Solmux-Broncho

Solmux-Broncho

Manufacturer:

United Lab

Distributor:

Westmont
Full Prescribing Info
Contents
Salbutamol, carbocisteine.
Description
Each capsule contains: Salbutamol 2 mg, Carbocisteine 500 mg.
Each 5 mL (1 teaspoonful) suspension contains: Salbutamol 2 mg, Carbocisteine 500 mg.
Action
Pharmacology: Pharmacodynamics: Salbutamol: Salbutamol is a selective short-acting beta2-adrenergic agonist with preferential effect on beta2-adrenergic receptors found in the respiratory tract. It stimulates adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). cAMP mediates cellular responses such as bronchial smooth muscle relaxation resulting in bronchodilation.
Carbocisteine: Carbocisteine, a derivative of Acetylcysteine, is a mucoregulating agent. Its major action is thought to be on the metabolism of mucus-producing cells. The mucus produced under the influence of Carbocisteine has an increased content of the less viscous sialomucin and a reduced content of the highly viscous fucomucin. Sialomucins influence the rheological properties of mucus and may also, through the inhibition of kinins, reduce or prevent bronchial inflammation and bronchospasm.
Carbocisteine's ability to inhibit invasion of human pharyngeal cells by Klebsiella pneumoniae, Pseudomonas aeruginosa and Escherichia coli was determined in vitro. The study showed a significant decrease in the number of bacterial colonies observed after 1 hour incubation with Carbocisteine compared with placebo. Increasing amounts of Carbocisteine decreased further the number of bacterial colonies observed.
Pharmacokinetics: Salbutamol: Salbutamol is readily absorbed from the gastrointestinal tract after oral administration. Salbutamol's onset of action is within 30 minutes, peaks in 2 to 3 hours and persists for 6 hours after a dose; the plasma half-life is from 4 to 6 hours. It is extensively metabolized in the liver, being converted to salbutamol 4'-O-sulfate. Salbutamol and its metabolites are rapidly excreted in urine and feces. After oral administration of Salbutamol to healthy individuals, about 75% of a single dose is excreted in urine within 72 hours, mainly as the major metabolite; about 4% of the dose is excreted in feces.
Animal studies show that Salbutamol crosses the blood-brain barrier and the placenta. It may be secreted in breast milk but concentrations are not known.
Carbocisteine: Carbocisteine is rapidly and well absorbed from the gastrointestinal tract. Peak serum concentration of 13.88 mg/L is achieved 1 to 1.7 hours after administration of 1.5 g Carbocisteine. Plasma half-life is 1.33 hours. Carbocisteine penetrates well into lung tissues and respiratory mucus, suggesting local action. Carbocisteine undergoes acetylation, decarboxylation and sulfoxidation. Most of the drug is excreted unchanged in the urine.
Indications/Uses
For the symptomatic treatment of productive cough associated with acute and chronic obstructive airways disease, such as acute and chronic bronchitis, bronchial asthma and bronchiectasis.
Dosage/Direction for Use
See table.

Click on icon to see table/diagram/image

Or, as prescribed by a physician.
Overdosage
Salbutamol: Symptoms of Salbutamol overdose include extensions of the common undesirable effects (e.g., tremor, nervousness, headache, dizziness, sleeplessness or insomnia, hypertension or hypotension, palpitation, tachycardia, arrhythmia, angina, dry mouth, and nausea). Hypokalemia has also been reported; thus, plasma potassium concentrations should be monitored.
Discontinue Salbutamol and institute appropriate symptomatic therapy in cases of Salbutamol overdosage. Administration of a beta-adrenergic blocking agent may be appropriate, but use with caution if the patient is asthmatic. There is no adequate evidence to support the use of dialysis in the treatment of Salbutamol overdose.
Carbocisteine: Gastrointestinal disturbance is the only likely symptom of Carbocisteine overdose. Gastric lavage followed by observation may be beneficial therapy for overdosage.
Contraindications
Hypersensitivity to any ingredient in the product.
Active peptic ulcer.
Special Precautions
Paradoxical bronchospasm, a potentially life-threatening event, may occur with the administration of oral Salbutamol. If it occurs, discontinue use of the product immediately.
Use with caution in acute severe asthma where concomitant therapy with steroids, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; plasma potassium concentrations should be monitored in severe asthma.
Therapy with Salbutamol and other beta2-agonists may produce decreases in plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular adverse effects.
Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias or hypertension; Convulsive disorders; Gastric or duodenal ulcer and gastrointestinal bleeding; Hyperthyroidism; Diabetes mellitus; In patients who are unusually responsive to sympathomimetic amines.
Use In Pregnancy & Lactation
Pregnancy: There have been reports of congenital anomalies (e.g., cleft palate and limb defects) in children of patients treated with Salbutamol. Some of the mothers, however, were receiving various medications in the course of their pregnancies. Since there is no consistent pattern of congenital abnormality development, a relationship between the use of Salbutamol and the development of congenital anomalies cannot be established. Therefore, Salbutamol should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Salbutamol may be secreted in breast milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefits of the drug justify the possible risk to the baby.
Adverse Reactions
Salbutamol: The most frequent adverse reactions of oral Salbutamol include tremors (particularly of the hands), nervousness, headache, dizziness, sleeplessness or insomnia, weakness, drowsiness, restlessness, irritability, tachycardia, palpitation, peripheral vasodilation, flushing, chest discomfort, nausea, dyspepsia, difficulty in micturition, and rarely muscle cramps.
Erythema multiforme or Stevens-Johnson syndrome has been reported rarely with administration of oral Salbutamol in children.
Potentially serious hypokalemia has also been reported.
Hypersensitivity reactions (including urticaria, angioedema, rash, paradoxical bronchospasm, anaphylaxis, oropharyngeal edema, and collapse) and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been observed with the use of Salbutamol.
Salbutamol, like other sympathomimetic agents, can cause vertigo, central nervous system stimulation, angina, hypertension, unusual taste, and drying or irritation of the oropharynx.
Carbocisteine: Carbocisteine is generally safe. The most common adverse effects include nausea, headache, gastric discomfort, and diarrhea. Gastrointestinal bleeding and skin rash has occasionally occurred. Other isolated reports include dizziness, insomnia, myalgia, dyspnea, palpitations, urinary incontinence, mild hypoglycemia, dry mouth, flatulence, atrial fibrillation, and minor psychiatric disturbance.
Drug Interactions
Do not use with other oral sympathomimetic bronchodilators or Epinephrine to avoid deleterious cardiovascular effects.
Concurrent administration with monoamine oxidase (MAO) inhibitors or tricyclic antidepressants may increase the risk of cardiac arrhythmia, tachycardia and increased or decreased blood pressure.
Do not administer with beta-blockers since these agents inhibit Salbutamol's effect.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
R03CK - Adrenergics and other drugs for obstructive airway diseases ; Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Cap (glossy, size #00, green-colored) 100's. Oral susp (homogeneous suspension with the color, odor, and taste of orange) 60 mL.
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