Mucosolvan

Generic name
Brand name
Drug Classification
Subclassification
General chemistry

Ambroxol HCl
Mucosolvan,Ambrolex, RiteMED Ambroxol, Atrivex
Expectorant
Mucolytic,
-metabolite of BROMHEXINE
-Ambroxol hydrochloride is trans-4-[(2-amino-3,5-dibromo-benzyl)amino]
cyclohexanol hydrochloride.
C13H19Br2ClN2O

Gen Mechanism of action

1. enhances pulmonary surfactant production and stimulates ciliary activity

thereby resulting in improved mucus flow and transport
2. May increase theoutput of fluid from therespiratory tract byreducing the
viscosity& surface tension of respiratory secretions,thereby
removingaccumulatedsecretions from upper & lower airway.

ABSORPTION
Absorption
Onset
Duration of action
Cmax
Tmax
Steady state
Bioavailability
First-pass
Protein Binding
Distribution
Distribution
Vd
Metabolism
Metabolism
Metabolites
Excretion
Excretion
t1/2
Indication
contraindication

Rapid and complete absorption

24 hrs (capsules), 8 hrs (tablets)
1-2.5hrs
79%
Yes, first pass metabolism
30%
Distributed from blood to tissue with highest concentrations of the active
substance found in the lungs
552L
metabolized in the liver by glucuronidation
Dibromanthranilic acid
26% in conjugated from excreted in urine
10 hrs
Secretory therapy in acute and chronic bronchopulmonary diseases
associated with abnormal mucus secretion and impaired mucus transport.
hypersensitive to ambroxol or other components of the formulation.

Adverse Effects

Gastric ulceration
mild upper gastro-intestinal side effects (primarily pyrosis, dyspepsia, and
occasionally nausea, vomiting) have been reported, principally following
parenteral administration. Allergic reactions have occurred rarely( primarily
skin rashes)
Immune System Disorder, Skin and Subcutaneous Tissue
Disorders:Anaphylactic reactions including anaphylactic shock,
angioedema, rash, urticaria, pruritus and other hypersensitivity.
Gastrointestinal Disorders: Nausea, vomiting, diarrhea, dyspepsia and
abdominal pain.

Special precautions

There is temporal association of Stevens-Johnson syndrome and toxic

epidermal necrolysis with the administration of expectorants such as
ambroxol. These can be manifested as sever skin lesions and non-specific
influenza-like symptoms.

Drug formulation

Available drug:
Mucosolvan retard capsule 75 mg
Mucosolvan tab 30 mg
Mucosolvan syrup 15mg/5ml or 30mg/5ml

Dosage & Administrations

It contains excipients:
Retard Capsules: Crospovidone collidon CL, carnauba wax, stearyl alcohol,
magnesium stearate.
Tablets: Lactose, maize starch, colloidal silica, magnesium stearate
Retard Capsules: Adults: 1 capsule once daily.
Tablets: Adults: 1 tablet thrice daily.
The therapeutic effect may be enhanced by administering 2 tablets twice
daily.
Syrup 30 mg/5 mL: Adults and Children >12 years: 10 mL (2 tsps) twice
daily.
This regimen is suitable for the therapy of acute respiratory tract disorders
and for the initial treatment of chronic conditions up to 14 days.
Children 6-12 years: 5 mL (1 tsp) 2-3 times daily, 2-5 years: 2.5 mL ( tsp)
thrice daily, 1-2 years: 2.5 mL ( tsp) twice daily. This higher strength
formula is for initial treatment; the dosage may be halved after 14 days.
Syrup 15 mg/5 mL: Adults and Children >12 years: 10 mL (2 tsps) thrice
daily, 6-12 years: 5 mL (1 tsp) 2-3 times daily, 2-5 years: 2.5 mL ( tsp)
thrice daily, <2 years: 2.5 mL ( tsp) twice daily.

Storage

Administration: Mucosolvan can be taken with and without water.

Store at temperatures not exceeding 30C.