ACC powder for solution preparation 200mg, No. 20

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BIDL3181362
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Expiration Date: 11/2025

Russian Pharmacy name:

АЦЦ порошок для приготовления раствора 200мг, №20

ACC powder for solution preparation 200mg, No. 20

  • diseases of the respiratory system, accompanied by the formation of viscous difficult to separate sputum (acute and chronic bronchitis, obstructive bronchitis, tracheitis, laryngotracheitis, pneumonia, lung abscess, bronchiectasis, bronchial asthma, COPD, bronchiolitis, cystic fibrosis);

  • acute and chronic sinusitis;

  • otitis media.

Granules for oral solution (orange) 100 mg and 200 mg, granules for oral solution 200 mg

Adults and adolescents over 14 years of age are recommended to prescribe the drug 200 mg 2-3 times / day. The daily dose is 400-600 mg.

Children aged 6 to 14 years are recommended to take 100 mg 3 times / day or 200 mg 2 times / day. The daily dose is 300-400 mg.

For children aged 2 to 5 years, the drug is recommended to take 100 mg 2-3 times / day. The daily dose is 200-300 mg.

For cystic fibrosis, children over the age of 6 years are advised to take the drug 200 mg 3 times / day. The daily dose is 600 mg.

Children aged 2 to 5 years - 100 mg 4 times / day. The daily dose is 400 mg.

Patients weighing more than 30 kg with cystic fibrosis, if necessary, can increase the dose to 800 mg / day.

For short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer period to prevent infections. With long-term illnesses, the duration of therapy is determined by the attending physician.

The drug is taken orally after meals. Additional fluid intake enhances the mucolytic effect of the drug.

ACCЃ in the form of granules for the preparation of oral solution (orange) 100 mg and 200 mg are dissolved in water, juice or cold tea.

ACCЃ in the form of granules for the preparation of a solution for oral administration 200 mg is dissolved with stirring in 1 glass of hot water and drunk, if possible, hot. If necessary, you can leave the prepared solution for 3 hours.

Granules for preparation of oral solution 600 mg

Adults and adolescents over 14 years of age are recommended to prescribe the drug at a dose of 600 mg (1 sachet) 1 time / day.

For short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer period to prevent infections. With long-term illnesses, the duration of therapy is determined by the attending physician.

The drug is taken orally after meals. Additional fluid intake enhances the mucolytic effect of the drug.

The granules are dissolved with stirring in 1 glass of hot water and drunk as hot as possible. If necessary, you can leave the prepared solution for 3 hours.

Syrup

Adults and adolescents over 14 years of age are prescribed 10 ml of syrup 2-3 times / day (400-600 mg of acetylcysteine).

Children aged 6 to 14 years - 5 ml of syrup 3 times / day or 10 ml of syrup 2 times / day (300-400 mg of acetylcysteine).

Children aged 2 to 5 years are prescribed 5 ml of syrup 2-3 times / day (200-300 mg of acetylcysteine).

In case of cystic fibrosis, children over the age of 6 years should take the drug 10 ml of syrup 3 times / day (600 mg of acetylcysteine); children aged 2 to 5 years - 5 ml of syrup 4 times / day (400 mg of acetylcysteine).

For short-term colds, the duration of admission is 4-5 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer period to prevent infections. With long-term illnesses, the duration of therapy is determined by the attending physician.

The drug is taken orally, after meals. Additional fluid intake enhances the mucolytic effect of the drug.

ACCЃ syrup is taken using a measuring syringe or a measuring cup in the package. 10 ml of ACCЃ syrup corresponds to 1/2 measuring cup or 2 filled syringes.

Using a measuring syringe

1. Open the bottle cap by pushing it in and turning it counterclockwise.

2. Remove the plug with a hole from the syringe, insert it into the neck of the bottle and press it in until it stops. The stopper is designed to connect the syringe to the vial and remains in the neck of the vial.

3. It is necessary to firmly insert the syringe into the stopper. Carefully turn the bottle upside down, pull the syringe plunger down and draw up the required amount of syrup (ml). If air bubbles are visible in the syrup, press the plunger all the way, then refill the syringe. Then return the bottle to its original position and remove the syringe.

4. The syrup from the syringe should be poured onto a spoon or directly into the child's mouth (in the cheek area, slowly so that the child can swallow the syrup). While taking the syrup, the child should be in an upright position.

5. After use, rinse the syringe with clean water.

acetylcysteine

  • peptic ulcer of the stomach and duodenum in the acute phase;

  • hemoptysis;

  • pulmonary bleeding;

  • pregnancy;

  • lactation period (breastfeeding);

  • children under 2 years of age (syrup, granules for the preparation of oral solution / orange / 100 mg and 200 mg);

  • children under 6 years of age (granules for the preparation of a solution for oral administration of 200 mg);

  • children under 14 years of age (granules for the preparation of a solution for oral administration of 600 mg);

  • intolerance to fructose, because the drug contains sorbitol (granules for the preparation of a solution for oral administration / orange / 100 mg and 200 mg, granules for the preparation of a solution for oral administration of 200 mg and 600 mg);

  • deficiency of sucrase / isomaltase, glucose-galactose deficiency (granules for preparation of oral solution / orange / 100 mg and 200 mg, granules for preparation of oral solution 200 mg and 600 mg);

  • hypersensitivity to acetylcysteine ??and other components of the drug.

The drug should be used with caution in patients with a history of gastric ulcer and duodenal ulcer; with bronchial asthma, obstructive bronchitis; hepatic and / or renal failure; histamine intolerance (long-term use of the drug should be avoided, because acetylcysteine ??affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching); varicose veins of the esophagus; diseases of the adrenal glands; arterial hypertension.

Mucolytic drug. Acetylcysteine ??is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates the discharge of sputum due to a direct effect on the rheological properties of sputum. The action is due to the ability to break disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins in sputum, which leads to a decrease in the viscosity of sputum. The drug remains active in the presence of purulent sputum.

It has an antioxidant effect due to the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidative radicals and thus neutralize them.

In addition, acetylcysteine ??promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body. The antioxidant effect of acetylcysteine ??increases the protection of cells against the damaging effects of free radical oxidation inherent in an intense inflammatory response.

With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics

Absorption and distribution

The absorption is high. Oral bioavailability is 10%, which is due to the pronounced effect of the 'first pass' through the liver. The time to reach Cmax in blood plasma is 1-3 hours.

Plasma protein binding - 50%. Penetrates the placental barrier. There are no data on the ability of acetylcysteine ??to penetrate the BBB and be excreted in breast milk.

Metabolism and excretion

It is rapidly metabolized in the liver to form a pharmacologically active metabolite - cysteine, as well as diacetylcysteine, cystine and mixed disulfides.

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T1 / 2 is about 1 hour.

Pharmacokinetics in special clinical situations

Liver dysfunction leads to an increase in T1 / 2 up to 8 hours.

Indications of the drug ACCЃ

  • diseases of the respiratory system, accompanied by the formation of viscous difficult to separate sputum (acute and chronic bronchitis, obstructive bronchitis, tracheitis, laryngotracheitis, pneumonia, lung abscess, bronchiectasis, bronchial asthma, COPD, bronchiolitis, cystic fibrosis);

  • acute and chronic sinusitis;

  • otitis media.

Dosage regimen

Granules for oral solution (orange) 100 mg and 200 mg, granules for oral solution 200 mg

Adults and adolescents over 14 years of age are recommended to prescribe the drug 200 mg 2-3 times / day. The daily dose is 400-600 mg.

Children aged 6 to 14 years are recommended to take 100 mg 3 times / day or 200 mg 2 times / day. The daily dose is 300-400 mg.

For children aged 2 to 5 years, the drug is recommended to take 100 mg 2-3 times / day. The daily dose is 200-300 mg.

For cystic fibrosis, children over the age of 6 years are advised to take the drug 200 mg 3 times / day. The daily dose is 600 mg.

Children aged 2 to 5 years - 100 mg 4 times / day. The daily dose is 400 mg.

Patients weighing more than 30 kg with cystic fibrosis, if necessary, can increase the dose to 800 mg / day.

For short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer period to prevent infections. With long-term illnesses, the duration of therapy is determined by the attending physician.

The drug is taken orally after meals. Additional fluid intake enhances the mucolytic effect of the drug.

ACCЃ in the form of granules for the preparation of oral solution (orange) 100 mg and 200 mg are dissolved in water, juice or cold tea.

ACCЃ in the form of granules for the preparation of a solution for oral administration 200 mg is dissolved with stirring in 1 glass of hot water and drunk, if possible, hot. If necessary, you can leave the prepared solution for 3 hours.

Granules for preparation of oral solution 600 mg

Adults and adolescents over 14 years of age are recommended to prescribe the drug at a dose of 600 mg (1 sachet) 1 time / day.

For short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer period to prevent infections. With long-term illnesses, the duration of therapy is determined by the attending physician.

The drug is taken orally after meals. Additional fluid intake enhances the mucolytic effect of the drug.

The granules are dissolved with stirring in 1 glass of hot water and drunk as hot as possible. If necessary, you can leave the prepared solution for 3 hours.

Syrup

Adults and adolescents over 14 years of age are prescribed 10 ml of syrup 2-3 times / day (400-600 mg of acetylcysteine).

Children aged 6 to 14 years - 5 ml of syrup 3 times / day or 10 ml of syrup 2 times / day (300-400 mg of acetylcysteine).

Children aged 2 to 5 years are prescribed 5 ml of syrup 2-3 times / day (200-300 mg of acetylcysteine).

In case of cystic fibrosis, children over the age of 6 years should take the drug 10 ml of syrup 3 times / day (600 mg of acetylcysteine); children aged 2 to 5 years - 5 ml of syrup 4 times / day (400 mg of acetylcysteine).

For short-term colds, the duration of admission is 4-5 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer period to prevent infections. With long-term illnesses, the duration of therapy is determined by the attending physician.

The drug is taken orally, after meals. Additional fluid intake enhances the mucolytic effect of the drug.

ACCЃ syrup is taken using a measuring syringe or a measuring cup in the package. 10 ml of ACCЃ syrup corresponds to 1/2 measuring cup or 2 filled syringes.

Using a measuring syringe

1. Open the bottle cap by pushing it in and turning it counterclockwise.

2. Remove the plug with a hole from the syringe, insert it into the neck of the bottle and press it in until it stops. The stopper is designed to connect the syringe to the vial and remains in the neck of the vial.

3. It is necessary to firmly insert the syringe into the stopper. Carefully turn the bottle upside down, pull the syringe plunger down and draw up the required amount of syrup (ml). If air bubbles are visible in the syrup, press the plunger all the way, then refill the syringe. Then return the bottle to its original position and remove the syringe.

4. The syrup from the syringe should be poured onto a spoon or directly into the child's mouth (in the cheek area, slowly so that the child can swallow the syrup). While taking the syrup, the child should be in an upright position.

5. After use, rinse the syringe with clean water.

Side effect

According to the WHO, undesirable effects are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10 000, <1/1000) and very rarely (<10 000), the frequency is unknown (the incidence cannot be determined from the available data).

Allergic reactions: infrequently - itching, rash, exanthema, urticaria, angioedema; very rarely - anaphylactic reactions up to shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the respiratory system: rarely - shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).

From the side of the cardiovascular system: infrequently - lowering blood pressure, tachycardia.

From the digestive system: infrequently - stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.

From the organ of hearing: infrequently - tinnitus.

Others: rarely - headache, fever; in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction, a decrease in platelet aggregation.

Contraindications for use

  • peptic ulcer of the stomach and duodenum in the acute phase;

  • hemoptysis;

  • pulmonary bleeding;

  • pregnancy;

  • lactation period (breastfeeding);

  • children under 2 years of age (syrup, granules for the preparation of oral solution / orange / 100 mg and 200 mg);

  • children under 6 years of age (granules for the preparation of a solution for oral administration of 200 mg);

  • children under 14 years of age (granules for the preparation of a solution for oral administration of 600 mg);

  • intolerance to fructose, because the drug contains sorbitol (granules for the preparation of a solution for oral administration / orange / 100 mg and 200 mg, granules for the preparation of a solution for oral administration of 200 mg and 600 mg);

  • deficiency of sucrase / isomaltase, glucose-galactose deficiency (granules for preparation of oral solution / orange / 100 mg and 200 mg, granules for preparation of oral solution 200 mg and 600 mg);

  • hypersensitivity to acetylcysteine ??and other components of the drug.

The drug should be used with caution in patients with a history of gastric ulcer and duodenal ulcer; with bronchial asthma, obstructive bronchitis; hepatic and / or renal failure; histamine intolerance (long-term use of the drug should be avoided, because acetylcysteine ??affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching); varicose veins of the esophagus; diseases of the adrenal glands; arterial hypertension.

Application during pregnancy and lactation

Due to insufficient data, the use of the drug during pregnancy is contraindicated.

?л¤ сиропа: применение препарата при беременности возможно только в том случае, если предполагаема¤ польза дл¤ матери превышает потенциальный риск дл¤ плода.

ѕри необходимости применени¤ препарата в период лактации следует решить вопрос о прекращении грудного вскармливани¤.

ѕрименение при нарушени¤х функции печени

ѕрепарат следует с осторожностью примен¤ть при печеночной недостаточности.

ѕрименение при нарушени¤х функции почек

ѕрепарат следует с осторожностью примен¤ть при почечной недостаточности.

ѕрименение у детей

ѕротивопоказани¤: детский возраст до 2 лет (препарат в форме сиропа и гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь /апельсиновые/ 100 мг и 200 мг); детский возраст до 6 лет (препарат в форме гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь 200 мг); детский возраст до 14 лет (препарат в форме гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь 600 мг).

¬ыбор формы выпуска и режима дозировани¤ провод¤т с учетом возраста пациента.

ќсобые указани¤

ѕри бронхиальной астме и обструктивном бронхите ацетилцистеин следует назначать с осторожностью под систематическим контролем бронхиальной проходимости.

ѕри применении ацетилцистеина очень редко сообщалось о случа¤х развити¤ т¤желых аллергических реакций, таких как синдром —тивенса-?жонсона и синдром Ћайелла. ѕри возникновении изменений кожи и слизистых оболочек пациенту следует немедленно прекратить прием препарата и обратитьс¤ к врачу.

Ќе рекомендуетс¤ назначать препарат пациентам с почечной и/или печеночной недостаточностью во избежание дополнительного образовани¤ азотистых соединений.

ѕри растворении препарата необходимо пользоватьс¤ стекл¤нной посудой, избегать контакта с металлами, резиной, кислородом, легко окисл¤ющимис¤ веществами.

Ќе следует принимать препарат непосредственно перед сном (предпочтительное врем¤ приема - до 18.00).

ѕри назначении препарата пациентам, соблюдающим диету, направленную на ограничение потреблени¤ натри¤, необходимо учитывать, что 1 мл сиропа ј??Ѓ содержит 41.02 мг натри¤.

Ќет необходимости в специальных мерах предосторожности при уничтожении неиспользованного препарата ј??Ѓ.

”казани¤ дл¤ пациентов с сахарным диабетом

ѕри лечении пациентов с сахарным диабетом необходимо учитывать, что ј??Ѓ в форме гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь (200 мг, 600 мг, апельсиновые 100 мг и 200 мг) содержат сахарозу.

ј??Ѓ в форме гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь /апельсиновые/ 100 мг и 200 мг: 1 пакетик 100 мг соответствует 0.24 ’?, 1 пакетик 200 мг - 0.23 ’?.

ј??Ѓ в форме гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь 200 мг: 1 пакетик соответствует 0.21 ’?.

ј??Ѓ в форме гранул дл¤ приготовлени¤ раствора дл¤ приема внутрь 600 мг: 1 пакетик соответствует 0.17 ’?.

¬ли¤ние на способность к вождению автотранспорта и управлению механизмами

—ведени¤ о вли¤нии препарата на способность управл¤ть транспортными средствами и заниматьс¤ другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций, отсутствуют.

ѕередозировка

јцетилцистеин при приеме в дозе 500 мг/кг/сут не вызывает признаков и симптомов передозировки.

—имптомы: при ошибочной или преднамеренной передозировке наблюдаютс¤ такие ¤влени¤, как диаре¤, рвота, боли в желудке, изжога, тошнота.

Ћечение: проведение симптоматической терапии.

Ћекарственное взаимодействие

With the simultaneous use of acetylcysteine ??and antitussives, sputum stagnation may occur due to suppression of the cough reflex.

With the simultaneous use of acetylcysteine ??and antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), the latter may interact with the thiol group of acetylcysteine, which can lead to a decrease in antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine ??should be at least 2 hours (except for cefixime and loracarbef).

Simultaneous use with vasodilators and nitroglycerin can lead to an increase in the vasodilator effect.

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