Lexxel Side Effects

Please note - some side effects for Lexxel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lexxel - for the Consumer

Lexxel

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lexxel:

Diarrhea; dizziness or lightheadedness when sitting up or standing; drowsiness; headache; nausea; persistent, dry cough; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast changes; changes in sexual function; chest pain; dry mouth; fainting; fast, slow, or irregular heartbeat; hoarseness; infection (fever, sore throat); infrequent urination; lethargy; muscle pain or cramps; muscle weakness; restlessness; thirst; unusual stomach pain; unusual swelling; weakness; yellowing of the skin or eyes.

Lexxel Side Effects - for the Professional

Lexxel

In a factorial study, combinations of enalapril at doses of 0, 5, and 20 mg and felodipine ER at doses of 0, 2.5, 5, and 10 mg were evaluated for safety in more than 700 patients with hypertension. In addition more than 500 patients received various combinations of enalapril (5 or 10 mg) and felodipine ER (2.5, 5, or 10 mg) with or without hydrochlorothiazide (12.5 mg) in an open-labeled study up to 52 weeks (mean 33 weeks). Adverse events were similar to those described with the individual components.

In general, treatment with enalapril maleate-felodipine ER was well tolerated and adverse events were mild and transient in nature. In the placebo-controlled, double-blind trial, discontinuation of therapy due to adverse events considered related (possibly, probably or definitely) occurred in 2.8% vs 1.3% of patients treated with the combination or placebo, respectively. The most frequently observed clinical adverse events considered related to treatment with the combination were headache, edema or swelling, and dizziness.

Clinical adverse events considered related (possibly, probably, or definitely) to treatment with enalapril-felodipine ER that occurred with an incidence of 1% or greater with the combination during the placebo-controlled, double-blind trial are compared to individual components and placebo in the table below:

Other clinical adverse events considered related (possibly, probably, or definitely) to treatment with enalapril-felodipine ER that occurred with an incidence of less than 1% in the placebo-controlled, double-blind trial are listed below. These events are listed in order of decreasing frequency within each category. Body as a Whole: Syncope, facial edema, orthostatic effects, chest pain; Cardiovascular: Palpitation, hypotension, bradycardia, premature ventricular contraction, increased blood pressure; Digestive: Dry mouth, constipation, dyspepsia, flatulence, acid regurgitation, vomiting, diarrhea, nausea, anal/rectal pain; Metabolic: Gout; Musculoskeletal: Neck pain, joint swelling; Nervous/Psychiatric: Insomnia, nervousness, somnolence, ataxia, agitation, paresthesia, tremor; Respiratory: Dyspnea, respiratory congestion, pharyngeal discomfort, dry throat; Skin: Rash, angioedema, pruritus, alopecia, dry skin; Special Senses: Increased intraocular pressure; Urogenital: Impotence, hot flashes.

Other infrequently reported adverse events were seen in clinical trials with enalapril-felodipine ER (causal relationship unknown). These included: Body as a Whole: Abdominal pain, fever; Digestive: Dental pain; Metabolic: Increased ALT and AST, hyperglycemia; Musculoskeletal: Back pain, myalgia, foot pain, knee pain, shoulder pain, tendinitis; Respiratory: Upper respiratory infection, sinusitis, pharyngitis, bronchitis, nasal congestion, influenza, sinus disorder; Special Senses: Conjunctivitis; Urogenital: Proteinuria, pyuria, urinary tract infection.

Enalapril Maleate

Other adverse events that have been reported with enalapril, without regard to causality, are listed (in decreasing severity) below:

Angioedema— Angioedema has been reported in patients receiving enalapril maleate, with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with Lexxel should be discontinued and appropriate therapy instituted immediately.

Body as a Whole: Anaphylactoid reactions; Cardiovascular: Cardiac arrest, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients, orthostatic hypotension, pulmonary embolism and infarction, pulmonary edema, rhythm disturbances including atrial tachycardia and bradycardia, atrial fibrillation, angina pectoris; Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice), melena, anorexia, glossitis, stomatitis; Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression; Musculoskeletal: Muscle cramps; Nervous/Psychiatric: Depression, confusion, peripheral neuropathy (eg paresthesia, dysesthesia), vertigo; Respiratory: Bronchospasm, rhinorrhea, sore throat and hoarseness, asthma, pneumonia, pulmonary infiltrates, eosinophilic pneumonitis; Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, herpes zoster, erythema multiforme, urticaria, diaphoresis, photosensitivity; Special Senses: Blurred vision, taste alteration, anosmia, tinnitus, dry eyes, tearing; Urogenital: Renal failure, oliguria, renal dysfunction, flank pain, gynecomastia; Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity rash and other dermatologic manifestations; Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Felodipine as an Extended-Release Formulation

Other adverse events that have been reported with felodipine ER, without regard to causality, are listed (in decreasing severity) below:

Body as a Whole: Flu-like illness; Cardiovascular: Myocardial infarction, angina pectoris, arrhythmia, tachycardia, premature beats; Digestive: Gingival hyperplasia; Endocrine: Gynecomastia; Hematologic: Anemia; Musculoskeletal: Arthralgia, leg pain, muscle cramps, arm pain, hip pain; Nervous/Psychiatric: Depression, anxiety disorders, irritability, decreased libido; Respiratory: Upper respiratory infection, rhinorrhea, sneezing, pharyngitis, influenza, epistaxis, respiratory infection; Skin: Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis; Special Senses: Visual disturbances; Urogenital: Urinary frequency, urinary urgency, dysuria, polyuria.

Laboratory Test Findings

In controlled clinical trials with enalapril-felodipine ER, clinically important changes in standard laboratory parameters associated with administration of Lexxel were rare. No changes peculiar to the combination treatment were observed.

Serum Electrolytes— See PRECAUTIONS.

Creatinine— Minor reversible increases in serum creatinine were observed in patients treated with Lexxel. Increases in creatinine are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis.

Other— Minor reversible increases or decreases in serum potassium were infrequently observed in patients treated with Lexxel; rarely were these measurements outside the normal range.

Side Effects by Body System

General

In general, side effects associated with this combination drug are similar to those associated with each component. There do not appear to be side effects unique to the combination drug. Side effects are typically mild and transient.

Nervous system

Nervous system side effects include headache in 3% to 7% (less than placebo), dizziness in approximately 3%, and asthenia/fatigue in approximately 3% of patients. Depression, sleeping problems (either insomnia or somnolence), ataxia, confusion, peripheral neuropathy, taste alterations, tinnitus, tearing, amblyopia, eye irritation, retinopathy, and vertigo have been reported in less than 1% of patients.

Cardiovascular

Angioedema associated with the use of ACE inhibitors may be a sign of allergy and may be an indication to discontinue therapy with this agent or any other ACE inhibitor. Angioedema that involves the face, larynx, or neck IS an absolute contraindication to therapy. The incidence of angioedema appears slightly higher in black than in non-black patients.

Cardiovascular side effects may be related to either component, and include edema or swelling in 3% and chest pain (relationship to drug questionable) in 0.5% to 1.6%. Calcium channel blockade can rarely result in bradycardia, AV block (1st, 2nd, and even 3rd-degree AV block), heart failure, and hypotension. Excessive hypotension related to either enalapril or felodipine has rarely resulted in angina pectoris, myocardial infarction, or stroke. Palpitations have been rarely reported.

Respiratory

Respiratory side effects including cough occur in approximately 3% of patients. Nasal congestion, pharyngitis, pulmonary infiltrates and bronchitis have rarely been reported.

Metabolic

Metabolic side effects are related to enalapril. By inhibiting angiotensin II-mediated aldosterone secretion, ACE inhibitors can induce mild hyperkalemia, particularly in patients with renal insufficiency.

Less common metabolic problems (associated with felodipine) include hyperglycemia, hyperuricemia (with rare cases of gout), hypokalemia, and increased creatine kinase.

Renal

Renal side effects including new or worsened renal insufficiency have been associated with ACE inhibitors. Patients at increased risk include patients with heart failure, renal insufficiency, and renal artery stenosis.

Hypersensitivity

Late-onset enalapril-induced angioedema (more than three months) is reported in at least one patient who had taken enalapril without incident for three years. Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.

Hypersensitivity reactions to enalapril, as with some other angiotensin converting enzyme (ACE) inhibitors, may be life-threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. Obstructive laryngeal and glossal angioedema due to enalapril is a rare, but potentially fatal reaction. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general. Enalapril is not recommended for patients with a history of idiopathic angioedema.

Other hypersensitivity reactions associated with enalapril including photosensitivity in 0.1%, or urticaria in 0.3% of patients have been reported. A single case of Henoch-Schonlein purpura has also been reported.

Dermatologic

Dermatologic side effects are typically mild. Rashes have been reported in 2% of patients. The following side effects have rarely been associated with either or both drugs when given alone: alopecia, diaphoresis, erythema multiforme, exfoliative dermatitis, pemphigus, photosensitivity, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Hypersensitivity reactions to ACE inhibitors can present as angioedema and severe rash.

Gastrointestinal

Gastrointestinal problems, such as nausea and diarrhea, have been reported in up to 2% of patients. These side effects were prevalent among placebo-treated patients in controlled trials.

Rarely, constipation, anorexia, dry mouth, dyspepsia, glossitis, and cholestatic jaundice/hepatitis, pancreatitis, ileus, stomatitis, vomiting, gingival hyperplasia (related to the use of some calcium channel blockers) have been associated with the use of enalapril or felodipine.

Musculoskeletal

Musculoskeletal discomfort has been reported in up to 1% of patients.

Hematologic

Hematologic side effects are rare, and are remarkable for rare cases of agranulocytosis in patients who are taking ACE inhibitors. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia. Thrombocytopenia has also rarely been reported.

Rare cases of hemolytic anemia have been reported in patients who are taking enalapril, particularly patients with G6PD deficiency.

Immunologic

Immunologic side effects have been rarely associated with the use of enalapril. This complex may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgias/arthritis, myalgias/myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash, and other dermatologic manifestations.

Genitourinary

Genitourinary complaints including impotence among male patients are extremely rare.

Hepatic

Hepatic side effects associated with the use of ACE inhibitors have included a rare syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Experts recommend discontinuation of therapy with this drug if jaundice or markedly elevated hepatic serum enzymes develop.

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