Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 86.8 mg - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake - amlodipine/atorvastatin-medis (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 43.4 mg - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake - amlodipine/atorvastatin-medis (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amlodipine besilate, quantity: 3.47 mg (equivalent: amlodipine, qty 2.5 mg) - tablet, uncoated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate; sodium starch glycollate; magnesium stearate - hypertension: first line treatment of hypertension. it can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine besylate, which has been used in combination with a thiazide diuretic, beta-adrenoreceptor blocking agent, or an angiotensin converting enzyme inhibitor. angina: first line treatment of chronic stable angina. amlodipine besylate may be used alone, as monotherapy, or in combination with other antianginal drugs.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amlodipine besilate, quantity: 3.47 mg (equivalent: amlodipine, qty 2.5 mg) - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; calcium hydrogen phosphate; magnesium stearate - hypertension: first line treatment of hypertension. it can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine besylate, which has been used in combination with a thiazide diuretic, beta-adrenoreceptor blocking agent, or an angiotensin converting enzyme inhibitor. angina: first line treatment of chronic stable angina. amlodipine besylate may be used alone, as monotherapy, or in combination with other antianginal drugs.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - amlodipine 2.5 mg - amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. amlodipine amlodipine is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. amlodipine may be used alone or in combination with other antihypertensive agents. amlodipine is indicated for the symptomatic treatment of chronic stable angina. amlodipine may be used alone or in combination with other antianginal agents. amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine may be used as monotherapy or in combination with other antianginal agents. in patients with recently documented cad by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. atorvastatin therapy with hmg coa-reductase inhibitors (lipid-altering agents) should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease from hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with coronary heart disease (chd) or multiple risk factors for chd, atorvastatin can be started simultaneously with diet restriction. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low high-density lipoprotein cholesterol (hdl-c), or a family history of early coronary heart disease, atorvastatin is indicated to: in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin is indicated to: in adult patients with clinically evident coronary heart disease, atorvastatin is indicated to: atorvastatin is indicated: atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (fredrickson types i and v). amlodipine and atorvastatin tablets are contraindicated in women who are pregnant. atorvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid-lowering drugs during pregnancy. because hmg-coa reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin may cause fetal harm when administered to a pregnant woman. amlodipine and atorvastatin tablets should be discontinued as soon as pregnancy is recognized [see contraindications (4)] . limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformations at doses up to 30 and 20 times, respectively, the human exposure at the mrhd of 80 mg, based on body surface area (mg/m2 ). in rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥ 6 times the mrhd (see data ). the limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy (see clinical considerations ). in animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times mrhd, respectively. however for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. atorvastatin: limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports have not shown an increased risk of major congenital malformations or miscarriage. rare reports of congenital anomalies have been received following intrauterine exposure to other hmg-coa reductase inhibitors. in a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. the number of cases is adequate to exclude a ≥ 3 to 4-fold increase in congenital anomalies over the background incidence. in 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. atorvastatin: atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. when administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively, atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. these doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the mrhd based on surface area (mg/m2 ). in rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. at the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. in a study in pregnant rats administered atorvastatin calcium at doses equivalent to 20, 100, or 225 mg/kg/day, from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225 mg/kg/day, a dose at which maternal toxicity was observed. pup body weight was decreased through postnatal day 21 at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day. pup development was delayed (rotarod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day). these doses of atorvastatin correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human exposure at the mrhd, based on auc. amlodipine: no evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the mrhd based on body surface area, respectively) during their respective periods of major organogenesis. however, for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. amlodipine and atorvastatin tablets are contraindicated during breastfeeding. atorvastatin use is contraindicated during breastfeeding [see contraindications (4)] . there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. it is not known whether atorvastatin is present in human milk, but it has been shown that another drug in this class passes into human milk and atorvastatin is present in rat milk. because of the potential for serious adverse reactions in a breastfed infant, advise women that breastfeeding is not recommended during treatment with amlodipine and atorvastatin tablets. limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. no adverse effects of amlodipine on the breastfed infant have been observed. there is no available information on the effects of amlodipine on milk production. atorvastatin may cause fetal harm when administered to a pregnant woman. advise females of reproductive potential to use effective contraception during treatment with amlodipine and atorvastatin tablets [see use in specific populations (8.1)] . the safety and effectiveness of amlodipine and atorvastatin tablets have not been established in pediatric populations. amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see clinical studies (14.1)] . the effect of amlodipine on blood pressure in patients less than 6 years of age is not known. safety and effectiveness of atorvastatin have been established in patients 10 years to 17 years of age with hefh as an adjunct to diet to reduce total cholesterol, ldl-c, and apo b levels when, after an adequate trial of diet therapy, the following are present: use of atorvastatin for this indication is supported by evidence from [see dosage and administration (2), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.11)] : advise postmenarchal girls of contraception recommendations, if appropriate for the patient [see use in specific populations (8.1)] . the long-term efficacy of atorvastatin therapy initiated in childhood to reduce morbidity and mortality in adulthood has not been established. the safety and efficacy of atorvastatin have not been established in pediatric patients younger than 10 years of age with hefh. clinical efficacy of atorvastatin with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with hofh including 8 pediatric patients [see clinical studies (14.10)] . safety and effectiveness of amlodipine and atorvastatin tablets have not been established in geriatric populations. clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. elderly patients have decreased clearance of amlodipine with a resulting increase of auc of approximately 40-60%, and a lower initial dose may be required [see dosage and administration (2)] . of the 39,828 patients who received atorvastatin in clinical studies, 15,813 (40%) were ≥ 65 years old and 2,800 (7%) were ≥ 75 years old. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older adults cannot be ruled out. advanced age (≥ 65 years) is a predisposing factor for myopathy. amlodipine and atorvastatin tablets are contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels [see contraindications (4) and clinical pharmacology (12.3)] .

Ισραήλ - Αγγλικά - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - amlodipine as besylate - tablets - amlodipine as besylate 5 mg - amlodipine - mild to moderate hypertension. vasospastic angina ( prinzmetal's or variant angina). chronic stable angina.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - amlodipine besilate,atorvastatin calcium trihydrate -

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - amlodipine besilate,atorvastatin calcium trihydrate -

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - amlodipine besilate,atorvastatin calcium trihydrate -

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - amlodipine besilate,atorvastatin calcium trihydrate -