NDC 70518-2896 Promethazine Hydrochloride

Promethazine Hydrochloride

NDC Product Code 70518-2896

NDC 70518-2896-0

Package Description: 25 VIAL, SINGLE-DOSE in 1 PACKAGE > 1 mL in 1 VIAL, SINGLE-DOSE (70518-2896-1)

NDC Product Information

Promethazine Hydrochloride with NDC 70518-2896 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Promethazine Hydrochloride is promethazine hydrochloride. The product's dosage form is injection and is administered via intramuscular; intravenous form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Promethazine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PROMETHAZINE HYDROCHLORIDE 25 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • PHENOL (UNII: 339NCG44TV)
  • WATER (UNII: 059QF0KO0R)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • SODIUM ACETATE (UNII: 4550K0SC9B)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA083312 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-25-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Promethazine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Warnings

Respiratory Depression – Pediatrics


Promethazine hydrochloride injection 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 in pediatric patients less than 2 years of age. Caution should be exercised when administering promethazine hydrochloride injection to pediatric patients 2 years of age and older (see WARNINGS - Respiratory Depression).Severe Tissue Injury, Including Gangrene


Promethazine hydrochloride injection can cause severe chemical irritation and


damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see


WARNINGS - Severe Tissue Injury, Including Gangrene).Due to the risks of intravenous injection, the preferred route of administration of promethazine hydrochloride injection is deep intramuscular injection. Subcutaneous injection is contraindicated. See DOSAGE AND ADMINISTRATION for important notes on administration.

Description

Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10


H-Phenothiazine-10-ethanamine,


N,N,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:


C


17H


21ClN


2S           MW 320.88


Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate.Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

Clinical Pharmacology

Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H


1 receptor antagonist, but does not block the release of histamine. Structural differences from the neuroleptic phenothiazines result in its relative lack (1


/10 that of chlorpromazine) of dopamine antagonist properties. Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8 ± 3.4 hours.

Indications And Usage

  • Promethazine hydrochloride injection is indicated for the following conditions:Amelioration of allergic reactions to blood or plasma.
  • In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
  • For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
  • For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
  • Active treatment of motion sickness.
  • Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
  • As an adjunct to analgesics for the control of postoperative pain.
  • Preoperative, postoperative, and obstetric (during labor) sedation.
  • Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

Children Less Than 2 Years Of Age

Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression


(see 


WARNINGS - Respiratory Depression).

Comatose State

Promethazine hydrochloride injection is contraindicated in comatose states.

Intra-Arterial Injection

Under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see


WARNINGS - Severe Tissue Injury, Including Gangrene).

Subcutaneous Injection

Promethazine hydrochloride injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.

Idiosyncratic Reaction Or Hypersensitivity

Promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

Pediatrics

Promethazine hydrochloride
injection 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 in pediatric patients less than 2 years
of age. A wide range of weight-based doses of
promethazine hydrochloride injection have resulted
in respiratory depression in these
patients.Caution should be exercised
when administering promethazine hydrochloride
injection to pediatric patients 2 years of age and
older. It is recommended that the lowest effective
dose of promethazine hydrochloride injection be used
in pediatric patients 2 years of age and older.
Avoid concomitant administration of other drugs with
respiratory depressant effects because of an
association with respiratory depression, and
sometimes death, in pediatric patients.

Other

Because of the risk of potentially fatal
respiratory depression, use of promethazine
hydrochloride injection in patients with compromised
respiratory function or patients at risk for respiratory
failure (e.g. COPD, sleep apnea) should be
avoided.

Angioneurotic edema. Neuroleptic Malignant Syndrome (potentially fatal) has also been reported. (See


WARNINGS - Neuroleptic Malignant Syndrome.)

Severe Tissue Injury, Including Gangrene

Promethazine hydrochloride injection can cause severe chemical irritation and


damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse event reports include burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required.


Because of the risks of intravenous injection, the preferred route of administration of promethazine hydrochloride injection is deep intramuscular injection (see DOSAGE AND ADMINISTRATION). Subcutaneous injection is contraindicated. Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection as pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Aspiration of dark blood does not preclude intra-arterial needle placement because blood is discolored upon contact with promethazine hydrochloride injection. Use of syringes with rigid plungers or of small-bore needles might obscure typical arterial backflow if this is relied upon alone.In the event that a patient complains of pain during intravenous injection of promethazine hydrochloride injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation.There is no proven successful management of unintentional intra-arterial injection or perivascular extravasation after it occurs. Sympathetic block and heparinization have been employed during the acute management of unintentional intra-arterial injection, because of the results of animal experiments with other known arteriolar irritants.

Promethazine hydrochloride injection can cause severe chemical irritation and


damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see


WARNINGS - Severe Tissue Injury, Including Gangrene; and


DOSAGE AND ADMINISTRATION).

Cns Depression

Promethazine hydrochloride injection 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, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride (see


PRECAUTIONS - Information for Patients  and


Drug Interactions).

Lower Seizure Threshold

Promethazine hydrochloride injection may lower seizure threshold and 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 hydrochloride injection should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride 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 hydrochloride 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 hydrochloride, 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 hydrochloride should be carefully considered.

Sulfite Sensitivity

Promethazine hydrochloride injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthma episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Visual Inspection

This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed.

Cholestatic Jaundice

Administration of promethazine has been associated with reported cholestatic jaundice.

General

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 hydrochloride injection should be used cautiously in persons with cardiovascular disease or impairment of liver function.

Information For Patients

Patients should be advised of the risk of respiratory depression, including potentially fatal respiratory depression in children less than 2 years of age (see


WARNINGS - Respiratory Depression).


Patients should be advised of the risk of severe tissue injury, including gangrene (see


WARNINGS - Severe Tissue Injury, Including Gangrene). Patients should be advised to immediately report persistent or worsening pain or burning at the injection site.


Promethazine hydrochloride injection may cause marked drowsiness or impair the mental or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers may enhance impairment (see


WARNINGS - CNS Depression and


PRECAUTIONS - Drug Interactions).


Patients should be advised to report any involuntary muscle movements (see


ADVERSE REACTIONS - Paradoxical Reactions).


Patients should be advised to avoid prolonged exposure to the sun (see


ADVERSE REACTIONS - Dermatologic).


Repackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762

Cns Depressants

Promethazine hydrochloride injection may
increase, prolong, or intensify the sedative action of
central-nervous-system depressants, such as alcohol,
sedative/hypnotics (including barbiturates), general
anesthetics, narcotics, narcotic analgesics, tricyclic
antidepressants, and tranquilizers; therefore, such
agents should be avoided or administered in reduced
dosage to patients receiving promethazine hydrochloride.
When given concomitantly with promethazine hydrochloride
injection, 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
hydrochloride injection 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.

Epinephrine

Because of the potential for promethazine
hydrochloride to reverse epinephrine’s vasopressor
effect, epinephrine should NOT be used to treat
hypotension associated with promethazine hydrochloride
injection overdose.

Anticholinergics

Concomitant use of other agents with
anticholinergic properties should be undertaken with
caution.

Monoamine Oxidase (Mao) Inhibitors

Drug interactions, including an increased
incidence of extrapyramidal effects, have been reported
when some MAO Inhibitors and phenothiazines are used
concomitantly. This possibility should be considered
with promethazine hydrochloride injection.

Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride injection:

Pregnancy Tests

Diagnostic pregnancy tests based on immunological
reactions between HCG and anti-HCG may result in
false-negative or false-positive
interpretations.

Glucose Tolerance Test

An increase in blood glucose has been reported in
patients receiving promethazine
hydrochloride.

Carcinogenesis, Mutagenesis And Impairment Of Fertility

Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine hydrochloride injection, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Promethazine hydrochloride injection was nonmutagenic in the


Salmonella test system of Ames.

Teratogenic Effects—Pregnancy Category C

Teratogenic effects have not been demonstrated in
rat-feeding studies at doses of 6.25 and 12.5 mg/kg
(approximately 2.1 and 4.2 times the maximum recommended
human daily dose) of promethazine hydrochloride
injection. Daily doses of 25 mg/kg intraperitoneally
have been found to produce fetal mortality in
rats.There are no adequate and well-controlled studies
of promethazine hydrochloride injection in pregnant
women. Because animal reproduction studies are not
always predictive of human response, promethazine
hydrochloride injection should be used during pregnancy
only if the potential benefit justifies the potential
risk to the fetus.Adequate studies to determine the action of the
drug on parturition, lactation and development of the
animal neonate have not been conducted.

Nonteratogenic Effects

Promethazine hydrochloride injection administered
to a pregnant woman within two weeks of delivery may
inhibit platelet aggregation in the newborn.

Labor And Delivery

Promethazine hydrochloride injection may be used alone or as an adjunct to narcotic analgesics during labor (see


DOSAGE AND ADMINISTRATION). Limited data suggest that use of promethazine hydrochloride injection during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also


Pregnancy - Nonteratogenic Effects.)

Nursing Mothers

It is not known whether promethazine hydrochloride injection is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Promethazine hydrochloride injection should be used with caution in pediatric patients 2 years of age and older


(see 


WARNINGS - Respiratory Depression).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 injection administration may be confused with the CNS signs of undiagnosed primary disease, e.g. encephalopathy or Reye's syndrome. The use of promethazine hydrochloride injection 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 injection, in pediatric patients may cause sudden death (see


OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride injection 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 hydrochloride injection.

Geriatric Use (Patients Approximately 60 Years Or Older)

Since therapeutic requirements for sedative drugs tend to be less in geriatric patients, the dosage should be reduced for these patients.

Respiratory Depression

Promethazine hydrochloride injection is contraindicated in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Promethazine hydrochloride injection should be used with caution in pediatric patients 2 years of age and older (see


WARNINGS - Respiratory Depression).

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


WARNINGS - Respiratory Depression.)

Paradoxical Reactions

Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride injection. Consideration should be given to the discontinuation of promethazine hydrochloride injection 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

Signs and symptoms of overdosage 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 pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in pediatric patients 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; etc., as well as gastrointestinal symptoms, may occur.

Treatment

Treatment of overdosage 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. 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. Note that any depressant effects of promethazine hydrochloride injection 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.

Important Notes On Administration

  • Promethazine hydrochloride injection can cause severe chemical irritation and
  • Damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration (see
  • WARNINGS - Severe Tissue Injury, Including Gangrene).
  • The preferred parenteral route of administration for promethazine hydrochloride injection is by deep intramuscular injection.Under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see
  • WARNINGS - Severe Tissue Injury, Including Gangrene).
  • Subcutaneous injection is contraindicated as it may result in tissue necrosis.
  • When administered intravenously, promethazine hydrochloride injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. It is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.
  • In the event that a patient complains of pain during intravenous injection of promethazine hydrochloride injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Do not use promethazine hydrochloride injection if solution has developed color or contains precipitate.To avoid the possibility of physical and/or chemical incompatibility, consult specialized literature before diluting with any injectable solution or combining with any other medication. Do not use if there is a precipitate or any sign of incompatibility.

Allergic Conditions

The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.

Sedation

In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of promethazine hydrochloride injection.

Nausea And Vomiting

For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the dosage of analgesics and barbiturates should be reduced accordingly (see


PRECAUTIONS - Drug Interactions).


Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see


PRECAUTIONS - Pediatric Use).

Preoperative And Postoperative Use

As an adjunct to preoperative or postoperative medication, 25 to 50 mg of promethazine hydrochloride injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly (see


PRECAUTIONS - Drug Interactions).


Promethazine hydrochloride is contraindicated for use in pediatric patients less than two years of age.

Obstetrics

Promethazine hydrochloride injection in doses of 50 mg will provide sedation and relieve apprehension in the early stages of labor. When labor is definitely established, 25 to 75 mg (average dose, 50 mg) promethazine hydrochloride injection may be given with an appropriately reduced dose of any desired narcotic (see


PRECAUTIONS - Drug Interactions). If necessary, promethazine hydrochloride injection with a reduced dose of analgesic may be repeated once or twice at four-hour intervals in the course of a normal labor. A maximum total dose of 100 mg of promethazine hydrochloride injection may be administered during a 24-hour period to patients in labor.

Pediatric Patients

Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than 2 years of age (see WARNINGS - Respiratory Depression). Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years of age or 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 (see WARNINGS - Respiratory Depression).In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 1.1 mg per kg of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug (see


PRECAUTIONS - Drug Interactions). Antiemetics should not be used in vomiting of unknown etiology in pediatric patients.

How Supplied

Promethazine Hydrochloride Injection, USP is available as follows:25 mg/1 MlNDC: 70518-2896-00PACKAGING: 25 in 1 PACKAGENDC: 70518-2896-01PACKAGING: 1 in 1 VIAL SINGLE DOSE, TYPE 0Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762StorageStore at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Protect from light. Keep covered in carton until time of use.Do not use if solution has developed color or contains a precipitate.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.For Product Inquiry call 1-877-845-0689.

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