Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - methamphetamine hydrochloride (unii: 997f43z9cv) (methamphetamine - unii:44ral3456c) - methamphetamine hydrochloride 5 mg - attention deficit disorder with hyperactivity: methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. in patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets, hypersensitivity reactions such as angioedema and anaphylactic reactions have been re

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - lorazepam (unii: o26fzp769l) (lorazepam - unii:o26fzp769l) - lorazepam 2 mg in 1 ml - lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. lorazepam is contraindicated in patients with: lorazepam is a schedule iv controlled substance. lorazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. 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. 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. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). physical dependence lorazepam may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of 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. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of lorazepam and warnings ). tolerance tolerance to lorazepam may develop from continued 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). tolerance to the therapeutic effect of lorazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate oral solution 2 mg/ml and 4 mg/ml is indicated for the management of: morphine sulfate oral solution 20 mg/ml is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients. limitations of use : because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings and precautions (5.2)], reserve morphine sulfate oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products) : morphine sulfate oral solution 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. morphine sulfate oral solution is contraindicated in patients with: risk summary use of opioid analgesics for an extended period of time during pregnancy can cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5)] . there are no available data with morphine sulfate oral solution in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects (see human data). in published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (hdd) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the hdd in the rabbit, growth retardation at 6 times the hdd in the rat, and axial skeletal fusion and cryptorchidism at 16 times the hdd in the mouse. administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3 to 4 times the hdd; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the hdd (see animal data). based on animal data, advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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%, respectively. clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.5)]. labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. morphine sulfate oral solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including morphine sulfate oral solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data human data the results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design. animal data formal reproductive and developmental toxicology studies for morphine have not been conducted. exposure margins for the following published study reports are based on human daily dose of 60 mg morphine using a body surface area comparison (hdd). neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of morphine sulfate (35 to 322 mg/kg) on gestation day 8 to pregnant hamsters (4.7 to 43.5 times the hdd). a no adverse effect level was not defined in this study and the findings cannot be clearly attributed to maternal toxicity. neural tube defects (exencephaly), axial skeletal fusions, and cryptorchidism were reported following a single subcutaneous (sc) injection of morphine sulfate to pregnant mice (100 to 500 mg/kg) on gestation day 8 or 9 at 200 mg/kg or greater (16 times the hdd) and fetal resorption at 400 mg/kg or higher (32 times the hdd). no adverse effects were noted following 100 mg/kg morphine in this model (8 times the hdd). in one study, following continuous subcutaneous infusion of doses greater than or equal to 2.72 mg/kg to mice (0.2 times the hdd), exencephaly, hydronephrosis, intestinal hemorrhage, split supraoccipital, malformed sternebrae, and malformed xiphoid were noted. the effects were reduced with increasing daily dose; possibly due to rapid induction of tolerance under these infusion conditions. the clinical significance of this report is not clear. decreased fetal weights were observed in pregnant rats treated with 20 mg/kg/day morphine sulfate (3.2 times the hdd) from gestation day 7 to 9. there was no evidence of malformations despite maternal toxicity (10% mortality). in a second rat study, decreased fetal weight and increased incidences of growth retardation were noted at 35 mg/kg/day (5.7 times the hdd) and there was a reduced number of fetuses at 70 mg/kg/day (11.4 times the hdd) when pregnant rats were treated with 10, 35, or 70 mg/kg/day morphine sulfate via continuous infusion from gestation day 5 to 20. there was no evidence of fetal malformations or maternal toxicity. an increased incidence of abortion was noted in a study in which pregnant rabbits were treated with 2.5 (0.8 times the hdd) to 10 mg/kg morphine sulfate via subcutaneous injection from gestation day 6 to 10. in a second study, decreased fetal body weights were reported following treatment of pregnant rabbits with increasing doses of morphine (10 to 50 mg/kg/day) during the pre-mating period and 50 mg/kg/day (16 times the hdd) throughout the gestation period. no overt malformations were reported in either publication; although only limited endpoints were evaluated. in published studies in rats, exposure to morphine during gestation and/or lactation periods is associated with: decreased pup viability at 12.5 mg/kg/day or greater (2 times the hdd); decreased pup body weights at 15 mg/kg/day or greater (2.4 times the hdd); decreased litter size, decreased absolute brain and cerebellar weights, cyanosis, and hypothermia at 20 mg/kg/day (3.2 times the hdd); alteration of behavioral responses (play, social-interaction) at 1 mg/kg/day or greater (0.2 times the hdd); alteration of maternal behaviors (e.g., decreased nursing and pup retrievals) in mice at 1 mg/kg or higher (0.08 times the hdd) and rats at 1.5 mg/kg/day or higher (0.2 times the hdd); and a host of behavioral abnormalities in the offspring of rats, including altered responsiveness to opioids at 4 mg/kg/day (0.7 times the hdd) or greater. fetal and/or postnatal exposure to morphine in mice and rats has been shown to result in morphological changes in fetal and neonatal brain and neuronal cell loss, alteration of a number of neurotransmitter and neuromodulator systems, including opioid and non-opioid systems, and impairment in various learning and memory tests that appear to persist into adulthood. these studies were conducted with morphine treatment usually in the range of 4 to 20 mg/kg/day (0.7 to 3.2 times the hdd). additionally, delayed sexual maturation and decreased sexual behaviors in female offspring at 20 mg/kg/day (3.2 times the hdd), and decreased plasma and testicular levels of luteinizing hormone and testosterone, decreased testes weights, seminiferous tubule shrinkage, germinal cell aplasia, and decreased spermatogenesis in male offspring were also observed at 20 mg/kg/day (3.2 times the hdd). decreased litter size and viability were observed in the offspring of male rats that were intraperitoneally administered morphine sulfate for 1 day prior to mating at 25 mg/kg/day (4.1 times the hdd) and mated to untreated females. decreased viability and body weight and/or movement deficits in both first- and second- generation offspring were reported when male mice were treated for 5 days with escalating doses of 120 to 240 mg/kg/day morphine sulfate (9.7 to 19.5 times the hdd) or when female mice treated with escalating doses of 60 to 240 mg/kg/day (4.9 to 19.5 times the hdd) followed by a 5-day treatment-free recovery period prior to mating. similar multigenerational findings were also seen in female rats pre-gestationally treated with escalating doses of 10 to 22 mg/kg/day morphine (1.6 to 3.6 times the hdd). risk summary morphine is present in breast milk. published lactation studies report variable concentrations of morphine in breast milk with administration of immediate-release morphine to nursing mothers in the early postpartum period with a milk-to-plasma morphine auc ratio of 2.5:1 measured in one lactation study. however, there is insufficient information to determine the effects of morphine on the breastfed infant and the effects of morphine on milk production. lactation studies have not been conducted with morphine sulfate oral solution and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for morphine sulfate oral solution and any potential adverse effects on the breastfed infant from morphine sulfate oral solution or from the underlying maternal condition. clinical considerations monitor infants exposed to morphine sulfate oral solution through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of morphine is stopped, or when breastfeeding is stopped. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6) and clinical pharmacology (12.2)]. in published animal studies, morphine administration adversely effected fertility and reproductive endpoints in male rats and prolonged estrus cycle in female rats [see nonclinical toxicology (13)]. the safety and effectiveness of morphine sulfate oral solution (2 mg/ml and 4 mg/ml) have been established for the management of pediatric patients 2 to 17 years of age with acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate. use of morphine sulfate oral solution in this age group is supported by clinical evidence in adults and supportive data from an open-label, safety and pharmacokinetic study in pediatric patients 2 through 17 years of age with post-operative acute pain. patients were excluded if they had used opioids for more than 7 days within the previous 30 days prior to surgery or had received opioids in any form in the previous 7 days prior to surgery.  initial dosing was approximately 0.15 mg/kg to 0.3 mg/kg. pharmacokinetic modeling and simulation indicate that an initial dose of 0.3 mg/kg in pediatric patients 2 years of age and older is expected to produce a maximum systemic exposure (cmax ) similar to that achieved after single dose administration of 10 mg morphine sulfate oral solution to adults [see clinical pharmacology (12.3)] . safety data were available in 81 patients who received single and multiple doses (63 patients aged 2 to 17 years received morphine sulfate oral solution; 18 patients aged 12 to 17 years received morphine sulfate tablets).  the median duration of treatment was 20 hours (range 4 hours to 36 hours). opioid and non-opioid rescue analgesics were allowed. the safety profile in pediatric patients consisted primarily of opioid-related adverse reactions and is similar to that observed in adults [see adverse reactions (6)]. the safety and effectiveness of morphine sulfate oral solution (2 mg/ml and 4 mg/ml) have not been established for the management of pediatric patients 2 to 17 years of age with chronic pain severe enough to require an opioid analgesic when alternative treatments are inadequate. the safety and effectiveness of morphine sulfate oral solution (2 mg/ml and 4 mg/ml) have not been established in pediatric patients less than 2 years of age. the safety and effectiveness of morphine sulfate oral solution 20 mg/ml have not been established in pediatric patients. elderly patients (aged 65 years or older) may have increased sensitivity to morphine. in general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of morphine sulfate oral solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.8)]. morphine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. morphine pharmacokinetics have been reported to be significantly altered in patients with cirrhosis. start these patients with a lower than usual dosage of morphine sulfate oral solution and titrate slowly while regularly evaluating for signs of respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)] . morphine pharmacokinetics are altered in patients with renal failure. start these patients with a lower than usual dosage of morphine sulfate oral solution and titrate slowly while regularly evaluating for signs of respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)] . morphine sulfate oral solution contains morphine, a schedule ii controlled substance. morphine sulfate oral solution contains morphine, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.2)]. 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 morphine sulfate oral solution 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 morphine sulfate oral solution with alcohol and/or 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 morphine sulfate oral solution abuse include those with a history of prolonged use of any opioids, including products containing morphine, those with a history of drug or alcohol abuse, or those who use morphine sulfate oral solution 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. morphine sulfate oral solution, 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 morphine sulfate oral solution abuse of morphine sulfate oral solution poses a risk of overdose and death. the risk is increased with concurrent use of morphine sulfate oral solution with alcohol and/or other cns depressants. morphine sulfate oral solution is approved for oral use only. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic 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 morphine sulfate oral solution in a patient physically dependent on opioids. rapid tapering of morphine sulfate oral solution 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 morphine sulfate oral solution, gradually taper the dosage using a patient-specific plan that considers the following: the dose of morphine sulfate oral solution 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 a long duration 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 (2.6) and warnings and precautions (5.15)] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)]. instructions for use morphine sulfate oral solution, cii 20 mg/ml important information you need to know before using morphine sulfate oral solution: each morphine sulfate oral solution carton contains: step 1: remove the morphine sulfate oral solution bottle and oral syringe from the carton. place all items on a flat surface. open the bottle by pressing downward firmly on the child-resistant cap and twisting it in the direction of the arrow (counter-clockwise). see figure a. do not throw away the child-resistant cap. figure a step 2: check the dose in milliliters (ml) as prescribed by your healthcare provider. find this number on the oral syringe. see figure b. figure b step 3: push the oral syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove excess air. see figure c. figure c step 4: on the flat surface, use one hand to hold the bottle and use your other hand to insert the oral syringe into the bottle opening. see figure d. figure d step 5: with the oral syringe in the bottle, pull the plunger to withdraw the dose prescribed by your healthcare provider (the amount of oral solution in step 2). see figure e. note: measure the dose of medicine from the widest part of the plunger. do not measure from the narrow tip. if you see air bubbles in the syringe, fully push in the plunger so that the oral solution flows back into the bottle. then withdraw your prescribed dose of oral solution. figure e step 6: remove the oral syringe from the bottle. see figure f. figure f step 7: check that the correct dose was drawn up into the oral syringe. see figure g. if the dose is not correct, insert the oral syringe tip into the bottle. fully push in the plunger so that the oral solution flows back into the bottle. repeat steps 4 through 6. figure g steps 8 : take the dose of morphine sulfate oral solution. see figure h. figure h step 9 : put the child-resistant cap back on the bottle. see figure i. figure i step 10 : rinse the oral syringe with tap water after each use. see figure j. do not throw away the oral syringe. figure j how should i store morphine sulfate oral solution? distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 for more information, please call 1-800-962-8364. this instructions for use has been approved by the u.s. food and drug administration c50001154/02 revised december 2023

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 5 mg in 5 ml - diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery. neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - peritonitis or mechanical obstruction of the urinary or intestinal tracts. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. no adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2-times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). anticholinesterase drugs, including neostigmine may cause uterine irritability and induce premature labor when administered to pregnant women near term. neostigmine methylsulfate injection should be given to a pregnant woman only if clearly needed. data animal data in embryofetal development studies, rats and rabbits were administered neostigmine methylsulfate at human equivalent doses (hed, on a mg/m2 basis) of 1.6, 4 and 8.1 mcg/kg/day 3.2, 8.1, and 13 mcg/kg/day, respectively, during the period of organogenesis (gestation days 6 through 17 for rats and gestation days 6 through 18 for rabbits). there was no evidence for a teratogenic effect in rats and rabbits up to hed 8.1 and 13 mcg/kg/day, which are approximately 0.097-times and 0.16-times the mrhd of 5 mg/60 kg, respectively in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. in a pre- and postnatal development study in rats, neostigmine methylsulfate was administered to pregnant female rats at human equivalent doses (hed) of 1.6, 4 and 8.1 mcg/kg/day from day 6 of gestation through day 20 of lactation, with weaning on day 21. there were no adverse effects on physical development, behavior, learning ability, or fertility in the offspring occurred at hed doses up 8.1 mcg/kg/day which is 0.097-times the mrhd of 5 mg/60 kg on a mg/m2 basis in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. it is not known whether neostigmine methylsulfate injection is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions from neostigmine methylsulfate injection in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. data from published literature support the intravenous use of neostigmine methylsulfate for reversal of nondepolarizing neuromuscular blocking agents in all pediatric age groups. recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. however, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. the risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine methylsulfate (up to 0.07 mg/kg or up to a total of 5 mg, whichever is lower). the dose of neostigmine methylsulfate injection required to reverse neuromuscular blockade in children varies between 0.03 mg to 0.07 mg/kg, the same dose range shown to be effective in adults, and should be selected using the same criteria as used for adult patients [see clinical pharmacology (12.3)]. since the blood pressure in pediatric patients, particularly infants and neonates is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension. elderly patients are likely to have decreased renal function, which may prolong the duration of action of neostigmine methylsulfate. however, elderly patients also experience slower spontaneous recovery from neuromuscular blocking agents. therefore, dosage adjustments are generally not needed in geriatric patients; however, they should be monitored for longer periods than younger adults to assure additional doses of neostigmine methylsulfate injection are not required. the duration of monitoring should be predicated on the anticipated duration of action for the neuromuscular blocking agents used on the patient. elimination half-life of neostigmine was prolonged in anephric patients compared to normal subjects, so neostigmine concentration may increase in patients with impaired renal functions. although no adjustments to neostigmine methylsulfate injection dosing appear to be warranted in patients with impaired renal function, they should be closely monitored for a longer period of time. to assure the effects of the neuromuscular blocking agent, particularly one cleared by the kidneys, do not persist beyond those of neostigmine methylsulfate injection, the interval for re‐dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post‐operative monitoring needs to be extended. the pharmacokinetics of neostigmine methylsulfate in patients with hepatic impairment have not been studied. neostigmine is metabolized by microsomal enzymes in the liver so neostigmine concentration may increase in patients with impaired hepatic functions. although no adjustments to the dosing of neostigmine methylsulfate injection appear to be warranted in patients with hepatic insufficiency, patients should be carefully monitored for a longer period of time. if hepatically cleared neuromuscular blocking agents were used during the surgical procedure, their duration of action may also be prolonged by hepatic insufficiency. this could result in the effects of the neuromuscular blocking agent outlasting those of neostigmine methylsulfate injection. in this regard, the interval for re-dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post-operative monitoring needs to be extended. figure 1 figure 1 figure 1 notes: - do not introduce any other fluid into the syringe at any time. - do not dilute for iv push. - do not re-sterilize the syringe. - do not use this product on a sterile field. - this product is for single dose only. 1. inspect the outer packaging (plastic overwrap) to confirm the integrity of the packaging. do not use if the plastic overwrap or the prefilled syringe has been damaged. 2. remove the syringe from the plastic overwrap. do not pop syringe through. (see figure 2) figure 2 figure 2 figure 2 3. visually inspect the syringe. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 4. twist off the syringe tip cap. (see figure 3) figure 3 figure 3 figure 3 5. expel air bubble(s). adjust the dose (if applicable). 6. administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. 7. discard the used syringe into an appropriate receptacle. for more information concerning this drug, please call hikma pharmaceuticals usa inc. at 1-877-845-0689. to report suspected adverse reactions, contact hikma pharmaceuticals usa, inc. at 1-877-845-0689 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .       manufactured by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 july 2022 462-949-00

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide anhydrous 21 ug - ipratropium bromide nasal solution 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. ipratropium bromide nasal solution 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution, 0.03% nasal spray, 21mcg/spray read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening.   ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. read complete instructions carefully and use only as directed. to use: figure 1 figure 1 figure 2 figure 2 figure 3 figure 3 to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. figure 4 figure 4 caution: ipratropium bromide nasal solution, 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution, 0.03% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent during the first full day of treatment with ipratropium bromide nasal solution, 0.03% some patients may require up to two weeks of treatment to obtain maximum benefit. do not spray ipratropium bromide nasal solution, 0.03% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution, 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution, 0.03% storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. keep out of reach of children. address medical inquiries to hikma pharmaceuticals usa inc. at 1-800-962-8364. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000619/01 revised july 2022

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. the safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established. ipratropium bromide nasal solution 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution 0.06% nasal spray, 42 mcg/spray rx only read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide nasal solution 0.06% does not relieve nasal congestion or sneezing, associated with the common cold or seasonal allergic rhinitis. do not use ipratropium bromide nasal solution 0.06 % for longer than four days for a common cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. read complete instructions carefully and use only as directed. to use: figure 1 figure 1 figure 2 figure 2 figure 3 figure 3 to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. figure 4 figure 4 caution: ipratropium bromide nasal solution 0.06% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution 0.06% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent following the first dose of treatment with ipratropium bromide nasal solution 0.06%. do not use ipratropium bromide nasal solution 0.06% for longer than four days for your cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. do not spray ipratropium bromide nasal solution 0.06% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution 0.06% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding, contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. if you are pregnant or breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. keep out of reach of children. address medical inquiries to hikma pharmaceuticals usa inc. at 1-800-962-8364. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000618/01 revised july 2022

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. as an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s recall of the procedures (see warnings ). diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. diazepam injection is a useful adjunct in status epilepticus. diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient’s recall of the procedure. diazepam is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy. diazepam injection is a schedule iv controlled substance. diazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. 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. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings; abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). diazepam may produce physical dependence if used more frequently than recommended. physical dependence is a state that develops as a result of 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. although diazepam is indicated only for intermittent use (see indications and usage and dosage and administration ), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings; dependence and withdrawal reactions ). for patients using diazepam more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam (see warnings; dependence and withdrawal reactions ). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance to diazepam may develop after use more frequently than recommended. 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). tolerance to the therapeutic effect of benzodiazepines may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. caution: certain glass syringes may malfunction, break or clog when connected to some needleless luer access devices (nlads) and needles. this syringe has a larger internal syringe tip and an external collar (luer collar). the external collar must remain attached to the syringe. (see figure 1) spontaneous disconnection of this glass syringe from needles and nlads with leakage of drug product may occur. assure that the needle or nlad is securely attached before beginning the injection. visually inspect the glass syringe-needle or glass syringe–nlad connection before and during drug administration. figure 1   diazepam injection may be administered intramuscularly or intravenously. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 1. inspect the outer packaging (plastic tube) and the syringe label by verifying: - plastic tube integrity - drug name - drug strength - fill volume - route of administration - expiration date to be sure that the drug has not expired - sterile field applicability do not use if package has been damaged. 2. open the outer packaging and remove the syringe from the tube. 3. perform visual inspection on the syringe by verifying: - absence of syringe damage - absence of external particles - absence of internal particles - proper drug color 4. push plunger rod slightly to break the stopper loose while tip cap is still on. 5. remove tip cap by twisting it off. (see figure 2) figure 2   6. discard the tip cap. 7. expel air bubble. 8. adjust dose into sterile material (if applicable). 9. connect the syringe to an appropriate injection connection depending on the route of administration. - before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (nlad). 10.   depress plunger rod to deliver medication. ensure that pressure is maintained on the plunger rod during the entire administration. 11.   remove syringe from nlad (if applicable) and discard into appropriate receptacle. when a needle is connected to the syringe, to prevent needle-stick injuries, needles must not be recapped. notes: - all steps must be done sequentially - do not autoclave syringe - do not use this product on a sterile field - do not introduce any other fluid into the syringe at any time - this product is for single dose only; discard unused portion caution: federal (usa) law prohibits dispensing without prescription. manufactured by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 revised: march 2024                                                                          462-887-06

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see clinical pharmacology, adjunctive use in septic shock ). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation. naloxone hydrochloride injection is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride injection has not been reported. tolerance to the opioid antagonist effect of naloxone is not known to occur. caution: certain glass syringes may malfunction, break or clog when connected to some needleless luer access devices (nlads) and needles. this syringe has a larger internal syringe tip and an external collar (luer collar). the external collar must remain attached to the syringe. data show that the syringe achieves acceptable connections with the bd eclipse™ needle and the terumo surguard3™ safety needle and with the following non-center post nlads: bd smartsite™ and bd-q syte™. the data also show acceptable connections are achieved to the center post icu medical clave™. however, spontaneous disconnection of this glass syringe from needles and nlads with leakage of drug product may occur. assure that the needle or nlad is securely attached before beginning the injection. visually inspect the glass syringe-needle or glass syringe-nlad connection before and during drug administration. figure 1 1. inspect the outer packaging (plastic tube) by verifying: - plastic tube integrity - drug name - drug strength - dose volume - route of administration - expiration date to be sure that the drug has not expired - sterile field applicability do not use if package has been damaged. 2. remove the plastic tube cap of the outer packaging to access the syringe. 3. remove the syringe from the plastic tube. 4. perform visual inspection on the syringe by verifying: - absence of syringe damage - absence of external particles - absence of internal particles - proper drug color - expiration date to be sure that the drug has not expired - drug name - drug strength - dose volume - route of administration - sterile field applicability 5. push plunger rod slightly to break the stopper loose while tip cap is still on. 6. remove tip cap by twisting it off. (see figure 2) figure 2         7. discard the tip cap. 8. expel air bubble. 9. adjust dose by expelling extra volume (where applicable) from the syringe into sterile material prior to administration. 10. connect the syringe to appropriate injection connection depending on route of administration. before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (nlad). 11. depress plunger rod to deliver medication. ensure that pressure is maintained on the plunger rod during the entire administration. 12. remove syringe from nlad (if applicable) and discard into appropriate receptacle. to prevent needle-stick injuries, needles should not be recapped. notes: - all steps must be done sequentially - do not autoclave syringe - do not use this product on a sterile field - do not introduce any other fluid into the syringe at any time - this product is for single dose only; discard unused portion. manufactured by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 462-892-01 revised may 2023