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Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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

Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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

Targeted Cancer Therapy

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.

The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.

For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).

It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.

The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.

Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.

Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.

There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.

Store in a dry place below 30°C, protect from light. Keep out of the reach of children.

Targeted Cancer Therapy

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.

The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.

For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).

It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.

The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.

Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.

Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.

There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.

Store in a dry place below 30°C, protect from light. Keep out of the reach of children.

Olopatadine is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Ophthalmic Non-Steroid drugs

Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1‐antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in human, olopatadine was shown to have low systemic exposure.

0.1% Sterile Eye Drops: One drop in each affected eye two times per day at an interval of 6 to 8 hours.

0.2% Sterile Eye Drops: One drop in the affected eye once a day.

0.7% Sterile Eye Drops: One drop in each affected eye once a day.

Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion

Olopatadine Hydrochloride ophthalmic solution is contraindicated in persons with a known hypersensitivity to Olopatadine Hydrochloride.

Olopatadine HCl ophthalmic solution should not be used to treat contact lens related irritation. Patients who wear soft contact lenses should be instructed to wait at least ten minutes after instilling Olopatadine Hydrochloride ophthalmic solution before they insert their contact lenses.

May result in additive CNS depression with CNS depressants.

There are no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.

It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine Hydrochloride ophthalmic solution is administered to a nursing mother.

Geriatric Use: No overall differences in safety or effectiveness have been observed betweents.

Symptoms: Drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in childn.

Management: Symptomatic or supportive treatment.

Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

Olopatadine is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Ophthalmic Non-Steroid drugs

Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1‐antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in human, olopatadine was shown to have low systemic exposure.

0.1% Sterile Eye Drops: One drop in each affected eye two times per day at an interval of 6 to 8 hours.

0.2% Sterile Eye Drops: One drop in the affected eye once a day.

0.7% Sterile Eye Drops: One drop in each affected eye once a day.

Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion

Olopatadine Hydrochloride ophthalmic solution is contraindicated in persons with a known hypersensitivity to Olopatadine Hydrochloride.

Olopatadine HCl ophthalmic solution should not be used to treat contact lens related irritation. Patients who wear soft contact lenses should be instructed to wait at least ten minutes after instilling Olopatadine Hydrochloride ophthalmic solution before they insert their contact lenses.

May result in additive CNS depression with CNS depressants.

There are no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.

It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine Hydrochloride ophthalmic solution is administered to a nursing mother.

Geriatric Use: No overall differences in safety or effectiveness have been observed betweents.

Symptoms: Drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in childn.

Management: Symptomatic or supportive treatment.

Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

Targeted Cancer Therapy

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.

The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.

For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).

It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.

The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.

Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.

Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.

There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.

Store in a dry place below 30°C, protect from light. Keep out of the reach of children.

Targeted Cancer Therapy

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.

The recommended total daily dose of Olaparib tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.

For treatment of ovarian cancer: Patients should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).

It is recommended that Olaparib treatment be continued until progression of the underlying disease or unacceptable toxicity. Olaparib should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olaparib.

The most common serious adverse reaction reported was anemia (2.4% olaparib vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olaparib due to adverse events was 4.9% in the Olaparib arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olaparib in more than one patient.

Olaparib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

Pneumonitis: occurred in patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

Clinical studies of olaparib in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olaparib monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olaparib is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease olaparib plasma concentration.

Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib wasteratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Nursing Mothers: It is not known whether olaparib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and efficacy of Olaparib has not been established in pediatric patients.

There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.

Store in a dry place below 30°C, protect from light. Keep out of the reach of children.

Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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

Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

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

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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

Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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

Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).

Drugs for subcutaneous and mycoses

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Adult (oral)-

• Vaginal candidiasis: 150 mg as a single dose.
• Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
• Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
• Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
• Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
• Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
• Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.

Child (oral):

• Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.

Intravenous-

• Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
• Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.

Fluconazole should be administered with caution to patients having proarrhythmic conditions.

Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.

US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).

Drugs for subcutaneous and mycoses

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Adult (oral)-

• Vaginal candidiasis: 150 mg as a single dose.
• Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
• Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
• Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
• Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
• Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
• Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.

Child (oral):

• Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.

Intravenous-

• Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
• Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.

Fluconazole should be administered with caution to patients having proarrhythmic conditions.

Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.

US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Appetite suppressant drugs/Anti-obesity drugs

Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.

The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.

Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.

Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.

Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.

In clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.

No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.

Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.

Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Appetite suppressant drugs/Anti-obesity drugs

Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.

The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.

Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.

Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.

Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.

In clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.

No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.

Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.

Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Nepafenac 0.1% Sterile Ophthalmic Suspension: The treatment of post-operative ocular pain and inflammation including cataract surgery Inhibition of surgery induced miosis and Prevention of post-operative cystoid macular edema (CME).

Nepafenac 0.3% Sterile Ophthalmic Suspension: Post-operative pain and inflammation associated with cataract surgery.

Ophthalmic Non-Steroid drugs

Nepafenac is a nonsteroidal anti-inflammatory prodrug (NSAID). After instillation in the eye, it penetrates the cornea and is converted by ocular tissue hydrolase to Amfenac, a potent nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of cyclooxygenase enzyme. This enzyme is required for prostaglandin synthesis.

Nepafenac 0.1% Sterile Ophthalmic Suspension-

• For post-operative pain & inflammation: Instill 1 drop 3 times daily 1 day prior to cataract surgery and continued on the day of surgery and through the first 2 weeks of the post-operative period.
• For surgery induced miosis: Instill 1 drop 3 times daily 1 day before surgery & on the day of surgery.
• For prevention of post-operative CME: Instill 1 drop 3 times daily 1 day before surgery and continued on the day of surgery and through the first 6 weeks of the post-operative period.

Nepafenac 0.3% Sterile Ophthalmic Suspension-

• For post-operative pain & inflammation: Instill 1 drop once daily 1 day prior to cataract surgery and continued on the day of surgery and through the first 2 weeks of the post-operative period. An additional drop should be administered 30 to 120 minutes prior to surgery.

Reported side effects are foreign body sensation, lid margin crusting, ocular discomfort, ocular hyperemia etc.

Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation or to other NSAIDs.

Nepafenac should be used with caution in patients with known bleeding tendencies or who are receiving medications which may prolong bleeding time.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Nepafenac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether this drug is excreted in human milk. So, caution should be exercised when Nepafenac ophthalmic suspension is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients below 18 years of age have not been established.

Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

This is indicated for the treatment of Hepatic Encephalopathy, Acute Liver Failure, Hyperammonemia due to Acute and Chronic Hepatitis, Fatty Liver, Alcoholic Liver damage, Adjunct to hepatotoxic drugs, Liver Cirrhosis, Post hepatitis convalescence etc.

Digestive Enzyme

L-Ornithine L-Aspartate is a stable combination of two important endogenous Amino Acids, L-Ornithine and L-Aspartate. After administration, it quickly breaks down into L-Ornithine and L-Aspartate. L-Ornithine being a substrate of urea cycle, converts toxic ammonia into non-toxic urea which is eliminated via kidneys, helping the diseased liver to carry out its normal function smoothly (detoxification). The process lowers the elevated level of ammonia in blood (hyperammonemia) which is a common problem in most of the liver diseases. L-Aspartate is an essential component of citric acid cycle which liberates energy (ATP), and thus helps in regeneration of damaged liver cells.

Sachet: 1-2 sachets granules is dissolved in a large amount of fluid (e.g. in a glass of water or juice) and is taken orally 3 times a day during or after meals.

Injection (Infusion Concentrate): The recommended dose is up to 20 gm (4 ampoules daily). In case of loss of consciousness (pre-coma) and clouding of consciousness (coma) up to 8 ampoules within 24 hours, depending on the severity of the condition.

Very rarely side effects like nausea and vomiting occur. These side effects are usually transient and do not necessitate the withdrawal of the drug.

Monitoring of serum and urinary urea levels at regular intervals should be done.

No data regarding the interactions of L-Ornithine L-Aspartate was found.

The administration in pregnancy and lactation should be avoided.

Store in a cool and dry place, keep away from light.

Atypical neuroleptic drugs

Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.

Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.

Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.

Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.

Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.

Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.

Children: Olanzapine has not been studied in subjects under 18 years of age.

Elderly patients (age 65 and over): starting dose 5 mg/day

Patients with hepatic, renal impairment: starting dose 5 mg/day

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