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Aminophylline

Tablet 100 mg Allopathic Bronchodilator

Indications

Status asthmaticus

Indication detailsView

It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.

Therapeutic classView

Bronchodilator, Methyl xanthine derivatives, Respiratory stimulants: analeptics, Theophylline & related drugs

PharmacologyView

Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; adenosine receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.

DosageView

Oral:
Chronic bronchospasm:

Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.
Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.

Intravenous:
Acute severe bronchospasm:

Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.
Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.
Elderly: Dose reduction may be necessary.
Hepatic impairment: Dose reduction may be necessary.

AdministrationView

Tablets should be swallowed whole and not chewed because of the structure of the tablet.

Side effectsView

The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.

ContraindicationsView

Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.

PrecautionsView

Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given withcaution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.

Pregnancy & lactationView

Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.

Aminophylline

IV Injection 125 mg/5 ml Allopathic Bronchodilator

Indications

Status asthmaticus

Indication detailsView

It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.

Therapeutic classView

Bronchodilator, Methyl xanthine derivatives, Respiratory stimulants: analeptics, Theophylline & related drugs

PharmacologyView

Aminophylline is a combination of theophylline and ethylenediamine. Ethylenediamine is inactive; it increases the solubility of theophylline in water. Theophylline relaxes bronchial smooth muscle. Suggested mechanisms are an increase in intracellular cAMP through inhibition of phosphodiesterase; adenosine receptor antagonism, prostaglandin antagonism and effects on intracellular calcium.

DosageView

Oral:
Chronic bronchospasm:

Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.
Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.

Intravenous:
Acute severe bronchospasm:

Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.
Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.
Elderly: Dose reduction may be necessary.
Hepatic impairment: Dose reduction may be necessary.

AdministrationView

Tablets should be swallowed whole and not chewed because of the structure of the tablet.

Side effectsView

The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia, hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.

ContraindicationsView

Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.

PrecautionsView

Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given withcaution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.

Pregnancy & lactationView

Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.

Aminosin

Amino Acid + D-Sorbitol + Electrolytes

IV Infusion 5% Allopathic Parenteral nutritional preparations

Indications

Protein supply for peritoneal nutrition

Indication detailsView

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

DosageView

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

ContraindicationsView

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

PrecautionsView

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

InteractionsView

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

Overdose effectsView

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

Aminosin Plus

Amino Acid + Glucose + Electrolytes

IV Infusion 7%+10% Allopathic Parenteral nutritional preparations

Indications

Prevent nitrogen loss

Indication detailsView

This is indicated as a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. This is particularly suitable for patients with basal amino acid requirements.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

A crystalline amino acid solution provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Amino Acids given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.

DosageView

Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range is 0.10-0.25 g nitrogen/kg/day corresponds to 11-27 ml/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon the patient’s requirements, 1000-2000 ml may be infused intravenously per 24 hours. This should be infused slowly; at a rate not exceeding 500 ml in 3 hours corresponding to approximately at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children: In infants & children, a maximal rate of infusion of 30 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week of treatment.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of the solution at rates exceeding the recommended maximal rate. Transient increases in liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion.

ContraindicationsView

This preparation is contraindicated in patients with inborn errors of amino acids metabolism, severe liver damage & severe uremia when dialysis facilities are not available. Due to the content of the glucose, this preparation is contraindicated in patients with hyperosmolar nonketotic diabetic coma. This preparation is also contraindicated in patients with known hypersensitivity to any of its ingredients.

PrecautionsView

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate to be adjusted as needed. This preparation should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restriction or oliguria/anuria of other origin. In patient with hyperglycemia, administration of exogenous insulin might be necessary. Do not use if the solution is turbid or contains particles. Discard any unused portion.

InteractionsView

At the recommended dosage this solution has no pharmacological effect and is expected not to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solution during pregnancy in human has been reported. Animal reproduction studies have not been carried out with 7% amino acid IV infusion with 10% glucose & electrolytes.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep away from the reach of children.

Aminosol Gold

Amino Acid + Glucose + Electrolytes

IV Infusion 7%+10% Allopathic Parenteral nutritional preparations

Indications

Prevent nitrogen loss

Indication detailsView

This is indicated as a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. This is particularly suitable for patients with basal amino acid requirements.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

A crystalline amino acid solution provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Amino Acids given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.

DosageView

Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range is 0.10-0.25 g nitrogen/kg/day corresponds to 11-27 ml/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon the patient’s requirements, 1000-2000 ml may be infused intravenously per 24 hours. This should be infused slowly; at a rate not exceeding 500 ml in 3 hours corresponding to approximately at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children: In infants & children, a maximal rate of infusion of 30 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week of treatment.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of the solution at rates exceeding the recommended maximal rate. Transient increases in liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion.

ContraindicationsView

This preparation is contraindicated in patients with inborn errors of amino acids metabolism, severe liver damage & severe uremia when dialysis facilities are not available. Due to the content of the glucose, this preparation is contraindicated in patients with hyperosmolar nonketotic diabetic coma. This preparation is also contraindicated in patients with known hypersensitivity to any of its ingredients.

PrecautionsView

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate to be adjusted as needed. This preparation should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restriction or oliguria/anuria of other origin. In patient with hyperglycemia, administration of exogenous insulin might be necessary. Do not use if the solution is turbid or contains particles. Discard any unused portion.

InteractionsView

At the recommended dosage this solution has no pharmacological effect and is expected not to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solution during pregnancy in human has been reported. Animal reproduction studies have not been carried out with 7% amino acid IV infusion with 10% glucose & electrolytes.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep away from the reach of children.

Aminosol Vit

Amino Acid + D-Sorbitol + Electrolytes

IV Infusion 5% Allopathic Parenteral nutritional preparations

Indications

Protein supply for peritoneal nutrition

Indication detailsView

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

DosageView

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

ContraindicationsView

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

PrecautionsView

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

InteractionsView

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

Overdose effectsView

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

Aminosteril N-Hepa

Amino Acid

IV Infusion 8% Allopathic Parenteral nutritional preparations

Indications

Parenteral nutrition

Indication detailsView

Parenteral amino acid supply in severe forms of hepatic failure (liver insufficiency) with and without encephalopathy. For supply of amino acids as part of a parenteral nutrition regimen when oral or enteral nutrition is impossible or insufficient or contraindicated.

Therapeutic classView

Parenteral nutritional preparations

DosageView

For intravenous infusion.
Usual dose: 1.0 to 1.25 ml/kg/hour.
Max. dosage: 1.5 g amino acids/kg/day = 1300 ml/day at 70 kg body weight.
Constant checking of serum electrolytes, fluid balance and acid-base balance is mandatory.
Amino Acid 8% is used as long as required by therapy.

Side effectsView

Due to the special composition of this preparation, use in indications other than those recommended may result in amino acid imbalances and severe metabolic disorders.

ContraindicationsView

Disturbance of amino acid metabolism, metabolic acidosis, fluid overload, hyponatremia, hypokalemia, renal insufficiency, decompensated cardiac insufficiency, shock, hypoxia. No specific studies have been performed to assess the safety of Amino Acid 8% in pregnancy and lactation.

InteractionsView

Because of the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other drugs. Should it become necessary to add other nutrients like carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to Amino Acid 8% for complete nutrition, care should be given to hygienic admixing, good blending and, in particular, to compatibility.

StorageView

Amino Acid 8% should not be stored after the addition of other components. Do not store above 25°C. Do not freeze. Shelf Life: 36 months. Do not use Amino Acid after the expiry date. Do not use if the solution is cloudy or if the container is damaged. Keep out of the reach of children.

Aminosyn

Amino Acid + D-Sorbitol + Electrolytes

IV Infusion 10% Allopathic Parenteral nutritional preparations

Indications

Protein supply for peritoneal nutrition

Indication detailsView

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

DosageView

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

ContraindicationsView

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

PrecautionsView

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

InteractionsView

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

Overdose effectsView

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

Amiodarone Hameln

Amiodarone Hydrochloride

IV Injection 150 mg/3 ml Allopathic Potassium channel blockers

Indications

Ventricular arrhythmias

Indication detailsView

Amiodarone tablet is used for many serious arrhythmias of the heart including ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter.

Amiodarone injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.

Therapeutic classView

Potassium channel blockers

PharmacologyView

Amiodarone Hydrochloride is used to correct abnormal rhythms of the heart. Amiodarone is considered a "broad spectrum" antiarrhythmic medication. The most important electrical effects of the drug includes : a delay in the rate at which the heart’s electrical system "recharges" after the heart contracts (repolarisation); a prolongation in the electrical phase during which the heart’s muscle cells are electrically stimulated (action potential); a slowing of the speed of electrical conduction (how fast each individual impulse is conducted through the heart’s electrical system); a reduction in the rapidity of firing of the normal generator of electrical impulses in the heart (the heart’s pacemaker); and a slowing of conduction through various specialised electrical pathways (called accessory pathways). In addition to being an antiarrhythmic medication, Amiodarone also causes blood vessels to dilate. Because of this effect it also may be of benefit in patients with congestive heart failure. This effect can result in drop of blood pressure.

DosageView

Tablet: 200 mg 3 times daily for 1 week reduced to 200 mg twice daily or the minimum required to control arrhythmia. Amiodarone is usually given in several daily doses to minimize stomach upset which is seen more frequently with higher doses. For this same reason, it is also recommended that Amiodarone should be taken with meals.

Injection: The recommended starting dose is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

Initial Load: 150 mg per 100 mL (in D5W or Normal Saline) infused over 10 minutes
Followed by: 1 mg/min for 6 hours
Followed by: 0.5 mg/min thereafter

In the event of breakthrough episodes of VF or hemodynamically unstable VT: Repeat the Initial Load described above as needed (infused over 10 minutes). Increase the rate of maintenance infusion to achieve effective arrhythmia suppression.

Side effectsView

The most severe side effects of Amiodarone therapy are related to the lungs. These reactions can be fatal. Patients should report any symptoms of cough, fever, or painful breathing. Although quite rare, fatal liver toxicity may occur with Amiodarone therapy. Reversible corneal microdeposits (sometimes with night glare), rarely impaired vision due to optic neuritis; peripheral neuropathy and myopathy (usually reversible on withdrawal); bradycardia and conduction disturbances; phototoxicity and rarely persistent skin discolouration; hypothyroidism, hyperthyroidism; raised serum transaminases; jaundice, hepatitis and cirrhosis are reported. Other rare complaints are nausea, vomiting, metallic taste, tremor, sweating, vertigo, headache, sleeplessness, fatigue, alopecia, benign raised intracranial pressure, ataxia, rashes, vasculitis, renal involvement, thrombocytopenia, haemolytic or aplastic anaemia. In some cases, dose of Amiodarone may be reduced. In other cases, Amiodarone therapy may need to be stopped.

ContraindicationsView

Amiodarone is contraindicated in patients with cardiogenic shock; severe sinus-node dysfunction, causing marked sinus bradycardia; second- or third degree atrioventricular block; and when episodes of bradycardia have caused syncope (except when used in conjunction with a pacemaker). Amiodarone is contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.

InteractionsView

Amiodarone may interact with b blockers such as Atenolol, Propranolol, Metoprolol, or certain calcium channel blockers, such as Verapamil or Diltiazem, resulting in an excessively slow heart rate. Amiodarone increases the blood levels of Digoxin when the two drugs are given together. Flecainide blood concentrations increase by more than 50% with Amiodarone. Procainamide and Quinidine concentrations increase by 30-50% during the first week of Amiodarone therapy. Amiodarone also can interact with tricyclic antidepressants (TCA). Amiodarone interacts with Warfarin and increases the risk of bleeding. Amiodarone inhibits the metabolism of Dextromethorphan.

Pregnancy & lactationView

In general, Amiodarone should not be administered during pregnancy because there have been reports of hypo or hyperthyroidism in infants from oral Amiodarone use during pregnancy. If Amiodarone use is considered essential, however, the patient should be warned of the risk to the foetus. The safe use of Amiodarone in lactating women has not been established.

StorageView

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

Amiphin

Ceftriaxone Sodium

IV Injection 2 gm/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftriaxone is indicated for the treatment of the following major infections:

Lower respiratory tract infections
Acute Bacterial Otitis Media
Skin and skin structure infections
Urinary tract infections
Gonorrhea
Bacterial Septicemia
Bone and joint infections
Meningitis
Prevention of postoperative infections
Perioperative prophylaxis of infections associated with surgery

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

DosageView

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Uncomplicated gonococcal infections: 250 mg IM as a single dose
Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

AdministrationView

Preparation of Solutions for Intramuscular / Intravenous Injections:

For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Side effectsView

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

ContraindicationsView

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

PrecautionsView

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

InteractionsView

No drug interactions have been reported.

Pregnancy & lactationView

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Pediatric usageView

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

Overdose effectsView

There is no specific antidote. Treatment of overdosage should be symptomatic.

StorageView

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Amipride

Amisulpride

Tablet 50 mg Allopathic Atypical neuroleptic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Amisulpride tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms.

Amisulpride injection is indicated in adults for:

Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
Treatment of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

Amisulpride binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.

Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain amisulpride’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its preferential limbic activity.

DosageView

Oral dose: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride.

Doses should be adjusted according to individual responses. Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Injectable dose: The recommended injectable adult dosage of Amisulpride and infusion rate by indication is shown in the table below:

Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia.
Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

ContraindicationsView

Hypersensitivity to the active ingredient or to other ingredients of the product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation.

PrecautionsView

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued. Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.

Pregnancy & lactationView

pregnancy Category C. The safety of amisulpride during human pregnancy has not been established, and therefore use of amisulpride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amisulpride has been found in the breast milk of treated women. Breast-feeding is contraindicated.

Pediatric usageView

Elderly: Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.

Children: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. In children up to puberty, the use of amisulpride is contraindicated

Use in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.

Use in renal impairment: Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered

StorageView

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

Amipride

Amisulpride

Tablet 100 mg Allopathic Atypical neuroleptic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Amisulpride tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms.

Amisulpride injection is indicated in adults for:

Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
Treatment of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

Amisulpride binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.

Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain amisulpride’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its preferential limbic activity.

DosageView

Oral dose: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride.

Doses should be adjusted according to individual responses. Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Injectable dose: The recommended injectable adult dosage of Amisulpride and infusion rate by indication is shown in the table below:

Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia.
Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

ContraindicationsView

Hypersensitivity to the active ingredient or to other ingredients of the product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation.

PrecautionsView

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued. Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.

Pregnancy & lactationView

pregnancy Category C. The safety of amisulpride during human pregnancy has not been established, and therefore use of amisulpride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amisulpride has been found in the breast milk of treated women. Breast-feeding is contraindicated.

Pediatric usageView

Elderly: Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.

Children: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. In children up to puberty, the use of amisulpride is contraindicated

Use in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.

Use in renal impairment: Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered

StorageView

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

Amipride

Amisulpride

Tablet 200 mg Allopathic Atypical neuroleptic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Amisulpride tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms.

Amisulpride injection is indicated in adults for:

Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
Treatment of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

Amisulpride binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.

Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain amisulpride’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its preferential limbic activity.

DosageView

Oral dose: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride.

Doses should be adjusted according to individual responses. Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Injectable dose: The recommended injectable adult dosage of Amisulpride and infusion rate by indication is shown in the table below:

Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia.
Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

ContraindicationsView

Hypersensitivity to the active ingredient or to other ingredients of the product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation.

PrecautionsView

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued. Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.

Pregnancy & lactationView

pregnancy Category C. The safety of amisulpride during human pregnancy has not been established, and therefore use of amisulpride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amisulpride has been found in the breast milk of treated women. Breast-feeding is contraindicated.

Pediatric usageView

Elderly: Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.

Children: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. In children up to puberty, the use of amisulpride is contraindicated

Use in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.

Use in renal impairment: Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered

StorageView

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

Amiquin

Gatifloxacin (Oral)

Tablet 400 mg Allopathic 4-Quinolone preparations

Indications

Urinary tract infection

Indication detailsView

Gatifloxacin is indicated in the following infections:

Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.
Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.
Community-acquired pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.
Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus or Streptococcus pyogenes.
Uncomplicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
Pyelonephritis due to Escherichia coli.
Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.
Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.

Therapeutic classView

4-Quinolone preparations

PharmacologyView

Gatifloxacin is a fluoroquinolone antibacterial which acts by inhibiting DNA synthesis in susceptible organisms via inhibition of both DNA gyrase (essential for bacterial reproduction) and topoisomerase IV (essential during bacterial cell division).

DosageView

Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg 5 days
Acute Sinusitis: 400 mg 10 days
Community-acquired Pneumonia: 400 mg 7-14 days
Uncomplicated Skin and Skin Structure Infections: 400 mg 7-10 days
Uncomplicated Urinary Tract Infections: 400 mg Single Dose or 200 mg 3 days
Complicated Urinary Tract Infections: 400 mg 7-10 days
Acute Pyelonephritis: 400 mg 7-10 days
Uncomplicated Urethral Gonnorrhea in Men: 400 mg Single dose

AdministrationView

Gatifloxacin can be administered without regard to food.

Side effectsView

Gatifloxacin is generally well tolerated. The most common side effects that can occur while taking this drug are usually mild and include nausea, vomiting, stomach pain, diarrhea, dizziness,and headache .

ContraindicationsView

Gatifloxacin is contraindicated in patients with a history of hypersensitivity of Gatifloxacin, quinolone antimicrobial agents, or any other components of this product.

PrecautionsView

Gatifloxacin should be administered with caution in the presence of renal insufficiency.

Pregnancy & lactationView

Pregnancy: Gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Lactation: It is not known whether Gatifloxacin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.

Pediatric usageView

Renal Impaired patient:

Creatinine Clearance 40 mL/min: 400 mg every day.
Creatinine Clearance < 40 mL/min: 400 mg 200 mg every day.

Dialysis patients:

Hemodialysis: 400 mg 200 mg every day.
Continuous peritoneal dialysis: 400 mg 200 mg every day.

Pediatric use: The safety and effectiveness of Gatifloxacinacin in pediatric populations (<18 years of age) have not been established.

Overdose effectsView

Gatifloxacin exhibits a low potential for acute toxicity in animal studies. In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed (including ECG monitoring) and given symptomatic and supportive treatment. Adequate hydration should be maintained.

Amirid

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Amiron

Mirtazapine

Tablet 15 mg Allopathic Atypical anti-depressant drugs

Indications

Major depressive disorder

Indication detailsView

Mirtazapine Tablets are indicated for the treatment of major depressive disorder (MDD).

Therapeutic classView

Atypical anti-depressant drugs

PharmacologyView

Pharmacodynamics: The mechanism of action of Mirtazapine as with other drugs effective in the treatment of major depressive disorder is unknown. Evidence gathered in preclinical studies suggests that Mirtazapine enhances central noradrenergic and serotonergic activity. These studies have shown that Mirtazapine acts as an antagonist at central presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors, an action that is postulated to result in an increase in central noradrenergic and serotonergic activity. Mirtazapine is a potent antagonist of 5- HT₂ and 5-HT₃ receptors. Mirtazapine has no significant affinity for the 5-HT_1A and 5-HT_1B receptors. Mirtazapine is a potent antagonist of histamine (H₁) receptors, a property that may explain its prominent sedative effects. Mirtazapine is a moderate peripheral α1-adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use. Mirtazapine is a moderate antagonist at muscarinic receptors, a property that may explain the relatively low incidence of anticholinergic side effects associated with its use.

Pharmacokinetics: After oral administration of Mirtazapine tablets, the active constituent mirtazapine is rapidly and well-absorbed, reaching peak plasma levels after about 2 hours. Binding of mirtazapine to plasma proteins is approximately 85%. The mean half-life of elimination is 20-40 hours; (26 hours in males, 37 hours in females). The half-life of elimination is sufficient to justify once-a-day dosing. Mirtazapine displays linear pharmacokinetics within the recommended dose range. Mirtazapine is extensively metabolized and eliminated via the urine and faeces four days. Major pathways of biotransformation are demethylation and oxidation followed by conjugation.

DosageView

Adult dose: The recommended starting dose for Mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening or prior to sleep. The effective dose range was generally 15 to 45 mg/day and the patients not responding to the initial 15 mg dose may benefit from dose increases up to a 30 mg to maximum of 45 mg/day. Mirtazapine has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for the therapeutic response to a given dose.

Use in children: Use in children are not recommended to Mirtazapine.

Missed Dose: If anyone misses a dose of mirtazapine, take it as soon as remember unless it is close to when the next dose is due. If anyone missed a dose of medication and it is close to the time of next dose, skip the missed dose and should take next dose at the regularly scheduled time. One should not take double or more than prescribed dose.

Side effectsView

The most common side effects of Mirtazapine are dizziness, drowsiness, dry mouth, increased appetite, weight gain etc.

ContraindicationsView

Hypersensitivity: Mirtazapine is contraindicated in patients with a known hypersensitivity to Mirtazapine or to any of the excipients.

Monoamine Oxidase Inhibitors: The concomitant use of Mirtazapine and a monoamine oxidase (MAO) inhibitor is contraindicated. Mirtazapine should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI).

PrecautionsView

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Patients who are to receive Mirtazapine should be warned about the risk of developing agranulocytosis. Mirtazapine may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. Clinically significant ALT (SGPT) elevations (≥3 times the upper limit of the normal range) may occur.

InteractionsView

Mirtazapine has clinically significant drug-drug interactions with Monoamine Oxidase Inhibitors (MAOI) & other serotonergic drugs such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort. Mirtazapine may interrupt the metabolism or activity of Carbamazepine, Phenytoin or Cimetidine. Patient should avoid Alcohol & Diazepam while taking Mirtazapine.

Pregnancy & lactationView

Pregnancy Category-C. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Mirtazapine therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.

StorageView

Keep away from light and moisture. Store below 30º C. Keep all medicine out of the reach of children.

Amiron

Mirtazapine

Tablet 7.5 mg Allopathic Atypical anti-depressant drugs

Indications

Major depressive disorder

Indication detailsView

Mirtazapine Tablets are indicated for the treatment of major depressive disorder (MDD).

Therapeutic classView

Atypical anti-depressant drugs

PharmacologyView

Pharmacodynamics: The mechanism of action of Mirtazapine as with other drugs effective in the treatment of major depressive disorder is unknown. Evidence gathered in preclinical studies suggests that Mirtazapine enhances central noradrenergic and serotonergic activity. These studies have shown that Mirtazapine acts as an antagonist at central presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors, an action that is postulated to result in an increase in central noradrenergic and serotonergic activity. Mirtazapine is a potent antagonist of 5- HT₂ and 5-HT₃ receptors. Mirtazapine has no significant affinity for the 5-HT_1A and 5-HT_1B receptors. Mirtazapine is a potent antagonist of histamine (H₁) receptors, a property that may explain its prominent sedative effects. Mirtazapine is a moderate peripheral α1-adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use. Mirtazapine is a moderate antagonist at muscarinic receptors, a property that may explain the relatively low incidence of anticholinergic side effects associated with its use.

Pharmacokinetics: After oral administration of Mirtazapine tablets, the active constituent mirtazapine is rapidly and well-absorbed, reaching peak plasma levels after about 2 hours. Binding of mirtazapine to plasma proteins is approximately 85%. The mean half-life of elimination is 20-40 hours; (26 hours in males, 37 hours in females). The half-life of elimination is sufficient to justify once-a-day dosing. Mirtazapine displays linear pharmacokinetics within the recommended dose range. Mirtazapine is extensively metabolized and eliminated via the urine and faeces four days. Major pathways of biotransformation are demethylation and oxidation followed by conjugation.

DosageView

Adult dose: The recommended starting dose for Mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening or prior to sleep. The effective dose range was generally 15 to 45 mg/day and the patients not responding to the initial 15 mg dose may benefit from dose increases up to a 30 mg to maximum of 45 mg/day. Mirtazapine has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for the therapeutic response to a given dose.

Use in children: Use in children are not recommended to Mirtazapine.

Missed Dose: If anyone misses a dose of mirtazapine, take it as soon as remember unless it is close to when the next dose is due. If anyone missed a dose of medication and it is close to the time of next dose, skip the missed dose and should take next dose at the regularly scheduled time. One should not take double or more than prescribed dose.

Side effectsView

The most common side effects of Mirtazapine are dizziness, drowsiness, dry mouth, increased appetite, weight gain etc.

ContraindicationsView

Hypersensitivity: Mirtazapine is contraindicated in patients with a known hypersensitivity to Mirtazapine or to any of the excipients.

Monoamine Oxidase Inhibitors: The concomitant use of Mirtazapine and a monoamine oxidase (MAO) inhibitor is contraindicated. Mirtazapine should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI).

PrecautionsView

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Patients who are to receive Mirtazapine should be warned about the risk of developing agranulocytosis. Mirtazapine may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. Clinically significant ALT (SGPT) elevations (≥3 times the upper limit of the normal range) may occur.

InteractionsView

Mirtazapine has clinically significant drug-drug interactions with Monoamine Oxidase Inhibitors (MAOI) & other serotonergic drugs such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort. Mirtazapine may interrupt the metabolism or activity of Carbamazepine, Phenytoin or Cimetidine. Patient should avoid Alcohol & Diazepam while taking Mirtazapine.

Pregnancy & lactationView

Pregnancy Category-C. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Mirtazapine therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.

StorageView

Keep away from light and moisture. Store below 30º C. Keep all medicine out of the reach of children.

Amisol

Amino Acid + D-Sorbitol + Electrolytes

IV Infusion 5% Allopathic Parenteral nutritional preparations

Indications

Protein supply for peritoneal nutrition

Indication detailsView

Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

DosageView

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rate. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. Hypersensitivity reactions have been reported. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

ContraindicationsView

This is contraindicated in patients with inborn errors of amino acids metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Amino Acids IV infusion and 10% Glucose with Electrolytes is contraindicated in patients with hyperosmolar nonketotic diabetic coma.

PrecautionsView

IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia may occur in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Amino Acids IV infusion and 10% Glucose with Electrolytes should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria/anuria of another origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome. Those at high risk are patients with a history of alcohol abuse, anorexia nervosa, prolonged fasting or starvation and pregnant women with hyperemesis gravidarum. In this kind of patients, parenteral nutrition containing glucose should be given with caution and parenteral administration of thiamine should be considered before and during the administration of glucose. Monitoring of serum potassium and blood glucose is recommended if Amino Acids IV infusion and 10% Glucose with electrolytes is infused rapidly or in a large quantity. For patients with hypophosphatemia, an additional supply of phosphate is recommended.

InteractionsView

At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.

Overdose effectsView

If Amino Acids IV infusion and 10% Glucose with Electrolytes is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia with Amino Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.

Amisol Gold

Amino Acid + Glucose + Electrolytes

IV Infusion 7%+10% Allopathic Parenteral nutritional preparations

Indications

Prevent nitrogen loss

Indication detailsView

This is indicated as a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. This is particularly suitable for patients with basal amino acid requirements.

Therapeutic classView

Parenteral nutritional preparations

PharmacologyView

A crystalline amino acid solution provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Amino Acids given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.

DosageView

Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range is 0.10-0.25 g nitrogen/kg/day corresponds to 11-27 ml/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon the patient’s requirements, 1000-2000 ml may be infused intravenously per 24 hours. This should be infused slowly; at a rate not exceeding 500 ml in 3 hours corresponding to approximately at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children: In infants & children, a maximal rate of infusion of 30 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week of treatment.

Side effectsView

This preparation is usually well tolerated. Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of the solution at rates exceeding the recommended maximal rate. Transient increases in liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion.

ContraindicationsView

This preparation is contraindicated in patients with inborn errors of amino acids metabolism, severe liver damage & severe uremia when dialysis facilities are not available. Due to the content of the glucose, this preparation is contraindicated in patients with hyperosmolar nonketotic diabetic coma. This preparation is also contraindicated in patients with known hypersensitivity to any of its ingredients.

PrecautionsView

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate to be adjusted as needed. This preparation should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restriction or oliguria/anuria of other origin. In patient with hyperglycemia, administration of exogenous insulin might be necessary. Do not use if the solution is turbid or contains particles. Discard any unused portion.

InteractionsView

At the recommended dosage this solution has no pharmacological effect and is expected not to interact with other medicaments.

Pregnancy & lactationView

Successful and safe administration of amino acid solution during pregnancy in human has been reported. Animal reproduction studies have not been carried out with 7% amino acid IV infusion with 10% glucose & electrolytes.

StorageView

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep away from the reach of children.

Amisure

Amisulpride

IV Infusion 5 mg/2 ml Allopathic Atypical neuroleptic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Amisulpride tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms.

Amisulpride injection is indicated in adults for:

Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
Treatment of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Therapeutic classView

Atypical neuroleptic drugs

PharmacologyView

Amisulpride binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.

Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain amisulpride’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its preferential limbic activity.

DosageView

Oral dose: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride.

Doses should be adjusted according to individual responses. Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Injectable dose: The recommended injectable adult dosage of Amisulpride and infusion rate by indication is shown in the table below:

Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia.
Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

ContraindicationsView

Hypersensitivity to the active ingredient or to other ingredients of the product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation.

PrecautionsView

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued. Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.

Pregnancy & lactationView

pregnancy Category C. The safety of amisulpride during human pregnancy has not been established, and therefore use of amisulpride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amisulpride has been found in the breast milk of treated women. Breast-feeding is contraindicated.

Pediatric usageView

Elderly: Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.

Children: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. In children up to puberty, the use of amisulpride is contraindicated

Use in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.

Use in renal impairment: Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered

StorageView

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