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    Ket

    Ketorolac Tromethamine
    IM/IV Injection 30 mg/ml Allopathic Drugs used for Rheumatoid Arthritis

    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.
    IV Dosing (Adult):
    • 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.
    IV or IM Dosing (2 to 16 years of age):
    • 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.
    Multiple-Dose Treatment (IV or IM)-
    • 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.
    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.

    Ketalar

    Ketamine
    IM/IV Injection 50 mg/ml Allopathic General (Intravenous) anesthetics

    Indications

    Induction of anesthesia

    Indication detailsView
    Ketamine is recommended for:
    • As the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures.
    • For the induction of anesthesia prior to the administration of other general anesthetic agents.
    • To supplement low-potency agents, such as nitrous oxide. 
    Therapeutic classView
    General (Intravenous) anesthetics
    PharmacologyView
    Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist that blocks glutamate. It has a direct action on the cortex and limbic system. It produces a cataleptic-like state wherein the patient is withdrawn from the surrounding environment.
    DosageView
    Adult:
    General Anesthesia-
    • IV Induction: 1-4.5 mg/kg single dose
    • IM Induction: 6.5-13mg
    • IV Infusion: 1-2mg/kg at 0.5mg/kg/min
    Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

    Rapid sequence Intubation, Induction - 2mg/kg IV

    Pediatric:
    General Anesthesia:
    • IV Induction: 1-2 mg/kg IV; range: 4-13 mg/kg
    • IM Induction: 5-10 mg/kg; range: 0.5-4.5 mg/kg
    • Maintenance: 0.01-0.03 mg/kg/min continuous IV infusion
    Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.
    AdministrationView
    Rate of Administration: It is recommended that ketamine should be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.

    The 100 mg/ml concentration of ketamine should not be injected intravenously without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water.
    Side effectsView
    Emergence reactions (e.g. vivid dreams, hallucinations, confusion, irrational behaviour); increased muscle tone sometimes resembling seizures; temporary HTN and tachycardia, hypotension, bradycardia, arrhythmias, apnoea, laryngospasm, resp depression, diplopia, nystagmus, nausea, vomiting, lacrimation, hypersalivation, raised intraocular and CSF pressure, transient rash and pain at inj site, cystitis.
    ContraindicationsView
    CV disease including severe HTN; patients with increased intraocular or CSF pressure.
    PrecautionsView
    Patient with cardiac decompensation, chronic alcoholic or acutely alcohol-intoxicated patients, pre-anaesth elevated CSF pressure, globe injuries, increased intraocular pressure (e.g. glaucoma), neurotic traits or psychiatric illness (e.g. schizophrenia, acute psychosis), acute intermittent porphyria, seizures, hyperthyroidism, pulmonary or upper resp infection, intracranial mass lesions, head injury, or hydrocephalus, hypovolaemia, dehydration, cardiac disease esp coronary artery disease (e.g. CHF, myocardial ischaemia, MI). Pregnancy and lactation.
    InteractionsView
    Prolonged recovery time with barbiturates or narcotics. May potentiate neuromuscular blocking effects of atracurium and tubocurarine including resp depression with apnoea. May increase risk of bradycardia, hypotension or decreased cardiac output with halogenated anaesthetics. May potentiate CNS depression and risk of resp depression with CNS depressants (e.g. phenothiazines, sedating H1-blockers, skeletal muscle relaxants). May antagonise hypnotic effect of thiopental. May increase risk of HTN with thyroid hormones. May increase risk of hypotension with antihypertensive agents. Reduction in seizure threshold resulting in unpredictable extensor-type seizures when given concurrently with theophylline.
    Pregnancy & lactationView
    Pregnancy: The safe use of ketamine in pregnancy has not been established, and such use is not recommended.

    Lactation: Ketamine is likely to be excreted in breast milk and therefore breastfeeding should be discontinued when ketamine is in use.
    Overdose effectsView
    Symptoms: Resp depression.
    Management: Employ supportive ventilation. Mechanical support of respiration is preferred to admin of analeptics.
    ReconstitutionView
    To prepare a dilute solution containing 1 mg of ketamine per ml, aseptically transfer 10 ml (50 mg per ml vial) to 500 ml of Dextrose Injection, 5% or Sodium Chloride Injection, 0.9% and mix well. The resultant solution will contain 1 mg of ketamine per ml.
    StorageView
    Store between 20-25° C.

    Ketaride

    Ketamine
    IM/IV Injection 50 mg/ml Allopathic General (Intravenous) anesthetics

    Indications

    Induction of anesthesia

    Indication detailsView
    Ketamine is recommended for:
    • As the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures.
    • For the induction of anesthesia prior to the administration of other general anesthetic agents.
    • To supplement low-potency agents, such as nitrous oxide. 
    Therapeutic classView
    General (Intravenous) anesthetics
    PharmacologyView
    Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist that blocks glutamate. It has a direct action on the cortex and limbic system. It produces a cataleptic-like state wherein the patient is withdrawn from the surrounding environment.
    DosageView
    Adult:
    General Anesthesia-
    • IV Induction: 1-4.5 mg/kg single dose
    • IM Induction: 6.5-13mg
    • IV Infusion: 1-2mg/kg at 0.5mg/kg/min
    Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

    Rapid sequence Intubation, Induction - 2mg/kg IV

    Pediatric:
    General Anesthesia:
    • IV Induction: 1-2 mg/kg IV; range: 4-13 mg/kg
    • IM Induction: 5-10 mg/kg; range: 0.5-4.5 mg/kg
    • Maintenance: 0.01-0.03 mg/kg/min continuous IV infusion
    Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.
    AdministrationView
    Rate of Administration: It is recommended that ketamine should be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.

    The 100 mg/ml concentration of ketamine should not be injected intravenously without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water.
    Side effectsView
    Emergence reactions (e.g. vivid dreams, hallucinations, confusion, irrational behaviour); increased muscle tone sometimes resembling seizures; temporary HTN and tachycardia, hypotension, bradycardia, arrhythmias, apnoea, laryngospasm, resp depression, diplopia, nystagmus, nausea, vomiting, lacrimation, hypersalivation, raised intraocular and CSF pressure, transient rash and pain at inj site, cystitis.
    ContraindicationsView
    CV disease including severe HTN; patients with increased intraocular or CSF pressure.
    PrecautionsView
    Patient with cardiac decompensation, chronic alcoholic or acutely alcohol-intoxicated patients, pre-anaesth elevated CSF pressure, globe injuries, increased intraocular pressure (e.g. glaucoma), neurotic traits or psychiatric illness (e.g. schizophrenia, acute psychosis), acute intermittent porphyria, seizures, hyperthyroidism, pulmonary or upper resp infection, intracranial mass lesions, head injury, or hydrocephalus, hypovolaemia, dehydration, cardiac disease esp coronary artery disease (e.g. CHF, myocardial ischaemia, MI). Pregnancy and lactation.
    InteractionsView
    Prolonged recovery time with barbiturates or narcotics. May potentiate neuromuscular blocking effects of atracurium and tubocurarine including resp depression with apnoea. May increase risk of bradycardia, hypotension or decreased cardiac output with halogenated anaesthetics. May potentiate CNS depression and risk of resp depression with CNS depressants (e.g. phenothiazines, sedating H1-blockers, skeletal muscle relaxants). May antagonise hypnotic effect of thiopental. May increase risk of HTN with thyroid hormones. May increase risk of hypotension with antihypertensive agents. Reduction in seizure threshold resulting in unpredictable extensor-type seizures when given concurrently with theophylline.
    Pregnancy & lactationView
    Pregnancy: The safe use of ketamine in pregnancy has not been established, and such use is not recommended.

    Lactation: Ketamine is likely to be excreted in breast milk and therefore breastfeeding should be discontinued when ketamine is in use.
    Overdose effectsView
    Symptoms: Resp depression.
    Management: Employ supportive ventilation. Mechanical support of respiration is preferred to admin of analeptics.
    ReconstitutionView
    To prepare a dilute solution containing 1 mg of ketamine per ml, aseptically transfer 10 ml (50 mg per ml vial) to 500 ml of Dextrose Injection, 5% or Sodium Chloride Injection, 0.9% and mix well. The resultant solution will contain 1 mg of ketamine per ml.
    StorageView
    Store between 20-25° C.

    Keteks

    Ketorolac Tromethamine
    IM/IV Injection 30 mg/ml Allopathic Drugs used for Rheumatoid Arthritis

    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.
    IV Dosing (Adult):
    • 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.
    IV or IM Dosing (2 to 16 years of age):
    • 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.
    Multiple-Dose Treatment (IV or IM)-
    • 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.
    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.

    Keteks

    Ketorolac Tromethamine
    Tablet 10 mg Allopathic Drugs used for Rheumatoid Arthritis

    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.
    IV Dosing (Adult):
    • 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.
    IV or IM Dosing (2 to 16 years of age):
    • 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.
    Multiple-Dose Treatment (IV or IM)-
    • 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.
    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.

    Keteks

    Ketorolac Tromethamine
    IM/IV Injection 60 mg/2 ml Allopathic Drugs used for Rheumatoid Arthritis

    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.
    IV Dosing (Adult):
    • 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.
    IV or IM Dosing (2 to 16 years of age):
    • 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.
    Multiple-Dose Treatment (IV or IM)-
    • 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.
    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.

    Ketifen

    Ketotifen Fumarate (Oral)
    Tablet 1 mg Allopathic Cromoglycate & related drugs

    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.
    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.

    Ketifen

    Ketotifen Fumarate (Oral)
    Syrup 1 mg/5 ml Allopathic Cromoglycate & related drugs

    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.
    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.

    Ketmine

    Ketamine
    IM/IV Injection 50 mg/ml Allopathic General (Intravenous) anesthetics

    Indications

    Induction of anesthesia

    Indication detailsView
    Ketamine is recommended for:
    • As the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures.
    • For the induction of anesthesia prior to the administration of other general anesthetic agents.
    • To supplement low-potency agents, such as nitrous oxide. 
    Therapeutic classView
    General (Intravenous) anesthetics
    PharmacologyView
    Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist that blocks glutamate. It has a direct action on the cortex and limbic system. It produces a cataleptic-like state wherein the patient is withdrawn from the surrounding environment.
    DosageView
    Adult:
    General Anesthesia-
    • IV Induction: 1-4.5 mg/kg single dose
    • IM Induction: 6.5-13mg
    • IV Infusion: 1-2mg/kg at 0.5mg/kg/min
    Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

    Rapid sequence Intubation, Induction - 2mg/kg IV

    Pediatric:
    General Anesthesia:
    • IV Induction: 1-2 mg/kg IV; range: 4-13 mg/kg
    • IM Induction: 5-10 mg/kg; range: 0.5-4.5 mg/kg
    • Maintenance: 0.01-0.03 mg/kg/min continuous IV infusion
    Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.
    AdministrationView
    Rate of Administration: It is recommended that ketamine should be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.

    The 100 mg/ml concentration of ketamine should not be injected intravenously without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water.
    Side effectsView
    Emergence reactions (e.g. vivid dreams, hallucinations, confusion, irrational behaviour); increased muscle tone sometimes resembling seizures; temporary HTN and tachycardia, hypotension, bradycardia, arrhythmias, apnoea, laryngospasm, resp depression, diplopia, nystagmus, nausea, vomiting, lacrimation, hypersalivation, raised intraocular and CSF pressure, transient rash and pain at inj site, cystitis.
    ContraindicationsView
    CV disease including severe HTN; patients with increased intraocular or CSF pressure.
    PrecautionsView
    Patient with cardiac decompensation, chronic alcoholic or acutely alcohol-intoxicated patients, pre-anaesth elevated CSF pressure, globe injuries, increased intraocular pressure (e.g. glaucoma), neurotic traits or psychiatric illness (e.g. schizophrenia, acute psychosis), acute intermittent porphyria, seizures, hyperthyroidism, pulmonary or upper resp infection, intracranial mass lesions, head injury, or hydrocephalus, hypovolaemia, dehydration, cardiac disease esp coronary artery disease (e.g. CHF, myocardial ischaemia, MI). Pregnancy and lactation.
    InteractionsView
    Prolonged recovery time with barbiturates or narcotics. May potentiate neuromuscular blocking effects of atracurium and tubocurarine including resp depression with apnoea. May increase risk of bradycardia, hypotension or decreased cardiac output with halogenated anaesthetics. May potentiate CNS depression and risk of resp depression with CNS depressants (e.g. phenothiazines, sedating H1-blockers, skeletal muscle relaxants). May antagonise hypnotic effect of thiopental. May increase risk of HTN with thyroid hormones. May increase risk of hypotension with antihypertensive agents. Reduction in seizure threshold resulting in unpredictable extensor-type seizures when given concurrently with theophylline.
    Pregnancy & lactationView
    Pregnancy: The safe use of ketamine in pregnancy has not been established, and such use is not recommended.

    Lactation: Ketamine is likely to be excreted in breast milk and therefore breastfeeding should be discontinued when ketamine is in use.
    Overdose effectsView
    Symptoms: Resp depression.
    Management: Employ supportive ventilation. Mechanical support of respiration is preferred to admin of analeptics.
    ReconstitutionView
    To prepare a dilute solution containing 1 mg of ketamine per ml, aseptically transfer 10 ml (50 mg per ml vial) to 500 ml of Dextrose Injection, 5% or Sodium Chloride Injection, 0.9% and mix well. The resultant solution will contain 1 mg of ketamine per ml.
    StorageView
    Store between 20-25° C.

    Keto SR

    Ketoprofen (oral & injection)
    Capsule (Sustained Release) 100 mg Allopathic Drugs for Osteoarthritis

    Indications

    Rheumatic disorders

    Indication detailsView
    The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
    • Rheumatoid arthritis
    • Degenerative joint diseases
    • Musculoskeletal and joint disorders such as tendinitis, sprain
    • Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.

    Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
    DosageView
    Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.

    Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
    AdministrationView
    The oral forms should be taken with fluids, preferably with food.
    Side effectsView
    • Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
    • Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
    • Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
    • Eye disorders- Rare: vision blurred
    • Ear and labyrinth disorders- Rare: tinnitus
    • Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
    • Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
    • Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
    • Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
    • Hepatobiliary disorders- Rare: hepatitis, transaminases increased
    • Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
    • General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
    ContraindicationsView
    Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
    • Severe heart failure
    • Active or history of peptic ulcer/hemorrhage
    • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
    • Severe hepatic insufficiency
    • Severe renal insufficiency
    • Third trimester of pregnancy
    • Rectitis or history of proctorrhagia (rectal administration)
    PrecautionsView
    Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.

    Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

    Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.

    As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

    In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.

    If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
    InteractionsView
    Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
    • Heparin
    • Vitamin K antagonists (such as warfarin)
    • Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
    • Thrombin inhibitors (such as dabigatran)
    • Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
    If coadministration is unavoidable, patient should be closely monitored.
    • Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
    • Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
    • Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
    • Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
    • Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
    • ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
    • Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
    • Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
    • Cyclosporin: Increased risk of nephrotoxicity.
    • Tacrolimus: Increased risk of nephrotoxicity.
    • Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
    • Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
    • Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
    • Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
    • Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
    • Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
    Pregnancy & lactationView
    During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
    Pediatric usageView
    Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

    Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.

    Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
    Overdose effectsView
    Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
    StorageView
    Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

    Keto-A

    Ketoprofen (oral & injection)
    Tablet (Enteric Coated) 50 mg Allopathic Drugs for Osteoarthritis

    Indications

    Rheumatic disorders

    Indication detailsView
    The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
    • Rheumatoid arthritis
    • Degenerative joint diseases
    • Musculoskeletal and joint disorders such as tendinitis, sprain
    • Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.

    Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
    DosageView
    Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.

    Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
    AdministrationView
    The oral forms should be taken with fluids, preferably with food.
    Side effectsView
    • Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
    • Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
    • Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
    • Eye disorders- Rare: vision blurred
    • Ear and labyrinth disorders- Rare: tinnitus
    • Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
    • Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
    • Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
    • Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
    • Hepatobiliary disorders- Rare: hepatitis, transaminases increased
    • Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
    • General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
    ContraindicationsView
    Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
    • Severe heart failure
    • Active or history of peptic ulcer/hemorrhage
    • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
    • Severe hepatic insufficiency
    • Severe renal insufficiency
    • Third trimester of pregnancy
    • Rectitis or history of proctorrhagia (rectal administration)
    PrecautionsView
    Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.

    Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

    Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.

    As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

    In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.

    If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
    InteractionsView
    Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
    • Heparin
    • Vitamin K antagonists (such as warfarin)
    • Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
    • Thrombin inhibitors (such as dabigatran)
    • Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
    If coadministration is unavoidable, patient should be closely monitored.
    • Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
    • Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
    • Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
    • Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
    • Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
    • ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
    • Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
    • Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
    • Cyclosporin: Increased risk of nephrotoxicity.
    • Tacrolimus: Increased risk of nephrotoxicity.
    • Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
    • Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
    • Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
    • Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
    • Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
    • Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
    Pregnancy & lactationView
    During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
    Pediatric usageView
    Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

    Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.

    Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
    Overdose effectsView
    Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
    StorageView
    Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

    Keto-A

    Ketoprofen (oral & injection)
    Tablet (Enteric Coated) 100 mg Allopathic Drugs for Osteoarthritis

    Indications

    Rheumatic disorders

    Indication detailsView
    The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
    • Rheumatoid arthritis
    • Degenerative joint diseases
    • Musculoskeletal and joint disorders such as tendinitis, sprain
    • Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.

    Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
    DosageView
    Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.

    Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
    AdministrationView
    The oral forms should be taken with fluids, preferably with food.
    Side effectsView
    • Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
    • Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
    • Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
    • Eye disorders- Rare: vision blurred
    • Ear and labyrinth disorders- Rare: tinnitus
    • Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
    • Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
    • Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
    • Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
    • Hepatobiliary disorders- Rare: hepatitis, transaminases increased
    • Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
    • General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
    ContraindicationsView
    Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
    • Severe heart failure
    • Active or history of peptic ulcer/hemorrhage
    • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
    • Severe hepatic insufficiency
    • Severe renal insufficiency
    • Third trimester of pregnancy
    • Rectitis or history of proctorrhagia (rectal administration)
    PrecautionsView
    Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.

    Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

    Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.

    As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

    In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.

    If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
    InteractionsView
    Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
    • Heparin
    • Vitamin K antagonists (such as warfarin)
    • Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
    • Thrombin inhibitors (such as dabigatran)
    • Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
    If coadministration is unavoidable, patient should be closely monitored.
    • Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
    • Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
    • Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
    • Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
    • Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
    • ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
    • Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
    • Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
    • Cyclosporin: Increased risk of nephrotoxicity.
    • Tacrolimus: Increased risk of nephrotoxicity.
    • Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
    • Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
    • Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
    • Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
    • Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
    • Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
    Pregnancy & lactationView
    During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
    Pediatric usageView
    Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

    Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.

    Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
    Overdose effectsView
    Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
    StorageView
    Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

    Keto-A

    Ketoprofen (oral & injection)
    IM Injection 100 mg/2 ml Allopathic Drugs for Osteoarthritis

    Indications

    Rheumatic disorders

    Indication detailsView
    The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
    • Rheumatoid arthritis
    • Degenerative joint diseases
    • Musculoskeletal and joint disorders such as tendinitis, sprain
    • Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.

    Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
    DosageView
    Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.

    Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
    AdministrationView
    The oral forms should be taken with fluids, preferably with food.
    Side effectsView
    • Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
    • Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
    • Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
    • Eye disorders- Rare: vision blurred
    • Ear and labyrinth disorders- Rare: tinnitus
    • Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
    • Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
    • Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
    • Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
    • Hepatobiliary disorders- Rare: hepatitis, transaminases increased
    • Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
    • General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
    ContraindicationsView
    Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
    • Severe heart failure
    • Active or history of peptic ulcer/hemorrhage
    • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
    • Severe hepatic insufficiency
    • Severe renal insufficiency
    • Third trimester of pregnancy
    • Rectitis or history of proctorrhagia (rectal administration)
    PrecautionsView
    Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.

    Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

    Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.

    As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

    In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.

    If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
    InteractionsView
    Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
    • Heparin
    • Vitamin K antagonists (such as warfarin)
    • Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
    • Thrombin inhibitors (such as dabigatran)
    • Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
    If coadministration is unavoidable, patient should be closely monitored.
    • Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
    • Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
    • Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
    • Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
    • Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
    • ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
    • Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
    • Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
    • Cyclosporin: Increased risk of nephrotoxicity.
    • Tacrolimus: Increased risk of nephrotoxicity.
    • Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
    • Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
    • Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
    • Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
    • Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
    • Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
    Pregnancy & lactationView
    During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
    Pediatric usageView
    Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

    Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.

    Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
    Overdose effectsView
    Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
    StorageView
    Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

    Keto-A

    Ketoprofen (oral & injection)
    Suppository 100 mg Allopathic Drugs for Osteoarthritis

    Indications

    Rheumatic disorders

    Indication detailsView
    The indications of ketoprofen are based on its anti-inflammatory, analgesic and antipyretic properties. Ketoprofen is indicated for symptomatic treatment of:
    • Rheumatoid arthritis
    • Degenerative joint diseases
    • Musculoskeletal and joint disorders such as tendinitis, sprain
    • Pain, regardless of the origin, such as dental pain, headache and primary dysmenorrhea.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.

    Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.
    DosageView
    Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.

    Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.
    AdministrationView
    The oral forms should be taken with fluids, preferably with food.
    Side effectsView
    • Blood and lymphatic system disorders- Rare: haemorrhagic anaemia; Unknown: agranulocytosis, thrombocytopenia, bone marrow failure, hemolytic anemia, leucopenia
    • Immune system disorders- Unknown: anaphylactic reactions (including shock) Psychiatric disorders; Unknown: depression, hallucinations, confusion, mood altered
    • Nervous system disorders- Uncommon: headache, dizziness, somnolence, Rare: paraesthesia; Unknown: aseptic meningitis, convulsions, dysgeusia, vertigo
    • Eye disorders- Rare: vision blurred
    • Ear and labyrinth disorders- Rare: tinnitus
    • Cardiac disorders- Unknown: exacerbation of heart failure, atrial fibrillation
    • Vascular disorders- Unknown: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)
    • Respiratory, thoracic and mediastinal disorders- Rare: asthma; Unknown: bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs)
    • Gastrointestinal disorders- Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: stomatitis, peptic ulcer; Unknown: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis
    • Hepatobiliary disorders- Rare: hepatitis, transaminases increased
    • Skin and subcutaneous disorders- Uncommon: rash, pruritis; Unknown: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis Renal and urinary disorders- Unknown: renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal
    • General disorders and administration site conditions- Uncommon: oedema Metabolism and nutritional disorders; Unknown: hyponatremia, hyperkalemia Investigations; Rare: weight increased.
    ContraindicationsView
    Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:
    • Severe heart failure
    • Active or history of peptic ulcer/hemorrhage
    • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
    • Severe hepatic insufficiency
    • Severe renal insufficiency
    • Third trimester of pregnancy
    • Rectitis or history of proctorrhagia (rectal administration)
    PrecautionsView
    Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.

    Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

    Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.

    As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

    In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.

    If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.
    InteractionsView
    Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.
    • Heparin
    • Vitamin K antagonists (such as warfarin)
    • Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
    • Thrombin inhibitors (such as dabigatran)
    • Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)
    If coadministration is unavoidable, patient should be closely monitored.
    • Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
    • Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
    • Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
    • Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
    • Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
    • ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
    • Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
    • Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
    • Cyclosporin: Increased risk of nephrotoxicity.
    • Tacrolimus: Increased risk of nephrotoxicity.
    • Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
    • Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
    • Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
    • Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
    • Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
    • Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
    Pregnancy & lactationView
    During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.
    Pediatric usageView
    Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

    Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.

    Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.
    Overdose effectsView
    Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
    StorageView
    Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

    Keto-D

    Dexketoprofen
    Tablet 25 mg Allopathic Drugs for Osteoarthritis

    Indications

    Rheumatic disorders

    Indication detailsView
    Symptomatic treatment of pain and inflammation of mild or moderate intensity, such as musculo-skeletal pain, menstrual pain, & dental pain
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Dexketoprofen is the S(+)-enantiomer of Ketoprofen and is responsible for the analgesic and anti-inflammatory activity of Ketoprofen. The inactive R(-)-enantiomer does not contribute to the therapeutic properties of Ketoprofen but adds to the metabolic load. Dexketoprofen has been formulated as a trometamol salt. Its high solubility in water means a rapid absorption through the gut wall which results in a more rapid onset of action than Ketoprofen. Peak plasma concentrations are attained more quickly than other widely used analgesics with an onset of action of 30 minutes. Dexketoprofen trometamol, given as a tablet, is rapidly absorbed, with a time to maximum plasma concentration (tmax) of between 0.25 and 0.75 hours, whereas the tmax for the S-enantiomer after the racemic drug, administered as tablets or capsules prepared with the free acid, is between 0.5 and 3 hours. Peak plasma concentrations of 1.4 and 3.1 mg/L are reached after administration of Dexketoprofen trometamol 12.5 and 25 mg, respectively. From 70 to 80% of the administered dose is recovered in the urine during the first 12 hours, mainly as the acyl-glucuronoconjugated parent drug. No R(-)-Ketoprofen is found in the urine after administration of Dexketoprofen [S(+)-Ketoprofen], confirming the absence of bioinversion of the S(+)-enantiomer in humans. The anti-inflammatory potency of Dexketoprofen was always equivalent to that demonstrated by twice the dose of Ketoprofen.
    DosageView
    The dose of Dexketoprofen 25 mg tablets depends on the type, severity, and duration of pain. The recommended dose is generally 1 tablet every 8 hours, with no more than 3 tablets daily. The elderly and patients with renal or hepatic impairment should start treatment with a total daily dose of no more than 2 tablets. Normally it is recommended to take the tablets with food. In the case of acute pain, it is recommended that tablets be taken at least 30 minutes before meals. Dexketoprofen is not recommended for children.
    Side effectsView
    As with all medicines, Dexketoprofen 25 mg tablets may cause some unwanted effects in some patients. These are described below and are characteristic of non-steroidal antiinflammatory drugs:
    • Common (1-10%): nausea, vomiting, diarrhoea, stomach pain or heartburn.
    • Uncommon (0.1-1%): sleep disorders, nervousness, headache, dizziness, vertigo, palpitations, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, shivering, general malaise.
    • Rare (0.01 0.1%): stomach ulceration, gastric haemorrhage or perforation; pins and needles, high blood pressure, water retention, slowed breathing rate, hepatic enzymes increased, increased sweating.
    • Very rare/isolated cases (<0.01%): blurred vision, ringing in the ear, low blood pressure, haematological reactions, hepatic or renal damage, dermatological and photosensitivity reactions, bronchospasm or anaphylaxis.
    • In patients with systemic lupus erythematosus or mixed connective tissue disease, antiinflammatory medicines may rarely cause isolated cases of fever, headache and rigidity of the nape (back of the neck).
    ContraindicationsView
    Dexketoprofen tablets are not recommended to use in patients who are allergic to this product or aspirin or other non-steroidal anti-inflammatory medicines; who have suffered attacks of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria, angioedema (swollen face, eyes, lips, or tongue, or difficulty in breathing) after taking aspirin or other non-steroidal anti-inflammatory medicines; who have or previously suffered from a peptic ulcer or chronic gastro-intestinal disorders; who had previously gastro-intestinal haemorrhage (bleeding); who have suffered bronchial asthma; who have severe heart failure, moderate to severe renal dysfunction or severely impaired hepatic function; who have a bleeding disorder, a blood clotting disorder or are taking an anticoagulant; and who are pregnant or breast-feeding.
    PrecautionsView
    Precaution should be exercised during using Dexketoprofen tablets in patient who are allergic to any other NSAIDs; who have kidney disease, liver disease, heart disease or fluid retention conditions; and who have blood disorder, systemic lupus erythematosus or mixed connective tissue disease.
    InteractionsView
    Any of the following drugs cannot be used at the same time while taking Dexketoprofen. Other non-steroidal anti-inflammatory drugs, anticoagulant medicines; lithium; methotrexate; hydantoins (a type of medicine used for epilepsy) or some antibiotics of sulphonamide type (e.g. sulfamethoxazole); medications used to treat high blood pressure (ACE inhibitors, diuretics and beta-blockers); pentoxifylline; zidovudine; cyclosporine or tacrolimus; some oral medicines for diabetes (sulphonylureas); thrombolytic medicines; probenecid; cardiac glycosides; mifepristone; and quinolone antibiotics.
    Pregnancy & lactationView
    The use of Dexketoprofen tablets during pregnancy or breast-feeding is not recommended.
    Pediatric usageView
    Should not be given to children.
    StorageView
    Store at a cool & dry place protected from light and moisture. Keep out of reach of children.

    Ketoact

    Ketorolac Tromethamine
    Tablet 10 mg Allopathic Drugs used for Rheumatoid Arthritis

    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.
    IV Dosing (Adult):
    • 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.
    IV or IM Dosing (2 to 16 years of age):
    • 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.
    Multiple-Dose Treatment (IV or IM)-
    • 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.
    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.

    Ketoalfa

    Amino Acid Keto Analogues
    Tablet 600 mg Allopathic Other genito-urinary preparations

    Indications

    Chronic renal failure

    Indication detailsView
    Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40 g/day or less (adult). Usually, this applies to patients whose glomerular filtration rate (GFR) is less than 25 mL/min.
    Therapeutic classView
    Other genito-urinary preparations
    PharmacologyView
    Amino Acid Keto Analogues tablets are administered for nutrition therapy in chronic kidney disease. Amino Acid Keto Analogues allow the intake of essential amino acids while minimizing the amino-nitrogen intake. The use of Amino Acid Keto Analogues in combination with a very low protein diet allows reducing nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.
    DosageView
    Adult dose (70 kg body weight): 4 to 8 tablets three times daily during meals. The tablets must not be chewed. Ingestion during meals facilitates proper absorption and the metabolization into the corresponding amino acids.

    Pediatric population: No experience has been gained so far with the administration in pediatric patients.
    Side effectsView
    Hypercalcaemia (Very Rare), If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of Amino Acid Keto Analogues as well as the intake of any other calcium sources has to be reduced.
    ContraindicationsView
    Hypersensitivity to the active substances or to any of the excipients, Hypercalcaemia, Disturbed amino acid metabolism.
    PrecautionsView
    • The serum calcium level should be monitored regularly
    • Ensure sufficient calorie intake
    • In the presence of hereditary phenylketonuria, attention should be given to the fact that Amino Acid Keto Analogues contains phenylalanine
    • Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide
    InteractionsView
    Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels. Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with Amino Acid Keto Analogues to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of Amino Acid Keto Analogues and these drugs.
    Pregnancy & lactationView
    There are no adequate data from the use of Amino Acid Keto Analogues in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. No experience has been made so far with the use during lactation.
    StorageView
    Store at a temperature not exceeding 30°C in a dry place. Protect from light & moisture.

    Ketobe

    Ketorolac Tromethamine
    Tablet 10 mg Allopathic Drugs used for Rheumatoid Arthritis

    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.
    IV Dosing (Adult):
    • 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.
    IV or IM Dosing (2 to 16 years of age):
    • 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.
    Multiple-Dose Treatment (IV or IM)-
    • 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.
    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.

    Ketocon

    Ketoconazole (Shampoo)
    Shampoo 2% Allopathic Drugs for subcutaneous and mycoses

    Indications

    Seborrhoeic dermatitis

    Indication detailsView
    ketoconazole 2% shampoo is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).
    Therapeutic classView
    Drugs for subcutaneous and mycoses
    PharmacologyView
    Ketoconazole 2% shampoo is a broad spectrum imidazole-dioxolane, synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floc-cosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).
    DosageView
    The affected areas of the skin or the scalp should be washed with ketoconazole 2% shampoo, which should be left on the skin/scalp for 3 to 5 minutes before rinsing.
    Treatment:
    • Pityriasis versicolor: Once daily for 5 days.
    • Seborrhoeic dermatitis and pityriasis capitis: Twice weekly for 2 to 4 weeks.
    Prophylaxis:
    • Pityriasis versicolor: Once daily for 3 days during a single treatment course before the summer.
    • Seborrhoeic dermatitis and pityriasis capitis: Once every 1 or 2 weeks
    Side effectsView
    Topical treatment with ketoconazole shampoo 2% is generally well tolerated. As with other shampoos, a local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of ketoconazole shampoo 2%.
    ContraindicationsView
    Contraindicated in patients with known hypersensitivity to ketoconazole.
    PrecautionsView
    In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole shampoo 2%, to prevent any potential rebound effect. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of ketoconazole shampoo 2%. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.
    InteractionsView
    No information was found for the Shampoo form of Ketoconazole.
    Pregnancy & lactationView
    Since ketoconazole is not absorbed through the skin after topical application, pregnancy and lactation are not a contraindication for the use of ketoconazole shampoo 2%.
    Overdose effectsView
    Not expected as ketoconazole shampoo 2% is intended for external use only. In the event of accidental ingestion, only supportive measures should be carried out. To avoid aspiration, emesis or gastric lavage should not be performed.
    StorageView
    Store in a cool and dry place, protected from light.

    Ketocon

    Ketoconazole (Tablet)
    Tablet 200 mg Allopathic Drugs for subcutaneous and mycoses

    Indications

    Vaginitis

    Indication detailsView
    Treatment of superficial and deep mycoses:
    • Infections of the skin, hair and nails by dermatophytes and/or yeasts (dermatomycosis, onychomycosis, perionyxis, pityriasis versicolor, chronic mucocutaneous candidiasis etc.) especially when topical treatment is difficult or not very effective, owing to involvement of large skin surfaces or to lesions affecting deeper dermal layers, nails and hairs
    • Yeast infection of the mouth (oral thrush, perleche) and the gastrointestinal tract
    • Vaginal candidiasis, especially chronic recurrent cases or cases responding poorly to topcial treatment
    • Systemic mycotic infections such as systemic candidiasis, paracoccidioidomycosis, histoplasmosis, coccidioidomycosis etc.
    Maintenance treatment to prevent recurrence in systemic mycotic infections and in chronic mucocutaneous candidiasis.

    Prophylactic treatment to prevent mycotic infection in patients with reduced host defenses, e.g., patients with cancer, organ transplant and burns.
    Therapeutic classView
    Drugs for subcutaneous and mycoses
    PharmacologyView
    Ketoconazole interferes with biosynthesis of triglycerides and phopholipids by blocking fungal CYP450, thus altering cell membrane permeability in susceptible fungi. It also inhibits other fungal enzymes resulting in the accumulation of toxic concentrations of hydrogen peroxide.
    DosageView
    Vaginal candidiasis: 1 tablet (200 mg) tablet twice daily for 5 days.

    All other indications: 1 tablet (200 mg) once daily until at least one week after the symptoms have disappeared and the cultures have become negative.
    AdministrationView
    Ketoconazole should be taken at meal times for maximal resorption. Because resorption depends on intact gastric activity, the concomitant treatment with agents that reduce gastric secretion (anticholinergic drugs, antacids, H2 blockers) should be avoided. When indicated, such drugs should be taken not earlier than two hours after ketoconazole. If clinical responsiveness is insufficient within the expected time, the dose of ketoconazole may be doubled (400 mg once daily).
    Side effectsView
    Ketoconazole is very well tolerated. Nausea and itching may occasionally occur. In some patients, an idosyncratic liver reaction may occur (incidence 1:10000).
    ContraindicationsView
    Ketoconazole is contraindicated in pregnancy and in patients with acute liver pathology.
    PrecautionsView
    In patients with a previous history of liver disease, liver enzyme levels should be monitored during treatment. When patients develop symptoms indicative of liver reaction, such as nausea or fatigue, accompanied with pale faeces, dark urine or jaundice, Ketoconazole therapy should be stopped immediately
    InteractionsView
    Reduced absorption with antimuscarinics, antacids, H2-blockers, PPIs and sucralfate. Reduced plasma concentrations with rifampicin, isoniazid, efavirenz, nevirapine, phenytoin. May also reduce concentrations of isoniazid and rifampicin. May reduce efficacy of oral contraceptives. May increase serum levels of CYP3A4 substrates e.g. digoxin, oral anticoagulants, sildenafil, tacrolimus.
    Pregnancy & lactationView
    Pregnancy category C. There is no adequate and well controlled studies in pregnant women. Ketoconazole Tablets should not be used during pregnancy and lactation.
    Duration of treatmentView
    • Pityriasis versicolor: 1 to 6 weeks
    • Dermatomycoses: 2 to 8 weeks
    • Onychomycoses: 1 to 12 months
    • Mycoses of hair and scalp: 1 to 2 months
    • Chronic mucocutaneous candidiasis : 1 to 12 months
    • Oral mycoses: 5 to 10 days
    • Systemic candidiasis: 1 to 2 months
    • Paracoccidioidomycosis,histoplasmosis
    • and other systemic mycosis: 1 month to 2 years
    StorageView
    Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.