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ROBITUSSIN ME SYRUP

Product Information

Registration Status: Active

SIN11973P

ROBITUSSIN ME SYRUP is approved to be sold in Singapore with effective from 2002-04-06. It is marketed by PFIZER PTE LTD, with the registration number of SIN11973P.

This product contains Bromhexine 8mg/10ml, and Guaiphenesin 200mg/10ml in the form of SYRUP. It is approved for ORAL use.

This product is manufactured by INTERPHIL LABORATORIES INC in PHILIPPINES.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. It is the active ingredient of Mucosolvan, Lasolvan or Mucoangin. The substance is a mucoactive drug with several properties including secretolytic and secretomotoric actions that restore the physiological clearance mechanisms of the respiratory tract which play an important role in the body’s natural defence mechanisms. It stimulates synthesis and release of surfactant by type II pneumocytes. Surfactants acts as an anti-glue factor by reducing the adhesion of mucus to the bronchial wall, in improving its transport and in providing protection against infection and irritating agents.

Indication

Ambroxol is indicated as “secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. It promotes mucus clearance, facilitates expectoration and eases productive cough, allowing patients to breathe freely and deeply.

Mechanism of Action

Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

Pharmacokinetics

Absorption
Rapid and almost complete.
Distribution
Metabolism
Elimination

Active Ingredient/Synonyms

Ambroxolum | Bisolvon metabolite vIII | Bromhexine metabolite vIII | Bromhexine-metabolite vIII | Cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)- (E)- | N-(2-Amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol | N-(2-Amino-3,4-dibromocyclohexyl)-trans-4-aminocyclohexanol | trans-4-((2-Amino-3,5-dibromobencil)amino)ciclohexanol | trans-4-((2-Amino-3,5-dibromobenzyl)amine)cyclohexanol | trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol | Ambroxol |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

An expectorant that also has some muscle relaxing action. It is used in many cough preparations. [PubChem]

Indication

Used to assist the expectoration of phlegm from the airways in acute respiratory tract infections.

Mechanism of Action

Guaifenesin may act as an irritant to gastric vagal receptors, and recruit efferent parasympathetic reflexes that cause glandular exocytosis of a less viscous mucus mixture. Cough may be provoked. This combination may flush tenacious, congealed mucopurulent material from obstructed small airways and lead to a temporary improvement in dyspnea or the work of breathing.

Pharmacokinetics

Absorption
Rapidly absorbed from the GI tract
Distribution
Metabolism
Rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite.
Elimination

Toxicity

LD50 1510 mg/kg (rat, oral)

Active Ingredient/Synonyms

Glyceryl guaiacolate | guaiphenesin | Hustosil | Guaifenesin |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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