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Ophthalmic steroid - antibiotic combined preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

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

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

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

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

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

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic steroid - antibiotic combined preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.

Ophthalmic steroid - antibiotic combined preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic steroid - antibiotic combined preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.

Larotrectinib is an inhibitor of the tropomyosin receptor kinases (TRK), TRKA, TRKB, and TRKC. In a broad panel of purified enzyme assays, larotrectinib inhibited TRKA, TRKB, and TRKC with IC50 values between 5-11 nM. One other kinase TNK2 was inhibited at approximately 100-fold higher concentrations. TRKA, B, and C are encoded by the genes NTRK1, NTRK2, and NTRK3. Chromosomal rearrangements involving in-frame fusions of these genes with various partner scan result in constitutively activated chimeric TRK fusion proteins that can act as an oncogenic driver, promoting cell proliferation and survival in tumor cell lines.

Absorption: The mean absolute bioavailability of Larotrectinib capsules was 34% (range: 32% to 37%).

Distribution: The mean (CV%) volume of distribution (Vss) of Larotrectinib is 48 (38%) L following intravenous administration of Larotrectinib in healthy subjects. Larotrectinib is 70% bound to human plasma proteins in vitro and binding is independent of drug concentrations. The blood-to-plasma concentration ratio is 0.9.

Elimination: The mean (CV%) clearance (CL/F) of Larotrectinib is 98 (44%) L/h and the half-life is 2.9 hours following oral administration of Larotrectinib in healthy subjects.

Metabolism: Larotrectinib is metabolized predominantly by CYP3A4. Following oral administration of a single [14C] radiolabeled 100 mg dose of Larotrectinib to healthy subjects, unchanged Larotrectinib constituted 19% and an O-linked glucuronide constituted 26% of the major circulating radioactive drug components in plasma.

Excretion: Following oral administration of a single [ 14 C] radiolabeled 100 mg dose of Larotrectinib to healthy subjects, 58% (5% unchanged) of the administered radioactivity was recovered in feces and 39% (20% unchanged) was recovered in urine.

Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1 m²: The recommended dosage of Larotrectinib is 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

Recommended Dosage in Pediatric Patients with Body Surface Area Less Than 1 m²: The recommended dosage of Larotrectinib is 100 mg/m² orally twice daily, with or without food, until disease progression or until unacceptable toxicity. Whole capsules should be swallowed with water and the capsules should not be chewed or crushed. A missed dose should not be made up within 6 hours of the next scheduled dose. If vomiting occurs after taking a dose of Larotrectinib, the next dose should be taken at the scheduled time. Or, as directed by the registered physicians.

Common side effects are Neurotoxicity, Hepatotoxicity.

It is contraindicated in patients with known hypersensitivity to Larotrectinib or any other components of this product.

Neurotoxicity: Among the 176 patients who received Larotrectinib, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively. The majority (65%) of neurologic adverse reactions occurred within the first three months of treatment (range: 1 day to 2.2 years). Grade 3 neurologic adverse reactions included delirium (2%), dysarthria (1%), dizziness (1%), gait disturbance (1%), and paresthesia (1%). Grade 4 encephalopathy (0.6%) occurred in a single patient. Neurologic adverse reactions leading to dose modification included dizziness (3%), gait disturbance (1%), delirium (1%), memory impairment (1%), and tremor (1%). Patients and caretakers should be advised of these risks with Larotrectinib. Patients should be advised not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Larotrectinib should be withheld or permanently discontinued based on the severity. If withheld, Larotrectinib dosage should be modified when resumed.

Hepatotoxicity: Among the 176 patients who received Larotrectinib, increased transaminases of any grade occurred in 45%, including Grade 3 increased AST or ALT in 6% of patients. One patient (0.6%) experienced Grade 4 increased ALT. The median time to onset of increased AST was 2 months (range: 1 month to 2.6 years). The median time to onset of increased ALT was 2 months (range: 1 month to 1.1 years). Increased AST and ALT leading to dose modifications occurred in 4% and 6% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 2% of patients. Liver tests should be monitored, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Larotrectinib should be withheld or permanently discontinued based on the severity. If withheld, Larotrectinib dosage should be modified when resumed.

Embryo-Fetal Toxicity: Based on literature reports in human subjects with congenital mutations leading to changes in TRK signaling, findings from animal studies, and its mechanism of action, Larotrectinib can cause fetal harm when administered to a pregnant woman. Women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use an effective method of contraception during treatment and for 1 week after the final dose of Larotrectinib.

Effects of Other Drugs on Larotrectinib: Strong CYP3A4 Inhibitors: Coadministration of Larotrectinib with a strong CYP3A4 inhibitor may increase Larotrectinib plasma concentrations, which may result in a higher incidence of adverse reactions. Coadministration of Larotrectinib should be avoided with strong CYP3A4 inhibitors, including grapefruit or grapefruit juice. If coadministration of strong CYP3A4 inhibitors cannot be avoided, Larotrectinib dose as recommended should be modified.

Strong CYP3A4 Inducers: Coadministration of Larotrectinib with a strong CYP3A4 inducer may decrease Larotrectinib plasma concentrations, which may decrease the efficacy of Larotrectinib. Coadministration of Larotrectinib should be avoided with strong CYP3A4 inducers, including St. John’s wort. If coadministration of strong CYP3A4 inducers cannot be avoided, Larotrectinib dose as recommended should be modified.

Effects of Larotrectinib on Other Drugs: Sensitive CYP3A4 Substrates: Coadministration of Larotrectinib with sensitive CYP3A4 substrates may increase their plasma concentrations, which may increase the incidence or severity of adverse reactions. Coadministration of Larotrectinib should be avoided with sensitive CYP3A4 substrates. If coadministration of these sensitive CYP3A4 substrates cannot be avoided, patients for increased adverse reactions of these drugs should be monitored.

Larotrectinib can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on Larotrectinib use in pregnant women. Pregnant women should be advised of the potential risk to a fetus. There are no data on the presence of Larotrectinib or its metabolites in human milk and no data on its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Larotrectinib and for 1 week after the final dose.

Females: Female patients of reproductive potential should be advised to use effective contraception during treatment with Larotrectinib and for at least 1 week after the final dose.

Males: Males with female partners of reproductive potential should be advised to use effective contraception during treatment with Larotrectinib and for 1 week after the final dose.

Pediatric Use: The safety and effectiveness of Larotrectinib in pediatric patients was established based upon data from three multicenter, open-label, single-arm clinical trials in adult or pediatric patients 28 days and older.

Geriatric Use: Clinical studies of Larotrectinib did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic Steroid preparations

Loteprednol (corticosteroids) are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. Gatifloxacin has been shown to be active against most isolates of the following organisms both microbiologically and clinically.

Aerobic Gram-Positive Bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae.

Aerobic Gram-Negative Bacteria: Haemophilus influenza.

Apply one or two drops of sterile ophthalmic suspension into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing maybe increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component or the anti-infective component, or the combination. Reactions associated with ophthalmic steroids include elevated IOP, which may be associated with infrequent optic nerve damage, visual acuity and field detects, posterior sub capsular cataract formation, delayed wound healing, and secondary ocular infections from pathogens including herpes simplex, and perforation of the globe where there is thinning of cornea or sclera. The most frequently reported adverse effects for gatifloxacin in the overall study population were conjunctival irritation, increased lacrimation, keratitis and papillary conjunctivitis. These events occurred in approximately 5-10% of patients. Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance. Redness was the most commonly observed adverse event occurring in 6%. Itching, discharge photophobia and blurred vision were seen in less than 2% cases.

This sterile ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex and also in mycobacterial infection of the eye and fungal diseases of ocular structures. It is also contraindicated in known hypersensitivity to any of the ingredients of this preparation. It is also contraindicated in patients with a history of hypersensitivity to other quinolones, acetylsalicylic acid and other no steroidal inflammatory medicines.

The preparation should not be injected sub conjunctively, nor should it be introduced directly into the anterior chamber of the eye. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling it before they insert their contact lenses.

No drug interaction is reported yet. If several medicines are to be administered to the eye, there should be an interval of at least 5 minutes between each application.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this is administered to a nursing woman.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used one month after first opening of the bottle. Protect from freezing.

Ophthalmic steroid - antibiotic combined preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.

Lercanidipine is indicated for the treatment of mild to moderate essential hypertension.

Calcium-channel blockers

Lercanidipine is a selective calcium channel blocker of the dihydropyridine group and it inhibits the transmembrane influx of calcium into smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle, thus lowering total peripheral resistance. Lercanidipine is endowed with a prolonged antihypertensive activity because of its high membrane partition coefficient and is devoid of negative inotropic effects due to its high vascular selectivity.

Use in the elderly: The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response. It may take about 2 weeks before the maximal antihypertensive effect is apparent.

Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of Lercanidipine to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an ACE inhibitor (ramiprii).

Use in children: Since there is no clinical data in patients under the age of 18 years, use in children is not currently recommended.

Use in renal or hepatic dysfunction: Special care should be exercised in patients with mild to moderate renal or hepatic dysfunction. Dosage above 20 mg daily must be approached with caution. Lercanidipine is not recommended for use in patients with severe hepatic or renal dysfunction.

Treatment with Lercanidipine is generally well tolerated. The most common side effects are related to the vasodilatory properties of Lercanidipine such as flushing, peripheral edema, headache, dizziness and asthenia. Other side effects, which occurred in less than 1% of patients include fatigue; Gl disturbances such as dyspepsia, nausea, vomiting, epigastric pain and diarrhea, polyurea, rash, somnolence and myalgia.

Lercanidipine is contraindicated in patients with left ventricular outflow tract obstruction, untreated congestive cardiac failure, unstable angina pectoris, within 1 month of a myocardial infarction and known hypersensitivity to any dihydropyridine. Lercanidipine should not be taken with grapefruit juice.

Special care should be exercised when Lercanidipine is used in patients with sick sinus syndrome, left ventricular dysfunction and ischaemic heart disease.

Concomitant treatment of Lercanidipine with cyclosporin, phenytoin, carbamazepine, rifampicin, ketoconazole, itraconazole, ritonavir, erythromycin, troleandomycin, and midazolam should be avoided. Caution should be exercised when Lercanidipine is co-prescribed with astemizole, amiodarone, quinidine, cimetidine, metoprolol and simvastatin.

Since there is no clinical data with Lercanidipine in pregnancy, it should not be administered during pregnancy or to woman with child bearing potential unless effective contraception is used. Lercanidipine is highly lipophilic and distribution in milk may be expected. Therefore, it should not be administered to nursing mother.

There is no data with Lercanidipine overdosage. As with other dihydropyridines, overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and reflex tachycardia. Since the drug is highly lipophilic, it is most probable that plasma levels are no guide to the duration of the period of risk and dialysis may not be effective.

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

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.

Ophthalmic steroid - antibiotic combined preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.

Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.

Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Use in lactation: Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.

Ophthalmic Steroid preparations

Loteprednol is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Loteprednol ophthalmic gel: Instill one to two drops of Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Loteprednol ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the eye(s) four times a day.
• For inflammation after surgery: Instill 1 drop of Ophthalmic Suspension into the conjunctival sac of the operated eye(s) four times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur.

It is contraindicated in most viral diseases of the cornea and conjunctiva. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

For ophthalmic use only. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and visual field, and in posterior subcapsular cataract formation. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

No clinical data available for use in pregnancy. It is not known whether Loteprednol Etabonate passes into breast milk.

Protect from light. Store in cool & dry place. Keep out of the reach of children.