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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.

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.

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.

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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.

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.

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.

Fluticasone Furoate Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.

Fluticasone Furoate inhalation powder is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. This is not indicated for the relief of acute bronchospasm.

Nasal Steroid Preparations

Fluticasone Furoate is a synthetic trifluorinated corticosteroid with potent anti inflammatory activity. Like other corticosteroids Fluticasone Furoate is found to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g.- histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Fluticasone Furoate Nasal Spray:

• Adults & Children over 12 years: 2 sprays in each nostril once a day. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.
• Children under 12 years (2-11 Years): 1 spray in each nostril once a day. Patients should use Fluticasone Furoate nasal spray at regular intervals as directed since its effectiveness depends on its regular use.
• Children (under 2 years of age): There are no data to recommend use of Fluticasone Furoate Nasal Spray for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.

Fluticasone Furoate Inhalation Capsule: should be administered as 1 inhalation once daily by the orally inhaled route. Fluticasone Furoate should be used at the same time every day. Do not use fluticasone furoate more than 1 time every 24 hours.

• Adults and Adolescents Aged 12 Years and Older: The starting dosage for Fluticasone Furoate should be based upon patients' asthma severity.
• The usual recommended starting dose for adults and adolescents aged 12 years and older not on an inhaled corticosteroid (ICS) is 100 mcg.
• For other adults and adolescents aged 12 years and older, the starting dose should be based on previous asthma drug therapy and disease severity.
• For adults and adolescents aged 12 years and older who do not respond to Fluticasone Furoate 100 mcg after 2 weeks of therapy, replacement with Fluticasone Furoate 200 mcg may provide additional asthma control.

If a dosage regimen of Fluticasone Furoate fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of Fluticasone Furoate with a higher strength, initiating an ICS and long- acting beta 2 -agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.

The highest recommended daily dose in adults and adolescents aged 12 years and older is 200 mcg. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of side effects.

Pediatric Patients Aged 5 to 11 Years: The recommended dosage for children aged 5 to 11 years is 50 mcg administered once daily

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Fluticasone Furoate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and an increase in the incidence of nosebleeds may occur.

Most common adverse reactions of Fluticasone Furoate inhalation capsule reported in ≥5% of adult and adolescent subjects are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.

Fluticasone Furoate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of Fluticasone Furoate nasal spray. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Furoate. Although systemic effects have been minimal with recommended doses of Fluticasone Furoate nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Furoate nasal spray should be avoided.

Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Fluticasone Furoate. Coadministration of ritonavir is not recommended. Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole.

Special instruction: Patients should be instructed that the device must be primed: before first use, and if the cap is left off or if the device does not seem to be working or if the nasal spray has not been used for 30 days or more. In order to prime the device, the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen. Once primed, the patient must shake the nasal spray vigorously each time before use.

Use in pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fluticasone Furoate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

Use in lactation: It is not known whether Fluticasone Furoate is excreted in human breast milk. However, since other corticosteroids have been detected in human milk, caution should be exercised when Fluticasone Furoate is administered to a nursing woman.

Geriatric use: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Use in hepatic impairment: Use Fluticasone Furoate with caution in patients with severe hepatic impairment.

Use in renal impairment: No dosage adjustment is required in patients with renal impairment.

Store at a temperature not exceeding 30°C. Do not refrigerate. Protect from light and moisture. Keep out of the reach of children.

Fluticasone Propionate is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive eczema/dermatitis.

Fluticasone & combined preparations topical

Fluticasone propionate is a glucocorticoid with high topical anti-inflammatorypotency, but a low HPA-axis suppressive activity after dermal administration. It, therefore, has a therapeutic index which is greater than most of the commonly available steroids. Fluticasone propionate has a high degree of selectivity for the glucocorticoid receptor. In vitro studies show that fluticasone propionate has a strong affinity for, and agonist activity at, human glucocorticoid receptors. This receptor is believed to be responsible for the anti-inflammatory properties of glucocorticoids. Fluticasone propionate has weak affinity forthe progesterone receptor, andvirtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the Fluticasone propionate glucocorticoid-receptor complex is approximately 10 hours.

Cream: Apply a thin layer of Fluticasone propionate cream to the affected skin areas once daily.
Ointment: Apply a thin layer of Fluticasone propionate Ointment to the affected skin areas twice daily.

The fluticasone propionate preparations are usually well tolerated; local burning and pruritus have been reported. If signs of hypersensitivity appear, application should be stopped immediately. Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, dilatation of the superficial blood vessels, hypertrichosis and hypopigmentation.

Secondary infection, particularly when occlusive dressings are used or when skin folds are involved and allergic contact dermatitis have also been reported with corticosteroid use. Exacerbation of the signs and symptoms of the dermatoses have been reported with corticosteroid use.

Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.

Fluticasone propionate is contraindicated in Rosacea, Acne vulgaris, Perioral dermatitis, Primary cutaneous viral infections (e.g., Herpes simplex, chicken pox), Hypersensitivity to any of the ingredients, Perianal and genital pruritus, etc. The use of Fluticasone propionate is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria and dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Fluticasone propionate has a very low propensity for systemic absorption, nevertheless, prolonged application of high doses to large areas of the body surface, especially in infants and small children might lead to adrenal suppression. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. The face, more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating severe eczema. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.

No information is available.

Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The excretion of fluticasone propionate into human breast milk has not been investigated. Plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low. When fluticasone propionate is used in breastfeeding mothers, the therapeutic benefits must be weighed against the potential hazards to the mother and baby.

Acute overdosage is very unlikely to occur, however, in case of chronic overdosage or misuse the features of hypercorticism may appear, and in this situation, as with any corticosteroid, the application should be discontinued. Overdosage by ingestion of fluticasone propionate cream or ointment is extremely unlikely to occur due to the very low oral bioavailability of fluticasone propionate.

Store below 30°C.Do not freeze.

Fluticasone Propionate is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive eczema/dermatitis.

Fluticasone & combined preparations topical

Fluticasone propionate is a glucocorticoid with high topical anti-inflammatorypotency, but a low HPA-axis suppressive activity after dermal administration. It, therefore, has a therapeutic index which is greater than most of the commonly available steroids. Fluticasone propionate has a high degree of selectivity for the glucocorticoid receptor. In vitro studies show that fluticasone propionate has a strong affinity for, and agonist activity at, human glucocorticoid receptors. This receptor is believed to be responsible for the anti-inflammatory properties of glucocorticoids. Fluticasone propionate has weak affinity forthe progesterone receptor, andvirtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the Fluticasone propionate glucocorticoid-receptor complex is approximately 10 hours.

Cream: Apply a thin layer of Fluticasone propionate cream to the affected skin areas once daily.
Ointment: Apply a thin layer of Fluticasone propionate Ointment to the affected skin areas twice daily.

The fluticasone propionate preparations are usually well tolerated; local burning and pruritus have been reported. If signs of hypersensitivity appear, application should be stopped immediately. Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, dilatation of the superficial blood vessels, hypertrichosis and hypopigmentation.

Secondary infection, particularly when occlusive dressings are used or when skin folds are involved and allergic contact dermatitis have also been reported with corticosteroid use. Exacerbation of the signs and symptoms of the dermatoses have been reported with corticosteroid use.

Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.

Fluticasone propionate is contraindicated in Rosacea, Acne vulgaris, Perioral dermatitis, Primary cutaneous viral infections (e.g., Herpes simplex, chicken pox), Hypersensitivity to any of the ingredients, Perianal and genital pruritus, etc. The use of Fluticasone propionate is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria and dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Fluticasone propionate has a very low propensity for systemic absorption, nevertheless, prolonged application of high doses to large areas of the body surface, especially in infants and small children might lead to adrenal suppression. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. The face, more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating severe eczema. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.

No information is available.

Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The excretion of fluticasone propionate into human breast milk has not been investigated. Plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low. When fluticasone propionate is used in breastfeeding mothers, the therapeutic benefits must be weighed against the potential hazards to the mother and baby.

Acute overdosage is very unlikely to occur, however, in case of chronic overdosage or misuse the features of hypercorticism may appear, and in this situation, as with any corticosteroid, the application should be discontinued. Overdosage by ingestion of fluticasone propionate cream or ointment is extremely unlikely to occur due to the very low oral bioavailability of fluticasone propionate.

Store below 30°C.Do not freeze.

Fluticasone Propionate is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive eczema/dermatitis.

Fluticasone & combined preparations topical

Fluticasone propionate is a glucocorticoid with high topical anti-inflammatorypotency, but a low HPA-axis suppressive activity after dermal administration. It, therefore, has a therapeutic index which is greater than most of the commonly available steroids. Fluticasone propionate has a high degree of selectivity for the glucocorticoid receptor. In vitro studies show that fluticasone propionate has a strong affinity for, and agonist activity at, human glucocorticoid receptors. This receptor is believed to be responsible for the anti-inflammatory properties of glucocorticoids. Fluticasone propionate has weak affinity forthe progesterone receptor, andvirtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the Fluticasone propionate glucocorticoid-receptor complex is approximately 10 hours.

Cream: Apply a thin layer of Fluticasone propionate cream to the affected skin areas once daily.
Ointment: Apply a thin layer of Fluticasone propionate Ointment to the affected skin areas twice daily.

The fluticasone propionate preparations are usually well tolerated; local burning and pruritus have been reported. If signs of hypersensitivity appear, application should be stopped immediately. Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, dilatation of the superficial blood vessels, hypertrichosis and hypopigmentation.

Secondary infection, particularly when occlusive dressings are used or when skin folds are involved and allergic contact dermatitis have also been reported with corticosteroid use. Exacerbation of the signs and symptoms of the dermatoses have been reported with corticosteroid use.

Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.

Fluticasone propionate is contraindicated in Rosacea, Acne vulgaris, Perioral dermatitis, Primary cutaneous viral infections (e.g., Herpes simplex, chicken pox), Hypersensitivity to any of the ingredients, Perianal and genital pruritus, etc. The use of Fluticasone propionate is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria and dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Fluticasone propionate has a very low propensity for systemic absorption, nevertheless, prolonged application of high doses to large areas of the body surface, especially in infants and small children might lead to adrenal suppression. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. The face, more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating severe eczema. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.

No information is available.

Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The excretion of fluticasone propionate into human breast milk has not been investigated. Plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low. When fluticasone propionate is used in breastfeeding mothers, the therapeutic benefits must be weighed against the potential hazards to the mother and baby.

Acute overdosage is very unlikely to occur, however, in case of chronic overdosage or misuse the features of hypercorticism may appear, and in this situation, as with any corticosteroid, the application should be discontinued. Overdosage by ingestion of fluticasone propionate cream or ointment is extremely unlikely to occur due to the very low oral bioavailability of fluticasone propionate.

Store below 30°C.Do not freeze.

Fluticasone Propionate is indicated for-

• The prophylaxis and treatment of seasonal allergic rhinitis including hay fever and perennial rhinitis.
• It has potent anti-inflammatory activity on the nasal mucosa without detectable systemic activity.

Fluocinolone & Combined Preparations, Nasal Steroid Preparations

Following topical administration into the nasal mucosa, Fluticasone propionate produces anti-inflammatory and vasoconstrictor effects. The exact mechanism of these actions remains unknown but may involve a reduction in the following: number of mediator cells (basophil, leukocytes and mast cells) at the epithelial level, number of eosinophils, the sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity. Other mechanisms may involve - inhibition of capillary dilation and permeability, stabilization of lysosomal membranes and subsequent prevention of release of proteolytic enzymes.

Adults & children over 12 years: 2 sprays in each nostril once a day preferably in the morning. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.

Children under 12 years (4-11 years): 1 spray in each nostril once a day. The maximum total daily dosage should not exceed 4 sprays. For perennial rhinitis in children, there are insufficient clinical data to recommend its use.

Children below 4 years: The safety and effectiveness of Fluticasone Propionate nasal spray in children below 4 years of age have not been established.

Patients should use Fluticasone Propionate Nasal Spray at regular intervals as directed since its effectiveness depends on its regular use. Or as directed by the physician.

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Fluticasone Propionate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and throat, unpleasant taste and smell and an increase in the incidence of nosebleeds may occur.

Fluticasone Propionate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Propionate. Although systemic effects have been minimal with recommended doses of Fluticasone Propionate nasal spray. Potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Propionate nasal spray should be avoided.

There are no adequate and well-controlled studies in pregnant women. Fluticasone Propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Fluticasone Propionate is excreted in human breast milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Fluticasone Propionate nasal spray is administered to a nursing woman.

Keep all medicines out of reach of the children. Store in a cool and dry place protected from light.

Respiratory corticosteroids

This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:

• Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.

This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of this inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.

Asthma:
Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only

• The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
• For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product- i.e. Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
• Children under 12 years: No data are available for this strength of this inhaler in children.
• This inhaler in any strength is not recommended for use in children less than 12 years of age.

Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only

• The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily normally taken in the morning and in the evening.
• Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.
• This inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.

COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily normally taken in the morning and in the evening.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Undesirable effects which have been associated with this inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

this inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.

The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their this inhaler maintenance dose as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this inhaler.

This inhaler should not be used as the first treatment for asthma.

This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.

As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.

Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Special patient groups: There is no need to adjust the dose in elderly patients.

Hepatic or renal: There are no data available for use of this inhaler in patients with hepatic or renal impairment.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.

There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:

FormoterolFumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.

Store in a cool and dry place, protected from light.

Respiratory corticosteroids

This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:

• Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.

This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of this inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.

Asthma:
Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only

• The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
• For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product- i.e. Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
• Children under 12 years: No data are available for this strength of this inhaler in children.
• This inhaler in any strength is not recommended for use in children less than 12 years of age.

Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only

• The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily normally taken in the morning and in the evening.
• Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.
• This inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.

COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily normally taken in the morning and in the evening.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Undesirable effects which have been associated with this inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

this inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.

The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their this inhaler maintenance dose as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this inhaler.

This inhaler should not be used as the first treatment for asthma.

This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.

As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.

Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Special patient groups: There is no need to adjust the dose in elderly patients.

Hepatic or renal: There are no data available for use of this inhaler in patients with hepatic or renal impairment.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.

There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:

FormoterolFumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.

Store in a cool and dry place, protected from light.