REGENERON TM Neuroleptic Malignant Syndrome, Epileptic

Seizure, Lower Seizure Threshold, Chronic

PROMETHAZINE Obstructive Lung Disease, Any Disorder of the
HYDROCHLORIDE Brain, Closed Angle Glaucoma, Chronic
Difficulty having a Bowel Movement, Very

DESCRIPTION: Rapid Heartbeat, Significant Decrease in Lung

Function and Stenosing Peptic Ulcer
A phenothiazine derivative with histamine H1-
blocking, antimuscarinic, and sedative SIDE EFFECTS:
properties. It is used as an antiallergic, in
pruritus, for motion sickness and sedation, and Muscle or facial twitches, blurred vision, skin

also in animals. rash, seizures, blurred vision, irregular heartbeat,

palpitations or chest pain, unusual bleeding or
COMPOSITION: bruising, yellowing of the eyes or skin , slowed
Each 5 ml consist of 6.25 mg of promethazine or shortness of breath , pain during urination,
hydrochloride stuffy nose, headache, nightmares, nervousness
and excitability.
ACTIONS:
ADVERSE REACTION:
Like other H1-antagonists, promethazine
competes with free histamine for binding at H1- It may cause nausea, vomiting and jaundice to
receptor sites in the GI tract, uterus, large blood patient in gastrointestinal system. It may cause
vessels, and bronchial muscle. The relief of nasal stuffiness, asthma, apnea and respiratory
nausea appears to be related to central depression in respiratory system. Drowsiness is
anticholinergic actions and may implicate the major central nervous system effect of the
activity on the medullary chemoreceptor trigger drug which leads to insomnia, tremors, blurred
zone. vision, disorientation, dizziness, sedation,
somnolence, confusion, dryness of mouth and
INDICATIONS:
extrapyramidal symptoms. In cardiovascular

To treat allergy symptoms such as itching, runny system, it may cause tachycardia, bradycardia,

nose, sneezing, itchy or watery eyes, hives and faintness, and increased or decreased in the

itchy skin rashes. Also prevent motion sickness, blood pressure.

treats nausea and vomiting or pain after surgery

PRECAUTIONS:
and aid in sedation.

CONTRAINDICATION:
Promethazine tablets and suppositories are Adult: 6 .25 mg every 4-6 hours
contraindicated in pediatric patients less than 2
OVERDOSE INFORMATION:
years of age because of the potential for fatal
respiratory depression. Treatment of overdosage is actuated charcoal
orally or by lavage might be given, or sodium or
Central and obstructive apneas have been
magnesium sulfate orally as a cathartic.
observed in infants given promethazine.
Diazepam might be utilized to control writhings.
Promethazine has been implicated by some as a
Stay away from analeptics which may bring
possible cause of the Sudden Infant Death
about writhings. If vasopressors are considered
Syndrome (SIDS).
for the administration of extreme hypotension

Promethazine should be used with caution in which does not react to intravenous liquids and

patients with seizure disorders because it may repositioning, the organization of norepinephrine

lower the seizure threshold. Similarly, if used or phenylephrine ought to be considered.

with other medications that may affect seizure Epinephrine should not be used, since its

threshold such as narcotics or local anesthetics. utilization in patients with fractional adrenergic
bar may facilitate bring down the circulatory
DRUG INTERACTIONS: strain. Extrapyramidal responses might be
treated with anticholinergic antiparkinsonian
Central nervous system depressants, specialists, diphenhydramine, or barbiturates.
Epinephrine, Anticholinergics , Monoamine Oxygen may likewise be directed.
Oxidase Inhibitors (MAOI), Acitretin,
Antipsychotic agents, Cabergoline, pergolide, STORAGE CONDITION:
Cefotetan, disulfiram, furazolidone,
metronidazole ,Cisapride, Local anesthetics, Keep at room temperature, away from moisture,

narcotics, tramadol, Drugs with respiratory heat and light.

depressant effects, Levodopa , Paroxetine,

MANUFACTURED BY:
Tretinoin and CYP2D6 inhibitors (bupropion,
fluoxetine, quinidine and retonavir) REGENERON PHARMACEUTICAL
CORPORATION
DOSAGE AND ADMINISTRATION:
19 D Section 12 C, Block 2, Pusat Perniagaan
Children less than 6 years and more than 2
years old: 1.56 mg every 4-6 hours Worldwide, Jalan Kanjus Senjus, 40675 Shah
Alam, Selangor.
Children between 7 to 12 years old: 3.215 mg
every 4-6 hours