Telmisartan and Amlodipine interacts in the following cases:
Limited experience is available in patients with severe renal impairment or haemodialysis. Caution is advised when using telmisartan/amlodipine in such patients as amlodipine and telmisartan are not dialysable.
In patients with mild to moderate hepatic impairment telmisartan/amlodipine should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily.
Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.
There are limited data from the use of telmisartan/amlodipine in pregnant women. Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed.
The use of angiotensin II receptor blockers is not recommended during the first trimester of pregnancy. The use of angiotensin II receptor blockers is contraindicated during the second and third trimesters of pregnancy.
Studies with telmisartan in animals have shown reproductive toxicity.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor blockers, similar risks may exist for this class of medicinal products. Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to angiotensin II receptor blocker therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Should exposure to angiotensin II receptor blockers have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II receptor blockers should be closely observed for hypotension.
The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses.
Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%. The effect of amlodipine on infants is unknown.
Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan/amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant.
No data from controlled clinical studies with the fixed dose combination or with the individual components are available. Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not been conducted.
In preclinical studies, no effects of telmisartan on male and female fertility were observed.
In some patients treated by calcium channel blockers, reversible biochemical changes in the head of spermatozoa have been reported. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse effects were found on male fertility.
Telmisartan/amlodipine combination has moderate influence on the ability to drive and use machines. When driving vehicles or operating machinery it should be taken into account that syncope, somnolence, dizziness, or vertigo may occasionally occur when taking antihypertensive therapy. If patients experience these adverse reactions, they should avoid potentially hazardous tasks such as driving or using machines.
The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may occur rarely (less than 1 case per 1,000 patients).
Adverse reactions previously reported with one of the individual components may be potential adverse reactions with telmisartan/amlodipine fixed dose combination as well, even if not observed in clinical trials or during the post-marketing period.
The safety and tolerability of telmisartan/amlodipine has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine.
Adverse reactions have been ranked under headings of frequency using the following convention: 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System Organ Class | Telmisartan/amlodipine fixed dose combination | Telmisartan | Amlodipine |
|---|---|---|---|
| Infections and infestations | |||
| Uncommon | upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis | ||
| Rare | cystitis | sepsis including fatal outcome1 | |
| Blood and lymphatic system disorders | |||
| Uncommon | anaemia | ||
| Rare | thrombocytopenia, eosinophilia | ||
| Very rare | leukocytopenia, thrombocytopenia | ||
| Immune system disorders | |||
| Rare | hypersensitivity, anaphylactic reaction | ||
| Very rare | hypersensitivity | ||
| Metabolism and nutrition disorders | |||
| Uncommon | hyperkalaemia | ||
| Rare | hypoglycaemia (in diabetic patients), hyponatraemia | ||
| Very rare | hyperglycaemia | ||
| Psychiatric disorders | |||
| Uncommon | mood change | ||
| Rare | depression, anxiety, insomnia | confusion | |
| Nervous system disorders | |||
| Common | dizziness | ||
| Uncommon | somnolence, migraine, headache, paraesthesia | ||
| Rare | syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor | ||
| Very rare | extrapyramidal syndrome, hypertonia | ||
| Eye disorders | |||
| Common | visual disturbance (including diplopia) | ||
| Uncommon | visual impairment | ||
| Rare | visual disturbance | ||
| Ear and labyrinth disorders | |||
| Uncommon | vertigo | tinnitus | |
| Cardiac disorders | |||
| Uncommon | bradycardia, palpitations | ||
| Rare | tachycardia | ||
| Very rare | myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation | ||
| Vascular disorders | |||
| Uncommon | hypotension, orthostatic hypotension, flushing | ||
| Very rare | vasculitis | ||
| Respiratory, thoracic and mediastinal disorders | |||
| Uncommon | cough | dyspnoea | dyspnoea, rhinitis |
| Very rare | interstitial lung disease3 | ||
| Gastrointestinal disorder | |||
| Common | altered bowel habits (including diarrhoea and constipation) | ||
| Uncommon | abdominal pain, diarrhoea, nausea | flatulence | |
| Rare | vomiting, gingival hypertrophy, dyspepsia, dry mouth | stomach discomfort | |
| Very rare | pancreatitis, gastritis | ||
| Hepato-biliary disorders | |||
| Rare | hepatic function abnormal, liver disorder2 | ||
| Very rare | hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis) | ||
| Skin and subcutaneous tissue disorders | |||
| Uncommon | pruritus | hyperhidrosis | alopecia, purpura, skin discolouration, hyperhidrosis |
| Rare | eczema, erythema, rash | angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria | |
| Very rare | angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity | ||
| Not known | toxic epidermal necrolysis | ||
| Musculoskeletal and connective tissue disorders | |||
| Common | ankle swelling | ||
| Uncommon | arthralgia, muscle spasms (cramps in legs), myalgia | ||
| Rare | back pain, pain in extremity (leg pain) | tendon pain (tendinitis like symptoms) | |
| Renal and urinary disorders | |||
| Uncommon | renal impairment including acute renal failure | micturition disorder, pollakiuria | |
| Rare | nocturia | ||
| Reproductive system and breast disorders | |||
| Uncommon | erectile dysfunction | gynaecomastia | |
| General disorders and administration site condition | |||
| Common | peripheral oedema | ||
| Uncommon | asthenia, chest pain, fatigue, oedema | pain | |
| Rare | malaise | influenza-like illness | |
| Investigations | |||
| Uncommon | hepatic enzymes increased | blood creatinine increased | weight increased, weight decreased |
| Rare | blood uric acid increased | blood creatine phosphokinase increased, haemoglobin decreased | |
1 the event may be a chance finding or related to a mechanism currently not known
2 most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
3 cases of interstitial lung disease (predominantly interstitial pneumonia and eosinophilic pneumonia) have been reported from post-marketing experience with telmisartan
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