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

amneal pharmaceuticals llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride oral solution, usp is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi).

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

akorn - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hcl, phenylephrine hcl and codeine phosphate oral solution, usp is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. important limitations of use: promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is contraindicated for: promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is also contraindicated in patients with: risk summary promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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 (5.20), clinical considerations ]. there are no available data with promethazine hcl, phenylephrine hcl and codeine phosphate oral solution use in pregnant women to inform a drug-associated risk for adverse developmental

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

akorn - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi).

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

amneal pharmaceuticals llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, 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 under 12 years of age [see contraindications (4), use in specific populations (8.4)] . - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see contraindications (4), use in specific populations (8.4)] . - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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. promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.2, 5.3, 5.5), use in specific populations (8.4)] . - postoperative pain management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.2, 5.3)] . promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is also contraindicated in patients with: promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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 (5.6)] . - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.11)] . - narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease, or peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds) [see warnings and precautions (5.13)] . - a history of an idiosyncratic reaction to promethazine or to other phenothiazines [see warnings and precautions (5.15)] . - concurrent use of monoamine oxidase inhibitors (maois) or use of maois within 14 days [see warnings and precautions (5.17), drug interactions (7.6)] . - hypersensitivity to codeine, promethazine, phenylephrine, or any of the inactive ingredients in promethazine hcl, phenylephrine hcl and codeine phosphate oral solution [see adverse reactions (6)] . persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine. risk summary promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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 (5.20), clinical considerations] .  there are no available data with promethazine hcl, phenylephrine hcl and codeine phosphate oral solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.  published studies with codeine have reported inconsistent findings and have important methodological limitations (see data ).  there are reports of respiratory depression when codeine is used during labor and delivery (see clinical considerations) . reproductive toxicity studies have not been conducted with promethazine hcl, phenylephrine hcl and codeine phosphate oral solution; however, studies are available with individual active ingredients (see data ).  in animal reproduction studies, codeine administered by the oral route to pregnant rats during the period of organogenesis increased resorptions and decreased fetal weights at a dose approximately 25 times the maximum recommended human dose (mrhd) in the presence of maternal toxicity (see data ).  for pregnant mice and rats that received promethazine at doses 0.2 and 3-6 times the mrhd, during various periods of gestation, there were findings of increased fetal resorptions and skeletal fragility, decreased pup weight, and developmental delays of pups (see data ).  in studies with normotensive pregnant rabbits, which received phenylephrine during the period of organogenesis or later, there were findings of increased fetal lethality, adverse placental effects, and possible teratogenic effects at subcutaneous doses approximately 0.8 times the mrhd on a mg/m2 basis.  premature labor was also observed when treatment was initiated during the second trimester or later (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 (5.20)] . maternal use of phenylephrine can cause fetal tachycardia. 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 promethazine hcl, phenylephrine hcl and codeine phosphate oral solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.  however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.  monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. data human data published data from case-control and observational studies on codeine use during pregnancy are inconsistent in their findings.  some studies of codeine exposure showed an increased risk of overall congenital malformations while others did not.  an increased risk of specific malformations with codeine exposure such as respiratory malformations, spina bifida and congenital heart defects were reported in some studies.  the majority of studies examining the use of phenylephrine and promethazine in pregnancy did not find an association with an increased risk of congenital anomalies.  in the few studies reporting an association, no consistent pattern of malformations was noted. most of the studies, both positive and negative, were limited by small sample size, recall bias and lack of information regarding dose and timing of exposure.  animal data reproductive toxicity studies have not been conducted with promethazine hcl, phenylephrine hcl and codeine phosphate oral solution; however, studies are available with individual active ingredients. codeine 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 25 times the mrhd (on a mg/m2 basis with a maternal oral dose of 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 15 and 65 times, respectively, the mrhd (on a mg/m2 basis with maternal oral doses of 30 mg/kg/day in rabbits and 600 mg/kg/day in mice).  promethazine in pregnant mice dosed during the period of implantation from gestation days 1 to 5, promethazine increased resorption at doses approximately 0.2 times the mrhd (on a mg/m2 basis with maternal intraperitoneal and subcutaneous doses up to 1 mg/kg/day). in pregnant rats dosed during the period of organogenesis from gestation days 5 to 16, promethazine hydrochloride induced complete resorption at doses approximately 6 times the mrhd (on a mg/m2 basis with maternal oral doses up to 20 mg/kg/day). in pregnant rats dosed during the period of organogenesis from gestation days 7 to 13, promethazine resulted in skeletal fragility of pups at doses approximately 3 times the mrhd (on a mg/m2 basis with maternal oral doses up to 10 mg/kg/day). in pregnant rats dosed during the period of organogenesis from gestation days 10 to 12, promethazine resulted in decreased weight and delays in initial occurrence of behavioral/reflex of pups at doses approximately 3 times the mrhd (on a mg/m2 basis with maternal oral doses up to 10 mg/kg/day). the relevance of these findings to humans is unclear. phenylephrine in studies with normotensive pregnant rabbits, which received phenylephrine during the period of organogenesis or later, there were findings of fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen), and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) at doses approximately 0.8 times the mrhd (on a mg/m2 basis with a maternal subcutaneous dose of 1 mg/kg/day).  premature labor was also observed when treatment was initiated during the second trimester or later.  mean percentage of implantations in rabbits was decreased by injection of phenylephrine. 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 promethazine hcl, phenylephrine hcl and codeine phosphate oral solution [see warnings and precautions (5.3)] . there are no data on the presence of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution in human milk, the effects of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution on the breastfed infant, or the effects of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution on milk production; however, data are available with codeine and promethazine. codeine codeine and its active metabolite, morphine, are present in human milk.  there are published studies and cases that have reported excessive sedation, respiratory depression and death (in one infant) in infants exposed to codeine via breast milk.  women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants.  in women with normal codeine metabolism (normal cyp2d6 activity), the amount of codeine secreted into human milk is low and dose-dependent.  there is no information on the effects of the codeine on milk production.  promethazine there are no data on the presence of promethazine in human milk.  however, direct oral administration of promethazine has been associated with respiratory depression, including fatalities, in pediatric patients [see warnings and precautions (5.4)] .  promethazine has been shown to decrease basal prolactin levels in non-nursing women, and therefore may affect milk production. phenylephrine there are no data on the presence of phenylephrine in human milk or on or on its effects on the breastfed infant.  phenylephrine is known to be poorly absorbed orally.  animal data indicate that phenylephrine can decrease milk production and pharmacologically similar vasoconstrictors, such as pseudoephedrine, decrease milk production in lactating women after oral use. clinical considerations infants exposed to promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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 codeine, a component of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution, 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)]. promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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 codeine in these patients [see indications (1), warnings and precautions (5.5)] .  life-threatening respiratory depression and death have occurred in children who received codeine [see warnings and precautions (5.2)] .  in most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome p450 isoenzyme 2d6 or high morphine concentrations).  children with sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine.  life-threatening respiratory depression and death have also occurred in children who received promethazine [see warnings and precautions (5.4)] .  because of the risk of life-threatening respiratory depression and death: - promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is contraindicated for all children younger than 12 years of age [see contraindications (4)] . - promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see contraindications (4)] . - avoid the use of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine unless the benefits outweigh the risks. risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression [see warnings and precautions (5.3, 5.6)]. clinical studies have not been conducted with promethazine hcl, phenylephrine hcl and codeine phosphate oral solution in geriatric populations.  use caution when considering the use of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution in patients 65 years of age or older.  elderly patients may have increased sensitivity to codeine; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see warnings and precautions (5.6)] .   respiratory depression is the chief risk for elderly patients treated with opioids, including promethazine hcl, phenylephrine hcl and codeine phosphate oral solution.  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 (5.6, 5.10)] .  codeine 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 promethazine hcl, phenylephrine hcl and codeine phosphate oral solution has not been characterized in patients with renal impairment.  codeine pharmacokinetics may be altered in patients with renal failure.  clearance may be decreased and the metabolites may accumulate to much higher plasma levels in patients with renal failure as compared to patients with normal renal function.  promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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. no formal studies have been conducted in patients with hepatic impairment so the pharmacokinetics of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution in this patient population are unknown.  promethazine hcl, phenylephrine hcl and codeine phosphate oral solution should be used with caution in patients with impairment of hepatic function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. promethazine hcl, phenylephrine hcl and codeine phosphate oral solution contains codeine, a schedule v controlled substance. codeine promethazine hcl, phenylephrine hcl and codeine phosphate oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including morphine and codeine.  promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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. promethazine hcl, phenylephrine hcl and codeine phosphate oral solution, 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 promethazine hcl, phenylephrine hcl and codeine phosphate oral solution promethazine hcl, phenylephrine hcl and codeine phosphate oral solution is for oral use only.  abuse of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution poses a risk of overdose and death.  the risk is increased with concurrent use of promethazine hcl, phenylephrine hcl and codeine phosphate oral solution with alcohol and other central nervous system depressants [see warnings and precautions (5.10)] . 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, promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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 promethazine hcl, phenylephrine hcl and codeine phosphate oral solution 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)

physicians total care, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi). promethazine products are contraindicated for use in pediatric patients less than two years of age. caution should be exercised when administering promethazine products to pediatric p

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

par pharmaceutical - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi).

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

preferred pharmaceuticals, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi). promethazine products are contraindicated for use in pediatric patients less than two years of age. caution should be exercised when administering promethazine products to pediatric p

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

preferred pharmaceuticals, inc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi). promethazine products are contraindicated for use in pediatric patients less than two years of age. caution should be exercised when administering promethazine products to pediatric p

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

pai holdings, llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi). promethazine products are contraindicated for use in pediatric patients less than two years of age. caution should be exercised when administering promethazine products to pediatric p

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

pai holdings, llc - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine vc with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, 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 under 12 years of age [see contraindications (4) and use in specific populations (8.4)]. • contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see contraindications (4) and use in specific populations (8.4)]. • because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve promethazine vc with codeine oral solution 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. promethazine vc with codeine oral solution is contraindicated for: • all children younger than 12 years of age [ see warnings and precautions ( 5.2, 5.3, 5.5 ), use in specific populations ( 8.4) ]. • postoperative pain management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see warnings and precautions ( 5.2, 5.3) ]. promethazine vc with codeine oral solution 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 ( 5.6) ]. • known or suspected gastrointestinal obstruction, including paralytic ileus [ see warnings and precautions ( 5.11) ]. • narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease, or peripheral vascular insufficiency (ischemia    may result with risk of gangrene or thrombosis of compromised vascular beds) [ see warnings and precautions ( 5.13 )]. • a history of an idiosyncratic reaction to promethazine or to other phenothiazines [ see warnings and precautions ( 5.15) ]. • concurrent use of monoamine oxidase inhibitors (maois) or use of maois within 14 days [ see warnings and precautions ( 5.17 ) and drug    interactions ( 7.6) ]. • hypersensitivity to codeine, promethazine, phenylephrine, or any of the inactive ingredients in promethazine vc with codeine oral solution [ see    adverse reactions ( 6) ]. persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine. risk summary promethazine vc with codeine oral solution 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 ( 5.20 ), clinical considerations ]. there are no available data with promethazine vc with codeine oral solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with codeine have reported inconsistent findings and have important methodological limitations ( see data ). there are reports of respiratory depression when codeine is used during labor and delivery ( see clinical considerations ). reproductive toxicity studies have not been conducted with promethazine vc with codeine oral solution; however, studies are available with individual active ingredients ( see data ). in animal reproduction studies, codeine administered by the oral route to pregnant rats during the period of organogenesis increased resorptions and decreased fetal weights at a dose approximately 26 times the maximum recommended human dose (mrhd) in the presence of maternal toxicity ( see data ). for pregnant mice and rats that received promethazine at doses 0.15 to 3 times the mrhd, during various periods of gestation, there were findings of increased fetal resorptions and skeletal fragility, decreased pup weight, and developmental delays of pups ( see data ). in studies with normotensive pregnant rabbits, which received phenylephrine during the period of organogenesis or later, there were findings of increased fetal lethality, adverse placental effects, and possible teratogenic effects at subcutaneous doses approximately 0.8 times the mrhd on a mg/m2 basis. premature labor was also observed when treatment was initiated during the second trimester or later ( 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 ( 5.20 )]. maternal use of phenylephrine can cause fetal tachycardia. 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 promethazine vc with codeine oral solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. data human data published data from case-control and observational studies on codeine use during pregnancy are inconsistent in their findings. some studies of codeine exposure showed an increased risk of overall congenital malformations while others did not. an increased risk of specific malformations with codeine exposure such as respiratory malformations, spina bifida and congenital heart defects were reported in some studies. the majority of studies examining the use of phenylephrine and promethazine in pregnancy did not find an association with an increased risk of congenital anomalies. in the few studies reporting an association, no consistent pattern of malformations was noted. most of the studies, both positive and negative, were limited by small sample size, recall bias and lack of information regarding dose and timing of exposure. animal data reproductive toxicity studies have not been conducted with promethazine vc with codeine oral solution; however, studies are available with individual active ingredients. codeine 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 26 times the mrhd (on a mg/m 2 basis with a maternal oral dose of 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 13 and 66 times, respectively, the mrhd (on a mg/m 2 basis with maternal oral doses of 30 mg/kg/day in rabbits and 600 mg/kg/day in mice). promethazine in pregnant mice dosed during the period of implantation from gestation days 1 to 5, promethazine increased resorption at doses approximately 0.2 times the mrhd (on a mg/m2 basis with maternal intraperitoneal and subcutaneous doses up to 1 mg/kg/day). in pregnant rats dosed during the period of organogenesis from gestation days 5 to 16, promethazine hydrochloride induced complete resorption at doses approximately 6 times the mrhd (on a mg/m 2 basis with maternal oral doses up to 20 mg/kg/day). in pregnant rats dosed during the period of organogenesis from gestation days 7 to 13, promethazine resulted in skeletal fragility of pups at doses approximately 3 times the mrhd (on a mg/m 2 basis with maternal oral doses up to 10 mg/kg/day). in pregnant rats dosed during the period of organogenesis from gestation days 10 to 12, promethazine resulted in decreased weight and delays in initial occurrence of behavioral/reflex of pups at doses approximately 3 times the mrhd (on a mg/m 2 basis with maternal oral doses up to 10 mg/kg/day). the relevance of these findings to humans is unclear. phenylephrine in studies with normotensive pregnant rabbits, which received phenylephrine during the period of organogenesis or later, there were findings of fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen), and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) at doses approximately 0.8 times the mrhd (on a mg/m 2 basis with a maternal subcutaneous dose of 1 mg/kg/day). premature labor was also observed when treatment was initiated during the second trimester or later. mean percentage of implantations in rabbits was decreased by injection of phenylephrine. 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 promethazine vc with codeine oral solution [see warnings and precautions ( 5.3) ]. there are no data on the presence of promethazine vc with codeine oral solution in human milk, the effects of promethazine vc with codeine oral solution on the breastfed infant, or the effects of promethazine vc with codeine oral solution on milk production; however, data are available with codeine and promethazine. codeine codeine and its active metabolite, morphine, are present in human milk. there are published studies and cases that have reported excessive sedation, respiratory depression and death (in one infant) in infants exposed to codeine via breast milk. women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants. in women with normal codeine metabolism (normal cyp2d6 activity), the amount of codeine secreted into human milk is low and dose-dependent. there is no information on the effects of the codeine on milk production. promethazine there are no data on the presence of promethazine in human milk. however, direct oral administration of promethazine has been associated with respiratory depression, including fatalities, in pediatric patients [ see warnings and precautions ( 5.4) ]. promethazine has been shown to decrease basal prolactin levels in non-nursing women, and therefore may affect milk production. phenylephrine there are no data on the presence of phenylephrine in human milk or on its effects on the breastfed infant. phenylephrine is known to be poorly absorbed orally. animal data indicate that phenylephrine can decrease milk production and pharmacologically similar vasoconstrictors, such as pseudoephedrine, decrease milk production in lactating women after oral use. clinical considerations infants exposed to promethazine vc with codeine oral solution 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 codeine, a component of promethazine vc with codeine oral solution, may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions ( 6) and clinical pharmacology ( 12.2) ]. promethazine vc with codeine oral solution 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 codeine in these patients [ see indications ( 1) and warnings and precautions ( 5.5) ]. life-threatening respiratory depression and death have occurred in children who received codeine [see warnings and precautions ( 5.2) ]. in most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine (ie, multiple copies of the gene for cytochrome p450 isoenzyme 2d6 or high morphine concentrations). children with sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine. life-threatening respiratory depression and death have also occurred in children who received promethazine [see warnings and precautions ( 5.4) ]. because of the risk of life-threatening respiratory depression and death: - promethazine vc with codeine oral solution is contraindicated for all children younger than 12 years of age [see contraindications ( 4) ]. - promethazine vc with codeine oral solution is contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see contraindications ( 4) ]. - avoid the use of promethazine vc with codeine oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine unless the benefits outweigh the risks. risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression [see warnings and precautions ( 5.3, 5.6) ]. clinical studies have not been conducted with promethazine vc with codeine oral solution in geriatric populations. use caution when considering the use of promethazine vc with codeine oral solution in patients 65 years of age or older. elderly patients may have increased sensitivity to codeine; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see warnings and precautions ( 5.6) ]. respiratory depression is the chief risk for elderly patients treated with opioids, including promethazine vc with codeine oral solution.  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 ( 5.6, 5.10) ]. codeine 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 promethazine vc with codeine oral solution has not been characterized in patients with renal impairment.  codeine pharmacokinetics may be altered in patients with renal failure. clearance may be decreased and the metabolites may accumulate to much higher plasma levels in patients with renal failure as compared to patients with normal renal function. promethazine vc with codeine oral solution 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. no formal studies have been conducted in patients with hepatic impairment so the pharmacokinetics of promethazine vc with codeine oral solution in this patient population are unknown. promethazine vc with codeine oral solution should be used with caution in patients with impairment of hepatic function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. promethazine vc with codeine oral solution contains codeine, a schedule v controlled substance. codeine promethazine vc with codeine oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including morphine and codeine. promethazine vc with codeine oral solution 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. promethazine vc with codeine oral solution, 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 promethazine vc with codeine oral solution promethazine vc with codeine oral solution is for oral use only. abuse of promethazine vc with codeine oral solution poses a risk of overdose and death. the risk is increased with concurrent use of promethazine vc with codeine oral solution with alcohol and other central nervous system depressants [see warnings and precautions ( 5.10 )]. 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, promethazine vc with codeine oral solution 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) and 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 promethazine vc with codeine oral solution 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 (eg, naloxone, nalmefene), mixed agonist/antagonist analgesics (eg, pentazocine, butorphanol, nalbuphine), or partial agonists (eg, 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) ].