Oxomemazine Guaifenesin

Each of 5 ml syrup contains:
Oxomemazine                            1.65mg

Pharmacological Properties
Pharmacodynamic Properties
Systemic antihistamine
(R. Respiratory system).
Oxomemazine: H1 antihistamine, phenothiazine with aliphatic side chain, characterized by:
  • a marked sedative effect at usual doses, of histaminergic and central adrenolytic origin,
  • an anticholinergic effect responsible for peripheral adverse effects,
  • a peripheral adrenolytic effect, with potential hemodynamic consequences (risk of orthostatic hypotension).
Antihistamines share the common property of opposing, via competitive antagonism of varying degrees of reversibility, the effects of histamine, on the skin, bronchi, intestine and blood vessels in particular.

Guaifenesin: Expectorant.

Pharmacokinetic Properties
No information is available on the pharmacokinetics of oxomemazine.

General features can be cited regarding all antihistamines, and phenothiazines in particular:
  • Bio availability is generally moderate.
  • The possibility exists metabolization, with formation of many metabolites, which explains the very low percentage of unchanged substance found in urine.
  • Half-life varies but is often long, offering the possibility of a single daily dose.
  • The large volume of distribution is due to the liposolubility of these substances.
Pathophysiological variations: risk of accumulation of antihistamines in the presence of impaired renal or liver function.

To reduce cough with sputum, accompanied by allergic condition.

Dosage and Method of Administration
For Use Only in Adults and Children over 2 Year of age. Oral route.

In adults and children weighing more than 40 kg (i.e. age 12):
10 ml per dose, 4 times a day.

In children: The daily dosage depends upon the weight of the child (1 ml of syrup per kg body weight and per day), i.e. by way of an indication:
  • children between 10 and 20 kg (i.e. age 2 to 6) : 5 ml per dose, 2 to 3 times a day;
  • children between 20 and 30 kg (i.e. age 6 to 10): 10 ml per dose, 2 to 3 times a day;
  • children between 30 and 40 kg (i.e. age 10 to 12): 10 ml per dose, 3 to 4 times a day.
Doses should be taken as and when needed, with a minimum interval of 4 hours between them.
Evening administration should be preferred, because of the sedative effect of oxomemazine, especially at the start of treatment.

Special Warnings and Special Precautions for Use.
  • Productive cough, a fundamental component of bronchopulmonary defence mechanisms, should not be suppressed.
  • It is illogical to combine an expectorant or mucolytic with this antitussive medicine.
  • Causes of cough requiring specific treatment must be ruled out before prescribing antitussive treatment.
  • If cough is resistant to an antitussive administered at usual dosage, the dose should not be increased but the clinical situation reassessed.
Related to the presence of oxomemazine:
Given that phenothiazines are considered to be hypothetical risk factors in sudden infant death syndrome, it is recommended not to use them in children less than 2 year of age. Enhanced monitoring (clinical and possibly EEG) is required in epileptics because of the possibility of lowering the epileptogenic threshold.
Oxomemazine must be used cautiously:
  • in the elderly with:
    • greater susceptibility to orthostatic hypotension, vertigo and sedation,
    • chronic constipation (risk of paralytic ileus),
    • possible prostatic hypertrophy;
  • in individuals with certain cardio-vascular disorders, because of the tachycardiac and hypertensive effects of phenothiazines,
  • in the presence of severe impaired liver and/or renal function (because of the risk of accumulation).
In children, it is important to rule out bronchial asthma or gastroesophageal reflux before using oxomemazine as an antitussive.
It is highly inadvisable to drink alcoholic beverages or take medicines containing alcohol during treatment (see Drug Interactions)
Because of the photosensitizing effect of phenothiazines, it is preferable to avoid exposure to the sun during treatment.
The sucrose content (3.7 g per 5 ml dose and 7.3 g per 10 ml dose) should be taken into account in patients with diabetes or on a low carbohydrate diet.

Adverse Effects
The pharmacological characteristics of oxomemazine are resposible for adverse effects of unequal degree and dose-related or not (see Pharmacodynamic properties).
  • Automatic effects:
    • sedation or drowsiness, more marked at the start of treatment;
    • anticholinergic effects, e.g. dry mucous membranes, constipation, impaired accommodation, mydriasis, cardiac palpitations, risk of urinary retention:
    • orthostatic hypotension;
    • impaired balance, vertigo, impaired memory of concentration (commoner in the elderly);
    • motor incoordination, tremor;
    • mental confusion,hallucinations;
    • more rarely, but especially in the newborn, effects in the form of excitation: agitation, nervousness, insomnia.
  • Sensitization reactions:
    • erythema, eczema, pruritus, purpura, possibly giant urticaria, - edema, more rarely angioneurotic edema,
    • anaphylactic shock,
    • photosensitization;
  • Hematological disorders: 
    • Lekopenia, neutropenia, extremely, rarely, : agranulocytosis
    • thrombocytopenia;
    • hemolytic anemia.
  • Signs of oxomemazine overdose: convulsions (especially in infants and children), impaired consciousness, coma
  • Symptomatic treatment should be provided in a specialist unit.
Contra Indications
This medicine is Contraindicated in the following situations:
  • allergy to any of the consituents, anti-histamines in particular;
  • because of the presence of oxomemazine:
    • history of agranulocytosis,
    • risk of urinary retention related to urethroprostatic disorders, 
    • risk of closed angle glaucoma. This medicine is Generally Inadvisable,
    • during the first trimester of pregnancy and while breast feeding,
    • in combination with sultopride (see Drug Interactions).
Drug Interactions
The interactions mentioned are related to the presence of oxomemazine.

Inadvisable combinations:
- Alcohol:
Alcohol increases the sedative effect of H1 antihistamines. Impaired alertness may make driving and machinery operations dangerous. Avoid alcoholic drinks and medicines containing alcohol.
- Sultopride:
Increased risk of ventricular arrythmias, especially torsade de pointes/ wave burst arrythmias, by addition of electrophysiological effects.

Combinations needing to be taken into account:

  • Other central nervous system depressants (sedative antidepressants, barbiturates, benzodia zepines, clonidine and related substances, hypnotics, morphine derivatives (analgesics and antitussives), methadone, neuroleptics, transquilizers): Increased central depression. Impaired alertness may make driving and machinery operation dangerous.
  • Atropine and other atropine-like substances (imipramine anti depressants, anticholinergic parkinsonism drugs, atropine-like antispasmodics, disopyramide, phenothiazine neuroleptics); Additions of atropine-like adverse effects, such as urinary retention, constipation, dry mouth.

Pregnancy and breast feeding
Decisions concerning possible use during pregnancy and breast feeding must take into account the presence of oxomemazine.

Malformative Aspect:
No reliable animal teratogenesis data are available.
Sufficiently pertinent data do not exist at present to enable evaluation of any possible malformative or fetotoxic effect of oxomemazine when administered during pregnancy.

Fetotoxic effect:
There have been rare reports of digestive manifestations related to atropine-like properties (abdominal distension, meconium ileus, delayed excretion of meconium, difficulty starting feeding, tachycardia, neurological problems, etc.) in the newborn infants of mothers on long term treatment with anticholinergic medicines.
In view of these data, use of this medicine is inadvisable during the first trimester of pregnancy. It should be prescribed later only if necessary with limitation during the 3rd trimester to occasional use only.
If this medicine is administered at the end of pregnancy, monitoring of the neurological and digestive function of the newborn infant for a time seems justified.

Breast feeding
Excretion of oxomemazine in breast milk is not known. Because of the possi bi lities of sedation or paradoxical excitation of the newborn, and even more the risk of sleep apnea suggested with phenothiazines, this medicine is inadvisable while breast feeding.

Effects on ability to drive and use machines
Attention is drawn, particularly that of drivers and machinery operators, to the risks of drowsiness associated with the use of this medicine, especially at the start of treatment.

This is accentuated by alcoholic drinks or medicines containing alcohol.

Store below 25°C

- TOPLEXIL Syrup, 60 ml in brown glass bottle,  Reg. No. DKL0121201737A1
- TOPLEXIL Syrup, 120 ml in brown glass bottle, Reg.No. DKL0121201737A1


Manufactured by
PT Boehringer Ingelheim Indonesia,
Bogor, Indonesia
PT Aventis Pharma,
Jakarta, Indonesia

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