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SP-BROM ELIXIR

Product Information

Registration Status: Active

SIN10897P

SP-BROM ELIXIR is approved to be sold in Singapore with effective from 1999-04-26. It is marketed by LUEN WAH MEDICAL COMPANY (SINGAPORE) PTE LTD, with the registration number of SIN10897P.

This product contains Bromhexine 4mg/5ml, and Ephedrine 7.5mg/5ml in the form of ELIXIR. It is approved for ORAL use.

This product is manufactured by SUNWARD PHARMACEUTICAL PTE LTD in SINGAPORE.

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 alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used in the treatment of several disorders including asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.

Indication

Ephedrine commonly used as a stimulant, appetite suppressant, concentration aid, decongestant, and to treat hypotension associated with anaesthesia.

Mechanism of Action

Ephedrine is a sympathomimetic amine - that is, its principal mechanism of action relies on its direct and indirect actions on the adrenergic receptor system, which is part of the sympathetic nervous system. Ephedrine increases post-synaptic noradrenergic receptor activity by (weakly) directly activating post-synaptic α-receptors and β-receptors, but the bulk of its effect comes from the pre-synaptic neuron being unable to distinguish between real adrenaline or noradrenaline from ephedrine. The ephedrine, mixed with noradrenaline, is transported through the noradrenaline reuptake complex and packaged (along with real noradrenaline) into vesicles that reside at the terminal button of a nerve cell. Ephedrine's action as an agonist at most major noradrenaline receptors and its ability to increase the release of both dopamine and to a lesser extent, serotonin by the same mechanism is presumed to have a major role in its mechanism of action.

Pharmacokinetics

Absorption
85%
Distribution
Metabolism
Elimination

Toxicity

Cardiovascular: tachycardia, cardiac arrhythmias, angina pectoris, vasoconstriction with hypertension

Active Ingredient/Synonyms

(-)-Ephedrine | (1R,2S)-1-Phenyl-1-hydroxy-2-methylaminopropane | L-Ephedrine | L-erythro-2-(Methylamino)-1-phenylpropan-1-ol | L(−)-ephedrine | Ephedrine |


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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