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Sertraline is indicated for the treatment of-

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

SSRIs & related anti-depressant drugs

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

Adults-
Major depressive disorder:

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

Obsessive-compulsive disorder:

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

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

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

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

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

The recommended interval between dose changes is one week.

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

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

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

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

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

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

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

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

This is indicated in-

• General debility
• Spermatorrhoea
• Polyuria
• Leucorrhoea

Herbal and Nutraceuticals

Salajeet is a unique combination of Mineral Pitch (Silajit), Sage (Salvia haematodes) and others natural ingredients. It enhances the activity of insulin, which is beneficial for diabetic patients. It is effective in leucorrhoea and polyuria. Salajeet acts as a powerful antioxidant, it provides protection against degenerative diseases such as heart disease, diabetes and arthritis. It also acts general tonic and effective in spermatorrhoea.

1 tablet twice daily or as prescribed 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.

Store at cool and dry place, protect from light.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.

Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

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

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.

Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

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

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.

Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

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

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.

Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

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

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.

Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

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

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide.

Swallow tablets whole. Do not cut, crush, or chew tablets. Start Semaglutide with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

Oral Medications: Semaglutide delays gastric emptying. When coadministering oral medications instruct patients to closely follow semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

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

Anti-dyspeptic/Carminatives

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.

Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.

Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).

Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.

Adults:

• 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
• 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

Do not exceed 12 doses per day except under the advice and supervision of a physician.

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.

Insulin Glargine is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Long Acting Insulin

Insulin Glargine is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analogue that is a long-acting (up to 24-hour duration of action), parenteral blood glucose lowering agent. Insulin Glargine is produced by recombinant DNA technology. Primary function of insulin glargine is regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulation peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis.

Insulin Glargine exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing. Potency of insulin glargine is approximately the same as human insulin.

Insulin Glargine is recommended for once daily subcutaneous administration & may be administered at any time during the day. However, once started should be administered at the same time every day. The dose of Insulin Glargine must be individualized based on clinical response. Blood glucose monitoring is essential in all patients with diabetes. In patients with type 1 diabetes, Insulin Glargine must be used in regimens with short-acting insulin. Insulin Glargine is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

Initiation of Insulin Glargine therapy:

• The recommended starting dose of Insulin Glargine in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
• The recommended starting dose of Insulin Glargine in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.

Converting to Insulin Glargine from other insulin therapies: If changing from a treatment regimen with an intermediate-or long-acting insulin to a regimen with Insulin Glargine , the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.

• If transferring patients from once-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is the same as the dose of NPH that is being discontinued.
• If transferring patients from twice-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is 80% of the total NPH dose that is being discontinued.

Insulin Glargine should be injected subcutaneously once daily at any time of day, but at the same time everyday.

Cartridge:

• Insert the Insulin Glargine cartridge into the pen correctly and equip the needle. Gently turn the pen upside down for 8-10 times until the insulin in the cartridge becomes uniformly mixed.
• Adjust the dosage button to get correct dose. After removal of the needle cap and discharge air bubbles in the cartridge, it is ready to be injected. In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.

Vial:

• Firstly, clean your hands. Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
• If using a new Insulin Glargine bottle then flip off the plastic protective cap and wipe the rubber stopper with an alcohol swab.
• Draw air into your syringe equal to the amount of Insulin Glargine needed. Puncture the needle into the vial and inject the air.
• Turn the bottle and syringe upside down. Withdraw correct dose of Insulin Glargine into the syringe. Before pulling out the needle, check if there are any bubbles remain in the syringe.
• If so, put the syringe upright and tap the syringe to discharge the air bubbles.

Injection Site: Choose the area where skin is less tight, such as the upper arm, thigh, buttock and abdomen, etc. To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.

Injection Method: Cleanse the skin with alcohol where the injection is to be made. Put the needle in such a position as to form 45° angle with the skin. Puncture the needle into skin and inject insulin. Then pull the needle out and apply gentle pressure over the injected site for several seconds. Do not rub the injection site.

Side effects of Insulin glargine are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.

Insulin glargine is contraindicated in patients with hypersensitivity to insulin glargine or any of its excipients.

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.

Administration: Insulin glargine must not be diluted or mixed with any other insulin or solution. It should not be administered subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur.

Renal or hepatic impairment: Reduction in the Insulin glarginedose may require in these cases.

A number of drugs affect glucose metabolism and may require dose adjustment.

The following substances may reduce the Insulin as well as Insulin glargine requirements: Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics.

The following substances may increase the Insulin as well as Insulin glargine requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.

Pregnancy category C. Insulin glargine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Insulin glargine is administered to a nursing woman. Lactating women may require adjustments in insulin dose & diet.

Use in Renal/ Hepatic impairment: Reduction in the insulin glargine doses may be required in these cases.

Insulin glargine overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.

Store at 2° C to 8° C in a refrigerator. Do not freeze. In case of insulin for recent use need not to be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.

Anti-diarrhoeal Antimicrobial drugs, Sulphonamides & Trimethoprim

Cotrimoxazole having broad spectrum bactericidal activity against a wide range of gram-positive & gram-negative bacteria and some protozoa. Co-trimoxazole containing Trimethoprim and Sulphamethoxazole in a 1:5 combination exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganism.

Cotrimoxazole double strength tablet: Over 12 years

• For mild to moderate infections: 1 tablet twice daily.
• For severe infections: 1.5 tablets twice daily.
• Long term therapy (>14 days): 0.5 tablet twice daily.
• Gonorrhoea: 2 tablets every 12 hours for two days or 2.5 tablets followed by a further dose of 2.5 tablets after 8 hours.

Cotrimoxazole tablet: over 12 years

• For mild to moderate infections: 2 tablets twice daily.
• For severe infections: 2 tablets thrice daily.
• Long term therapy: (>14 days): 1 tablet twice daily.

Cotrimoxazole suspension: Under 12 years

• 6-12 years: 2 teaspoonful twice daily.
• 6 month-5 years: 1 teaspoonful twice daily.
• 6 weeks-6 months: 0.5 teaspoonful twice daily.

The side effects like crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis etc. have been reported rarely with Sulphamethoxazole-Trimethoprim combination. Other side effects are less serious in nature such as malaise, headache, nausea and vomiting. These are normally transient and do not require withdrawal of treatment.

Prolonged full dose treatment with sulfamethoxazole-trimethoprim combination is associated with the risk of macrocytic anaemia due to the drug’s interference in the conversion of Folic acid into Folinic acid. If this occurs, it can be reversed by giving Folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.

Pregnancy and during the nursing period, because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus.

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

Anti-diarrhoeal Antimicrobial drugs, Sulphonamides & Trimethoprim

Cotrimoxazole having broad spectrum bactericidal activity against a wide range of gram-positive & gram-negative bacteria and some protozoa. Co-trimoxazole containing Trimethoprim and Sulphamethoxazole in a 1:5 combination exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganism.

Cotrimoxazole double strength tablet: Over 12 years

• For mild to moderate infections: 1 tablet twice daily.
• For severe infections: 1.5 tablets twice daily.
• Long term therapy (>14 days): 0.5 tablet twice daily.
• Gonorrhoea: 2 tablets every 12 hours for two days or 2.5 tablets followed by a further dose of 2.5 tablets after 8 hours.

Cotrimoxazole tablet: over 12 years

• For mild to moderate infections: 2 tablets twice daily.
• For severe infections: 2 tablets thrice daily.
• Long term therapy: (>14 days): 1 tablet twice daily.

Cotrimoxazole suspension: Under 12 years

• 6-12 years: 2 teaspoonful twice daily.
• 6 month-5 years: 1 teaspoonful twice daily.
• 6 weeks-6 months: 0.5 teaspoonful twice daily.

The side effects like crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis etc. have been reported rarely with Sulphamethoxazole-Trimethoprim combination. Other side effects are less serious in nature such as malaise, headache, nausea and vomiting. These are normally transient and do not require withdrawal of treatment.

Prolonged full dose treatment with sulfamethoxazole-trimethoprim combination is associated with the risk of macrocytic anaemia due to the drug’s interference in the conversion of Folic acid into Folinic acid. If this occurs, it can be reversed by giving Folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.

Pregnancy and during the nursing period, because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus.

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

Escitalopram Oxalate is indicated in the-

• Treatment of major depressive episodes.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of social anxiety disorder (social phobia).
• Treatment of generalised anxiety disorder.
• Treatment of obsessive-compulsive disorder.

SSRIs & related anti-depressant drugs

Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.

Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.

Escitalopram should generally be administered once daily, morning or evening with or without food.

SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.

Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.

SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.

As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.

Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.

Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Sulfonylureas

Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.

In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.

Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.

Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.

Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.

Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.

Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.

Glimepiride tablet must be swallowed with sufficient amount of liquid.

Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.

Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.

in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).

Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.

In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.

Drugs which may attenuate the hypoglycaemic action of Glimepiride include:

• Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
• H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
• Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
• Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.

Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.

Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of  concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.

Do not store above 30°C. Keep away from light and out of the reach of children.

Sulfonylureas

Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.

In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.

Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.

Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.

Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.

Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.

Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.

Glimepiride tablet must be swallowed with sufficient amount of liquid.

Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.

Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.

in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).

Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.

In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.

Drugs which may attenuate the hypoglycaemic action of Glimepiride include:

• Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
• H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
• Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
• Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.

Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.

Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of  concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.

Do not store above 30°C. Keep away from light and out of the reach of children.

Clozapine is indicated in-

• Schizophrenia in patients unresponsive to, or intolerant of, conventional antipsychotic drugs.
• Psychosis in Parkinson's disease.

Atypical neuroleptic drugs

Clozapine is classified as an 'atypical' antipsychotic drug because of its profile of binding to dopamine receptors and its effects on various dopamine-mediated behaviors differ from those exhibited by other typical antipsychotic drug products. In particular, although Clozapine does interfere with the binding of dopamine at D1, D2, D3 and D5 receptors, and has a high affinity for the D4 receptor. This evidence, consistent with the view that Clozapine is preferentially more active at limbic than at striatal dopamine receptors. This may explain the relative freedom of Clozapine from extrapyramidal side effects. Clozapine also acts as an antagonist at adrenergic, cholinergic, histaminergic and serotonergic receptors.

Schizophrenia: Adult over 16 years, 12.5 mg once or twice (elderly 12.5 mg once) on first day then 25-50 mg (elderly 25-37.5 mg) on second day then increased gradually (if well tolerated) in steps of 25-50 mg daily (elderly max. increment 25 mg daily) over 14-21 days up to 300 mg daily in divided doses (larger dose at night, up to 200 mg daily may be taken as a single dose at bedtime); if necessary may be further increased in steps of 50-100 mg once (preferably) or twice weekly; usual dose 200-450 mg daily (max. 900 mg daily)

Psychosis in Parkinson's disease: Adult over 16 years, 12.5 mg at bedtime then increased according to response in steps of 12.5 mg up to twice weekly; usual dose range 25-37.5 mg at bedtime, usual maximum 50 mg daily; exceptionally, dose may be increased further in steps of 12.5 mg weekly to maximum 100 mg daily in 1-2 divided doses.

Common side effects are constipation, dizziness or lightheadedness (mild), drowsiness, headache (mild), increased watering of mouth, nausea or vomiting, unusual weight gain. Less common side effects include abdominal discomfort or heartburn, dryness of mouth.

Severe cardiac disorders (e.g. myocarditis); renal impairment (avoid if creatinine clearance less than 10 ml/minute); history of neutropenia or agranulocytosis; bone-marrow disorders; paralytic ileus; alcoholic and toxic psychoses; history of circulatory collapse; drug intoxication; coma or severe CNS depression; uncontrolled epilepsy; breast-feeding.

Medication should not be stopped abruptly; should be tapered off over 1-2 weeks. If conditions warrant abrupt discontinuation (leukopenia, myocarditis, cardiomyopathy), monitor patient for psychosis and cholinergic rebound (headache, nausea, vomiting, diarrhea). Elderly patients are more susceptible to adverse effects  (including agranulocytosis, cardiovascular, anticholinergic, and tardive dyskinesia). Significant risk of agranulocytosis, potentially life-threatening. WBC testing should occur weekly for the first 6 months of therapy; thereafter, if acceptable WBC counts are maintained (WBC 3000/mm3, ANC 1500/mm3) then WBC counts can be monitored every other week. WBCs must be monitored weekly for the first 4 weeks after therapy discontinuation. Use with caution in patients receiving other marrow suppressive agents. Eosinophilia has been reported to occur with Clozapine and may require temporary or permanent interruption of therapy.

Cognitive and/or motor impairment (sedation) is common with Clozapine, resulting in impaired performance of tasks requiring alertness (eg, operating machinery or driving). Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold. Has been associated with benign, self-limiting fever (<100.4°F, usually within first 3 weeks). However, dozapine may also be associated with severe febrile reactions, including neuroleptic malignant syndrome (NMS). Clozapine's potential for extrapyramidal symptoms appear to be extremely low.

May cause anticholinergic effects; should be used with caution in patients with urinary retention, benign prostatic hyperplasia, narrow-angle glaucoma, xerostomia, visual problems, constipation, or history of bowel obstruction. May cause hyperglycemia; in some cases may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control. Use with caution in patients with hepatic disease or impairment; hepatitis has been reported as a consequence of therapy.

May cause orthostatic hypotension and tachycardia; should be used with caution in patients at risk of hypotension or in patients where transient hypotensive episodes would be poorly tolerated (cardiovascular disease or cerebrovascular disease). Concurrent use of psychotropics and benzodiazepines may increase the risk of severe cardiopulmonary reactions.

Myocarditis, pericarditis, pericardial effusion, cardiomyopathy, and CHF have also been associated with clozapine. Fatalities due to myocarditis have been reported; highest risk in the first month of therapy, however, later cases also reported. Myocarditis or cardiomyopathy should be considered in patients who present with signs/symptoms of heart failure (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea, peripheral edema), chest pain, palpitations, new electrocardiographic abnormalities (arrhythmias, ST-T wave abnormalities), or unexplained fever. Patients with tachycardia during the first month of therapy should be closely monitored for other signs of myocarditis. Discontinue clozapine if myocarditis is suspected; do not rechallenge in patients with clozapine-related myocarditis. The reported rate of cardiomyopathy in clozapine treated patients is similar to that in the general population. The majority of patients were over 50 years of age and were taking clozapine for >6 months. Clozapine should be discontinued in patients with confirmed cardiomyopathy unless benefit clearly outweighs risk. Rare cases of thromboembolism, including pulmonary embolism and stroke resulting in fatalities, have been associated with clozapine.

Myelosuppression may be aggravated with concomitant use of myelosuppressants. Clozapine may interact with other CNS active drugs or alcohol. Orthostatic hypotension may occur with benzodiazepine usage or other psychotropics. Since Clozapine is highly bound to proteins. It may be displaced by other drugs, which are also highly protein bound. Conversely, Clozapine may also displace protein bound drugs (e.g. warfarin, digoxin). Cimetidine may decrease plasma Clozapine levels.

Although concomitant administration of Carbamazepine and Clozapine is not recommended, it should be noted that discontinuation of concomitant Carbamazepine may result in an increase in plasma Clozapine levels. A reduced Clozapine dosage should be used when it is combined with drugs like fluvoxamine, paroxetine and sertraline. The action of hypotensive drugs may be potentiated. Other anticholinergic drug action may also be increased. Administration of adrenaline should generally be avoided due to possibility of reversal of adrenaline effect due to alpha adrenergic blockade by Clozapine. Concomitant use of Clozapine with other drugs metabolized by cytochrome P450 2D6 (such as phenothiazines, antidepressants, propafenone, flecainide and encainide) or those that inhibit this enzyme such as quinidine; require lower doses of either Clozapine or the other drugs.

There are no adequate studies of Clozapine in pregnant women. Studies in animals suggest no important effects on the fetus. Clozapine can be used in pregnancy if the physician feels that it is necessary. Animal studies suggest that Clozapine is secreted in breast milk. Therefore, women taking Clozapine should not nurse their infants.

The most commonly reported signs and symptoms associated with Clozapine overdose are: altered states of consciousness, including drowsiness, delirium and coma; tachycardia; hypotension; respiratory depression or failure; hypersalivation. Aspiration pneumonia and cardiac arrhythmias have also been reported. Seizures have occurred in a minority of reported cases. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 gm.

Management of Overdose: Should be established and maintained an airway; should be ensured adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdosage. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Additional surveillance should be continued for several days because of the risk of delayed effects. Avoid epinephrine and derivatives when treating hypotension, and quinidine and procainamide when treating cardiac arrhythmia. There are no specific antidotes for Clozapine. Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. ln managing overdosage, the physician should consider the possibility of multiple drug involvement.

Do not store above 30°C. Keep away from light and out of the reach of children.

Flupentixol and Melitracen tablet is indicated in-

• Anxiety
• Depression
• Apathy
• Psychogenic depression.
• Depressive neurosses.
• Masked depression.
• Psychosomatic affections accompanied by anxiety and apathy.
• Menopausal depressions.
• Dysphoria and depression in alcoholics and drug addicts.

Combined anxiolytics & anti-depressant drugs

This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

This tablet should preferably not be given during pregnancy and lactation.

In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

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

Third generation Cephalosporins

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.

Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.

• In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
• In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.

Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.

The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.

Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.

Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

Single-dose vial Administration Amount of WFI to be added: 250 mg IM in 1.5 ml, 250 mg IV in 5 ml, 500 mg IM in 1.5 ml, 500 mg IV in 5 ml and 1 g IM in 3 ml, 1 g IV in 10 ml.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.

Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.

• In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
• In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.

Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.

The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.

Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.

Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

Single-dose vial Administration Amount of WFI to be added: 250 mg IM in 1.5 ml, 250 mg IV in 5 ml, 500 mg IM in 1.5 ml, 500 mg IV in 5 ml and 1 g IM in 3 ml, 1 g IV in 10 ml.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Psychoses, Depression with or without anxiety, Psychoses

SSRIs & related anti-depressant drugs

Flupentixol is a thioxanthene antipsychotic that inhibits dopamine-mediated effects by blocking postsynaptic dopamine receptors in the CNS.

Oral-
Depression with or without anxiety:

• Adult: Initially, 1 mg daily increased after 1 wk to 2 mg daily and then to a max of 3 mg daily, last dose should be given not later than 4 p.m. Doses >2 mg should be given in 2 divided doses. Discontinue treatment if there is no improvement within 1 wk of using the max dose.
• Elderly: Initially, 0.5 mg daily increased after 1 wk to 1 mg daily with the last dose given not later than 4 p.m. Max: 2 mg daily in 2 divided doses.

Psychoses:

• Adult: Initially, 3-9 mg bid, adjusted according to response. Max: 18 mg daily.
• Elderly: Initial dose: ¼ or ½ of the usual initial dose.

Intramuscular-
Psychoses:

• Adult: Initially, 20 mg (1 ml of a 2% oily solution) is given as test dose. After at least 7 days and depending on the response, subsequent doses of 20-40 mg may be given at intervals of 2-4 wk. Usual maintenance dose: 50 mg every 4 wk to 300 mg every 2 wk. Up to 400 mg wkly may be used in severe or resistant cases.
• Elderly: Initial dose: ¼ or ½ of the usual initial dose.

May be taken with or without food.

Rigidity, tremors, restlessness, tardive dyskinesia, insomnia, dryness of mouth, wt gain, sexual dysfunction, galactorrhoea and menstrual disturbances.

Potentially Fatal: Neuroleptic malignant syndrome (hyperthermia, hypertonicity of skeletal muscles, unconsciousness and autonomic nervous system instability).

Hypersensitivity. Extremely excitable and overactive patients; mania; porphyria; coma; preexisting CNS depression; bone-marrow supression; phaeochromocytoma. Lactation.

Patients with convulsive disorders; advanced hepatic, renal, CV or resp disease; tasks requiring mental alertness; elderly (especially with dementia), and debilitated patients; neuroleptics with sedative effect must be withdrawn gradually; history of angle-closure glaucoma; urinary retention; prostatic hyperplasia; breast cancer, prolactin dependent tumours; parkinsonism; myasthenia gravis; pregnancy; Avoid direct sunlight.

May potentiate the adverse effects of drugs with antimuscarinic effects e.g. TCAs. Reduced efficacy of levodopa. Increases adverse extrapyramidal symptoms with dopamine antagonists (metoclopramide and prochlorperazine).

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus

Store below 25° C.