Promethazine Hydrochloride And Dextromethorphan Hydrobromide


Tris Pharma Inc
Human Prescription Drug
NDC 27808-057
Promethazine Hydrochloride And Dextromethorphan Hydrobromide is a human prescription drug labeled by 'Tris Pharma Inc'. National Drug Code (NDC) number for Promethazine Hydrochloride And Dextromethorphan Hydrobromide is 27808-057. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Promethazine Hydrochloride And Dextromethorphan Hydrobromide drug includes Dextromethorphan Hydrobromide - 15 mg/5mL Promethazine Hydrochloride - 6.25 mg/5mL . The currest status of Promethazine Hydrochloride And Dextromethorphan Hydrobromide drug is Active.

Drug Information:

Drug NDC: 27808-057
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Tris Pharma Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:DEXTROMETHORPHAN HYDROBROMIDE - 15 mg/5mL
PROMETHAZINE HYDROCHLORIDE - 6.25 mg/5mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 31 Jan, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 12 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA091687
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Tris Pharma Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:991528
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0327808057013
UPC stands for Universal Product Code.
UNII:9D2RTI9KYH
R61ZEH7I1I
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Phenothiazine [EPC]
Phenothiazines [CS]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
27808-057-01473 mL in 1 BOTTLE, PLASTIC (27808-057-01)15 Nov, 2021N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Promethazine hydrochloride and dextromethorphan hydrobromide promethazine hydrochloride and dextromethorphan hydrobromide promethazine hydrochloride promethazine dextromethorphan hydrobromide dextromethorphan alcohol anhydrous citric acid ascorbic acid edetate disodium fd&c yellow no. 6 methylparaben propylene glycol propylparaben sodium benzoate sodium citrate saccharin sodium sucrose water amber mint

Boxed Warning:

Warning promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. a wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age and older. it is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided.

Indications and Usage:

Indications and usage promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Warnings:

Warnings warning promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. a wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age and older. it is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided. dextromethorphan: administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. promethazine: cns depression prometha
zine 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 precautions-information for patients and drug interactions ). respiratory depression 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. 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.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. use in pediatric patients 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 overdosage ). 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 consideration: administration of promethazine has been associated with reported cholestatic jaundice.

General Precautions:

General 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.

Dosage and Administration:

Dosage and administration it is important that promethazine hydrochloride and dextromethorphan hydrobromide oral solution is measured with an accurate measuring device (see precautions-information for patients ). a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. it is strongly recommended that an accurate measuring device be used. a pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see warnings black box warning and use in pediatric patients ). the average effective dose is given in the following table: adults 1 teaspoonful (5 ml) every 4 to 6 hours, not to exceed 30 ml in 24 hours. children 6 years to under 12 years ½ to 1 teaspoonful (2.5 to 5 ml) every 4 to 6 hours, not to exceed 20 ml in 24 hours. children 2 ye
ars to under 6 years ¼ to ½ teaspoonful (1.25 to 2.5 ml) every 4 to 6 hours, not to exceed 10 ml in 24 hours.

Contraindications:

Contraindications promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for use in pediatric patients less than two years of age. dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (maoi) (see precautions, drug interactions ). 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.

Adverse Reactions:

Adverse reactions 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 a
pnea (potentially fatal) (see warnings-promethazine; respiratory depression ) . other - angioneurotic edema. neuroleptic malignant syndrome (potentially fatal) has also been reported (see warnings-promethazine; neuroleptic malignant syndrome ). 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.

Overdosage:

Overdosage dextromethorphan: 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. promethazine: 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. treatment: 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 reestablishment 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. the treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. in the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. epinephrine should not be used, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. oxygen may also be administered. limited experience with dialysis indicates that it is not helpful.

Description:

Description each 5 ml (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. alcohol 8%(v/v). inactive ingredients: anhydrous citric acid, ascorbic acid, edetate disodium, fd&c yellow no. 6, methylparaben, natural and artificial lemon mint flavor, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate anhydrous, saccharin sodium, 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 c 18 h 25 no•hbr•h 2 o, and the following structural formula: promethazine is a racemic compound. promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10 h -phenothiazine-10-ethanamine, n,n, 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 c 17 h 20 n 2 s•hcl, and the following structural formula: dex prom prome

Clinical Pharmacology:

Clinical pharmacology dextromethorphan: 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: promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by th
e 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 1 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.

How Supplied:

How supplied this preparation is a yellow to amber colored lemon-mint flavored oral solution, containing promethazine hydrochloride 6.25 mg/5 ml, dextromethorphan hydrobromide 15 mg/5 ml and alcohol 8 percent, and is available in 16 fl. oz. (473 ml) bottles, (ndc 27808-057-01). keep tightly closed. protect from light. store at 20° to 25°c (68° to 77°f); excursions permitted from 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container with a child-resistant closure as defined in the usp. manufactured by: tris pharma, inc. monmouth junction, nj 08852 www.trispharma.com lb8077 rev. 01 07/2021

Package Label Principal Display Panel:

Package label.principal display panel ndc 27808-057-01 promethazine hydrochloride and dextromethorphan hydrobromide oral solution 6.25 mg and 15 mg per 5 ml alcohol 8% (v/v) rx only 16 fl. oz. (473 ml) 16 oz label


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