BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

bacitracin zinc and polymyxin b sulfate ointment

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - this product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

ALBUTEROL SULFATE aerosol, metered Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

albuterol sulfate aerosol, metered

preferred pharmaceuticals inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other albuterol sulfate inhalation aerosol components. instructions for use albuterol sulfate (al-byoo-ter-ole) inhalation aerosol with dose indicator read this instructions for use before you start using albuterol sulfate inhalation aerosol and eachtime you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. your doctor should show you how your child should use albuterol sulfate inhalation aerosol. important information: albuterol sulfate inhalation aerosol comes as a canister with a dose indicator. the dose indicator is located on the top of the canister that fits into an actuator (see error! hyperlink reference not valid. ). the dose indicator display window will show you how many puffs of medicine you have left. a puff of medicine is released each time you press the center of the dose indicator. figure a before you use albuterol sulfate inhalation aerosol for the first time make sure that the pointer on the dose indicator is pointing to the right of the “200” inhalation mark in the dose indicator display window (see error! hyperlink reference not valid.) . each canister of albuterol sulfate inhalation aerosol contains 200 puffs of medicine. this does not include the sprays of medicine used for priming your inhaler. figure b before using your albuterol sulfate inhalation aerosol for the first time, you should prime your inhaler. if you do not use your albuterol sulfate inhalation aerosol for more than 2 weeks , you should re-prime it before use. using your albuterol sulfate inhalation aerosol inhaler: step 1: shake the inhaler well before each use. remove the cap from the mouthpiece ( see error! hyperlink reference not valid. ). check inside the mouthpiece for objects before use. make sure the canister is fully inserted into the actuator. figure c step 2: breathe out as fully as you comfortably can through your mouth. hold the inhaler in the upright position with the mouthpiece pointing towards you and place the mouthpiece fully into the mouth ( see error! hyperlink reference not valid. ). close your lips around the mouthpiece. figure d step 3: while breathing in deeply and slowly, press down on the center of the dose indicator with your index finger until the canister stops moving in the actuator and a puff of medicine has been released ( see error! hyperlink reference not valid. ). then stop pressing the dose indicator. step 4: hold your breath as long as you comfortably can, up to 10 seconds. remove the inhaler from your mouth, and then breathe out. step 5: if your doctor has prescribed additional puffs of albuterol sulfate inhalation aerosol , wait 1 minute then shake the inhaler well. repeat steps 3 through 5 in the section “ error! hyperlink reference not valid.”. step 6: replace the cap right away after use. cleaning your albuterol sulfate inhalation aerosol inhaler: it is very important that you keep the mouthpiece clean so that medicine will not build up and block the spray through the mouthpiece. clean the mouthpiece 1 time each week or if your mouthpiece becomes blocked ( see error! hyperlink reference not valid. ). step 1: remove the canister from the actuator and take the cap off the mouthpiece. do not clean the metal canister or let it get wet. step 2: wash the mouthpiece through the top and bottom with warm running water for 30 seconds ( see error! hyperlink reference not valid. ). figure e step 3 : shake off as much water from the mouthpiece as you can. step 4: look in the mouthpiece to make sure any medicine buildup has been completely washed away. if the mouthpiece is blocked with buildup, little to no medicine will come out of the mouthpiece ( see error! hyperlink reference not valid. ). if there is any buildup, repeat steps 2 through 4 in the section “ error! hyperlink reference not valid.”. figure f step 5: let the mouthpiece air-dry such as overnight ( figure g ). do not put the canister back into the actuator if it is still we figure g step 6: when the mouthpiece is dry, put the canister back in the actuator and put the cap on the mouthpiece. note: if you need to use your albuterol sulfate inhalation aerosol inhaler before it is completely dry, put the canister back in the actuator and shake the inhaler well. press down on the center of the dose indicator 2 times to release a total of 2 sprays into the air, away from your face. take your dose as prescribed then clean and air-dry your inhaler as described in the section “ error! hyperlink reference not valid.”. how should i store albuterol sulfate inhalation aerosol? developed and manufactured by:  kindeva drug delivery l.p. northridge, ca 91324, usa distributed by: sandoz inc. princeton, nj 08540 copyright © 1996, 2011, 2012, 2017, 2018, 2020all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: 12/2020          34-8726-6023-7 relabeled by: preferred pharmaceuticals inc.

TRIPLE ANTIBIOTIC bacitracin zinc and neomycin sulfate polymyxin ointment Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

triple antibiotic bacitracin zinc and neomycin sulfate polymyxin ointment

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - bacitracin 400 [usp'u] in 1 g

TRIPLE ANTIBIOTIC bacitracin zinc neomycin polymyxin ointment Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

triple antibiotic bacitracin zinc neomycin polymyxin ointment

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - bacitracin 400 [usp'u] in 1 g

DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

double antibiotic- bacitracin zinc and polymyxin b sulfate ointment

preferred pharmaceuticals, inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - bacitracin 500 [usp'u] in 1 g - antibiotic antibiotic first aid to help prevent infection in do not use ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns when using this product do not use longer than 1 week unless directed by a doctor stop use and ask a doctor if keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. directions other information store at room temperature inactive ingredient white petrolatum questions or comments? call toll free 1-800-645-9833

PREFERRED MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

preferred maximum strength urinary pain relief- phenazopyridine hydrochloride tablet

preferred pharmaceuticals inc. - phenazopyridine hydrochloride (unii: 0ewg668w17) (phenazopyridine - unii:k2j09emj52) - urinary analgesic ■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine caution: do not use this product if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless approved by your physician ■ your symptoms last for more than 2 days ■ you suspect you are having an adverse reaction to the medication fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

PREFERRED MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

preferred maximum strength urinary pain relief- phenazopyridine hydrochloride tablet

preferred pharmaceuticals inc. - phenazopyridine hydrochloride (unii: 0ewg668w17) (phenazopyridine - unii:k2j09emj52) - urinary analgesic ■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine ■ your symptoms last for more than 2 days ■ you suspect you are having an adverse reaction to the medication fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

AMLODIPINE BESYLATE tablet Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

amlodipine besylate tablet

preferred pharmaceuticals inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 10 mg - amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal 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 besylate tablet, usp. 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 besylate tablets may be used alone or in combination with other antihypertensive agents. chronic stable angina amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets may be used alone or in combination with other antianginal agents. vasospastic angina (prinzmetal's or variant angina) amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. amlodipine besylate is contraindicated in patients with known sensitivity to amlodipine. risk summary the limited available data based on post-marketing reports with norvasc 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 the maximum recommended human dose (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%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk 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. data animal data 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. risk summary 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. amlodipine besylate (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see clinical studies (14.1)] . effect of amlodipine besylate on blood pressure in patients less than 6 years of age is not known. clinical studies of amlodipine besylate 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 (2.1)] .

AMLODIPINE BESYLATE tablet Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

amlodipine besylate tablet

preferred pharmaceuticals inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal 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 besylate tablets. 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 besylate tablets may be used alone or in combination with other antihypertensive agents. chronic stable angina amlodipine besylate tablets is indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets may be used alone or in combination with other antianginal agents. vasospastic angina (prinzmetal’s or variant angina) amlodipine besylate tablets is indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. risk summary 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 the maximum recommended human dose (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%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk 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. data animal data 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. risk summary 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 product amlodipine besylate tablets (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see clinical studies (14.1)] . effect of amlodipine on blood pressure in patients less than 6 years of age is not known. 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 to 60%, and a lower initial dose may be required [see dosage and administration (2.1)] .

AMLODIPINE BESYLATE tablet Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

amlodipine besylate tablet

preferred pharmaceuticals inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal 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 besylate tablets. 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 mm hg 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 besylate tablets may be used alone or in combination with other antihypertensive agents. chronic stable angina amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets may be used alone or in combination with other antianginal agents. vasospastic angina (prinzmetal's or variant angina) amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization  procedure. amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. risk summary 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 the maximum recommended human dose (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%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk 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. data animal data 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. risk summary 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. amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see clinical studies (14.1)] . effect of amlodipine on blood pressure in patients less than 6 years of age is not known. 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 (2.1)] .