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Carbocisteine is indicated for- Acute bronchitis, Chronic bronchitis, Bronchial asthma, Upper respiratory tract inflammation (pharyngitis, laryngitis), Cystic fibrosis Bronchiectasis, Pulmonary tuberculosis, Drainage in chronic sinusitis and pneumonia, Drainage in otitis media in children.

Cough expectorants & mucolytics

Carbocisteine reduces goblet cell hyperplasia and therefore plays a role in the management of disorders characterised by abnormal mucous. Carbocisteine loosens thick sputum effectively by reducing its viscosity and thereby helps to expectorate that mucus more easily from the respiratory tract. The mucolytic action happens in several mechanisms. It breaks the disulphide bonds, which cross-link certain glycoprotein molecules in the mucus, the mucus produced under the influence of Carbocisteine has high sialomucin and low fucomucin content. This combined effect ultimately reduces the viscosity of the sputum and increases its volume.

Adult: Initially, 2.25 g daily in divided doses, then 1.5 g daily in divided doses as condition improves.
Child: 2-5 year: 62.5-125 mg 4 times daily; 6-12 year 250 mg tid.

Should be taken with food.

Gastrointestinal discomfort, nausea, diarrhoea, gastrointestinal bleeding, palpitation, dizziness, headache, heartburn and skin rash may occur.

Contraindicated in active peptic ulceration and in patients with hypersensitivity to the drug.

No specific precaution is recommended but Carbocisteine should be used with caution in patients with a recent history of peptic ulcer and recurrent gastrointestinal bleeding.

Neither hazardous nor therapeutically useful interactions have been reported.

There is no information on the use of Carbocisteine during lactation. While there are no reports of teratogenic effects, the manufacturers do not recommend the use of Carbocisteine in the first trimester.

Symptoms: GI disturbance.
Management: May perform gastric lavage, followed by observation.

Store in a cool and dry place protected from light.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Antidote preparations, Cough expectorants & mucolytics

Effervescent tablet or Dispersible tablet: Adults and children above 6 years: One effervescent tablet of Acetylcysteine 600 mg a day (preferably in the evening). The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician. Dissolve the tablets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Effervescent Granules:

• Adults and children above 6 years: 1 sachet Acetylcysteine 200 mg or 2 sachets Acetylcysteine 100 mg, 2-3 times a day.
• Children (2-6 years of age): 1 sachet Acetylcysteine 100 mg from 2 to 4 times a day, according to the age.

The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician.

Dissolve the contents of the sachets in a glass containing a small quantity of water; mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Nebuliser Solution: The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for injection, Sodium Chloride for inhalation, sterile water for injection, or sterile water for inhalation.

• Adult: 5-10 ml of 10% or 20% solution by Nebuliser every 6-8 hr PRN.
• Children: 1-11 months: 1-2 ml of 20% or 2-4 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• 12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• Below 12 years: 5-10 ml of 10/20% solution by Nebuliser every 6-8 hr PRN.

** Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10% solution 2-3 times by Nebulisation or by instillation intratracheally prior to procedure.

** Nebulisation tent or croupette: This form of administration requires very large volumes of the solution, occasionally as much as 300 ml during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine (using 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.

** Direct Instillation: When used by direct instillation, 1-2 ml of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution may be given every 1-4 hours by instillation into the tracheostomy.

Like all medicines, Acetylcysteine can cause side effects, although not everybody gets them. In very rare cases, severe immune reactions may occur such as anaphylactic shock and severe skin reaction. In rare cases the oral administration can be followed by shortness of breath, upset stomach and bronchospasm. The most frequent side effects are headache, increased heart rate, stomatitis, pruritus, urticaria, nausea, vomiting, abdominal pain, fever, decrease in the blood pressure, diarrhoea and noises in the ears.

Known hypersensitivity to Acetylcysteine. Acetylcysteine contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria.

Patients suffering from bronchial asthma must be strictly controlled during the therapy; should bronchospasm occur, the treatment must immediately be suspended. Caution should be taken in patients suffering from or with a history of peptic ulcer. As Viscotin contains sodium (156.9mg per dose) this has to be taken into consideration by patients on a controlled sodium diet. The possible presence of a sulphureous odor does not indicate an alteration of the product but is a characteristic of the active ingredient contained in this preparation. It is preferable not to mix other drugs with the Viscotin solution.

The thiol group of Acetylcysteine can reduce the efficacy of certain antibiotics such as ampicillin, tetracycline, macrolides, cephalosporins, aminoglycosides and amphotericin. Concomitant use of Acetylcysteine and amoxicillin will increase the level of the antibiotic in tissues. It is, therefore, advisable to use the two medicines 2 hours apart from each other. Acetylcysteine can increase the inhibitory effect of thrombocyte aggregation and vasodialation by nitroglycerine.

In case of pregnancy & lactation the medicine should be taken consulting physician or pharmacist.

Overdose of Acetylcysteine may cause nausea, vomiting or diarrhoea.

Store in a cool and dry place, protected from light.

Antidote preparations, Cough expectorants & mucolytics

Effervescent tablet or Dispersible tablet: Adults and children above 6 years: One effervescent tablet of Acetylcysteine 600 mg a day (preferably in the evening). The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician. Dissolve the tablets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Effervescent Granules:

• Adults and children above 6 years: 1 sachet Acetylcysteine 200 mg or 2 sachets Acetylcysteine 100 mg, 2-3 times a day.
• Children (2-6 years of age): 1 sachet Acetylcysteine 100 mg from 2 to 4 times a day, according to the age.

The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician.

Dissolve the contents of the sachets in a glass containing a small quantity of water; mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Nebuliser Solution: The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for injection, Sodium Chloride for inhalation, sterile water for injection, or sterile water for inhalation.

• Adult: 5-10 ml of 10% or 20% solution by Nebuliser every 6-8 hr PRN.
• Children: 1-11 months: 1-2 ml of 20% or 2-4 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• 12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• Below 12 years: 5-10 ml of 10/20% solution by Nebuliser every 6-8 hr PRN.

** Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10% solution 2-3 times by Nebulisation or by instillation intratracheally prior to procedure.

** Nebulisation tent or croupette: This form of administration requires very large volumes of the solution, occasionally as much as 300 ml during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine (using 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.

** Direct Instillation: When used by direct instillation, 1-2 ml of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution may be given every 1-4 hours by instillation into the tracheostomy.

Like all medicines, Acetylcysteine can cause side effects, although not everybody gets them. In very rare cases, severe immune reactions may occur such as anaphylactic shock and severe skin reaction. In rare cases the oral administration can be followed by shortness of breath, upset stomach and bronchospasm. The most frequent side effects are headache, increased heart rate, stomatitis, pruritus, urticaria, nausea, vomiting, abdominal pain, fever, decrease in the blood pressure, diarrhoea and noises in the ears.

Known hypersensitivity to Acetylcysteine. Acetylcysteine contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria.

Patients suffering from bronchial asthma must be strictly controlled during the therapy; should bronchospasm occur, the treatment must immediately be suspended. Caution should be taken in patients suffering from or with a history of peptic ulcer. As Viscotin contains sodium (156.9mg per dose) this has to be taken into consideration by patients on a controlled sodium diet. The possible presence of a sulphureous odor does not indicate an alteration of the product but is a characteristic of the active ingredient contained in this preparation. It is preferable not to mix other drugs with the Viscotin solution.

The thiol group of Acetylcysteine can reduce the efficacy of certain antibiotics such as ampicillin, tetracycline, macrolides, cephalosporins, aminoglycosides and amphotericin. Concomitant use of Acetylcysteine and amoxicillin will increase the level of the antibiotic in tissues. It is, therefore, advisable to use the two medicines 2 hours apart from each other. Acetylcysteine can increase the inhibitory effect of thrombocyte aggregation and vasodialation by nitroglycerine.

In case of pregnancy & lactation the medicine should be taken consulting physician or pharmacist.

Overdose of Acetylcysteine may cause nausea, vomiting or diarrhoea.

Store in a cool and dry place, protected from light.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Cough expectorants & mucolytics

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Cough expectorants & mucolytics

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Cough expectorants & mucolytics

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

Mupirocin ointment is indicated for the topical treatment of impetigo (skin diseases) due to Staphylococcus aureus and Streptococcus pyogenes. It is also indicated in folliculitis, furunculosis.

Topical Antibiotic preparations

Mupirocin is a naturally occurring antibiotic. This antibacterial agent is produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of bacteria (e.g. Staphylococcus aureus including methicillin-resistant strains and Streptococcus pyogenes) those responsible for the majority of skin infections. It is also active against gram-negative pathogens, such as Escherichia coli and Haemophilus influenzae. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase.

A small amount of Bactropen ointment should be applied to the affected area 3 times daily for up to 10 days. The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years.

Reported side effects are burning, stinging or pain, itching and some patient may be suffered rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis and increased exudate.

The drug is contraindicated in individuals with a history of hypersensitivity reactions to Mupirocin or any of the components of the preparation.

Mupirocin ointment is not for ophthalmic or intra-nasal use. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. When Mupirocin is used on the face care should be taken to avoid the eyes. This is not suitable in conjunction with cannulae and at the site of central venous cannulation. In the event of a sensitization or severe local irritation from Mupirocin ointment, usage should be discontinued and appropriate alternative therapy for the infection instituted. Mixing of Mupirocin ointment with other preparations causes risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the Mupirocin in the ointment.

No drug interaction has been identified with Mupirocin ointment.

Reproduction studies on Mupirocin ointment in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on it’s use during pregnancy, Mupirocin ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin ointment is administered to a nursing woman.

There is currently limited data with overdose of Mupirocin ointment. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.

Keep below 25° C temperature, protected from light and moisture. Do not keep in freeze. Keep out of the reach of children.

This is indicated in

• Mild to moderate mixed anxiety/depression
• Emotional disturbance
• Sleep disorder
• Gastric problems

Combined anxiolytics & anti-depressant drugs

Nortriptyline hydrochloride is a tricyclic antidepressant. Nortriptyline inhibits the uptake of norepinephrine and serotonin at nerve terminals. In contrast to its parent compound amitriptyline which is equally potent in inhibiting the uptake of norepinephrine and serotonin, Nortriptyline has a greater effect on norepinephrine reuptake than on serotonin reuptake.

Fluphenazine is a tranquilizer of the phenothiazine type with piperazine side chain. Fluphenazine primarily acts as a neuroleptic drug whose main therapeutic effect is believed to reside in potent dopamine (specially D2) receptor antagonism.

Adults: One tablet 2 to 3 times daily.

Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, Malignant Neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride.

It is contraindicated in :

• History of gradual epilepsy or organic brain damage
• Blood dyscrasia
• Severe cardiac insufficiency
• Renal or liver damage
• Patients taking monoamine oxidase inhibitor (MAOI)
• Younger children
• Hypersensitivity to any component of the preparation

Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery.

Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution.

The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast milk.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Sertraline is indicated for the treatment of-

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD).

SSRIs & related anti-depressant drugs

Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.

Adults-
Major depressive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Obsessive-compulsive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

• Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
• Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).

Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.

Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.

Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).

Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.

Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.

Do not store above 30°C. Keep out of the reach of children.

Sertraline is indicated for the treatment of-

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD).

SSRIs & related anti-depressant drugs

Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.

Adults-
Major depressive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Obsessive-compulsive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

• Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
• Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).

Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.

Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.

Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).

Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.

Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.

Do not store above 30°C. Keep out of the reach of children.

Cough expectorants & mucolytics

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Antidote preparations, Cough expectorants & mucolytics

Effervescent tablet or Dispersible tablet: Adults and children above 6 years: One effervescent tablet of Acetylcysteine 600 mg a day (preferably in the evening). The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician. Dissolve the tablets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Effervescent Granules:

• Adults and children above 6 years: 1 sachet Acetylcysteine 200 mg or 2 sachets Acetylcysteine 100 mg, 2-3 times a day.
• Children (2-6 years of age): 1 sachet Acetylcysteine 100 mg from 2 to 4 times a day, according to the age.

The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician.

Dissolve the contents of the sachets in a glass containing a small quantity of water; mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Nebuliser Solution: The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for injection, Sodium Chloride for inhalation, sterile water for injection, or sterile water for inhalation.

• Adult: 5-10 ml of 10% or 20% solution by Nebuliser every 6-8 hr PRN.
• Children: 1-11 months: 1-2 ml of 20% or 2-4 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• 12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• Below 12 years: 5-10 ml of 10/20% solution by Nebuliser every 6-8 hr PRN.

** Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10% solution 2-3 times by Nebulisation or by instillation intratracheally prior to procedure.

** Nebulisation tent or croupette: This form of administration requires very large volumes of the solution, occasionally as much as 300 ml during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine (using 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.

** Direct Instillation: When used by direct instillation, 1-2 ml of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution may be given every 1-4 hours by instillation into the tracheostomy.

Like all medicines, Acetylcysteine can cause side effects, although not everybody gets them. In very rare cases, severe immune reactions may occur such as anaphylactic shock and severe skin reaction. In rare cases the oral administration can be followed by shortness of breath, upset stomach and bronchospasm. The most frequent side effects are headache, increased heart rate, stomatitis, pruritus, urticaria, nausea, vomiting, abdominal pain, fever, decrease in the blood pressure, diarrhoea and noises in the ears.

Known hypersensitivity to Acetylcysteine. Acetylcysteine contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria.

Patients suffering from bronchial asthma must be strictly controlled during the therapy; should bronchospasm occur, the treatment must immediately be suspended. Caution should be taken in patients suffering from or with a history of peptic ulcer. As Viscotin contains sodium (156.9mg per dose) this has to be taken into consideration by patients on a controlled sodium diet. The possible presence of a sulphureous odor does not indicate an alteration of the product but is a characteristic of the active ingredient contained in this preparation. It is preferable not to mix other drugs with the Viscotin solution.

The thiol group of Acetylcysteine can reduce the efficacy of certain antibiotics such as ampicillin, tetracycline, macrolides, cephalosporins, aminoglycosides and amphotericin. Concomitant use of Acetylcysteine and amoxicillin will increase the level of the antibiotic in tissues. It is, therefore, advisable to use the two medicines 2 hours apart from each other. Acetylcysteine can increase the inhibitory effect of thrombocyte aggregation and vasodialation by nitroglycerine.

In case of pregnancy & lactation the medicine should be taken consulting physician or pharmacist.

Overdose of Acetylcysteine may cause nausea, vomiting or diarrhoea.

Store in a cool and dry place, protected from light.