CHLORPHENIRAMINE MALEATE | PREDNISOLONE ACETATE - search results

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

antihistalone prednisolone acetate 10 mg/ml chlorpheniramine maleate 2 mg/ml

apex laboratories pty ltd - prednisolone acetate | chlorpheniramine - anti-inflammatory

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

prednil tablets

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

antihistalone tablets anti-inflammatory and antihistamine

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

broncochem allergy control- cholpheniramine maleate-phenylephrine hcl syrup

laboratorio magnachem international srl - chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - chlorpheniramine maleate 4 mg in 10 ml - nasal congestion, irritation of the upper respiratory passages, temporarily reduces allergy, swelling of nasal passages, sneezing, itching of the nose or throat, itchy watery eyes, allergic rhinitis. nervousness, dizziness or sleeplessness occur. symptoms last more than five days. if fever is presented that last more than 3 days or headache appers, this could be signs of a serious condition.

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

hydrocodone polistirex and chlorpheniramine polistirex extended-release- hydrocodone polistirex and chlorpheniramine polistirex

tris pharma inc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - hydrocodone bitartrate 10 mg in 5 ml - hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold 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 polistirex and chlorpheniramine polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made. hydrocodone polistirex and chlorpheniramine polistirex is contraindicated for: - all children younger than 6 years of age [see warnings and precautions (5.2 , 5.3 ),

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

hydrocodone polistirex and chlorpheniramine polistirex extended-release- hydrocodone polistirex and chlorpheniramine polistirex suspension, extended release

bryant ranch prepack - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold 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 polistirex and chlorpheniramine polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made. hydrocodone polistirex and chlorpheniramine polistirex 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) ]. all children younger than 6 years of age [see warnings and precautions (5.2 , 5.3 ), use in specific populations (8.4) ]. hydrocodone polistirex and chlorpheniramine polistirex is also contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2) ]. 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) ]. 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) ]. known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.9) ]. - hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in hydrocodone polistirex and chlorpheniramine polistirex [see adverse reactions (6) ]. hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in hydrocodone polistirex and chlorpheniramine polistirex [see adverse reactions (6) ]. risk summary hydrocodone polistirex and chlorpheniramine polistirex is 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 polistirex and chlorpheniramine polistirex 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 polistirex and chlorpheniramine polistirex; 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 70 times the maximum recommended human dose (mrhd) (see data ). chlorpheniramine administered by the oral route to mice throughout pregnancy was embryo lethal at a dose approximately 9 times the mrhd and decreased postnatal survival when dosing was continued after parturition. chlorpheniramine administered by the oral route to male and female rats prior to mating produced embryolethality at a dose approximately 9 times the 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 polistirex and chlorpheniramine polistirex, 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. chlorpheniramine the majority of studies examining the use of chlorpheniramine in pregnancy did not find an association with an increased risk of congenital anomalies. in the few studies reporting an association, there was no consistent pattern of malformations noted. animal data reproductive toxicity studies have not been conducted with hydrocodone polistirex and chlorpheniramine polistirex; 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 70 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 95 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 50 and 240 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). chlorpheniramine in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, chlorpheniramine produced no adverse developmental effects at oral doses up to approximately 35 and 45 times, respectively, the mrhd on a mg/m2 basis. however, in a reproduction study with pregnant mice dosed throughout pregnancy, chlorpheniramine produced embryolethality at a dose approximately 9 times the mrhd (on a mg/m2 basis with a maternal oral dose of 20 mg/kg/day) and decreased postnatal survival when dosing was continued after parturition. in a fertility and reproduction study with male and female rats dosed prior to mating, chlorpheniramine produced embryolethality at a dose approximately 9 times the mrhd(on a mg/m2 basis with an oral parental dose of 10 mg/kg/day). 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 polistirex and chlorpheniramine polistirex. there are no data on the presence of hydrocodone polistirex and chlorpheniramine polistirex in human milk, the effects of hydrocodone polistirex and chlorpheniramine polistirex on the breastfed infant, or the effects of hydrocodone polistirex and chlorpheniramine polistirex on milk production; however, data are available with hydrocodone and chlorpheniramine. 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. chlorpheniramine chlorpheniramine is present in human milk. chlorpheniramine has not been reported to cause effects on the breastfed infant. the published literature suggests that chlorpheniramine may decrease milk production based on its anticholinergic effects. (see clinical considerations ) clinical considerations infants exposed to hydrocodone polistirex and chlorpheniramine polistirex 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 polistirex and chlorpheniramine polistirex, 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 polistirex and chlorpheniramine polistirex is 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 polistirex and chlorpheniramine polistirex is contraindicated in children less than 6 years of age [see contraindications (4) ]. clinical studies have not been conducted with hydrocodone polistirex and chlorpheniramine polistirex in geriatric populations. use caution when considering the use of hydrocodone polistirex and chlorpheniramine polistirex 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 polistirex and chlorpheniramine polistirex. 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 polistirex and chlorpheniramine polistirex 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) ]. chlorpheniramine is cleared substantially by the kidney. as such, impaired renal function could potentially lead to the risk of decreased clearance and thereby increased retention or systemic levels of chlorpheniramine. therefore, hydrocodone polistirex and chlorpheniramine polistirex should be used with caution in patients with severe impairment of renal function, and patients should be monitored closely for signs of hydrocodone toxicity (respiratory depression, sedation, and hypotension) and chlorpheniramine toxicity. the pharmacokinetics of hydrocodone polistirex and chlorpheniramine polistirex 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) ]. chlorpheniramine is extensively metabolized by liver before elimination from the body. as such, impaired hepatic function could potentially lead to the risk of decreased metabolism and thereby increased systemic levels of chlorpheniramine. therefore, hydrocodone polistirex and chlorpheniramine polistirex should be used with caution in patients with severe impairment of hepatic function, and patients should be monitored closely for signs of hydrocodone toxicity (respiratory depression, sedation, and hypotension) and chlorpheniramine toxicity. hydrocodone polistirex and chlorpheniramine polistirex contains hydrocodone bitartrate, a schedule ii controlled substance. hydrocodone hydrocodone polistirex and chlorpheniramine polistirex contains hydrocodone, a substance with a high potential for abuse similar to other opioids including morphine and codeine. hydrocodone polistirex and chlorpheniramine polistirex 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 polistirex and chlorpheniramine polistirex, 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 polistirex and chlorpheniramine polistirex hydrocodone polistirex and chlorpheniramine polistirex is for oral use only. abuse of hydrocodone polistirex and chlorpheniramine polistirex poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone polistirex and chlorpheniramine polistirex with alcohol and other central nervous system depressants [see warnings and precautions (5.8) , drug interactions (7.1 , 7.5) ]. 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 polistirex and chlorpheniramine polistirex 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 polistirex and chlorpheniramine polistirex is 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)

hydrocodone polistirex and chlorpheniramine polistirex extended-release- hydrocodone polistirex and chlorpheniramine polistirex

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

hydrocodone polistirex and chlorpheniramine polistirex extended-release- hydrocodone polistirex and chlorpheniramine polistirex

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

hydrocodone polistirex and chlorpheniramine polistirex suspension

physicians total care, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - hydrocodone bitartrate 10 mg in 5 ml - hydrocodone polistirex and chlorpheniramine polistirex er oral suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older. hydrocodone polistirex and chlorpheniramine polistirex er oral suspension is contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine. the use of hydrocodone polistirex and chlorpheniramine polistirex er oral suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression. hydrocodone polistirex and chlorpheniramine polistirex er oral suspension is a schedule iii narcotic. psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, hydrocodone polistirex and chlorpheniramine polistirex er oral suspension should be prescribed and administered with caution. however, psychic dependence is unlikely to develop when hydrocodone polistirex and chlor

New Zealand - English - Ministry for Primary Industries

prednil tablets

zoetis new zealand limited - prednisolone; chlorpheniramine maleate - prednisolone 43.4 g/litre; chlorpheniramine maleate 17.4 g/litre - endocrine agent (hormone)