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Promethazine DM
Overview
What is Promethazine DM?
Each 5 mL (one teaspoonful), for oral administration contains:
Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol
7%.
Inactive Ingredients: Ascorbic acid, citric acid, D and C yellow #10,
FD and C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene
glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium
citrate and sucrose.
Dextromethorphan hydrobromide is a salt of the methyl ether of the
dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically
designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide
monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly
soluble in water and freely soluble in alcohol. It has a molecular weight of
370.32, a molecular formula of CHNO•HBr•HO, and the following
structural formula:
Promethazine is a racemic compound. Promethazine hydrochloride, a
phenothiazine derivative, is chemically designated as 10-Phenothiazine-10-ethanamine, ,,
α-trimethyl-monohydrochloride.
Promethazine hydrochloride occurs as a white to faint yellow, practically
odorless, crystalline powder which slowly oxidizes and turns blue on prolonged
exposure to air. It is soluble in water and freely soluble in alcohol. It has a
molecular weight of 320.88, a molecular formula of CHNS•HCI, and
the following structural formula:
What does Promethazine DM look like?
What are the available doses of Promethazine DM?
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What should I talk to my health care provider before I take Promethazine DM?
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How should I use Promethazine DM?
Promethazine hydrochloride and dextromethorphan hydrobromide
syrup is indicated for the temporary relief of coughs and upper respiratory
symptoms associated with allergy or the common cold.
The average effective dose is given in the following table:
What interacts with Promethazine DM?
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What are the warnings of Promethazine DM?
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What are the precautions of Promethazine DM?
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What are the side effects of Promethazine DM?
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What should I look out for while using Promethazine DM?
Dextromethorphan should not be used in patients receiving a
monoamine oxidase inhibitor (MAOI) (see
).
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.
WARNINGS
Administration of dextromethorphan may be accompanied by
histamine release and should be used with caution in atopic children.
Promethazine may impair the mental and/or physical abilities
required for the performance of potentially hazardous tasks, such as driving a
vehicle or operating machinery. The impairment may be amplified by concomitant
use of other central nervous system depressants such as alcohol,
sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics,
general anesthetics, tricyclic antidepressants, and tranquilizers; therefore,
such agents should either be eliminated or given in reduced dosage in the
presence of promethazine HCl (see
and ).
Promethazine may lead to potentially fatal respiratory
depression.
Use of promethazine in patients with compromised respiratory function (e.g.,
COPD, sleep apnea) should be avoided.
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.
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.
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.g., pneumonia, systemic
infection, etc.) and untreated or inadequately treated extrapyramidal signs and
symptoms (EPS). 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.
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 PATIENTS 2 YEARS OF AGE AND
OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY
DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED
WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED
WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION.
CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY
DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH,
IN PEDIATRIC PATIENTS.
ANTIEMETICS ARE NOT RECOMMENDED FOR
TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD
BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS
WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE ADMINISTRATION MAY BE
CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY
OR REYE'S SYNDROME. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN
PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER
HEPATIC DISEASES.
Excessively large dosages of antihistamines, including promethazine
hydrochloride, in pediatric patients may cause sudden death (see ). 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.
Administration of promethazine has been associated with reported
cholestatic jaundice.
What might happen if I take too much Promethazine DM?
Dextromethorphan may produce central excitement and mental
confusion. Very high doses may produce respiratory depression. One case of toxic
psychosis (hyperactivity, marked visual and auditory hallucinations) after
ingestion of a single dose of 20 tablets (300 mg) of dextromethorphan has been
reported.
Signs and symptoms of overdosage with promethazine HCl range from
mild depression of the central nervous system and cardiovascular system to
profound hypotension, respiratory depression, unconsciousness, and sudden death.
Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis,
and extensor-plantar reflexes (Babinski reflex).
Stimulation may be evident, especially in children and geriatric patients.
Convulsions may rarely occur. A paradoxical reaction has been reported in
children receiving single doses of 75 mg to 125 mg orally, characterized by
hyperexcitability and nightmares.
Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing,
as well as gastrointestinal symptoms, may occur.
The treatment of overdosage with promethazine and
dextromethorphan is essentially symptomatic and supportive. Only in cases of
extreme overdosage or individual sensitivity do vital signs including
respiration, pulse, blood pressure, temperature, and EKG need to be monitored.
Activated charcoal orally or by lavage may be given, or sodium or magnesium
sulfate orally as a cathartic. Attention should be given to the re-establishment
of adequate respiratory exchange through provision of a patent airway and
institution of assisted or controlled ventilation. Diazepam may be used to
control convulsions. Acidosis and electrolyte losses should be corrected. The
antidotal efficacy of narcotic antagonists to dextromethorphan has not been
established; note that any of the depressant effects of promethazine are not
reversed by naloxone. Avoid analeptics, which may cause convulsions.
Severe hypotension usually responds to the administration of norepinephrine
or phenylephrine.
since its use in a patient with partial adrenergic blockage may further lower
the blood pressure.
Limited experience with dialysis indicates that it is not helpful.
How should I store and handle Promethazine DM?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).Keep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.Manufactured for: Huntsville, AL 358118181650R12/07-R1This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).Keep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.Manufactured for: Huntsville, AL 358118181650R12/07-R1This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).Keep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.Manufactured for: Huntsville, AL 358118181650R12/07-R1This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).Keep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.Manufactured for: Huntsville, AL 358118181650R12/07-R1This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).Keep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.Manufactured for: Huntsville, AL 358118181650R12/07-R1This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).Keep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.Manufactured for: Huntsville, AL 358118181650R12/07-R1
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dextromethorphan is an antitussive agent and, unlike the isomeric
levorphanol, it has no analgesic or addictive properties.
The drug acts centrally and elevates the threshold for coughing. It is about
equal to codeine in depressing the cough reflex. In therapeutic dosage
dextromethorphan does not inhibit ciliary activity.
Dextromethorphan is rapidly absorbed from the gastrointestinal tract and
exerts its effect in 15 to 30 minutes. The duration of action after oral
administration is approximately three to six hours. Dextromethorphan is
metabolized primarily by liver enzymes undergoing O-demethylation,
N-demethylation, and partial conjugation with glucuronic acid and sulfate. In
humans, (+)-3-hydroxy-N-methyl-morphinan, (+)-3-hydroxymorphinan, and traces of
unmetabolized drug were found in urine after oral administration.
Promethazine is a phenothiazine derivative which differs
structurally from the antipsychotic phenothiazines by the presence of a branched
side chain and no ring substitution. It is thought that this configuration is
responsible for its relative lack (1/10 that of chlorpromazine) of dopamine
antagonist properties.
Promethazine is an H receptor blocking agent. In
addition to its antihistaminic action, it provides clinically useful sedative
and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract. Clinical
effects are apparent within 20 minutes after oral administration and generally
last four to six hours, although they may persist as long as 12 hours.
Promethazine is metabolized by the liver to a variety of compounds; the
sulfoxides of promethazine and N-demethylpromethazine are the predominant
metabolites appearing in the urine.
Non-Clinical Toxicology
Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see ).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.
WARNINGS
Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.
Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central nervous system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see and ).
Promethazine may lead to potentially fatal respiratory depression.
Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.
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.
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.
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.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). 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.
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 PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES.
Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see ). 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.
Administration of promethazine has been associated with reported cholestatic jaundice.
Combined use of haloperidol and lithium. An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.
The possibility of similar adverse interactions with other antipsychotic medication exists.
Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.
Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDS): Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteriodal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone.
Animal reproduction studies have not been conducted with the drug combination–promethazine and dextromethorphan. 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 dextromethorphan should be given to a pregnant woman only if clearly needed.
Dextromethorphan should be used with caution in sedated patients, in the debilitated, and in patients confined to the supine position.
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 with impairment of liver function.
Dextromethorphan:
Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances.
Promethazine:
Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
Dermatologic – Dermatitis, photosensitivity, urticaria.
Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.
Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See .)
Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See .)
Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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