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hikma pharmaceuticals usa inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine is contraindicated in patients: risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] . 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%, respectiv

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

hikma pharmaceuticals usa inc. - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride 250 mg - mefloquine is indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax . there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae .   note: patients with acute p. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine is indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum . use of mefloquine is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (e.g., quinine and quinidine) or to any of th

United States - English - 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

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

hikma pharmaceuticals usa inc. - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate 2 mg - levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see warnings] , reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: levorphanol tartrate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. levorphanol tartrate tablets are contraindicated in patients with: levorphanol tartrate tablets contains levorphanol, a schedule ii controlled substance. levorphanol tartrate tablets contains levorphanol, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. 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 levorphanol tartrate tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of levorphanol tartrate tablets with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of levorphanol tartrate tablets abuse include those with a history of prolonged use of any opioid, including products containing levorphanol, those with a history of drug or alcohol abuse, or those who use levorphanol tartrate tablets in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. levorphanol tartrate tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of levorphanol tartrate tablets abuse of levorphanol tartrate tablets poses a risk of overdose and death. the risk is increased with concurrent use of levorphanol tartrate tablets with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. 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). physical dependence is a state that develops as a result of a 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 may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue levorphanol tartrate tablets in a patient physically dependent on opioids. rapid tapering of levorphanol tartrate tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing levorphanol tartrate tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of levorphanol tartrate tablets, the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration ; and warnings]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy].

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hikma pharmaceuticals usa inc. - floxuridine (unii: 039lu44i5m) (floxuridine - unii:039lu44i5m) - floxuridine 100 mg in 1 ml - floxuridine for injection, usp is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents. floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.

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hikma pharmaceuticals usa inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate injection, usp is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection, usp may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer patients, beca

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

hikma pharmaceuticals usa inc. - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection, usp is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions [see clinical considerations]. in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimated backgro

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

hikma pharmaceuticals usa inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies ( 14.1)] , heart [see clinical studies ( 14.2)] or liver transplants [see clinical studies ( 14.3)] , in combination with other immunosuppressants . allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary: use of mycophenolate mofetil (mmf) during pregnancy is asso

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

hikma pharmaceuticals usa inc. - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone lactate 10 mg in 10 ml - milrinone lactate injection, usp and milrinone lactate in 5% dextrose injection are indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone lactate injection, usp and milrinone lactate in 5% dextrose injection are contraindicated in patients who are hypersensitive to it.

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

hikma pharmaceuticals usa inc. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate 0.2 mg in 1 ml - glycopyrrolate injection, usp is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection, usp may be used intraoperatively to counteract surgically or drug‑induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer patients, because