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methapharm inc. - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by streptococcus pneumoniae, staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae, and group a beta-hemolytic streptococci. bacterial meningitis caused by e. coli, group b streptococci, and other gram-negative bacteria (listeria monocytogenes, n. meningitidis). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp. , penicillin g-susceptible staphylococci, and enterococci. gram-negative sepsis caused by e. coli, proteus mirabilis and salmonella spp . responds to ampicillin. endocarditis due to enterococcal strains usually respond to intravenous therapy. the addition of an aminoglycoside may enhance the effectiveness of amp

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methapharm, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. this product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam tablets or oral solution. the abuse and dependence potential of levetiracetam has not been evaluated in human studies.

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methapharm inc. - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods). nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to methicillin resistant staphylococcus sp., therapy with nafcillin for injection should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection and other antibacterial drugs. nafcillin for injection 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 s

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methapharm, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated: - in patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity (see warnings). - in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. - in patients with active intravascular clotting. - in patients with hypersensitivity to tranexamic acid or any of the ingredients.

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methapharm, inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (gerd) and a history of erosive esophagitis (ee). safety and efficacy of pantoprazole sodium for injection as a treatment of patients with gerd and a history of ee for more than 10 days have not been demonstrated. pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including zollinger-ellison (ze) syndrome in adults. • pantoprazole sodium for injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2, 5.4), adverse reactions (6)] . • proton pump inhibitors (ppis), including pantoprazole sodium for injection, are contraindicated in patients receiving rilpivirine-containing products [see drug interactions (7)] . risk summary available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. in animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see data) . a pre- and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (gd) 6 through lactation day (ld) 21. changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (pnd) 4 through pnd 21 [see use in specific populations (8.4)] . there were no drug-related findings in maternal animals. advise pregnant women of the potential risk of fetal harm. 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use. methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. in a prospective study by the european network of teratology information services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (ppis). there was no difference in the rate of major malformations between women exposed to ppis and the control group, corresponding to a relative risk (rr)=0.55, [95% confidence interval (ci) 0.08-3.95]. in a population-based retrospective cohort study covering all live births in denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. a meta-analysis that compared 1,530 pregnant women exposed to ppis in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to ppis (for major malformations or=1.12 ([95% ci 0.86-1.45] and for spontaneous abortions or=1.29 [95% ci 0.84-1.97]). animal data reproduction studies have been performed in rats at intravenous pantoprazole doses up to 20 mg/kg/day (4 times the recommended human dose based on body surface area) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. a pre- and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (gd) 6 through lactation day (ld) 21. on postnatal day (pnd 4) through pnd 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (auc) in humans at a dose of 40 mg). there were no drug-related findings in maternal animals. during the preweaning dosing phase (pnd 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (auc) in humans receiving the 40 mg dose) and higher doses. on pnd 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (auc) in humans at the 40 mg dose) and higher doses. the femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. there were no microscopic changes in the distal femur, proximal tibia, or stifle joints. changes in bone parameters were partially reversible following a recovery period, with findings on pnd 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (auc) in humans at the 40 mg dose) and higher doses. risk summary pantoprazole has been detected in breast milk of a nursing mother after a single 40 mg oral dose of pantoprazole. there were no effects on the breastfed infant (see data ). there are no data on pantoprazole effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pantoprazole sodium for injection and any potential adverse effects on the breastfed child from pantoprazole or from the underlying maternal condition. data the breast milk of a 42-year-old woman receiving 40 mg of oral pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of pantoprazole present in the breast milk. pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/l and 24 mcg/l, respectively. a milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. pantoprazole was not detectable (<10 mcg/l) in milk at 6, 8 and 24 hours after the dose. the relative dose to the infant was estimated to be 7.3 mcg of pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose. no adverse events in the infant were reported by the mother. the safety and effectiveness of pantoprazole sodium for injection have not been established in pediatric patients. animal toxicity data in a pre-and post-natal development toxicity study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day on postnatal day (pnd 4) through pnd 21, in addition to lactational exposure through milk. on pnd 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day and higher doses. changes in bone parameters were partially reversible following a recovery period [see use in specific populations (8.1)] . in neonatal/juvenile animals (rats and dogs) toxicities were similar to those observed in adult animals, including gastric alterations, decreases in red cell mass, increases in lipids, enzyme induction and hepatocellular hypertrophy. an increased incidence of eosinophilic chief cells in adult and neonatal/juvenile rats, and atrophy of chief cells in adult rats and in neonatal/juvenile dogs, was observed in the fundic mucosa of stomachs in repeated-dose studies. full to partial recovery of these effects were noted in animals of both age groups following a recovery period. of 286 patients in clinical studies of intravenous pantoprazole sodium in patients with gerd and a history of ee, 86 (43%) were 65 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience with oral pantoprazole sodium has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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methapharm, inc - polidocanol (unii: 0awh8bfg9a) (polidocanol - unii:0awh8bfg9a) - asclera® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. asclera has not been studied in varicose veins more than 3 mm in diameter. asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases. risk summary the available data from case reports on use of polidocanol-containing products, including asclera, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. although none of these risks have been identified, there is minimal benefit in treating uncomplicated spider veins and reticular veins in the lower extremity during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. the animal reproduction studies were conducted in a manner to achieve systemic e

United States - English - NLM (National Library of Medicine)

methapharm, inc. - mannitol (unii: 3owl53l36a) (mannitol - unii:3owl53l36a) - aridol is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. limitations of use: aridol is not a standalone test or a screening test for asthma. bronchial challenge testing with aridol should be used only as part of a physician's overall assessment of asthma. aridol is contraindicated in: - patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules - patients with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident [see warnings and precautions (5.2)]. risk summary there are no available human data regarding inhaled mannitol to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. based on animal reproduction studies, no eviden

United States - English - NLM (National Library of Medicine)

methapharm inc. - methacholine chloride (unii: 0w5etf9m2k) (methacholine - unii:03v657zd3v) - methacholine 100 mg in 100 mg - provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. provocholine is contraindicated in the following: - hypersensitivity to methacholine or other parasympathomimetic agents. reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. - baseline fev1 < 60% predicted (adults or pediatric patients) or <1.5 l (adults) risk summary the available data from published literature on provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant wo

United States - English - NLM (National Library of Medicine)

methapharm, inc. - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd), sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330) - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus, escherichia coli,2 klebsiella spp.2 (including k. pneumoniae 2 ), proteus mirabilis,2 bacteroides fragilis,2 enterobacter spp.,2 and acinetobacter calcoaceticus.2 note: for information on use in pediatric patients see precautions – pediatric use and clinical studies sections. intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli, klebsiella spp. (including k. pneumoniae2 ), bacteroides spp. (including b. fragilis ), and enterobacter spp. 2 gynecological infections caused by beta-lactamase producing strains of escherichia coli ,2 and bacteroides spp .2 (including b. fragilis 2 ). __________ 2 efficacy for this microorganism in this organ system was studied in fewer than 10 infections. while ampicillin and sulbactam for injection, usp is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, usp due to its ampicillin content. therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, usp should not require the addition of another antibacterial. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, usp. therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. once the results are known, therapy should be adjusted if appropriate. to reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, usp and other antibacterial drugs, ampicillin and sulbactam for injection, usp should be used only to treat 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. the use of ampicillin and sulbactam for injection usp is contraindicated in individuals with a history of hypersensitivity reactions (e.g. anaphylaxis or steven-johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g. penicillins and cephalosporins). ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.

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methapharm inc. - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride injection, usp is indicated for the following: - rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [w-p-w] and lown-ganong-levine [l-g-l] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. - temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white (w-p-w) and lown-ganong-levine (l-g-l) syndromes). in controlled studies in the united states, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole – see contraindications and warnings ), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including d.c.-cardioversion capability (see adverse reactions , suggested treatment of acute cardiovascular adverse reactions). as familiarity with the patient's response is gained, use in an office setting may be acceptable. cardioversion has been used safely and effectively after verapamil hydrochloride injection. verapamil hydrochloride injection is contraindicated in: - severe hypotension or cardiogenic shock. - second- or third-degree av block (except in patients with a functioning artificial ventricular pacemaker). - sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). - severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to verapamil therapy). - patients receiving intravenous beta-adrenergic blocking drugs (e.g., propranolol). intravenous verapamil and intravenous beta-adrenergic blocking drugs should not be administered in close proximity to each other (within a few hours), since both may have a depressant effect on myocardial contractility and av conduction. - patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., wolff-parkinson-white, lown-ganong-levine syndromes) are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil is administered. therefore, the use of verapamil in these patients is contraindicated. - ventricular tachycardia: administration of intravenous verapamil to patients with wide-complex ventricular tachycardia (qrs ≥ 0.12 sec) can result in marked hemodynamic deterioration and ventricular fibrillation. proper pretherapy diagnosis and differentiation from wide-complex supraventricular tachycardia is imperative in the emergency room setting. - known hypersensitivity to verapamil hydrochloride.