Abstract In the early s, several studies reported the misuse of codeine and promethazine hydrochloride cough syrup. Publication types Systematic Review. Substances Antitussive Agents Promethazine Codeine.
Jump to content. Keep the medication in a place where others cannot get to it. Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Codeine and promethazine is a combination medicine used to treat cold or allergy symptoms such as runny nose, sneezing, and cough.
Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids. If you use opioid medicine while you are pregnant, your baby could become dependent on the drug.
This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Follow the directions on your prescription label and read all medication guides.
Never use this medicine in larger amounts, or for longer than prescribed. Take this medicine only until your symptoms clear up. Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction.
Selling or giving away opioid medicine is against the law. Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device not a kitchen spoon.
Rinse after each use. 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. Respiratory Depression: Promethazine may lead to potentially fatal respiratory depression.
Use of Promethazine in patients with compromised respiratory function e. Lower Seizure Threshold: Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression: Promethazine should be used with caution in patients with bone-marrow depression.
Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome: A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome NMS has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias. The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness e.
Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system CNS pathology. The management of NMS should include 1 immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2 intensive symptomatic treatment and medical monitoring, and 3 treatment of any concomitant serious medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.
Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.
Other Considerations: Administration of promethazine has been associated with reported cholestatic jaundice. Because phenylephrine is an adrenergic agent, it should be given with caution to patients with thyroid diseases, diabetes mellitus, and heart disease or those receiving tricyclic antidepressants. Men with symptomatic, benign prostatic hypertrophy can experience urinary retention when given oral nasal decongestants. Phenylephrine should be used with caution in patients taking diet preparations, such as amphetamines or phenylpropanolamine, because synergistic adrenergic effects could result in serious hypertensive response and possible stroke.
Animal reproduction studies have not been conducted with the drug combination—promethazine and phenylephrine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine and phenylephrine should be given to a pregnant woman only if clearly needed.
Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or impairment of liver function.
Phenylephrine should be used with caution in patients with cardiovascular disease, particularly hypertension. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and phenylephrine therapy.
Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.
Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Anticholinergics: Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine oxidase inhibitors MAOI : Drug interactions, nincluding an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.
Phenylephrine with bronchodilator sympathomimetic agents and with epinephrine or other sympathomimetics. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug.
Promethazine was nonmutagenic in the Salmonella test system of Ames. A study which followed the development of cancer in , patients over a four-year period indicated that in 11, patients who received phenylephrine systemic or topical , there was no statistically significant association between the drug and cancer at any or all sites.
Long-term animal studies have not been performed to assess the carcinogenic potential of phenylephrine, nor are there other animal or human data concerning mutagenicity. A study of the effects of adrenergic drugs on ovum transport in rabbits indicated that treatment with phenylephrine did not alter incidence of pregnancy; the number of implantations was significantly reduced when high doses of the drug were used. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.
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