Release form and composition
- modified-release tablets, coated: round, biconvex, white (10 pcs. in blister packs, 30 and 50 pcs. in polymer jars; 1 jar or 1-2 blister packs in a cardboard pack);
- syrup: colorless liquid (100 and 200 ml in dark glass bottles, 1 bottle in a cardboard box);
- drops for oral administration: transparent or slightly opalescent, colorless to colorless with a yellowish tint, liquid with a vanilla odor (20 ml in dark glass dropper bottles, 1 bottle in a cardboard box).
Composition of 1 tablet:
- active substance: butamirate citrate – 50 mg (based on 100% substance);
- additional components: magnesium stearate, hypromellose (methocel K4M), low molecular weight povidone (low molecular weight polyvinylpyrrolidone), talc, lactose monohydrate (milk sugar), colloidal silicon dioxide (Aerosil);
- film shell: Opadry II white 57M280000, including maltodextrin/dextrin, titanium dioxide, hypromellose (15 cP), polydextrose, talc, glycerin/glycerol.
Composition of 5 ml syrup:
- active substance: butamirate citrate – 7.5 mg;
- auxiliary components: sodium saccharinate, sodium hydroxide solution 30%, glycerol (glycerin), purified water, benzoic acid, ethanol (ethyl alcohol) 95%, vanillin, sorbitol (Neosorb 70/70, sorbitol syrup).
Composition of 1 ml drops:
- active substance: butamirate citrate – 5 mg;
- auxiliary components: sodium saccharinate, sodium hydroxide solution 30%, glycerol (glycerin), purified water, benzoic acid, ethanol (ethyl alcohol) 95%, vanillin, sorbitol (Neosorb 70/70, sorbitol syrup).
Description
The medicine is produced in drops, syrup and tablets, the latter intended only for adults. The medication contains butamirate citrate as the main ingredient.
The drops are a liquid that smells like vanilla. It can be colorless, transparent, a yellowish tint or slight opalescence is allowed.
The syrup is a clear liquid with a vanilla aroma.
In addition to butamirate, liquid dosage forms include indifferent components:
- E 420;
- E 422;
- E 1510;
- E 954;
- E 210;
- vanilla;
- E 500;
- water.
Butamirate suppresses the cough center located in the medulla oblongata and the cough goes away. The active substance expands the bronchi and makes breathing easier, improves the results of spirography, and enriches the body with oxygen.
After oral administration, the medication is quickly and completely absorbed from the gastrointestinal tract. The maximum content in the bloodstream is observed after approximately 90 minutes. Passing through the liver, the medication is metabolized.
The half-life of the drug is 6 hours, and it is excreted from the body primarily through urine.
Codelac Neo drops and syrup are not produced separately for adults or children; only the dosage regimen of the medication changes.
Pharmacological properties
Pharmacodynamics
Butamirate citrate is neither pharmacologically nor chemically related to opium alkaloids.
It has a direct effect on the cough center and has a moderate bronchodilator, expectorant and anti-inflammatory effect. Improves blood oxygenation, reduces airway resistance, thereby improving spirometry.
Pharmacokinetics
After taking Codelac Neo butamirate drops or syrup, citrate is completely and quickly absorbed from the gastrointestinal tract. When taking a dose of 150 mg, the maximum concentration of the main metabolite, 2-phenylbutyric acid, in the blood plasma is 6.4 mcg/ml, and is achieved after approximately 90 minutes.
In tablet form, Codelac Neo is also characterized by high absorption. After oral administration, the maximum concentration of 2-phenylbutyric acid in blood plasma is 1.4 mcg/ml and is achieved within 9 hours.
Hydrolysis of the active substance Codelac Neo begins in the blood, initially two metabolites are formed - 2-phenylbutyric acid and diethylaminoethoxyethanol - which also have antitussive properties and, like butamirate, are characterized by high binding to plasma proteins (about 95%), which is why they have a long-lasting effect. half-life.
2-phenylbutyric acid is partially metabolized by hydroxylation.
The drug does not have a cumulative effect when taken repeatedly.
Metabolites are excreted primarily by the kidneys in the urine, while 2-phenylbutyric acid is excreted mainly in the form associated with glucuronic acid.
The half-life after taking syrup/drops is 6 hours, tablets are 13 hours.
How does the medicine work?
The drug "Codelac Neo" has positive reviews due to its effectiveness. The maximum concentration of the active substance in the blood is achieved after one and a half hours. The effect of the medication lasts for six hours. Consumers say that you can simply take the medicine and forget about the cough.
The drug Codelac Neo blocks cough receptors, which are normally irritated by bronchial mucus. The drug also has an anti-inflammatory effect. If there is sputum, then the described remedy helps to expectorate it.
Contraindications
- I trimester of pregnancy;
- breastfeeding period;
- hypersensitivity to the components of the drug.
Additional contraindications for different release forms of Codelac Neo:
- tablets: glucose-galactose malabsorption, lactase deficiency, lactose intolerance, age up to 18 years;
- syrup: fructose intolerance, children under 3 years of age;
- drops: fructose intolerance, children up to 2 months.
For the following conditions/diseases, the drug should be used with caution due to the risk of complications:
- liver diseases;
- alcoholism;
- brain diseases;
- epilepsy;
- tendency to drug addiction.
Interaction with other drugs
Codelac Neo is used carefully in the treatment of alcohol dependence, since it contains ethanol.
During therapy, expectorants should be avoided. Their simultaneous use with Codelac Neo can lead to the formation of a large amount of sputum and mucus in the lungs. This contributes to the development of various complications.
It is not recommended to drive a car while taking this medicine, as the patient's emotional state may not be completely stable. Decreased attention has a negative impact on the ability to drive safely.
Instructions for use of Codelac Neo: method and dosage
All dosage forms of Codelac Neo are indicated for oral use. A measuring device should be used to dispense drops and syrup. The drug should be taken before meals; the tablets should be swallowed whole without chewing.
Codelac Neo tablets are prescribed only to adults - 1 pc. 2–3 times a day.
Recommended doses of Codelac Neo syrup depending on age:
- children 3–6 years old: 5 ml 3 times a day;
- children 6–12 years old – 10 ml 3 times a day;
- adolescents 12–18 years old – 15 ml 3 times a day;
- adults – 15 ml 4 times a day.
Recommended doses of Codelac Neo drops for children depending on age:
- 2–12 months – 10 drops 4 times a day;
- 1–3 years – 15 drops 4 times a day;
- from 3 years – 25 drops 4 times a day (children under 2 years of age can be treated with the drug only after consultation with a doctor).
1 ml (corresponding to 22 drops) contains 5 mg of butamirate.
Indications for use of the medication
What else do reviews say about Codelac Neo? For children and adult patients, the medication is equally effective. It is prescribed for cough. You already know this. However, doctors say this information is not enough. It is imperative to take into account the nature of the pathology. The instructions indicate the following indications for use of the composition:
- diseases of the upper and lower respiratory tract, accompanied by irritation of the bronchial tree;
- dry cough, including during whooping cough;
- carrying out diagnostic operations, during and after which an irritating cough occurs.
Often the medication is prescribed in combination with other compounds. However, it is not recommended to take it together with reverse-acting medications that thin mucus and promote its elimination.
special instructions
Each Codelac Neo tablet contains 241 mg of lactose, therefore in this dosage form the drug is contraindicated for glucose-galactose malabsorption, lactase deficiency, lactose intolerance.
In the form of syrup and drops, Codelac Neo does not contain glucose and sucrose, so it can be used by patients with diabetes.
Impact on the ability to drive vehicles and complex mechanisms
Since there are known cases of dizziness and drowsiness developing during therapy, it is recommended to refrain from driving vehicles and performing activities that require rapid psychophysical reactions and increased attention.
Opinions about the described cough medicine
The drug "Codelac Neo" (syrup) has positive reviews. Consumers say that the taste of the medicine is quite pleasant, despite the ethanol content. The medicine does not irritate the larynx and does not cause disgust.
Reviews about the medicine “Codelac Neo” (drops) say that they are very convenient to take. Unlike a suspension, the medication must be taken in smaller quantities. You can always take this type of drug with you.
Doctors report that Codelac Neo cannot be used independently. If you have an inflammatory process in the bronchi, which requires sputum to be expelled, then the use of this medicine may cause complications. Indeed, in such a situation, sputum will not separate, but, on the contrary, accumulate. As a result, there is a high likelihood of pneumonia. If you feel worse, contact your doctor immediately.
Reviews of Codelac Neo
Reviews of Codelac Neo in the form of syrup and tablets are contradictory. Some patients indicate that the drug is effective, inexpensive and relatively safe (it has few contraindications and practically does not cause side effects), others, on the contrary, write that in their case the drug did not help cope with the main problem for which it was intended - to stop dry cough.
As for Codelac Neo drops, they are mainly reviewed by mothers who used the drug to treat dry cough in their children. Reviews about this dosage form are mostly positive; many consider the only disadvantages to be the presence of ethanol in the composition.
Side effects
Side effects may occur while taking Codelac Neo:
- dizziness, loss of coordination, constant desire to sleep;
- nausea, abdominal pain, indigestion, diarrhea, vomiting;
- intolerance to the components is manifested by external redness and itching of the skin, and the appearance of urticaria.
Large excess of the prescribed dose causes discomfort:
twisting abdominal pain;- spontaneous loss of urine, bowel movements;
- low blood pressure;
- gagging;
- irritability, excitability, emotional decline or rise;
- loss of orientation, distracted attention.
In case of overdose, it is necessary to give the patient a large amount of water and then rinse the stomach. After which you need to take several tablets of Activated Carbon and laxatives.