Amlodipine And Benazepril Hydrochloride (Amlodipine And Benazepril Hydrochloride)

Trade Name : Amlodipine and Benazepril Hydrochloride

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 2.510 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 And Benazepril Hydrochloride (Amlodipine And Benazepril Hydrochloride) which is also known as Amlodipine and Benazepril Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2.5; 10 mg/1; mg/1 per ml. Read more

Amlodipine And Benazepril Hydrochloride (Amlodipine 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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When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible ().
Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ().
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible (). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ().

Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Amlodipine 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 and benazepril hydrochloride capsules are 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. ()
May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor ()
Patients who experience edema with amlodipine may be switched to amlodipine and benazepril hydrochloride capsules containing a lower dose of amlodipine. ()

Amlodipine and benazepril hydrochloride capsules, USP are available as follows:
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/benazepril mg): 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg ()

No data

Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride, in patients with diabetes. (4)
Amlodipine and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine. (4)
Amlodipine and benazepril hydrochloride capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [].

No data

Anaphylactoid reactions, including angioedema ()
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 amlodipine and benazepril hydrochloride capsule-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride capsules were cough and edema. ()
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Amlodipine
Simvastatin:
CYP3A4 Inhibitors:
CYP3A4 Inducers:
Benazepril
Potassium Supplements and Potassium-Sparing Diuretics:
Lithium:
Gold:
Non-Steroidal 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 amlodipine besylate and benazepril hydrochloride in patients with diabetes. Avoid use of aliskiren with amlodipine besylate and benazepril hydrochloride in patients with renal impairment [glomerular filtration rate (GFR) < 60 mL/min].
Neprilysin Inhibitor
Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema .

Potassium supplements/potassium-sparing diuretics: hyperkalemia ()
Lithium: Increased serum lithium levels; toxicity symptoms ()
Injectable gold: facial flushing, nausea, vomiting, hypotension ()
Non-Steroidal 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 renin-angiotensin system (RAS): Increased risk of renal impairment, hypotension, and hyperkalemia ()
Neprilysin inhibitors: increased risk of angioedema ()

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.
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.
Arrayn- 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 amlodipine besylate and benazepril hydrochloride).
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 amlodipine besylate and benazepril hydrochloride capsules 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.

Benazepril hydrochloride, USP 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:
CHNOu2022HCl M.W. 460.96
Benazeprilat, 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.
Amlodipine besylate, USP 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:
CHClNOu2022CHOS M.W. 567.1
Amlodipine besylate, USP is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.
Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. The capsules are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate, USP equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride, USP 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.
The inactive ingredients of the capsules are black iron oxide, calcium phosphate dibasic anhydrous, colloidal silicon dioxide, corn starch, crospovidone, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. In addition, the 5 mg/10 mg capsule contains red iron oxide and yellow iron oxide; the 5 mg/20 mg capsule contains D&C Red 28, FD&C Blue 1, and FD&C Red 40; the 10 mg/20 mg capsule contains FD&C Blue 1 and FD&C Red 3; and the 5 mg/40 mg and 10 mg/40 mg capsules contain FD&C Blue 1.

No data

No data

Over 950 patients received amlodipine and benazepril hydrochloride capsules 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 10 to 25/6 to 13 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 amlodipine and benazepril hydrochloride capsules, 10 mg/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 amlodipine and benazepril hydrochloride capsules 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 amlodipine and benazepril hydrochloride capsules, the maximum reduction in blood pressure with any given dose is generally achieved after 1 to 2 weeks. The antihypertensive effects of amlodipine and benazepril hydrochloride capsules have continued during therapy for at least 1 year. Abrupt withdrawal of amlodipine and benazepril hydrochloride capsules has not been associated with a rapid increase in blood pressure.

Amlodipine and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate, USP equivalent to 2.5 mg, 5 mg, or 10 mg of amlodipine, with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride, USP 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. All 6 strengths are packaged with a desiccant in bottles. They are available as follows:
2.5 mg/10 mg capsules: a hard gelatin capsule with a white opaque cap and body, filled with white to off-white powder, imprinted u201cTEVAu201d on the cap and u201c7370u201d on the body in bottles of 100 (NDC 0093-7370-01).
5 mg/10 mg capsules: a hard gelatin capsule with an orange opaque cap and white opaque body, filled with white to off-white powder, imprinted u201cTEVAu201d on the cap and u201c7371u201d on the body in bottles of 100 (NDC 0093-7371-01).
5 mg/20 mg capsules: a hard gelatin capsule with a pink opaque cap and white opaque body, filled with white to off-white powder, imprinted u201cTEVAu201d on the cap and u201c7372u201d on the body in bottles of 100 (NDC 0093-7372-01).
5 mg/40 mg capsules: a hard gelatin capsule with a light turquoise blue cap and light turquoise blue body, filled with white to off-white powder, imprinted u201cTEVAu201d on the cap and u201c7670u201d on the body in bottles of 100 (NDC 0093-7670-01).
10 mg/20 mg capsules: a hard gelatin capsule with a blue violet opaque cap and body, filled with white to off-white powder, imprinted u201cTEVAu201d on the cap and u201c7373u201d on the body in bottles of 100 (NDC 0093-7373-01).
10 mg/40 mg capsules: a hard gelatin capsule with a light blue cap and light blue body, filled with white to off-white powder, imprinted u201cTEVAu201d on the cap and u201c7671u201d on the body in bottles of 100 (NDC 0093-7671-01).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Advise the patient to read the FDA-approved patient labeling (Patient Information).n- [see Warnings and Precautions ()]
Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. W 7/2017

Amlodipine (amlu014du00b4dipu0113n) and Benazepril (bu0259-nu0101u2032zu0259-pru012dlu2032) Hydrochloride Capsules, USP
Read this Patient Information leaflet before you start taking amlodipine and benazepril hydrochloride capsules 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 are amlodipine and benazepril hydrochloride capsules?
Amlodipine and benazepril hydrochloride capsules contain 2 prescription medicines that work together to lower blood pressure: amlodipine besylate (the active ingredient found in Norvasc), a calcium channel blocker, and benazepril hydrochloride (Lotensin), an ACE inhibitor. Your doctor will prescribe amlodipine and benazepril hydrochloride capsules only after other medicines havenu2019t worked.
High Blood Pressure (hypertension).
Amlodipine and benazepril hydrochloride capsules have not been studied in children.
Who should not take amlodipine and benazepril hydrochloride capsules?
Donu2019t take amlodipine and benazepril hydrochloride capsules if you are allergic to any of the ingredients.
What should I tell my Doctor before taking amlodipine and benazepril hydrochloride capsules?
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 amlodipine and benazepril hydrochloride capsules 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 amlodipine and benazepril hydrochloride capsules?
What are the possible side effects of amlodipine and benazepril hydrochloride capsules?
Amlodipine and benazepril hydrochloride capsules can cause serious side effects including:
These allergic reactions are rare but happen more times in people who are African-American.
The more common side effects of amlodipine and benazepril hydrochloride capsules are:
If any of these affects you severely, tell your doctor.
These are not all the side effects of amlodipine and benazepril hydrochloride capsules. For a complete list, ask your doctor or pharmacist.
How do I store amlodipine and benazepril hydrochloride capsules?
General Information about amlodipine and benazepril hydrochloride capsules
Doctors can also use medicine for a condition that is not in the patient information leaflet. Take amlodipine and benazepril hydrochloride capsules the way your doctor tells you. Do not share them with other people. They may harm them.
For more information, ask your doctor or pharmacist, or call 1-866-832-8537.
What are the ingredients in amlodipine and benazepril hydrochloride capsules, USP?
Active ingredients: amlodipine besylate, USP (the active ingredient found in Norvasc), benazepril hydrochloride, USP (Lotensin)
Inactive ingredients: black iron oxide, calcium phosphate dibasic anhydrous, colloidal silicon dioxide, corn starch, crospovidone, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. In addition, the 5 mg/10 mg capsule contains red iron oxide and yellow iron oxide; the 5 mg/20 mg capsule contains D&C Red 28, FD&C Blue 1, and FD&C Red 40; the 10 mg/20 mg capsule contains FD&C Blue 1 and FD&C Red 3; and the 5 mg/40 mg and 10 mg/40 mg capsules contain FD&C Blue 1.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. K 7/2017

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Amlodipine And Benazepril Hydrochloride (Amlodipine And Benazepril Hydrochloride)

Trade Name : Amlodipine and Benazepril Hydrochloride

CAPSULE

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Product information is meant for

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

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About GNH

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Amlodipine And Benazepril Hydrochloride (Amlodipine And Benazepril Hydrochloride)

Trade Name : Amlodipine and Benazepril Hydrochloride

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

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