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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.

Other Antifungal preparations, Topical Antifungal preparations

Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.

Terbinafine tablet:

• For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
• For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
• The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.

Terbinafine granules:

• Body Weight: <25 kg: 125 mg/day up to 6 weeks
• Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
• Body Weight: >35 kg: 250 mg/day up to 6 weeks

Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows:

• Tinea corporis, cruris: 1 to 2 weeks
• Tinea pedis: 1 week
• Cutaneous candidiasis: 2 weeks
• Pityriasis versicolor: 2 weeks

Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.

• Tinea pedis: once a day,1 week
• Tinea corporis/cruris: once a day,1 week
• Pityriasis versicolor: twice a day, 1 week

Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after two weeks the diagnosis should be verified.

The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.

Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.

Warnings-

• Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
• Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.

Precautions: Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) teste are advised for all patients before taking terbinafine tablets.

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.

Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.

Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Store in a cool and dry place, below 30°C, protect from light.

Other Antifungal preparations, Topical Antifungal preparations

Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.

Terbinafine tablet:

• For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
• For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
• The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.

Terbinafine granules:

• Body Weight: <25 kg: 125 mg/day up to 6 weeks
• Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
• Body Weight: >35 kg: 250 mg/day up to 6 weeks

Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows:

• Tinea corporis, cruris: 1 to 2 weeks
• Tinea pedis: 1 week
• Cutaneous candidiasis: 2 weeks
• Pityriasis versicolor: 2 weeks

Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.

• Tinea pedis: once a day,1 week
• Tinea corporis/cruris: once a day,1 week
• Pityriasis versicolor: twice a day, 1 week

Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after two weeks the diagnosis should be verified.

The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.

Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.

Warnings-

• Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
• Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.

Precautions: Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) teste are advised for all patients before taking terbinafine tablets.

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.

Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.

Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Store in a cool and dry place, below 30°C, protect from light.

Ferric Derisomaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:

• who have intolerance to oral iron or have had unsatisfactory response to oral iron.
• who have non-hemodialysis dependent chronic kidney disease.

Parenteral Iron Preparations

This is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides. Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

For patients weighing 50 kg or more: Administer 1,000 mg of Ferric Derisomaltose by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

For patients weighing less than 50 kg: Administer Ferric Derisomaltose as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

The dosage of Ferric Derisomaltose is expressed in mg of elemental iron. Each mL of Ferric Derisomaltose contains 100 mg of elemental iron. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Derisomaltose is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Ferric Derisomaltose and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Ferric Derisomaltose with other drugs has not been established. Ferric Derisomaltose should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Ferric Derisomaltose solution may be stored at room temperature for up to 8 hours.
• Extravasation of Ferric Derisomaltose may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Derisomaltose administration at that site.

Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Ferric Derisomaltose is contraindicated in patients with a history of serious hypersensitivity to Ferric Derisomaltose or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Derisomaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric Derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric Derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to Ferric Derisomaltose or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Ferric Derisomaltose treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload: Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Ferric Derisomaltose to patients with iron overload

There are no available data on Ferric Derisomaltose use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects.

The available data on the use of Ferric Derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

Excessive dosages of Ferric Derisomaltose may lead to the accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Ferric Derisomaltose in patients with iron overload.

Store at 20° to 25°C; excursions permitted to 15° to 30°C. Do not freeze.

Ferric Derisomaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:

• who have intolerance to oral iron or have had unsatisfactory response to oral iron.
• who have non-hemodialysis dependent chronic kidney disease.

Parenteral Iron Preparations

This is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides. Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

For patients weighing 50 kg or more: Administer 1,000 mg of Ferric Derisomaltose by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

For patients weighing less than 50 kg: Administer Ferric Derisomaltose as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

The dosage of Ferric Derisomaltose is expressed in mg of elemental iron. Each mL of Ferric Derisomaltose contains 100 mg of elemental iron. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Derisomaltose is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Ferric Derisomaltose and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Ferric Derisomaltose with other drugs has not been established. Ferric Derisomaltose should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Ferric Derisomaltose solution may be stored at room temperature for up to 8 hours.
• Extravasation of Ferric Derisomaltose may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Derisomaltose administration at that site.

Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Ferric Derisomaltose is contraindicated in patients with a history of serious hypersensitivity to Ferric Derisomaltose or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Derisomaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric Derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric Derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to Ferric Derisomaltose or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Ferric Derisomaltose treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload: Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Ferric Derisomaltose to patients with iron overload

There are no available data on Ferric Derisomaltose use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects.

The available data on the use of Ferric Derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

Excessive dosages of Ferric Derisomaltose may lead to the accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Ferric Derisomaltose in patients with iron overload.

Store at 20° to 25°C; excursions permitted to 15° to 30°C. Do not freeze.

Ferric Derisomaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:

• who have intolerance to oral iron or have had unsatisfactory response to oral iron.
• who have non-hemodialysis dependent chronic kidney disease.

Parenteral Iron Preparations

This is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides. Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

For patients weighing 50 kg or more: Administer 1,000 mg of Ferric Derisomaltose by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

For patients weighing less than 50 kg: Administer Ferric Derisomaltose as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

The dosage of Ferric Derisomaltose is expressed in mg of elemental iron. Each mL of Ferric Derisomaltose contains 100 mg of elemental iron. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Derisomaltose is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Ferric Derisomaltose and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Ferric Derisomaltose with other drugs has not been established. Ferric Derisomaltose should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Ferric Derisomaltose solution may be stored at room temperature for up to 8 hours.
• Extravasation of Ferric Derisomaltose may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Derisomaltose administration at that site.

Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Ferric Derisomaltose is contraindicated in patients with a history of serious hypersensitivity to Ferric Derisomaltose or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Derisomaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric Derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric Derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to Ferric Derisomaltose or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Ferric Derisomaltose treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload: Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Ferric Derisomaltose to patients with iron overload

There are no available data on Ferric Derisomaltose use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects.

The available data on the use of Ferric Derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

Excessive dosages of Ferric Derisomaltose may lead to the accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Ferric Derisomaltose in patients with iron overload.

Store at 20° to 25°C; excursions permitted to 15° to 30°C. Do not freeze.

Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).

Drugs for subcutaneous and mycoses

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Adult (oral)-

• Vaginal candidiasis: 150 mg as a single dose.
• Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
• Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
• Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
• Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
• Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
• Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.

Child (oral):

• Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.

Intravenous-

• Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
• Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.

Fluconazole should be administered with caution to patients having proarrhythmic conditions.

Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.

US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

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

Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).

Drugs for subcutaneous and mycoses

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Adult (oral)-

• Vaginal candidiasis: 150 mg as a single dose.
• Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
• Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
• Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
• Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
• Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
• Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.

Child (oral):

• Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.

Intravenous-

• Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
• Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.

Fluconazole should be administered with caution to patients having proarrhythmic conditions.

Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.

US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

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

This is indicated in the treatment of topical bacterial infections. This is particularly effective in atopic, contact stasis and infections, eczematoid dermatitis, neurodermatitis, eczema, anogenital pruritus. It may also be useful as an adjunct in certain pyodermas, such as impetigo, during specific systemic antibiotic therapy for these infections.

Ophthalmic and Topical antibacterial products

Bacitracin inhibits bacterial cell wall synthesis and is active against many gram-positive bacteria (e.g. staphylococci, streptococci, corynebacteria and Clostridia) and some gram-negative species (e.g. Neisseria and Haemophilus influenzae). They are often found in combinations in topical preparations as broad spectrum antibacterial agents.

Neomycin, an aminoglyoside with antimicrobial spectrum similar to gentamicin, binds to the 30S subunits of the bacterial ribosome, inhibiting protein synthesis and thereby disrupting DNA synthesis. It is active against many gram negative aerobes and against some strains of staphylococci.

Ointment: Before use, the area for application should be cleaned gently. Derbis such as pus or crusts should be removed from the affected area. Apply two to three times daily to the affected skin area.

Dusting Powder: Antibiotic powder is a non- sterile dusting powder and used for superficial skin infections. A light dusting of the powder to be applied to the affected skin area upto 4 times daily.

This preparation is usually well tolerated. In rare cases, allergic reactions may be occurred.

Hypersensitivity to any of its components.

Bacitracin & Neomycin antibiotic powder should not be used to large open wounds or to severely injured skin or on areas that exude large volumes of fluid as hard crusts may form. Since this skin ointment contains Neomycin, it should not be used for the treatment of otitis external when the eardrum is perforated because of risk of ototoxicity.

Patients considering self-medication with a topical anti-infective for deep or puncture wounds, animal bites, or serious burns should be advised to first consult a physician. Patients using the preparations for the prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns) should be advised to discontinue the topical anti-infective preparation and consult a physician if the condition persists or worsens; it should not be used for longer than 1 week unless directed by a physician.

Bacitracin Zinc: Increased risk of nephrotoxicity when used with other nephrotoxic drugs. May enhance the action of neuromuscular-blocking agents.

Neomycin Sulphate: Additive nephrotoxic and neurotoxic effect with other aminoglycosides, bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin. Enhanced toxicity with potent diuretics. May impair the absorption of other drugs. May enhance the effect of acarbose. May enhance the effect of non-depolarising muscle relaxants. May antagonise the parasympathomimetic effect of neostigmine and pyridostigmine. May increase the risk of hypocalcaemia in patients receiving bisphosphonates. May alter INR when givenwithanticoagulants. May inactivate oral typhoid vaccine.

The safe use of this preparation during pregnancy & lactation has not been established. Therefore it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Children and Infants: This ointment is suitable for use in children at the same dose as adults, but the dose should be reduced in infants. This ointment is not recommended for use in neonates.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

This is indicated in the treatment of topical bacterial infections. This is particularly effective in atopic, contact stasis and infections, eczematoid dermatitis, neurodermatitis, eczema, anogenital pruritus. It may also be useful as an adjunct in certain pyodermas, such as impetigo, during specific systemic antibiotic therapy for these infections.

Ophthalmic and Topical antibacterial products

Bacitracin inhibits bacterial cell wall synthesis and is active against many gram-positive bacteria (e.g. staphylococci, streptococci, corynebacteria and Clostridia) and some gram-negative species (e.g. Neisseria and Haemophilus influenzae). They are often found in combinations in topical preparations as broad spectrum antibacterial agents.

Neomycin, an aminoglyoside with antimicrobial spectrum similar to gentamicin, binds to the 30S subunits of the bacterial ribosome, inhibiting protein synthesis and thereby disrupting DNA synthesis. It is active against many gram negative aerobes and against some strains of staphylococci.

Ointment: Before use, the area for application should be cleaned gently. Derbis such as pus or crusts should be removed from the affected area. Apply two to three times daily to the affected skin area.

Dusting Powder: Antibiotic powder is a non- sterile dusting powder and used for superficial skin infections. A light dusting of the powder to be applied to the affected skin area upto 4 times daily.

This preparation is usually well tolerated. In rare cases, allergic reactions may be occurred.

Hypersensitivity to any of its components.

Bacitracin & Neomycin antibiotic powder should not be used to large open wounds or to severely injured skin or on areas that exude large volumes of fluid as hard crusts may form. Since this skin ointment contains Neomycin, it should not be used for the treatment of otitis external when the eardrum is perforated because of risk of ototoxicity.

Patients considering self-medication with a topical anti-infective for deep or puncture wounds, animal bites, or serious burns should be advised to first consult a physician. Patients using the preparations for the prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns) should be advised to discontinue the topical anti-infective preparation and consult a physician if the condition persists or worsens; it should not be used for longer than 1 week unless directed by a physician.

Bacitracin Zinc: Increased risk of nephrotoxicity when used with other nephrotoxic drugs. May enhance the action of neuromuscular-blocking agents.

Neomycin Sulphate: Additive nephrotoxic and neurotoxic effect with other aminoglycosides, bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin. Enhanced toxicity with potent diuretics. May impair the absorption of other drugs. May enhance the effect of acarbose. May enhance the effect of non-depolarising muscle relaxants. May antagonise the parasympathomimetic effect of neostigmine and pyridostigmine. May increase the risk of hypocalcaemia in patients receiving bisphosphonates. May alter INR when givenwithanticoagulants. May inactivate oral typhoid vaccine.

The safe use of this preparation during pregnancy & lactation has not been established. Therefore it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Children and Infants: This ointment is suitable for use in children at the same dose as adults, but the dose should be reduced in infants. This ointment is not recommended for use in neonates.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

In following skin diseases where bacterial infections are already present or suspected to occur-

• Primary irritant dermatitis
• Contact allergic dermatitis
• Eczema (atopic, infantile, discoid, stasis)
• Seborrhoeic dermatitis

Hydrocortisone & Combined preparations

Fusidic Acid BP 2% & Hydrocortisone Acetate BP 1% combination cream contains the potent topical antibacterial action of Fusidic Acid with the anti-inflammatory & anti-pruritic effects of Hydrocortisone Acetate. When applied topically, Fusidic Acid is effective against Staphylococci, Streptococci, Corynebacteria, Neisseria and certain Clostridia & Bacteroides. Fusidic Acid is an antimicrobial agent that acts as an inhibitor of protein synthesis in the microorganism. It interferes with translocation step by stabilizing the ribosome-guanosine diphosphate elongation factor G-complex. This prevents binding of aminoacyl t-RNA to the ribosome and thereafter stops transfer of additional amino acids to the growing polypeptide. In humans, Hydrocortisone is the principal naturally occurring glucocorticosteroid. In pharmaceutical dosage, its main action is to reduce the response of the skin to injury (i.e. anti-in ammatory). It also has immuno suppressant & anti-mitotic actions.

Adults: This Cream should be applied 3 times daily and gently massaged onto the affected areas for 2 weeks. A shorter course should be considered if symptoms improve.

Children: It is not recommended in children under 3 years of age.

Fusidic Acid has been reported to cause mild irritation at the application site, but did not usually require discontinuation of therapy. Reports of hypersensitivity reactions have been rare. Adverse effects are generally local and include: dryness, itching, burning, local irritation, striae, skin atrophy, atrophy of subcutaneous tissues, telangiectasia, hypertrichosis, change in pigmentation and secondary infection. If applied to the face, acne rosacea or perioral dermatitis can occur.

This preparation is contraindicated in patients with hypersensitivity to Fusidic Acid, Hydrocortisone Acetate, or other components of the cream. As with other topical antibiotic/corticosteroid combination preparations, it is contraindicated in bacterial infections due to non-susceptible organisms, fungal infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations and viral diseases of the skin in general.

Fusidic Acid and Hydrocortisone Acetate should not be used in or near the eye because of the possibility of conjuctival irritation by Fusidic Acid. When used under occlusive dressing, over extensive areas or on the face, scalp, axillae and scrotum, suffcient absorption may occur, giving rise to adrenal suppression and other systemic effects.

If absorbed systemically, Fusidic Acid may inhibit the metabolism of drugs that undergo extensive biotransformation in the liver, but no evidence for this is available. No hazardous drug interactions are reported with topical Hydrocortisone Acetate.

The safety of Fusidic Acid and/or topical Hydrocortisone Acetate during pregnancy or lactation has not been established. The use of this cream during pregnancy or lactation requires that the potential bene ts be weighed against the risks to the fetus or nursing infant.

Use in children: Clinical trials with Fusidic Acid & Hydrocortisone Acetate have not demonstrated any increased incidence of adverse effects in children 3 years and over. There are no data from randomized, controlled clinical trials on the safety and efficacy of this combination in children under 3 years of age.

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

This cream is indicated in the treatment of-

• Mixed and complicated Fungal, Protozoal & Bacterial infections,
• Mild to moderate vaginitis,
• Candidiasis and trichomoniasis,
• Pruritus vulvae,
• Dermatitis,
• Eczema,
• Genito-urinary infections.

Clobetasol / Clobetasone & Combined Preparations

This cream is a combination cream which exhibits anti-bacterial, anti-fungal, anti-protozoal & anti-inflammatory actions. Ofloxacin is a broad-spectrum antibiotic that acts against many gram-positive & gram-negative bacteria. Ornidazole belongs to the nitroimidazole group of antibiotics and is used to treat amoeba and trichomonas infections. Terbinafine is an Allylamine antifungal that inhibits biosynthesis of Ergosterol (an essential components if fungal cell membrane) via inhibition of Squalene Epoxidase enzyme causing fungal cell death. Clobetasol is a potent corticosteroid which exhibits anti-inflammatory, anti-pruritic and vasoconstrictive properties.

Apply by gently rubbing onto the affected area twice daily.

Burning, itching, irritation, dry skin

Contraindicated in patients hypersensitive to any of the components of the formulation.

Do not shallow. For external use only

No hazardous interactions have been reported.

The safe use of this preparation during pregnancy & lactation has not been established.

Store below 30°C. keep away from light and out of the reach of children. Do not freeze.

Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent steroids

Other Topical corticosteroids

Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.

Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.

Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.

The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.

It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.

In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.

Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.

There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.

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

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.

Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.

Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.

Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent steroids

Other Topical corticosteroids

Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.

Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.

Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.

The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.

It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.

In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.

Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.

There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.

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

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.

Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.

Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.

Other Antifungal preparations, Topical Antifungal preparations

Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.

Terbinafine tablet:

• For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
• For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
• The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.

Terbinafine granules:

• Body Weight: <25 kg: 125 mg/day up to 6 weeks
• Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
• Body Weight: >35 kg: 250 mg/day up to 6 weeks

Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows:

• Tinea corporis, cruris: 1 to 2 weeks
• Tinea pedis: 1 week
• Cutaneous candidiasis: 2 weeks
• Pityriasis versicolor: 2 weeks

Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.

• Tinea pedis: once a day,1 week
• Tinea corporis/cruris: once a day,1 week
• Pityriasis versicolor: twice a day, 1 week

Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after two weeks the diagnosis should be verified.

The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.

Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.

Warnings-

• Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
• Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.

Precautions: Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) teste are advised for all patients before taking terbinafine tablets.

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.

Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.

Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Store in a cool and dry place, below 30°C, protect from light.

Marham Kharish is indicated in-

• Scabies
• Itching
• Pustular
• Piles
• Eczema
• Proriasis
• Ring worm
• Skin eruption and burn

Herbal and Nutraceuticals

Marham Kharish is a unique combination of Camphor (Cinnamomum camphora), Henna (Lawsonia inermis), Catechu (Acacia catechu) and others natural ingredients. It acts as antiseptic, anti-inflammatory and anti-microbial. Marham Kharish is very effective in scabies, itching, pustular, piles, boils, eczema and proriasis.

Rub gently the affected area and 2 to 4 times daily or as directed by the physician.

No significant side effect has been observed in proper dosage.

There is no known contraindication.

Keep out of reach of the children.

Keep from light. Keep in cool and dry place.

Halcinonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Other Topical corticosteroids

The precise mechanism of action of topical corticosteroids is unclear. However they possess anti-inflammatory, antipruritic, and vasoconstrictive actions. New research indicates that halcinonide activates MBP (myelin basic protein) expression via smoothened receptor activation. This finding suggests that halcinonide could be used in the treatment of multiple sclerosis therapy as an alternative to Dexamethasone or Methylprednisolone.

Apply the 0.1% Halcinonide Cream to the affected area two to three times daily. Rub in gently.

Prolonged application causes epidermal thinning, contact dermatitis, perioral dermatitis, papular disorder, mild depigmentation; telangiectasia, striae (especially face and flexures). Application on eyelids and surrounding skin can raise intraocular pressure, cataracts, glaucoma, corneal ulcers and raised intracranial pressure. Systemic absorption with adrenal suppression may be seen when applied to large areas, when skin is broken or under occlusive dressing.

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations, Primary infectious (viral, fungal, bacterial) ulcers, acne vulgaris.

Neonates, childn, elderly, hepatic failure. Not to be applied over large areas under occlusive dressings. Caution when applied to areas of broken skin. Pregnancy, lactation.

Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use: Of approximately 3000 patients included in clinical studies of 0.1% Halcinonide cream , 14% were 60 years or older, while 4% were 70 years or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluated for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

Should be stored in cool and dry place

Permethrin cream is indicated for the treatment of scabies and crab lice infestations (Pediculosis). Scabies can affect everyone in the family. If one is infected, all family members must be treated together.

Parasiticidal preparations

Permethrin cream contains Permethrin, a pyrethroid, which is a topical scabicidal agent for the treatment of infestation with Sarcoptes Scabiei (scabies). It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization & paralysis of the pests are the consequences of this disturbance.

Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.

Recommended duration of Treatment:

• Adults and children over 12 years: a full tube
• Children aged 6-12 years: up to 1⁄2 of a tube
• Children aged 1-5 years: up to  ¼ of a tube
• Children aged 2 months to 1 year: up to ⅛ of a tube
• Children Less then 2 month: dose is not established

Before application of Permethrin cream the skin should be clean, cool and dry. Do not have a hot shower or bath before applying.

For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.

For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth.

Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, permethrin cream should be used again after 7 days as per the advice of the doctor.

In Scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Others transient signs and symptoms of irritation including enythema, edema, eczema, rash and puritis.

Permethrin is contraindicated in patients with known hypersensitivity to any component of pyrethroids or permethrin. Nursing staff who routinely apply permethrin may wear globes to avoid any possible irritation to the hands.

Scabies infestation is often accompanied by pruritus, edema & erythema. Treatment with permethrin may temporarily exacerbate these conditions. Patients should be advised to avoid contact with eyes during application & to flash with water immediately if the cream gets in the eyes.

The treatment of eczemodous like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.

In the absence of specific studies in pregnant women, its use in pregnancy should only follow medical advice. It is not known whether permethrin is excreted in human milk so it should not be used in nursing mothers.

Store in a cool, dry place, away from light & keep out of the reach of children...

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.

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.