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Drugs that act directly on the renin-angiotensin system RAS can cause injury and death to the developing fetus. 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-ethylmethyl 2-aminoethoxymethyl 2-chlorophenyl -1,4-dihydromethyl- 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:.
Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Lotrel capsules are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2. Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. The recommended initial dose of Lotrel is 1 capsule of amlodipine 2.
It is usually appropriate to begin therapy with Lotrel only after a patient has either amlodipine besylate 5mg tamyl failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or b demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.
The antihypertensive effect of Lotrel is largely attained within 2 weeks. Amlodipine is an effective treatment of hypertension in once-daily doses of 2. Lotrel is available as capsules containing amlodipine amlodipine besylate 5mg tamyl equivalent to 2.
All 6 strengths are packaged in bottles of capsules. Dispense in tight container USP. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of amlodipine besylate 5mg tamyl drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Lotrel has been evaluated for safety in over 2, patients with hypertension ; over of these patients were treated for at least 6 months, and over were treated for more than 1 year.
The most common reasons for discontinuation of therapy with Lotrel in these studies were cough and edema including angioedema. The peripheral edema associated with amlodipine use is dose-dependent.
When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Cough was the only adverse event with at least possible relationship to treatment that was more common on Lotrel 3.
Percent Incidence in U. The incidence of edema was greater in patients treated with amlodipine monotherapy 5. Other side effects considered possibly or probably related to study drug that occurred in U.
Body as a Whole: Insomnia, nervousness, anxiety, tremorand decreased libido. Flushing, hot flashesrash, skin noduleand dermatitis. Dry mouthnausea, abdominal pain, constipation, amlodipine besylate 5mg tamyl, diarrhea, dyspepsiaand esophagitis.
Back pain amlodipine besylate 5mg tamyl, musculoskeletal pain, cramps, and muscle cramps. Sexual problems such as impotenceand polyuria. Monotherapies of benazepril and amlodipine have been evaluated for safety in clinical trials in over 6, and 11, patients, respectively. The observed adverse reactions to the monotherapies in these trials were similar to those seen in trials of Lotrel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to amlodipine besylate 5mg tamyl estimate their frequency or establish a causal relationship to drug exposure.
In postmarketing experience with benazepril, there have been rare reports of Stevens-Johnson syndromepancreatitishemolytic anemiapemphigusamlodipine besylate 5mg tamyl, thrombocytopeniaparesthesiadysgeusia, orthostatic symptoms and hypotensionangina amlodipine besylate 5mg tamyl and arrhythmiapruritusphotosensitivity reaction, arthralgiaarthritismyalgiablood urea nitrogen BUN increase, serum creatinine increase, renal impairment, vision impairment, agranulocytosisneutropenia.
Rare reports in association with use of amlodipine: Other potentially important adverse experiences attributed to other ACE inhibitors and calcium channel blockers include: Other infrequently reported events included chest pain, ventricular extrasystolegoutneuritis, tinnitusalopeciaupper respiratory tract infection, palpitations and somnolence.
Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin, amlodipine besylate 5mg tamyl. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. Coadministration with CYP3A inhibitors moderate and strong results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A4 inhibitors to determine the need for dose amlodipine besylate 5mg tamyl. No information is available on the quantitative effects of CYP3A4 inducers on amlodipine.
Blood pressure should be monitored when amlodipine is coadministered with CYP3A4 inducers. Benazepril can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics spironolactoneamiloride, amlodipine besylate 5mg tamyl, triamtereneand others or potassium supplements can increase the risk of hyperkalemia.
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium.
When coadministering Lotrel and lithium, amlodipine besylate 5mg tamyl, frequent monitoring of serum lithium levels is recommended.
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.
In patients who are elderly, volume-depleted including those on diuretic therapyor with compromised renal function, coadministration of NSAIDsincluding selective COX-2 inhibitors, amlodipine besylate 5mg tamyl, with ACE inhibitors, including benazepril, may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible. In rare cases, diabetic patients receiving an ACE inhibitor including benazepril concomitantly with insulin or oral antidiabetics may develop hypoglycemia.
Such patients should therefore be advised about the possibility of hypoglycemic reactions, and should be monitored accordingly. The risk of angioedema may be increased in patients receiving coadministration of ACE inhibitors and mTOR inhibitors e. Dual blockade of the Amlodipine besylate 5mg tamyl with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function including acute renal failure compared to monotherapy.
Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Lotrel and other agents that block the RAS. Do not coadminister aliskiren with Lotrel in patients with diabetes.
Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema. Presumably because angiotensin -converting enzyme inhibitors affect the metabolism of eicosanoids amlodipine besylate 5mg tamyl polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors including Lotrel may be subject to a variety of adverse reactions, some of them serious.
These reactions usually occur after one of the first few doses of the ACE inhibitor, but they sometimes do not appear until after months of therapy. Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.
Angioedema of the face, extremities, lips, tongue, glottisand larynx has been reported in patients treated with ACE inhibitors. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue treatment with Lotrel and treat immediately.
When involvement of the tongue, glottis, or larynx appears likely to cause airway obstructionappropriate therapy, e. Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain with or without nausea or vomiting ; in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.
The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. Two patients undergoing desensitizing treatment with hymenoptera wasp sting venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.
In the same patients, amlodipine besylate 5mg tamyl, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge, amlodipine besylate 5mg tamyl. Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipineparticularly in patients with severe obstructive coronary artery disease. As with all other vasodilatorsspecial caution is required when using amlodipine in patients suffering from aortic or mitral stenosisor obstructive hypertrophic cardiomyopathy. Lotrel can cause symptomatic hypotension.
Symptomatic hypotension is most likely to occur in patients who have been volume or salt depleted as a result of diuretic therapy, dietary salt restriction, amlodipine besylate 5mg tamyl, dialysisdiarrhea, or vomiting. If hypotension occurs, the patient should be placed in the supine position and if necessary given physiological saline intravenously. Treatment with benazepril can be continued amlodipine besylate 5mg tamyl blood pressure and volume have returned to normal.
In patients with congestive heart failurewith or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguriaazotemiaand rarely with acute renal failure and death. In such patients, start Lotrel therapy under close medical supervision; follow closely for the first 2 weeks of treatment and whenever the dose of the benazepril component is increased or a diuretic is added or its dose increased.
Symptomatic hypotension is also possible in patients with severe aortic stenosis. Use of drugs that act on the RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Amlodipine besylate 5mg tamyl pregnancy is detected, discontinue Lotrel as soon as possible [see Use In Specific Populations ].
There have been rare reports of predominantly cholestatic hepatitis and isolated cases of acute liver failuresome of them fatal, in patients on ACE inhibitors.
The mechanism is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevation of hepatic enzymes should discontinue the ACE inhibitor and be kept under medical surveillance.
Monitor renal function periodically in patients treated with Lotrel. Changes in renal function, including acute renal failure, can be caused by drugs that affect the RAS. Patients whose renal function may depend in part on the activity of the RAS e, amlodipine besylate 5mg tamyl. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Lotrel.
Monitor serum potassium periodically in patients receiving Lotrel. Drugs that affect the RAS can cause hyperkalemia.
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