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Ophthalmic Steroid preparations

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.

Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

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

Flunarizine is indicated for

• Prophylaxis of classic (with aura) or common (without aura) migraine
• Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
• Peripheral Vascular Disease (PVD)
• Motion sickness
• Refractory epilepsy resistant to conventional antiepileptic therapy.

Miscellaneous prophylactic migraine preparations

Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.

Migraine Prophylaxis:

• Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
• Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.

Peripheral Vascular disease: 10 mg twice daily, up to 30 mg per day if required.

Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).

Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy

Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.

Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.

Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.

Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.

Safety in pregnancy and lactation has not been established.

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

Flunarizine is indicated for

• Prophylaxis of classic (with aura) or common (without aura) migraine
• Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
• Peripheral Vascular Disease (PVD)
• Motion sickness
• Refractory epilepsy resistant to conventional antiepileptic therapy.

Miscellaneous prophylactic migraine preparations

Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.

Migraine Prophylaxis:

• Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
• Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.

Peripheral Vascular disease: 10 mg twice daily, up to 30 mg per day if required.

Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).

Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy

Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.

Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.

Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.

Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.

Safety in pregnancy and lactation has not been established.

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

Flunarizine is indicated for

• Prophylaxis of classic (with aura) or common (without aura) migraine
• Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
• Peripheral Vascular Disease (PVD)
• Motion sickness
• Refractory epilepsy resistant to conventional antiepileptic therapy.

Miscellaneous prophylactic migraine preparations

Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.

Migraine Prophylaxis:

• Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
• Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.

Peripheral Vascular disease: 10 mg twice daily, up to 30 mg per day if required.

Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).

Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy

Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.

Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.

Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.

Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.

Safety in pregnancy and lactation has not been established.

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

Flunarizine is indicated for

• Prophylaxis of classic (with aura) or common (without aura) migraine
• Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
• Peripheral Vascular Disease (PVD)
• Motion sickness
• Refractory epilepsy resistant to conventional antiepileptic therapy.

Miscellaneous prophylactic migraine preparations

Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.

Migraine Prophylaxis:

• Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
• Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.

Peripheral Vascular disease: 10 mg twice daily, up to 30 mg per day if required.

Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).

Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy

Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.

Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.

Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.

Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.

Safety in pregnancy and lactation has not been established.

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

Fluorescein does not stain a normal cornea but conjunctival abrasions are stained yellow or orange, corneal abrasions or ulcers are stained a bright green and foreign bodies are surrounded by a green ring. Fluorescein can be used in diagnostic examinations including Goldmann tonometry and in the fitting of hard contact lenses

Preparations for Ophthalmic diagnosis

Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465- 490 nm and fluoresces, i.e., emits light at wavelengths of 520-530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish-green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

Ophthalmic-
Aid in the fitting of hard contact lenses, Detection of corneal lesions and foreign bodies, Diagnostic ophthalmic procedures:

• Adult: Apply 1% or 2% solution as eye drops or as sterile papers impregnated with fluorescein sodium. May also be given in combination with a local anaesthetic: as a 0.25% solution with oxybuprocaine HCl or proxymetacaine HCl.

Nausea and vomiting (IV); extravasation is painful; hypersensitivity reactions; transient yellow coloration of skin and urine; staining of the skin, clothing and soft contact lenses.

Acute necrotising pancreatitis (oral fluorescein dilaurate).

Special care should be taken to avoid microbial contamination. Pseudomonas aeruginosa grows well in fluorescein solutions, therefore, a single dose solution is preferred.

None known

Safety for use in pregnancy and lactation has not been established, therefore use only when considered essential by the physician

Store below 25°C. Do not freeze. Protect from light.

Sodium fluoride is an antiseptic & anticavity mouthwash which- 

• Restores enamel to strengthen teeth
• Protects teeth from cavity
• Helps to prevent tooth decay
• Controls tartar that can discolor teeth
• whitens teeth safety

Anticavity Mouthwash

Sodium fluoride is a cariostatic agent that is used to prevent dental caries. It can also be used as a source of fluoride in total parenteral nutrition.

Rinse (gargle) with fall strength Sodium fluoride for 30 seconds with 20 ml (with the help of supplied cup) two times daily (morning and evening). Do not swallow. Don’t eat or drink within 30 minutes after rinsing with Sodium fluoride restoring.

Hypersensitivity reactions, rash, nausea, vomiting. Products containing stannous fluoride may cause teeth staining.

Not to use 1 mg tablets in children less then 3 yr of age or when drinking water fluoride content is >= 0.3 ppm.

Prolonged treatment with large amounts of fluoride may result in dental fluorosis and osseous changes; do not exceed recommended dosage. Renal impairment. Pregnancy.

Absorption of fluoride may be reduced by aluminium, calcium and magnesium salts.

No data found

In acute poisoning, symptoms include a salty or soapy taste, increased salivation, GI disturbances, abdominal pain, weakness, drowsiness, faintness and shallow breathing; more serious effects include hypocalcaemia, hypomagnesaemia, hyperkalaemia, tremors, convulsions, cardiac arrhythmias, shock, respiratory arrest and cardiac failure. Death may occur within 2-4 hr. Treatment includes gastric lavage with lime water or a weak solution of another calcium salt to precipitate fluoride. Maintain high urine output, slow IV inj of calcium gluconate 10% may be used for hypocalcaemia and tetany. Magnesium sulfate may be given to treat hypomagnesaemia, and aluminium hydroxide may help to reduce fluoride absorption. Haemodialysis may be considered. Chronic fluoride poisoning may cause skeletal fluorosis resulting in bone pain, stiffness, limited movment and in severe cases, crippling deformities. In children, prolonged excessive intake during tooth development before eruption may cause dental fluorosis characterised by mottled enamel.

Store in tight plastic containers.

Ophthalmic Steroid preparations

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.

Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin it is also indicated in postoperative infection.

Ophthalmic steroid - antibiotic combined preparations

Gentamicin belongs to the group of aminoglycoside antibiotics. It covers a broad spectrum of gram-positive and gram-negative pathogens, including Pseudomonas aeruginosa, Staphylococci, Haemophilus influenzae H. aegypticus, Klebsiella, Enterobacteria, Proteus, Escherichia coli, Shigella and Salmonella. It inhibits specifically bacterial protein synthesis. Fluorometholone is a synthetic fluorinated corticosteroid possessing anti-inflammatory properties. The combination brings concomitantly the bacterial treatment or prophylaxis and the anti-inflammatory effect. In addition, the presence of gentamicin protects from a risk of potential aggravation of a bacterial infection due to the steroid.

Sterile Ophthalmic Suspension: 

• Bacterial infection: The dosage depends on the severity of the disease. The application of 1 drop 5 times daily into the conjunctival sac of the affected eye is recommended. In severe cases the dosage can be increased up to 1 drop per hour for 1 to 2 days.
• Ocular postoperative infection: 1 drop 4 times daily into the conjunctival sac for 1 week. Then a reduced application frequency is recommended for the remaining part of the treatment.

Sterile Eye Ointment:

• Bacterial infection: Apply 3-4 times daily into the affected eye.
• Ocular postoperative infection: To support the therapy with Ophthalmic Suspension during the night apply ointment before retiring.

A transient burning sensation may occur after instillation. Rare: Hypersensitivity reactions including eczema of the eyelid and puncture keratitis. Prolonged use of topical steroids may delay wound healing, increase of IOP, develop cataract and cause thinning of cornea & sclera.

No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

Store in a cool and dry place, protect from light. Do not use longer than 30 days after first opening. Keep out of reach of children.

Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin it is also indicated in postoperative infection.

Ophthalmic steroid - antibiotic combined preparations

Gentamicin belongs to the group of aminoglycoside antibiotics. It covers a broad spectrum of gram-positive and gram-negative pathogens, including Pseudomonas aeruginosa, Staphylococci, Haemophilus influenzae H. aegypticus, Klebsiella, Enterobacteria, Proteus, Escherichia coli, Shigella and Salmonella. It inhibits specifically bacterial protein synthesis. Fluorometholone is a synthetic fluorinated corticosteroid possessing anti-inflammatory properties. The combination brings concomitantly the bacterial treatment or prophylaxis and the anti-inflammatory effect. In addition, the presence of gentamicin protects from a risk of potential aggravation of a bacterial infection due to the steroid.

Sterile Ophthalmic Suspension: 

• Bacterial infection: The dosage depends on the severity of the disease. The application of 1 drop 5 times daily into the conjunctival sac of the affected eye is recommended. In severe cases the dosage can be increased up to 1 drop per hour for 1 to 2 days.
• Ocular postoperative infection: 1 drop 4 times daily into the conjunctival sac for 1 week. Then a reduced application frequency is recommended for the remaining part of the treatment.

Sterile Eye Ointment:

• Bacterial infection: Apply 3-4 times daily into the affected eye.
• Ocular postoperative infection: To support the therapy with Ophthalmic Suspension during the night apply ointment before retiring.

A transient burning sensation may occur after instillation. Rare: Hypersensitivity reactions including eczema of the eyelid and puncture keratitis. Prolonged use of topical steroids may delay wound healing, increase of IOP, develop cataract and cause thinning of cornea & sclera.

No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

Store in a cool and dry place, protect from light. Do not use longer than 30 days after first opening. Keep out of reach of children.

Ophthalmic Steroid preparations

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.

Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Ophthalmic Steroid preparations

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.

Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Ophthalmic Steroid preparations

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.

Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Fluorouracil is indicated alone or in combination for- 

• Carcinoma of the colon or rectum
• Carcinoma of the stomach and exocrine pancreas
• Carcinoma of the liver
• Carcinoma of the breast
• Carcinoma of the bladder
• Carcinoma of the lung
• Epithelial ovarian carcinoma
• Cervical carcinoma.

Fluorouracil is inactive as such in mammalian cells but is converted into the active 5-fluorodeoxyuridine monophosphate (FdUMP) by a variety of different metabolic pathways. The drug works by inhibiting the enzyme thymidylate kinase which results in reduced formation of thymidine and thus of DNA. The active metabolite FdUMP appears to form a stable complex with the folate cofactor N-5, 10-methylene tetrahydrofolate which inactivates thymidylate kinase. Fluorouracil as FdUMP is also incorporated into RNA which results in fluorination of RNA. The effect of fluorouracil on living cells is limited mainly to those in the proliferative phase but while cells in the G2 and S phase are most affected there may be effects at any stage of the cell cycle.

Intravenous 5-fluorouracil can be delivered by rapid intravenous bolus injection or slow infusion. The vial contents can rapidly be injected directly into a peripheral vein, the commonest schedules being: 12-13.5 mg/Kg (500 mg/m2) daily for 5 days repeated at 4-weekly intervals. Slow intravenous infusion requires the drug, to be diluted in 500 ml of dextrose 5% solution, then infused over 2-3 hr on 5 successive days.

For palliative management of cancer: Initial Dose: 12 mg/kg intravenously once daily for 4 successive days. Maximum Dose: 800 mg/day. If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day (No therapy is given on days 5, 7, 9, or 11). Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state: Initial Dose: 6 mg/kg/day for 3 days. Maximum Dose: 400 mg/day. If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9 (No therapy is to be administered on days 4, 6, or 8). Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

• Repeat the dosage of the first course every 30 days after the last day of the previous course, or
• When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose. Maximum Dose: 1g/week .The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual adult dose for cervical cancer: In combination with cisplatin 1 gm/m2 IV on day 1. The cycle is repeated every 21 days.

Usual pediatric dose for malignant disease: The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.

Intra-arterial infusion: Fluorouracil has also been given by intra-arterial infusion for adult in doses of 5 to 7.5 mg/kg body weight is dissolved in 20-100 ml of 5% Dextrose solution and administered 10-20 days by using an infusion pump.

Combination with radiation: Usual adult daily dose of 5-10 mg/kg body weight is given in combination with radiation according to systemic administration method or intra-arterial infusion method.

Combination with other anticancer drugs: Fluorouracil is used alone or in combination in the adjuvant treatment of breast and gastro-intestinal cancer, and palliation of inoperable malignant neoplasms, especially those of the gastro-intestinal tract, breast, head and neck, liver, genito-urinary system, and pancreas. It is also used with cyclophosphamide and methotrexate in the combination chemotherapy of breast cancer. A usual adult dose of 5 to 10 mg/kg body weight daily is given in combination with other anticancer drugs every day or intermittently once to twice a week by systemic administration method or intra-arterial infusion method.

Potentially life-threatening effects: Severe effects from 5-fluorouracil are related to the dosage and duration of therapy.

Cardiac effects: Occasional case reports associating 5-fluorouracil therapy with 'ischemic cardiac events' evidence against the autoimmune phenomenon is the fact that in several cases cardiotoxicity occurred within several hours of the first dose.

Hematological effects: Potentially lethal effects caused by severe hematological toxicity may develop within the first 10 days of treatment being instituted but generally resolves within 3 weeks. At the recommended dose and schedule it is rather uncommon for hematological toxicity to be severe. Any ontribute to severe effects from 5-fluorouracil on the blood-forming cells. Thus extensive prior irradiation or the concomitant use of cytotoxic drugs tend to exacerbate the severity of the hematological side effects of 5-fluorouracil.

Neurological effects: Effects on the central nervous system have been occasionally reported and cerebral ataxia is dose-dependent with an incidence of between 3.1 and 7%. Acute cerebellar syndromes and myelopathy have been described following intrathecal 5-fluorouracil. Neurological syndromes may occur rarely after carotid artery perfusion in head and neck cancer. Other effects Allergic reaction (including difficulty in breathing, closing of the throat, swelling of the lips, tongue, or face, or hives), decreased bone marrow function and blood problems (extreme fatigue, easy bruising or bleeding, black, bloody or tarry stools, or fever, chills, or signs of infection), hand-foot syndrome (tingling, pain, redness, swelling or tenderness of the hands and feet), severe vomiting, diarrhoea, frequent bowel movements or watery stools, or sores in the mouth or throat, or stomach pain or heartburn or black, bloody or tarry stools. Other less serious side effects may include mild to moderate nausea, vomiting or loss of appetite, balance problems, confusion, rash and itching, or temporary hair loss. Conjunctivitis, both acute and chronic can proceed to tear duct stenosis and ectropion following prolonged administration. Very chronic administration, extending beyond 3 months, of low dosage has been associated with low systemic toxicity but includes the possibility of painful and tender hands and feet associated with erythema of the extremities.

It is contraindicated in patients that are severely debilitated or in patients with bone marrow suppression due to either radiotherapy or chemotherapy. It is likewise contraindicated in pregnant or breastfeeding women. It should also be avoided in patients that do not have malignant illnesses.

5-fluorouracil is highly toxic drug with a narrow margin of safety. Therefore patients should be carefully supervised, since therapeutic response is unlikely to occur without some evidence of toxicity. Daily dose should not exceed 1 gram. Treatment should be discontinued promptly when one of the following signs of toxicity appears: Leucopenia (WBC under 3500/mm3). Thrombocytopenia (platelet under 100000/mm3). Stomatitis ( the first small ulceration at the inner margin of the lips is a signal for stopping treatment). Severe diarrhoea (frequent bowel movements and watery stools). Gastro-intestinal ulceration and bleeding.

Pre-treatment with cimetidine for 4 weeks led to increased plasma concentrations of fluorouracil following intravenous and oral administration in 6 patients. The effect was probably due to a combination of hepatic enzyme inhibition and reduced hepatic blood flow.

Fluorouracil is contraindicated throughout pregnancy. The literature pertaining to pregnancy and cytotoxic drugs is necessarily limited but it appears in general that risk of teratogenesis diminishes with the advancement of pregnancy. Therefore most cytotoxic drugs are absolutely contraindicated in the first trimester and 5-fluorouracil, used in the first trimester has been reported to cause multiple congenital abnormalities. There are many case reports, however, of pregnancy being conducted successfully with combination chemotherapy being given to the mother during the second and third trimesters. Because of the age of the population and the natural history of the tumors treated, most of the data on long-term follow-up pertain to therapy for leukemias. More data need to be accrued on the subsequent development of neonates before it is certain that any of these compounds are free of late effects.

It is not known whether fluorouracil is excreted in human milk. Because fluorouracil inhibits DNA, RNA and protein synthesis, mothers should not nurse while receiving this drug.

Neonates: No dosage recommendations are made for neonates.

Children: Safety and effectiveness in children have not been established.

The elderly: No special precautions are required, doses being adjusted for the patient's weight and height.

Cases of deliberate overdose are unknown but excessive toxicity because of the hematological effects as described above. There is no specific antidote to 5-fluorouracil toxicity; treatment consists in supportive care. In addition to the hematological toxicity other toxicities will occur with overdose. Sign and symptoms are qualitatively similar to the side effects. Treatment should be performed promptly and appropriate drugs are given to control symptoms of overdose.

5-Fluorouracil is a cytotoxic anticancer drug and, caution should be exercised in handling 5-Fluorouracil. Special, trained personnel should reconstitute the drug. Preparation requires a room reserved for this purpose. The work surface should be covered with disposable plastic-backed absorbent paper. Smoking, eating and drinking are prohibited in the room. The handling staff must have a set of appropriate equipment, particularly long-sleeved coats, protective masks, caps, protective goggles, sterile disposable gloves, worktop protection sheets and waste collection containers and bags. If 5-Fluorouracil solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If 5-Fluorouracil contacts mucous membranes, the membranes should be flashed thoroughly with water. Pregnant women must be warned and avoid handling cytotoxic agents. All broken containers must be treated with the same precautions and regarded as contaminated waste. Contaminated waste is to be disposed of by incineration in rigid containers labeled for this purpose or must be destroyed as per the government rules.

Store the vial in original carton not exceeding 25℃. Do not refrigerate. Protect from light.

Fluorouracil is indicated alone or in combination for- 

• Carcinoma of the colon or rectum
• Carcinoma of the stomach and exocrine pancreas
• Carcinoma of the liver
• Carcinoma of the breast
• Carcinoma of the bladder
• Carcinoma of the lung
• Epithelial ovarian carcinoma
• Cervical carcinoma.

Fluorouracil is inactive as such in mammalian cells but is converted into the active 5-fluorodeoxyuridine monophosphate (FdUMP) by a variety of different metabolic pathways. The drug works by inhibiting the enzyme thymidylate kinase which results in reduced formation of thymidine and thus of DNA. The active metabolite FdUMP appears to form a stable complex with the folate cofactor N-5, 10-methylene tetrahydrofolate which inactivates thymidylate kinase. Fluorouracil as FdUMP is also incorporated into RNA which results in fluorination of RNA. The effect of fluorouracil on living cells is limited mainly to those in the proliferative phase but while cells in the G2 and S phase are most affected there may be effects at any stage of the cell cycle.

Intravenous 5-fluorouracil can be delivered by rapid intravenous bolus injection or slow infusion. The vial contents can rapidly be injected directly into a peripheral vein, the commonest schedules being: 12-13.5 mg/Kg (500 mg/m2) daily for 5 days repeated at 4-weekly intervals. Slow intravenous infusion requires the drug, to be diluted in 500 ml of dextrose 5% solution, then infused over 2-3 hr on 5 successive days.

For palliative management of cancer: Initial Dose: 12 mg/kg intravenously once daily for 4 successive days. Maximum Dose: 800 mg/day. If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day (No therapy is given on days 5, 7, 9, or 11). Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state: Initial Dose: 6 mg/kg/day for 3 days. Maximum Dose: 400 mg/day. If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9 (No therapy is to be administered on days 4, 6, or 8). Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

• Repeat the dosage of the first course every 30 days after the last day of the previous course, or
• When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose. Maximum Dose: 1g/week .The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual adult dose for cervical cancer: In combination with cisplatin 1 gm/m2 IV on day 1. The cycle is repeated every 21 days.

Usual pediatric dose for malignant disease: The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.

Intra-arterial infusion: Fluorouracil has also been given by intra-arterial infusion for adult in doses of 5 to 7.5 mg/kg body weight is dissolved in 20-100 ml of 5% Dextrose solution and administered 10-20 days by using an infusion pump.

Combination with radiation: Usual adult daily dose of 5-10 mg/kg body weight is given in combination with radiation according to systemic administration method or intra-arterial infusion method.

Combination with other anticancer drugs: Fluorouracil is used alone or in combination in the adjuvant treatment of breast and gastro-intestinal cancer, and palliation of inoperable malignant neoplasms, especially those of the gastro-intestinal tract, breast, head and neck, liver, genito-urinary system, and pancreas. It is also used with cyclophosphamide and methotrexate in the combination chemotherapy of breast cancer. A usual adult dose of 5 to 10 mg/kg body weight daily is given in combination with other anticancer drugs every day or intermittently once to twice a week by systemic administration method or intra-arterial infusion method.

Potentially life-threatening effects: Severe effects from 5-fluorouracil are related to the dosage and duration of therapy.

Cardiac effects: Occasional case reports associating 5-fluorouracil therapy with 'ischemic cardiac events' evidence against the autoimmune phenomenon is the fact that in several cases cardiotoxicity occurred within several hours of the first dose.

Hematological effects: Potentially lethal effects caused by severe hematological toxicity may develop within the first 10 days of treatment being instituted but generally resolves within 3 weeks. At the recommended dose and schedule it is rather uncommon for hematological toxicity to be severe. Any ontribute to severe effects from 5-fluorouracil on the blood-forming cells. Thus extensive prior irradiation or the concomitant use of cytotoxic drugs tend to exacerbate the severity of the hematological side effects of 5-fluorouracil.

Neurological effects: Effects on the central nervous system have been occasionally reported and cerebral ataxia is dose-dependent with an incidence of between 3.1 and 7%. Acute cerebellar syndromes and myelopathy have been described following intrathecal 5-fluorouracil. Neurological syndromes may occur rarely after carotid artery perfusion in head and neck cancer. Other effects Allergic reaction (including difficulty in breathing, closing of the throat, swelling of the lips, tongue, or face, or hives), decreased bone marrow function and blood problems (extreme fatigue, easy bruising or bleeding, black, bloody or tarry stools, or fever, chills, or signs of infection), hand-foot syndrome (tingling, pain, redness, swelling or tenderness of the hands and feet), severe vomiting, diarrhoea, frequent bowel movements or watery stools, or sores in the mouth or throat, or stomach pain or heartburn or black, bloody or tarry stools. Other less serious side effects may include mild to moderate nausea, vomiting or loss of appetite, balance problems, confusion, rash and itching, or temporary hair loss. Conjunctivitis, both acute and chronic can proceed to tear duct stenosis and ectropion following prolonged administration. Very chronic administration, extending beyond 3 months, of low dosage has been associated with low systemic toxicity but includes the possibility of painful and tender hands and feet associated with erythema of the extremities.

It is contraindicated in patients that are severely debilitated or in patients with bone marrow suppression due to either radiotherapy or chemotherapy. It is likewise contraindicated in pregnant or breastfeeding women. It should also be avoided in patients that do not have malignant illnesses.

5-fluorouracil is highly toxic drug with a narrow margin of safety. Therefore patients should be carefully supervised, since therapeutic response is unlikely to occur without some evidence of toxicity. Daily dose should not exceed 1 gram. Treatment should be discontinued promptly when one of the following signs of toxicity appears: Leucopenia (WBC under 3500/mm3). Thrombocytopenia (platelet under 100000/mm3). Stomatitis ( the first small ulceration at the inner margin of the lips is a signal for stopping treatment). Severe diarrhoea (frequent bowel movements and watery stools). Gastro-intestinal ulceration and bleeding.

Pre-treatment with cimetidine for 4 weeks led to increased plasma concentrations of fluorouracil following intravenous and oral administration in 6 patients. The effect was probably due to a combination of hepatic enzyme inhibition and reduced hepatic blood flow.

Fluorouracil is contraindicated throughout pregnancy. The literature pertaining to pregnancy and cytotoxic drugs is necessarily limited but it appears in general that risk of teratogenesis diminishes with the advancement of pregnancy. Therefore most cytotoxic drugs are absolutely contraindicated in the first trimester and 5-fluorouracil, used in the first trimester has been reported to cause multiple congenital abnormalities. There are many case reports, however, of pregnancy being conducted successfully with combination chemotherapy being given to the mother during the second and third trimesters. Because of the age of the population and the natural history of the tumors treated, most of the data on long-term follow-up pertain to therapy for leukemias. More data need to be accrued on the subsequent development of neonates before it is certain that any of these compounds are free of late effects.

It is not known whether fluorouracil is excreted in human milk. Because fluorouracil inhibits DNA, RNA and protein synthesis, mothers should not nurse while receiving this drug.

Neonates: No dosage recommendations are made for neonates.

Children: Safety and effectiveness in children have not been established.

The elderly: No special precautions are required, doses being adjusted for the patient's weight and height.

Cases of deliberate overdose are unknown but excessive toxicity because of the hematological effects as described above. There is no specific antidote to 5-fluorouracil toxicity; treatment consists in supportive care. In addition to the hematological toxicity other toxicities will occur with overdose. Sign and symptoms are qualitatively similar to the side effects. Treatment should be performed promptly and appropriate drugs are given to control symptoms of overdose.

5-Fluorouracil is a cytotoxic anticancer drug and, caution should be exercised in handling 5-Fluorouracil. Special, trained personnel should reconstitute the drug. Preparation requires a room reserved for this purpose. The work surface should be covered with disposable plastic-backed absorbent paper. Smoking, eating and drinking are prohibited in the room. The handling staff must have a set of appropriate equipment, particularly long-sleeved coats, protective masks, caps, protective goggles, sterile disposable gloves, worktop protection sheets and waste collection containers and bags. If 5-Fluorouracil solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If 5-Fluorouracil contacts mucous membranes, the membranes should be flashed thoroughly with water. Pregnant women must be warned and avoid handling cytotoxic agents. All broken containers must be treated with the same precautions and regarded as contaminated waste. Contaminated waste is to be disposed of by incineration in rigid containers labeled for this purpose or must be destroyed as per the government rules.

Store the vial in original carton not exceeding 25℃. Do not refrigerate. Protect from light.

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.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

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

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

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