Synecod

The active ingredient of Sinekod is butamirate citrate, which depresses cough and differs from opium alkaloids in its structure and pharmacological action.

Indications Synekoda

Symptomatic treatment of cough (including dry cough) of different origin.

Release form

1 ml of syrup contains 1.5 mg of butamirate citrate;

excipients: sorbitol solution 70% (E 420), glycerin, sodium saccharin, benzoic acid (E 210), vanillin, ethanol 96%, sodium hydroxide 30%, purified water.

Syrup.

Basic physico-chemical properties: transparent solution from colorless to brownish-yellowish color.

Pharmacodynamics

A non-opiate cough suppressant with central action. However, the exact mechanism of action remains unknown.

Butamirate is believed to act on the CNS. Butamyrate citrate causes a non-specific anticholinergic and bronchospasmolytic effect, which improves respiratory function. Synekod does not cause addiction or dependence.

Butamirate citrate has a wide therapeutic range, so Sinekod is well tolerated in therapeutic doses and is well suited as a cough remedy for children.

Pharmacokinetics

Butamyrate is rapidly absorbed, distributed in the body and further predominantly hydrolyzed to 2-phenyl butyric acid and diethylaminoethoxyethanol, which also have anti-cough activity. 2-Phenyl butyric acid is further partially metabolized by hydroxylation. Butamyrate and 2-phenyl butyric acid are largely bound to blood proteins in the body.

The effect of food on bioavailability has not been confirmed. Metabolism of butamirate to 2-phenyl butyric acid and diethylaminoethoxyethanol is fully proportional over the dose range of 22.5-90 mg.

Measurable concentrations of butamirate are detectable in blood within 5 to 10 minutes after administration of 22.5 mg, 45 mg, 67.5 mg, and 90 mg. Maximum plasma concentrations are reached within 1 hour for all four doses with a mean maximum plasma concentration of 16.1 ng/mL when the 90 mg dose is administered.

The mean maximum plasma concentration of 2-phenyl butyric acid is reached within 1.5 hours with the highest observed exposure after 90 mg (3052 nanograms/mL).

The mean maximum plasma concentration of diethylaminoethoxyethanol is reached within 0.67 hours with the highest observed exposure after 90 mg (160 nanograms/mL).

Metabolites are excreted mainly by the kidneys. Butamyrate is detectable in urine up to 48 hours after administration. According to measurements, the elimination half-life for butamirate is 1.48-1.93 hours, for 2-phenyl butyric acid - 23.26-24.42 hours, for diethylaminoethoxyethanol - 2.72-2.90 hours.

There is no indication of the effect of hepatic and renal dysfunction on the pharmacokinetic parameters of butamirate.

Dosing and administration

For oral administration only.

Children from 3 to 6 years: 5 ml (7.5 mg) 3 times a day; maximum daily dose - 15 ml (22.5 mg);

Children from 6 to 12 years: 10 ml (15 mg) 3 times a day; maximum daily dose - 30 ml (45 mg);

Adolescents aged 12 years and older: 15 mL (22.5 mg) 3 times daily; maximum daily dose - 45 mL (67.5 mg).

Adults: 15 mL (22.5 mg) 4 times daily; maximum daily dose - 60 mL (90 mg).

The measuring cup should be washed and dried after each use and after use by another person.

The maximum course of treatment without a doctor's prescription should not exceed 1 week.

The drug should preferably be used before meals.

The lowest dose necessary to achieve efficacy should be used for the shortest treatment period.

Do not exceed the indicated dose.

Children

For children under 3 years of age, the drug in this dosage form is not used, you can use another dosage form, namely Sinekod, oral drops for children.

Use Synekoda during pregnancy

Safety in the use of Synecod during pregnancy or lactation has not been evaluated in special studies. Animal studies do not indicate direct or indirect harmful effects on pregnancy or fetal health.

During pregnancy, Synekod may be used only when prescribed by a physician, if there are direct indications for such treatment. If the expected benefit to the pregnant woman exceeds the possible risk to the fetus, a low effective dose and minimal duration of treatment should be considered.

It is not known whether the active substance and/or metabolites pass into breast milk.

For safety reasons, the benefits and risks of using Sinekod during breastfeeding should be carefully weighed. The use of the drug during breastfeeding is possible only on the advice of a physician if, in his/her opinion, the expected positive effect for the mother exceeds the potential risk for the child. In this case, the lowest effective dose and the shortest duration of treatment should be considered.

Contraindications

Hypersensitivity to the active or excipients of the drug.

Side effects Synekoda

Nervous system (single: ≥1/10000, <1/1000): dizziness, somnolence.

Gastrointestinal tract (single: ≥ 1/10000, < 1/1000): nausea, diarrhea.

Immune system (single: ≥1/10000, <1/1000): anaphylactic shock.

Skin and subcutaneous tissue (single: ≥ 1/10000, < 1/1000): angioedema, skin rash, urticaria, pruritus.

Overdose

Synekod overdose may cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness, and arterial hypotension.

Further treatment should be given according to clinical indications.

There is no specific way to treat butamirate overdose. In case of overdose, the patient needs symptomatic treatment and control of vital body functions.

Interactions with other drugs

Concomitant use of expectorants should be avoided. The exact mechanism of interaction with other drugs is not studied, but the central mechanism of action of the cough suppressant drug may be enhanced by the action of strong depressants, including alcohol.

Storage conditions

Store out of reach of children and out of sight at temperatures not exceeding 30 °C.

Special instructions

Given that butamirate depresses the cough reflex, concomitant use of expectorants should be avoided, as this may lead to stagnation of mucus in the airways, which increases the risk of bronchospasm and infection of the respiratory tract.

The syrup contains sweeteners - sodium saccharin and sorbitol (284 mg per 1 ml), therefore it can be administered to diabetics. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Sorbitol is a source of fructose, therefore it should not be used in patients with fructose intolerance. It should not be used in patients with rare hereditary problems of lactose intolerance or glucose-galactose malabsorption.

The medicinal product contains a small amount (less than 100 mg per dose) of ethanol (alcohol), which is less than 100 mg per dose. The medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. The sodium content can be neglected.

If the cough persists for more than 7 days, a doctor should be consulted.

Patients whose symptoms worsen or do not improve within 7 days and are accompanied by fever, rash, or persistent headache should have further investigations to determine the underlying cause of the condition.

Keep out of reach of children and out of their sight.

Ability to influence reaction speed when driving motor transport or other mechanisms

May cause fatigue and affect the reaction when driving vehicles or other mechanisms.

Shelf life

3 years.