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Lotensin HCT
Overview
What is Lotensin HCT?
Benazepril hydrochloride USP 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-1-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is
Its empirical formula is CHNO·HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.
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 -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide’s chemical name is 6-chloro-3,4-dihydro-2-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is
Its empirical formula is C H ClN O S, and its molecular weight is 297.73. Hydrochloro-thiazide is a thiazide diuretic.
Lotensin HCT is a combination of benazepril and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are cellulose compounds, crospovidone, hydrogenated castor oil, iron oxides (10/12.5 mg, 20/12.5 mg, and 20/25 mg tablets), lactose, polyethylene glycol, talc, and titanium dioxide.
What does Lotensin HCT look like?
What are the available doses of Lotensin HCT?
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What should I talk to my health care provider before I take Lotensin HCT?
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How should I use Lotensin HCT?
Lotensin HCT USP is indicated for the treatment of hypertension.
This fixed combination drug is not indicated for the initial therapy of hypertension
(see
).
Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20/25 mg.
Switch Therapy:
Replacement Therapy:
What interacts with Lotensin HCT?
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What are the warnings of Lotensin HCT?
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What are the precautions of Lotensin HCT?
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What are the side effects of Lotensin HCT?
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What should I look out for while using Lotensin HCT?
Lotensin HCT is contraindicated in patients who are anuric.
Lotensin HCT is also contraindicated in patients who are hypersensitive to benazepril, to any
other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.
Lotensin HCT is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment.
Lotensin HCT is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotensin HCT within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor
Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including Lotensin HCT in patients with diabetes.
What might happen if I take too much Lotensin HCT?
No specific information is available on the treatment of overdosage with Lotensin HCT; treatment should be symptomatic and supportive. Therapy with Lotensin HCT should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.
Single oral doses of 1 g/kg of benazepril caused reduced activity in mice, and doses of 3 g/kg were associated with significant lethality. Reduction of activity in rats was not seen until they had received doses of 5 g/kg, and doses of 6 g/kg were not lethal. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg.
Data from human overdoses of benazepril are scanty, but the most common manifestation of human benazepril overdosage is likely to be hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
Laboratory determinations of serum levels of benazepril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of benazepril overdose.
No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of benazepril and its metabolites. Benazeprilat is only slightly dialyzable, but dialysis might be considered in overdosed patients with severely impaired renal function
Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of benazepril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of benazepril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat benazepril overdose by infusion of normal saline solution.
How should I store and handle Lotensin HCT?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze BRIVIACT injection or oral solution.Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle.BRIVIACT injection vials are single-dose only .Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze BRIVIACT injection or oral solution.Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle.BRIVIACT injection vials are single-dose only .Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze BRIVIACT injection or oral solution.Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle.BRIVIACT injection vials are single-dose only .Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017Lotensin HCT USP is available in tablets of three different strengths:Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.The National Drug Codes for the various packages are:Tablets are oblong and scored, with “LOTENSIN HCT” on one side and appropriate number imprinted on the other side.Storage: Dispense in a tight, light-resistant container (USP). Manufactured for and Distributed by:© 2017 Validus Pharmaceuticals LLC 60024-01 August 2017
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.
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 alone for up to 52 weeks had elevations of serum potassium of up to 0.2 mEq/L. Similar patients treated with benazepril and hydrochlorothiazide for up to 24 weeks had no consistent changes in their serum potassium
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 Lotensin HCT 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.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin, so coadministration of an ACE inhibitor tends to reverse the potassium loss associated with these diuretics.
The mechanism of the antihypertensive effect of thiazides is unknown.
Non-Clinical Toxicology
Lotensin HCT is contraindicated in patients who are anuric.Lotensin HCT is also contraindicated in patients who are hypersensitive to benazepril, to any
other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.
Lotensin HCT is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment.
Lotensin HCT is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotensin HCT within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor
Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including Lotensin HCT in patients with diabetes.
Neprilysin Inhibitors:
Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema.
Interactions Common for Both Benazepril and Hydrochlorothiazide
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not coadminister aliskiren with Lotensin HCT in patients with diabetes. Avoid use of aliskiren with Lotensin HCT in patients with renal impairment (GFR < 60 mL/min).
The antihypertensive effect of benazepril and hydrochlorothiazide may be attenuated by NSAIDs.
Benazepril
Benazepril has been used concomitantly with beta-adrenergic-blocking agents, calcium-blocking agents, cimetidine, diuretics, digoxin, hydralazine, and naproxen without evidence of clinically important adverse interactions. Other ACE inhibitors have had less than additive effects with beta-adrenergic blockers, presumably because drugs of both classes lower blood pressure by inhibiting parts of the renin-angiotensin system.
Interaction studies with warfarin and acenocoumarol have failed to identify any clinically important effects of benazepril on the serum concentrations or clinical effects of these anticoagulants.
Gold:
have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
Hydrochlorothiazide
Ion exchange resins:
Digitalis glycosides:
Antidiabetic agents:
Alcohol, barbiturates or narcotics:
Pressor amines:
Serum Electrolyte Abnormalities
In clinical trials of Lotensin HCT, the average change in serum potassium was near zero in subjects who received 5/6.25 mg or 20/12.5 mg, but the average subject who received 10/12.5 mg or 20/25 mg experienced a mild reduction in serum potassium, similar to that experienced by the average subject receiving the same dose of hydrochlorothiazide monotherapy.
Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesema can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.
Metabolic Disturbances
Hydrochlorothiazide
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
Thiazides decrease urinary calcium excretion and may cause mild elevation of serum calcium. Avoid using Lotensin HCT in patients with hypercalcemia.
Cough:
Surgery/Anesthesia:
Lotensin HCT has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year.
The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 7% of U.S. patients treated with Lotensin HCT and in 4% of patients treated with placebo.
The most common reasons for discontinuation of therapy with Lotensin HCT in U.S. studies were cough (1.0%; , “dizziness” (1.0%), headache (0.6%), and fatigue (0.6%).
The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Lotensin HCT are shown in the table below.
Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in 0.3% to 1.0% of patients treated with Lotensin HCT were the following:
Cardiovascular:
Gastrointestinal:
Neurologic and Psychiatric:
Dermatologic:
Other:
Other adverse experiences reported in 0.3% or more of Lotensin HCT patients in U.S. controlled clinical trials, and rarer events seen in post-marketing experience, were the following; asterisked entries occurred in more than 1% of patients (in some, a causal relationship to Lotensin HCT is uncertain):
Cardiovascular:
Body as a Whole:
Dermatologic:
Gastrointestinal:
Neurologic and Psychiatric:
Respiratory:
Other:
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of either benazepril or hydrochlorothiazide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:
Benazepril
Hydrochlorothiazide
Digestive:
Neurologic:
Musculoskeletal:
Hematologic:
Metabolic:
Hypersensitivity:
Skin
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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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. 315.72Tips
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