Toplexil сироп инструкция на русском

Toplexil Syrup Generic drug of the therapeutic class: Allergology
active ingredients: Oxomemazine

Important to know about Toplexil Syrup ?

what is toplexil Syrup used for and indication?

Toplexil Syrup Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.

toplexil dosage for adults

• 10 ml per dose, 4 times a day.

Pediatric population

toplexil dosage for 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.

Administration mode

Oral way.

•  Use the measuring cup.

Evening intake should be favored because of the sedative effect, especially at the beginning of treatment, of oxomemazine.

Contraindications

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:

•  sedation or drowsiness, more marked at the beginning of treatment;
•  anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention;
• orthostatic hypotension;
• balance disorders, dizziness, memory loss or concentration (more common in the elderly);
• motor incoordination, tremors;
• mental confusion, hallucinations;
• more rarely, effects like excitation: agitation, nervousness, insomnia.

· Awareness Reactions:

• erythema, eczema, pruritus, purpura, possibly giant urticaria,
• edema, more rarely angioedema,
• anaphylactic shock,
• photosensitization;

· Hematological disorders:

• leukopenia, neutropenia, exceptional agranulocytosis ;
• thrombocytopenia,
• 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 :

1. 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.
2. 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:

• greater sensitivity to orthostatic hypotension, vertigo and sedation,
• chronic constipation (paralytic diluted risk),
• 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

1. 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.
2. 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.

toplexil for pregnant

Malformative aspect

• 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.

Fetotoxic appearance

• 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.

Breastfeeding

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?

What happens if I overdose from Toplexil Syrup ?

Immediately consult your doctor or pharmacist

What is  Forms and Composition ?

1. 0.33 mg / ml syrup:   150 ml bottle, with measuring cup graduated to 5 ml and 10 ml. 0.33 mg / ml sugar-free
2. oral solution, sweetened with acesulfame potassium:   150 ml vial, with measuring cup graduated to 5 ml and 10 ml.

• 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.

• 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.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Description

This drug contains an antihistamine, oxomemazine, and guaifenesin.

Composition

Each 100 mL of Toplexil Syrup contains:

• Oxomemazine : 0.033 g.
• Guaifenesin : 0.666 g.
• Excipients: S.Q.for 100 mL.

Indications

Toplexil is indicated to soothe dry coughs and irritative coughs in adults and children over 2 years of age, particularly when they occur in the evening or at night.

Dosage & Administration

For use only in adults and children over 2 years of age.

Adults and children weighing more than 40 kg (i.e. age 12):

10 mL per dose, 4 times a day.

Children: the daily dosage depends upon the weight of your child:

• 10 to 20 kg ( i.e. age 2 to 6): 5 mL per dose, 2 to 3 times a day.
• 20 to 30 kg ( i.e. age 6 to 10): 10 mL per dose, 2 to 3 times a day.
• 30 to 40 kg ( i.e. age 10 to 12): 10 mL per dose, 3 to 4 times a day.

In all cases, strictly follow the Physician’s prescription.

_{*The information provided above is general in nature and for informational purposes only. It is NOT a substitute for the advice of your doctor. You must always consult your healthcare professional before starting any medication/supplementation program.} 

Toplexil Syrup

Trade Name:

Toplexil Syrup

Generic Name:
Oxomemazine
Guaifenesin
Sodium benzoate
Paracetamol

Composition:

Each 100 ml contains:
Active ingredients:
Oxomemazine                         0.033 gm
Guaifenesin                             0.666 gm
Sodium benzoate                   0.666 gm
Paracetamol                            0.666 gm
Inactive ingredients:
Glycerol, Citric acid monohydrate, Sodium citrate dihydrate, Caramel flavour, Caramel colour, Sucrose and Purified water.

Pharmaceutical Form:
Syrup

Pharmacological Action:

This medicine is a combination of substances which contains an antihistamine, antitussive and sedative (Oxomemazine), two expectorants (Guaifenesin and Sodium benzoate) and antipyretics (paracetamol).

Pharmacokinetics:

Guaifenesin is absorbed from the gastrointestinal tract it is melabolised and then excreted in the urine. Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses and is distributed into most body tissues. It crosses the placenta and is present in breast milk. Paracetamol is metabolised predominantly
in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol. Sodium benzoate is absorbed from the gastrointestinal
tract and conjugated with glycine in the liver to form hippuric acid, which is rapidly excreted in the urine.

Indications:

It is used in the treatment of dry and wet cough, including allergies and irritants.

Dosage and administration:

Treatment should not exceed a few days.
The use of this medication must be distributed during the day.

Adults:

– 1 or 2 teaspoons of syrup, 2 or 3 times a day. In the elderly, starting with the lowest dose.

– Don’t use this medicine for children under 6 years without medical advice.

Children:

– Above 30 months: 3 to 5 teaspoons of syrup per day, in 2 or 3 divided doses under medical advice
– From 24 to 30 months: 1 to 3 teaspoons of syrup per day, in 2 or 3 divided doses under medical advice
– Don’t use this medicine for children under 2 years.

Contraindications:

This medicine should not be used in cases of respiratory or hepatit insufficiencies.

Adverse effects:

Sleepiness, digestive disorders, thickening of the bronchial secretions, dry mouth, blurred vision, constipation, urine retention, mental confusion in the elderly and more rarely agitation in children.

Drug Interactions:

This medication may interact with other sedatives or atropine report to your doctor or pharmacist for any other treatment course.

Pregnancy and lactation:

The effect of this medicine during pregnancy or lactation is poorly understood. The evaluation of possible risks associated with its use is individual. Ask your pharmacist or doctor.

Precautions and Warnings:

– Don’t use this mediclne for chiTaren under 6 years without medical advice.
– Don’t use this medicine for children under 2 years.
– Cough is a symptom that can reveal many diseases:Consult your physician if it persists more than a few days.

– This syrup contains sugar (sucrose) in significant quantity, so not to be used in patients with diabetes mellitus

– This medicine contains paracetamol; you must consider when taken together with other medication containing it.
– Avoid alcoholic beverages: increased risk of drowsiness. Driver: This medication may be responsible for drowsiness or impaired alertness.

Presentation:

A carton box containing a bottle of 125 ml syrup + inner leaflet.

Storage:

Store away from light, at a temperature not exceeding 30°C.

PRODUCED BY :

EUROPEAN EGYPTIAN PHAMACEUTICAL INDUSTRIES
ALEXANDRlA-EGYPT

توبلكسيل لعلاج السعال الجاف والسعال المصحوب بالبلغم

Toplexil is indicated to soothe dry coughs and irritative coughs in adults and children over 2 years of age, particularly when they occur in the evening or at night.
TOPLEXIL SYRUP 150ML
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 Uses, Dosage, Side Effects, Precautions



  


                       
  



what is toplexil Syrup used for and indication?
Symptomatic treatment of troublesome nonproductive coughs, especially at night.
Toplexil Syrup Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.
toplexil dosage for adults
10 ml per dose, 4 times a day.
Pediatric population
toplexil dosage for 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.
Administration mode



  


                       
  



Oral way.
 Use the measuring cup.
Evening intake should be favored because of the sedative effect, especially at the beginning of treatment, of oxomemazine.
Contraindications
Oxomemazine hypersensitivity
Infant less than 2 years old
History of agranulocytosis
Urethroprostatic disorders at risk of urinary retention
Risk of narrow-angle glaucoma
Sun exposure
Fructose intolerance
Glucose galactose malabsorption syndrome
Sucrase / isomaltase deficiency
Alcohol consumption
Pregnancy 1st trimester
Feeding with milk
This drug is CONTRAINDICATED in the following cases:
Hypersensitivity to any component, including antihistamines,
Due to the presence of oxomemazine
 infant (less than 2 years) (see section Warnings and precautions for use),
history of agranulocytosis,
risk of urinary retention linked to urethro-prostatic disorders,
risk of glaucoma by closing the angle,
In association with cabergoline and quinagolide (see Interactions with other drugs and other forms of interaction).
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:
 sedation or drowsiness, more marked at the beginning of treatment;
 anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention;
orthostatic hypotension;
balance disorders, dizziness, memory loss or concentration (more common in the elderly);
motor incoordination, tremors;
mental confusion, hallucinations;
more rarely, effects like excitation: agitation, nervousness, insomnia.
· Awareness Reactions:
erythema, eczema, pruritus, purpura, possibly giant urticaria,
edema, more rarely angioedema,
anaphylactic shock,
photosensitization;
· Hematological disorders:
leukopenia, neutropenia, exceptional agranulocytosis ;
thrombocytopenia,
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.