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Non-sedating antihistamines

Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.

Pediatric drops:

• Child 6-11 months of age: 2 ml drops once daily.
• Child 1-2 years of age: 2.5 ml drops once daily.

Syrup:

• Child 6-11 months of age: 2 ml once daily.
• Child 1-5 years of age: 2.5 ml once daily.
• Child 6-11 years of age: 5 ml once daily.
• Adults & >12 years of age: 10 ml once daily.

Tablet:

• Adults and children 12 years of age and over: 1 tablet daily

Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.

Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.

No clinically relevant drug interactions have been reported.

Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

Recommended in the use in children & adolescents.

No clinically relevant adverse effects have been reported.

Store in a cool & dry place, protected from light. Store below 30°C. Keep all medicines out of the reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as perennial allergic rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.

Non-sedating antihistamines

This preparation contains Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.

Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.

Children 6 to 11 years of age: The recommended dose is 2.5 mg (1/2 tablet or 1 teaspoon oral solution) once daily.

Children 6 months to 5 years of age: The recommended dose is 1.25 mg (1/2 teaspoon oral solution) once daily.

Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.

Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.

Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.

Levocetirizine is not known to have any interactions with other drugs.

Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.

Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older.

Geriatric use: In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Hepatic impairment: No dosage adjustment is required in patients with solely hepatic impairment.

Renal impairment:

• Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended.
• Moderate renal impairment (creatinine clearance: 30-50 ml/min): a dose of 2.5 mg once every other day is recommended.
• Severe renal impairment (creatinine clearance: 10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended.
• End-stage renal disease patients (creatinine clearance: <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine.

No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.

Store at a temperature not exceeding 30°C in a dry place. Protect from light.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Clotrimazole Ear Drop is indicated for the treatment of fungal infections of the ear.

Aural Anti-fungal preparations

Clotrimazole kills fungi and yeasts by interfering with their cell membranes. It works by stopping the production of ergosterol, which is an essential component of fungal cell membranes resulting in increased membrane permeability and leakage of essential constituents of the fungal cells.

Instill 2-3 drops of Clotrimazole Ear Drops in the affected ear two or three times daily. The treatment should be continued for at least two weeks after the disappearance of all signs of infection to prevent re-infection.

Clotrimazole is generally well tolerated after local application but the few side effects have been reported infrequently like erythema, stinging, edema, pruritus and general irritation.

Individuals who have hypersensitivity to any of its components.

If local intolerance develops, consider withdrawal of the medicine and institution of appropriate therapy. Clotrimazole ear drop is not intended for ophthalmic use.

There have been reports of a heat reaction when this medication used concomitantly with Sofradex drops in the ear.

Clotrimazole is recommended during pregnancy only after first consulting a doctor. Because systemic absorption of clotrimazole following topical application is marginal, there should be no risk for the infant during lactation.

In case of accidental oral ingestion, supportive measures should be taken.

Protect from light, store in cool & dry place. Keep out of the reach of children. Protect from freezing. Do not use more than 4 weeks after opening.

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole causes inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is either completely or partially inhibited, the cell is no longer able to construct an intact and functional cell membrane. Because ergosterol directly promotes the growth of fungal cells in a hormone‐like fashion, rapid onset of the above events leads to dose-dependent inhibition of fungal growth.

Though decreased ergosterol, due to the inhibition of lanosterol 14-demethylase (also known as CYP51) is accepted to be primarily responsible for the antimycotic properties of clotrimazole, this drug also shows other pharmacological effects. These include the inhibition of sarcoplasmic reticulum Ca²⁺ ATPase, depletion of intracellular calcium, and blocking of calcium‐dependent potassium channels and voltage‐dependent calcium channels. The action of clotrimazole on these targets accounts for other effects of this drug that are separate from its antimycotic activities.

Clotrimazole Cream: This should be thinly applied 2-3 times daily to the infected sites and rubbed in. On account of the excellent efficacy, a small amount of cream is usually sufficient for an area about the size of the palm. For the treatment to become a complete success, reliable and sufficiently long-time application of Clotrimazole Cream is important. The duration of treatment varies; it depends among other factors on the extent and localization of the disease.

Recommended duration of treatment-

• Dermatomycoses: 3-4 weeks
• Candida vulvitis and Candida balanitis: 1-2 weeks
• Erythrasma and Pityriasis Versicolor: 3 weeks (approximately)

In fungal infection of the feet, to prevent relapse, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease. After washing, the feet should be thoroughly dried (particularly spaces between the toes). Clotrimazole Cream is odorless, can be washed off and does not stain clothing.

Clotrimazole topical solution: Apply this sparingly to the affected areas and rub in gently, two or three times daily.

When applied topically, Clotrimazole is well tolerated.With external application, systemic effects are not observed. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful.

Hypersensitivity to Clotrimazole.

No information is available.

It is recommended that Clotrimazole should be used in pregnancy only when considered necessary by the physician.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Clarithromycin is indicated in-

• Streptococcal pharyngitis
• Sinusitis
• Infective exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Atypical pneumonia
• Skin and soft tissue infection
• Adjunct in the treatment of duodenal ulcers by eradication of H.pylori.

Macrolides

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin's activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Adults:

• Pharyngitis / Tonsillitis 250 mg every 12 hours for 10 days.
• Acute maxillary sinusitis 500 mg every 12 hours for 14 days.
• Chronic bronchitis 250-500 mg every 12 hours for 7-14 days.
• Pneumonia 250 mg every 12 hours for 7-14 days.
• Uncomplicated skin & skin structure infections 250 mg every 12 hours for 7-14 days.
• Community-acquired upper and lower respiratory tract infections 250-500 mg every 12 hours for 5-14 days.

Children:

• Bodyweight under 8 kg: 7.5 mg/kg twice daily.
• Bodyweight of 8-11 kg (1-2 years): 2.5 ml (Half teaspoonful) twice daily.
• Bodyweight of 12-19 kg (3-6 years): 5 ml (One teaspoonful) twice daily.
• Bodyweight of 20-29 kg (7-9 years): 7.5 ml (One & half teaspoonfuls) twice daily.
• Bodyweight of 30-40 kg (10-12 years): 10 ml (Two teaspoonfuls) twice daily.

Clarithromycin may be given with or without meals.

Clarithromycin is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Hypersensitivity to Clarithromycin, Erythromycin, or any of the macrolide antibiotics. Patients receiving Terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.

Clarithromycin is principally excreted by the liver and kidney. Caution should be taken in administering this antibiotic to patients with impaired hepatic and renal function. Prolonged or repeated use of Clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, Clarithromycin should be discontinued and appropriate therapy should be instituted.

Theophylline: Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of Terfenadine.

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

Store in a cool and dry place, protected from light & moisture. The reconstituted suspension must be used within 7 days if kept at room temperature and within 14 days when stored in a refrigerator. Keep out of reach of children.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.

The recommended oral dose is one tablet daily.

This combination is generally well tolerated.

This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.

There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.

It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.

Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.

Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.

Clascoterone cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Acne treatment preparations

Acne is a multifactorial skin condition characterized by excess sebum production, epithelial hyperkeratinization, proliferation of the skin commensal bacteria, and inflammation. Circulating and locally synthesized natural ligands, testosterone and dihydrotestosterone (DHT), serve as causative factors in both males and females. Upon binding of DHT, the DHT-androgen receptor complex dimerizes and translocates to the nucleus where it promotes the transcription of genes involved in acne pathogenesis, including proliferation and differentiation of sebocytes, excess sebum production, and inflammatory cytokine production. Clascoterone is a potent antagonist at ARs and competes for androgens in binding to the receptor, thereby inhibiting downstream signalling of ARs that promote acne.

Androgenetic alopecia is also an androgen-dependent and highly genetic condition. Dihydrotestosterone (DHT) binds to ARs expressed on dermal papilla cells (DPC) in the scalp to induce AR-mediated transcription of genes that contribute to androgenic alopecia. By blocking the interaction between DHT and aARs, clascoterone inhibits AR-regulated transcription and DHT-induced IL-6 synthesis.

Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of Clascoterone cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of Clascoterone cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water. Clascoterone cream is for topical use only. This cream is not for ophthalmic, oral or vaginal use.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied Clascoterone cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years.

Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of subjects treated with vehicle.

Local Skin Reactions: Clascoterone cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness). Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited. The product should not be applied to cuts, abrasions, eczematous or sunburned skin.

Hypothalamic-pituitary-adrenal (HPA) Axis Suppression: Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. In the PK trial, all subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. If HPA axis suppression develops, an attempt should be made to withdraw the drug. Pediatric patients may be more susceptible to systemic toxicity.

Pregnancy: There are no available data on Clascoterone cream use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of clascoterone to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the maximum recommended human dose (MRHD), respectively, increased malformations in rats and post-implantation loss and resorptions in rabbits. The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Lactation: There are no data regarding the presence of clascoterone or metabolite in human milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of clascoterone to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clascoterone and any potential adverse effects on the breastfed child from clascoterone or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two identical multicenter, randomized, double-blind, vehicle-controlled, 12-week trials and 2 open-label pharmacokinetic studies. Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris has not been established in pediatric patients under 12 years of age. 

Geriatric Use: Clinical studies of Clascoterone cream did not include sufficient numbers of subjects aged 65 years of age and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Broad spectrum penicillins

Pharmacodynamic properties: Co-amoxiclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the (3-lactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms but it is susceptible to degradation by (3-lactamases and therefore the spectrum of activity does not include microorganisms, which produce these enzymes. Clavulanic acid possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in this preparation protects Amoxicillin from degradation by (3-lactamase enzymes and effectively extends the antibiotic spectrum to embrace a wide range of microorganisms.

Pharmacokinetic properties: The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and Amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.

Adults and children over 12 years:

Tablet:

• The usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours.
• For more severe infections and infections of the respiratory tract, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours.

Suspension:

• Children 6-12 years: 2 teaspoonful every 8 hours.
• Children 1-6years: 1 teaspoonful every 8 hours.
• Children below 1 year: 25 mg/kg/day in divided doses every 8 hours, for example a 7.5 kg child would require 2 ml suspension t.i.d, Treatment should not be extended beyond 14 days without review.

Forte suspension:

• The usual recommended daily dosage: 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsilitis, lower respiratory infections, and skin and soft tissue infections)।
• For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections, e.g. otitis media and sinusitis, lower respiratory infections e.g. bronchopneumonia, and urinary tract infections).

Children of 2 to 12 years:
Mild to moderate infections:

• 25/3.6 mg/kg/day (Suspension)
• 2-6 years (13-21 kg) 2.5 ml suspension b.i.d
• 7-12years (22-40kg) 5 ml suspension b.i.d

Serious infections:

• 45/6.4 mg/kg/day (Forte Suspension)
• 2-6 years (13-21 kg) 5 ml suspension b.i.d
• 7-12 years (22-40 kg) 10 ml suspension b.i.d

IV Injection

Adults-

• Usually, 1.2 gm every 8 hours
• Increased in more serious infections to 1.2 gm every 6 hours
• For surgical prophylaxis: The usual dose is 1.2 gm at induction, for high risk procedures (eg. colorectal surgery) up to 2-3 gm may be given every 8 hours.

Children-

• 0 to 3 months: 30 mg/kg every 8 hours. (every 12 hours in the perinatal period and in premature infants.
• 3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infection to 30 mg/kg every 6 hours.

Oral dosage form: This may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanic acid are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanic acid should be taken at the start of the meal.

IV injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes). The contents of the content of the vial must be used within 20 minutes and thereafter any unused material should be discarded.

Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported, if gastrointestinal side effects occur with oral therapy, that may be reduced by taking Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics, angioedema and anaphylaxis have been reported.

History of Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Also contraindicated for patients with a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice.

Co-amoxiclav should be used with care in patients on anticoagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of a high dose of Co-amoxiclav adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.

Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Co-amoxiclav. In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Co-amoxiclav and allopurinol.

Animal studies with orally and parenterally administered Co-amoxiclav have shown no teratogenic effect. The drug has been used orally in human pregnancy in a limited number of cases with no untoward effect; however, the use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.

The dose should be adjusted in case of patients with renal impairment

Adult:

• Mild impairment (Creatinine clearance> 30ml/minute): No changein dosage.
• Moderate impairment (Creatinine clearance 10-30 ml/minute): One 375 Tablet or one 625 Tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 12 hourly.
• Severe impairment (Creatinine clearance <10 ml/minute): Not more than one 375 mg tablet 12 hourly or 1.2 gm IV followed by 0.6 gm IV 24 hourly. Dialysis decreases serum concentrations of this preparation and an additional 0.6 gm IV dose may need to be given during dialysis and at the end of dialysis.

Children:

• A similar reduction in dosage should be made for children.
• Administration hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.

Problems of overdose with Co-amoxiclav are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Co-amoxiclav may be removed from the circulation by haemodialysis.

IV injection: 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP. This IV injection should not be reconstituted or mixed with: Dextrose solution, Sodium Bicarbonate solution for injection, Protein Hydrolysates or other Proteinaceous fluids, blood or plasma, Intravenous lipids. However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.

This should be stored below 25°C, protected from light and moisture. Once reconstituted suspension should be kept in the refrigerator (but not frozen) and should be usedby 7 days. Once reconstituted vial must be used within 20 minutes.