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Prolert
Fluoxetine Hydrochloride
Prolert
Fluoxetine Hydrochloride
Indications
Obsessive-compulsive disorder (OCD)
Indication detailsView
Fluoxetine is indicated for the treatment of-
- depressive illness
- bulimia nervosa
- obsessive compulsive disorder.
Therapeutic classView
Phenothiazine related drugs
PharmacologyView
Fluoxetine has been shown to selectively inhibit the reuptake of serotonin at the presynaptic neuronal membrane which causes increased synaptic concentration of serotonin in the CNS. This result in numerous functional changes associated with enhanced serotonergic neurotransmission. Fluoxetine appears to have no effect on the reuptake of norepinephrine and dopamine and does not exhibit anticholinergic, antihistaminic or α1 adrenergic blocking activity at usual therapeutic doses.
DosageView
Initial treatment: Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient to obtain satisfactory antidepressant response. Consequently, a dose of 20 mg/day administered in the morning is recommended as the initial dose.
A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.
A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day.
Maintenance treatment: It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa.
Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.
A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.
A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day.
Maintenance treatment: It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa.
Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.
Side effectsView
Gastrointestinal: Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea.
Neurological: Anxiety, nervousness, insomnia/ drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
Neurological: Anxiety, nervousness, insomnia/ drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
ContraindicationsView
Fluoxetine Hydrochloride is contraindicated in patients known to be hypersensitive to it.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued Fluoxetine and are then started on MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with MAOI, or within 14 days of discontinuing therapy with MAOI. Since Fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping Fluoxetine and before starting MAOI.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued Fluoxetine and are then started on MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with MAOI, or within 14 days of discontinuing therapy with MAOI. Since Fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping Fluoxetine and before starting MAOI.
PrecautionsView
As Fluoxetine undergoes hepatic metabolism and renal excretion, it should be used with caution and in reduced doses in patients with impaired hepatic or renal function. Because of its epileptogenic effect, it should be used with caution in patients with epilepsy or a history of such disorders. Fluoxetine may alter glycaemic control and therefore caution is also warranted in diabetic subjects. Depressed patients with suicidal tendencies should be carefully supervised during treatment. Fluoxetine is not usually considered a suitable form of therapy for the depressive component of bipolar (manic depressive) illness as mania may be precipitated.
InteractionsView
- MAO inhibitors: Sometimes serious fatal reactions have been reported with concomitant use.
- Antidepressants: There have been greater than two fold increases of previously stable plasma levels of other antidepressants.
- Lithium: There have been reports of increased or decreased lithium levels when used concomitantly with Fluoxetine.
- Antipsychotics: Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant Fluoxetine.
- Anticonvulsants: Patients on stable dose of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.
- CNS active drugs: Caution is advised if concomitant administration of Fluoxetine is required.
Pregnancy & lactationView
In animal studies, no teratogenicity or harmful effect was found. Because animal reproductive studies are not always predictive of human responses, Fluoxetine should be used in pregnancy only if clearly needed. As Fluoxetine is excreted in human milk, caution should be exercised when Fluoxetine is administered to nursing women.
StorageView
Protect from light & moisture. Keep in cool & dry place. Store below 30°C. Keep all the medicines out of the reach of children.
Prolert
Fluoxetine Hydrochloride
Prolert
Fluoxetine Hydrochloride
Indications
Obsessive-compulsive disorder (OCD)
Indication detailsView
Fluoxetine is indicated for the treatment of-
- depressive illness
- bulimia nervosa
- obsessive compulsive disorder.
Therapeutic classView
Phenothiazine related drugs
PharmacologyView
Fluoxetine has been shown to selectively inhibit the reuptake of serotonin at the presynaptic neuronal membrane which causes increased synaptic concentration of serotonin in the CNS. This result in numerous functional changes associated with enhanced serotonergic neurotransmission. Fluoxetine appears to have no effect on the reuptake of norepinephrine and dopamine and does not exhibit anticholinergic, antihistaminic or α1 adrenergic blocking activity at usual therapeutic doses.
DosageView
Initial treatment: Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient to obtain satisfactory antidepressant response. Consequently, a dose of 20 mg/day administered in the morning is recommended as the initial dose.
A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.
A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day.
Maintenance treatment: It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa.
Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.
A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.
A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day.
Maintenance treatment: It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa.
Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.
Side effectsView
Gastrointestinal: Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea.
Neurological: Anxiety, nervousness, insomnia/ drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
Neurological: Anxiety, nervousness, insomnia/ drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
ContraindicationsView
Fluoxetine Hydrochloride is contraindicated in patients known to be hypersensitive to it.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued Fluoxetine and are then started on MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with MAOI, or within 14 days of discontinuing therapy with MAOI. Since Fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping Fluoxetine and before starting MAOI.
Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and changes of mental status that include extreme agitation progressing to delirium and coma) in patients receiving Fluoxetine in combination with monoamine oxidase inhibitors (MAOIs), and in patients who have recently discontinued Fluoxetine and are then started on MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fluoxetine should not be used in combination with MAOI, or within 14 days of discontinuing therapy with MAOI. Since Fluoxetine and its major metabolites have very long elimination half-lives, at least 5 weeks should be allowed after stopping Fluoxetine and before starting MAOI.
PrecautionsView
As Fluoxetine undergoes hepatic metabolism and renal excretion, it should be used with caution and in reduced doses in patients with impaired hepatic or renal function. Because of its epileptogenic effect, it should be used with caution in patients with epilepsy or a history of such disorders. Fluoxetine may alter glycaemic control and therefore caution is also warranted in diabetic subjects. Depressed patients with suicidal tendencies should be carefully supervised during treatment. Fluoxetine is not usually considered a suitable form of therapy for the depressive component of bipolar (manic depressive) illness as mania may be precipitated.
InteractionsView
- MAO inhibitors: Sometimes serious fatal reactions have been reported with concomitant use.
- Antidepressants: There have been greater than two fold increases of previously stable plasma levels of other antidepressants.
- Lithium: There have been reports of increased or decreased lithium levels when used concomitantly with Fluoxetine.
- Antipsychotics: Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant Fluoxetine.
- Anticonvulsants: Patients on stable dose of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.
- CNS active drugs: Caution is advised if concomitant administration of Fluoxetine is required.
Pregnancy & lactationView
In animal studies, no teratogenicity or harmful effect was found. Because animal reproductive studies are not always predictive of human responses, Fluoxetine should be used in pregnancy only if clearly needed. As Fluoxetine is excreted in human milk, caution should be exercised when Fluoxetine is administered to nursing women.
StorageView
Protect from light & moisture. Keep in cool & dry place. Store below 30°C. Keep all the medicines out of the reach of children.
Prolimus
Tacrolimus (Topical)
Prolimus
Tacrolimus (Topical)
Indications
Vitiligo
Indication detailsView
Tacrolimus ointment is indicated for short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies. Tacrolimus ointment is also indicated in other skin conditions such as chronic cutaneous graft-vs-host disease, hand and foot eczema, allergic contact dermatitis, vitiligo, psoriasis, lichen planus, facial lichen, vulvar lichen sclerosus, pyoderma gangrenosum, leg ulcers in rheumatoid arthritis, steroid-induced rosacea & alopecia areata, annular erythema, chronic actinic dermatitis and recalcitrant facial erythema.
Therapeutic classView
Drugs affecting the immune response
PharmacologyView
Tacrolimus is a macroiide immunomodulator produced by fungus, Streptomyces tsukubaensis. It has been demonstrated that Tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This leads to a general decrease in the entire inflammatory cascade.
DosageView
Use in adults: Apply a thin layer of Tacrolimus ointment onto the affected skin areas twice daily and rub in gently and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Tacrolim ointment under occlusion which may promote systemic exposure has not been evaluated. Tacrolimus ointment should not be used with occlusive dressings.
Use in Children:
Use in Children:
- Tacrolimus 0.03% ointment can be used in pediatric patients 2 years of age and older.
- Tacrolimus 0.1% ointment can be used in children 16 years of age and older.
Side effectsView
Topically applied Tacrolimus ointment have very few and rare type of side-effects including skin burning, pruritus, flu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc.
ContraindicationsView
Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.
PrecautionsView
Cautions should be exercised while treatment with Tacrolimus ointment in patients with atopic dermatitis predisposed to superficial skin infections. The safety of Tacrolimus ointment has not been established in patients with generalized erythroderma.
InteractionsView
Formal topical drug interaction studies with Tacrolimus ointment have not been conducted. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies of topically administered Tacrolimus in pregnant women. Although systemic absorption of Tacrolimus following topical applications of Tacrolimus ointment is minimal relative to systemic administration, it is known that Tacrolimus is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Tacrolimus ointment is not for oral use. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. If oral ingestion occurs, medical advice should be sought.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Prolimus
Tacrolimus (Topical)
Prolimus
Tacrolimus (Topical)
Indications
Vitiligo
Indication detailsView
Tacrolimus ointment is indicated for short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies. Tacrolimus ointment is also indicated in other skin conditions such as chronic cutaneous graft-vs-host disease, hand and foot eczema, allergic contact dermatitis, vitiligo, psoriasis, lichen planus, facial lichen, vulvar lichen sclerosus, pyoderma gangrenosum, leg ulcers in rheumatoid arthritis, steroid-induced rosacea & alopecia areata, annular erythema, chronic actinic dermatitis and recalcitrant facial erythema.
Therapeutic classView
Drugs affecting the immune response
PharmacologyView
Tacrolimus is a macroiide immunomodulator produced by fungus, Streptomyces tsukubaensis. It has been demonstrated that Tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This leads to a general decrease in the entire inflammatory cascade.
DosageView
Use in adults: Apply a thin layer of Tacrolimus ointment onto the affected skin areas twice daily and rub in gently and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Tacrolim ointment under occlusion which may promote systemic exposure has not been evaluated. Tacrolimus ointment should not be used with occlusive dressings.
Use in Children:
Use in Children:
- Tacrolimus 0.03% ointment can be used in pediatric patients 2 years of age and older.
- Tacrolimus 0.1% ointment can be used in children 16 years of age and older.
Side effectsView
Topically applied Tacrolimus ointment have very few and rare type of side-effects including skin burning, pruritus, flu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc.
ContraindicationsView
Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.
PrecautionsView
Cautions should be exercised while treatment with Tacrolimus ointment in patients with atopic dermatitis predisposed to superficial skin infections. The safety of Tacrolimus ointment has not been established in patients with generalized erythroderma.
InteractionsView
Formal topical drug interaction studies with Tacrolimus ointment have not been conducted. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies of topically administered Tacrolimus in pregnant women. Although systemic absorption of Tacrolimus following topical applications of Tacrolimus ointment is minimal relative to systemic administration, it is known that Tacrolimus is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Tacrolimus ointment is not for oral use. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. If oral ingestion occurs, medical advice should be sought.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Proliv
Amino Acid + D-Sorbitol + Electrolytes
Proliv
Amino Acid + D-Sorbitol + Electrolytes
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).
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.
- 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.
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.
Proliv Plus
Amino Acid + Glucose + Electrolytes
Proliv Plus
Amino Acid + Glucose + Electrolytes
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.
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.
Prolok
Omeprazole
Prolok
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Prolok
Omeprazole
Prolok
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Prolok
Omeprazole
Prolok
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Prolol
Metoprolol Tartrate
Prolol
Metoprolol Tartrate
Indication detailsView
ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction.
PharmacologyView
Metoprolol is a selective beta1-blocker. Metoprolol reduces or inhibits the agonistic effect on the heart of catecholamines (which are released during physical and mental stress). This means that the usual increase in heart rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase in catecholamines, is reduced by Metoprolol. Metoprolol interferes less with Insulin release and carbohydrate metabolism than do non-selective beta-blockers. Metoprolol interferes much less with the cardiovascular response to hypoglycaemia than do non-selective beta-blockers.
DosageView
Film-coated tablet-
- Hypertension: Total daily dosage Metoprolol 100-400 mg to be given as a single or twice-daily dose. The starting dose is 100 mg (two Metoprolol-50 tablets) per day. This may be increased by 100 mg per day at weekly intervals. lf full control is not achieved using a single daily dose, a b.i.d. regimen should be initiated. Combination therapy with a diuretic or other antihypertensive agents may also be considered.
- Angina: Usually Metoprolol 50 mg (one Metoprolol-50 tablet) to 100 mg (two Metoprolol-50 tablets) twice or three times daily.
- Cardiac arrhythmias: Metoprolol 50 mg (one Metoprolol-50 tablet) b.i.d or t.i.d should usually control the condition. It is necessary the dose can be increased up to 300 mg per day in divided doses. Following the treatment of an acute arrhythmia with Metoprolol injection, continuation therapy with Metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not exceed 50 mg t.i.d.
- Hyperthyroidism: Metoprolol 50 mg (one Metoprolol-50 tablet) four times a day. The dose should be reduced as the euthyroid state is achieved.
- Myocardial infarction: Orally, therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose. Maintenance- The usual maintenance dose is 200 mg daily given in divided doses. Elderly’ There are no special dosage requirements in otherwise healthy elderly patients. Significant hepatic dysfunction: A reduction in dosage may be necessary.
- Hypertension: The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic.
- Angina Pectoris: The dosage of extended-release Metoprolol Succinate should be individualized. The usual initial dosage is 100 mg daily, in a single dose.
- Heart Failure: The recommended starting dose of sustained-release Metoprolol Succinate is 25 mg once daily for two weeks in patients with NYHA class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1-2 weeks.
- Arrhythmias: By intravenous injection, up to 5 mg at a rate of 1-2 mg/minute, repeated after 5 minutes if necessary, total dose 10-15 mg.
- In surgery: By slow intravenous injection 2-4 mg at induction or to control arrhythmias developing during anaesthesia; 2 mg doses may be repeated to a maximum of 10 mg.
- Myocardial Infarction: Early intervention within 12 hours of infarction, by intravenous injection 5 mg every 2 minutes to a maximum of 15 mg, followed after 15 minutes by 50 mg by mouth every 6 hours for 48 hours; maintenance 200 mg daily in divided doses.
Side effectsView
Tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, slow heart rate, mental confusion, headache, somnolence, nightmares, insomnia, dyspnea, Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, heartburn, pruritus, musculoskeletal pain, blurred vision, decreased libido, and tinnitus have also been reported, intensification of AV block.
ContraindicationsView
AV block, Uncontrolled heart failure, severe bradycardia, sick-sinus syndrome, cardiogenic shock and severe peripheral arterial disease. Known hypersensitivity to Metoprolol or other B-blockers. Metoprolol is also contra-indicated when myocardial infarction is complicated by significant bradycardia, first-degree heart block, systolic hypotension (<100mmHg) and/or severe heart failure.
PrecautionsView
Bronchospastic Diseases: Because of its relative beta 1 ‐selectivity, however, Metoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate other antihypertensive treatment.
Major Surgery: The necessity or desirability of withdrawing beta‐blocking therapy prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Diabetes and Hypoglycemia: Beta‐blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Peripheral Vascular Disease: Beta‐blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients, caution should be exercised in patients treated with these agents concomitantly.
Major Surgery: The necessity or desirability of withdrawing beta‐blocking therapy prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Diabetes and Hypoglycemia: Beta‐blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Peripheral Vascular Disease: Beta‐blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients, caution should be exercised in patients treated with these agents concomitantly.
InteractionsView
Catecholamine‐depleting drugs (e.g. Reserpine, Monoamine Oxidase (MAO) inhibitors) may have an additive effect when given with beta‐blocking agents. Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine and propafenone are likely to increase Metoprolol concentration. These increases in plasma concentration would decrease the cardioselectivity of Metoprolol. Concomitant use of digitalis glycosides and beta‐blockers can increase the risk of bradycardia. Beta‐blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well‐controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Metoprolol is excreted in breast milk in very small quantities. Caution should be exercised when Metoprolol is administered to a nursing woman.
Pediatric usageView
Hepatic impaired patient: Metoprolol should be used with caution in patients with impaired hepatic function.
Pediatric Use: No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of Metoprolol have not been established in patients <6 years of age.
Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
Pediatric Use: No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of Metoprolol have not been established in patients <6 years of age.
Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
Overdose effectsView
Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, nausea, vomiting, cyanosis, hypoglycaemia and, occasionally, hyperkalaemia. The first manifestations usually appear 20 minutes to 2 hours after drug ingestion. Treatment: Treatment should include close monitoring of cardiovascular, respiratory and renal function, and blood glucose and electrolytes. Further absorption may be prevented by induction of vomiting, gastric lavage or administration of activated-charcoal if ingestion is recent. Cardiovascular complications should be treated symptomatically, which may require the use of sympathomimetic agents (e.g. noradrenaline, metaramionl), atropine or inotropic agents (e.g. dopamine, dobutamine). Temporary pacing may be required for AV block. Glucagon can reverse the effects of excessive B-blockade, given in a dose of 1-10 mg intravenously. Intravenous B2-stimulants e.g. terbutaline may be required to relieve bronchospasm. Metoprolol cannot be effectively removed by haemodialysis.
StorageView
Store in a cool and dry place, protected from light.
Prolong
Dapoxetine Hydrochloride
Prolong
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Prolong
Dapoxetine Hydrochloride
Prolong
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Prolonga
Tadalafil
Prolonga
Tadalafil
Indications
Pulmonary arterial hypertension
Indication detailsView
Tadalafil is indicated in-
- Erectile Dysfunction (ED)
- Benign Prostatic Hyperplasia (BPH)
- Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.
DosageView
Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.
Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.
Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.
Side effectsView
Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.
ContraindicationsView
- Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
- Hypersensitivity reactions to Tadalafil
PrecautionsView
Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.
InteractionsView
May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.
Pregnancy & lactationView
Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Prolonga
Tadalafil
Prolonga
Tadalafil
Indications
Pulmonary arterial hypertension
Indication detailsView
Tadalafil is indicated in-
- Erectile Dysfunction (ED)
- Benign Prostatic Hyperplasia (BPH)
- Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.
DosageView
Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.
Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.
Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.
Side effectsView
Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.
ContraindicationsView
- Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
- Hypersensitivity reactions to Tadalafil
PrecautionsView
Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.
InteractionsView
May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.
Pregnancy & lactationView
Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Prolonga
Tadalafil
Prolonga
Tadalafil
Indications
Pulmonary arterial hypertension
Indication detailsView
Tadalafil is indicated in-
- Erectile Dysfunction (ED)
- Benign Prostatic Hyperplasia (BPH)
- Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.
DosageView
Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.
Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.
Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.
Side effectsView
Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.
ContraindicationsView
- Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
- Hypersensitivity reactions to Tadalafil
PrecautionsView
Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.
InteractionsView
May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.
Pregnancy & lactationView
Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Promalex-M
Promethazine Hydrochloride
Promalex-M
Promethazine Hydrochloride
Indications
Vasomotor rhinitis
Indication detailsView
- Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
- Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
- Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
- For sedation, allergic rhinitis, urticaria and insomnia.
- As an adjunct in pre-operative sedation in surgery and obstetrics.
- As a paediatric sedative
Therapeutic classView
Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine
PharmacologyView
Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.
Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.
Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.
DosageView
Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.
Elderly: No specific dosage recommendations.
Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.
As an antihistamine in allergy:
Elderly: No specific dosage recommendations.
Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.
As an antihistamine in allergy:
- Children of 2-5 years: 5-15 mg
- Children of 5-10 years: 10-25 mg
- In the case where two doses in 24 hours are required, the lower dose stated should be given.
- Children of 2-5 years: 15-20 mg
- Children of 5-10 years: 20-25 mg
- Given as a single night-time dose
Side effectsView
- Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
- Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
- Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
- Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
- Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
- Eye Disorders- Frequency unknown: Blurred vision
- Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
- Renal and Urinary Disorders- Frequency unknown: Urinary retention
- Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
- Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
- Vascular disorders- Frequency unknown: Hypotension
- Hepatobiliary disorders- Frequency unknown: Jaundice
- General Disorders and Administration Site Conditions- Frequency unknown: Tiredness
ContraindicationsView
- Promethazine is contraindicated for use in children less than two years of age
- Hypersensitivity to promethazine or to any of the excipients.
- Phenergan should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants.
- Phenergan should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days
PrecautionsView
- The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
- Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
- Use with care in patients with severe coronary artery disease.
- Use with care in patients with narrow angle glaucoma.
- Use with care in patients with epilepsy.
- Use with care in patients with hepatic insufciency.
- Use with care in patients with renal insufciency.
- Caution should be exercised in patients with bladder neck obstruction.
- Caution should be exercised in patients with pyloro-duodenal obstruction.
InteractionsView
- Promethazine Hydrochloride may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic, Alcohol should be avoided during drug treatment.
- Phenergan may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
- Phenergan should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.
Pregnancy & lactationView
There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.
Overdose effectsView
Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.
StorageView
Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
Promef
Mudir [Aloe, Saffron, Ferrus sulphate]
Promef
Mudir [Aloe, Saffron, Ferrus sulphate]
Indications
Secondary amenorrhoea
Indication detailsView
This is indicated in amenorrhoea.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
This is a special preparation of synergistically acting natural ingredients such as Aloe (Aloe barbadensis), Saffron (Crocus sativus) and other natural ingredients. It helps to prevent amenorrhoea, irregular menstruation, and other female disorders. It strengthens & maintains the normal function of uterus.
DosageView
1-2 tablet(s) 3 times daily, from 3-4 days before to start menstrual cycle, not to be taken if the menstrual cycle started or as prescribed by the physician.
Side effectsView
No significant side effect has been observed in the therapeutic dosage.
ContraindicationsView
There is no known contraindication.
PrecautionsView
Keep out of reach of the children.
StorageView
Store at cool and dry place, protect from light.
Promel
Paracetamol
Promel
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Promel
Paracetamol
Promel
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Promel Plus
Paracetamol + Caffeine
Promel Plus
Paracetamol + Caffeine
Indications
Toothache
Indication detailsView
The is indicated in the following condition-
- Headache
- Migraine
- Toothache
- Neuralgia
- Feverishness
- Period pain
- Sore throat
- Backache
- Help to reduce the temperature
- Aches and pain of colds and flu
Therapeutic classView
Non opioid analgesics
PharmacologyView
This is a combination of Paracetamol and Caffeine. Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Caffeine is an alkaloid which is a theophylline-like xanthine derivative. By intermolecular association with Paracetamol, Caffeine increases the solubility and transmembrane permeation of Paracetamol. In addition, Caffeine increases the pain threshold and tolerance of pain. Caffeine has also an intrinsic power to raise vessel tone in the brain, which provides another benefit to treat migraine and headache.
DosageView
Adult dose: 1-2 tablets every 4-6 hours. Maximum dose: 8 tablets daily.
Child dose: Not recommended for children below 12 years.
Child dose: Not recommended for children below 12 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis). Known hypersensitivity to paracetamol or caffeine.
PrecautionsView
Paracetamol & Caffeine should be given cautiously in the following cases: In patients with hepatic or renal failure, in patients taking other hepatotoxic medication. Prolonged use of the drug without consulting a physician should be avoided.
InteractionsView
May reduce serum levels with anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine). May enhance the anticoagulant effect of warfarin and other coumarins with prolonged use. Accelerated absorption with metoclopramide and domperidone. May increase serum levels with probenecid. May increase serum levels of chloramphenicol. May reduce absorption with colestyramine within 1 hr of admin. May cause severe hypothermia with phenothiazine.
Pregnancy & lactationView
Pregnant mothers should consult with doctors before taking Paracetamol & Caffeine. Paracetamol & Caffeine can be taken whilst breast feeding.
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Store in a cool and dry place, protect from light and moisture.Keep all medicines out of the reach of the children.