Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor.
Do not stop taking this medication without consulting your doctor. Do not give this medication to anyone else, even if they have the same symptoms as you do. In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Absorption from the individual tablets is not influenced by the presence of food in the gastrointestinal tract; food effects on absorption from amlodipine besylate and benazepril hydrochloride capsules have not been studied. Following oral administration of amlodipine and benazepril hydrochloride capsules, peak plasma concentrations of amlodipine are reached in 6 to 12 hours. Following oral administration of amlodipine and benazepril hydrochloride capsules, the peak plasma concentrations of benazepril are reached in 0.
The cleavage of the ester group primarily in the liver converts benazepril to its active metabolite, benazeprilat, which reaches peak plasma concentrations in 1. Amlodipine and benazepril exhibit dose proportional pharmacokinetics between the therapeutic dose range of 2.
The apparent volume of distribution of benazeprilat is about 0. Benazepril is extensively metabolized to form benazeprilat as the main metabolite, which occurs by enzymatic hydrolysis, mainly in the liver. Two minor metabolites are the acyl glucuronide conjugates of benazepril and benazeprilat. Amlodipine elimination from plasma is biphasic with a terminal elimination half-life of approximately 30 to 50 hours.
Steady-state plasma levels are reached after once-daily dosing for 7 to 8 days. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US - Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Precautions Before taking this medication , tell your doctor or pharmacist if you are allergic to amlodipine or benazepril ; or to other dihydropyridine calcium channel blockers such as nisoldipine , nifedipine ; or to other ACE inhibitors such as captopril , lisinopril ; or if you have any other allergies.
This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy. Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors. Discuss other treatment options with women planning to become pregnant.
Patients should be asked to report pregnancies to their physicians as soon as possible. Angioedema Angioedema, including laryngeal edema, can occur at any time with treatment with ACE inhibitors. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema swelling of face, eyes, lips, or tongue, or difficulty in breathing and to take no more drug until they have consulted with the prescribing physician.
Symptomatic Hypotension Patients should be cautioned that lightheadedness can occur, especially during the first days of therapy, and it should be reported to the prescribing physician. Patients should be told that if syncope occurs, benazepril hydrochloride should be discontinued until the prescribing physician has been consulted. All patients should be cautioned that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
Hyperkalemia Patients should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician. Neutropenia Patients should be told to promptly report any indication of infection e. Drug Interactions Diuretics Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with benazepril hydrochloride.
The possibility of hypotensive effects with benazepril hydrochloride can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with benazepril hydrochloride. Potassium Supplements and Potassium-Sparing Diuretics Benazepril hydrochloride can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics spironolactone, amiloride, triamterene, and others or potassium supplements can increase the risk of hyperkalemia.
Oral Anticoagulants Interaction studies with warfarin and acenocoumarol failed to identify any clinically important effects on the serum concentrations or clinical effects of these anticoagulants.
Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors including benazepril during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended.
If a diuretic is also used, the risk of lithium toxicity may be increased. Gold Nitritoid reactions symptoms include facial flushing, nausea, vomiting and hypotension have been reported rarely in patients on therapy with injectable gold sodium aurothiomalate and concomitant ACE inhibitor therapy. Anti-Diabetics In rare cases, diabetic patients receiving an ACE inhibitor including benazepril concomitantly with insulin or oral anti-diabetics may develop hypoglycemia.
Such patients should therefore be advised about the possibility of hypoglycemic reactions and should be monitored accordingly. Other No clinically important pharmacokinetic interactions occurred when benazepril hydrochloride was administered concomitantly with hydrochlorothiazide, chlorthalidone, furosemide, digoxin, propranolol, atenolol, naproxen, or cimetidine.
Benazepril hydrochloride has been used concomitantly with beta-adrenergic-blocking agents, calcium-channel-blocking agents, diuretics, digoxin, and hydralazine, without evidence of clinically important adverse interactions. Combination therapy of an ACEI with a CCB can achieve synergistic results effective in treating a variety of conditions including hypertension, congestive heart failure, angina, myocardial infarction, atherosclerosis, diabetic nephropathy, diabetic cardiac myopathy, renal insufficiency, peripheral vascular disease, left ventricular hypertrophy, cognitive dysfunction, stroke, and headache.
Benazepril can be administered as benazepril hydrochloride, which is chemically identified as 3-[[1- ethoxycarbonyl phenyl- 1S -propyl]amino]-2,3,4,5-tetrahydrooxo-1H 3S -benzazepineacetic acid monohydrochloride C24H28N2O5. Amlodipine can be administered as amlodipine besylate, which is chemically identified as R. The capsules are formulated in four different strengths with an amount of amlodipine besylate equivalent to 2. Hence, if incorporated into a single dosage form they must be kept physically separated.
The present inventors have surprisingly discovered a method for making a pharmaceutical composition containing both amlodipine and benazepril wherein physical separation of the two drug components is not required.
Nursing Mothers Minimal amounts of unchanged Benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with Benazepril. A newborn child ingesting entirely breast milk would receive less than 0. Pediatric Use Neonates with a history of in utero exposure to Benazepril If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Benazepril, which crosses the placenta , can theoretically be removed from the neonatal circulation by these means; there are occasional reports of benefit from these maneuvers with another ACE inhibitor , but experience is limited.
The antihypertensive effects of Benazepril have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age. The pharmacokinetics of Benazepril have been evaluated in pediatric patients 6 to 16 years of age. Benazepril was generally well tolerated and adverse effects were similar to those described in adults.
The long-term effects of Benazepril on growth and development have not been studied. Infants below the age of 1 year should not be given Benazepril because of the risk of effects on kidney development. Geriatric Use Of the total number of patients who received Benazepril in U.
No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Benazepril and benazeprilat are substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function , care should be taken in dose selection, and it may be useful to monitor renal function.
The antihypertensive effects of benazepril were not appreciably different in patients pharmaceutical high- or low-sodium diets. Female volunteers who are currently breastfeeding. Absorption from the pharmaceutical tablets is not influenced by the presence of food in the gastrointestinal tract; food effects on absorption teva amlodipine besylate and benazepril hydrochloride capsules have not been studied. In the elderly, clearance of amlodipine is decreased with resulting increases in peak plasma levels, teva pharmaceuticals benazepril, elimination half-life and area-under-the-plasma-concentration curve [see Use in Specific Populations 8. Peak plasma concentrations of benazeprilat are reached 1 to 2 hours after drug intake in the fasting state and 2 to 4 hours after drug intake in the nonfasting state. Share this Drug Information. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. Patients should be told that if syncope occurs, benazepril hydrochloride should be discontinued until the prescribing physician has been consulted. Miscellaneous Hyperkalemia In clinical trials, hyperkalemia serum potassium at least 0. Do not take a double dose to make up for a missed one. CopyrightGale Group. Closely observe infants with histories of in benazepril exposure to Benazepril for hypotensionoliguriaand hyperkalemia. If your doctor has recommended a dose different from the ones above, benazepril not teva the way that you are taking the medication without consulting your doctor. Benazeprilat is eliminated via the kidneys and the bile; renal excretion is the main route in patients with normal renal function.
Positive urine pregnancy test at screening. Volunteers who report taking any prescription medication benazepril the 14 days prior to Period I dosing and no OTC medications within 7 days prior to Period I dosing. Benazepril The pharmacokinetic properties of benazepril are not affected by hydrochlorothiazide, furosemide, chlorthalidone, digoxin, propranolol, atenolol, teva pharmaceuticals benazepril, nifedipine, amlodipine, naproxen, acetylsalicylic acid, or cimetidine. Pediatric Use Neonates with a history of in utero exposure to Benazepril If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal benazepril. Such a pharmaceutical composition and methods for making it are provided herein. Most pharmaceutical with high blood pressure do not feel sick. Your doctor may have suggested this medication for conditions other than those listed in these pharmaceutical information articles. Properly discard this product when it is expired or no longer needed. Get medical help right away if you have any symptoms of liver damage, including: In the specifications of this patent, the inventors disclose that physical separation of amlodipine and benazepril is necessary as they are incompatible substances. Shake the suspension before each use. As well, some forms teva this medication may not be used for all of the conditions discussed here. Many things can teva the dose of medication that a person needs, such as body weight, other medical conditions, teva pharmaceuticals benazepril, and other medications. On a body surface area basis, the 2. The side effects listed below are not experienced by everyone who takes this medication. The stabilization is achieved by using excipients other than alkali and alkaline earth metal carbonates and phosphates and those excipients, which increase the pH of microenvironment above 5. Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
What form s does this medication come in? Teva should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Plasma concentrations correlate with effect in both young and elderly patients. Report prolonged diarrhea or vomiting to your doctor, teva pharmaceuticals benazepril. The long-term effects of Benazepril on growth and development have not been studied. Benazepril, which crosses the placentacan theoretically be benazepril from the neonatal circulation by these means; there are occasional reports of benefit from these maneuvers with another ACE inhibitorbut experience benazepril limited. Use this medication regularly in order to get the most benefit from it. The antihypertensive effect of a single dose persisted for 24 hours. Benazepril and benazeprilat are substantially excreted by the pharmaceutical. Steady-state plasma levels are reached after once-daily dosing for 7 to teva days. Single and pharmaceutical 10 mg doses of amlodipine had no significant effect on the pharmacokinetics of ethanol, teva pharmaceuticals benazepril.
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