- 1 Important to know about Toplexil Syrup ?
- 2 Toplexil Syrup indication and Uses :
- 3 Toplexil Syrup Dosage :
- 4 How it works Toplexil Syrup :
- 5 Toplexil Syrup Side Effects :
- 6 Toplexil Syrup Interactions :
- 7 Toplexil Syrup Warnings and Precautions :
- 8 Drive and use machines:
- 9 Toplexil Syrup and Pregnancy / Breastfeeding :
- 10 What should I do if I miss a dose?
- 11 What happens if I overdose from Toplexil Syrup ?
- 12 What is Forms and Composition Toplexil Syrup ?
Important to know about Toplexil Syrup ?
It is recommended to calm dry coughs and irritation coughs in adults and children over 2 years of age, especially when they occur in the evening or at night.
Toplexil Syrup indication and Uses :
Toplexil Syrup Dosage :
RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.
In adults : 10 ml per dose, 4 times a day.
In children : the daily dosage depends on the weight of the child (1 ml of syrup per kg of body weight per day), which is indicative:
· Child from 13 to 20 kg (ie 2 to 6 years): 5 ml per dose, 2 to 3 times a day,
· Child from 20 to 30 kg (6 to 10 years): 10 ml per dose, 2 to 3 times a day,
· Child from 30 to 40 kg (10 to 12 years): 10 ml per dose, 3 to 4 times a day
· Child over 40 kg (12 years old): 10 ml per dose, 4 times a day.
The catches are to be renewed when necessary and spaced at least 4 hours apart.
Oral way. Use the measuring cup.
Evening intake should be favored because of the sedative effect, especially at the beginning of treatment, of oxomemazine.
How it works Toplexil Syrup :
Pharmacotherapeutic group: ANTIHISTAMINE FOR SYSTEMIC USE, ATC code: R06AD08 (R: Respiratory system).
Oxomemazine : antihistamine H1, phenothiazine with aliphatic side chain, which is characterized by:
· A marked sedative effect at the usual doses, of histaminergic and central adrenolytic origin,
· An anticholinergic effect causing peripheral adverse effects,
· A peripheral adrenolytic effect, which may have a hemodynamic effect (risk of orthostatic hypotension).
Antihistamines have in common the property of opposing, by more or less reversible competitive antagonism, the effects of histamine especially on the skin, the bronchi, the intestine, and the vessels.
Toplexil Syrup Side Effects :
The pharmacological characteristics of the oxomemazine molecule cause undesirable effects of unequal intensity and linked or not to dose (see section Pharmacodynamic properties ):
· Neurovegetative effects:
o sedation or drowsiness, more marked at the beginning of treatment;
o anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention;
o orthostatic hypotension;
o balance disorders, dizziness, memory loss or concentration (more common in the elderly);
motor incoordination, tremors;
o mental confusion, hallucinations;
o more rarely, effects like excitation: agitation, nervousness, insomnia.
· Awareness Reactions:
o erythema, eczema, pruritus, purpura, possibly giant urticaria,
o edema, more rarely angioedema,
o anaphylactic shock,
· Hematological disorders:
o leukopenia, neutropenia, exceptional agranulocytosis ;
o Hemolytic anemia.
Due to the presence of glycerol, risk of digestive disorders and diarrhea.
Toplexil Syrup Interactions :
Drugs lowering the epileptogenic threshold :
The joint use of proconvulsant drugs, or lowering the epileptogenic threshold, should be carefully weighed, because of the severity of the risk involved. These drugs are represented by most antidepressants (imipramines, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, bupropion, tramadol.
Atropine drugs :
It must be taken into account that atropine substances can add their adverse effects and more easily result in urinary retention, acute glaucoma, constipation, dryness of the mouth, etc.
The various atropine drugs are represented by imipramine antidepressants, most atropine H1 antihistamines, antiparkinsonian anticholinergics, atropine antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.
Sedative drugs :
It must be taken into account that many drugs or substances can add their depressant effects of the central nervous system and help reduce alertness. These are morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (eg meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin , mianserine, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensives, baclofen and thalidomide.
Associations contraindicated :
· Dopaminergics, excluding Parkinson’s (cabergoline, quinagolide): Reciprocal antagonism of the dopaminergic agonist and neuroleptics.
Associations advised against :
·Other sedative drugs : Potentiation of the sedative effect of H1 antihistamines.
·Alcohol consumption : Alcohol enhancement of the sedative effect of these substances. Impairment of alertness can make driving and using machines dangerous. Avoid taking alcoholic drinks and drugs containing alcohol.
Associations subject to precautions for use :
·Gastrointestinal topicals, antacids and anthrax : Decreased digestive absorption of phenothiazine neuroleptics. Take gastrointestinal topicals and antacids away from phenothiazinic neuroleptics (more than 2 hours, if possible).
Associations to consider :
·Antihypertensive drugs : Increase the risk of hypotension, including orthostatic.
·Beta-blockers (except esmolol and sotalol) : Vasodilator effect and risk of hypotension, especially orthostatic (additive effect).
·Beta-blockers in heart failure (bisoprolol, carved idol, metoprolol, nebivolol ): Vasodilator effect and risk of hypotension, particularly orthostatic (additive effect).
·Nitrate and related derivatives : Increased risk of hypotension, especially orthostatic.
Toplexil Syrup Warnings and Precautions :
Special warnings :
The productive coughs, which are a fundamental element of bronchopulmonary defense, must be respected.
It is illogical to associate an expectorant or mucolytic with this antitussive drug.
Before prescribing antitussive therapy, cough causes that require specific treatment should be investigated.
If the cough is resistant to an antitussive given at a usual dosage, the doses should not be increased, but the clinical situation should be reconsidered.
Precautions for use:
RELATED TO THE PRESENCE DOXOMEMAZINE:
Since phenothiazines have been considered as hypothetical risk factors in the occurrence of sudden infant death, loxomemazine should not be used in children under 2 years of age.
Surveillance (clinical and possibly electrical) should be reinforced in epileptics because of the possibility of lowering the epileptogenic threshold.
Loxomemazine should be used with caution:
· In the elderly subject with:
o greater sensitivity to orthostatic hypotension, vertigo and sedation,
o chronic constipation (paralytic diluted risk),
o a possible prostatic hypertrophy.
· In subjects with certain cardiovascular diseases, because of the tachycardic and hypertensive effects of phenothiazines.
· In case of severe hepatic and / or renal insufficiency (due to the risk of accumulation).
If used in children, bronchial asthma or gastroesophageal reflux should be eliminated before using loxomemazine as a cough suppressant.
Taking alcoholic beverages or alcohol-containing medicines (see section 4.5) is strongly discouraged during the course of treatment.
Given the photosensitizing effect of phenothiazines, it is best not to expose to the sun during treatment.
H1 antihistamines should be used with caution because of the risk of sedation. Association with other sedating medicinal products should be discouraged (see section 4.5).
This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase / isomaltase deficiency.
This medicine contains 3.7 g of sucrose per 5 ml dose and 7.3 g per 10 ml dose, which should be taken into account in the daily ration in case of low sugar diet or diabetes.
This medicine contains sodium. This medicine contains 8.25 mg of sodium per 5 ml of syrup and 16.50 mg of sodium per 10 ml of syrup: to be taken into account in people on a strict sodium diet.
Drive and use machines:
Attention is drawn to the risks of drowsiness associated with the use of this drug, especially in the case of vehicle drivers and machine users , especially at the beginning of treatment. This phenomenon is accentuated by the intake of alcoholic beverages or drugs containing alcohol.
Toplexil Syrup and Pregnancy / Breastfeeding :
The presence of oxomemazine determines the course of action during pregnancy and lactation.
There is no reliable data on teratogenesis in animals.
There are currently no data of sufficient relevance to evaluate the possible malformative or foetotoxic effect of oxomemazine when administered during pregnancy.
In neonates of long-term mothers treated with high doses of anticholinergic drugs have been rarely described digestive signs related to atropine properties (abdominal distention, meconium ileus, delay in emission of meconium, difficulty of getting started). of food, tachycardias, neurological disorders …).
Given these data, the use of this drug is not recommended during the first trimester of pregnancy. It should only be prescribed if necessary thereafter, limiting the 3 rd quarter, a one-time use.
If the administration of this drug took place at the end of pregnancy, it seems justified to observe a period of surveillance of the neurological and digestive functions of the newborn.
The passage of oxomemazine in breast milk is not known. Given the possibilities of sedation or paradoxical excitement of the newborn, and even more risks of sleep apnea evoked with phenothiazines, this drug is not recommended when breastfeeding.
What should I do if I miss a dose?
Do not take a double dose to make up for the dose you forgot to take.
What happens if I overdose from Toplexil Syrup ?
Immediately consult your doctor or pharmacist
What is Forms and Composition Toplexil Syrup ?
|FORMS and PRESENTATIONS|
0.33 mg / ml syrup: 150 ml bottle, with measuring cup graduated to 5 ml and 10 ml. 0.33 mg / ml sugar-free oral solution, sweetened with acesulfame potassium: 150 ml vial, with measuring cup graduated to 5 ml and 10 ml.
|Syrup:||p 5 ml||p 10 ml|
|oxomemazine||1.65 mg||3.3 mg|
Excipients: sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel compound flavor (caramel, fenugreek resin, methylcyclopentenolone hydrate, maltol, butyric acid, piperonal, diacetyl, ethyl vanillin, vanillin, propylene glycol, distilled water), caramel ( E150), sucrose solution, purified water.
Excipients with known effect: sucrose (3.7 g / 5 ml, 7.3 g / 10 ml), sodium (8.25 mg / 5 ml, 16.5 mg / 10 ml), glycerol.
|Drinkable solution :||p 5 ml||p 10 ml|
|oxomemazine||1.65 mg||3.3 mg|
Excipients: sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel compound flavor (mainly heliotropine [piperonal], vanilla, propylene glycol, alcohol, maltol, water), liquid maltitol, acesulfame potassium, purified water.
Excipients with known effect: maltitol, sodium (8.26 mg / 5 ml, 16.53 mg / 10 ml), glycerol.