Codelac Neo, 1.5 mg/ml syrup 100 ml

Pharmacotherapeutic group: central antitussive.

ATX code:R05DB13

Pharmacological properties

Pharmacodynamics

Butamirate, the active ingredient of Codelac® Neo, is an anti-cough medicine of central action. It is neither chemically nor 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

Intake

After oral administration, butamirate is quickly and completely absorbed from the gastrointestinal tract. After taking 150 mg of butamirate, the maximum concentration of the main metabolite (2-phenyl butyric acid) in blood plasma is reached after about 1.5 hours and is 6.4 µg/ml.

Distribution and metabolism

Hydrolysis of butamyrate initially to 2-phenyl butyric acid and diethylaminoethoxyethanol begins in the blood. These metabolites also have anti-cough 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.

There is no cumulation if the drug is taken repeatedly.

Elimation

The elimination half-life of butamirate is 6 hours. The metabolites are eliminated mainly by the kidneys. And 2-phenyl butyric acid is excreted mainly in the form bound to glucuronic acid.

Indications

• Dry cough of any aetiology,
• cough in the pre- and post-operative period,
• cough during surgery and bronchoscopy,
• pertussis.

Active ingredient

Butamirate

Composition

Composition per 5 ml:

active ingredient:

• butamirate citrate – 7.5 mg;

excipients:

• sorbitol (Neosorb 70/70 B, sorbitol syrup) – 2025.0 mg,
• glycerol (glycerin) – 1450,0 mg,
• ethanol 95% (ethanol 95%) – 12,69 mg,
• sodium saccharinate – 3,0 mgSodium saccharinate – 3,0 mg,
• benzoic acid – 5,75 mg,
• vanillin – 3,0 mg,
• vanillin – 3,0 mg
• Sodium hydroxide 30 % solution – 1.55 mg,
• purified water – up to 5 ml.

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How to take, the dosage

The syrup should be taken orally before meals.

The syrup is prescribed to children: ages 3 to 6 years – 5 ml 3 times a day; 6 to 12 years – 10 ml 3 times a day; 12 years and older – 15 ml 3 times a day. Adults – 15 ml 4 times a day.

A measuring device should be used when taking the drug.

If the cough persists more than 5 days after starting treatment, a doctor should be consulted.

Interaction

No drug interactions have been described for butamirate.

When treating with the drug it is not recommended to drink alcoholic beverages, as well as CNS depressants (including hypnotics, neuroleptics, tranquilizers).

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Special Instructions

The syrup contains sodium saccharinate and sorbitol as sweeteners, so it can be used by patients with diabetes.

In connection with the presence of ethyl alcohol in the drug, there is a danger when using the drug in patients with predisposition to the development of drug addiction, with liver disease, alcoholism, epilepsy, brain disease, pregnant women and children.

Impact on ability to drive vehicles, mechanisms

It is recommended to refrain from driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions, since the drug may cause dizziness and somnolence.

Contraindications

High sensitivity to the drug components, fructose intolerance, pregnancy (I trimester), breast-feeding period. Children under 3 years of age.

With caution

Pregnancy (II and III trimesters).

In view of the presence of ethyl alcohol in the drug, use with caution in patients with predisposition to drug addiction, liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.

Side effects

Frequency classification of adverse reactions: very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (< 1/10000), including individual reports.

Nervous system disorders:

Rarely: drowsiness, dizziness, which subsides when the drug is withdrawn or the dose is reduced.

Gastrointestinal tract disorders:

Rarely: nausea, diarrhea.

Skin and subcutaneous tissue disorders:

Rarely: urticaria, possibly allergic reactions.

Overdose

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, decreased blood pressure, loss of balance.

Treatment: activated charcoal, saline laxatives, symptomatic therapy (as indicated).

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Pregnancy use

There are no data on the safety of using the drug during pregnancy and its passage through the placental barrier. Administration of the drug in the first trimester of pregnancy is contraindicated. In II and III trimesters of pregnancy the drug may be used taking into account the ratio of benefit to the mother and potential risk to the fetus.

Perfusion of the drug into the breast milk has not been studied; therefore it is not recommended to use the drug during breast feeding.

Similarities

Sinekod, Omnitus, For cough and runny nose