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Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

This IV preparation is intended as a supplement for intravenous nutrition in order to meet the daily requirements of the water-soluble vitamins in infants, children and adults.

Specific combined vitamin preparations

This IV preparation is a sterile, lyophilized powder of water soluble vitamins for infusion. It contains balanced amount of all the important water soluble vitamins which act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells. Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action.

Adults and children weighing 10 kg or more: 1 vial (10 ml) daily.
Children weighing less than 10 kg: should be given 1 ml of the dissolved mixture per kg body weight/day.

The contents of one vial are dissolved by the aseptic addition of 10 ml of one of the following:

• Water for injection
• Fat emulsion 10%
• Glucose solution for infusion (5% to 60%)
• Normal saline (0.9% Sodium Chloride)

This IV preparation may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements provided that compatibility and stability have been confirmed.

Allergic reactions may occur in patients hypersensitive to any component of the preparation, e.g. Thiamine.

Known hypersensitivity to any of the components, e.g. Thiamine.

This IV preparation is diluted with water-based solutions, the admixture should be protected from light. This is not necessary if this IV preparation is diluted with intralipid because of the protective effect of the fat emulsion.

Vitamin B6 can reduce the effect of levodopa. Folic acid may lower the serum concentration of phenytoin.

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with this preparation. However, there are published reports on safe administration of water soluble vitamins in this patient group.

No adverse effects of an overdose of water soluble multivitamin have been reported, with exception of cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if the content of This IV preparation is dissolved in another multivitamin injection.

Before reconstitution: Store below 25° C. Protect from light. After reconstitution: The reconstituted IV preparation should be added to the infusion solution aseptically immediately before the start of the infusion & used within 24 hours.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. 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.

SSRIs & related anti-depressant drugs

Citalopram is bicyclic phthalane derivative and a selective serotonin re-uptake inhibitor, with little or no effect on noradrenaline, dopamine and GABA re-uptake. The inhibitory activity explains the antidepressant property of citalopram. It has no or very low affinity for 5-HT_1AA, 5-HT_2A, D₁ and D₂ receptors, α₁, α₂, β-adrenergic, histamine H₁, muscarinic, cholinergic, benzodiazepine and opioid receptors.

Depression, Depressive phase of bipolar disorder:

• Adult: Initially, 20 mg/day, increased to max 40 mg/day after at least 1 wk.
• Child: Contraindicated.
• Elderly: 10 mg/day. Max: 20 mg/day.

Panic disorder with or without agoraphobia:

• Adult: Initially, 10 mg/day, increased to 20 mg/day after 1 wk.
• Child: Contraindicated.
• Elderly: 10 mg/day. Max: 20 mg/day.

SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. However, side-effects may be seen, includes gastro-intestinal effects (nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss, palpitations, tachycardia, postural hypotension, cough, confusion, impaired concentration, amnesia, urinary retention, sweating, movement disorders, urticaria, anaphylaxis, arthralgia, myalgia and photosensitivity.

Citalopram should not be used if the patient enters a manic phase. Concomitant use in patients taking MAO inhibitor is contraindicated. Citalopram is contraindicated in patients with a hypersensitivity to this drug or any of its ingredients.

Caution should be taken in patients with epilepsy, concurrent electroconvulsive therapy, history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, history of bleeding disorders, hepatic and renal impairment. Abrupt withdrawal of Citalopram should be avoided.

Ketoconazole, Itraconazole or Macrolide antibiotics and Citalopram co-administration decreases the metabolism of Citalopram. Omeprazole and Citalopram co-administration might decrease the clearance of Citalopram.

Pregnancy: There are no adequate and well-controlled studies in pregnant women; therefore, Citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Citalopram is excreted in human breast milk. So, the decision whether to continue or discontinue either nursing or Citalopram therapy should take into account the risks of Citalopram exposure for the infants and the benefits of Citalopram treatment for the mother.

Symptoms: Dizziness, sweating, nausea, vomiting, tremor, somnolence and sinus tachycardia. Rarely, amnesia, confusion, coma, seizures, hyperventilation, cyanosis, rhabdomyolysis and ECG changes (e.g. QT prolongation, sinus bradycardia, ventricular arrhythmias, nodal rhythm, torsade de pointes and left bundle branch block).

Management: Symptomatic and supportive treatment. Maintain and ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Frequently monitor cardiac function and vital signs.

Store at 25° C.

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.

Elderly: No specific dosage recommendations.

Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.

As an antihistamine in allergy:

• Children of 2-5 years: 5-15 mg
• Children of 5-10 years: 10-25 mg
• In the case where two doses in 24 hours are required, the lower dose stated should be given.

As a sedative:

• Children of 2-5 years: 15-20 mg
• Children of 5-10 years: 20-25 mg
• Given as a single night-time dose

• Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
• Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
• Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
• Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
• Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
• Eye Disorders- Frequency unknown: Blurred vision
• Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
• Renal and Urinary Disorders- Frequency unknown: Urinary retention
• Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
• Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
• Vascular disorders- Frequency unknown: Hypotension
• Hepatobiliary disorders- Frequency unknown: Jaundice
• General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.

There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.

Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Apremilast is indicated for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Disease-modifying antirheumatic drugs (DMARDs)

Apremilast is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, apremilast increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.

The recommended initial dosage titration of Apremilast from Day 1 to Day 5 is shown below. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Apremilast can be administered without regard to meals.

Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily

Dosage adjustment in patients with severe renal impairment. Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Apremilast be titrated using only the morning schedule and the evening doses be skipped.

The most frequently occurring side effects of Apremilast are nausea, diarrhea and headache. Other less frequent side effects are upper respiratory tract infection, vomiting, naospharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.

Apremilast is contraindicated in patients with a known hypersensitivity to Apremilast or to any of the excipients in the formulation.

Treatment with Apremilast is associated with an increase in adverse reactions of depression. Patients, their caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Apremilast if such events occur.

During the controlled period of the studies in psoriatic arthritis, weight decrease between 5-10% of body weight was reported in 10% of subjects treated with Apremilast 30 mg twice daily compared to 3.3% treated with placebo.

Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Apremilast.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Apremilast is not recommended.

Pregnancy Category C. It is not known whether Apremilast or its metabolites are present in human milk; however, Apremilast was detected in milk of lactating mice. Caution should be exercised when Apremilast is administered to a nursing woman.

Use in Paediatric patient: The safety and effectiveness of Apremilast in paediatric patients less than 18 years of age have not been established.

Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.

Apremilast is indicated for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Disease-modifying antirheumatic drugs (DMARDs)

Apremilast is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, apremilast increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.

The recommended initial dosage titration of Apremilast from Day 1 to Day 5 is shown below. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Apremilast can be administered without regard to meals.

Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily

Dosage adjustment in patients with severe renal impairment. Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Apremilast be titrated using only the morning schedule and the evening doses be skipped.

The most frequently occurring side effects of Apremilast are nausea, diarrhea and headache. Other less frequent side effects are upper respiratory tract infection, vomiting, naospharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.

Apremilast is contraindicated in patients with a known hypersensitivity to Apremilast or to any of the excipients in the formulation.

Treatment with Apremilast is associated with an increase in adverse reactions of depression. Patients, their caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Apremilast if such events occur.

During the controlled period of the studies in psoriatic arthritis, weight decrease between 5-10% of body weight was reported in 10% of subjects treated with Apremilast 30 mg twice daily compared to 3.3% treated with placebo.

Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Apremilast.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Apremilast is not recommended.

Pregnancy Category C. It is not known whether Apremilast or its metabolites are present in human milk; however, Apremilast was detected in milk of lactating mice. Caution should be exercised when Apremilast is administered to a nursing woman.

Use in Paediatric patient: The safety and effectiveness of Apremilast in paediatric patients less than 18 years of age have not been established.

Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.

Iodine compounds (Anti-septic Preparations)

Povidone Iodine is a complex of iodine and an organic polymer, povidone. This polymerization makes Povidone Iodine superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly. Consequently it has a lower toxicity than elemental iodine. It gives rapid microbicidal activity against both Gram-positive and Gram-negative bacteria, protozoa, viruses and fungi/yeasts. It is also sporicidal. It is the only microbicide with this broad spectrum of activity. It is non-staining, exerts prolong germicidal action and is also active in the presence of soap, blood, serum, pus, mucosal secretions and water.

Cream or ointment:

• For the treatment of infection: Apply once or twice daily or at dressing changes for a maximum of 14 days.
• For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried and can be covered with a dressing or bandage.

Solution: Apply full strength as often as needed as paint, spray, or wet soak. Maybe bandaged (where necessary).

Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.

Surgical Scrub:

• For Preoperative and Postoperative washing by Operating Personnel: Wet hands and forearms with water. Pour about 5 mL of Povidone Iodine Surgical Scrub on the palm of the hand and spread over both hands and forearms. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use a brush if desired. Clean thoroughly under fingernails. Add a little water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL of Povidone Iodine Surgical Scrub in the same way.
• For Preoperative use on Patients: After the skin area is shaved, wet it with water. Apply Povidone Iodine Surgical Scrub (1 mL is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water.
• For use in the Physician's Office: Use for washing whenever a germicidal soap is required.

Powder: Apply a light dusting of powder to the affected area. When dry, this forms a protective antiseptic layer over the area treated. Or use as advised by the Registered Physician. There are no special dosage recommendations for children or elderly patients.

Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.

Povidone Iodine may cause hypersensitivity reactions and irritation of the skin and mucous membranes. The application of povidone Iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. It may interfere with thyroid function tests.

It can cause hypersensitivity reactions. Regular use in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis) or those receiving lithium therapy is to be avoided. In severely burnt patients serum iodide levels should be assessed due to possible hepatic and renal impairment. Povidone Iodine Powder should not be used in serious cavities and in Children under the age of 2 years.

Cream or ointment: In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.

Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.

Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.

Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.

It exhibits interaction with strong alkali, sodium thiosulphate, sodium metabisulphite and thiomersal. Use with concurrent lithium therapy has been shown to exhibithypothyroidic effect.

Povidone Iodine Cream, Solution & Powder are not recommended for use during pregnancy because of the possibility of absorption of sufficient iodine to affect the fetal thyroid. American Academy of Pediatrics considers that the use of Povidone-Iodine is usually compatible with breast feeding. Consult Registered Physician. Regular use of Gargle & Mouthwash and Surgical Scrub should also be avoided in pregnant and lactating women.

There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

Store below 25°C. Do not freeze. Store in a cool and dry place, protected from light. Keep out of the reach of children. Do not touch the ophthalmic solution dropper tip to any surface as this may contaminate this preparation. Do not use it after one month of the first opening.

Anti-malarial drugs

This preparation contains a fixed ratio of 1:6 parts of Artemether and Lumefantrine respectively. Artemether is a derivative of naturally occurring substance Artemisinin. Lumefantrine is a synthetic racemic fluorine mixture belonging to the aryl amino alcohol family like other anti-malarials (e.g. Quinine, mafloquine, halofantrine). Both components act in the food vacuoles of malarial parasites, where they are thought to interfere with the conversion of haem, a toxic intermediate formed during haemoglobin breakdown, to the non-toxic haemozin (a malaria pigment). Lumefantrine is thought to interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between the peroxide bridge and haem iron. Both Artemether and Lumefantrine have a secondary action involving inhibition of nucleic acid - protein synthesis within the malarial parasites. This tablet did not induce resistance. This tablet is active against blood stages of Plasmodium vivax, but it is not active against hypnozoites. Therefore, sequential treatment with premaquine should be used to achieve hypnozoite eradication.

Patients with acute malaria are frequently averse to food. The dose should be taken with high fat food or drinks such as milk. In the event of vomiting within 1 hour of administration a repeat dose should be taken.

Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).

5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).

15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).

25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).

It is generally very well tolerated by children and adults, with most adverse effects are of mild to moderate severity and duration. Hypersensitivity, headache, dizziness, sleep disorder, somnolence, involuntary muscle contractions, paraesthesia, hypoesthesia, abnormal gait, ataxia, palpitation, cough, abdominal pain, anorexia, diarrhoea, vomiting, nausea, pruritus, rash, arthralgia, myalgia, asthenia, fatigue.

Hypersensitivity to any of the ingredients or excipients; Patients with severe malaria according to WHO definition; First trimester of pregnancy; Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrythmias with clinically relevant bradycardia or with severe cardiac disease; Patients with known disturbance of electrolyte balance e.g. hypokalaemia or hypomagnesemia; Patients taking any drug which is metabolized by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).

This has not been evaluated for prophylaxis and is therefore not indicated. This is also not evaluated for the treatment of cerebral malaria or other severe manifestations of severe malaria including pulmonary oedema or renal failure.

No such result is available.

Use in pregnancy & lactation is contraindicated; especially in the first trimester of pregnancy. Breast feeding women should not take this preparation. Due to the long elimination half-life of Lumefantrine (4-6 days), it is recommended that breast feeding should not resume before day 28 unless potential benefits to the mother and child outweigh the risk of treatment.

In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.

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

Anti-malarial drugs

This preparation contains a fixed ratio of 1:6 parts of Artemether and Lumefantrine respectively. Artemether is a derivative of naturally occurring substance Artemisinin. Lumefantrine is a synthetic racemic fluorine mixture belonging to the aryl amino alcohol family like other anti-malarials (e.g. Quinine, mafloquine, halofantrine). Both components act in the food vacuoles of malarial parasites, where they are thought to interfere with the conversion of haem, a toxic intermediate formed during haemoglobin breakdown, to the non-toxic haemozin (a malaria pigment). Lumefantrine is thought to interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between the peroxide bridge and haem iron. Both Artemether and Lumefantrine have a secondary action involving inhibition of nucleic acid - protein synthesis within the malarial parasites. This tablet did not induce resistance. This tablet is active against blood stages of Plasmodium vivax, but it is not active against hypnozoites. Therefore, sequential treatment with premaquine should be used to achieve hypnozoite eradication.

Patients with acute malaria are frequently averse to food. The dose should be taken with high fat food or drinks such as milk. In the event of vomiting within 1 hour of administration a repeat dose should be taken.

Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).

5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).

15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).

25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).

It is generally very well tolerated by children and adults, with most adverse effects are of mild to moderate severity and duration. Hypersensitivity, headache, dizziness, sleep disorder, somnolence, involuntary muscle contractions, paraesthesia, hypoesthesia, abnormal gait, ataxia, palpitation, cough, abdominal pain, anorexia, diarrhoea, vomiting, nausea, pruritus, rash, arthralgia, myalgia, asthenia, fatigue.

Hypersensitivity to any of the ingredients or excipients; Patients with severe malaria according to WHO definition; First trimester of pregnancy; Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrythmias with clinically relevant bradycardia or with severe cardiac disease; Patients with known disturbance of electrolyte balance e.g. hypokalaemia or hypomagnesemia; Patients taking any drug which is metabolized by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).

This has not been evaluated for prophylaxis and is therefore not indicated. This is also not evaluated for the treatment of cerebral malaria or other severe manifestations of severe malaria including pulmonary oedema or renal failure.

No such result is available.

Use in pregnancy & lactation is contraindicated; especially in the first trimester of pregnancy. Breast feeding women should not take this preparation. Due to the long elimination half-life of Lumefantrine (4-6 days), it is recommended that breast feeding should not resume before day 28 unless potential benefits to the mother and child outweigh the risk of treatment.

In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.

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

Anti-malarial drugs

This preparation contains a fixed ratio of 1:6 parts of Artemether and Lumefantrine respectively. Artemether is a derivative of naturally occurring substance Artemisinin. Lumefantrine is a synthetic racemic fluorine mixture belonging to the aryl amino alcohol family like other anti-malarials (e.g. Quinine, mafloquine, halofantrine). Both components act in the food vacuoles of malarial parasites, where they are thought to interfere with the conversion of haem, a toxic intermediate formed during haemoglobin breakdown, to the non-toxic haemozin (a malaria pigment). Lumefantrine is thought to interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between the peroxide bridge and haem iron. Both Artemether and Lumefantrine have a secondary action involving inhibition of nucleic acid - protein synthesis within the malarial parasites. This tablet did not induce resistance. This tablet is active against blood stages of Plasmodium vivax, but it is not active against hypnozoites. Therefore, sequential treatment with premaquine should be used to achieve hypnozoite eradication.

Patients with acute malaria are frequently averse to food. The dose should be taken with high fat food or drinks such as milk. In the event of vomiting within 1 hour of administration a repeat dose should be taken.

Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).

5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).

15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).

25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).

It is generally very well tolerated by children and adults, with most adverse effects are of mild to moderate severity and duration. Hypersensitivity, headache, dizziness, sleep disorder, somnolence, involuntary muscle contractions, paraesthesia, hypoesthesia, abnormal gait, ataxia, palpitation, cough, abdominal pain, anorexia, diarrhoea, vomiting, nausea, pruritus, rash, arthralgia, myalgia, asthenia, fatigue.

Hypersensitivity to any of the ingredients or excipients; Patients with severe malaria according to WHO definition; First trimester of pregnancy; Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrythmias with clinically relevant bradycardia or with severe cardiac disease; Patients with known disturbance of electrolyte balance e.g. hypokalaemia or hypomagnesemia; Patients taking any drug which is metabolized by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).

This has not been evaluated for prophylaxis and is therefore not indicated. This is also not evaluated for the treatment of cerebral malaria or other severe manifestations of severe malaria including pulmonary oedema or renal failure.

No such result is available.

Use in pregnancy & lactation is contraindicated; especially in the first trimester of pregnancy. Breast feeding women should not take this preparation. Due to the long elimination half-life of Lumefantrine (4-6 days), it is recommended that breast feeding should not resume before day 28 unless potential benefits to the mother and child outweigh the risk of treatment.

In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.

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

Anti-malarial drugs

Artesunate is metabolized to the active DHA. the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the Plasmodium parasites during all erythrocytic stages. Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase.

It is to be given by oral route. The oral dose of Artesunate tablet can be defined as follows:

For Artesunate 50 mg tablet:
Adults:

• Two Artesunate 50 tablets twice on the first day, then
• one Artesunate 50 tablet twice daily for the next four days (4, 2, 2, 2, 2)

Children:

• 1-3 years: 3 Artesunate 50 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
• 4-5 years: 6 Artesunate 50 tablets for 5 days (2, 1, 1, 1, 1)
• 6-12 years: 8 Artesunate 50 tablets for 5 days (3, 2, 1, 1, 1)

For Artesunate 100 mg tablet:
Adults: One Artesunate 100 tablet twice on the first day, then half Artesunate 100 tablet twice daily for the next four days (2, 1, 1, 1, 1)

Children:

• 4-5 years: 3 Artesunate 100 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
• 6-12 years: 4 Artesunate 100 tablets for 5 days (11⁄2,1,1⁄2,1⁄2,1⁄2)
• Patients aged more than 12 years: should be given same as adult dose.

Dosage for the prevention of malaria: Two Artesunate 50 tablets (or one Artesunate 100 tablet) as a single dose once a week, from one week before entering a malaria-affected area to four weeks after leaving the area.

Artesunate tablet is well tolerated. No adverse effects have been reported from the treatment of artesunate at recommended dose.

Artesunate is contraindicated for patients with known hypersensitivity to Artemisinin and its derivatives or its inactive ingredients.

Artesunate may have interaction with other artemisinin drugs i.e. artemether, arteether which have the same effect in prolonging the PQ and QT interval. It has interaction when it is given with other antimalarial drugs (eg. Quinine, quinidine, mafloquine and halofantrine) which have cardiac action. It also has interaction with other drugs which prolong QT interval (such as erythromycin, terfenadine, astemizole, probucol, procainamide, disopyramide, amiodarone, bretylium, bepridil, sotalol, tricyclic antidepressants and neuroleptics).

A WHO report assessing the safety of artemisinin derivatives in pregnancy concluded that these drugs should continue to be available for the treatment of malaria in pregnancy, irrespective of the trimester. WHO also stressed that further study was needed. Therefore Artesunate tablet should be given to pregnant women especially, in first trimester if recommended by Registered Physician. Like many other drugs there is possibility for presence of artesunate in breast milk. Because of potential of adverse effect of artesunate in nursing baby, breast-feeding should be stopped during the treatment of malaria by Artesunate tablet.

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

Anti-malarial drugs

Artesunate is metabolized to the active DHA. the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the Plasmodium parasites during all erythrocytic stages. Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase.

It is to be given by oral route. The oral dose of Artesunate tablet can be defined as follows:

For Artesunate 50 mg tablet:
Adults:

• Two Artesunate 50 tablets twice on the first day, then
• one Artesunate 50 tablet twice daily for the next four days (4, 2, 2, 2, 2)

Children:

• 1-3 years: 3 Artesunate 50 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
• 4-5 years: 6 Artesunate 50 tablets for 5 days (2, 1, 1, 1, 1)
• 6-12 years: 8 Artesunate 50 tablets for 5 days (3, 2, 1, 1, 1)

For Artesunate 100 mg tablet:
Adults: One Artesunate 100 tablet twice on the first day, then half Artesunate 100 tablet twice daily for the next four days (2, 1, 1, 1, 1)

Children:

• 4-5 years: 3 Artesunate 100 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
• 6-12 years: 4 Artesunate 100 tablets for 5 days (11⁄2,1,1⁄2,1⁄2,1⁄2)
• Patients aged more than 12 years: should be given same as adult dose.

Dosage for the prevention of malaria: Two Artesunate 50 tablets (or one Artesunate 100 tablet) as a single dose once a week, from one week before entering a malaria-affected area to four weeks after leaving the area.

Artesunate tablet is well tolerated. No adverse effects have been reported from the treatment of artesunate at recommended dose.

Artesunate is contraindicated for patients with known hypersensitivity to Artemisinin and its derivatives or its inactive ingredients.

Artesunate may have interaction with other artemisinin drugs i.e. artemether, arteether which have the same effect in prolonging the PQ and QT interval. It has interaction when it is given with other antimalarial drugs (eg. Quinine, quinidine, mafloquine and halofantrine) which have cardiac action. It also has interaction with other drugs which prolong QT interval (such as erythromycin, terfenadine, astemizole, probucol, procainamide, disopyramide, amiodarone, bretylium, bepridil, sotalol, tricyclic antidepressants and neuroleptics).

A WHO report assessing the safety of artemisinin derivatives in pregnancy concluded that these drugs should continue to be available for the treatment of malaria in pregnancy, irrespective of the trimester. WHO also stressed that further study was needed. Therefore Artesunate tablet should be given to pregnant women especially, in first trimester if recommended by Registered Physician. Like many other drugs there is possibility for presence of artesunate in breast milk. Because of potential of adverse effect of artesunate in nursing baby, breast-feeding should be stopped during the treatment of malaria by Artesunate tablet.

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

Indicated for the treatment of osteoarthritis of knee, hip, spine, hand, and other locations as a dietary supplement. It is also beneficial in rheumatoid arthritis, sport injuries, migraine, different skin problems (e.g., psoriasis), vascular complications (e. g., atherosclerosis), kidney stones, and inflammatory bowel disease (e.g., ulcerative colitis, leaky gut syndrome).

Stimulation of Cartilage formation

Glucosamine is a natural amino-sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate, and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates,Osteoarthritis develops. It also helps to form ligaments, tendon, nails, and various other connective tissues.When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.

Chondroitin Sulfate is a glycosaminoglycan (acid muco polysaccharide) found in connective tissue, especially in the articular cartilage of all mammals. Chondroitin Sulfate supplement acts similarly as Glucosamine Sulfate, since it also provide substrate for proteoglycans. Chondroitin also protects existing healthy cartilage from premature decline by preventing the MMP (Matrix metalloproteinase) enzyme that breakdowns the proteoglycans.

Combining Glucosamine with Chondroitin Sulfate shows synergistic effect. Data supports that this combination has been shown to be very much effective in severe cases of Osteoarthritis that treats both sign and symptoms of Osteoarthritis & modifies disease progression. It prevents Osteoarthritis in case of normal adults. In Osteoarthritic pain it is as effective as NSAIDs with significantly better tolerability and clinical compliance. It is also helpful during the repair phase of musculo-skeletal soft tissue injuries such as tendon or ligament strains

250/200 mg tablet: 1 to 2 tablets, three times daily. Dose may be adjusted according to the response of the drug and body weight. Doses can be tapered after 60 days as per requirement of the individual and for cost convenience. Typical dosage recommendation, based on body weight is as follows-

• Under 54 Kg: 1000 mg Glucosamine Sulfate & 800 mg Chondroitin Sulfate per day
• 54 Kg to 91 Kg: 1500 mg Glucosamine Sulfate & 1200 mg Chondroitin Sulfate per day
• Over 91 Kg: 2000 mg Glucosamine Sulfate & 1600 mg Chondroitin Sulfate per day.

750/600 mg tablet: 1 tablet two times daily or as directed by the physician.

Safety studies with Glucosamine Sulfate & Chondroitin Sulfate show no demonstrable side effects. Rarely occurring side effects (such as, mild & reversible intestinal flatulence) are almost like placebo.

There are no known contraindications for Glucosamine and Chondroitin. But proven hypersensitivity (e. g. allergic to shellfish or sulfur) to Glucosamine and Chondroitin is a contraindication.

Patients with Diabetes Mellitus are advised to monitor blood glucose levels regularly when taking Glucosamine. No special studies were formed in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of Glucosamine and Chondroitin does not indicate limitations for these patients. However, administration to patients with severe hepatic or renal insufficiency should be under appropriate medical supervision. Children should not be supplemented with Glucosamine and Chondroitin.

There have been no reports of significant drug interactions of Glucosamine and Chondroitin with Antibiotics/ Antidepressants/ Antihypertensives/ Nitrates/ Antiarrythmics/ Anxiolytics/ Hypoglycemic agents/ Antisecretives/ Antiasthmatics. Chondroitin may enhance the blood thinning effects of anticoagulants like Warfarin, Heparin.

Women who are pregnant or who could become pregnant should not supplement with Glucosamine Sulfate or Chondroitin Sulfate. Glucosamine and Chondroitin has not been studied enough to determine their effects on a developing fetus. No studies have evaluated the use of Glucosamine and Chondroitin during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.

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

This tablet is indicated in-

• Osteoarthritis
• Rheumatoid arthritis
• Bone and Joint injuries

Stimulation of Cartilage formation

Glucosamine: Glucosamine (2-amino-2-deoxy-alpha-D-glucose) is a natural amino sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates, Osteoarthritis develops. It also helps to form ligaments, tendon, nails and various other connective tissues. When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.

In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract. Predominantly metabolized by liver & excreted through urine.

Diacerein: This is used for the treatment of Osteoarthritis. It has also analgesic, antipyretic and anti-inflammatory activity. It release in vitro and directly inhibits InterLeukin-1(IL-1) synthesis, which is the main cytokine involved in cartilage destruction. Due to specific mode of action, it have been shown to have disease-modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis.

Oral bioavailability of Diacerein 56%. Concurrent intake of food delays the time to peak concentration but associated with a 25% increase in absorption. Therefore, diacerein is best given with food. Mainly binds with protein albumin. Diacerein is metabolized extensively (100%) in liver following oral dosing. Urinary excretion of diacerein in the form of its metabolites has ranged between 35% and 60%.

Use in adults: One tablet twice daily with food.

Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.

No serious adverse effect has been reported. Nausea, vomiting, diarrhea, epigastria pain, headache, skin rashes & intense yellow coloring of urine may be occurred.

Contraindicated for those who shows hypersensitivity to Glucosamine or Diacerein.

Caution should be practised when administering this tablet in case of patients who are allergic to Glucosamine or Diacerein.

Decrease absorption of Diacerein with aluminium and/ or magnesium hydroxide antacids. Increase risk of diarrhea with laxatives or antibiotics.

This tablet is contraindicated during pregnancy and breastfeeding.

Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.