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

xgen pharmaceuticals djb, inc. - acetazolamide sodium (unii: 429zt169uh) (acetazolamide - unii:o3fx965v0i) - acetazolamide 500 mg in 5 ml - for adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. hypersensitivity to acetazolamide or any excipients in the formulation. since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. it is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. long-term administration of acetazolamide is contraindicated in patients with chronic noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

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

xgen pharmaceuticals djb, inc. - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - neomycin 40 mg in 1 ml - neomycin and polymyxin b sulfates solution for irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. the use of closed systems with indwelling catheters has been shown to reduce the risk of infection. a three-way closed catheter system with constant neomycin-polymyxin b bladder rinse is indicated to prevent the development of infection while using indwelling catheters. if uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated. hypersensitivity to neomycin, the polymyxins, or any ingredient in the solution is a contraindication to its use. a history of hypersensitivity or serious toxic reaction to an aminoglycoside may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs of this class.

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

xgen pharmaceuticals djb, inc. - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe) - amphotericin b 50 mg in 10 ml - amphotericin b for injection usp should be administered primarily to patients with progressive, potentially life-threatening fungal infections. this potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. amphotericin b for injection usp is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), north american blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera absidia , mucor and rhizopus , and infections due to related susceptible species of conidiobolus and basidiobolus , and sporotrichosis. amphotericin b may be useful in the treatment of american mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy. this product is contraindicated in those patients who have shown hypersensitivity to amphote

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

xgen pharmaceuticals djb, inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate is indicated for the prevention of pneumocystis jiroveci pneumonia (pjp) in high-risk, hiv-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of pjp ii. a peripheral cd4+ (t4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . these indications are based on the results of an 18-month randomized, dose-response trial in high risk hiv-infected patients and on existing epidemiological data from natural history studies. the patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of pjp. the remaining patients without a history of pjp included 55 patients with kaposi’s sarcoma and 116 patients with other aids diagnoses, arc or asymptomatic hiv infection. patients were randomly assigned to receive pentamidine isethionate via the respirgard ® ii nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). the results of the trial demonstrated a significant protective effect (p<0.01) against pjp with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. the 300 mg dose regimen reduced the risk of developing pjp by 50 to 70% compared to the 30 mg regimen. a total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. the analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. the results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of pentamidine isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. no dose-response was observed for reduction in overall mortality; however, mortality from pjp was low in all three dosage groups. pentamidine isethionate is contraindicated in patients with a ­history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

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

xgen pharmaceuticals djb, inc. - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 1.2 g in 30 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa, e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginosa, klebsiella sp, enterobacter sp, serratia sp, e. coli, and s. aureus (penicillinase and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli, klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa, proteus sp, e. coli, klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa, proteus sp (indole-positive and indole-negative), e. coli, klebsiella sp, enterobacter sp, serratia s

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

xgen pharmaceuticals djb, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 100 ug in 1 ml - clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see clinical trials ). the safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. other use is of unproven safety and is not recommended. in a rare patient, the potential benefits may outweigh the known risks (see warnings ). clonidine hydrochloride injection is contraindicated in patients with a history of sensitization or allergic reactions to clonidine. epidural administration is contraindicated in the presence of an injection site infection, in patients on anticoagulant therapy, and in those with a bleeding diathesis. administration of clonidine hydrochloride injection above the c4 dermatome is contraindicated since there are no adequate safety data to support such use (see warnings ).

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

xgen pharmaceuticals djb, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg in 1 ml - promethazine hydrochloride injection is indicated for the following conditions: - amelioration of allergic reactions to blood or plasma. - in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. - for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. - for sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. - active treatment of motion sickness. - prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. - as an adjunct to analgesics for the control of postoperative pain. - preoperative, postoperative, and obstetric (during labor) sedation. - intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia. the use of promethazine hydrochloride injection is contraindicated: - in pediatric patients less than 2 years of age due to the risk of respiratory depression ( warnings - respiratory depression ). - for use as an intravenous injection at concentrations greater than 1 mg/ml due to the risk of perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration ( see warnings - severe tissue injury, including gangrene and dosage and administration ). - for use as an intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene ( see warnings - severe tissue injury, including gangrene ). - for use as a subcutaneous injection because chemical irritation and necrotic lesions have been reported ( see warnings - severe tissue injury, including gangrene ). - in patients in a comatose state. - in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine hydrochloride or other phenothiazines.

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

xgen pharmaceuticals djb, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride injection is indicated for the following conditions: - amelioration of allergic reactions to blood or plasma. - in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. - for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. - for sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. - active treatment of motion sickness. - prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. - as an adjunct to analgesics for the control of postoperative pain. - preoperative, postoperative, and obstetric (during labor) sedation. - intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia. the use of promethazine hydrochloride injection is contraindicated: - in pediatric patients less than 2 years of age due to the risk of respiratory depression (see warnings - respiratory depression ). - for use as an intravenous injection at concentrations greater than 1 mg/ml due to the risk of perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration ( see warnings-severe tissue injury, including gangrene and dosage and administration ). - for use as an intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see warnings-severe tissue injury, including gangrene ). - for use as a subcutaneous injection because chemical irritation and necrotic lesions have been reported ( see warnings-severe tissue injury, including gangrene ). - in patients in a comatose state. - in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine hydrochloride or other phenothiazines.

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

xgen pharmaceuticals djb, inc. - streptomycin sulfate (unii: cw25ikj202) (streptomycin - unii:y45qso73ob) - streptomycin 1 g - streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below: - mycobacterium tuberculosis: the advisory council for the elimination of tuberculosis, the american thoracic society, and the center for disease control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (inh), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of inh or rifampin resistance is very low. the need for a fourth drug should be reassessed when the results of susceptibility testing are known. in the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. if community rates of inh resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be co

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

xgen pharmaceuticals djb, inc. - liothyronine sodium (unii: gca9vv7d2n) (liothyronine - unii:06lu7c9h1v) - liothyronine 10 ug in 1 ml - liothyronine sodium injection (t 3 ) is indicated in the treatment of myxedema coma/precoma. liothyronine sodium injection (t 3 ) can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef. thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency or untreated thyrotoxicosis. thyroid hormone preparations are also generally contraindicated in patients with hypersensitivity to any of the active or extraneous constituents of these preparations; however, there is no well-documented evidence in the literature of true allergic or idiosyncratic reactions to thyroid hormone. concomitant use of liothyronine sodium injection (t 3 ) and artificial rewarming of patients is contraindicated. (see precautions.)