USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole 10 mg in 1 ml - fluconazole for oral suspension, usp is indicated for the treatment of: prophylaxis: fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. fluconazole for oral suspension usp is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. co-administration of te

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - rifampin 600 mg - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin for injection, usp and they should be repeated throughout therapy to monitor the response to treatment.  since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin for injection, usp and the patient is not responding to therapy, the drug regimen should be modified. rifampin for injection, usp is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council f

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - propranolol hydrochloride (unii: f8a3652h1v) (propranolol - unii:9y8nxq24vq) - propranolol hydrochloride 1 mg in 1 ml - intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1.  supraventricular arrhythmias intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including wolff‑parkinson‑white syndrome and thyrotoxicosis, to decrease ventricular rate. use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia. 2.  ventricular tachycardias with the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. in critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. if, after consideration of the risks involved, propranolol is used, it should be given intravenously in lo

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - chloroprocaine hydrochloride (unii: lt7z1yw11h) (chloroprocaine - unii:5yvb0pot2h) - chloroprocaine hydrochloride 20 mg in 1 ml - chloroprocaine hydrochloride injection 2% and 3%, in single dose vials, without methylparaben preservative, without edta, is indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks. chloroprocaine hydrochloride injection is not to be used for subarachnoid administration. chloroprocaine hydrochloride is contraindicated in patients hypersensitive (allergic) to drugs of the paba ester group. lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the following conditions: existing neurological disease, spinal deformities, septicemia, and severe hypertension.

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - propranolol hydrochloride (unii: f8a3652h1v) (propranolol - unii:9y8nxq24vq) - propranolol hydrochloride 20 mg in 5 ml - hypertension propranolol hydrochloride is indicated in the management of hypertension. it may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. propranolol is not indicated in the management of hypertensive emergencies. angina pectoris due to coronary atherosclerosis propranolol hydrochloride is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. atrial fibrillation propranolol hydrochloride is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. myocardial infarction propranolol hydrochloride is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. migraine propranolol hydrochloride is indicated for the prophylaxis of common migraine headache. the efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and pro

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15 mg in 1 ml - 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 ). acute pain in adult patients 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 alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. (see also boxed warning .) ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings – anaphylactoid reactions , and precautions – pre-existing asthma ). ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ). ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see warnings  for correction of volume depletion). ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see warnings and precautions ). ketorolac tromethamine is contraindicated in patients currently receiving aspirin or nsaids because of the cumulative risks of inducing serious nsaid-related adverse events. the concomitant use of ketorolac tromethamine and probenecid is contraindicated. the concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated. ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - dexamethasone phosphate 4 mg in 1 ml - a. intravenous or intramuscular administration. when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance) acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used) preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus acute rheumatic carditis 4. dermatologic diseases pemphigus severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema (epinephrine is the drug of first choice) 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus iritis, iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy) regional enteritis (systemic therapy) 8. respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy loeffler's syndrome not manageable by other means aspiration pneumonitis 9. hematologic disorders acquired (autoimmune) hemolytic anemia idiopathic thrombocytopenic purpura in adults (i.v. only; i.m. administration is contraindicated) secondary thrombocytopenia in adults erythroblastopenia (rbc anemia) congenital (erythroid) hypoplastic anemia 10. neoplastic diseases for palliative management of: leukemias and lymphomas in adults acute leukemia of childhood 11. edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 12. nervous system acute exacerbations of multiple sclerosis 13. miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. b. intra-articular or soft tissue administration. when the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post-traumatic osteoarthritis c. intralesional administration. when the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for: keloids localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis) discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon (ganglia). systemic fungal infections.

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - phenobarbital (unii: yqe403bp4d) (phenobarbital - unii:yqe403bp4d) - phenobarbital 15 mg - phenobarbital tablets, usp are indicated for use as a sedative or anticonvulsant. phenobarbital is contraindicated in patients who are hypersensitive to barbiturates. in such patients, severe hepatic damage can occur from ordinary doses and is usually associated with dermatitis and involvement of parenchymatous organs. a personal or familial history of acute intermittent porphyria represents one of the few absolute contraindications to the use of barbiturates. phenobarbital is also contraindicated in patients with marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. it should not be administered to persons with known previous addiction to the sedative/hypnotic group, since ordinary doses may be ineffectual and may contribute to further addiction. controlled substance: phenobarbital is a schedule iv drug. prolonged, uninterrupted use of barbiturates (particularly the short-acting drugs), even in therapeutic doses, may result in psychic and physical dependence. withdrawal symptoms due to physical dependence following chronic use of large doses of barbiturates may include delirium, convulsions, and death.

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa 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. promethazine hydrochloride injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression (see warnings - respiratory depression). promethazine hydrochloride injection is contraindicated in comatose states. under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see warnings - severe tissue injury, including gangrene). promethazine hydrochloride injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. the preferred parenteral route of administration is by deep intramuscular injection. promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - phenergan 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. phenergan injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression ( see  warnings - respiratory depression) . phenergan injection is contraindicated in comatose states. under no circumstances should phenergan injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see warnings - severe tissue injury, including gangrene). phenergan injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. the preferred parenteral route of administration is by deep intramuscular injection. phenergan injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.