Australia - English - Department of Health (Therapeutic Goods Administration)

bridgewest perth pharma pty ltd - atropine sulfate monohydrate, quantity: 600 microgram/ml - injection, solution - excipient ingredients: water for injections; sodium chloride - indications as at 23 october 2001: preanaesthetic medication to reduce salivary secretions and bronchial secretions. to prevent cholinergic cardiac effects such as cardiac arrhythmias, hypotension and bradycardia. management of patients with acute myocardial infarction and sinus bradycardia who have associated hypotension and increased ventricular irritability. concurrent administration with anticholinesterase agents (eg. neostigmine, physostigmine) to block the adverse muscarinic effects of these agents following surgery to terminate curarisation. for poisoning by organophosphate pesticides, atropine may be used concomitantly with a cholinesterase reactivator such as pralidoxime to reverse muscarinic effects.

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

avpak - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - for mydriasis and/or cycloplegia. for cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract. this product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma. this product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. this product should not be used in those persons showing hypersensitivity to any component of this preparation.

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

sebela pharmaceuticals inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i), difenoxin hydrochloride (unii: vqz63k01iw) (difenoxin - unii:3zz5bj9f2q) - atropine sulfate 0.025 mg - motofen® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea. motofen® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic e. coli, salmonella species, shigella ) and pseudomembranous colitis associated with broad spectrum antibiotics. antiperistaltic agents should not be used in the conditions because they may prolong and/or worsen diarrhea. motofen® is contraindicated in children under 2 years of age because of the decreased margin of safety of drugs in this class in younger age groups. motofen® is contraindicated in patients with a known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced. motofen® tablets are a schedule iv controlled substance. addiction to (dependence on) difenoxin hydrochloride is theoretically possible at high dosage. therefore, the recommended dosage should not be e

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

lupin pharmaceuticals,inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and homatropine methylbromide tablets are indicated for the symptomatic relief of cough in patients 18 years of age and older. important limitations of use: -   not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. -   contraindicated in pediatric patients less than 6 years of age [see contraindications (4) ]. -   because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve hydrocodone bitartrate and homatropine methylbromide tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. hydrocodone bitartrate and homatropine methylbromide tablets is contraindicated for: -   all children younger than 6 years of age [see warnings and precautions (5.2, 5.3) use in specific populations (8.4) ]. hydrocodone bitartrate and homatropine methylbromide tablets is also contraindicated in patients with: -   significant respiratory depression [see warnings and precautions (5.2) ]. -   acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.4) ]. -   known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.9) ]. -   hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide tablets [see adverse reactions (6) ]. risk summary hydrocodone bitartrate and homatropine methylbromide tablets are not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.13), clinical considerations ]. there are no available data with hydrocodone bitartrate and homatropine methylbromide tablets use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (see data ). reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets; however, studies are available with individual active ingredients or related active ingredients (see data ). in animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (mrhd) (see data ). based on the animal data, advise pregnant women of the potential risk to a fetus. the estimated 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 prolonged use of opioid analgesics 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 (5.13) ]. 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.  opioids, including hydrocodone bitartrate and homatropine methylbromide tablets, 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 opioids during labor for signs of excess sedation and respiratory depression. data human data hydrocodone a limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. however, these data cannot definitely establish or exclude any drug-associated risk during pregnancy. methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. animal data reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets; however, studies are available with individual active ingredients or related active ingredients. hydrocodone in an embryofetal development study in pregnant hamsters dosed on gestation day 8 during the period of organogenesis, hydrocodone induced cranioschisis, a malformation, at approximately 45 times the mrhd (on a mg/m2 basis with a maternal subcutaneous dose of 102 mg/kg).  reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. in an embryofetal development study in pregnant rats dosed throughout the period of organogenesis, codeine increased resorptions and decreased fetal weights at a dose approximately 65 times the mrhd of hydrocodone (on a mg/m2 basis with a maternal oral dose of codeine at 120 mg/kg/day); however, these effects occurred in the presence of maternal toxicity. in embryofetal development studies with pregnant rabbits and mice dosed throughout the period of organogenesis, codeine produced no adverse developmental effects at doses approximately 30 and 160 times, respectively, the mrhd of hydrocodone (on a mg/m2 basis with maternal oral doses of codeine at 30 mg/kg/day in rabbits and 600 mg/kg/day in mice). homatropine animal studies with homatropine are not available. risk summary because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with hydrocodone bitartrate and homatropine methylbromide tablets. there are no data on the presence of hydrocodone bitartrate and homatropine methylbromide tablets in human milk, the effects of hydrocodone bitartrate and homatropine methylbromide tablets on the breastfed infant, or the effects of hydrocodone bitartrate and homatropine methylbromide tablets on milk production; however, data are available with hydrocodone and homatropine. hydrocodone hydrocodone is present in breast milk. published cases report variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of immediate-release hydrocodone to nursing mothers in the early post-partum period with relative infant doses of hydrocodone ranging between 1.4 and 3.7%. there are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone.  no information is available on the effects of hydrocodone on milk production. homatropine no information is available on the levels of homatropine in breast milk or on milk production. the published literature suggests that homatropine may decrease milk production based on its anticholinergic effects. (see clinical considerations ) clinical considerations infants exposed to hydrocodone bitartrate and homatropine methylbromide tablets through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid is stopped, or when breastfeeding is stopped. infertility chronic use of opioids, such as hydrocodone, a component of hydrocodone bitartrate and homatropine methylbromide tablets, 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) ]. hydrocodone bitartrate and homatropine methylbromide tablets are not indicated for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients [see indications (1), warnings and precautions (5.3) ]. life-threatening respiratory depression and death have occurred in children who received hydrocodone [see warnings and precautions (5.2) ]. because of the risk of life-threatening respiratory depression and death, hydrocodone bitartrate and homatropine methylbromide tablets are contraindicated in children less than 6 years of age [see contraindications (4) ]. clinical studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets in geriatric populations. use caution when considering the use of hydrocodone bitartrate and homatropine methylbromide tablets in patients 65 years of age or older. elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see warnings and precautions (5.4) ]. respiratory depression is the chief risk for elderly patients treated with opioids, including hydrocodone bitartrate and homatropine methylbromide tablets. respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [see warnings and precautions (5.4, 5.8) ]. hydrocodone 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, monitor these patients closely for respiratory depression, sedation, and hypotension. the pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide tablets has not been characterized in patients with renal impairment. patients with renal impairment may have higher plasma concentrations than those with normal function [see clinical pharmacology (12.3) ]. hydrocodone bitartrate and homatropine methylbromide tablets should be used with caution in patients with severe impairment of renal function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. the pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide tablets has not been characterized in patients with hepatic impairment. patients with severe hepatic impairment may have higher plasma concentrations than those with normal hepatic function [see clinical pharmacology (12.3) ].  therefore, hydrocodone bitartrate and homatropine methylbromide tablets should be used with caution in patients with severe impairment of hepatic function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. hydrocodone bitartrate and homatropine methylbromide tablets contains hydrocodone, a schedule ii controlled substance. hydrocodone hydrocodone bitartrate and homatropine methylbromide tablets contains hydrocodone, a substance with a high potential for abuse similar to other opioids including morphine and codeine. hydrocodone bitartrate and homatropine methylbromide tablets can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1) ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic and antitussive products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "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 health care provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. hydrocodone bitartrate and homatropine methylbromide tablets, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of hydrocodone bitartrate and homatropine methylbromide tablets hydrocodone bitartrate and homatropine methylbromide tablets are for oral use only. abuse of hydrocodone bitartrate and homatropine methylbromide tablets poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and homatropine methylbromide tablets with alcohol and other central nervous system depressants [see warnings and precautions (5.8), drug interactions (7.1, 7.4) ]. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. psychological dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, hydrocodone bitartrate and homatropine methylbromide tablets should be prescribed and administered for the shortest duration that is consistent with individual patient treatment goals and patients should be reevaluated prior to refills [see dosage and administration (2.3), warnings and precautions (5.1) ]. physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. if hydrocodone bitartrate and homatropine methylbromide tablets are abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, 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)

novel laboratories, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) are indicated for the symptomatic relief of cough in patients 18 years of age and older. important limitations of use: -   not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. -   contraindicated in pediatric patients less than 6 years of age [see contraindications (4)]. -   because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) is contraindicated for: -   all children younger than 6 years of age [see warnings and precautions (5.2, 5.3), use in specific populations (8.4) ]. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) is also contraindicated in patients with: -   significant respiratory depression [see warnings and precautions (5.2)]. -   acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.4)]. -   known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.9)]. -   hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) [see adverse reactions (6) ]. risk summary hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) are not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.13), clinical considerations ]. there are no available data with hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (see data ). reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution (syrup); however, studies are available with individual active ingredients or related active ingredients (see data ). in animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (mrhd) (see data ). based on the animal data, advise pregnant women of the potential risk to a fetus. the estimated 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 prolonged use of opioid analgesics 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 (5.13) ]. 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.  opioids, including hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 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 opioids during labor for signs of excess sedation and respiratory depression. data human data hydrocodone a limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. however, these data cannot definitely establish or exclude any drug-associated risk during pregnancy. methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. animal data reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution (syrup); however, studies are available with individual active ingredients or related active ingredients. hydrocodone in an embryofetal development study in pregnant hamsters dosed on gestation day 8 during the period of organogenesis, hydrocodone induced cranioschisis, a malformation, at approximately 45 times the mrhd (on a mg/m2 basis with a maternal subcutaneous dose of 102 mg/kg).  reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. in an embryofetal development study in pregnant rats dosed throughout the period of organogenesis, codeine increased resorptions and decreased fetal weights at a dose approximately 65 times the mrhd of hydrocodone (on a mg/m2 basis with a maternal oral dose of codeine at 120 mg/kg/day); however, these effects occurred in the presence of maternal toxicity. in embryofetal development studies with pregnant rabbits and mice dosed throughout the period of organogenesis, codeine produced no adverse developmental effects at doses approximately 30 and 160 times, respectively, the mrhd of hydrocodone (on a mg/m2 basis with maternal oral doses of codeine at 30 mg/kg/day in rabbits and 600 mg/kg/day in mice). homatropine animal studies with homatropine are not available. risk summary because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with hydrocodone bitartrate and homatropine methylbromide oral solution (syrup). there are no data on the presence of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) in human milk, the effects of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) on the breastfed infant, or the effects of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) on milk production; however, data are available with hydrocodone and homatropine. hydrocodone hydrocodone is present in breast milk. published cases report variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of immediate-release hydrocodone to nursing mothers in the early post-partum period with relative infant doses of hydrocodone ranging between 1.4 and 3.7%. there are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone.  no information is available on the effects of hydrocodone on milk production. homatropine no information is available on the levels of homatropine in breast milk or on milk production. the published literature suggests that homatropine may decrease milk production based on its anticholinergic effects. (see clinical considerations ) clinical considerations infants exposed to hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid is stopped, or when breastfeeding is stopped. infertility chronic use of opioids, such as hydrocodone, a component of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 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) ]. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) are not indicated for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients. [see indications (1), warnings and precautions (5.3) ]. life-threatening respiratory depression and death have occurred in children who received hydrocodone [see warnings and precautions (5.2) ]. because of the risk of life-threatening respiratory depression and death, hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) are contraindicated in children less than 6 years of age [see contraindications (4) ]. clinical studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) in geriatric populations. use caution when considering the use of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) in patients 65 years of age or older. elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see warnings and precautions (5.4) ]. respiratory depression is the chief risk for elderly patients treated with opioids, including hydrocodone bitartrate and homatropine methylbromide oral solution (syrup). respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [see warnings and precautions (5.4, 5.8) ]. hydrocodone 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, monitor these patients closely for respiratory depression, sedation, and hypotension. the pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) has not been characterized in patients with renal impairment. patients with renal impairment may have higher plasma concentrations than those with normal function [see clinical pharmacology (12.3) ]. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) should be used with caution in patients with severe impairment of renal function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. the pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) has not been characterized in patients with hepatic impairment. patients with severe hepatic impairment may have higher plasma concentrations than those with normal hepatic function [see clinical pharmacology (12.3) ].  therefore, hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) should be used with caution in patients with severe impairment of hepatic function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) contains hydrocodone, a schedule ii controlled substance. hydrocodone hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) contains hydrocodone, a substance with a high potential for abuse similar to other opioids including morphine and codeine. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1) ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic and antitussive products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "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 health care provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 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 hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) are for oral use only. abuse of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) with alcohol and/or other cns depressants [see warnings and precautions (5.8), drug interactions (7.1, 7.4) ]. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. psychological dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) should be prescribed and administered for the shortest duration that is consistent with individual patient treatment goals and patients should be reevaluated prior to refills [see dosage and administration (2.3), warnings and precautions (5.1) ]. physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. if hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) are abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, 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)

novel laboratories, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hydrocodone bitartrate and homatropine methylbromide tablets are indicated for the symptomatic relief of cough in adult patients 18 years of age and older. limitations of use: -   not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. -   contraindicated in pediatric patients less than 6 years of age [see contraindications (4) ]. -   because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve hydrocodone bitartrate and homatropine methylbromide tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. hydrocodone bitartrate and homatropine methylbromide tablets is contraindicated for: - all pediatric patients younger than 6 years of age [see warnings and precautions (5.2, 5.3) use in specific populations (8.4) ]. -   significant respiratory depression [see warnings and precautions (5.2) ]. -   acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.4) ]. -   known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.9) ]. -   hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide tablets [see adverse reactions (6) ]. risk summary hydrocodone bitartrate and homatropine methylbromide tablets are not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.13), clinical considerations ]. there are no available data with hydrocodone bitartrate and homatropine methylbromide tablets use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (see data ). reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets; however, studies are available with individual active ingredients or related active ingredients (see data ). in animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (mrhd) (see data ). based on the animal data, advise pregnant women of the potential risk to a fetus. the estimated 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 prolonged use of opioid analgesics 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 (5.13) ]. 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.  opioids, including hydrocodone bitartrate and homatropine methylbromide tablets, 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 opioids during labor for signs of excess sedation and respiratory depression. data human data hydrocodone a limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. however, these data cannot definitely establish or exclude any drug-associated risk during pregnancy. methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. animal data reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets; however, studies are available with individual active ingredients or related active ingredients. hydrocodone in an embryofetal development study in pregnant hamsters dosed on gestation day 8 during the period of organogenesis, hydrocodone induced cranioschisis, a malformation, at approximately 45 times the mrhd (on a mg/m2 basis with a maternal subcutaneous dose of 102 mg/kg).  reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. in an embryofetal development study in pregnant rats dosed throughout the period of organogenesis, codeine increased resorptions and decreased fetal weights at a dose approximately 65 times the mrhd of hydrocodone (on a mg/m2 basis with a maternal oral dose of codeine at 120 mg/kg/day); however, these effects occurred in the presence of maternal toxicity. in embryofetal development studies with pregnant rabbits and mice dosed throughout the period of organogenesis, codeine produced no adverse developmental effects at doses approximately 30 and 160 times, respectively, the mrhd of hydrocodone (on a mg/m2 basis with maternal oral doses of codeine at 30 mg/kg/day in rabbits and 600 mg/kg/day in mice). homatropine animal studies with homatropine are not available. risk summary because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with hydrocodone bitartrate and homatropine methylbromide tablets. there are no data on the presence of hydrocodone bitartrate and homatropine methylbromide tablets in human milk, the effects of hydrocodone bitartrate and homatropine methylbromide tablets on the breastfed infant, or the effects of hydrocodone bitartrate and homatropine methylbromide tablets on milk production; however, data are available with hydrocodone and homatropine. hydrocodone hydrocodone is present in breast milk. published cases report variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of immediate-release hydrocodone to nursing mothers in the early post-partum period with relative infant doses of hydrocodone ranging between 1.4% and 3.7%. there are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone.  no information is available on the effects of hydrocodone on milk production. homatropine no information is available on the levels of homatropine in breast milk or on milk production. the published literature suggests that homatropine may decrease milk production based on its anticholinergic effects. (see clinical considerations ) clinical considerations infants exposed to hydrocodone bitartrate and homatropine methylbromide tablets through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid is stopped, or when breastfeeding is stopped. infertility chronic use of opioids, such as hydrocodone, a component of hydrocodone bitartrate and homatropine methylbromide tablets, 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) ]. hydrocodone bitartrate and homatropine methylbromide tablets is contraindicated in pediatric patients younger than 6 years of age because of life-threatening respiratory depression and death have occurred in pediatric patients who received hydrocodone [see contraindications (4), warnings and precautions (5.2)]. the safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide tablets have not been established in patients younger than 18 years of age. hydrocodone bitartrate and homatropine methylbromide tablets is not recommended for use in patients. younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients [see indications (1), warnings and precautions (5.3)]. clinical studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide tablets in geriatric populations. use caution when considering the use of hydrocodone bitartrate and homatropine methylbromide tablets in patients 65 years of age or older. elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see warnings and precautions (5.4) ]. respiratory depression is the chief risk for elderly patients treated with opioids, including hydrocodone bitartrate and homatropine methylbromide tablets. respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [see warnings and precautions (5.4, 5.8) ]. hydrocodone 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, monitor these patients closely for respiratory depression, sedation, and hypotension. the pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide tablets has not been characterized in patients with renal impairment. patients with renal impairment may have higher plasma concentrations than those with normal function [see clinical pharmacology (12.3) ]. hydrocodone bitartrate and homatropine methylbromide tablets should be used with caution in patients with severe impairment of renal function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. the pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide tablets has not been characterized in patients with hepatic impairment. patients with severe hepatic impairment may have higher plasma concentrations than those with normal hepatic function [see clinical pharmacology (12.3) ].  therefore, hydrocodone bitartrate and homatropine methylbromide tablets should be used with caution in patients with severe impairment of hepatic function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. hydrocodone bitartrate and homatropine methylbromide tablets contains hydrocodone, a schedule ii controlled substance. hydrocodone hydrocodone bitartrate and homatropine methylbromide tablets contains hydrocodone, a substance with a high potential for abuse similar to other opioids including morphine and codeine. hydrocodone bitartrate and homatropine methylbromide tablets can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1) ]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic and antitussive products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "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 health care provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. hydrocodone bitartrate and homatropine methylbromide tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of hydrocodone bitartrate and homatropine methylbromide tablets hydrocodone bitartrate and homatropine methylbromide tablets are for oral use only. abuse of hydrocodone bitartrate and homatropine methylbromide tablets poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and homatropine methylbromide tablets with alcohol and/or other cns depressants [see warnings and precautions (5.8), drug interactions (7.1, 7.4) ]. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. psychological dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, hydrocodone bitartrate and homatropine methylbromide tablets should be prescribed and administered for the shortest duration that is consistent with individual patient treatment goals and patients should be reevaluated prior to refills [see dosage and administration (2.3), warnings and precautions (5.1) ]. physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. if hydrocodone bitartrate and homatropine methylbromide tablets are abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, 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) ].

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - atropine sulfate - solution for injection in pre-filled syringe - 0.2 milligram(s)/millilitre - belladonna alkaloids, tertiary amines; atropine

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

altaire pharmaceuticals inc. - homatropine hydrobromide (unii: bew7469qz0) (homatropine - unii:8qs6wcl55z) - a moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. for pre and postoperative states when mydriasis is required. use as an optical aid in some cases of axial lens opacities. contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g. narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - somatropin; somatropin - powder and solvent for solution for injection - 0.2 milligram(s) - somatropin and somatropin agonists; somatropin

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - somatropin; somatropin - powder and solvent for solution for injection - 0.4 milligram(s) - somatropin and somatropin agonists; somatropin