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blenheim pharmacal, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 12.5 mg - promethazine hydrochloride, is useful orally for. perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of post-operative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hydrochloride tablets, usp are contraindicated for use

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h.j. harkins company, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg - promethazine hydrochloride, is useful orally for. perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of post-operative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hydrochloride tablets, usp are contraindicated for use

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b. braun medical inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium gluconate (unii: r6q3791s76) (sodium cation - unii:lyr4m0nh37, gluconic acid - unii:r4r8j0q44b), sodium acetate (unii: 4550k0sc9b) (sodium cation - unii:lyr4m0nh37, acetate ion - unii:569dqm74sc), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), magnesium chloride (unii: 02f3473h9o) (magnesium cation - unii:t6v3lhy838, chloride ion - uni - sodium chloride 0.53 g in 100 ml - this solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent. contraindications: none known. accurate clinical and laboratory estimation of fluid and electrolyte balance in order to access benefit/risk ratio are essential prior to administration of this solution (see warnings and precautions ).

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general injectables & vaccines, inc - calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698) - calcium chloride 100 mg in 1 ml - 10% calcium chloride injection, usp is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation. none known.

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lupin pharmaceuticals,inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 2.5 mg - dexmethylphenidate hydrochloride tablet is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)]. - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets. hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)] . risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations) . embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (mrhd) of 20 mg/day given to adults based on plasma levels. a decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the mrhd of 20 mg/day given to adults based on plasma levels. plasma levels in adults were comparatively similar to plasma levels in adolescents (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants such as dexmethylphenidate hydrochloride, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. data animal data in embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. no evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. when dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. at the highest doses tested, plasma levels [area under the curves (aucs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the mrhd of 20 mg/day. racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of dexmethylphenidate hydrochloride have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see clinical studies (14)]. the safety and effectiveness of dexmethylphenidate hydrochloride in pediatric patients less than 6 years have not been established. the long-term efficacy of dexmethylphenidate hydrochloride in pediatric patients has not been established. long term suppression of growth growth should be monitored during treatment with stimulants, including dexmethylphenidate hydrochloride tablets. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.7)] . juvenile animal toxicity data rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 6 times the mrhd of 60 mg/day given to children on a mg/m2 basis. in a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg of racemic methylphenidate given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the mrhd given to children on a mg/m2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. dexmethylphenidate hydrochloride has not been studied in the geriatric population. dexmethylphenidate hydrochloride tablet contains dexmethylphenidate hydrochloride, a schedule ii controlled substance. dexmethylphenidate hydrochloride tablet has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1) ]. dexmethylphenidate hydrochloride tablet can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse ofcns stimulants, including dexmethylphenidate hydrochloride tablets, can result in overdose and death [see overdosage (10) ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence dexmethylphenidate hydrochloride tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dexmethylphenidate hydrochloride tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance dexmethylphenidate hydrochloride tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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upsher-smith laboratories, llc - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride 25 mg - clomipramine hydrochloride capsules, usp are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the dsm-iii-r (circa 1989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on the yale-brow

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sandoz inc - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride 25 mg - clomipramine hydrochloride capsules, usp are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the dsm-iii-r (circa 1989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on the yale-brow

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preferred pharmaceuticals inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 15 mg - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual d

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astrazeneca pharmaceuticals, lp - cefotetan disodium (unii: 0gxp746vxb) (cefotetan - unii:48spp0pa9q) - injection, solution - 1 g in 50 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotan and other antibacterial drugs, cefotan 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefotan is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: cefotetan, like other cephalosporins, has no activity against chlamydia trachomatis . therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and c. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. *efficacy for this organism in this organ system was studied in fewer tha

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novartis ophthalmics - levocabastine hydrochloride (unii: 124xma6yei) (levocabastine - unii:h68bp06s81) - suspension - 0.5 mg in 1 ml - livostin™ 0.05% (levocabastine hydrochloride ophthalmic suspension) is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. this product is contraindicated in persons with known or suspected hypersensitivity to any of its components. it should not be used while soft contact lenses are being worn.