Codelac Neo, 100 mg+100 mg 10 pcs

Pharmacotherapeutic group: central antitussive.

The ATX code: R05DB13

Pharmacological properties

Pharmacodynamics

Butamirate, the active ingredient of Codelac^® Neo, is an anti-cough medicine of central action. It is not chemically or pharmacologically related to opium alkaloids. It is not addictive or addictive.

It suppresses cough having a direct effect on the coughing center. It has a bronchodilator effect (dilates the bronchi). Helps ease breathing by improving spirometry (reduces airway resistance) and blood oxygenation (saturates blood with oxygen).

Pharmacokinetics

The absorption is high. After oral administration of sustained-release tablet, maximum plasma concentration of the main metabolite (2-phenyl butyric acid) is observed after 9 h and is 1.4 µg/ml.

Hydrolysis of butamyrate, initially to 2-phenyl butyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity, and, like butamirate, are largely (about 95%) bound to plasma proteins, which accounts for their long elimination half-life. 2-phenyl butyric acid is partially metabolized by hydroxylation. No cumulation is observed when taking the drug again.

Indications

Dry cough of any etiology (with “colds”, flu, whooping cough and other conditions). To suppress cough in the preoperative and postoperative period, during surgical interventions and bronchoscopy.

Pharmacological effect

Pharmacotherapeutic group: centrally acting antitussive.

ATX code: R05DB13

Pharmacological properties

Pharmacodynamics

Butamirate, the active ingredient of Codelac® Neo, is a centrally acting antitussive agent. It is not classified as an opium alkaloid either chemically or pharmacologically. Does not form dependence or addiction.

Suppresses cough, having a direct effect on the cough center. Has a bronchodilator effect (expands the bronchi). Helps make breathing easier by improving spirometry (reduces airway resistance) and blood oxygenation (saturates the blood with oxygen).

Pharmacokinetics

Absorption is high. After oral administration of the extended-release tablet, the maximum plasma concentration of the main metabolite (2-phenylbutyric acid) is observed after 9 hours and is 1.4 mcg/ml.

Hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylaminoethoxy-ethanol, begins in the blood. These metabolites also have antitussive activity and, like butamirate, are highly (about 95%) bound to plasma proteins, resulting in their long half-life. 2-phenylbutyric acid is partially metabolized by hydroxylation. When taking the drug again, no accumulation is 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 form associated with glucuronic acid.

Special instructions

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

Impact on the ability to drive vehicles and machinery

It is recommended to refrain from driving vehicles and
engaging in other potentially hazardous activities that require
increased concentration of attention and speed of psychomotor reactions, since
the drug may cause drowsiness and dizziness.

Active ingredient

Butamirat

Composition

Active ingredient:

butamirate citrate – 50.00 mg.

Excipients: lactose monohydrate (milk sugar) – 241.00 mg, hypromellose – 85.00 mg, talc – 4.00 mg, magnesium stearate – 4.00 mg, colloidal silicon dioxide (Aerosil) – 6.00 mg, low molecular weight povidone (low molecular weight polyvinylpyrrolidone) – 5.00 mg.

Shell: opadry white (opadry 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 or dextrin – 0.90 mg, glycerin or
glycerol – 0.72 mg) – 18.00 mg.

Pregnancy

There is no data on the safety of the drug in
period of pregnancy and its passage through the placental barrier. Use of the drug
Contraindicated in the first trimester of pregnancy. In the II and III trimesters of pregnancy
the use of the drug is possible taking into account the balance of benefits for the mother and
potential risk to the fetus. The penetration of the drug into breast milk is not
has been studied, therefore the use of the drug during breastfeeding is not
recommended.

Contraindications

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

With caution

Pregnancy (II and III trimesters).

Side Effects

Classification of the frequency of adverse reactions: very often (≥1/10), often (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000), including individual reports.

From the nervous system: rarely – drowsiness, dizziness, which goes away when the drug is discontinued or the dose is reduced.

From the gastrointestinal tract: rarely – nausea, diarrhea.

From the skin and subcutaneous
tissues: rarely – urticaria, allergic reactions may develop.

Interaction

No drug interactions have been reported for butamirate. During treatment with the drug, it is not recommended to drink alcoholic beverages, as well as drugs that depress the central nervous system (hypnotics, antipsychotics, tranquilizers and other drugs).

Due to the fact that butamirate suppresses the cough reflex, you should
avoid concomitant use of expectorants to avoid accumulation
sputum in the respiratory tract with a risk of bronchospasm and infection
respiratory tract.

Overdose

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

Treatment: gastric lavage, activated charcoal, saline laxatives, symptomatic
therapy (according to indications).

Storage conditions

Store at a temperature not exceeding 25 ºС.

Keep out of the reach of children!

Shelf life

2 years

Manufacturer

Pharmstandard-UfaVITA, Russia