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phebra pty ltd - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 84 mg in 1 ml - sodium bicarbonate injection is indicated as an alkalinising agent in the treatment of metabolic acidosis which may occur in many conditions including diabetes, starvation, hepatitis, cardiac arrest, shock, severe dehydration, renal insufficiency, severe diarrhoea, addison's disease or administration of acidifying salts (e.g. excessive sodium chloride, calcium chloride, ammonium chloride). sodium bicarbonate injection is also used to increase urinary ph in order to increase the solubility of certain weak acids (e.g. cystine, sulphonamides, uric acid) and in the treatment of certain intoxications (e.g. methanol, phenobarbitone, salicylates, lithium) to decrease renal absorption of the drug or to correct acidosis. sodium bicarbonate injection is contraindicated in patients with renal failure, respiratory or metabolic alkalosis, hypoventilation or chloride depletion, hypernatraemia, hypertension, oedema, congestive heart failure, eclampsia, aldosteronism, a history of urinary calculi and consistent potassium dep

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hainan poly pharm. co., ltd. - sodium nitroprusside (unii: eao03pe1tc) (nitroprusside - unii:169d1260km) - sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding. sodium nitroprusside is indicated for the treatment of acute heart failure to reduce, left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. - diseases with compensatory hypertension (e.g., coarctation of the aorta, arteriovenous shunting). - inadequate cerebral circulation or in moribund patients (a.s.a. class 5e) coming to emergency surgery. - patients with congenital (leber’s) optic atrophy or with tobacco amblyopia.   - acute heart failure associated with reduced peripheral vascular resistance. - concomitant use with sildenafil, tadalafil, vardenifil, or riociguat.  risk summary based on animal data and mechanism of action, sodium nitroprussid

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mallinckrodt nuclear medicine llc - sodium iodide i-131 (unii: 29vco8achh) (iodide ion i-131 - unii:4gc1foq22u) - iodide ion i-131 5 mci in 1 ml

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american regent, inc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection, usp is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.  for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.1)] . nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload.  reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c there are no adequate and well-controlled studies of nicardipine use in pregnant women. however, limited human data in pregnant women with preeclampsia or pre-term labor are available. in animal studies, no embryotoxicity occurred in rats with oral doses 8 times the maximum recommended human dose (mrhd) based on body surface area (mg/m2 ), but did occur in rabbits with oral doses

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west-ward pharmaceuticals corp. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096

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sandoz inc - betaxolol hydrochloride (unii: 6x97d2xt0o) (betaxolol - unii:o0zr1r6rz2) - betaxolol hydrochloride 5.6 mg in 1 ml - betaxolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. it may be used alone or in combination with other anti-glaucoma drugs. in clinical studies, betaxolol hydrochloride ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. however, caution should be used in treating patients with severe reactive airway disease or a history of asthma. hypersensitivity to any component of this product. betaxolol hydrochloride ophthalmic solution is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure. safety and effectiveness in pediatric patients have not been established. no overall differences in safety or effectiveness have been observed between elderly

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somerset therapeutics, llc - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride 0.5 mg in 1 ml - epinastine hcl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd.  in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hcl ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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amneal pharmaceuticals llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride oral solution, usp is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi).

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amneal pharmaceuticals llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (maoi) (see precautions, drug interactions ). promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. according to the who expert committee on drug dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

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american regent, inc. - papaverine hydrochloride (unii: 23473ec6bq) (papaverine - unii:daa13nkg2q) - papaverine hydrochloride 30 mg in 1 ml - papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic. intravenous injection of papaverine is contraindicated in the presence of complete atrioventricular heart block. when conduction is depressed, the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia. papaverine hydrochloride is not indicated for the treatment of impotence by intracorporeal injection. the intracorporeal injection of papaverine hydrochloride has been reported to have resulted in persistent priapism requiring medical and surgical intervention. drug dependence resulting from the abuse of many of the selective depressants, includin