Pectolvan® stop

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PECTOLVAN® STOP (PECTOLVAN STOP)

Composition:

Active substances: butamirate citrate, guaifenesin;

1 ml of the preparation (33 drops) contains butamirate citrate, calculated as 100 % substance, 4 mg; guaifenesin, calculated as 100 % substance, 100 mg;

Excipients: propylene glycol, polysorbate 80, licorice root extract, purified water, ethanol 96 %.

Pharmaceutical form. Oral drops.

Main physicochemical characteristics: clear, viscous liquid, yellow to yellowish-brown in color.

Pharmacotherapeutic group. Antitussives and expectorants, combinations.

ATC code R05FB02.

Pharmacological properties.

Pharmacodynamics.

A combination drug exerting antitussive, mucolytic, and expectorant effects. Butamirate citrate, included in the drug composition, belongs to non-opioid antitussive agents with peripheral action. It exerts a local anesthetic effect on nerve endings transmitting ascending irritation signals from the respiratory tract. Unlike opioid antitussive agents, it does not cause dependence and does not suppress the respiratory center.

The antitussive effect of butamirate citrate is complemented by the expectorant action of guaifenesin. Guaifenesin has secretolytic properties (due to direct enhancement of bronchial gland secretion and stimulation of elimination of acidic glycoproteins from acinar cells) and secretomotor properties (reduces sputum viscosity and facilitates mucus evacuation and expectoration).

Pharmacokinetics.

Butamirate citrate is rapidly and completely absorbed after oral administration and is up to 98% plasma protein-bound. It is metabolized to form two metabolites exerting antitussive effects; more than 90% of them are excreted by the kidneys, with only a small fraction eliminated in feces. The biological half-life is approximately 6 hours.

Guaifenesin is rapidly and readily absorbed from the gastrointestinal tract after oral administration. It has negligible plasma protein binding. It is excreted by the kidneys, mainly in the form of metabolites, with a small portion excreted unchanged. The biological half-life is 1 hour.

Clinical characteristics.

Indications.

Dry, irritating, paroxysmal cough of various origins. The drug may be used to relieve cough during pre- and postoperative periods.

Contraindications.

Hypersensitivity to any component of the drug, myasthenia gravis. First trimester of pregnancy (see section "Use during pregnancy or breastfeeding"). Children under 6 months of age.

Interaction with other medicinal products and other forms of interaction.

Since butamirate suppresses the cough reflex, concomitant use of expectorants should be avoided, as this may lead to mucus stasis in the airways, increasing the risk of bronchospasm and respiratory tract infection.

Lithium and magnesium enhance the effect of guaifenesin.

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid, enhances the suppressive effect of alcohol, sedatives, hypnotics, general anesthetics acting on the CNS, and also enhances the effect of muscle relaxants.

Muscle relaxants with a central mechanism of action may enhance the adverse effects of guaifenesin, particularly muscle weakness.

Guaifenesin may cause false-positive results in diagnostic tests measuring 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as reagent) and vanillylmandelic acid in urine. Treatment with Pectolvan® Stop should be discontinued 48 hours before urine collection for this test.

Special precautions for use

The drug should not be administered to patients with bronchial asthma, chronic bronchitis or emphysema, productive cough and/or persistent or chronic cough associated with smoking.

Use with caution in patients with tuberculosis or pneumoconiosis.

If cough persists or worsens, the treatment should be re-evaluated.

Pectolvan® Stop contains 36.96% v/v ethanol (alcohol), i.e. 353.57 mg in the maximum single dose (40 drops), which is equivalent to approximately 8.87 ml of beer or 3.06 ml of wine per maximum single dose. This medicinal product may be harmful for patients suffering from alcoholism. The ethanol content should be taken into account when administering to pregnant women or women during breastfeeding, as well as to children and patients with liver disease or epilepsy.

During treatment, patients should abstain from consuming alcoholic beverages.

Use during pregnancy or breastfeeding

Pregnancy

Controlled studies in pregnant women or animals have not been conducted. There have been reports of increased incidence of inguinal hernia in newborns following use of guaifenesin during the first trimester of pregnancy. Therefore, the drug is contraindicated during the first trimester of pregnancy.

Use of the drug during the second and third trimesters of pregnancy is possible only if, in the opinion of the physician, the expected therapeutic benefit to the mother outweighs the potential risk to the fetus/child.

Breastfeeding

It is unknown whether butamirate citrate or guaifenesin are excreted in breast milk. Experience with use in women during breastfeeding is limited; therefore, the risk of adverse effects in infants cannot be excluded. It is recommended to discontinue breastfeeding during treatment with this medicinal product.

Ability to influence reaction rate while driving or operating machinery

The medicinal product may negatively affect activities requiring high concentration (driving vehicles, operating machinery, or working at heights) due to the possibility of somnolence and dizziness.

Dosage and Administration

For oral use. It is recommended to take after meals. Dilute the appropriate number of drops in 100 mL of liquid (water, tea, fruit juice) according to age. For children unable to drink 100 mL, the volume of liquid may be reduced to ensure administration of the required dose.

The interval between doses should be 4–6 hours.

Dosing should be adjusted according to the patient's body weight:

• up to 7 kg: 8 drops every 6–8 hours, 3–4 times daily,
• 7–12 kg: 9 drops 3–4 times daily,
• 12–20 kg: 14 drops 3 times daily,
• 20–30 kg: 14 drops 3–4 times daily,
• 30–40 kg: 16 drops 3–4 times daily,
• 40–50 kg: 25 drops 3 times daily,
• 50–70 kg: 30 drops 3 times daily,
• 70–90 kg: 40 drops 3 times daily.

Maximum daily dose of guaifenesin:

• Children aged 6 months to 2 years: 300 mg/day (99 drops),
• Children aged 2 to 6 years: 600 mg/day (198 drops),
• Children aged 6 to 12 years: 1200 mg/day,
• Adults and children aged 12 years and older: 2400 mg/day.

Administration with larger amounts of liquid increases treatment efficacy. If Pectolvan® Stop is prescribed for very young children (with body weight less than 7 kg), the dose may be reduced.

Do not use the medication for more than 7 days without consulting a physician.

Children

The medication may be used in children aged 6 months and older, according to indications (see section "Dosage and Administration").

Overdose

Symptoms of overdose are primarily due to the toxic effects of guaifenesin: drowsiness, nausea, vomiting, muscle weakness.

Other signs of overdose may include diarrhea, dizziness, arterial hypotension. Radiopaque urolithiasis may occur.

There is no specific antidote.

Treatment: Gastric lavage, administration of activated charcoal. Symptomatic therapy aimed at supporting cardiovascular and respiratory functions, kidney function, and electrolyte balance.

Side effects.

When the recommended dosage is followed, the drug is usually well tolerated. Adverse effects usually disappear after reducing the dose.

Metabolic disorders: loss of appetite, anorexia.

Nervous system disorders: headache, drowsiness.

Ear and labyrinthine disorders: dizziness.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: discomfort in the gastrointestinal tract, nausea, abdominal pain, vomiting, diarrhea. If gastric discomfort or other unusual effects occur, discontinue use of the drug and consult a physician.

Urinary system disorders: urolithiasis.

Skin and subcutaneous tissue disorders: allergic reactions including anaphylactic shock, angioneurotic edema, skin rashes, pruritus, urticaria, exanthema.

Shelf life. 3 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

25 ml in a bottle. 1 bottle per pack.

Availability. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.