medical conditions, including if:
  • Keep a list of your medicines with you, including vitamins and natural or herbal remedies, to show your doctor or pharmacist. Some of your other medicines and LOTREL could affect each other, causing serious side effects. Tell your doctor about all your medicines, especially:
  • Avoid alcohol until you have discussed the matter with your doctor. Alcohol may make blood pressure fall more and/or increase the possibility of dizziness or fainting.
  • How do I take LOTREL?
  • What are the possible side effects of LOTREL?
  • LOTREL can cause serious side effects including:
  • The more common side effects of LOTREL are:
  • If any of these affects you severely, tell your doctor.
  • These are not all the side effects of LOTREL. For a complete list, ask your doctor or pharmacist.
  • How do I store LOTREL?
  • General Information about LOTREL
  • Doctors can also use medicine for a condition that is not in the patient information leaflet. Take LOTREL the way your doctor tells you. Do not share it with other people. It may harm them.
  • For more information, ask your doctor or pharmacist, visit www.LOTREL.com on the Internet, or call 1-888-669-6682.
  • What are the ingredients in LOTREL?
  • Active ingredients: amlodipine besylate (the active ingredient found in Norvascu00ae), benazepril hydrochloride (Lotensinu00ae)
  • Inactive ingredients: calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg and 10/40 mg strengths), iron oxides, lactose monohydrate, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2020-20February 2020
  • NDC 0078-0405-05
  • Lotrel 5/10
  • amlodipine besylate
  • (equivalent to amlodipine 5 mg)
  • benazepril HCl 10 mg
  • 100 capsules
  • Rx only
  • NOVARTIS
  • NDC 0078-0406-05
  • Lotrel 5/20
  • amlodipine besylate
  • (equivalent to amlodipine 5 mg)
  • benazepril HCl 20 mg
  • 100 capsules
  • Rx only
  • NOVARTIS
  • NDC 0078-0364-05
  • Lotrel 10/20
  • amlodipine besylate
  • (equivalent to amlodipine 10 mg)
  • benazepril HCl 20 mg
  • 100 capsules
  • Rx only
  • NOVARTIS
  • NDC 0078-0379-05
  • Lotrel 10/40
  • amlodipine besylate
  • (equivalent to amlodipine 10 mg)
  • benazepril HCl 40 mg
  • 100 capsules
  • Rx only
  • NOVARTIS

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