Фенерган крем инструкция по применению

• Код товара: s190521
• Производитель: DB Pharma Франция
• Действующее вещество: прометазин
• Наличие: нет в наличии

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 (see PRECAUTIONS−Information for Patients and Drug Interactions).

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.

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.

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.

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

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 (see OVERDOSAGE). 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.

Other Considerations

Administration of promethazine HCl 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.

Phenergan Tablets and Suppositories should be used cautiously
in persons with cardiovascular disease or with impairment of liver function.

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.

Drug Interactions

Drug/Laboratory Test Interactions

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

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.

Pregnancy

Labor and Delivery

Promethazine HCl may be used alone or as an adjunct
to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). 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.)

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.

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).

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.

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.)

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.

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.

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.

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.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown
etiology in children and adolescents (see WARNINGS-Use in Pediatric Patients).

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.

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.

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.

This page provides information for Phenergan Cream Product in English.

Components:

Method of action:

Name of the medicinal product

Phénergan 2.5%

Qualitative and quantitative composition

Promethazine

Therapeutic indications

Dosage (Posology) and method of administration

Contraindications

Special warnings and precautions for use

Effects on ability to drive and use machines

Because the duration of action may be up to 12 hours, patients should be advised that if they feel drowsy they should not drive or operate heavy machinery.

Undesirable effects

Overdose

Pharmacodynamic properties

Pharmacokinetic properties

Promethazine is distributed widely in the body. It enters the brain and crosses the placenta. Promethazine is slowly excreted via urine and bile. Phenothiazines pass into the milk at low concentrations.

Pharmacotherapeutic group

Antihistamines for systemic use; Phenothiazine derivatives, ATC code: R06AD02

Preclinical safety data

Incompatibilities

Not applicable

Special precautions for disposal and other handling

No special requirements

Phénergan 2.5% price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

The approximate cost of Promethazine 25 mg per unit in online pharmacies is from 0.32$ to 0.43$, per package is from 25$ to 43$.

The approximate cost of Promethazine 10 mg per unit in online pharmacies is from 0.33$ to 0.43$, per package is from 26$ to 30$.