Kodelak Neo - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate (sugar milk) - 241.00 mg, hypromellose (methocel-K4M) - 85.00 mg, talc - 4.00 mg, magnesium stearate - 4.00 mg, silicon dioxide colloid (aerosil) - 6.00 mg , povidone low molecular weight (polyvinylpyrrolidone low molecular weight) - 5.00 mg;

Sheath: opadraj white (opadraj II white 57M280000) (in the form of a powder containing hypromellose (15 cP) - 5.58 mg, titanium dioxide - 4.86 mg, polydextrose - 4.68 mg, talc 1.26 mg, maltodextrin / dextrin - 0.90 mg, glycerol / glycerol - 0.72 mg) - 18.00 mg.

Description:Round biconvex tablets, covered with a film coating of white color.On a cross-section of a tablet of white or almost white color.

Pharmacotherapeutic group:Antitussive remedy of central action

ATX: & nbsp

R.05.D.B.13 Butamate

Pharmacodynamics:

Butamirate, the active substance of the drug Kodelak® Neo, is a central antitussive drug. Does not apply to opium alkaloids either chemically or pharmacologically. Does not form addiction or addiction.

Suppresses cough, having direct influence on the cough center. Has bronchodilator effect (enlarges the bronchi). It facilitates breathing, improving the spirometry (reduces the resistance of the respiratory tract) and oxygenation of the blood (oxygenates the blood).

Pharmacokinetics:

Absorption is high. After ingestion of the modified release tablet, the maximum plasma concentration of the main metabolite (2-phenyl-butyric acid) is observed after 9 hours and is 1.4 μg / ml.

Hydrolysis of butamate, initially to 2-phenylbutyric acid and diethylaminoethoxy ethanol, begins in the blood. These metabolites also have antitussive activity, and, like butamirate, to a large extent (about 95%) bind to plasma proteins, which causes their long half-life.2-Phenyl-butyric acid is partially metabolized by hydroxylation. When you re-take the drug cumulation is not observed.

The half-life of butamirate is 13 hours. Metabolites are excreted mainly by the kidneys. Moreover, 2-phenylbutyric acid is mainly excreted in the glucuronic acid-related form.

Indications:Dry cough of any etiology (with "cold" diseases, flu, whooping cough and other conditions). To suppress cough in the preoperative and postoperative period, with surgical interventions and bronchoscopy.

Contraindications:Hypersensitivity to the components of the drug, pregnancy (1 trimester), the period of breastfeeding, lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Children under 18 years.

Carefully:Pregnancy (II and III trimesters).

Pregnancy and lactation:There is no data on the safety of the drug during pregnancy and its passage through the placental barrier. The use of the drug in the first trimester of pregnancy is contraindicated. In the II and III trimesters of pregnancy, the use of the drug is possible, taking into account the ratio of benefits to the mother and the potential risk to the fetus.Penetration of the drug into breast milk has not been studied, so the use of the drug during breastfeeding is not recommended.

Dosing and Administration:

Inside.

Tablets are taken before meals without chewing.

1 tablet every 8-12 hours.

If the cough persists for more than 5 days after the start of treatment, then you should consult a doctor.

Side effects:

Classification of incidence of adverse reactions: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1 / 1000), very rarely (<1/10000), including individual messages.

From the nervous system: rarely drowsiness, dizziness, passing with the abolition of taking the drug or lowering the dose.

From the gastrointestinal tract: rarely - nausea, diarrhea.

From the skin and subcutaneous tissues: rarely - hives, it is possible the development of allergic reactions.

Overdose:

Symptoms: nausea, vomiting, drowsiness, diarrhea, abdominal pain, dizziness, irritability, lowering blood pressure, impaired coordination of movements.

Treatment: rinse the stomach, Activated carbon, saline laxatives, symptomatic therapy (according to indications).

Interaction:

No drug interactions for butamir are described. During the treatment with the drug is not recommended to drink alcoholic beverages, as well as drugs that depress the central nervous system (hypnotics, neuroleptics, tranquilizers and other drugs).

Due to butamate suppresses the cough reflex, simultaneous use of expectorants should be avoided in order to avoid congestion of sputum in the respiratory tract with the risk of bronchospasm and respiratory tract infection.

Special instructions:Each tablet contains 241 mg of lactose. The drug is contraindicated in patients with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Effect on the ability to drive transp. cf. and fur:It is recommended to refrain from driving vehicles and practicing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, since the drug may cause drowsiness and dizziness.

Form release / dosage:Tablets with modified release, film-coated, 50 mg.

Packaging:For 10 tablets in a contour mesh box made of polyvinylchloride film and billet aluminum printed lacquered. For 30 or 50 tablets in a can of polymer. 1, 2 contoured cell packs or a jar along with instructions for medical use are placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002526

Date of registration:08.07.2014 / 21.05.2015

Expiration Date:08.07.2019

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

FARMSTANDART-UFAVITA, JSC Russia

Information update date: & nbsp30.01.2018

Illustrated instructions

Instructions

Codelac® Neo (Codelac® Neo)