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K-Pol
Paracetamol + Caffeine
K-Pol
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.
K-Saline Fruity
Oral Rehydration Salt [Flavored]
K-Saline Fruity
Oral Rehydration Salt [Flavored]
Indications
Vomiting
Indication detailsView
Indicated for Diarrhea, Dehydration, Vomiting, Fluid and Electrolytes imbalance
Therapeutic classView
Oral electrolytes preparations
PharmacologyView
Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes.
It is also used as diluents for infusion of compatible drug additives.
Dextrose is a monosaccharide that is used as a source of calories and water for hydration. It helps to reduce loss of body protein and nitrogen. It also promotes glycogen deposition in the liver. When used with insulin, it stimulates the uptake of potassium by cells, especially in muscle tissue, thus lowering serum potassium levels.
Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.
Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes.
It is also used as diluents for infusion of compatible drug additives.
Dextrose is a monosaccharide that is used as a source of calories and water for hydration. It helps to reduce loss of body protein and nitrogen. It also promotes glycogen deposition in the liver. When used with insulin, it stimulates the uptake of potassium by cells, especially in muscle tissue, thus lowering serum potassium levels.
Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.
DosageView
Daily dose should be equivalent to patients fluid requirement for maintenance and replenishment of losses. During saline therapy mother should not stop breast-feeding to their child and normal food should be continued in case of adults.
Children less than 2 years: After each loose stool or vomiting 10 to 20 spoonful (50-100 ml) of prepared saline.
Children 2 to 10 years: After each loose stool or vomiting 100-200 ml of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 ml of prepared saline.
Children less than 2 years: After each loose stool or vomiting 10 to 20 spoonful (50-100 ml) of prepared saline.
Children 2 to 10 years: After each loose stool or vomiting 100-200 ml of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 ml of prepared saline.
Side effectsView
No significant side effects.
ContraindicationsView
Patients with known hypersensitivity.
PrecautionsView
Depressed renal function, severe continuing diarrhoea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline. Reconstitue saline should be used within 6 hours.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
K-Saline N
Oral Rehydration Salt [Powder]
K-Saline N
Oral Rehydration Salt [Powder]
Indication detailsView
Oral Rehydration Salt replacement of fluid and electrolyte loss due to-
- Acute diarrhea
- Vomiting
- Dehydration
Therapeutic classView
Oral electrolytes preparations
PharmacologyView
This is the preparation of oral rehydration salt. It is composed of anhydrous glucose, sodium chloride, potassium chloride and sodium citrate (as dihydrate). This is a single formulation of glucose based oral rehydration salt to treat or prevent dehydration from diarrhea of any etiology, including cholera and in individuals of any age. This also prevents acidosis due to electrolyte imbalance.
DosageView
Daily dose should be equivalent to patients' fluid requirement for maintenance and replenishment of losses. During this therapy, mother should not stop breastfeeding to their child and normal food should be continued in case of adults.
Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.
Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.
Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.
Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.
AdministrationView
- Disperse the full contents of the sachet in 500 mL (1/2 liter) of pure drinking water.
- Do not mix the oral saline with hot water or heat the prepared solution.
- Discard the unused prepared oral saline after 12 hours of preparation.
PrecautionsView
Depressed renal function, severe continuing diarrhea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline.
InteractionsView
There are no known drug interactions and none well documented.
StorageView
Do not store above 30°C temperature. Keep away from light and wet places. Keep out of reach of children.
K-Y Jelly
Glycerol
K-Y Jelly
Glycerol
Indications
Skin irritations
Indication detailsView
This Jelly is indicated to enhance the comfort and ease of intimate activity with or without latex condoms. This personal lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourses.
Therapeutic classView
Miscellaneous topical agents
DosageView
Apply the desired amount of lubricant to your intimate areas. Reapply as needed. This Jelly is not applicable for pediatric Use.
Side effectsView
No common side effects have been reported with this preparation. Few allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation may occur.
ContraindicationsView
This Jelly is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.
PrecautionsView
Discontinue if irritation or discomfort occurs. Do not eat and keep the gel away from nose, eye and open wounds.
This Jelly is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on the opening of the tube or bottle is broken or missing. Avoid use if pregnant or breast feeding unless prescribed by your doctor. Glycerol-based lubricants may slow sperm down, so if you're trying to have a baby, talk to your doctor before use.
This Jelly is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on the opening of the tube or bottle is broken or missing. Avoid use if pregnant or breast feeding unless prescribed by your doctor. Glycerol-based lubricants may slow sperm down, so if you're trying to have a baby, talk to your doctor before use.
InteractionsView
Drug interaction-related data not found. If any abnormality consults with the doctor.
Pregnancy & lactationView
It may feel strange to have sex as the baby grows within, but so long as you're having a normal, healthy pregnancy, intercourse is generally considered safe but be sure to consult with doctor if you have any questions about safety. Avoid use if pregnant unless prescribed by physician. No known risk found during the lactation period.
StorageView
Store at room temperature below 30°C. Do not freeze.
KCL
Potassium Chloride
KCL
Potassium Chloride
Indications
Ulcerative colitis
Indication detailsView
Potassium Chloride is indicated in-
- Replacement of potassium deficit
- Diuretic (Potassium losing)-induced hypokalaemia
- Hypokalaemia from renal potassium wasting
- Hypokalaemia from gastrointestinal losses
- Hypochloraemic alkalosis associated with hypokalaemia
Therapeutic classView
Electrolytes preparations, Oral electrolytes preparations
PharmacologyView
Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
DosageView
Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Side effectsView
Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.
ContraindicationsView
Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.
PrecautionsView
It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.
InteractionsView
Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.
Pregnancy & lactationView
As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.
Pediatric usageView
Use in children: No special precautions are required.
StorageView
Store below 25°C in a dry place, away from light. Keep out of the reach of children.
KCL
Potassium Chloride
KCL
Potassium Chloride
Indications
Ulcerative colitis
Indication detailsView
Potassium Chloride is indicated in-
- Replacement of potassium deficit
- Diuretic (Potassium losing)-induced hypokalaemia
- Hypokalaemia from renal potassium wasting
- Hypokalaemia from gastrointestinal losses
- Hypochloraemic alkalosis associated with hypokalaemia
Therapeutic classView
Electrolytes preparations, Oral electrolytes preparations
PharmacologyView
Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
DosageView
Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Side effectsView
Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.
ContraindicationsView
Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.
PrecautionsView
It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.
InteractionsView
Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.
Pregnancy & lactationView
As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.
Pediatric usageView
Use in children: No special precautions are required.
StorageView
Store below 25°C in a dry place, away from light. Keep out of the reach of children.
KPR
Ketorolac Tromethamine
KPR
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
KT
Potassium Chloride
KT
Potassium Chloride
Indications
Ulcerative colitis
Indication detailsView
Potassium Chloride is indicated in-
- Replacement of potassium deficit
- Diuretic (Potassium losing)-induced hypokalaemia
- Hypokalaemia from renal potassium wasting
- Hypokalaemia from gastrointestinal losses
- Hypochloraemic alkalosis associated with hypokalaemia
Therapeutic classView
Electrolytes preparations, Oral electrolytes preparations
PharmacologyView
Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
DosageView
Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Side effectsView
Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.
ContraindicationsView
Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.
PrecautionsView
It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.
InteractionsView
Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.
Pregnancy & lactationView
As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.
Pediatric usageView
Use in children: No special precautions are required.
StorageView
Store below 25°C in a dry place, away from light. Keep out of the reach of children.
KT
Potassium Chloride
KT
Potassium Chloride
Indications
Ulcerative colitis
Indication detailsView
Potassium Chloride is indicated in-
- Replacement of potassium deficit
- Diuretic (Potassium losing)-induced hypokalaemia
- Hypokalaemia from renal potassium wasting
- Hypokalaemia from gastrointestinal losses
- Hypochloraemic alkalosis associated with hypokalaemia
Therapeutic classView
Electrolytes preparations, Oral electrolytes preparations
PharmacologyView
Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
DosageView
Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.
Side effectsView
Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.
ContraindicationsView
Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.
PrecautionsView
It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.
InteractionsView
Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.
Pregnancy & lactationView
As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.
Pediatric usageView
Use in children: No special precautions are required.
StorageView
Store below 25°C in a dry place, away from light. Keep out of the reach of children.
KTL
Ketorolac Tromethamine
KTL
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
KTM
Ketorolac Tromethamine
KTM
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Kabiven
Glucose 19% + Vamin 18 Novum + Intralipid 20%
Kabiven
Glucose 19% + Vamin 18 Novum + Intralipid 20%
Indications
Parenteral nutrition
Indication detailsView
This parenteral nutrition is indicated for patients and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Therapeutic classView
Parenteral nutritional preparations
DosageView
The dose should be individualized and the choice of bag size should be made with regard to the patients clinical condition, body weight and nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patients condition (e.q. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day). The corresponding commonly accepted requirements are 2.0-6.0 g for glucose and 1.0-2.0g for fat. The dose range of 0.10-0.20 g nitrogen/kg/day (0.7-1.3 g amino acid/kg/day) which covers the need of the majority of the patients. This corresponds to 19 ml-38 ml/kg/day. For a 70-kg-patient this is equivalent to 1330 ml-2660 ml of this solution per day. The total energy requirement depends on the patient's clinical condition and is most often between 25 - 35 kcal/kg/ day. In obese patients the dose should be based on the estimated ideal weight. This solution is produced in four sizes intended for patients with high, moderately increased, basal, or low nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose i.e. 12.5-25 ml/kg (corresponding to 0.49-0.98 g fat/kg/day,0.41-0.83 g amino acids/kg/day and 1.2-2.4 g glucose/kg/day) and increased by10-15ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age, the dosage for adults can be applied. The use of this parenteral nutrition is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patients condition (e.q. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day). The corresponding commonly accepted requirements are 2.0-6.0 g for glucose and 1.0-2.0g for fat. The dose range of 0.10-0.20 g nitrogen/kg/day (0.7-1.3 g amino acid/kg/day) which covers the need of the majority of the patients. This corresponds to 19 ml-38 ml/kg/day. For a 70-kg-patient this is equivalent to 1330 ml-2660 ml of this solution per day. The total energy requirement depends on the patient's clinical condition and is most often between 25 - 35 kcal/kg/ day. In obese patients the dose should be based on the estimated ideal weight. This solution is produced in four sizes intended for patients with high, moderately increased, basal, or low nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose i.e. 12.5-25 ml/kg (corresponding to 0.49-0.98 g fat/kg/day,0.41-0.83 g amino acids/kg/day and 1.2-2.4 g glucose/kg/day) and increased by10-15ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age, the dosage for adults can be applied. The use of this parenteral nutrition is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
AdministrationView
Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg/hour. Amino acid dosage should not exceed 0.1 g/kg/hour. Fat dosage should not provide more than 0.15 g/kg/hour. The infusion rate should not exceed 2.6 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.1g fat/kg). The recommended infusion period is 12-24 hours. This parenteral nutrition is recommended to be infused only into a central vein. The infusion may be continued for as long as required by the patient's clinical condition.
Side effectsView
Intralipid may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence <1%). Transient increases in liver enzymes during intravenous nutrition have also been reported. As with all hypertonic solutions for infusion, thrombophlebitis may occur if peripheral veins are used. Reports of other undesirable effects in conjunction with Intralipid infusions are extremely rare; less than one adverse event per million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haemolysis, reticulocytosis, abdominal pain, headache, tiredness and priapism have been reported.
Fat overload syndrome: An impaired capacity to eliminate Intralipid (the fat component in this parenteral nutrition) may lead to the fat overload syndrome as a result of over-dosage, but also at recommended rates of infusion in association with a sudden change in the patients clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. All symptoms are usually reversible if the infusion is discontinued.
Fat overload syndrome: An impaired capacity to eliminate Intralipid (the fat component in this parenteral nutrition) may lead to the fat overload syndrome as a result of over-dosage, but also at recommended rates of infusion in association with a sudden change in the patients clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. All symptoms are usually reversible if the infusion is discontinued.
ContraindicationsView
- Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. Severe hyperlipaemia
- Severe liver insufficiency
- Severe blood coagulation disorders
- Inborn errors of amino acid metabolism
- Severe renal insufficiency without access to haemofiltration or dialysis
- Acute shock
- Hyperglycemia, which requires more than 6 units insulin/h
- Pathologically elevated serum levels of any of the included electrolytes.
- General contra-indications to infusion therapy acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency and hypotonic dehydration
- Haemophagocytotic syndrome
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma)
- Infants under 2 years of age
PrecautionsView
The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/l during infusion. The bag size, especially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use. Disturbances of the electrolyte and fluid balance (e g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.
Overdose effectsView
Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate. If symptoms of overdose occur, the infusion should be slowed down or discontinued. Additionally, an overdose might cause fluid overload, electrolyte imbalances, hyperglycemia, and hyperosmolality. In some rare serious cases, haemodialysis, haemofiltration or haemo diafiltration may be necessary.
StorageView
Store at 25°C. Do not freeze. It is recommended to store.
Kabiven Perifer
Glucose 11% + Vamin 18 Novum + Intralipid 20%
Kabiven Perifer
Glucose 11% + Vamin 18 Novum + Intralipid 20%
Indications
Negative nitrogen balance
Indication detailsView
This parenteral nutrition is indicated for patients and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Therapeutic classView
Parenteral nutritional preparations
DosageView
The dose should be individualized and the choice of bag size should be made with regard to the patient's clinical condition, body weight, and nutritional requirements
Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-030 g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day); The corresponding commonly accepted requirements are 2-6 g for glucose and 1.0-2.0 g for fat.
The total energy requirement depends on the patient's clinical condition and is often between 20-30 kcal/kg/day In obese patients, the dose should be based on the estimated ideal weight. This solution is produced in three sizes intended for patients with moderately increased, basal or low nutritional requirements. To provide total parenteral nutrition, the addition of trace elements, vitamins and supplemental electrolytes may be required. The dose range of 0.10-0 15 g N/kg/day (0.7-1.0 g amino acid/kg/day) and total energy of 20-30 kcal body weight/day corresponds to approx. 27-40 ml/kg/day.
Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose l.e. 14-28 ml/kg (corresponding to 0.49-0.98 g fat/kg/day, 0.34-0.67 g amino acids/kg/day and 0.95-1.9 g glucose/kg/day) and increased by 10-15 ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age the dosage for adults can be applied. The use of this solution is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-030 g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day); The corresponding commonly accepted requirements are 2-6 g for glucose and 1.0-2.0 g for fat.
The total energy requirement depends on the patient's clinical condition and is often between 20-30 kcal/kg/day In obese patients, the dose should be based on the estimated ideal weight. This solution is produced in three sizes intended for patients with moderately increased, basal or low nutritional requirements. To provide total parenteral nutrition, the addition of trace elements, vitamins and supplemental electrolytes may be required. The dose range of 0.10-0 15 g N/kg/day (0.7-1.0 g amino acid/kg/day) and total energy of 20-30 kcal body weight/day corresponds to approx. 27-40 ml/kg/day.
Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose l.e. 14-28 ml/kg (corresponding to 0.49-0.98 g fat/kg/day, 0.34-0.67 g amino acids/kg/day and 0.95-1.9 g glucose/kg/day) and increased by 10-15 ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age the dosage for adults can be applied. The use of this solution is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
AdministrationView
Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg/hour Amino acid dosage should not exceed 0.1 g/kg/hour Fat dosage should not provide more than 0.15 g/kg/hour The infusion rate should not exceed 3.7 ml/kg/hour (corresponding to 0.25 g glucose, 0.09 g amino acids, 0.13 g fat per kg body weight). The recommended infusion period for individual bags of this solution is 12-24 hours.
Method and duration of administration: Intravenous infusion into a Perifer or central vein. The infusion may be continued for as long as required by the patient's clinical condition. In order to minimize the risk of thrombophlebitis, daily rotation of the infusion site is recommended.
Method and duration of administration: Intravenous infusion into a Perifer or central vein. The infusion may be continued for as long as required by the patient's clinical condition. In order to minimize the risk of thrombophlebitis, daily rotation of the infusion site is recommended.
Side effectsView
The infusion may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence<1 %). Transient increases in liver enzymes during intravenous nutrition have also been reported. Reports of other undesirable effects in conjunction with the included components are extremely rare. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haernolvsis. reticulocytosis, abdominal pain, headache, nausea, vomiting, tiredness and priapism have been reported.
ContraindicationsView
- Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. Severe hyperlipaemia
- Severe liver insufficiency
- Severe blood coagulation disorders
- Inborn errors of amino acid metabolism
- Severe renal insufficiency without access to haemofiltration or dialysis
- Acute shock
- Hyperglycemia, which requires more than 6 units insulin/h
- Pathologically elevated serum levels of any of the included electrolytes.
- General contra-indications to infusion therapy acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency and hypotonic dehydration
- Haemophagocytotic syndrome
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma)
- Infants under 2 years of age
PrecautionsView
The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/l during infusion. The bag size, especially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use. Disturbances of the electrolyte and fluid balance (e g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.
InteractionsView
The soybean oil present in this intravenous preparation has vitamin K1. Vitamin K1 can reverse the anticoagulant activity of coumarin and coumarin derivatives, including warfarin, which works by blocking recycling of vitamin K1. Monitor laboratory parameters for anticoagulant activity in patients who are on both this intravenous preparation and coumarin or coumarin derivatives.
Overdose effectsView
Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate. An impaired capacity to eliminate fat may lead to the fat overload syndrome as a result of overdosage, but also at recommended rates of infusion in association with a sudden change in the patient's clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. These changes are invariably reversible on discontinuation of the fat infusion If symptoms of overdose occur, the infusion should be slowed down or discontinued. In some rare serious cases, hemodialysis. haemofiltration or haemo-diafiltration may be necessary.
StorageView
Store at 25°C. Do not freeze. It is recommended to store.
Kacin
Amikacin
Kacin
Amikacin
Indications
Urinary tract infection
Indication detailsView
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Amikacin is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and postoperative infections (including postvascular surgery). Clinical studies have shown Amikacin also to be effective in serious complicated and recurrent urinary tract infections due to those organisms.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Therapeutic classView
Aminoglycosides
PharmacologyView
Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.
DosageView
Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
AdministrationView
Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Side effectsView
The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.
ContraindicationsView
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.
PrecautionsView
Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.
InteractionsView
Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.
Pregnancy & lactationView
Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established
Overdose effectsView
In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Kacin
Amikacin
Kacin
Amikacin
Indications
Urinary tract infection
Indication detailsView
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Amikacin is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and postoperative infections (including postvascular surgery). Clinical studies have shown Amikacin also to be effective in serious complicated and recurrent urinary tract infections due to those organisms.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Therapeutic classView
Aminoglycosides
PharmacologyView
Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.
DosageView
Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
AdministrationView
Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Side effectsView
The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.
ContraindicationsView
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.
PrecautionsView
Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.
InteractionsView
Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.
Pregnancy & lactationView
Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established
Overdose effectsView
In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Kacin
Amikacin
Kacin
Amikacin
Indications
Urinary tract infection
Indication detailsView
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Amikacin is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and postoperative infections (including postvascular surgery). Clinical studies have shown Amikacin also to be effective in serious complicated and recurrent urinary tract infections due to those organisms.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Therapeutic classView
Aminoglycosides
PharmacologyView
Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.
DosageView
Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
AdministrationView
Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Side effectsView
The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.
ContraindicationsView
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.
PrecautionsView
Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.
InteractionsView
Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.
Pregnancy & lactationView
Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established
Overdose effectsView
In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Kadcyla
Trastuzumab Emtansine
Kadcyla
Trastuzumab Emtansine
Indications
Metastatic breast carcinoma
Indication detailsView
Metastatic Breast Cancer (MBC): Trastuzumab Emtansine, as a single agent, is indicated for the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane.
Therapeutic classView
Anti neoplastic preparations
PharmacologyView
Trastuzumab Emtansine is a HER2-targeted antibody-drug conjugate which contains the humanized anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitory drug DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to the MCC-DM1 complex. An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumor cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Trastuzumab Emtansine has the mechanisms of action of both trastuzumab and DM1.
Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain (ECD), as well as to Fcγ receptors and complement C1q. In addition, Trastuzumab Emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signaling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
DM1, the cytotoxic drug component of Trastuzumab Emtansine, binds to tubulin. By inhibiting tubulin polymerization, both DM1 and Trastuzumab Emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death. Results from in vitro cytotoxicity assays show that DM1 is 20–200 times more potent than taxanes and vinca alkaloids.
The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumor cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Trastuzumab Emtansine has the mechanisms of action of both trastuzumab and DM1.
Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain (ECD), as well as to Fcγ receptors and complement C1q. In addition, Trastuzumab Emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signaling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
DM1, the cytotoxic drug component of Trastuzumab Emtansine, binds to tubulin. By inhibiting tubulin polymerization, both DM1 and Trastuzumab Emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death. Results from in vitro cytotoxicity assays show that DM1 is 20–200 times more potent than taxanes and vinca alkaloids.
The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
DosageView
Recommended Doses And Schedules: The recommended dose of Trastuzumab Emtansine is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer Trastuzumab Emtansine at doses greater than 3.6 mg/kg. Do not substitute Trastuzumab Emtansine for or with trastuzumab. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration
First Infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusionrelated reactions
Subsequent Infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
First Infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusionrelated reactions
Subsequent Infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
ContraindicationsView
Trastuzumab Emtansine is contraindicated in patients with a known hypersensitivity to Trastuzumab Emtansine or any of its excipients
PrecautionsView
Patients treated with Trastuzumab Emtansine must have confirmed HER2-positive tumor status as assessed by either HER2 protein overexpression or gene amplification.
InteractionsView
No formal drug-drug interaction studies with trastuzumab emtansine in humans have been conducted. In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolized mainly by CYP3A4 and, to a lesser extent, by CYP3A5. DM1 does not induce or inhibit P450-mediated metabolism in vitro. Caution should be taken when trastuzumab emtansine is co-administered with potent CYP3A inhibitors.
Pregnancy & lactationView
Pregnancy: There are no clinical studies of trastuzumab emtansine in pregnant women. No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Trastuzumab, a component of trastuzumab emtansine, can cause fetal harm or death when administered to a pregnant woman. In the postmarketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic drug component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic.
Administration of trastuzumab emtansine to pregnant women is not recommended. Women who become pregnant must contact their doctor and should be advised of the possibility of harm to the fetus. If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Nursing Mothers: It is not known whether trastuzumab emtansine is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Kadcyla, women should discontinue nursing prior to initiating treatment with trastuzumab emtansine. Women may begin nursing 7 months after concluding treatment.
Trastuzumab, a component of trastuzumab emtansine, can cause fetal harm or death when administered to a pregnant woman. In the postmarketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic drug component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic.
Administration of trastuzumab emtansine to pregnant women is not recommended. Women who become pregnant must contact their doctor and should be advised of the possibility of harm to the fetus. If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Nursing Mothers: It is not known whether trastuzumab emtansine is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Kadcyla, women should discontinue nursing prior to initiating treatment with trastuzumab emtansine. Women may begin nursing 7 months after concluding treatment.
Pediatric usageView
Pediatric Use: The safety and efficacy of Trastuzumab Emtansine in children below 18 years of age have not been established.
Geriatric Use: There are insufficient data to establish the safety and efficacy of Trastuzumab Emtansine in patients 75 years of age or older.
Geriatric Use: There are insufficient data to establish the safety and efficacy of Trastuzumab Emtansine in patients 75 years of age or older.
StorageView
Store vials at 2°C-8°C.
Kadcyla
Trastuzumab Emtansine
Kadcyla
Trastuzumab Emtansine
Indications
Metastatic breast carcinoma
Indication detailsView
Metastatic Breast Cancer (MBC): Trastuzumab Emtansine, as a single agent, is indicated for the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane.
Therapeutic classView
Anti neoplastic preparations
PharmacologyView
Trastuzumab Emtansine is a HER2-targeted antibody-drug conjugate which contains the humanized anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitory drug DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to the MCC-DM1 complex. An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumor cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Trastuzumab Emtansine has the mechanisms of action of both trastuzumab and DM1.
Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain (ECD), as well as to Fcγ receptors and complement C1q. In addition, Trastuzumab Emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signaling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
DM1, the cytotoxic drug component of Trastuzumab Emtansine, binds to tubulin. By inhibiting tubulin polymerization, both DM1 and Trastuzumab Emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death. Results from in vitro cytotoxicity assays show that DM1 is 20–200 times more potent than taxanes and vinca alkaloids.
The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
Conjugation of DM1 to trastuzumab confers selectivity of the cytotoxic agent for HER2-overexpressing tumor cells, thereby increasing intracellular delivery of DM1 directly to malignant cells. Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Trastuzumab Emtansine has the mechanisms of action of both trastuzumab and DM1.
Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain (ECD), as well as to Fcγ receptors and complement C1q. In addition, Trastuzumab Emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signaling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
DM1, the cytotoxic drug component of Trastuzumab Emtansine, binds to tubulin. By inhibiting tubulin polymerization, both DM1 and Trastuzumab Emtansine cause cells to arrest in the G2/M phase of the cell cycle, ultimately leading to apoptotic cell death. Results from in vitro cytotoxicity assays show that DM1 is 20–200 times more potent than taxanes and vinca alkaloids.
The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
DosageView
Recommended Doses And Schedules: The recommended dose of Trastuzumab Emtansine is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer Trastuzumab Emtansine at doses greater than 3.6 mg/kg. Do not substitute Trastuzumab Emtansine for or with trastuzumab. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration
First Infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusionrelated reactions
Subsequent Infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
First Infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusionrelated reactions
Subsequent Infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
ContraindicationsView
Trastuzumab Emtansine is contraindicated in patients with a known hypersensitivity to Trastuzumab Emtansine or any of its excipients
PrecautionsView
Patients treated with Trastuzumab Emtansine must have confirmed HER2-positive tumor status as assessed by either HER2 protein overexpression or gene amplification.
InteractionsView
No formal drug-drug interaction studies with trastuzumab emtansine in humans have been conducted. In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolized mainly by CYP3A4 and, to a lesser extent, by CYP3A5. DM1 does not induce or inhibit P450-mediated metabolism in vitro. Caution should be taken when trastuzumab emtansine is co-administered with potent CYP3A inhibitors.
Pregnancy & lactationView
Pregnancy: There are no clinical studies of trastuzumab emtansine in pregnant women. No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Trastuzumab, a component of trastuzumab emtansine, can cause fetal harm or death when administered to a pregnant woman. In the postmarketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic drug component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic.
Administration of trastuzumab emtansine to pregnant women is not recommended. Women who become pregnant must contact their doctor and should be advised of the possibility of harm to the fetus. If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Nursing Mothers: It is not known whether trastuzumab emtansine is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Kadcyla, women should discontinue nursing prior to initiating treatment with trastuzumab emtansine. Women may begin nursing 7 months after concluding treatment.
Trastuzumab, a component of trastuzumab emtansine, can cause fetal harm or death when administered to a pregnant woman. In the postmarketing setting, cases of oligohydramnios, some associated with fatal pulmonary hypoplasia, have been reported in pregnant women receiving trastuzumab. Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic drug component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic.
Administration of trastuzumab emtansine to pregnant women is not recommended. Women who become pregnant must contact their doctor and should be advised of the possibility of harm to the fetus. If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Nursing Mothers: It is not known whether trastuzumab emtansine is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Kadcyla, women should discontinue nursing prior to initiating treatment with trastuzumab emtansine. Women may begin nursing 7 months after concluding treatment.
Pediatric usageView
Pediatric Use: The safety and efficacy of Trastuzumab Emtansine in children below 18 years of age have not been established.
Geriatric Use: There are insufficient data to establish the safety and efficacy of Trastuzumab Emtansine in patients 75 years of age or older.
Geriatric Use: There are insufficient data to establish the safety and efficacy of Trastuzumab Emtansine in patients 75 years of age or older.
StorageView
Store vials at 2°C-8°C.
Kadol
Tramadol Hydrochloride
Kadol
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Kafu
Ketotifen Fumarate (Oral)
Kafu
Ketotifen Fumarate (Oral)
Indications
Asthma prophylaxis
Indication detailsView
Ketotifen is indicated in the following conditions-
- For the prophylactic treatment of bronchial asthma.
- Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
- For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
- Symptomatic treatment of allergy such as hayfever, urticaria.
Therapeutic classView
Cromoglycate & related drugs
PharmacologyView
Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
DosageView
Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Side effectsView
Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.
ContraindicationsView
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.
PrecautionsView
It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.
InteractionsView
Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Pregnancy & lactationView
Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
Overdose effectsView
The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.
StorageView
Store in a cool and dry place, protect from light. Keep out of the reach of children.