Buy Lotrel (Amlodipine Besylate, Benazepril HCl) antihypertensive drug
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LOTREL (AMLODIPINE, BENAZEPRIL): PRESCRIBING INFORMATION
Lotrel 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 empirical formula is C24H28N2O5xHCl, 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)-1,4dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate.
Its empirical formula is C20H25ClN2O5xC6H6O3S, 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 six 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, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg.
The inactive ingredients of the capsules are cellulose compounds, calcium phosphate, colloidal silicon dioxide, gelatin, crospovidone, hydrogenated castor oil (not present in 5 / 40 mg or 10 / 40 mg strengths), lactose, iron oxides, magnesium stearate, silicon dioxide, polysorbate 80, sodium lauryl sulfate, starch (corn), sodium starch (potato) glycolate, talc, and titanium dioxide.
INDICATIONS AND USAGE
Lotrel (Amlodipine, Benazepril) is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
DOSAGE AND ADMINISTRATION
Lotrel dosage and administration
DOSAGE FORMS AND STRENGTHS
Lotrel (Amlodipine Besylate, Benazepril HCl) capsules are available as follows:
2.5 / 10 mg, 5 / 10 mg, 5 / 20 mg, 5 / 40 mg, 10 / 20 mg, and 10 / 40 mg.
Amlodipine with Benazepril (Lotrel) is 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.
WARNINGS AND PRECAUTIONS
Lotrel warnings and precautions
Lotrel adverse reactions
Lotrel drug interactions
USE IN SPECIFIC POPULATIONS
Lotrel use in specific populations
Lotrel clinical pharmacology
Lotrel nonclinical toxicology
Lotrel clinical studies
PATIENT COUNSELING INFORMATION
Information for Patients
Pregnancy: Tell female patients of childbearing age that use of drugs like benazepril that act on the renin-angiotensin system can cause serious problems in the fetus and infant including: low blood pressure, poor development of skull bones, kidney failure and death. Discuss other treatment options with female patients planning to become pregnant. Tell women using Lotrel (Amlodipine, Benazepril) who become pregnant to notify their physicians as soon as possible.
HOW SUPPLIED / STORAGE AND HANDLING
Lotrel is available as capsules containing amlodipine besylate equivalent to 2.5 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 / 10 mg, 5 / 10 mg, 5 / 20 mg, 5 / 40 mg, 10 / 20 mg and 10 / 40 mg. All six strengths are packaged in bottles of 100 capsules.
Capsules are imprinted with "Lotrel" and appropriate code.
2.5 / 10 mg: white with 2 gold bands/2255
5 / 10 mg: light brown with 2 white bands/2260
5 / 20 mg: pink with 2 white bands/2265
5 / 40 mg: light blue with 2 white bands/0384
10 / 20 mg: purple (amethyst) with 2 white bands/0364
10 / 40 mg: dark blue with 2 white bands/0379
Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture. Dispense in tight container (USP).
Manufactured and distributed by Novartis pharmaceutical company and its divisions.
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