Instructions for Pectolvan C syrup bottle 100 ml
Composition
active ingredients: ambroxol hydrochloride, carbocysteine;
5 ml of the drug contains ambroxol hydrochloride in terms of 100% substance - 15 mg, carbocysteine in terms of 100% substance - 100 mg;
Excipients: glucose monohydrate; sorbitol (E 420); propylene glycol; glycerin; meglumine; disodium edetate; citric acid, monohydrate; sodium benzoate (E 211); aspartame (E 951); strawberry flavoring; purified water.
Dosage form
Syrup.
Main physicochemical properties: clear, colorless, viscous liquid with a strawberry flavor.
Pharmacotherapeutic group
Mucolytics. Combinations. ATX code R05C B10.
Pharmacological properties
Pharmacodynamics
Pectolvan® C is a combined mucolytic and expectorant containing a balanced combination of two components – ambroxol and carbocysteine.
Ambroxol is an active metabolite of bromhexine, but more effective. Increases the secretion of the glands of the respiratory tract, promotes the dilution of viscous bronchial secretions and facilitates their discharge by increasing mucociliary clearance, changes the ratio of serous and mucous components of sputum. Stimulates Clara cells and activates hydrolyzing enzymes, which also leads to a decrease in sputum viscosity. Ambroxol has secretomotor properties - stimulates the work of the ciliated epithelium of the bronchi, restores the drainage function of small bronchi and bronchioles. The drug stimulates the formation of endogenous surfactant, does not cause excessive secretion formation, reduces spastic hyperreactivity of the bronchi. Cough and sputum volume are significantly reduced. Ambroxol hydrochloride has demonstrated an anti-inflammatory effect in vitro. In vitro studies have shown that ambroxol hydrochloride significantly reduces cytokine release from the blood and tissue binding of mononuclear and polymorphonuclear cells.
Carbocysteine has a mucolytic and expectorant effect; by breaking the disulfide bridges of glycoproteins, it causes the dilution of excessively viscous bronchial secretion, which promotes the excretion of sputum. The mucoregulatory effect of carbocysteine is associated with the activation of sialic transferase, an enzyme of the goblet cells of the bronchial mucosa. It normalizes the quantitative ratio of acidic and neutral sialomucins, which helps reduce the viscosity of bronchial secretion. It facilitates the discharge of sputum by increasing mucociliary clearance, has antioxidant and pneumoprotective properties, which is due to the ability of sulfhydryl groups to bind free radicals. It also promotes the regeneration of the mucous membrane, normalizes its structure and reduces goblet cell hyperplasia and, as a result, reduces mucus production. Activates the activity of the ciliated epithelium, restores the secretion of IgA (specific protection) and the number of sulfhydryl groups of mucus components (nonspecific protection). It exhibits an anti-inflammatory effect due to the kinin-inhibiting activity of sialomucins, which leads to a decrease in edema and bronchial obstruction.
Pharmacokinetics
After ingestion, ambroxol is almost completely absorbed in the digestive tract, penetrates well into the lung tissue. Absolute bioavailability when taken orally is 70-80%. The maximum concentration in blood plasma is reached approximately 2 hours after oral administration. The half-life is 7-12 hours. It is excreted mainly in the urine (up to 90%). Penetrates through the blood-brain barrier, into breast milk, does not accumulate.
When taken orally, carbocysteine is rapidly absorbed. The peak concentration of the active substance in the blood plasma is reached after 2 hours. Bioavailability is low - less than 10% of the administered dose (due to intensive metabolism in the gastrointestinal tract and the effect of the first passage through the liver). Carbocysteine is excreted almost completely in the form of inactive metabolites (inorganic sulfates, diacetylcystine) with urine. Only a small amount is excreted unchanged with feces. It can penetrate the placental barrier and accumulate in the amniotic fluid.
Indication
Acute and chronic respiratory diseases accompanied by the formation of secretions that are difficult to separate:
chronic obstructive pulmonary disease;
pneumonia;
bronchial asthma with severe sputum production;
bronchiectasis;
respiratory distress syndrome;
treatment of complications after lung surgery;
when caring for a tracheostomy before and after bronchoscopy.
Inflammatory diseases of the middle ear and paranasal sinuses.
Contraindication
Hypersensitivity to any of the components of the drug. In the case of rare hereditary conditions that may cause incompatibility with the excipients of the drug (see section "Special instructions for use"), the use of the drug is contraindicated.
Peptic ulcer of the stomach and duodenum during the exacerbation period. I trimester of pregnancy due to insufficient data on teratogenic and embryotoxic effects.
Interaction with other medicinal products and other types of interactions
Increases the effectiveness of glucocorticoid and antibacterial therapy in the treatment of inflammatory diseases of the upper and lower respiratory tract. However, it is not recommended to use it simultaneously with tetracycline antibiotics (except doxycycline), the interval between their administration should be at least 2 hours.
The simultaneous use of ambroxol and cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, such a combination is possible only after a careful assessment by the doctor of the ratio of the expected benefit and the possible risk of use.
During treatment with carbocysteine, antitussives and agents that suppress bronchial secretion should not be used.
Application features
Productive cough is a fundamental defense mechanism of the bronchopulmonary system and as such should not be suppressed. It is irrational to combine drugs that modify bronchial secretion with cough suppressants and/or substances that reduce secretion (atropine group).
The use of mucolytic agents may lead to impaired bronchial patency in children under 2 years of age. In children of the first year of life, the ability to clear the respiratory tract from bronchial secretions is limited due to age-related anatomical and physiological characteristics. Any mucolytic agents should not be used in children under 2 years of age.
Treatment should be reviewed in case of lack of effect or worsening of symptoms.
There are reports of severe skin reactions: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and acute generalized exanthematous pustulosis associated with the use of ambroxol. Most of them can be explained by the severity of the underlying disease and/or the simultaneous use of another drug. Therefore, if new skin or mucous membrane lesions appear, medical advice should be sought immediately and treatment with ambroxol hydrochloride should be discontinued.
Also, in the initial stage of Stevens–Johnson syndrome or Lyell syndrome, patients may have nonspecific, flu-like symptoms such as fever, aches, rhinitis, cough, and sore throat. Symptomatic treatment with cough and cold medications is mistakenly used for such nonspecific, flu-like symptoms.
In cases of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), the drug should be used with caution, since ambroxol may increase mucus secretion.
Patients with impaired renal function or severe hepatic insufficiency should take the drug only after consulting a doctor. When using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites that are formed in the liver in patients with severe renal insufficiency.
Close medical supervision is necessary if purulent sputum is produced or if the patient has a high temperature.
The drug should be used with caution in the treatment of patients with a history of gastric or duodenal ulcer.
The drug contains sorbitol, so patients with rare hereditary fructose intolerance should not take it.
The drug contains aspartame - it is a derivative of phenylalanine, which is dangerous for patients with phenylketonuria, so do not use the drug in this category of patients.
The drug contains glucose, therefore patients with hereditary glucose intolerance, glucose-galactose malabsorption should avoid taking the drug.
Use during pregnancy or breastfeeding
Contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug is used after a careful assessment of the benefit to the mother/risk to the fetus (child), which is determined by the doctor. It is not recommended for use during breastfeeding.
Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect on the reaction rate when driving vehicles or working with other mechanisms have not been conducted. In case of dizziness, you should refrain from driving vehicles or other mechanisms.
Method of administration and doses
Apply internally.
Children aged 6 to 12 years - 5 ml (1 measuring spoon) 2-3 times a day, from 2 to 6 years - 2.5 ml (1/2 measuring spoon) 2-3 times a day.
The duration of treatment, as a rule, should not exceed 7-10 days.
The duration of use in children should be as short as possible, no more than 5 days.
Children
The drug can be used in children from 2 years of age. Treatment of children should be carried out under the supervision of a doctor.
Overdose
Symptoms: stomach pain, nausea, vomiting, diarrhea.
Treatment: symptomatic and supportive.
Side effects
Skin and subcutaneous tissue disorders: skin rashes (including maculopapular, maculopapular, maculopapular, and confluent plaques), urticaria, pruritus, dermatitis, severe skin lesions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and acute generalized exanthematous pustulosis.
From the nervous system: dysgeusia (taste disorder), dizziness, headache, anxiety.
Gastrointestinal: nausea, decreased sensitivity in the oral cavity, vomiting, diarrhea, dyspepsia, heartburn, stomach pain, abdominal pain, indigestion, dry mouth, constipation, salivation, gastrointestinal bleeding.
Respiratory, thoracic and mediastinal disorders: decreased sensitivity in the pharynx, rhinorrhea, dyspnea (as a symptom of a hypersensitivity reaction), dry throat.
From the urinary system: dysuria.
Cardiac: palpitations.
General disorders: general weakness, fever, mucous membrane reactions.
Expiration date
1 year 6 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Do not refrigerate.
Shelf life after opening the bottle is 60 days at a temperature not exceeding 25 ° C. Do not refrigerate.
Keep out of reach of children.
Packaging
100 ml in a bottle. 1 bottle with a dosing spoon in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
