Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1408
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Promethazine Hydrochloride (Injection, Solution)
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Promethazine HCl Injection is contraindicated for
use in pediatric patients less than 2 years of age. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. Do not use Promethazine HCl 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. Important Notes on Administration The preferred parenteral route
of administration for Promethazine HCl Injection is by deep intramuscular
injection. The proper intravenous administration of this product is
well tolerated, but use of this route is not without some hazard.
Not for subcutaneous administration. UNINTENTIONAL
INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY
(see CONTRAINDICATIONS, WARNINGS���Injection Site Reactions).
SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE
NECROSIS (see CONTRAINDICATIONS, WARNINGS���Injection Site
Reactions, and ADVERSE REACTIONS). Injection into or near a nerve
may result in permanent tissue damage (see ADVERSE REACTIONS). When used intravenously, Promethazine HCl Injection should be given
in concentration no greater than 25 mg/mL 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. The Carpuject with Luer Lock is suitable for substances to be administered intravenously
or intramuscularly. 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 HCl 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 medication may be administered either intramuscularly
or intravenously and dosage of analgesics and barbiturates reduced
accordingly. Antiemetics should not be used
in vomiting of unknown etiology in children and adolescents (see WARNINGS-Use
in Pediatric Patients). Preoperative
and Postoperative Use As an adjunct to preoperative
or postoperative medication, 25 to 50 mg of Promethazine HCl 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. Promethazine HCl is contraindicated for use in pediatric patients
less than two years of age. Obstetrics Promethazine HCl 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
HCl Injection may be given intramuscularly or intravenously with an
appropriately reduced dose of any desired narcotic. If necessary,
Promethazine HCl 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 HCl Injection
may be administered during a 24-hour period to patients in labor. Pediatric Patients Promethazine HCl Injection is contraindicated for
use in pediatric patients less than 2 years of age (see WARNINGS���Black Box Warning and Use in Pediatric Patients). Caution should be
exercised when administering promethazine HCl 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���Black Box Warning and Use in Pediatric Patients). 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
0.5 mg per lb. of body weight in combination with an appropriately
reduced dose of narcotic or barbiturate and the appropriate dose of
an atropine-like drug. Antiemetics should not be used in vomiting
of unknown etiology in pediatric patients.
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Promethazine HCl Injection, is a sterile, pyrogen-free
solution for deep intramuscular or intravenous administration. Promethazine
HCl (10H-Phenothiazine-10-ethanamine, N,N,��-trimethyl-, monohydrochloride, (��)-) is a racemic compound
and has the following structural formula: Each mL contains promethazine
HCl, 25 mg, with 0.1 mg edetate disodium, 0.04 mg calcium chloride,
not more than 5 mg monothioglycerol and 5 mg phenol in water for injection
with sodium acetate-acetic acid buffer. pH 4.9 (4.0 to 5.5), and it
is sealed under nitrogen. Promethazine HCl 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.
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Promethazine HCl, a phenothiazine
derivative, possesses antihistaminic, sedative, antimotion-sickness,
antiemetic, and anticholinergic effects. Promethazine is a competitive
H1 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 effectsmay persist up to 12 hours. Promethazine HCl 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.
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Promethazine HCl is contraindicated
for use in pediatric patients less than two years of age. Promethazine HCl is contraindicated
in comatose states, and in patients who have demonstrated an idiosyncratic
reaction or hypersensitivity to promethazine or other phenothiazines. Under no circumstances should
promethazine HCl be given by intra-arterial injection due to the likelihood
of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS���Injection Site Reactions). Promethazine HCl
Injection should not be given by the subcutaneous route; 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.
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Promethazine HCl Injection, USP is available in
the following package configuration: Store at 20 to 25��C (68 to 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. Carpujects are packaged in the Slim-Pak tamper detection package. Revised: November,
2007
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WARNING: PROMETHAZINE HCl INJECTION, USP 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 HCl INJECTION,
USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF
WEIGHT-BASED DOSES OF PROMETHAZINE HCl INJECTION, USP HAVE RESULTED
IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE
HCl INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS
RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl INJECTION
BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT
ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS
BE AVOIDED.
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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 HCl Injection should be used cautiously in persons with
cardiovascular disease or impairment of liver function.<br/>Information for Patients: Promethazine HCl
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. The use of alcohol,
sedative/hypnotics (including barbiturates), general anesthetics,
narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers
with Promethazine HCl Injection may enhance impairment (see WARNINGS���CNS Depression and PRECAUTIONS���Drug Interactions). Pediatric patients
should be supervised to avoid potential harm in bike riding or in
other hazardous activities. Patients should be advised to report any involuntary muscle movements. Persistent or worsening
pain or burning at the injection site should be reported immediately. Avoid prolonged exposure
to the sun.<br/>Drug Interactions: CNS Depressants Promethazine HCl 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 HCl. When given
concomitantly with Promethazine HCl 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 HCl 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 HCl to reverse epinephrine's vasopressor effect,
epinephrine should NOT be used to treat hypotension associated with
Promethazine HCl Injection overdose. Anticholinergics Concomitant use of other
agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including
an increased incidence of extrapyramidal effects, have been reported
when some MAOI and phenothiazines are used concomitantly. This possibility
should be considered with Promethazine HCl Injection.<br/>Drug/Laboratory Test Interactions: The following laboratory
tests may be affected in patients who are receiving therapy with Promethazine
HCl 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 glucose
tolerance has been reported in patients receiving promethazine HCl.<br/>Carcinogenicity, Mutagenicity
and Impairment of Fertility: Long-term animal
studies have not been performed to assess the carcinogenic potential
of Promethazine HCl Injection, nor are there other animal or human
data concerning carcinogenicity, mutagenicity, or impairment of fertility.
Promethazine HCl Injection was nonmutagenic in the Salmonella test system of Ames.<br/>Pregnancy: 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 HCl 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
HCl Injection in pregnant women. Because animal reproduction studies
are not always predictive of human response, Promethazine HCl 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 HCl Injection
administered to a pregnant woman within two weeks of delivery may
inhibit platelet aggregation in the newborn.<br/>Labor and Delivery: Promethazine HCl
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 HCl 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.)<br/>Nursing Mothers: It is not known
whether Promethazine HCl 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
HCl Injection, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of
the drug tothe mother.<br/>Pediatric Use: PROMETHAZINE HCl IS CONTRAINDICATED FOR USE IN PEDIATRIC
PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS���Black Box Warning and Use in Pediatric Patients). Promethazine HCl Injection
should be used with caution in pediatric patients 2 years of age and
older (see WARNINGS���Use in Pediatric
Patients).<br/>Use in Geriatric 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.
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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 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 HCl Injection are not reversedby 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.
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Promethazine Hydrochloride
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Promethazine Hydrochloride (Injection, Solution)
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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. Thrombophlebitis, venous thrombosis, and phlebitis at the
injection site have been reported and in some cases have required
surgical intervention. INTRA-ARTERIAL INJECTION MAY RESULT IN GANGRENE
OF THE AFFECTED EXTREMITY (see CONTRAINDICATIONS,WARNINGS���Injection Site Reactions, and DOSAGE AND ADMINISTRATION). 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.) Other Angioneurotic edema. Neuroleptic Malignant Syndrome (potentially
fatal) has also been reported. (See WARNINGS���Neuroleptic Malignant Syndrome.) Administration
of Promethazine HCl Injection has resulted in nerve damage ranging
from temporary sensory loss to palsies and paralysis. Injection into
or near a nerve may result in permanent tissue damage. Subcutaneous
injection has resulted in tissue necrosis. Injection site reactions
including burning, erythema, pain, and edema have been reported. Administration
of Promethazine HCl Injection has resulted in abscesses and/or tissue
necrosis and gangrene, regardless of the route of administration.
In some cases, surgical intervention (including fasciotomy, skin graft,
and/or amputation) may be required (see CONTRAINDICATIONS, WARNINGS���Injection Site Reactions and DOSAGE AND ADMINISTRATION). Paradoxical
Reactions Hyperexcitability and abnormal movements have been reported in patients
following a single administration of Promethazine HCl Injection. Consideration
should be given to the discontinuation of the Promethazine HCl 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.
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WARNING: PROMETHAZINE HCl INJECTION, USP 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 HCl INJECTION,
USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF
WEIGHT-BASED DOSES OF PROMETHAZINE HCl INJECTION, USP HAVE RESULTED
IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE
HCl INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS
RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl INJECTION
BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT
ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS
BE AVOIDED. CNS Depression Promethazine HCl 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 HCl (see PRECAUTIONS���Information for Patients and Drug Interactions). Respiratory Depression Promethazine HCl Injection
may lead to potentially fatal respiratory depression. Use of Promethazine HCl Injection in patients with compromised respiratory
function (e.g., COPD, sleep apnea) should be avoided. Lower
Seizure Threshold Promethazine HCl 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 HCl Injection 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 HCl INJECTION IS CONTRAINDICATED FOR
USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE
HCl INJECTION 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
NOT FIRMLY WEIGHT-RELATED, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION
OF INDIVIDUALIZED DOSING. 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 HCl INJECTION ADMINISTRATION MAY BE CONFUSED WITH
THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, E.G., ENCEPHALOPATHY
OR REYE'S SYNDROME. THE USE OF PROMETHAZINE HCl 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 HCl Injection, in pediatric
patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic
doses and overdoses of Promethazine HCl 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 HCl Injection. Injection
Site Reactions Promethazine HCl Injection
can cause severe chemical irritation and damage to tissues, regardless of the route of administration. Irritation and damage can also result from perivascular extravasation,
unintentional intra-arterial injection, and intraneuronal or perineuronal
infiltration. Signs, symptoms, and manifestations of severe tissue irritation include
burning, pain, erythema, swelling, severe spasm of distal vessels,
thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue
necrosis, and gangrene. Administration of Promethazine HCl Injection
has resulted in nerve damage ranging from temporary sensory loss to
palsies and paralysis. Injection into or near a nerve may result in
permanent tissue damage. In some cases, surgical intervention (including
fasciotomy, skin graft, and/or amputation) may be required (see ADVERSE REACTIONS). Inadvertent
Intra-Arterial Injection 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. Reports compatible
with unintentional intra-arterial injection of Promethazine HCl Injection,
usually in conjunction with other drugs intended for intravenous use,
suggest that pain, severe chemical irritation, severe spasm of distal
vessels, and resultant gangrene requiring amputation are likely under
such circumstances. Intravenous injection was intended in all the
cases reported, but perivascular extravasation or arterial placement
of the needle is now suspect. There is no proven successful management
of this condition 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. Aspiration of dark blood does not preclude
intra-arterial needle placement, because blood is discolored upon
contact with Promethazine HCl Injection. Use of syringes with rigid
plungers or of small bore needles might obscure typical arterial backflow
if this is relied upon alone. When used intravenously, Promethazine HCl 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. When administering any irritant drug intravenously,
it is usually preferable to inject it 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 intended intravenous
injection of Promethazine HCl Injection, the injection should be stopped
immediately to provide for evaluation of possible arterial placement
or perivascular extravasation. Visual
Inspection This product is light sensitive and should be inspected before use
and discarded if either color or particulate is observed. Other Considerations Sedative drugs or CNS
depressants should be avoided in patients with a history of sleep
apnea. Administration
of promethazine has been associated with reported cholestatic jaundice.
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Promethazine HCl Injection
is indicated for the following conditions:
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Promethazine Hydrochloride
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