MUCOXIN TABLET: A round scored tablet, blue in colour, 7mm diameter with
MUCOXIN SYRUP: A clear, green syrup.
MUCOXIN TABLET: Each tablet contains Bromhexine Hydrochloride 8 mg.
MUCOXIN SYRUP: Each 5 ml syrup contains Bromhexine Hydrochloride 4 mg.
Preservatives: Methyl Paraben 0.1%; Propyl Paraben 0.033%
Bromhexine hydrochloride is a mucolytic. It has been shown to enhance the
transport of mucus by reducing its viscosity and by activating the ciliated
epithelium (mucociliary clearance). Preclinical studies show that there is
an increase in the amount of thin watery bronchial secretion.
Enteric absorption of bromhexine in man is relatively rapid, with an
absorption half-life of 0.4 hours. Peak blood levels are reached within
approximately 1 hour after oral administration. Bromhexine undergoes
extensive first-pass metabolism with at least ten metabolites identified.
Food eaten before administration of bromhexine enhances bioavailability.
Following oral administration, bromhexine shows dose-linearity in the dose
range 8-32 mg. There is a high level of protein binding and a large
distribution volume. Bromhexine accumulates in the lung rather than in the
plasma. The dominant elimination half-life is 1 hour; the terminal
elimination half-life is 13-40 hours. Following oral administration of 8 mg,
the plasma levels fell after 8-12 hours to 1.5 ng/mL and 0.2 ng/mL,
respectively. For the most part, bromhexine is excreted in the urine as
metabolites that pass through the kidneys while only minor amounts of parent
compound are found in unchanged form in the urine. After 24 hours and 5
days, 70 and 88% of the oral dose respectively is recovered in the urine, 4%
is excreted with the faeces. Bromhexine does not accumulate, as the long
terminal elimination half-life is not dominant. Steady state levels are
reached after three days at the latest. Reduced clearance of bromhexine
parent substance can be expected in the case of severe liver disease; in the
case of severe renal insufficiency accumulation of metabolites cannot be
ruled out; pharmacokinetic studies for these conditions are not available.
For use as a mucolytic in conditions such as bronchitis and emphysema.
Adults: 10 mL (8 mg) three times a day. May be increased to 16
mg (20 mL) three times a day for the first seven days.
Over the age of three years: 10 mL (8 mg) three times a day. 1 - 3 years: 5
mL (4 mg) three times a day. Not recommended for children under 1 year.
Adults: Initially two tablets (16 mg) three times a day for
the first seven days.
Maintenance: One tablet (8 mg) three times a day.
Over the age of three years: one tablet (8 mg) three times a day.
1 - 3 years: half a tablet (4 mg) three times a day.
Not recommended for children under 1 year.
Hypersensitivity to Bromhexine or any ingredients of the tablet or elixir.
WARNING & PRECAUTIONS
Mucoxin should be used with caution in patients with severe liver disease
and severe renal failure (refer Pharmacokinetics). Use with caution in
patients with gastric ulceration. Patients should be advised to expect an
increase in the flow of mucus secretions.
INTERACTION WITH OTHER MEDICATIONS
Bromhexine may increase the concentration of currently administered
antibiotics (for example - amoxycillin, erythromycin, doxycycline and
cefuroxime) in bronchial secretions and lung tissue. No clinically relevant
unfavourable interactions with other indications have been reported.
USE IN PREGNANCY & LACTATION
Use in Pregnancy: Available preclinical studies as well as clinical
experience to date have shown no evidence of ill-effects during pregnancy.
However, the usual precautions regarding the use of drugs during pregnancy,
especially during the first trimester, should be observed.
Use in Lactation: Bromhexine is expected to enter the breast milk.
Therefore, Mucoxin should be avoided during the lactation period.
Occasional gastrointestinal side effects like nausea, diarrhoea, indigestion
and abdominal fullness may occur with bromhexine, but these are mild and do
not necessitate withdrawal of treatment. Very rarely allergic reactions
including skin rashes, bronchospasm, angio-oedema, and anaphylaxis have also
SYMPTOMS AND TREATMENT OF OVERDOSE
Overdosage in humans has not been reported. Should overdosage occur,
symptomatic treatment is recommended.
Store below 25°C. Protect from light. Keep out of reach of children.
Tablets: 100 x 10's in blister pack. Loose pack 500 tabs for export
Syrup: Bottles of 60ml, 90m1, 100ml and 120ml.
Please refer to outer package.