�zz Active 0.6 N10 sachet, portion for oral administration
Category
Thinning phlegm
,
Expectorants
Scope of the drug
Respiratory system
Release form
Powder
Manufacturer country
Austria
Package quantity, pcs
ten
Dosage form
A homogeneous mass of white or almost white.
The presence of a weak specific smell is allowed.
Structure
100 g of cream contains:
active ingredients: lidocaine - 2.5 g, prilocaine - 2.5 g
excipients: PEG-54 hydrogenated castor oil - 1.9 g
carbomer - 1.0 g
sodium hydroxide - 0.52 g
purified water - up to 100 g.
general description
Local anesthetic
Special conditions
Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more prone to drug-dependent methemoglobinemia.
The effectiveness of using the drug in newborns during the procedure for taking blood samples from the heel has not been established.
Care should be taken when applying Acriol Pro around the eyes, as it irritates the eyes.
Eliminating protective reflexes can irritate or damage the cornea.
In case of contact with the eyes, immediately flush the eyes with water or 0.9% sodium chloride solution, and protect the eyes until the protective reflexes are restored.
Care must be taken when applying the drug to the skin with atopic dermatitis
application time should be reduced (15-30 minutes).
In children under 3 months of age, the safety and efficacy of the drug was determined after applying a single dose.
In such children, after application of the drug, a temporary increase in blood methemoglobin levels was often observed, lasting up to 13 hours.
However, the observed increase in the content of methemoglobin in the blood is probably not of clinical significance.
Patients taking class III antiarrhythmics (eg, amiodarone) should be monitored and ECG monitored closely.
possible influence on cardiac activity.
Do not apply the drug to a damaged eardrum or in other cases of possible drug penetration into the middle ear.
Do not apply Acriol Pro to open wounds.
Due to the lack of data on the absorption of the drug, it is not recommended to apply the drug to the genital mucosa in children.
Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties.
In this regard, it is recommended to take special care when using the drug before the subcutaneous administration of a live vaccine (for example, BCG).
Due to the lack of data, the combined use of Acriol Pro and drugs that cause methemoglobinemia in children aged 0 to 12 months is not recommended.
The effect of the drug on the ability to drive vehicles and other mechanisms:
Does not affect.
Drug interactions
In patients receiving drugs that induce the development of methemoglobinemia (for example, drugs containing a sulfo group), Acriol Pro may increase the concentration of methemoglobin in the blood.
When treating with other local anesthetics and drugs structurally similar to them (including tocinide), the risk of increased systemic effects when using high doses of the drug should be taken into account.
Special studies to assess the interaction of lidocaine / prilocaine with class III antiarrhythmic drugs have not been conducted, caution should be exercised when drugs are used together.
Pharmaceutical interaction: not found.
Drugs that reduce the clearance of lidocaine (for example, cimetidine or beta-blockers) can cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used over an extended period of time.
This interaction has no clinical significance in short-term therapy with lidocaine (including Acriol Pro) at recommended doses.
Pharmacodynamics
Acriol Pro is a combined preparation, which includes lidocaine and prilocaine, local anesthetics of the amide type.
Skin anesthesia is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis.
The degree of anesthesia depends on the dose of the drug and the duration of the application.
Intact skin
After applying the drug to intact skin for 1-2 hours, the duration of anesthesia after removing the occlusive dressing is 2 hours.
There were no differences in efficacy (including the time to achieve an analgesic effect) and safety when using the drug on intact skin in elderly (65-96 years old) and younger patients.
Due to the action of the drug on the superficial vessels, temporary blanching or redness of the skin is possible.
Similar reactions in patients with generalized neurodermatitis (atopic dermatitis) may occur faster, within 30-60 minutes after application of the drug, which indicates a faster penetration of the cream through the skin.
With a puncture biopsy (4 mm in diameter), the use of Acriol Pro provides adequate anesthesia for intact skin in 90% of patients 60 minutes after application of the drug when the needle is inserted to a depth of 2 mm and after 120 minutes when the needle is inserted to a depth of 3 mm. The effectiveness of the drug does not depend on the color or pigmentation of the skin (skin types I-IV).
When using combination vaccines against infections such as measles, rubella, mumps, or intramuscular combination vaccines against diphtheria, whooping cough, tetanus, poliomyelitis and Haemophilius influenzae type b infection, as well as with vaccination against hepatitis B, the use of the drug did not affect the average antibody titer, the rate at which specific antibodies appear or disappear in the serum, or the number of patients who have achieved a protective or positive antibody titer after immunization.
Genital mucosa
Anesthesia of the genital mucosa is achieved faster compared to anesthesia of intact skin due to the faster absorption of the drug.
In women, 5-10 minutes after applying the drug to the mucous membrane of the genitals, anesthesia is achieved sufficient to relieve pain caused by the use of an argon laser
the duration of anesthesia is 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).
Trophic ulcers of the lower extremities
After applying the drug when treating trophic ulcers of the lower extremities, the duration of anesthesia is up to 4 hours.
There was no negative effect of the drug on the healing process of ulcers or in relation to the bacterial flora.
Pharmokinetics
Systemic absorption of the drug depends on the dose, the duration of application and the thickness of the skin (depending on the area of the body), as well as other skin conditions, such as skin diseases and shaving.
When applied to the ulcerative surface of the lower extremities, the absorption of the drug can be influenced by the characteristics of ulcers, for example, size (with an increase in the area of the ulcer, absorption increases).
Intact skin
In adults, after applying 60 g of cream to intact thigh skin with an area of 400 cm2 (1.5 g per 10 cm2) for 3 hours, systemic absorption for lidocaine was approximately 3% and for prilocaine 5%.
Absorption is slow.
The maximum concentration of lidocaine (average value 0.12 μg / ml) and prilocaine (average value 0.07 μg / ml) in blood plasma was reached approximately 4 hours after application of the drug.
The risk of toxic symptoms exists only when the concentration of active substances in the blood plasma is 5-10 μg / ml.
When the drug is applied to intact skin 8-12 hours after shaving, the maximum plasma concentration of lidocaine and prilocaine in both young and elderly patients is very low and significantly lower than the possible toxic level.
Trophic ulcers of the lower extremities
The time to reach the maximum concentration of lidocaine (0.05-0.84 μg / ml) and prilocaine (0.02-0.08 μg / ml) in blood plasma is 1-2.5 hours from the moment the drug is applied to the ulcerative surface (5 -10 g cream for 30 minutes).
With repeated application of the drug to the ulcerative surface, there was no accumulation of prilocaine, lidocaine or their metabolites in the blood plasma.
2-10 g of the drug were applied to the ulcerative surface with an area of up to 62 cm2 for 30-60 minutes from 3 to 7 times a week (15 times a month).
Genital mucosa
The time to reach the maximum concentration of lidocaine and prilocaine in blood plasma (on average 0.18 μg / ml and 0.15 μg / ml, respectively) is approximately 35 minutes from the moment the drug is applied to the vaginal mucosa (10 g of the drug for 10 minutes).
Indications
In adults:
- surface anesthesia of the skin during injections (including during vaccination), punctures and catheterization of blood vessels and superficial surgical interventions, including minor cosmetic procedures and epilation
- surface anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues
- surface anesthesia of the genital mucosa before painful manipulations and for anesthesia before injections of local anesthetics.
In children:
- surface anesthesia of the skin during injections (including during vaccination), punctures and catheterization of blood vessels and superficial surgical interventions (including when removing molluscum contagiosum).
Contraindications
Hypersensitivity to local anesthetics of the amide type or any other component of the drug.
Premature infants born before 37 weeks of gestation.
Newborns weighing less than 3 kg.
Carefully:
Deficiency of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, widespread neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (eg, amiodarone).
Pregnancy and lactation:
Pregnancy
There is insufficient data on the use of the drug in pregnant women.
In the course of studies on animals, no direct or indirect negative effects of the drug on pregnancy, intrauterine development of the fetus, on the process of childbirth or postnatal development were revealed.
Lidocaine and prilocaine cross the placental barrier and can be absorbed into the fetal tissues.
No specific reproductive disorders have been reported, such as an increase in the incidence of malformations or other direct or indirect adverse effects on the fetus.
Breastfeeding period
Lidocaine and prilocaine are excreted in breast milk in quantities that do not pose a risk to the child, when using the drug in therapeutic doses.
Overdose
Subject to the recommended dosage regimen of the drug, the development of signs of systemic toxicity is unlikely.
Symptoms of intoxication are probably the same as with other local anesthetics, for example, excitation of the central nervous system (CNS), and in severe cases, depression of the central nervous system and cardiac activity.
In rare cases, the development of clinically significant methemoglobinemia was noted.
Prilocaine in high doses can cause an increase in the content of methemoglobin.
Topical application of 125 mg of prilocaine for 5 hours caused the development of moderate methemoglobinemia in a 3 month old baby.
Superficial application of lidocaine at a dose of 8.6-17.2 mg / kg caused severe intoxication in newborns.
Treatment: Severe neurological symptoms (seizures, depression of the central nervous system) require symptomatic treatment, including prescription
anticonvulsants and, if necessary, artificial ventilation.
In the case of development of methemoglobinemia, methylthioninium chloride (methylene blue) is the antidote.
Due to the slow systemic absorption of the drug, patients should be monitored for several hours after the start of treatment for intoxication.
Side effects
The following adverse reactions are distributed in frequency of occurrence as follows: very often (greater than or equal to 1/10)
often (greater than or equal to 1/100, < 1/10)
infrequently (greater than or equal to 1/1000, < 1/100)
rarely (more than or equal to 1/10 000, < 1/1 000), very rarely (< 1/10 000), the frequency is unknown (there is not enough data to estimate the incidence).
When applied to intact skin
Violations of the skin and subcutaneous tissues: often - transient local reactions in the area of application of the drug, such as pallor, redness and swelling
infrequently - at the first moment after application, there is a slight burning sensation, itching and a feeling of warmth (in the area of application of the drug).
General disorders and disorders at the injection site: rarely - allergic reactions, in the most severe cases - anaphylactic shock
methemoglobinemia and / or cyanosis.
Reactions in the area of application of the drug, such as hemorrhagic rash or pinpoint hemorrhages, especially after prolonged application in children with atopic dermatitis or molluscum contagiosum.
Corneal irritation due to accidental contact with the eye cream.
When applied to trophic ulcers of the lower extremities
Violations of the skin and subcutaneous tissues: often - transient local reactions in the area of application of the drug, such as pallor, redness and swelling
at the first moment after application, a slight burning sensation, itching and a feeling of warmth (in the area of application of the drug)
infrequently - skin irritation (in the area of application of the drug).
General disorders and disorders at the injection site: rarely - allergic reactions, in the most severe cases - anaphylactic shock.
Special storage conditions
Do not freeze.
Dosage
2.5% + 2.5% x 100g
Indications
In adults: - surface anesthesia of the skin during injections (including vaccination), punctures and catheterization of blood vessels and superficial surgical interventions, including minor cosmetic procedures and epilation
- surface anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues
- surface anesthesia of the genital mucosa before painful manipulations and for anesthesia before injections of local anesthetics.
In children: - surface anesthesia of the skin during injections (including during vaccination), punctures and catheterization of vessels and superficial surgical interventions (including when removing molluscum contagiosum).
INN / Active ingredient
Lidocaine + Prilocaine
Storage conditions and periods
At a temperature not exceeding 30 degrees. (Do not freeze).
Expiration date: 2 years
Contraindications
Hypersensitivity to local anesthetics of the amide type or any other component of the drug.
Premature infants born before 37 weeks of gestation.
Newborns weighing less than 3 kg.
Precautions: Insufficiency of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, generalized neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (eg, amiodarone).
Specifications
Category
Anesthesia and muscle relaxants
Scope of the drug
Dermatology
Release form
Cream
Manufacturer country
Russia
Package quantity, pcs
one
Vacation conditions
Without recipe
Brand name
Akrikhin
The amount of the dosage form in the primary package
100 g
Primary packaging type
Tuba https://translate.google.com/translate?hl=&sl=ru&tl=en&u=https://zz.buy-pharm.com/xzzalul.html;Description
Active ingredientsAcetylcysteine
Country of origin: Austria / Germany
ManufacturerHermes Pharma Ges.
M.b.H. / Salyutas Pharma GmbH
Release form Powder for oral administration, 600 mg per sachet - 10 pcs.
Keep out of reach of children
Dosage form
Powder from white to yellowish-white color with easily disintegrating agglomerates, with a blackberry smell.
There may be a slight sulfur odor.
Structure
1 sachet contains:
active substance: acetylcysteine 600 mg
excipients: glyceryl tripalmitate, polysorbate 65, sorbitol, xylitol, citric acid, sodium citrate, magnesium citrate, sodium carmellose, aspartame, Blackberry "B" flavoring (natural / identical to natural liquid flavor "Forest Berry", code 5752 natural / identical to natural liquid flavoring "Blackberry", code 5337 vanillin maltodextrin mannitol gluconolactone sorbitol colloidal anhydrous silicon dioxide magnesium carbonate), magnesium stearate.
Special conditions
Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine with caution under systemic control of bronchial patency.
If the patient is unable to effectively cough, drainage or aspiration of secretions should be performed.
With the use of acetylcysteine, cases of severe allergic reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been reported very rarely.
If changes occur in the skin and mucous membranes, you should immediately consult a doctor, and stop taking the drug.
You should not take the drug immediately before bedtime (it is recommended to take the drug before 18.00).
Impact on laboratory data.
Acetylcysteine can affect the results of colorimetric determination of the concentration of salicylates in blood plasma.
In the analysis of urine, acetylcysteine can interfere with the results of the determination of ketone bodies.
Influence on the ability to drive vehicles, mechanisms
Acetylcysteine has no effect on the ability to drive vehicles and operate machinery.
Drug interactions
With the simultaneous use of acetylcysteine with antitussive drugs, due to suppression of the cough reflex, sputum stagnation in the bronchi may occur.
Before prescribing such combination therapy, a thorough assessment of the patient's condition is necessary.
The current reports of acetylcysteine inactivation of antibacterial drugs such as tetracyclines (excluding doxycycline), aminoglycosides, cephalosporins, penicillins (ampicillin), as well as antifungal drugs (amphotericin B) relate exclusively to in vitro studies (pharmaceutical incompatibility).
However, oral antibacterial drugs and ACTS® Active should be used at intervals of at least 2 hours (not applicable to cefixime and loracarbef).
Simultaneous use with acetylcysteine can lead to an increase in the vasodilating and antiplatelet effects of nitroglycerin.
If the combined use of nitroglycerin and acetylcysteine is required, then the patient's condition should be monitored for the potential development of arterial hypotension (sometimes severe, may manifest as headache).
The simultaneous use of acetylcysteine and carbamazepine can be expressed in a decrease in the concentration of carbamazepine to a subtherapeutic level.
The simultaneous use of activated carbon can reduce the effect of acetylcysteine.
Acetylcysteine eliminates the toxic effects of paracetamol.
Pharmacodynamics
Acetylcysteine is a derivative of the amino acid cysteine.
It has a mucolytic and secretomotor effect in the respiratory tract, facilitates the passage of sputum due to a direct effect on the rheological properties of sputum.
The effect of the drug is due to the ability of its free sulfhydryl groups to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity.
In addition, it reduces the induced hyperplasia of mucoid cells, enhances the production of surface-active compounds (surfactant) by stimulating type II pneumocytes, stimulates ciliary activity, which leads to an improvement in mucociliary clearance.
The drug remains active in the presence of purulent, mucopurulent and mucous sputum.
Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa.
Stimulates the cells of the bronchial mucosa, the secretion of which lyses fibrin.
It has a similar effect on the secretion formed in inflammatory diseases of the ENT organs.
It has an antioxidant effect due to the presence of sulfhydryl groups (SH-groups) capable of neutralizing electrophilic oxidative toxins. Acetylcysteine easily penetrates into the cell, where it is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, cytoprotectant, trapping endogenous and exogenous free radicals and toxins. Acetylcysteine prevents depletion and increases the synthesis of intracellular glutathione, which is involved in redox processes in cells, thus contributing to the detoxification of harmful substances. This explains the action of acetylcysteine as an antidote for paracetamol poisoning. Paracetamol exerts its cytotoxic effect through the progressive depletion of glutathione.The main role of acetylcysteine is to maintain proper levels of glutathione concentration, which provides protection for cells.
Protects alpha-1-antitrypsin (elastase inhibitor) from the inactivating effect of HOCl, an oxidant produced by myeloperoxidase of active phagocytes.
It also has an anti-inflammatory effect (by suppressing the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).
With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations of bacterial infections in patients with chronic bronchitis and cystic fibrosis.
Pharmokinetics
Suction
Acetylcysteine is rapidly and almost completely absorbed when taken orally.
Due to the high first-pass metabolism (the effect of "primary passage" through the liver), the bioavailability of oral forms of acetylcysteine is about 10%.
The maximum concentration (Cmax) of acetylcysteine in the blood plasma after oral administration is reached in 1-3 hours and is 15 mmol / L, Cmax of the cysteine metabolite is approximately 2 μmol / L.
Distribution
The connection with blood plasma proteins is about 50% after 4 hours and decreases to 20% after 12 hours.
Acetylcysteine is distributed both unchanged (20%) and in the form of active metabolites (80%), penetrates into the intercellular space, is distributed mainly in the liver, kidneys, lungs and bronchial secretions.
Acetylcysteine crosses the placental barrier and is detected in the umbilical cord blood.
There is no information on excretion into breast milk.
There are no data on the ability of acetylcysteine to cross the blood-brain barrier.
Metabolism
Acetylcysteine is metabolized in the liver to cysteine, a pharmacologically active metabolite, as well as to diacetylcysteine, cystine and other mixed disulfides.
In the body, acetylcysteine and its metabolites can be detected in different forms: in free form, bound to plasma proteins by labile disulfide bonds, or as linked amino acids.
Withdrawal
Acetylcysteine is excreted almost exclusively in the form of inactive metabolites (inorganic sulfates, diacetylcysteine) by the kidneys, a small part is excreted unchanged through the intestines.
The half-life of the drug from blood plasma (T1 / 2) is approximately 1 hour and depends on the rate of biotransformation in the liver.
In case of impaired liver function, T1 / 2 of acetylcysteine may increase up to 8 hours.
Indications
Acute and chronic diseases of the respiratory system associated with the formation of a viscous difficult-to-separate bronchial secretion (as an expectorant): bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases (due to atelectasis blockage of the bronchi with a mucous plug).
Inflammation of the middle ear (otitis media), acute and chronic sinusitis, rhinosinusitis (relief of secretion discharge).
Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.
Contraindications
Hypersensitivity to acetylcysteine or other components of the drug
hemoptysis, pulmonary bleeding
peptic ulcer of the stomach and duodenum in the acute stage
children under 18 years of age (for this dosage form)
pregnancy and the period of breastfeeding
hereditary fructose intolerance (contains sorbitol), phenylketonuria (contains a source of phenylalanine aspartame).
Overdose
Cases of toxic overdose when taking acetylcysteine by mouth have not been described.
Acetylcysteine, when taken in doses up to 500 mg / kg / day, did not cause overdose symptoms.
Healthy volunteers received acetylcysteine at a dose of 11.6 g per day for 3 months without developing any severe adverse reactions.
Symptoms: Gastrointestinal manifestations such as nausea, vomiting and diarrhea may occur.
Treatment: symptomatic therapy if necessary.
Side effects
According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (> 1/10), often (from> 1/100 to < 1/10), infrequently (from> 1/1000 up to < 1/100), rarely (from> 1/10000 to < 1/1000), very rarely (< 1/10000)
frequency unknown - from available data it was not possible to establish the frequency of occurrence.
Immune system disorders are uncommon: hypersensitivity reactions
very rare: anaphylactic shock, anaphylactic / anaphylactoid reactions.
Nervous system disorders infrequently: headache.
Violations of the heart and blood vessels infrequently ', tachycardia, arterial hypotension
very rare, bleeding *
the frequency is unknown: when taking acetylcysteine, cases of collapse have been described.
Respiratory system disorders
rarely: shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity against the background of bronchial asthma).
Disorders from the gastrointestinal tract are uncommon: abdominal pain, nausea, vomiting, diarrhea, stomatitis
rarely: dyspepsia
frequency unknown: heartburn.
Skin and subcutaneous tissue disorders
infrequently, urticaria, exanthema, rash, angioedema, pruritus
very rare: Stevens-Johnson syndrome, Lyell's syndrome (see the section "Special instructions").
Hearing disorders and labyrinthine disorders are uncommon: ringing in the ears.
Common disorders are uncommon: fever
frequency unknown: swelling of the face.
* Isolated reports of the development of bleeding against the background of the use of acetylcysteine, sometimes together with hypersensitivity reactions.
A decrease in platelet aggregation against the background of the use of acetylcysteine has been confirmed in some studies, the clinical significance of this phenomenon has not yet been clarified.
Dosage
600mg x 1.6g
Indications
Diseases of the respiratory system and conditions accompanied by the formation of viscous and mucopurulent sputum: acute and chronic bronchitis, tracheitis due to bacterial and / or viral infection, pneumonia, bronchiectasis, bronchial asthma, atelectasis due to bronchial obstruction by a mucous plug, sinusitis (to facilitate secretion discharge ), cystic fibrosis (as part of combination therapy) ._ x000D_
_x000D_
Preparation for bronchoscopy, bronchography, aspiration drainage ._x000D_
_x000D_
Removal of viscous secretions from the airways in post-traumatic and postoperative conditions ._x000D_
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For flushing abscesses, nasal passages, maxillary sinuses, middle ear, treatment of fistulas, surgical field for operations on the nasal cavity and mastoid process.
INN / Active ingredient
Acetylcysteine
Contraindications
Hypersensitivity to acetylcysteine or other components of the drug
hemoptysis, pulmonary bleeding
peptic ulcer of the stomach and duodenum in the acute stage
children under 18 years of age (for this dosage form)
hereditary fructose intolerance (contains sorbitol), phenylketonuria (contains a source of phenylalanine aspartame).
Storage conditions and periods
At a temperature not exceeding 25 degrees, in the original packaging.
Expiration date: 2 years
Specifications
Category
Thinning phlegm
,
Expectorants
Scope of the drug
Respiratory system
Release form
Powder
Manufacturer country
Austria
Package quantity, pcs
ten
Vacation conditions
Without recipe
Brand name
Sandoz
The amount of the dosage form in the primary package
1.6 g
Primary packaging type
Sachet (sachet)
Type of consumer packaging
Pack of cardboard
Pharmaco-therapeutic group
Mucolytic expectorant
Anatomical and therapeutic characteristics
R05CB01 Acetylcysteine
Dosage form
Powder for oral administration
Expiration date in days
730
Package weight, g
25
Information on technical characteristics, delivery set, country of manufacture "