Salbutamol 10

1. Name of the product

Salbutamol 10 — 10 mg/tablet

Uncoated tablet for oral administration.

2. Qualitative and quantitative composition

3. Pharmaceutical form

Uncoated tablet for oral administration. Oral use.

4. Clinical particulars

4.1 Indications

Supplied for professional and research applications only. Any therapeutic application, including bronchodilator use, is determined exclusively by a qualified physician on the basis of individual clinical assessment. This product is not intended for self-medication.

4.2 Posology and method of administration

As directed by the physician. Dose and duration are established by the treating clinician. Tablets are taken with water. The prescribed dose must not be exceeded, as adverse cardiovascular effects are dose-dependent.

4.3 Contraindications

• Known hypersensitivity to the active substance or to any of the excipients.
• Tachyarrhythmia, hypertrophic obstructive cardiomyopathy or idiopathic subvalvular aortic stenosis.
• Recent myocardial infarction or unstable ischaemic heart disease.
• Thyrotoxicosis.
• Pregnancy and breast-feeding, unless specifically directed by a physician.
• Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption (contains lactose).

4.4 Special warnings and precautions for use

• Beta-2 agonists may produce potentially serious hypokalaemia; serum potassium should be monitored, particularly where concomitant xanthines, corticosteroids or diuretics are administered.
• Tachycardia, palpitations and tremor are expected dose-dependent pharmacological effects; persistent tachycardia requires medical review.
• Caution is required in diabetes mellitus, as beta-2 agonists may raise blood glucose and, rarely, precipitate ketoacidosis.
• Receptor down-regulation occurs with continuous administration and reduces the pharmacological response over time.
• Cardiovascular status should be assessed before administration in any subject with a cardiac history.

4.5 Interaction with other medicinal products

Non-selective beta-blockers antagonise the pharmacological action and may provoke bronchospasm. Concurrent xanthine derivatives, corticosteroids or diuretics increase the risk of hypokalaemia. Monoamine oxidase inhibitors and tricyclic antidepressants may potentiate cardiovascular effects. Additive effects occur with other sympathomimetic agents.

4.6 Fertility, pregnancy and lactation

Administration during pregnancy and breast-feeding is not advised unless specifically directed by a physician after assessment of benefit and risk.

4.7 Effects on ability to drive and use machines

Tremor and palpitations may occur; caution is advised when driving or operating machinery if affected.

4.8 Undesirable effects

• Cardiovascular: tachycardia, palpitations, peripheral vasodilatation, increased pulse pressure.
• Nervous system: fine tremor of the skeletal muscle, headache, nervousness, insomnia.
• Metabolic: hypokalaemia, hyperglycaemia, increased lactate.
• Musculoskeletal: muscle cramp.
• Gastrointestinal: nausea, dry mouth.
• Rarely: cardiac arrhythmia, myocardial ischaemia in predisposed individuals.

If any adverse effect becomes serious, or if an effect not listed in this leaflet is observed, medical advice must be sought without delay.

4.9 Overdose

Overdose produces exaggerated beta-adrenergic effects: marked tachycardia, tremor, hypokalaemia and metabolic acidosis. Discontinue administration and seek immediate medical assistance. Serum potassium must be monitored; a cardioselective beta-blocker may be considered by the treating physician, with caution in subjects with bronchospastic disease.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Salbutamol stimulates beta-2 adrenoceptors coupled to Gs proteins, activating adenylate cyclase and elevating intracellular cAMP. In smooth muscle, elevated cAMP drives protein kinase A phosphorylation of myosin light chain kinase, producing muscle relaxation and bronchodilation. In adipose tissue and skeletal muscle, cAMP elevation activates hormone-sensitive lipase driving lipolysis, increases metabolic rate, and produces anti-catabolic effects in skeletal muscle via reduced ubiquitin-proteasome pathway activation. Unlike clenbuterol, salbutamol's significantly shorter half-life limits the degree of beta-2 receptor down-regulation with routine use.

Pharmacotherapeutic group: Selective beta-2 adrenoreceptor agonist.

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

Each production lot is released against the full pharmaceutical testing protocol: identity and purity by HPLC (specification ≥ 98 %), verification of concentration against label claim (± 5 %), sterility in accordance with USP <71>, bacterial endotoxin quantification by LAL assay (< 0.25 EU/mL) and inspection of particulate matter in accordance with USP <788>.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months from the date of manufacture. Do not use after the expiry date printed on the carton and blister.

6.4 Special precautions for storage

Store below 30 °C in the original package in order to protect from light and moisture. Keep out of the reach and sight of children.

6.5 Nature and contents of container

Blister strips in a printed outer carton, 100 tablets for oral use.

6.6 Special precautions for disposal

Any unused product or waste material must be disposed of in accordance with local requirements. Do not dispose of via wastewater or household waste.

7. Authentication

Every unit carries a unique authentication code on the outer packaging. The code confirms that the product originates from Biomedica and has not been substituted. Verify it before use.

8. Manufacturer

Biomedica
Pharmaceutical manufacturing — GMP compliant
biomedicapharmacies@protonmail.com
biomedica.it.com