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₹48

Ambroxal HCL 7.5 mg, Guaiphenesin 12.5 mg, Terbutaline Sulphate 0.25 mg Drops


Indications

Cough and cold , allergic rhinitis.

Mechanism Of Action

Ambroxol hydrochloride comes in the category of mucokinetic, they are the drugs that reduce the cough viscosity and facilitates its removal by coughing. Terbutaline is a bronchodilator, it relieves cough in individuals where it is caused due to bronchospasm. It also improves the effectiveness of cough in clearing secretions by increasing the surface velocity of airflow during coug. It should only be used when element of bronchoconstriction is present. They cause bronchodilation through beta 2 receptors stimulation which leads to increased CAMP formation in bronchial muscle cells which further leads to relaxation and in addition increased cAMP in mast cells and other inflammatory cells decrease mediator release.

Guaiphenesin a plant product which enhances the bronchial secretion and reduce its viscosity, allowing ciliary movement to carry the loosened secretions upward toward the pharynx. The increased flow of less viscous secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent. By reducing the viscosity and adhesiveness of secretions, guaifenesin increases the efficacy of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway

Pharmacology

Pharmacodynamics

Pharmacokinetics:
Ambroxol:
Absorption: Ambroxol is rapidly absorbed (70-80%) after oral administration. The time to reach peak plasma concentration is approximately 2 hours.
Distribution: The distribution half-life of ambroxol is around 1.3 hours.
Metabolism: Metabolite is dibromoanthranilic acid (activity unspecified).
Excretion: Excretion is primarily via the kidneys. Renal clearance (rate) is approximately 53 ml/minute; approximately 5-6% of a dose is excreted unchanged in the urine. The elimination half-life of ambroxol is biphasic, with an alpha half-life of 1.3 hours and a beta half-life of 8.8 hours.

Guaiphenesin:
Absorption: Guaiphenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information regarding its pharmacokinetics is available. After the administration of 600 mg Guaiphenesin to healthy adult volunteers, the Cmax was approximately 1.4ug/ml, with tmax occurring approximately 15 minutes after drug administration.
Distribution: No information is available on the distribution of Guaiphenesin in humans. Metabolism and elimination: Guaiphenesin appears to undergo both oxidation and demethylation. Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours. Pharmacokinetics in Renal/Hepatic Impairment: There have been no specific studies of Guaiphenesin in subjects with renal or hepatic impairment. Caution is therefore recommended when administering this product to subjects with severe renal or hepatic impairment.

Terbutaline has approximately 30-50% if administered orally elimination half-life of terbutaline was approximately 3.4 hours
About 90% of the drug was excreted in the urine at 96 hours, with about 60% of this being unchanged drug. It appears that the sulfate conjugate is a major metabolite of terbutaline and urinary excretion is the primary route of elimination

Contraindications

Ambroxol Hydrochloride should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution Contraindicated in conditions like Thyrotoxicosis, Ischaemic heart disease, Haemorrhage, Taxaemia. It is used with caution in patients with renal disorders, liver diseases, heart diseases, diabetes, epilepsy, hyperthyroidism and hypertension.
Patients with diabetes, hypertension, arrhythmia, hyperthyroidism and myocardial insufficiency.

Warning and Precautions

Use with caution in elderly patients, usually starting at the low end of the dosage range because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Terbutaline sulfate is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness

Drug Interactions

Guaiphenesin and Terbutaline may interact with naloxone, furosemide, oxycodone, sildenafil citrate, cetirizine, ipratropium, cephalexin, tiotropium, bisacodyl, ascorbic acid, budenoside, nitroglycerine, docusate, albuterol, ampicillin, probenecid, activated charcoal, succinyl choline, alprazolam and beta-blocker Terbutaline also should not be given with caffeine, decongestants, tricyclic anti-depressants, beta-blockers, MAOIs and diet pills.

Undesirable Effects

Though well tolerated side effects may headache; dizziness or light-headedness; insomnia; tremor or nervousness; sweating; nausea, vomiting, skin rash, urticaria, Transient elevations in serum aminotransferase levels,Nocturnal enuresis

Overdosage

Overdose may result into chronic side effects such a s hyperglycemia, nausea or vomiting, renal lithiasis, palpitations, muscle cramps, anxiety, flushes, vomiting, tinnitus, transient hypokalemia and tachycardia.
Symptomatic treatment should be provided and usage must be terminated.

Shelf Life

24 Months

Storage & Handling Instrutions

Store below 30°C. Protect from light & moisture.
Keep it out of reach of children

Contact Details

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