Salamol Steri-Neb (Solution) Instructions for Use

Marketing Authorization Holder

NORTON HEALTHCARE, Limited (United Kingdom)

Marketed Under the Trademark

IVAX Pharmaceuticals UK, Limited (United Kingdom)

Manufactured By

IVAX Pharmaceuticals UK, Limited (United Kingdom)

ATC Code

R03AC02 (Salbutamol)

Active Substance

Salbutamol (Rec.INN registered by WHO)

Dosage Forms

	Salamol Steri-Neb	Solution for inhalation 1 mg/1 ml: amp. 2.5 ml 20 pcs.
		Solution for inhalation 2 mg/1 ml: amp. 2.5 ml 20 pcs.

Dosage Form, Packaging, and Composition

Solution for inhalation from colorless to light yellow, transparent.

Excipients : sodium chloride – 9 mg, diluted sulfuric acid – to pH 3.8-4.2, water for injection – to 1 ml.

2.5 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (4) – cardboard packs.

Solution for inhalation from colorless to light yellow, transparent.

Excipients : sodium chloride – 9 mg, diluted sulfuric acid – to pH 3.8-4.2, water for injection – to 1 ml.

2.5 ml – polyethylene ampoules, welded together in the form of a block (5) – blocks (4) – cardboard packs.

Clinical-Pharmacological Group

Bronchodilator drug – beta₂-adrenergic agonist

Pharmacotherapeutic Group

Selective beta2-adrenomimetic

Pharmacological Action

Bronchodilator drug, stimulator of β₂-adrenergic receptors. It acts on the smooth muscles of the airways, causing their relaxation and preventing bronchospasm. It reduces resistance in the airways and increases lung capacity.

It prevents the release of histamine, leukotrienes, prostaglandin D2, and other biologically active substances from mast cells. In recommended therapeutic doses, it does not have a negative effect on the cardiovascular system and does not cause an increase in blood pressure.

To a lesser extent compared to other drugs in this group, it has a positive chronotropic and inotropic effect. It causes dilation of the coronary arteries. It has a number of metabolic effects: it reduces the concentration of potassium ions in plasma, affects glycogenolysis and insulin release, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, and increases the risk of acidosis.

Pharmacokinetics

During inhalation, 10-20% of the inhaled dose reaches the small bronchi, the rest settles in the upper respiratory tract. After inhalation use, systemic absorption is rapid but low.

The C_max of salbutamol in blood plasma is observed after 3 hours. Plasma protein binding is 10%. It undergoes presystemic metabolism in the liver and intestinal wall. T_1/2 is 3-7 hours.

It is excreted by the kidneys, mainly unchanged (about 90%) and as an inactive phenol sulfate metabolite (about 60%) within 72 hours, and with bile. Salbutamol penetrates the blood-brain barrier, creating concentrations approximately equal to 5% of the concentration in blood plasma.

Indications

• Prevention and relief of bronchospasm in bronchial asthma;
• Symptomatic treatment of broncho-obstructive syndrome (including in chronic bronchitis and pulmonary emphysema);
• Chronic obstructive pulmonary disease.

ICD codes

Dosage Regimen

Salamol Steri-Neb is used by inhalation using inhalers – nebulizers.

Adults (including elderly patients) and children over 18 months the usual single dose is 2.5 mg, the frequency of administration is 3-4 times/day via inhalation through a nebulizer. If necessary, the dose can be increased to 5 mg 3-4 times/day.

Technique for using the drug

Before using the drug, it is necessary to read the manufacturer’s instructions for the nebulizer.

1. Prepare the nebulizer according to the manufacturer’s instructions.
2. Separate the ampoule with the sterile solution from the block by twisting and pulling it.
3. Holding the ampoule vertically upwards by the cap, break off the cap.
4. Squeeze the solution into the nebulizer reservoir.
5. Use the nebulizer according to the manufacturer’s instructions.

The solution remaining unused in the nebulizer chamber should be discarded immediately after each use. The nebulizer should be thoroughly washed.

When using the drug, avoid getting the solution into the eyes.

Adverse Reactions

Definition of frequency of adverse effects (according to WHO recommendations): very common (≥ 10%); common (≥ 1%, but < 10%); uncommon (≥ 0.1%, but < 1%); rare (≥ 0.01%, but < 0.1%); very rare (< 0.01%).

From the cardiovascular system common – palpitations; rare – arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole, increased heart rate accompanied by increased blood pressure.

From the nervous system common – headache, tremor, anxiety; uncommon – dizziness; rare – drowsiness, sleep disturbance, fatigue.

From the respiratory system rare – bronchospasm (paradoxical or caused by hypersensitivity to the drug).

From the digestive system rare – nausea, vomiting.

Allergic reactions rare – angioedema, skin rash, urticaria, arterial hypotension and collapse (hypersensitivity reactions).

From the skin rare – dermatitis, facial skin redness.

From metabolism: rare – hypokalemia, hyperglycemia, lactic acidosis.

Local reactions uncommon – cough, irritation of the respiratory tract, oral and pharyngeal mucosa, dry mouth and throat, change in taste sensations.

Other rare – chest discomfort or pain, muscle cramps.

Contraindications

• Children under 18 months of age;
• Hypersensitivity to the components of the drug.

With caution in patients with tachyarrhythmia, coronary artery disease, myocarditis, heart defects, aortic stenosis, severe chronic heart failure, arterial hypertension, thyrotoxicosis, pheochromocytoma, decompensated diabetes mellitus, during pregnancy and lactation.

Use in Pregnancy and Lactation

Salbutamol is not recommended during pregnancy and breastfeeding, except in cases where the expected benefit to the mother outweighs any possible risk to the fetus.

Pediatric Use

Contraindicated in children under 18 months.

Special Precautions

Patients using Salamol Steri-Neb at home should be warned that if the effect of the usual dose becomes less effective or less prolonged, they should not independently increase the dose or frequency of use of the drug, but should immediately consult a doctor.

When using the drug, avoid getting the solution into the eyes.

As with the use of other means of inhalation therapy, the development of paradoxical bronchospasm is possible. In this case, it is necessary to immediately stop taking the drug and prescribe alternative treatment. Solutions that do not correspond to a neutral pH level may cause paradoxical bronchospasm in some patients.

Salbutamol should be prescribed with caution to patients with thyrotoxicosis. Treatment with beta₂-adrenomimetics can lead to significant hypokalemia. Particular caution should be exercised in cases of severe bronchial asthma, since concomitant treatment with xanthine derivatives, corticosteroids, diuretics, as well as hypoxia can contribute to the occurrence of hypokalemia. In such situations, it is recommended to monitor the level of potassium in the serum.

Salamol Steri-Neb should not be used to prevent preterm labor and threatened miscarriage.

Overdose

Symptoms nausea, vomiting, increased excitability, tachycardia, ventricular flutter, decreased blood pressure, hypoxemia, lactic acidosis, hypokalemia, hyperglycemia, muscle tremor, headache, hallucinations.

Treatment symptomatic therapy; for tachycardia, cardioselective beta₁-adrenergic blockers are administered. The prescription of cardioselective beta₁-adrenergic blockers to patients with bronchial asthma requires extreme caution due to the danger of bronchospasm.

Drug Interactions

Incompatible (pharmacological antagonism) with non-selective beta-blockers (which must also be taken into account when using ophthalmic forms of beta-blockers).

Due to the hypokalemic effect, Salbutamol enhances the effect of CNS stimulants, enhances the cardiotropic effect of thyroid hormones, and increases the likelihood of glycoside intoxication.

Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of tachyarrhythmias; agents for inhalation anesthesia, levodopa – severe ventricular arrhythmias.

A possible increase in heart rate and increase in blood pressure while taking salbutamol may necessitate correction of the dose of antihypertensive and antianginal drugs.

MAO inhibitors and tricyclic antidepressants may enhance the beta-adrenergic effect of salbutamol and lead to a sharp decrease in blood pressure.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

Concomitant use with m-anticholinergics (including inhaled) may contribute to an increase in intraocular pressure.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

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.