Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1362
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Phenergan (Tablet)
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Phenergan Tablets
and Phenergan Rectal Suppositories are contraindicated for children under
2 years of age (see WARNINGS���Black
Box Warning and Use
in Pediatric Patients). Phenergan Suppositories are
for rectal administration only.<br/>Allergy: The average oral dose is 25 mg taken before
retiring; however, 12.5 mg may be taken before meals and on retiring,
if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken
three times daily will usually suffice. After initiation of treatment
in children or adults, dosage should be adjusted to the smallest amount adequate
to relieve symptoms. The administration of promethazine HCl in 25-mg doses
will control minor transfusion reactions of an allergic nature.<br/>Motion Sickness: The average adult dose is 25 mg taken twice
daily. The initial dose should be taken one-half to one hour before
anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding
days of travel, it is recommended that 25 mg be given on arising and
again before the evening meal. For children, Phenergan Tablets, Syrup, or
Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered.<br/>Nausea and Vomiting: Antiemetics should not be used in vomiting of unknown
etiology in children and adolescents . The average effective dose of Phenergan for the active therapy
of nausea and vomiting in children or adults is 25 mg. When oral medication
cannot be tolerated, the dose should be given parenterally (cf. Phenergan
Injection) or by rectal suppository. 12.5- to 25-mg doses may be repeated,
as necessary, at 4- to 6-hour intervals. For
nausea and vomiting in children, the usual dose is 0.5 mg per pound of
body weight, and the dose should be adjusted to the age and weight of the
patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and
the postoperative period, the average dose is 25 mg repeated at 4- to
6-hour intervals, as necessary.<br/>Sedation: This product relieves apprehension and induces a
quiet sleep from which the patient can be easily aroused. Administration of
12.5 to 25 mg Phenergan by the oral route or by rectal suppository at
bedtime will provide sedation in children. Adults usually require 25 to 50 mg
for nighttime, presurgical, or obstetrical sedation.<br/>Pre- and Postoperative Use: Phenergan in 12.5- to 25-mg doses for children and
50-mg doses for adults the night before surgery relieves apprehension and
produces a quiet sleep. For preoperative medication,
children require doses of 0.5 mg per pound of body weight in combination
with an appropriately reduced dose of narcotic or barbiturate and the appropriate
dose of an atropine-like drug. Usual adult dosage is 50 mg Phenergan
with an appropriately reduced dose of narcotic or barbiturate and the required
amount of a belladonna alkaloid. Postoperative
sedation and adjunctive use with analgesics may be obtained by the administration
of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Phenergan Tablets and Phenergan Rectal Suppositories are
contraindicated for children under 2 years of age.
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Each tablet of Phenergan contains 12.5 mg, 25 mg,
or 50 mg promethazine HCl. The inactive ingredients present are lactose,
magnesium stearate, and methylcellulose. Each dosage strength also contains
the following: 12.5 mg���FD&C
Yellow 6 and saccharin sodium;25 mg���saccharin sodium;50 mg���FD&C
Red 40. Each rectal suppository of Phenergan
contains 12.5 mg, 25 mg, or 50 mg promethazine HCl with ascorbyl
palmitate, silicon dioxide, white wax, and cocoa butter. Phenergan Suppositories
are for rectal administration only. Promethazine
HCl is a racemic compound; the empirical formula is CHNS���HCl
and its molecular weight is 320.88. Promethazine
HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,��-trimethyl-, monohydrochloride, (��)- with the following
structural formula: Promethazine HCl occurs as a white to
faint yellow, practically odorless, crystalline powder which slowly oxidizes
and turns blue on prolonged exposure to air. It is freely soluble in water
and soluble in alcohol.
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Promethazine is a phenothiazine derivative which differs
structurally from the antipsychotic phenothiazines by the presence of a branched
side chain and no ring substitution. It is thought that this configuration
is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine
antagonist properties. Promethazine is an Hreceptor
blocking agent. In addition to its antihistaminic action, it provides clinically
useful sedative and antiemetic effects. Promethazine
is well absorbed from the gastrointestinal tract. Clinical effects are apparent
within 20 minutes after oral administration and generally last four to six
hours, although they may persist as long as 12 hours. Promethazine is metabolized
by the liver to a variety of compounds; the sulfoxides of promethazine and
N-demethylpromethazine are the predominant metabolites appearing in the urine.
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Phenergan Tablets and Suppositories are contraindicated
for use in pediatric patients less than two years of age. Phenergan Tablets and Suppositories are contraindicated in comatose
states, and in individuals known to be hypersensitive or to have had an idiosyncratic
reaction to promethazine or to other phenothiazines. Antihistamines
are contraindicated for use in the treatment of lower respiratory tract symptoms
including asthma.
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Phenergan (promethazine HCl) Tablets
are available as follows: 12.5 mg, orange
tablet with���WYETH���on one side and���19���on the
scored reverse side. NDC 0008-0019-01,
bottle of 100 tablets. 25 mg, white tablet
with���WYETH���and���27���on one side and scored on
the reverse side. NDC 0008-0027-02, bottle
of 100 tablets. NDC 0008-0027-07, Redipak carton
of 100 tablets (10 blister strips of 10). 50 mg,
pink tablet with���WYETH���on one side and���227���on the other side. NDC 0008-0227-01, bottle
of 100 tablets. Keep
tightly closed. Store at controlled room temperature 20��to 25��C
(68��to 77��F). Protect from light. Dispense in light-resistant,
tight container. Use carton to protect contents from light. Phenergan (promethazine HCl)
Rectal Suppositories are available in boxes of 12 as follows: 12.5 mg, ivory, torpedo-shaped suppository wrapped in
copper-colored foil, NDC 0008-0498-01. 25 mg,
ivory, torpedo-shaped suppository wrapped in light-green foil, NDC 0008-0212-01. 50 mg, ivory, torpedo-shaped suppository wrapped in blue
foil, NDC 0008-0229-01. Store refrigerated between 2��-8��C (36��-46��F). Dispense in well-closed container. Wyeth Wyeth Pharmaceuticals Inc.Philadelphia,
PA 19101 W10448C003ET02Rev 07/05
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PHENERGAN 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE
OF WEIGHT-BASED DOSES OF PHENERGAN HAVE RESULTED IN RESPIRATORY DEPRESSION
IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED
THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN 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 Tablets and Suppositories should be used cautiously
in persons with cardiovascular disease or with impairment of liver function.<br/>Information for Patients: Phenergan Tablets and Suppositories may cause marked
drowsiness or impair the mental and/or physical abilities required for the
performance of potentially hazardous tasks, such as driving a vehicle or operating
machinery. The use of alcohol or other central-nervous-system depressants
such as sedatives/hypnotics (including barbiturates), narcotics, narcotic
analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers,
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. Avoid prolonged exposure to the
sun.<br/>Drug Interactions: CNS Depressants - Phenergan Tablets and Suppositories may increase, prolong, or
intensify the sedative action of other central-nervous-system depressants,
such as alcohol, sedatives/hypnotics (including barbiturates), narcotics,
narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers;
therefore, such agents should be avoided or administered in reduced dosage
to patients receiving promethazine HCl. When given concomitantly with Phenergan
Tablets and Suppositories, the dose of barbiturates should be reduced by at
least one-half, and the dose of narcotics should be reduced by one-quarterto one-half. Dosage must be individualized. Excessive amounts of promethazine
HCl 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 Phenergan to reverse epinephrine's
vasopressor effect, epinephrine should NOT be used to treat hypotension associated
with Phenergan Tablets and Suppositories 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 Phenergan Tablets and Suppositories.<br/>Drug/Laboratory Test Interactions: The following laboratory tests may be affected in
patients who are receiving therapy with promethazine HCl:<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, Impairment of Fertility: Long-term animal studies have not been performed
to assess the carcinogenic potential of promethazine, nor are there other
animal or human data concerning carcinogenicity, mutagenicity, or impairment
of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test 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 of promethazine
HCl. These doses are from approximately 2.1 to 4.2 times the maximum
recommended total daily dose of promethazine for a 50-kg subject, depending
upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg
intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition,
lactation, and development of the animal neonate were not done, but a general
preliminary study in rats indicated no effect on these parameters. Although
antihistamines have been found to produce fetal mortality in rodents, the
pharmacological effects of histamine in the rodent do not parallel those in
man. There are no adequate and well-controlled studies of Phenergan Tablets
and Suppositories in pregnant women. Phenergan
Tablets and Suppositories should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.<br/>Nonteratogenic Effects: Phenergan Tablets and Suppositories administered
to a pregnant woman within two weeks of delivery may inhibit platelet aggregation
in the newborn.<br/>Labor and Delivery: Promethazine HCl may be used alone or as an adjunct
to narcotic analgesics during labor . Limited data
suggest that use of Phenergan 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 Nonteratogenic Effects.)<br/>Nursing Mothers: It is not known whether promethazine HCl 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
Tablets and Suppositories, 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 TABLETS
AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN
TWO YEARS OF AGE (see WARNINGS���Black
Box Warning and Use
in Pediatric Patients). Phenergan
Tablets and Suppositories should be used with caution in pediatric patients
2 years of age and older (see WARNINGS-Use
in Pediatric Patients).<br/>Geriatric Use: Clinical studies of Phenergan formulations did not
include sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
patients. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal or cardiac function, and of concomitant
disease or other drug therapy. Sedating drugs
may cause confusion and over-sedation in the elderly; elderly patients generally
should be started on low doses of Phenergan Tablets and Suppositories and
observed closely.
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Signs and symptoms of overdosage with promethazine
HCl range from mild depression of the central nervous system and cardiovascular
system to profound hypotension, respiratory depression, unconsciousness,
and sudden death. Other reported reactions include hyperreflexia, hypertonia,
ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric
patients. Convulsions may rarely occur. A paradoxical-type reaction has been
reported in children receiving single doses of 75 mg to 125 mg
orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms���dry mouth, fixed, dilated
pupils, flushing, as well as gastrointestinal symptoms���may occur.<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. Activated charcoal orally or by lavage may
be given, or sodium or magnesium sulfate orally as a cathartic. Attention
should be given to the reestablishment of adequate respiratory exchange through
provision of a patent airway and institution of assisted or controlled ventilation.
Diazepam may be used to control convulsions. Acidosis and electrolyte losses
should be corrected. Note that any depressant effects of promethazine HCl
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 patients with partial adrenergic blockade may
further lower the blood pressure. Extrapyramidal reactions may be treated
with anticholinergic antiparkinsonian 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 (Tablet)
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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. 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.)<br/>Paradoxical Reactions: Hyperexcitability and abnormal movements have been
reported in patients following a single administration of promethazine HCl.
Consideration should be given to the discontinuation of promethazine HCl and
to the use of other drugs if these reactions occur. Respiratory depression,
nightmares, delirium, and agitated behavior have also been reported in some
of these patients.
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PHENERGAN 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE
OF WEIGHT-BASED DOSES OF PHENERGAN HAVE RESULTED IN RESPIRATORY DEPRESSION
IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED
THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN BE USED IN PEDIATRIC PATIENTS
2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH
RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.<br/>CNS Depression: Phenergan Tablets and Suppositories may impair the
mental and/or physical abilities required for the performance of potentially
hazardous tasks, such as driving a vehicle or operating machinery. The impairment
may be amplified by concomitant use of other central-nervous-system depressants
such as alcohol, sedatives/hypnotics (including barbiturates), narcotics,
narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers;
therefore such agents should either be eliminated or given in reduced dosage
in the presence of promethazine HCl .<br/>Respiratory Depression: Phenergan Tablets and Suppositories may lead to
potentially fatal respiratory depression. Use
of Phenergan Tablets and Suppositories in patients with compromised respiratory
function (e.g., COPD, sleep apnea) should be avoided.<br/>Lower Seizure Threshold: Phenergan Tablets and Suppositories may lower seizure
threshold. It should be used with caution in persons with seizure disorders
or in persons who are using concomitant medications, such as narcotics or
local anesthetics, which may also affect seizure threshold.<br/>Bone-Marrow Depression: Phenergan Tablets and Suppositories 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 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.<br/>Use in Pediatric Patients: PHENERGAN TABLETS
AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN
TWO YEARS OF AGE. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING
PHENERGAN TABLETS AND SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND
OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY
DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED
WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED
WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT
ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS
HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC
PATIENTS. ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED
VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED
VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY
TO PHENERGAN TABLETS AND SUPPOSITORIES ADMINISTRATION MAY BE CONFUSED WITH
THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S
SYNDROME. THE USE OF PHENERGAN TABLETS AND SUPPOSITORIES 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 Tablets and Suppositories,
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 promethazine HCl.<br/>Other Considerations: Administration of promethazine HCl has been associated
with reported cholestatic jaundice.
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Phenergan, either orally or by suppository, is useful
for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic
conjunctivitis due to inhalant allergens and foods. Mild,
uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic
reactions, as adjunctive therapy to epinephrine and other standard measures,
after the acute manifestations have been controlled. Preoperative,
postoperative, or obstetric sedation. Prevention
and control of nausea and vomiting associated with certain types of anesthesia
and surgery. Therapy adjunctive to meperidine
or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension
and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.
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Phenergan
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