Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1544
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Phenergan (Injection, Solution)
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PHENERGAN 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 PHENERGAN 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.<br/>Important Notes on
Administration: The
preferred parenteral route of administration for PHENERGAN
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 .SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT
MAY RESULT IN TISSUE
NECROSIS (seeCONTRAINDICATIONS, WARNINGS���Injection Site Reactions, andADVERSE
REACTIONS). Injection
into or near a nerve may result in permanent tissue damage (seeADVERSE
REACTIONS). When used
intravenously, PHENERGAN Injection should be given in a
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.<br/>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.<br/>Sedation: In
hospitalized adult patients, nighttime sedation may be achieved
by a dose of 25 to 50 mg of PHENERGAN Injection.<br/>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).<br/>Preoperative and
Postoperative Use: As an
adjunct to preoperative or postoperative medication, 25 to 50 mg
of PHENERGAN 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. PHENERGAN
is contraindicated for use in pediatric patients less than two years of age.<br/>Obstetrics: PHENERGAN
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)
PHENERGAN Injection may be given intramuscularly or
intravenously with an appropriately reduced dose of any desired
narcotic. If necessary, PHENERGAN 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 PHENERGAN Injection may be administered during a
24-hour period to patients in labor.<br/>Pediatric Patients: PHENERGAN 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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PHENERGAN
(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, 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. PHENERGAN
(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 is
a phenothiazine derivative which possesses antihistaminic, sedative,
antimotion-sickness, antiemetic, and anticholinergic effects.
Promethazine is a competitive Hreceptor 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 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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PHENERGAN is
contraindicated for use in pediatric patients less than two years of
age. PHENERGAN Injection
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 PHENERGAN Injection be given by intra-arterial
injection due to the likelihood of severe arteriospasm and the
possibility of resultant gangrene (see WARNINGS���Injection
Site Reactions). PHENERGAN 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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PHENERGAN
(promethazine HCl) Injection is available as follows: 25 mg/mL 50 mg/mL<br/>Storage: Store 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. PHENERGAN
is a registered trademark of Wyeth and is used under license. Baxter, the
ESI logo, and Dosette are registered trademarks of Baxter
International Inc., or its subsidiaries. Manufactured by Baxter Healthcare
Corporation Deerfield,
IL 60015 USA For Product
Inquiry 1 800 ANA DRUG (1-800-262-3784) MLT-00071/5.0
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BOXED WARNING: WARNING: PHENERGAN 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 PHENERGAN
INJECTION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE
RANGE OF WEIGHT-BASED DOSES OF PHENERGAN INJECTION HAVE RESULTED IN
RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN
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. PHENERGAN
Injection should be used cautiously in persons with
cardiovascular disease or impairment of liver
function.<br/>Information for
Patients: PHENERGAN
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
PHENERGAN Injection may enhance impairment . 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:<br/>CNS Depressants: PHENERGAN 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 PHENERGAN 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 PHENERGAN 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.<br/>Epinephrine: Because of the potential for PHENERGAN to reverse
epinephrine's vasopressor effect, epinephrine should NOT
be used to treat hypotension associated with PHENERGAN
Injection overdose.<br/>Anticholinergics: Concomitant use of other agents with anticholinergic
properties should be undertaken with
caution.<br/>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 PHENERGAN
(promethazine HCl) Injection.<br/>Drug/Laboratory
Test Interactions: The
following laboratory tests may be affected in patients who are
receiving therapy with PHENERGAN Injection:<br/>Pregnancy
Tests: Diagnostic pregnancy tests based on immunological
reactions between HCG and anti-HCG may result in
false-negative or false-positive
interpretations.<br/>Glucose
Tolerance Test: An
increase in blood glucose has been reported in patients
receiving promethazine HCl.<br/>Carcinogenesis,
Mutagenesis and Impairment of Fertility: Long-term
animal studies have not been performed to assess the
carcinogenic potential of PHENERGAN Injection, nor are there
other animal or human data concerning carcinogenicity,
mutagenicity, or impairment of fertility. PHENERGAN Injection
was nonmutagenic in the Salmonellatest system of Ames.<br/>Pregnancy:<br/>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 PHENERGAN 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
PHENERGAN Injection in pregnant women. Because animal
reproduction studies are not always predictive of human
response, PHENERGAN 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.<br/>Nonteratogenic Effects: PHENERGAN Injection administered to a pregnant woman
within two weeks of delivery may inhibit platelet
aggregation in the newborn.<br/>Labor and Delivery: PHENERGAN
Injection may be used alone or as an adjunct to narcotic
analgesics during labor (see DOSAGE AND
ADMINISTRATION). Limited data suggest that use of
PHENERGAN 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 PHENERGAN 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 PHENERGAN 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.<br/>Pediatric Use: PHENERGAN IS CONTRAINDICATED FOR USE
IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS���Black Box Warning and Use in
Pediatric Patients). PHENERGAN
Injection should be used with caution in pediatric patients 2
years of age and older .<br/>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.
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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-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.<br/>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 patentairway 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 PHENERGAN
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.
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Promethazine hydrochloride
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Phenergan (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.<br/>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).<br/>Dermatologic: Dermatitis,
photosensitivity, urticaria.<br/>Hematologic: Leukopenia,
thrombocytopenia, thrombocytopenic purpura,
agranulocytosis.<br/>Gastrointestinal: Dry mouth,
nausea, vomiting, jaundice.<br/>Respiratory: Asthma,
nasal stuffiness, respiratory depression (potentially fatal) and
apnea (potentially fatal).<br/>Other: Angioneurotic edema. Neuroleptic Malignant Syndrome
(potentially fatal) has also been reported.
Administration of PHENERGAN 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
PHENERGAN 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 (seeCONTRAINDICATIONS, WARNINGS���Injection Site Reactions, and DOSAGE AND
ADMINISTRATION).<br/>Paradoxical
Reactions: Hyperexcitability and abnormal movements have been reported in
patients following a single administration of PHENERGAN Injection. Consideration should be given to the discontinuation
of PHENERGAN 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: PHENERGAN 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 PHENERGAN
INJECTION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE
RANGE OF WEIGHT-BASED DOSES OF PHENERGAN INJECTION HAVE RESULTED IN
RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN
INJECTION BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND
CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY
DEPRESSANT EFFECTS BE AVOIDED.<br/>Sulfite Sensitivity: PHENERGAN
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.<br/>CNS Depression: PHENERGAN
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 andDrug
Interactions).<br/>Respiratory
Depression: PHENERGAN
Injection may lead to potentially fatal respiratory depression. Use of
PHENERGAN Injection in patients with compromised respiratory
function (e.g. COPD, sleep apnea) should be avoided.<br/>Lower Seizure
Threshold: PHENERGAN
Injection may lower seizure threshold and should be used with
caution in persons with seizure disorders or in persons who areusing concomitant medications, such as narcotics or local
anesthetics, which may also affect seizure
threshold.<br/>Bone-Marrow
Depression: PHENERGAN
Injection should be used with caution in patients with
bone-marrow depression. Leukopenia and agranulocytosis have been
reported, usually when PHENERGAN has been used in association
with other known marrow-toxic agents.<br/>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 signsand 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.<br/>Use in Pediatric
Patients: PHENERGAN INJECTION IS CONTRAINDICATED
FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF
AGE. CAUTION SHOULD BE EXERCISED WHEN
ADMINISTERING PHENERGAN 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 PHENERGAN INJECTION ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE,
E.G., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF
PHENERGAN 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 PHENERGAN Injection,
in pediatric patients may cause sudden death . Hallucinations and convulsions have
occurred with therapeutic doses and overdoses of PHENERGAN in
pediatric patients. In pediatric patients who are acutely ill
associated with dehydration, there is an increased
susceptibility to dystonias with the use of PHENERGAN
Injection.<br/>Injection Site
Reactions: PHENERGAN
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
PHENERGAN 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).<br/>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 PHENERGAN 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 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. Aspiration of dark blood does not
preclude intra-arterial needle placement, because blood
is discolored upon contact with PHENERGAN 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, PHENERGAN 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 PHENERGAN
Injection, the injection should be stopped immediately
to provide for evaluation of possible arterial placement
or perivascular extravasation.<br/>Visual Inspection: This
product is light sensitive and should be inspected before use
and discarded if either color or particulate is
observed.<br/>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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PHENERGAN Injection
is indicated for the following conditions:
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Phenergan
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