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maia pharmaceuticals, inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)]. - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide for inj

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ani pharmaceuticals, inc. - desipramine hydrochloride (unii: 1y58do4my1) (desipramine - unii:tg537d343b) - desipramine hydrochloride tablets usp are indicated for the treatment of depression. the use of maois intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of desipramine hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration) . starting desipramine hydrochloride in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration) . desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. it should not be used in those who have shown prior hypersensitivity to the drug. cross-sensitivity between this and other dibenzazepines is a possibility.

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ani pharmaceuticals, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg in 5 ml - the use of metoclopramide oral solution is recommended for adults only. therapy should not exceed 12 weeks in duration. metoclopramide oral solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. the principal effect of metoclopramide is on symptoms of post-prandial and daytime heartburn with less observed effect on nocturnal symptoms. if symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of 12-week trial using doses of 15 mg 4 times daily. as there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. metoclopramide is indicated for the relief

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ani pharmaceuticals, inc. - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 300 mg - carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac capsules are indicated:             1. osteoarthritis             2. rheumatoid arthritis etodolac capsules are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. etodolac capsules should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions and precautions, preexisting asthma ). etodolac capsules are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

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ani pharmaceuticals, inc. - methsuximide (unii: 0g76k8x6c0) (methsuximide - unii:0g76k8x6c0) - methsuximide is indicated for the control of absence (petit mal) seizures that are refractory to other drugs. methsuximide should not be used in patients with a history of hypersensitivity to succinimides.

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ani pharmaceuticals, inc. - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate tablets usp are not indicated as a first line antiepileptic treatment (see warnings ). felbamate tablets usp are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate tablets usp can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. it should not be used in patients with a history of any blood dyscras

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dynamic pharmaceuticals inc. - zinc oxide (unii: soi2loh54z) (zinc - unii:j41csq7qds), zinc gluconate (unii: u6wsn5sq1z) (zinc - unii:j41csq7qds), sambucus nigra flowering top (unii: ct03bsa18u) (sambucus nigra flowering top - unii:ct03bsa18u) - zinc oxide 0.25 mg in 1 ml - - reduces duration of the common cold - reduces severity of cold symptoms: sneezing sore throat stuffy nose coughing congestion - sneezing - sore throat - stuffy nose - coughing - congestion

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ani pharmaceuticals, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride capsules are an opioid agonist indicated in adults 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 and precautions (5.1)] , reserve oxycodone hydrochloride capsules for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: oxycodone hydrochloride capsules 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. oxycodone hydrochloride capsules are contraindicated in patients with: risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions ( 5.4 )] . available data with oxycodone hydrochloride capsules are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. in several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see 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 ( 5.4 )] . 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. oxycodone hydrochloride capsules are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including oxycodone hydrochloride capsules, 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 in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and 25 mg/kg/day, respectively. these studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. the highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m2 basis. in published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day iv from gestation day 8 to 21 and postnatal day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m2 basis). risk summary oxycodone is present in breast milk. published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period. the lactation studies did not assess breastfed infants for potential adverse reactions. lactation studies have not been conducted with oxycodone hydrochloride capsules, 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 oxycodone hydrochloride capsules and any potential adverse effects on the breastfed infant from oxycodone hydrochloride capsules or from the underlying maternal condition. clinical considerations monitor infants exposed to oxycodone hydrochloride capsules 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 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), clinical pharmacology (12.2)] . the safety and effectiveness of oxycodone hydrochloride capsules have not been established in pediatric patients. the safety and pharmacokinetics of a single-dose of an oxycodone hydrochloride oral solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain. however, definitive conclusions are not possible because of insufficient information. elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. 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 oxycodone hydrochloride capsules slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions ( 5.2)] . oxycodone 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. since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. initiate therapy in these patients with a lower than usual dosage of oxycodone hydrochloride capsules and titrate carefully. regularly evaluate for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)] . information from oxycodone tablets indicate that patients with renal impairment had higher plasma concentrations of oxycodone than subjects with normal renal function. initiate therapy with a lower than usual dosage of oxycodone hydrochloride capsules and titrate carefully. regularly evaluate for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)] . oxycodone hydrochloride capsules contain oxycodone, a schedule ii controlled substance. oxycodone hydrochloride capsules contain oxycodone, 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 (5.1)] . 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 given to drug use than to other activities and obligations), and possible tolerance of physical dependence. misuse and abuse of oxycodone hydrochloride capsules 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 oxycodone hydrochloride capsules 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 oxycodone hydrochloride capsules abuse include those with a history of prolonged use of any opioid, including products containing oxycodone, those with a history of drug or alcohol abuse, or those who use oxycodone hydrochloride capsules 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 drug abusers and among people who abuse drugs and people with substance abuse disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. oxycodone hydrochloride capsules, 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 oxycodone hydrochloride capsules abuse of oxycodone hydrochloride capsules poses a risk of overdose and death. the risk is increased with concurrent use of oxycodone hydrochloride oral capsules with alcohol and/or other cns depressants. oxycodone hydrochloride capsules are 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 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 oxycodone hydrochloride capsules in a patient physically dependent on opioids. rapid tapering of oxycodone hydrochloride capsules 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 oxycodone hydrochloride capsules, gradually taper the dosage using a patient-specific plan that considers the following: the dose of oxycodone hydrochloride capsules 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 (2.5), warnings and precautions (5.14)]. 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)].

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ani pharmaceuticals, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg - reglan tablets are indicated for the: limitations of use : reglan tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see use in specific populations (8.4)]. reglan is contraindicated: risk summary published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. there are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see clinical considerations] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (mrhd) [see data] . the estimated background risk of major birth defects and miscarriage for the indic

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ani pharmaceuticals, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide tablets are indicated for the:   limitations of use : metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see use in specific populations (8.4)]. metoclopramide tablets are contraindicated: risk summary published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. there are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see clinical considerations] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (mrhd) [see data] . the estimated background risk of major birth de