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akorn - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 10 mg in 15 ml - lortab elixir is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve lortab elixir for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia lortab elixir is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see warnings, adverse reactions ] lortab elixir contains hydrocodone, a schedule ii controlled substance.

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

akorn - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine is useful for: perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated 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 postoperative 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 is contraindicated for use in pediatric patients less than two years of age. promethazin

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akorn - benztropine mesylate (unii: wmj8tl7510) (benztropine - unii:1nhl2j4x8k) - benztropine mesylate 1 mg in 1 ml - for use as an adjunct in the therapy of all forms of parkinsonism (see dosage and administration). useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see precautions) due to neuroleptic drugs (e.g., phenothiazines). hypersensitivity to any component of benztropine mesylate injection, usp. because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with caution in older pediatric patients.

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

akorn operating company llc - cimetidine hydrochloride (unii: wf10491673) (cimetidine - unii:80061l1wgd) - cimetidine 300 mg in 5 ml - cimetidine hydrochloride oral solution is indicated in: (1) short-term treatment of active duodenal ulcer. most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see dosage and administration-duodenal ulcer). concomitant antacids should be given as needed for relief of pain. however, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years. (3) short-term treatment of active benign gastric ulcer. there is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) erosive gastroesophageal reflux disease (gerd). erosive esophagitis diagnosed by endoscopy. treatment is indicated for 12 weeks for hea

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akorn - levocarnitine (unii: 0g389fzz9m) (levocarnitine - unii:0g389fzz9m) - levocarnitine 1 g in 10 ml - levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. in the reported cases, the clinical presentation consisted of recurrent episodes of reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. associated symptoms included hypotonia, muscle weakness and failure to thrive. a diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see clinical pharmacology ). in some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. none known.

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akorn - lactulose (unii: 9u7d5qh5ae) (lactulose - unii:9u7d5qh5ae) - lactulose 10 g in 15 ml - for the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. controlled studies have shown that lactulose solution therapy reduced the blood ammonia levels by 25-50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in eeg patterns. the clinical response has been observed in about 75% of the patients, which is at least as satisfactory as that resulting from neomycin therapy. an increase in patients’ protein tolerance is also frequently observed with lactulose therapy. in the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies. since lactulose solution contains galactose (less than 1.6 g/15 ml), it is contraindicated in patients who require a low galactose diet.

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akorn - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac 1.035 mg in 1 ml - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (cl

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

akorn - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - lidocaine hydrochloride anhydrous 20 mg in 1 ml - lidocaine hydrochloride oral topical solution, usp (viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. it is also useful for reducing gagging during the taking of x-ray pictures and dental impressions. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.

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

akorn - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam oral solution is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.10) ]. pregnancy category c there are no adequate and controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human th

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

akorn - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 120 mg in 5 ml - acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve acetaminophen and codeine phosphate oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: acetaminophen and codeine phosphate oral solution is contraindicated in: acetaminophen and codeine phosphate oral solution is contraindicated in patients with: acetaminophen and codeine phosphate oral solution contains codeine. codeine in combination with acetaminophen, is a schedule v controlled substance. acetaminophen and codeine phosphate oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxy