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pfizer laboratories div pfizer inc - prazosin hydrochloride (unii: x0z7454b90) (prazosin - unii:xm03yj541d) - prazosin 1 mg - minipress 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 this drug. 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 mechanis

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pfizer laboratories div pfizer inc - ramipril (unii: l35jn3i7sj) (ramiprilat - unii:6n5u4qfc3g) - ramipril 1.25 mg - altace 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 this drug. 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 o

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pfizer laboratories div pfizer inc - diphenoxylate hydrochloride (unii: w24od7yw48) (diphenoxylate - unii:73312p173g), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - diphenoxylate hydrochloride 2.5 mg - lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. lomotil is contraindicated in: lomotil is classified as a schedule v controlled substance by federal regulation. diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. in doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. at high doses it exhibits codeine-like subjective effects. the dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. the insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. a dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. since addiction to diphenoxylate hydrochlo

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pfizer laboratories div pfizer inc - spironolactone (unii: 27o7w4t232) (spironolactone - unii:27o7w4t232) - spironolactone 25 mg - aldactone is indicated for treatment of nyha class iii–iv heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. aldactone is usually administered in conjunction with other heart failure therapies. aldactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. 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. 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. aldactone is indicated for the management of edema in the following settings: because it increases serum potassium, aldactone may be useful for treating edema when administration of other diuretics has caused hypokalemia. aldactone is indicated in the following settings: aldactone is contraindicated in the patients with: risk summary based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis (see data) . rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone. there are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy (see error! hyperlink reference not valid. ) . because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. 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 pregnant women with congestive heart failure are at increased risk for preterm birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death. closely monitor pregnant patients for destabilization of their heart failure. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. 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. data animal data teratology studies with aldactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day. on a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. no teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, aldactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis. when administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. offspring exposed during late pregnancy to 50 and 100 mg/kg/day doses of aldactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood. aldactone has known endocrine effects in animals including progestational and antiandrogenic effects. risk summary spironolactone is not present in breastmilk; however, limited data from a lactating woman at 17 days postpartum reports the presence of the active metabolite, canrenone, in human breast milk in low amounts that are expected to be clinically inconsequential. in this case, there were no adverse effects reported for the breastfed infant after short term exposure to spironolactone; however, long term effects on a breastfed infant are unknown. there are no data on spironolactone effects on milk production. consider the developmental and health benefits of breastfeeding along with the mother's clinical need for spironolactone and any potential adverse effects on the breastfed child from spironolactone or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. aldactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, monitor renal function. aldactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. patients with renal impairment are at increased risk of hyperkalemia. monitor potassium closely. aldactone can cause sudden alterations of fluid and electrolyte balance which may precipitate impaired neurological function, worsening hepatic encephalopathy and coma in patients with hepatic disease with cirrhosis and ascites. in these patients, initiate aldactone in the hospital [see dosage and administration (2.4) and clinical pharmacology (12.3)] . clearance of spironolactone and its metabolites is reduced in patients with cirrhosis. in patients with cirrhosis, start with lowest initial dose and titrate slowly [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

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pfizer laboratories div pfizer inc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 2 mg - estring is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. estring is contraindicated in women with any of the following conditions: how should i use estring? estring is a local estrogen therapy used after menopause to treat moderate to severe menopausal changes in and around the vagina. estring provides relief of local symptoms of menopause only. estrogens should be used only as long as needed. you and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with estring. estring insertion estring can be inserted and removed by you or your doctor or healthcare provider. to insert estring yourself, choose the position that is most comfortable for you: standing with one leg up, squatting, or lying down. estring placement the exact position of estring is not critical, as long as it is placed in the upper third of the vagina. when estring is in place, you should not feel anything. if you fee

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pfizer laboratories div pfizer inc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 25 mg - viagra is indicated for the treatment of erectile dysfunction. consistent with its known effects on the nitric oxide/cgmp pathway [see clinical pharmacology (12.1, 12.2) ], viagra was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. after patients have taken viagra, it is unknown when nitrates, if necessary, can be safely administered. although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see dosage and administration (2.3), drug interactions (7.1), and clinical pharmacology (12.2) ]. viagra is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in viagra and revatio, or any component of the tablet. hypersensitivity reactions have been reported, in

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pfizer laboratories div pfizer inc - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 25 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain effectiveness of vibramycin and other antibacterial drugs, vibramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline is indicated for the treatment of the following infections: doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (see dosage and administration section and information for patients subsection of the precautions section.) this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

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pfizer laboratories div pfizer inc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - norvasc® 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 norvasc. 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. norvasc may be used alone or in combination with other antihypertensive agents. norvasc 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 error! hyperlink reference not valid. ] . 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 error! hyperlink reference not valid. ]. 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. norvasc (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see clinical studies (14.1)] . clinical studies of norvasc 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)] .

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pfizer laboratories div pfizer inc - axitinib (unii: c9lvq0yuxg) (axitinib - unii:c9lvq0yuxg) - axitinib 1 mg - inlyta in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc). inlyta in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced rcc. inlyta as a single agent is indicated for the treatment of advanced rcc after failure of one prior systemic therapy. none. risk summary based on findings in animal studies and its mechanism of action, inlyta can cause fetal harm when administered to a pregnant woman. there are no available human data to inform the drug-associated risk. in developmental toxicity studies, axitinib was teratogenic, embryotoxic and fetotoxic in mice at exposures lower than human exposures at the recommended starting dose (see data) . advise females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the united states (u.s.) general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. when inlyta is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for pregnancy information. data animal data oral axitinib administered twice daily to female mice prior to mating and through the first week of pregnancy caused an increase in post-implantation loss at all doses tested (≥15 mg/kg/dose, approximately 10 times the systemic exposure (auc) in patients at the recommended starting dose). in an embryo-fetal developmental toxicity study, pregnant mice received oral doses of 0.15, 0.5 and 1.5 mg/kg/dose axitinib twice daily during the period of organogenesis. embryo-fetal toxicities observed in the absence of maternal toxicity included malformation (cleft palate) at 1.5 mg/kg/dose (approximately 0.5 times the auc in patients at the recommended starting dose) and variation in skeletal ossification at ≥0.5 mg/kg/dose (approximately 0.15 times the auc in patients at the recommended starting dose). risk summary there are no data on the presence of axitinib in human milk, or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in a breastfed child from inlyta, advise lactating women not to breastfeed during treatment and for 2 weeks after the last dose. when inlyta is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for lactation information. based on findings in animal studies, inlyta can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. when inlyta is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for contraception information. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating treatment with inlyta. contraception females advise females of reproductive potential to use effective contraception during treatment with inlyta and for 1 week after the last dose. males based on findings in animal studies, advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. infertility females and males based on findings in animals, inlyta may impair fertility in females and males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of inlyta in pediatric patients have not been studied. juvenile animal toxicity data toxicities in bone and teeth were observed in immature mice and dogs administered oral axitinib twice daily for 1 month or longer. effects in bone consisted of thickened growth plates in mice and dogs at ≥15 mg/kg/dose (approximately 6 and 15 times, respectively, the systemic exposure (auc) in patients at the recommended starting dose). abnormalities in growing incisor teeth (including dental caries, malocclusions and broken and/or missing teeth) were observed in mice administered oral axitinib twice daily at ≥5 mg/kg/dose (approximately 1.5 times the auc in patients at the recommended starting dose). other toxicities of potential concern to pediatric patients have not been evaluated in juvenile animals. in a controlled clinical study with inlyta for the treatment of patients with rcc, 123/359 patients (34%) treated with inlyta were ≥65 years of age. although greater sensitivity in some older individuals cannot be ruled out, no overall differences were observed in the safety and effectiveness of inlyta between patients who were ≥65 years of age and younger. of the 434 patients randomized to inlyta 5 mg twice daily administered in combination with avelumab 10 mg/kg in the javelin renal 101 trial, 38% were 65 years or older and 8% were 75 years or older. no overall difference in safety or efficacy was reported between patients who were ≥65 years of age and younger. of the 432 patients randomized to inlyta 5 mg twice daily administered in combination with pembrolizumab 200 mg in the keynote-426 trial, 40% were 65 years or older. no overall difference in safety or efficacy was reported between patients who were ≥65 years of age and younger. no dosage adjustment is required in elderly patients [see dosage and administration (2.2), clinical pharmacology (12.3)] . in a dedicated hepatic impairment trial, compared to subjects with normal hepatic function, systemic exposure following a single dose of inlyta was similar in subjects with baseline mild hepatic impairment (child-pugh class a) and higher in subjects with baseline moderate hepatic impairment (child-pugh class b). no starting dose adjustment is required when administering inlyta to patients with mild hepatic impairment (child-pugh class a). a starting dose decrease is recommended when administering inlyta to patients with moderate hepatic impairment (child-pugh class b) [see dosage and administration (2.2), warnings and precautions (5.12), clinical pharmacology (12.3)] . inlyta has not been studied in subjects with severe hepatic impairment (child-pugh class c). no dedicated renal impairment trial for axitinib has been conducted. based on the population pharmacokinetic analyses, no significant difference in axitinib clearance was observed in patients with pre-existing mild to severe renal impairment (15 ml/min ≤creatinine clearance [clcr] <89 ml/min) [see clinical pharmacology (12.3)] . no starting dose adjustment is needed for patients with pre-existing mild to severe renal impairment. caution should be used in patients with end-stage renal disease (clcr <15 ml/min).

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pfizer laboratories div pfizer inc - penicillin g procaine (unii: 17r794esyn) (penicillin g - unii:q42t66vg0c) - penicillin g 600000 [iu] in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin g procaine and other antibacterial drugs, penicillin g procaine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. penicillin g procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin-g-susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below. therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response. note: when high, sustained serum levels are required, aqueous