Codelac® Neo (Tablets, Solution, Drops) Instructions for Use
ATC Code
R05DB13 (Butamirate)
Active Substance
Butamirate (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antitussive drug
Pharmacotherapeutic Group
Drugs used for cough and colds; antitussives, excluding combinations with expectorants; other antitussives
Pharmacological Action
Antitussive agent of central action. Butamirate does not belong to the opium alkaloids. It does not cause dependence or addiction.
It suppresses cough by directly affecting the cough center. It has a moderate bronchodilatory effect. It helps to facilitate breathing, improves spirometry parameters (reduces airway resistance) and blood oxygenation.
Pharmacokinetics
After oral administration, Butamirate is rapidly and completely absorbed; measurable concentrations are detected in the blood 5-10 minutes after administration.
Cmax in blood plasma is reached within 1 hour. Mean plasma concentrations of 2-phenylbutyric acid are reached within 1.5 hours.
Butamirate has a large Vd in the range of 81-112 L (adjusted for body weight in kg), as well as a high degree of binding to plasma proteins. 2-phenylbutyric acid has a high degree of binding to plasma proteins – on average 89.3 – 91.6%. The ability of diethylaminoethoxyethanol to bind to plasma proteins is also detected, with average rates ranging from 28.8% to 45.7%. It is not known whether Butamirate crosses the placenta or is excreted in breast milk.
The hydrolysis of butamirate, which results in the formation of 2-phenylbutyric acid and diethylaminoethoxyethanol, which have antitussive activity, occurs very rapidly. 2-phenylbutyric acid undergoes further partial metabolism by hydroxylation in the para position.
Excretion of the three metabolites occurs mainly through the kidneys; after conjugation in the liver, acid-reactive metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are detected in urine in significantly higher concentrations than in blood plasma. Butamirate is detected in urine for 48 hours. Butamirate is excreted in the urine in greater amounts as diethylaminoethoxyethanol than as unchanged Butamirate or as unconjugated 2-phenylbutyric acid.
The measured T1/2 of 2-phenylbutyric acid, butamirate, and diethylaminoethoxyethanol is 23.26-24.42 hours, 1.48-1.93 hours, and 2.27-2.90 hours, respectively.
Indications
Treatment of dry cough of various etiologies: for cough suppression in the pre- and postoperative period, during surgical interventions, bronchoscopy, whooping cough.
ICD codes
| ICD-10 code | Indication |
| A37 | Whooping cough |
| R05 | Cough |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| 1C12.Z | Whooping cough, unspecified |
| MD12 | Cough |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally. Adhere strictly to the age-specific and formulation-specific dosing instructions.
For Codelac® Neo Tablets: Do not use in children under 6 years of age. For children aged 6 to 12 years: administer one tablet three times daily. For adults and adolescents aged 12 years and older: administer one tablet four times daily.
For Codelac® Neo Drops: Do not use in infants under 2 months of age. For infants aged 2 to 12 months: administer 10 drops four times daily. For children aged 1 to 3 years: administer 15 drops four times daily. For children aged 3 years and older: administer 25 drops four times daily.
For Codelac® Neo Solution: Do not use in children under 3 years of age. For children aged 3 to 6 years: administer 5 ml three times daily. For children aged 6 to 12 years: administer 10 ml three times daily. For adults and adolescents aged 12 years and older: administer 15 ml three times daily.
Maintain a minimum 6-hour interval between doses. Do not exceed the maximum daily dose for any patient group. The total duration of treatment should not exceed 5-7 days without medical supervision.
Adverse Reactions
From the CNS rarely – drowsiness, dizziness.
From the digestive system rarely – nausea, vomiting, diarrhea.
From the skin rarely – exanthema.
Other possible development of allergic reactions.
Contraindications
Hypersensitivity to butamirate; first trimester of pregnancy, lactation period (breastfeeding); children under 2 months of age; children under 3 years of age (for syrup), children under 6 years of age (for tablets); children under 18 years of age (for prolonged-release tablets).
With caution
Second and third trimesters of pregnancy. Use dosage forms containing ethyl alcohol with caution in patients prone to drug dependence, with liver disease, alcoholism, epilepsy, brain diseases, and in children.
Use in Pregnancy and Lactation
Contraindicated in the first trimester of pregnancy and during lactation (breastfeeding). In the second and third trimesters of pregnancy, use with caution and only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
Pediatric Use
Contraindication: children under 2 months of age (for drops), under 3 years of age (for syrup), under 12 years of age (for prolonged-release tablets).
Special Precautions
In children, use only dosage forms that are specifically intended for this category of patients according to age.
Influence on the ability to drive vehicles and mechanisms
Butamirate can cause drowsiness, therefore, during the treatment period, patients should exercise caution when driving vehicles and engaging in other activities that require increased concentration and speed of psychomotor reactions.
Drug Interactions
Since Butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to prevent the accumulation of sputum in the airways.
During treatment with butamirate, it is not recommended to use drugs that have a depressant effect on the central nervous system (including hypnotics, antipsychotics, tranquilizers).
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Oral drops 5 mg/1 ml: dropper bottle 20 ml
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
 |
Codelac® Neo | Oral drops 5 mg/1 ml: dropper bottle 20 ml |
Dosage Form, Packaging, and Composition
Oral drops in the form of a transparent, colorless or slightly yellowish liquid with a vanilla smell; slight opalescence is allowed.
| 1 ml | |
| Butamirate citrate | 5 mg |
Excipients: sorbitol (sorbitol syrup) – 8100 mg, glycerol (glycerin) – 5800 mg, ethanol 95% (ethyl alcohol 95%) – 61 mg, sodium saccharin – 23 mg, benzoic acid – 23 mg, vanillin – 23 mg, sodium hydroxide solution 30% – 10 mg, purified water – 20 ml.
20 ml – dropper bottles of dark glass (1) – cardboard packs.
Oral solution 1.5 mg/1 ml: bottle 100 ml or 200 ml with a measuring spoon
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Codelac® Neo | Oral solution 1.5 mg/1 ml: bottle 100 ml or 200 ml with a measuring spoon |
Dosage Form, Packaging, and Composition
Oral solution in the form of a transparent, colorless or yellowish liquid with a vanilla smell.
| 1 ml | |
| Butamirate citrate | 1.5 mg |
Excipients: sorbitol (sorbitol syrup 70% (non-crystallizing)) – 405 mg, glycerol (glycerin) – 290 mg, ethanol 95% (ethyl alcohol 95%) – 2.538 mg, sodium saccharin – 0.6 mg, benzoic acid – 1.15 mg, vanillin – 0.6 mg, sodium hydroxide solution 30% – 0.31 mg, purified water – up to 1 ml.
100 ml – bottles of dark glass (1) with a measuring spoon – cardboard packs.
200 ml – bottles of dark glass (1) with a measuring spoon – cardboard packs.
Prolonged-release film-coated tablets, 50 mg: 10, 20, 30, or 50 pcs.
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-UfaVITA OJSC (Russia)
Or
Otisipharm Pro, JSC (Russia)
Dosage Form
|
Codelac® Neo | Prolonged-release film-coated tablets, 50 mg: 10, 20, 30, or 50 pcs. |
Dosage Form, Packaging, and Composition
Prolonged-release film-coated tablets white, round, biconvex; on the cross-section, the tablet is white or almost white.
| 1 tab. | |
| Butamirate citrate | 50 mg |
Excipients: lactose monohydrate (milk sugar) – 241 mg, hypromellose (Methocel-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.
Film coating composition Opadry white (Opadry II white 57M280000) (including hypromellose – 5.58 mg, titanium dioxide – 4.86 mg, polydextrose – 4.68 mg, talc – 1.26 mg, maltodextrin/dextrin – 0.9 mg, glycerol/glycerin – 0.72 mg) – 18 mg.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
![Codelac® Neo [Tablets, Solution, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Codelac® Neo [Tablets, Solution, Drops] 2")