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Amlobenz

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Overview

What is Amlobenz?

Amlodipine besylate and benazepril hydrochloride capsules is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)- propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is

Its molecular formula is CHN0•HCl, and its molecular weight is 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 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

Its molecular formula is CHClN0•CH0S, and its molecular weight is 567.1. 

Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.  Amlodipine besylate and benazepril hydrochloride capsules are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. Each hard-gelatin capsule contains gelatin, titanium dioxide and D&C yellow # 10, D&C red # 28 (5 mg/20 mg), FD&C blue # 1(5 mg/20 mg), FD&C green # 3 (2.5 mg/10 mg), FD&C red # 40 (5 mg/20 mg) , iron oxide black (10 mg/20 mg) and iron oxide red (5 mg/20 mg and 10 mg/20 mg) as coloring agents.



What does Amlobenz look like?



What are the available doses of Amlobenz?

Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 10/20 ()

What should I talk to my health care provider before I take Amlobenz?

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How should I use Amlobenz?

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Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. 

The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. 

It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. 

Renal Impairment:

Hepatic Impairment and Elderly Patients:


What interacts with Amlobenz?

Sorry No Records found


What are the warnings of Amlobenz?

Sorry No Records found


What are the precautions of Amlobenz?

Sorry No Records found


What are the side effects of Amlobenz?

Sorry No records found


What should I look out for while using Amlobenz?

Amlodipine besylate and benazepril hydrochloride capsules are 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. ()


What might happen if I take too much Amlobenz?

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:

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, andpatients 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 amlodipine’s 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. 


How should I store and handle Amlobenz?

Store bottles at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30                                                               NDC 21695-916-30Bottles of 90                                                             NDC 21695-916-90 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30                                                               NDC 21695-916-30Bottles of 90                                                             NDC 21695-916-90 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30                                                               NDC 21695-916-30Bottles of 90                                                             NDC 21695-916-90 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30                                                               NDC 21695-916-30Bottles of 90                                                             NDC 21695-916-90 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30                                                               NDC 21695-916-30Bottles of 90                                                             NDC 21695-916-90 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). Amlodipine besylate and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg. All four strengths are packaged with 1 desiccant in bottles of  30 capsules, 2 desiccants in bottles of 100 capsules and   3 desiccants in bottles of 500 capsules. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500. Bottles of 30                                                               NDC 21695-916-30Bottles of 90                                                             NDC 21695-916-90 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]Protect from moisture. Dispense in tight container (USP). 


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Benazepril

 

Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. Hypertensive patients treated with benazepril and amlodipine for up to 56 weeks had elevations of serum potassium up to 0.2 mEq/L [see ]. 

Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. In animal studies, benazepril had no inhibitory effect on the vasopressor response to angiotensin II and did not interfere with the hemodynamic effects of the autonomic neurotransmitters acetylcholine, epinephrine, and norepinephrine. 

ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of amlodipine besylate and benazepril hydrochloride  remains to be elucidated. 

While the mechanism through which benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, benazepril has an antihypertensive effect even in patients with low-renin hypertension. 

Amlodipine

 

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Non-Clinical Toxicology
Amlodipine besylate and benazepril hydrochloride capsules are 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. ()

Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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