Candesartan and Amlodipine interacts in the following cases:
Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
Caution is advised because of limited experience available in patients with severe or end-stage renal impairment (Clcr<15 mL/min) or on haemodialysis.
Amlodipine and candesartan are not dialysable.
In patients with mild to moderate hepatic impairment candesartan/amlodipine should be administered with caution.
Candesartan/amlodipine combination is not recommended during the first trimester of pregnancy as no data are available and safety profile has not been established for both amlodipine and candesartan. Use in early pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Candesartan/amlodipine combination is contraindicated during the second and third trimesters of pregnancy due to candesartan content.
Because no information is available regarding the use of candesartan and amlodipine during breast-feeding, it is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
No information is available regarding potential effect of candesartan and amlodipine on fertility.
No studies on the effects of candesartan on the ability to drive and use machines have been performed. However, it should be taken into account that occasionally dizziness or weariness may occur during treatment with candesartan.
Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. Caution is recommended especially at the start of treatment.
No clinical studies have been performed. Undesirable effects observed for particular active ingredients are described below.
Adverse reactions previously reported with one of the individual components (candesartan or amlodipine) may be potential adverse reactions with candesartan/amlodipine as well, even if not observed in clinical trials or during the post-marketing period.
In controlled clinical studies with candesartan for treatment of hypertension adverse reactions were mild and transient. The overall incidence of adverse events showed no association with dose or age. Withdrawals from treatment due to adverse events were similar with candesartan cilexetil (3.1%) and placebo (3.2%).
In a pooled analysis of clinical trial data of hypertensive patients, adverse reactions with candesartan cilexetil were defined based on an incidence of adverse events with candesartan cilexetil at least 1% higher than the incidence seen with placebo. By this definition, the most commonly reported adverse reactions were dizziness/vertigo, headache and respiratory infection.
The most commonly reported adverse reactions during treatment were oedema (very common) somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, and fatigue (common).
The frequencies used in the tables are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
The Table 1 below presents adverse reactions from clinical trials and post-marketing experience.
Table 1:
| MedDRA System Organ Class | Frequency | Undesirable Effect |
|---|---|---|
| Infections and infestations | Common | Respiratory infection |
| Blood and lymphatic system disorders | Very rare | Leukopenia, neutropenia, agranulocytosis |
| Metabolism and nutrition disorders | Very rare | Hyperkalaemia, hyponatraemia |
| Nervous system disorders | Common | Dizziness/vertigo, headache |
| Respiratory, thoracic and mediastinal disorders | Very rare | Cough |
| Gastrointestinal disorders | Very rare | Nausea |
| Not known | Diarrhoea | |
| Hepatobiliary disorders | Very rare | Increased liver enzymes, abnormal hepatic function, hepatitis |
| Skin and subcutaneous tissue disorders | Very rare | Angioedema, rash, urticaria, pruritus |
| Musculoskeletal and connective tissue disorders | Very rare | Back pain, arthralgia, myalgia |
| Renal and urinary disorders | Very rare | Renal impairment, including renal failure in susceptible patients |
As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen. No routine monitoring of laboratory variables is usually necessary for patients receiving candesartan. However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Within each frequency grouping, adverse reactions in Table 2 are presented in order of decreasing seriousness.
Table 2:
| MedDRA System organ class | Frequency | Adverse reactions |
|---|---|---|
| Blood and lymphatic system disorders | Very rare | Leukocytopenia, thrombocytopenia |
| Immune system disorders | Very rare | Allergic reactions |
| Metabolism and nutrition disorders | Very rare | Hyperglycaemia |
| Psychiatric disorders | Uncommon | Insomnia, mood changes (including anxiety), depression |
| Rare | Confusion | |
| Nervous system disorders | Common | Somnolence, dizziness, headache (especially at the beginning of the treatment) |
| Uncommon | Tremor, dysgeusia, syncope, hypoesthesia, paresthesia | |
| Very rare | Hypertonia, peripheral neuropathy | |
| Not known | Extrapyramidal disorder | |
| Eye disorders | Common | Visual disturbance (including diplopia) |
| Ear and labyrinth disorders | Uncommon | Tinnitus |
| Cardiac disorders | Common | Palpitations |
| Uncommon | Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) | |
| Very rare | Myocardial infarction | |
| Vascular disorders | Common | Flushing |
| Uncommon | Hypotension | |
| Very rare | Vasculitis | |
| Respiratory, thoracic and mediastinal disorders | Common | Dyspnoea |
| Uncommon | Cough, rhinitis | |
| Gastrointestinal disorders | Common | Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation) |
| Uncommon | Vomiting, dry mouth | |
| Very rare | Pancreatitis, gastritis, gingival hyperplasia | |
| Hepatobiliary disorders | Very rare | Hepatitis, jaundice, hepatic enzymes increased* |
| Skin and subcutaneous tissue disorders | Uncommon | Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria |
| Very rare | Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity | |
| Not known | Toxic epidermal necrolysis | |
| Musculoskeletal and connective tissue disorders | Common | Ankle swelling |
| Uncommon | Arthralgia, myalgia, muscle cramps, back pain | |
| Renal and urinary disorders | Uncommon | Micturition disorder, nocturia, increased urinary frequency |
| Reproductive system and breast disorders | Uncommon | Impotence, gynaecomastia |
| General disorders and administration site conditions | Very common | Oedema |
| Common | Fatigue, asthenia | |
| Uncommon | Chest pain, pain, malaise | |
| Investigations | Uncommon | Weight increase, weight decrease |
* mostly consistent with cholestasis
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