Brown, plum flavoured, viscous liquid.
Each 5 ml contains :
............... 3.6 mg
....... 15.0 mg
Actions and Pharmacology
Promethazine, a phenothiazine derivative, is a sedating antihistamine with
antimuscarinic, significant sedative, and some serotonin-antagonist
properties. It is usually given as the hydrochloride or teoclate.
Promethazine Hydrochloride has anticholinergic actions of most
antihistamines which provide a drying effect on the nasal and oral mucosa.
Dextromethorphan Hydrobromide is a cough suppressant used for the relief of
non-productive cough. It has a central action on the cough centre in the
medulla. It is also an antagonist of N-methyl-D-aspartate (NMDA) receptors.
Dextromethorphan has no classical analgesic properties and little sedative
Promethazine is well absorbed after oral administration. Peak plasma
concentrations have been observed 2 to 3 hours after administration. Onset
of action occurs 15 to 60 minutes after oral administration and may have the
duration of action from 4 to 12 hours. Promethazine crosses the blood-brain
barrier and the placenta, and is distributed into breast milk. Values
ranging from 76 to 93% have been reported for plasma-protein binding. It is
excreted slowly via the urine and bile. Elimination half-lives of 5 to 14
hours have been reported.
Dextromethorphan Hydrobromide is rapidly absorbed from the gastrointestinal
tract. It is metabolized in the liver and excreted in the urine as unchanged
dextromethorphan and demethylated metabolites including dextrorphan. It is
reported to act within half an hour of administration by mouth and to exert
an effect for up to 6 hours.
For short term symptomatic relief of troublesome non-productive cough and
common cold, particularly at night.
This medication is contraindicated with patients with sensitivity to
promethazine and dextromethorphan or other components of the formulation.
The presence of other medical problems may affect the use of this
medication. A doctor should be consulted before using this medicine it any
other medical problems exist, especially: bladder neck obstruction,
symptomatic prostatic hypertrophy, urinary retention, bone marrow
depression, cardiovascular disease, coma, glaucoma, jaundice, Reye's
syndrome, asthma, chronic bronchitis, productive cough, emphysema, diabetes,
hepatic function impairment and respiration depression.
Warnings and Precautions
- Caution should be exercised to patients sensitive to promethazine or to
other phenothiazine medications.
- For pediatrics: Use of promethazine is not recommended in newborn or
premature infants because this age group has an increased susceptibility to
anticholinergic side effects, such as central nervous system (CNS)
excitation, and an increased tendency toward convulsions.
- This product contains
Promethazine Hydrochloride. It should not be used in pediatric patients less
than 2 years of age because of the potential for fatal respiratory
- For adolescents: Promethazine
should not be used in adolescents with signs and symptoms suggestive of
Reye's syndrome since extrapyramidal symptoms may occur.
- For geriatrics: Dizziness,
sedative, confusion, hypotension and paradoxidal reaction may be more likely
to occur in geriatric patients taking promethazine.
- Prolonged use of promethazine may decrease or inhibit salivary flow.
Involuntary orofacial muscle movements may result from extrapyramidal
Dextromethorphan should not be given to patients at risk of developing
respiratory failure and caution is needed in patients with a history of
asthma and should not be given during an acute attack.
* This medicine may cause drowsiness and dizziness, less alert than normal
or to feel a false sense of well being. Patients should know how they react
to this medicine before they drive, use machines or doing anything that
could be dangerous if they are dizzy or are not alert and clearheaded.
Children should be supervised to avoid potential harm in bike riding or
other dangerous activities.
Use in pregnancy and lactation
This medication should not be taken by pregnant patients especially during
the 2 weeks before delivery to avoid possible inhibition of platelet
aggregation in newborn. Jaundice and extrapyramidal effects also may occur
This medication is not recommended for nursing mothers because of adverse
effects like unusual excitement or irritability in infants. The nursing
infants may be associated with the sudden infant death syndrome (SIDS) and
an increase in sleep apnea. Promethazine may also inhibit lactation because
of their anticholinergic actions.
Main Side/ Adverse Effects
The side effects with this medication appear to be rare and may include
drowsiness, blood dyscrasias, dizziness, gastrointestinal disturbances and
other common side effects of sedating antihistamines like headache,
confusion, difficult or painful urination, dryness of mouth, nose or throat,
hypotension, increased sweating, loss of appetite, paradoxical reaction,
photosensitivity, ringing or buzzing in ears, skin rash and tachycardia.
Concurrent use of this medication with combination products containing any
of the following medications, may interact with promethazine and
dextromethorphan: alcohol or central nervous system (CNS) depressants,
anticholinergics medications, epinephrine, extrapyramidal reactioncausing
medication, levodopa, intrathecal metrizamide, monoamine oxidase (MAO)
inhibitors including furazolidone, phenelzine, procarbazine, selegiline and
tranylcypromine; other enzyme inhibitors like amiodarone or fluoxetine or
quinidine; and smoking tobacco. The diagnostic test results for the
following laboratory tests may be affected in patients receiving
promethazine: Glucose tolerance test, Immunologic urine pregnancy tests and
skin tests using allergen extracts.
Symptoms of overdose:
Anticholinergic effects, CNS depression (severe drowsiness), CNS
stimulation, extrapyramidal effects, severe hypotension, ataxia, blurred
vision, coma, confusion, drowsiness or dizziness, respiratory depression,
severe nausea or vomiting, severe unusual excitement nervousness,
restlessness or irritability and urinary retention.
Treatment for overdose:
Treatment is symptomatic and supportive with possible utilization of the
- induction of emesis and gastric
lavage to decrease absorption.
- saline cathartics (milk of magnesia) are sometimes used to enhance
- assisted respiration, vital
sign monitoring and intravenous naloxone.
Dosage and Administration
Adult and children over 12 years : 5 - 10 ml (1 to 2 teaspoons), 3 to
4 times daily, not to exceed 40 ml in a day.
Children 6 to 12 years : 2.5 - 5 ml (½ to 1 teaspoon), 3 to 4 times
daily, not to exceed 20 ml in a day.
Children 2 to 6 years : 1.25 - 2.5 ml (¼ to
½ teaspoon), 3 to 4 times daily, not to exceed 10 ml in a day. It is
also advised that the dose of promethazine for this age group be under the
direction of a doctor.
Children below 2 years : Not recommended.
Patients are advised to use a calibrated measuring device as 5 ml is a rough
approximation of one teaspoon and different teaspoons differ in their
3 years from the
date of manufacture.
Store below 25°C.
Protect from light.
glass bottle of 120 ml.