Release form and composition
Fluditek is available in the following forms:
- syrup for children 2% (orange transparent liquid with banana flavor);
- syrup 5% (green transparent liquid with caramel aroma).
The drug is packaged in glass bottles of 125 ml and packed in cardboard packs (1 bottle per pack).
The composition of 1 ml of syrup 2% includes:
- active ingredient: carbocysteine – 20 mg;
- excipients: sucrose, methyl parahydroxybenzoate, glycerol, sunset yellow dye, purified water, banana flavor, sodium hydroxide.
The composition of 1 ml of syrup 5% includes:
- active ingredient: carbocysteine – 50 mg;
- excipients: sucrose, methyl parahydroxybenzoate, glycerol, proprietary blue and sunset yellow dyes, purified water, caramel flavor, sodium hydroxide.
FLUDITECH
Drug: FLUDITEC Active substance: carbocisteine ATC code: R05CB03 CPG: Mucolytic drug ICD-10 codes (indications): H66, J00, J01, J04, J15, J20, J31, J32, J37, J42, J45, J47, Z51.4 Reg. number: P N014782/01-2003 Registration date: 02/09/09 Owner of reg. credential: Laboratoire INNOTECH INTERNATIONAL (France) produced by INNOTHERA CHOUZY (France)
DOSAGE FORM, COMPOSITION AND PACKAGING
◊ Syrup for children in the form of a transparent orange liquid with the smell of banana.
| 1 ml | |
| carbocisteine | 20 mg |
Excipients: glycerol - 5 g, methyl parahydroxybenzoate - 150 mg, sucrose - 70 g, sunset yellow dye (E110) - 1 mg, sodium hydroxide - up to pH6.2, banana flavor - 200 mg, purified water - up to 100 ml.
125 ml - glass bottles (1) - cardboard packs.
◊ Syrup in the form of a transparent green liquid with the smell of caramel.
| 1 ml | |
| carbocisteine | 50 mg |
Excipients: glycerol - 5 g, methyl parahydroxybenzoate - 150 mg, sucrose - 35 g, sunset yellow dye (E110) - 1.6 mg, patent blue dye V (E131) - 1 mg, sodium hydroxide - up to pH6.2, caramel flavoring - 200 mg, purified water - up to 100 ml.
125 ml - glass bottles (1) - cardboard packs.
INSTRUCTIONS FOR USE FOR SPECIALISTS.
The description of the drug was approved by the manufacturer in 2013. PHARMACOLOGICAL ACTION
Mucolytic drug. The mucolytic and expectorant effect is due to the activation of sialic transferase, an enzyme of goblet cells of the bronchial mucosa. Normalizes the quantitative ratio of acidic and neutral sialomucins in bronchial secretions, restores the viscosity and elasticity of mucus, and facilitates its discharge. Promotes the regeneration of the mucous membrane, normalizes its structure, activates the activity of the ciliated epithelium, and improves mucociliary clearance. Restores the secretion of immunologically active IgA (specific protection) and the amount of sulfhydryl groups of mucus components (non-specific protection).
PHARMACOKINETICS
Suction
After oral administration, Cmax in the blood serum and in the mucous membrane of the respiratory tract is achieved 2-3 hours after oral administration and remains in the mucous membrane for 8 hours.
Removal
It is excreted mainly in the urine, partly unchanged, partly in the form of metabolites.
INDICATIONS
- acute and chronic bronchopulmonary diseases, accompanied by the formation of viscous, difficult to separate sputum (tracheitis, bronchitis, tracheobronchitis, bronchial asthma, bronchiectasis);
- acute and chronic inflammatory diseases of the nasal cavity, nasopharynx, paranasal sinuses and middle ear, accompanied by the formation of viscous, difficult-to-discharge mucus (rhinitis, adenoiditis, sinusitis, otitis media);
— preparation for bronchoscopy and/or bronchography.
DOSING REGIME
Syrup 20 mg/ml for children
1 teaspoon (5 ml) contains 100 mg of carbocysteine.
Children aged 2 to 5 years are prescribed 1 teaspoon (5 ml) 2 times a day, the daily dose should not exceed 200 mg; children over 5 years old are prescribed 1 teaspoon (5 ml) 3 times a day, the daily dose should not exceed 300 mg. Treatment should not continue for more than 8-10 days without consulting a doctor.
Syrup 50 mg/ml
1 tablespoon (15 ml) contains 750 mg of carbocysteine.
Children over 15 years of age and adults are prescribed 1 tablespoon (15 ml) 3 times a day, preferably 1 hour before meals or 2 hours after meals. Treatment should not continue for more than 8-10 days without consulting a doctor.
SIDE EFFECT
From the digestive system: nausea, vomiting, diarrhea, epigastric pain, flatulence, gastrointestinal bleeding.
From the side of the central nervous system: dizziness, weakness, malaise.
Allergic reactions: in isolated cases - itching, urticaria, exanthema, angioedema.
CONTRAINDICATIONS
- peptic ulcer of the stomach and duodenum in the acute phase;
— chronic glomerulonephritis (in the acute phase), cystitis;
- children under 2 years of age (for syrup 20 mg/ml for children) and up to 15 years (for syrup 50 mg/ml);
— I trimester of pregnancy (for syrup 50 mg/ml);
- hypersensitivity to carbocisteine or other components of the drug.
The drug should be prescribed with caution in case of chronic glomerulonephritis (history), gastric ulcer and duodenal ulcer (history).
PREGNANCY AND LACTATION
The use of Fluditec syrup 50 mg/ml in the first trimester of pregnancy is contraindicated.
Fluditec syrup 50 mg/ml should be prescribed with caution in the second and third trimesters of pregnancy and during breastfeeding.
SPECIAL INSTRUCTIONS
Patients with diabetes or on a low-carbohydrate diet should take into account that 1 teaspoon of 20 mg/ml syrup for children contains 3.5 g of sucrose, and 1 tablespoon of 50 mg/ml syrup contains 5.25 g of sucrose.
Fluditec in the form of syrup 50 mg/ml is intended only for adults and children over 15 years of age.
Impact on the ability to drive vehicles and operate machinery
There is no data on the negative effect of the drug on the ability to drive vehicles and other mechanisms.
OVERDOSE
Symptoms: gastralgia, nausea, diarrhea.
Treatment: carry out symptomatic therapy.
DRUG INTERACTIONS
With simultaneous use, Fluditec increases the effectiveness of glucocorticosteroid (mutually) and antibacterial therapy for inflammatory diseases of the upper and lower respiratory tract.
With simultaneous use, Fluditec enhances the bronchodilator effect of theophylline.
The activity of carbocisteine is weakened by antitussives and atropine-like drugs.
CONDITIONS OF VACATION FROM PHARMACIES
The drug is approved for use as a means of OTC.
CONDITIONS AND DURATION OF STORAGE
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 2 years.
Indications for use
- chronic and acute bronchopulmonary diseases in which difficult to separate viscous sputum is formed (for example, with bronchitis, tracheitis, tracheobronchitis, bronchiectasis, bronchial asthma);
- chronic and acute inflammatory processes of the nasopharynx, nasal cavity, paranasal sinuses of the middle ear and nose, in which viscous mucus is formed (for example, with otitis media, sinusitis, rhinitis, adenoiditis);
- preparatory stage before bronchography and/or bronchoscopy.
Contraindications
The instructions for use of the syrup indicate the following contraindications for which taking Fluditec is undesirable or completely prohibited:
- peptic ulcer of the stomach, duodenum, chronic glomerulonephritis in the acute stage;
- cystitis;
- children under two years of age (for syrup with a carbocysteine concentration of 20 mg/ml), adolescents up to 15 years of age (for a drug with an active substance concentration of 50 mg/ml);
- first trimester of pregnancy;
- hypersensitivity to components;
- with caution in the second and third trimesters of pregnancy, with breastfeeding, chronic glomerulonephritis, a history of gastric and duodenal ulcers.
Directions for use and dosage
When treating children aged 2 to 5 years, 5 ml (1 teaspoon) of 2% syrup is prescribed 2 times a day. The maximum dose of the drug is 200 mg (10 ml) per day.
Children over 5 years old are recommended to take 5 ml (1 teaspoon) of 2% syrup 3 times a day. The maximum dose of the drug is 300 mg (15 ml) per day.
When treating children over 15 years of age and adults, 15 ml (1 tablespoon) of 5% syrup is prescribed 3 times a day. It is advisable to take the drug 1 hour before or 2 hours after meals.
The course of Fluditec therapy without consulting a doctor should not exceed 8–10 days.
pharmachologic effect
The expectorant and mucolytic effect exerted by the active component of Fluditec is associated with the activation of the enzyme of goblet cells of the bronchial mucosa.
According to the instructions, Fluditek promotes:
- Regeneration of the mucous membrane;
- Restoration of specific protection (secretion of immunologically active IgA);
- Activation of the activity of the ciliated epithelium;
- Normalization of the structure of the mucous membrane;
- Improving mucociliary clearance.
The maximum effect from using Fluditec is observed two to three hours after taking the therapeutic dose. The mucolytic effect usually lasts up to eight hours.
special instructions
When prescribing Fluditec to patients with diabetes or people on a low-carbohydrate diet, it is necessary to take into account that the drug contains sucrose (3500 mg in 1 teaspoon of 2% syrup and 5250 mg in 1 tablespoon of 5% syrup).
Syrup 5% is prescribed with caution during pregnancy (II and III trimesters), as well as during breastfeeding.
There are no data on the effect of the drug on the ability to control moving machinery and vehicles.
Fluditek syrup: analogues of the drug for children
"Libexin Muco"
Its composition is almost identical to Fluditec and is considered its pure analogue - the active substance is also carbocysteine, it is also not devoid of dye, but now E124, it has natural fruit flavors, sucrose, vanillin, sodium hydroxide. The mucolytic drug is available both in the format of an adult syrup and in the form of a syrup for children, where the active substance is 20 mg per 1 ml of product. Indications for use are absolutely similar to those indicated for Fluditec - bronchopulmonary diseases, bronchial asthma, preparation for bronchial examinations.
- The drug has side effects from the digestive and nervous systems: dizziness, weakness, dyspeptic disorders, nausea, pain in the epigastric region. Allergic skin reactions are also possible.
- Libexin Muco is allowed for children from 2 years of age, it is strictly prohibited for pregnant women, and can be used while breastfeeding. Contraindications include inflammation of the digestive tract mucosa, cystitis and hypersensitivity to any of the components of the syrup. For people with diabetes, the dosage is calculated separately due to the presence of sucrose in the drug. Available without a prescription.
"Bronchobos"
Also an almost complete analogue of Fluditec, based on carbocysteine, 25 mg per 1 ml of the drug in syrup and 375 mg in 1 capsule. Syrup is indicated for children due to the lower concentration of the active substance. Indications for use are similar to those indicated for Fluditek and Libexin, the spectrum of action is also no different - a classic expectorant drug that promotes the rapid removal of sputum from the lungs.
- Side effects in most cases are observed only in the digestive system, as well as in the form of an allergic skin reaction. With asthma, spasms of the airways are possible. Clear contraindications to taking the drug are children (up to 2 years), pregnancy and lactation, ulcers, cystitis, glomerulonephritis.
- The duration of treatment with Bronchobos should not exceed 10 days, and the dosage is reduced by half when the main manifestations of the disease are eliminated (mainly on days 2-3). Judging by the comments of young parents, negative reactions to this drug in children occur less frequently than to Fluditek, as a result of which it is in great demand.
"Mukosol"
The same close analogue for “Fluditek”, acting due to carbocysteine, however, the dosage of the active substance allows the use of this drug even in newborns (from the 2nd month of life), without causing them to deteriorate their well-being from other systems of the body: digestive, nervous and etc. True, this applies specifically to syrup and capsules - granules are allowed for children over 12 years of age.
- For infants under 2.5 years of age, syrup is prescribed in a volume of no more than 50 mg at a time, twice a day. After 2.5 years, the dosage is increased to 100 mg, and from 5 years, the dosage can be increased to 200 mg per single dose. In this case, the duration of treatment can be either 5 days (to relieve an exacerbation) or 30 days if the disease is in a chronic stage.
- It is undesirable to use the drug from the 4th month of pregnancy, as well as with a history of peptic ulcer disease or lactation. In acute forms of inflammatory processes of the digestive tract, Mukosol is prohibited; side effects are possible from the digestive and nervous systems
"Mukodin"
Also a good analogue of Fluditec, based on carbocysteine, at a dosage of 25 mg per 1 ml of syrup (children's version). The scheme of action is identical; the indications for use, instructions and dosage are also no different. Side effects occur from the digestive system. Not suitable for children under 2 years of age.
If we are not talking about analogues in chemical composition, but about drugs with a similar principle of action and the same indications for use, then attention can be paid to the following products:
- "Bromhexine." Allowed for children from 2 years old, works due to bromhexine.
- "Fluimucil." Granules, the active ingredient acetylthysteine, are allowed for children from 1 year.
- "Lazolvan." It works on the basis of ambroxol and is safe even for newborns.
- "Mukaltin." Based on an extract from marshmallow, approved for children from 1 year.
- "Gedelix". Based on ivy leaves, it is allowed in the treatment of newborns, and has no restrictions on the age of the child.
All of the above drugs are the same mucolytic agents as Fluditec, most of them are aimed at drawing out phlegm from the lungs, and additional functions may also be present, depending on the active components. The choice of a specific drug should be made in consultation with a doctor or after carefully studying the composition of the drug.
Fluditec syrup 20 mg summary (instructions for use) in photographs
Photo instructions for use of Fluditec syrup, part 1
Photo instructions for use of fluditec syrup, part 2
Composition and active substance
Fluditek includes:
Fluditec syrup for children 2%: 100 ml of syrup contains carbocisteine 2 g excipients: glycerol - 5 g methyl parahydroxybenzoate - 0.15 g sucrose - 70 g Sunset yellow dye (E110) - 0.001 g sodium hydroxide - up to pH 6, 2 banana flavoring - 0.2 g purified water - up to 100 ml.
Fluditec syrup 5%: 100 ml contain carbocisteine 5 g excipients: glycerol - 5 g methyl parahydroxybenzoate - 0.15 g sucrose - 35 g dye "Sunset" yellow (E110) - 0.0016 g dye patent blue V (E131) - 0.001 g sodium hydroxide - up to pH 6.2 caramel flavoring - 0.2 g purified water - up to 100 ml.
Fluditek for children - analogues
There are a number of drugs that can be called analogues of Fluditec, since their main component is cabrocysteine. These include:
- Libexin Muco. This is the most complete analogue, since the drug is available in the form of syrup with the same concentrations and with the same age restrictions.
- Fluifort. The main component of Fluifort is the lysine salt of carbocisteine. The drug is also available in the form of syrup and is approved for use in children over 1 year old, as well as in the form of granules from which a suspension is made. In this form, it is allowed to be given to children under 16 years of age.
- Bronchobos. This mucolytic drug is available in the form of syrup (2.5%) and capsules. The syrup is suitable for children over 3 years of age, and capsules or syrup (5%) are suitable for adolescents over 15 years of age.
