Codelac neo pills 50mg №10

pharmachologic effect

Codelac Neo is an antitussive, expectorant, bronchodilator, anti-inflammatory.

Pharmacodynamics

Antitussive non-opioid, has a direct effect on the cough center. Butamirate citrate is neither chemically nor pharmacologically related to opium alkaloids. It has an antitussive, expectorant, moderate bronchodilating and anti-inflammatory effect, improves spirometry indices (decreases the resistance of the respiratory tract) and oxygenation of the blood.

Pharmacokinetics

Drops for oral administration, syrup

Suction. After ingestion, the drug is rapidly and completely absorbed from the gastrointestinal tract. After taking 150 mg butamirata C_max The main metabolite (2-phenylbutyric acid) in blood plasma is reached in about 1.5 hours and is 6.4 mcg / ml.

Distribution and metabolism. The hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity, and, like butamirata, are largely (about 95%) bound to plasma proteins, which makes them lasting T_1/2. 2-Phenylbutyric acid is partially metabolized by hydroxylation.

When re-taking the drug cumulation is not observed.

Inference. T_1/2 makes 6 h. All three metabolites are removed mainly with urine. Moreover, 2-phenylbutyric acid is mainly derived in the form associated with glucuronic acid.

Tablets with modified release film coated

Absorption is high. After ingestion of modified release pills C_max in the plasma of the main metabolite (2-phenylbutyric acid) is observed after 9 hours and is 1.4 μg / ml.

The hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity, and, like butamirata, are largely (about 95%) bound to plasma proteins, which makes them lasting T_1/2. 2-Phenylbutyric acid is partially metabolized by hydroxylation. When re-taking the drug cumulation is not observed.

T_1/2 butamiraty - 13 hours. Metabolites are excreted mainly by the kidneys. Moreover, 2-phenylbutyric acid is mainly derived in the form associated with glucuronic acid.

Indications

Dry cough of any etiology (for colds, flu, whooping cough and other conditions); suppression of cough in the preoperative and postoperative period, with surgical interventions and bronchoscopy.

Contraindications

• hypersensitivity to the drug;
• pregnancy (I term);
• breastfeeding period;
• fructose intolerance (drops for oral administration, syrup);
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption (modified-release tablets, film-coated)
• children up to 2 months (drops for oral administration), up to 3 years (syrup), up to 18 years (modified-release tablets, film-coated).

Use during pregnancy and lactation

There are no data on the safety of the drug during pregnancy and passing it 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.

The penetration of the drug into breast milk has not been studied, so the use of the drug during breastfeeding is not recommended.

special instructions

There is a danger when using the drug in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, and brain diseases.

Drops for oral administration, syrup. The drug can be used for patients with diabetes, because sucrose or glucose is not used as a sweetener.

Tablets with modified release film coated. Each pill contains 241 mg of lactose. The drug is contraindicated in patients with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Influence on ability to drive vehicles and work with mechanisms. It is recommended to refrain from driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed, because The drug may cause drowsiness and dizziness.

Composition

Active substance: butamirata citrate (in terms of 100% substance) 50 mg;

Excipients: lactose monohydrate (milk sugar) - 241 mg; Hypromellose (Metocel K4M) - 85 mg; talc - 4 mg; Magnesium stearate - 4 mg; colloidal silicon dioxide (Aerosil) - 6 mg; low molecular weight povidone (low molecular weight polyvinylpyrrolidone) - 5 mg

Dosage and administration

No chewing. 1 tab. every 8-12 hours

Side effects

From the side of the central nervous system: dizziness, passing when taking the drug or reducing the dose; drowsiness.

Gastrointestinal: nausea, vomiting, diarrhea.

From the skin: exanthema.

Allergic reactions: skin rash, itching.

Drug interaction

No drug interactions for butamirate are described. During the period of drug treatment, it is not recommended to drink alcoholic beverages, as well as drugs that depress the central nervous system (including hypnotics, antipsychotics, tranquilizers).

Overdosage

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

Treatment: the appointment of Activated carbon, gastric lavage, saline laxatives, symptomatic therapy (if indicated).

Storage conditions

At temperatures not above 25 ° C.