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exela pharma sciences, llc - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components. this leaflet tells you about caffeine citrate oral solution and how to give it to your baby. read the following information before giving this medicine to your baby. completely discuss caffeine citrate with your baby’s doctor. continue to discuss any questions you have about this medicine at your baby’s checkups. after you remove your baby’s dose, throw away the open bottle (vial) and all medicine left in it. use each vial of caffeine citrate oral solution for only one dose. there will be extra medicine left in the vial after one dose is removed. leftover medicine should not be used because caffeine citrate oral solution does not contain preservatives. once the vial is open

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

exela pharma sciences, llc - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components. this leaflet tells you about caffeine citrate oral solution and how to give it to your baby. read the following information before giving this medicine to your baby. completely discuss caffeine citrate with your baby’s doctor. continue to discuss any questions you have about this medicine at your baby’s checkups. after you remove your baby’s dose, throw away the open bottle (vial) and all medicine left in it. use each vial of caffeine citrate oral solution for only one dose. there will be extra medicine left in the vial after one dose is removed. leftover medicine should not be used because caffeine citrate oral solution does not contain preservatives. once the vial is open

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

exela pharma sciences, llc - cysteine hydrochloride (unii: zt934n0x4w) (cysteine - unii:k848jz4886) - elcys® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (tpn); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require tpn. it can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. elcys® is contraindicated in: risk summary appropriate administration of elcys® is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with cysteine hydrochloride. the estimated background risk for major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary data available on the effects of cysteine hydrochloride on infants, either directly or through breastmilk, do not suggest a significant risk of adverse events from exposure. although there are no data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk production, appropriate administration of elcys® is not expected to cause harm to a breastfed infant. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for elcys® and any potential adverse effects on the breastfed infant from elcys® or from the underlying maternal condition. elcys® is approved for use in pediatric patients, from birth to 17 years of age, for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants, including preterm infants, requiring total parenteral nutrition (tpn) and pediatric patients with severe liver disease who may have impaired enzymatic processes and require tpn. the safety profile for elcys® use in pediatric patients includes risks of acid-base imbalance and hyperammonemia. acid-base imbalance, including metabolic acidosis, may occur with elcys® administration in preterm infants. frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, and acid-base balance during parenteral nutrition therapy [see warnings and precautions (5.4)] . hyperammonemia is of special significance in infants (birth to two years of age). this reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. it is essential that blood ammonia be measured frequently in infants [see warnings and precautions (5.6)]. because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with elcys® may be at higher risk of aluminum toxicity [see warnings and precautions (5.7)]. clinical studies with elcys® have not been performed to determine whether patients aged 65 and over respond differently from younger patients. monitor patients with impaired renal function receiving pn solutions containing the recommended dosage of elcys® with frequent clinical evaluation and laboratory tests to assess renal function, including serum electrolytes and fluid balance [see dosage and administration (2.4), warnings and precautions (5.8)]. monitor patients with impaired liver function receiving pn solutions containing the recommended dosage of elcys® with frequent clinical evaluation and laboratory tests to assess liver function, such as bilirubin and liver function parameters [see dosage and administration (2.4), warnings and precautions (5.8)].

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exela pharma sciences, llc - sodium nitroprusside (unii: eao03pe1tc) (nitroprusside - unii:169d1260km) - sodium nitroprusside 0.5 mg in 1 ml - sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding. sodium nitroprusside is indicated for the treatment of acute heart failure to reduce, left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. risk summary based on animal data and mechanism of action, sodium nitroprusside may lead to cyanide exposure and potential adverse effects in the fetus [see clinical pharmacology (12.3) and clinical considerations] . published post-marketing reports with sodium nitroprusside use in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy related outcomes [see data] . there were no animal reproduction studies conducted with sodium nitroprusside during pregnancy.  however, there are

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exela pharma sciences, llc - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl citrate injection is indicated in adult and pediatric patients ages 2 years and older for: fentanyl citrate injection is contraindicated in patients with: risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. available data with fentanyl citrate injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. there are adverse outcomes reported with fetal exposure to opioid analgesics (see clinical considerations) . in animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing.  no evidence of malformations was noted in animal studies completed to date [see data] . 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 2-4% and 15-20%, 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. labor or delivery there are insufficient data to support the use of fentanyl in labor or delivery. therefore, such use is not recommended. 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.  fentanyl citrate injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate.  opioid analgesics, including fentanyl citrate injection, 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 animal data fentanyl has been shown to be embryocidal in pregnant rats at doses of 30 mcg/kg intravenously (0.05 times the human dose of 100 mcg/kg on a mg/m2 basis) and 160 mcg/kg subcutaneously (0.26 times the human dose of 100 mcg/kg on a mg/m2 basis). there was no evidence of teratogenicity reported. no evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via  subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2-weeks prior to breeding and throughout pregnancy. the high dose was approximately 0.81 times the human dose of 100 mcg/kg on a mg/m2 basis.  risk summary fentanyl is present in breast milk. one published lactation study reports a relative infant dose of fentanyl of 0.38%. however, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fentanyl citrate injection and any potential adverse effects on the breastfed infant from fentanyl citrate injection or from the underlying maternal condition. clinical considerations monitor infants exposed to fentanyl through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding 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), clinical pharmacology (12.2), nonclinical toxicology (13.1)] . the safety and efficacy of fentanyl citrate injection in pediatric patients under two years of age has not been established. rare cases of unexplained clinically significant methemoglobinemia have been reported in premature neonates undergoing emergency anesthesia and surgery which included combined use of fentanyl, pancuronium and atropine. a direct cause and effect relationship between the combined use of these drugs and the reported cases of methemoglobinemia has not been established. elderly patients (aged 65 years or older) may have increased sensitivity to fentanyl. in general, use caution when selecting a dosage 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 fentanyl citrate injection slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see warnings and precautions (5.2)] . fentanyl 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 monitor renal function. fentanyl citrate injection should be administered with caution to patients with liver dysfunction because of the extensive hepatic metabolism. reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. fentanyl citrate injection should be administered with caution to patients with kidney dysfunction because of the renal excretion of fentanyl citrate injection and its metabolites. reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. fentanyl citrate injection contains fentanyl, a schedule ii controlled drug substance. fentanyl citrate injection contains fentanyl, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.1)]. 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 fentanyl citrate injection 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 fentanyl citrate injection 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 fentanyl citrate injection abuse include those with a history of prolonged use of any opioid, including products containing fentanyl, those with a history of drug or alcohol abuse, or those who use fentanyl citrate injection 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. fentanyl citrate injection, 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 fentanyl citrate injection abuse of fentanyl citrate injection poses a risk of overdose and death.  the risk is increased with concurrent use of fentanyl citrate injection 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. fentanyl citrate injection should not be abruptly discontinued in a physically-dependent patient. if fentanyl citrate injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. 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)].

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

exela pharma sciences, llc - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: - rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [wpw] and lown-ganong-levine [lgl] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil administration. - temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white [wpw] and lown-ganong-levine [lgl] syndromes). in controlled studies in the u.s., about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial flutter and/or fi

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exela pharma sciences, llc - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 500 mg in 1 ml - magnesium sulfate injection, usp is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. in such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 meq/l) and the serum calcium level is normal (4.3 to 5.3 meq/l) or elevated. in total parenteral nutrition (tpn), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

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exela pharma sciences,llc - zinc chloride (unii: 86q357l16b) (zinc cation - unii:13s1s8sf37) - plastic vial rx only zinc chloride injection, usp, 1 mg/ml is indicated for use as a supplement to intravenous solutions given for tpn. administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms. none known. none known.

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exela pharma sciences, llc - sodium acetate anhydrous (unii: nvg71zz7p0) (sodium cation - unii:lyr4m0nh37) -

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exela pharma sciences, llc - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 2.5 mg in 1 ml - verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: in controlled studies in the u.s., about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial flutter and/or fibrillation with a fast ventricular rate respond with a decrease in heart rate of at least 20%. conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. the effect of a single injection lasts for 30–60 minutes when conversion to sinus rhythm does not occur. because a small fraction (<1.0%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation w