ACTS Long tab. spike. 600 mg # 10

Release form, composition and packaging

Effervescent tablets, white, round, flat-cylindrical, with a chamfer and a score on one side, with a blackberry smell

there may be a faint sulfur smell

reconstituted solution - colorless transparent with a blackberry odor

a slight sulfur odor is possible

1 tab.

acetylcysteine ��600 mg

anhydrous citric acid - 625 mg, sodium bicarbonate - 327 mg, sodium carbonate - 104 mg, mannitol - 72.8 mg, lactose - 70 mg, ascorbic acid - 75 mg, sodium cyclamate - 30.75 mg, sodium saccharinate dihydrate - 5 mg, sodium citrate dihydrate - 0.45 mg, blackberry flavor B" - 40 mg

10 pieces.

- polypropylene tubes (1) - cardboard packs.

20 pcs.

- polypropylene tubes (1) - cardboard packs.

pharmachologic effect

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 the 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 reaction

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.

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 excreted in breast milk.

Metabolism and excretion Rapidly metabolized in the liver with the formation of 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 h

Pharmacokinetics in special clinical situations Abnormal liver function leads to an extension of T1 / 2 to 8 hours.

Indications for use

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.

Contraindications for use

peptic ulcer of the stomach and duodenum in the acute phase hemoptysis pulmonary bleeding pregnancy lactation period (breastfeeding) children under 14 years old (ACC Long) children up to 2 years old (ACC 100, ACC 200) lactase deficiency, lactose intolerance, glucose-galactose malabsorption hypersensitivity to drug components. 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 per

Name ENG

ACC Long

Clinical and pharmacological group

Mucolytic drug

ATX code

Acetylcysteine

Dosage

600mg

Structure

1 effervescent tablet contains: active substance: acetylcysteine ��600 mg auxiliary substances: anhydrous citric acid - 625.00 mg

sodium bicarbonate - 327.00 mg

sodium carbonate - 104.00 mg

mannitol - 72.80 mg

lactose - 70.00 mg

ascorbic acid - 75.00 mg

sodium cyclamate - 30.75 mg

sodium saccharinate dihydrate - 5.00 mg

sodium citrate dihydrate - 0.45 mg

blackberry flavoring "B" - 40.00 mg.

Indications

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, chronic obstructive pulmonary disease (COPD), bronchiolitis

cystic fibrosis

Acute and chronic sinusitis, otitis media (otitis media).

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

Contraindications

hypersensitivity to acetylcysteine ��or other components of the drug

peptic ulcer of the stomach and duodenum in the acute stage

hemoptysis, pulmonary bleeding

pregnancy

lactation period

children's age up to 14 years (for this dosage form)

lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

With caution, a history of gastric ulcer and duodenal ulcer, bronchial asthma, obstructive bronchitis, hepatic and / or renal failure, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine ��affects the metabolism of histamine and may lead to signs of intolerance, such as headache, vasomotor rhinitis, itching), varicose veins of the esophagus, adrenal diseases, arterial hypertension.

INN / Active ingredient

acetylcysteine

Specifications

Category

Thinning phlegm

,

Expectorants

Scope of the drug

Respiratory system

Release form

Tablet

Manufacturer country

Germany

Package quantity, pcs

ten

Scope of application

Virology

Minimum age from

14 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Sandoz

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Mucolytic agent

Anatomical and therapeutic characteristics

R05CB01 Acetylcysteine

Dosage form

Effervescent tablets

Dosage (volume) of the substance in the preparation

600 mg

Expiration date in days

1095

Package weight, g

thirty

Mode of application

:

Inside, after eating.

Effervescent tablets should be dissolved in one glass of water.

The tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug.

For short-term colds, the duration of admission is 5-7 days.

In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a prophylactic effect < br> In the absence of other prescriptions, it is recommended to adhere to the following dosages: Mucolytic therapy: Adults and children over 14 years old: 1 effervescent tablet once a day (600 mg).

Information on technical characteristics, delivery set, country of manufacture "