Product Information
Registration Status: ActiveDURO-TUSS EXPECTORANT is approved to be sold in Singapore with effective from 1994-02-02. It is marketed by INOVA PHARMACEUTICALS (SINGAPORE) PTE LTD, with the registration number of SIN07632P.
This product contains Bromhexine 12mg/15mL, and Pholcodine 15mg/15mL in the form of ELIXIR. It is approved for ORAL use.
This product is manufactured by Ensign Laboratories Pty Ltd in AUSTRALIA.
It is a Pharmacy Only Medicine that can be obtained from a pharmacist at a retail pharmacy.
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
Pholcodine formula is 3-o-morpholinoethylmorphine and it is classified as an antitussive which is defined as an opioid cough suppressant. It belongs to the opioid family of compounds and it is widely used.[A31738] Pholcodine activity is the suppression of unproductive cough and it also has a mild sedative effect with little or no analgesic effects.[A31742] Pholcodine is not prescribed in the United States where it is classed as a Schedule I drug. It is categorized as Class B drug in the UK and officially taken out of the shelves in 2008. Pholcodine is not approved in Canada.
Indication
Pholcodine is indicated as a cough suppressant for the temporary relief of non-productive dry cough. It is stated to present a required label indication of "temporary relief of dry cough."[L1200] Cough is the respiratory movement that occurs after an irritation signal is transmitted to the central nervous system and further stimulates the medulla oblongata. This stimulation causes a motor output that is sent through motoneurons to the respiratory muscles. A non-productive cough is a type of cough characterized by the absence of sputum, and it has a large inspiration that will cause continuous coughing.
Mechanism of Action
The mechanism of action of pholcodine is directly performed in the medulla oblongata. In this site, it exerts analgesic properties on the peripheric reflexogenic receptors. This site is commonly known as the "cough center."[L1202]
Pharmacokinetics
- Absorption
- After oral administration of 60 mg of pholcodine, the Tmax and Cmax are reported to be 1.3 hours and 26.3 ng/ml. In the same administration, the AUC in plasma and saliva are reported to be 1.67 and 6.61 mg h/l respectively. The absorption of pholcodine is reported to represent approximately 88% of the administered dose.[A31738]
- Distribution
- The reported volume of distribution depends on the pharmacokinetic model and it can be of 265L based on a one-compartment model to 3207L in a two-compartment model.[A31747]
- Metabolism
- The metabolism of pholcodine seems to be very slow[A31747] and due to the elimination profile, it is thought that most of the administered dose undergoes metabolism. There is some evidence in preclinical trials that indicate that morphine is a minor metabolite of pholcodine and that it accounts for 1% of the administered dose.[A31738]
- Elimination
Clearance
After oral administration of 60 mg of pholcodine, the clearance rate was reported to be 126 ml/min.[A31738]
Toxicity
Generally, pholcodine is significantly less toxic than codeine. Nonetheless, it is important to consider the significant depressive respiratory effect.[L1202]
Active Ingredient/Synonyms
Pholcodine | Pholcodine |
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.