The clinical translation of these PK variations may be more pronounced in the elderly. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 4.4 and 5.2).Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. The long-term efficacy of amlodipine on therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood have also not been established.After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels between 6-12 hours post dose. rifampicin, Hypericum perforatum).Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects.Dantrolene (infusion): In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. The results indicate that amlodipine treatment was associated with fewer hospitalizations for angina and revascularization procedures in patients with CAD. There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: RR 0.98 95% CI (0.90-1.07) p=0.65.
Paediatric population. Amlodipine does not change the levels of calcium in the blood. For angina, amlodipine may be used as monotherapy or in combination with other anti-anginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers.No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors.The recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Amlodipine belongs to a class of medicines called calcium channel blockers (sometimes called calcium channel antagonists). The patients had at least one additional CHD risk factor, including: previous myocardial infarction or stroke (> 6 months prior to enrollment) or documentation of other atherosclerotic CVD (overall 51.5%), type 2 diabetes (36.1%), HDL-C < 35 mg/dL (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%). Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose. Then, as additional units are injured secondarily, more extreme adaptations develop in those that remain until all nephrons are destroyed. At the conclusion of the study, CON rats weighed 394±7 g and AM rats 404±9 g. Mean values for awake systolic BP are shown in Fig 3Glomerular lesions in uninephrectomized SHR were mainly sclerotic, consisting of increases in both mesangial matrix and basement membrane material. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). Caution is recommended especially at the start of treatment.The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.The following undesirable effects have been observed and reported during treatment with amlodipine with the following frequencies: 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.Insomnia, mood changes (including anxiety), depressionSomnolence, dizziness, headache (especially at the beginning of the treatment)Tremor, dysgeusia, syncope, hypoaesthesia, paraesthesiaArrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation)Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation)Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticariaAngioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivityMicturition disorder, nocturia, increased urinary frequencyReporting suspected adverse reactions after authorisation of the medicinal product is important. For example, maneuvers such as dietary protein restrictionSalt intake also has a major effect on kidney size and compensatory renal growth. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1). Amlodipine is a dihydropyridine calcium antagonist devel- oped by Pfizer, Inc. Clinical trials have shown that it has a slow onset and long duration of action and also exhibits a good anti- hypertensive effect and high safety at doses of 2.5-5 mg once a Close observation of patients is recommended when amlodipine is co-administered with clarithromycin.Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. At the midpoint of each collection, 100 μL blood was collected in microhematocrit tubes. The terminal plasma elimination half life is about 35-50 hours and is consistent with once daily dosing.
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