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Hosolvon DM Elixir

 
Description
Green, vanillin, peppermint and menthol flavoured liquid.


Composition
Each 5 ml contains:

Bromhexine Hydrochloride 4.0 mg

Dextromethorphan Hydrobromide 15.0 mg


Actions and Pharmacology
Bromhexine is a mucolytic used in the treatment of respiratory disorders associated with productive cough, where it changes the structure of bronchial secretions leading to a reduction in the viscosity of sputum.


Dextromethorphan Hydrobromide is a cough suppressant used for the relief of non-productive cough. It has a central action on the cough centre in the medulla. It is also an antagonist of N-methyl-D-aspartate (NMDA) receptors. Dextromethorphan has no classical analgesic properties and little sedative activity.


Pharmacokinetics
Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism in the liver. It is widely distributed to body tissues. About 85 to 90% of a dose is excreted in the urine mainly as metabolites. Bromhexine is highly bound to plasma proteins and has a terminal elimination half-life of up to about 12 hours. It crosses the blood-brain barrier and small amounts cross the placenta.


Dextromethorphan Hydrobromide is rapidly absorbed from the gastrointestinal tract. It is metabolized in the liver excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan. It is reported to act within half an hour of administration by mouth and to exert an effect for up to 6 hours.


Indications
For short term symptomatic relief of cough associated with reduction in sputum viscosity.


Contraindications
This medication is contraindicated with patients with sensitivity to bromhexine and dextromethorphan or other components of the formulation.


The presence of other medical problems may affect the use of this medication. A doctor should be consulted before using this medicine if any other medical problems exist, especially: peptic ulceration, asthma, chronic bronchitis, productive cough, emphysema, diabetes, hepatic function impairment and respiration depression.


Precautions
Bromhexine should be used with care in patients with a history of asthma and peptic ulceration. Clearance of bromhexine or its
metabolites may be reduced in patients with severe hepatic or renal impairment.


Dextromethorphan should not be given to patients at risk of developing respiratory failure and caution is needed in patients with a history of asthma and should not be given during an acute attack.


This medicine may cause drowsiness and dizziness, less alert than normal or to feel a false sense of well being. Patients should know how they react to this medicine before they drive, use machines or doing anything that could be dangerous if they are dizzy or are not alert and clearheaded. Children should be supervised to avoid potential harm in bike riding or other dangerous activities.


Not to be used in children less than 2 years of age. To be used with caution and doctor's advice in children 2 to 6 years of age.


Use in pregnancy and lactation
It is advisable not to use this medication during the first trimester of pregnancy. This medication also should be avoided during lactation.


Main Side/Adverse Effects
The side effects with this medication appear to be rare and may include: gastrointestinal disturbance, transient rise in serum aminotransferase values, headache, drowsiness, dizziness, sweating, skin rashes and occasionally produced cough or bronchospasm in susceptible subjects, confusion, constipation, nausea or vomiting and stomach pain.


Drug Interactions
Concurrent use of this medication with combination products containing any of the following medications, may interact with dextromethorphan: central nervous system (CNS) depressants, monoamine oxidase (MAO) inhibitors including furazolidone,
phenelzine, procarbazine, selegiline and tranylcypromine; other enzyme inhibitors like amiodarone or fluoxetine or quinidine; and
smoking tobacco.


Overdose
Symptoms of overdose:
Ataxia, blurred vision, coma, confusion, drowsiness or dizziness, respiratory depression, severe nausea or vomiting, severe unusual excitement nervousness, restlessness or irritability and urinary retention.


Treatment for overdose:
Treatment is symptomatic and is directed toward the affected body system. Gastric lavage, assisted respiration, vital sign monitoring
and intravenous naloxone are some of the possible prescribed treatment.

Dosage and Administration
Oral.
Adult and children over 12 years: 10 ml (2 teaspoons), 3 times daily.
Children 6 to 12 years: 5 ml (1 teaspoon), 3 times daily.
Children 2 to 6 years: A doctor's direction is recommended as young children have a greater chance of experiencing serious adverse effects.
Children below 2 years: Not recommended.


Patients are advised to use a calibrated measuring device as 5 ml is a rough approximation of one teaspoon and different teaspoons differ in their volume.

 

Storage: Store below 25C. Protect from light.
Presentation/Packing: Plastic bottle of 120 ml.

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