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

somerset therapeutics, llc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate 0.2 mg in 1 ml - in anesthesia: glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug‑induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. in peptic ulcer: for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulc

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

northstar rx llc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer  patients, because of the lon

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

civica, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse reactions ). patients should be switched to alter

Philippines - English - FDA (Food And Drug Administration)

ece pharma'l inc - ranitidine (as hydrochloride) - solution for injection im/iv - 25mg/ml (50mg/2ml)

Canada - English - Health Canada

tersera therapeutics llc - goserelin (goserelin acetate) - implant - 3.6mg - goserelin (goserelin acetate) 3.6mg - gonadotropins and antigonadotropins

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

lupin pharmaceuticals, inc. - thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j) - thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. it is also indicated when giving iv dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given. a history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (see warnings for further information.)

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

armas pharmaceuticals inc. - etomidate (unii: z22628b598) (etomidate - unii:z22628b598) - etomidate injection usp is indicated by intravenous injection for the induction of general anesthesia. when considering use of etomidate, the usefulness of its hemodynamic properties (see clinical pharmacology ) should be weighed against the high frequency of transient skeletal muscle movements (see adverse reactions ). intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization. etomidate is contraindicated in patients who have shown hypersensitivity to it.

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

fresenius kabi usa, llc - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - the injection form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.  the mode of action of this drug has not been clearly identified, but may be related to its sedative properties.  methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol injection should not be administered to patients with known or suspected renal pathology.  this caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. a much larger amount of polyethylene glycol 300 than is present in recommended doses of methocarbamol injection is known to have increased pre-existing acidosis and urea retention in patients with renal impairment.  although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any of the i

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

baxter healthcare corporation - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated: risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see data ). reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see data ). the estimated background risk for 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 2-4% and 15-20%, respectively. it is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. for decisions regarding the use of tranexamic acid during pregnancy, the potential risk of tranexamic acid administration on the fetus should always be considered along with the mother’s clinical need for tranexamic acid; an accurate risk-benefit evaluation should drive the treating physician’s decision. data human data tranexamic acid passes through the placenta. the concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/l, as high as in the maternal blood. there were 13 clinical studies that described fetal and/or neonatal functional issues such as low apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22-36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. animal data in embryo-fetal development studies, tranexamic acid was administered to pregnant mice from gestation day (gd) 6 through gd 12 and rats from gd 9 through gd 14 at daily doses of 0.3 or 1.5 g/kg. there was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. in rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from gd 6 through gd 18. there was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area. intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits. risk summary published literature reports the presence of tranexamic acid in human milk. there are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tranexamic acid and any potential adverse effects on the breastfed child from tranexamic acid or from the underlying maternal condition. contraception concomitant use of tranexamic acid, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. advise patients to use an effective alternative (nonhormonal) contraceptive method [see warnings and precautions (5.1), drug interactions (7.1)] . there are limited data concerning the use of tranexamic acid in pediatric patients with hemophilia who are undergoing tooth extraction. the limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients. clinical studies of tranexamic acid 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. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [ see dosage and administration (2.2) , clinical pharmacology (12.3)] . reduce the dosage of tranexamic acid in patients with renal impairment, based on the patient’s serum creatinine [see dosage and administration (2.2) , clinical pharmacology (12.3)] .

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

baxter healthcare corporation - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension. labetalol hydrochloride injection is contraindicated in bronchial asthma, overt cardiac failure, greater than first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see warnings ). beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.