Cozaar XQ

Cozaar XQ Adverse Reactions

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Cozaar XQ: The safety of Cozaar XQ has been evaluated in 325 patients treated with amlodipine/losartan combination therapy among 646 essential hypertension patients in 3 clinical trials (study 201, study 301 and study 302) for 8 weeks. Adverse reactions have been ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).
The Treatment-Related* Adverse Events: Nervous System Disorders: Common: Dizziness, headache. Uncommon: Somnolence.
General Disorders and Administration Site Conditions: Uncommon: Asthenia, chest discomfort, chest pain, early satiety, peripheral edema, pitting edema.
Gastrointestinal Disorders: Uncommon: Abdominal discomfort, dyspepsia, nausea, reflux esophagitis.
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus (generalized), urticaria (generalized).
Cardiac Disorders: Uncommon: Palpitation.
Vascular Disorders: Uncommon: Flushing, orthostatic hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnoea.
Sensory Organ Disorders: Uncommon: Vertigo.
Renal and Urinary Disorders: Uncommon: Pollakiuria.
*The adverse experiences to be definitely related, probably related or possibly related to drug or uncertain considered by investigators.
The following adverse reactions have been reported with the components of Cozaar XQ.
Losartan: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Losartan has been found to be generally well-tolerated in controlled clinical trials for hypertension; side effects have usually been mild and transient in nature and have not required discontinuation of therapy. The overall incidence of side effects reported with losartan was comparable to placebo.
In controlled clinical trials for essential hypertension, dizziness was the only side effect reported as drug related that occurred with an incidence greater than placebo in ≥1% of patients treated with losartan. In addition, dose-related orthostatic effects were seen in <1% of patients. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo.
In these double-blind controlled clinical trials for essential hypertension, the following adverse experiences reported with losartan occurred in ≥1% of patients, regardless of drug relationship: See Table 4.

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Losartan was generally well-tolerated in a controlled clinical trial in hypertensive patients with left ventricular hypertrophy. The most common drug-related side effects were dizziness, asthenia/fatigue and vertigo.
In that study, among patients without diabetes at baseline, there was a lower incidence of new onset diabetes mellitus with losartan as compared to atenolol (242 patients vs 320 patients, respectively, p<0.001). Because there was no placebo group included in the study, it is not known if this represents a beneficial effect of losartan or an adverse effect of atenolol.
Losartan was generally well-tolerated in a controlled clinical trial in type 2 diabetic patients with proteinuria. The most common drug-related side effects were asthenia/fatigue, dizziness, hypotension and hyperkalemia (see Precautions).
The following additional adverse reactions have been reported in post-marketing experience: Hypersensitivity: Anaphylactic reactions, angioedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including angiotensin-converting enzyme (ACE) inhibitors. Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely.
Gastrointestinal: Hepatitis (reported rarely), liver function abnormalities, vomiting.
General Disorders and Administration Site Conditions: Malaise.
Hematologic: Anemia, thrombocytopenia (reported rarely).
Musculoskeletal: Myalgia, arthralgia.
Nervous System/Psychiatric: Migraine, dysgeusia.
Reproductive System and Breast Disorders: Erectile dysfunction/impotence.
Respiratory: Cough.
Skin: Urticaria, pruritus, erythroderma, photosensitivity.
Amlodipine Besylate: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Amlodipine besylate has been evaluated for safety in >11,000 patients in worldwide clinical trials. In general, treatment with amlodipine besylate was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine besylate were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate (n=1730) at doses up to 10 mg to placebo (n=1250), discontinuation of amlodipine besylate due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema.
The incidence (%) of side effects that occurred in a dose related manner are as follows (see Table 5).

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Other adverse experiences that were not clearly dose related but were reported with an incidence >1% in placebo-controlled clinical trials include the following (see Table 6).

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For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine besylate treatment as shown in Table 7.

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The following events occurred in <1% but >0.1% of patients in controlled clinical trials, or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.
Central and Peripheral Nervous System: Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.
Gastrointestinal: Anorexia, constipation, dyspepsia1, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
General: Allergic reaction, asthenia1, back pain, hot flushes, malaise, pain, rigors, gained weight, decreased weight.
Musculoskeletal System: Arthralgia, arthrosis, muscle cramps1, myalgia.
Psychiatric: Sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.
Respiratory System: Dyspnea1, epistaxis.
Skin and Appendages: Angioedema, erythema multiforme, pruritus1, rash1, erythematous rash, maculopapular rash.
Special Senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary System: Micturition frequency, micturition disorder, nocturia.
Autonomic Nervous System: Dry mouth, increased sweating.
Metabolic and Nutritional: Hyperglycemia, thirst.
Hemopoietic: Leukopenia, purpura, thrombocytopenia.
1These events occurred in <1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
The following events occurred in <0.1% of patients: Cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation and xerophthalmia.
Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states eg, myocardial infarction and angina.
The following additional adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following post-marketing event has been reported infrequently where a causal relationship is uncertain: Gynecomastia. In post-marketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine besylate.
Amlodipine besylate has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus and abnormal lipid profiles.
Laboratory Test Findings: Cozaar XQ: Slowed heart rate was observed in some patients 8 weeks after administration of losartan/amlodipine, but the change in heart rate was not clinically significant.
Increased blood creatinine and increased hepatic enzyme were reported in some patients but specific laboratory monitoring is not required.
Losartan: In controlled clinical trials for essential hypertension, clinically important changes in standard laboratory parameters were rarely associated with administration of Cozaar. Hyperkalemia (serum potassium >5.5 mEq/L) occurred in 1.5% of patients in the hypertension clinical trials. In a clinical study conducted in type 2 diabetic patients with proteinuria, 9.9% of patients treated with Cozaar and 3.4% of patients treated with placebo developed hyperkalemia (see Precautions). Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
Amlodipine: Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
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