Composition: Bromhexine Hydrochloride BP 4mg in 2ml.
Description: Mucolex injection is a clear, colourless solution.
Action & mode or mechanisms of actions: Bromhexine is a systematically active mucolytic agent. The onset of action clinically manifested by an increase in sputum production becomes evident within 15 minutes. The breakdown of acid mucopolysaccharide fibres makes the sputum thinner and less viscid and therefore more easily removed by coughing. Although sputum volume eventually decreases, its viscosity remains low as long as removed by coughing. Although sputum volume eventually decreases, its viscocity remains low as treatment with bromhexine is maintained. There is also an increased response to brochodilator drugs.
Pharmacology: 50-60% of the administered dose is excreted in the first 12 hours and a further 30-40% is excreted within 4 days. Total excretion amounts to about 90% of the administered dose, most of which is excreted in the urines as metabolites.
Indications: Secretolytic therapy in acute and chronic bronchopulmonary
disease with abnormal mucus secretion and impaired mucus transport.
Contraindications: Should not be used in patients known to be hypersensitive to bromhexine.
Side effects/adverse reactions: Ocassional gastrointestinal side effects, like nausea, diarrhoea, indigestions and abdominal fullness may occur but these are mild and do not necessitate withdrawal of treatment. Isolated instances of headache, vertigo, perspiration and skin rash have also been reported. In a very few patients, a transient rise in serum transaminase levels may be observed but these fall again with continuation of bromhexine treatment. Note: Patients being treated with Bromhexine should be warned to expect an increase in the flow of secretions.
Precautions/warnings: Use with caution in patients with gastric ulceration. When patients under treatment for tuberculosis are receiving Bromhexine, continue the sputum culture for the tubercle bacilli for at least three months before assuming a negative result.
Use in Pregnancy: Dysmophogenicity studies in animals have given no suggestion that Bromhexine has any teratogenic potential in humans. Nevertheless, as with any drug, it is advisable its use during the first trimester of pregnancy.
Use in Lactation: No information of lactating women is available but excretion of the drug into breast milk cannot be excluded. Hence, bromhexine should not be given during the lactating period.
Drug interactions: Administration of Bromhexine together with antibiotics (amoxicillin. cefuroxine, erythromycin, doxycycline) leads to higher antibiotic concentration in the lung tissue. No clinical relevant unfavourable interaction with other medications have been reported.
Warning for Sodium Metabisulphite: This preparation contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulphite sensitivity in the general population is unknown and probably low. Sulphite sensitivity is seen more frequently in asthmatic than non asthmatic people.
Rrecommended dosage, dosage, schedule & route of administration: The administration of Bromhexine ampoules is recommended for the treatment of the most severe cases as well as for reducing post operative complications. In severe cases as well as before and after surgical intervention, 1 amp. intravenously (duration of injection 2 - 3 minutes) or deep intramuscularly, 2 - 3 times a day.
The injection solution can also be given as an i.v. infusion together with glucose, levulose or Ringer's solution. Bromhexine should not be mixed with alkaline solution as the acid character of Bromhexine solution (pH 2.8) may cause cloudiness or flocculation.
Route of Administration: By i.m., i.v. or infusion.
Symptoms and treatment for overdosage and antidote: Overdosage in man has not been reported. Should overdosage occur, symptomatic treatment is recommended.
Packing/pack sizes: 10 amps x 2m1; 30 amps x 2m1; 50 amps x 2m1; 100 amps x 2m1.
Store below 25°C. Protect from light. Shelf life 3 years.
Keep out of reach of children