Chiesi Usa, Inc.

Chiesi Usa, Inc. Drugs

• Factive
  

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  Factive

  

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  FACTIVE can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of FACTIVE is 320 mg daily, according to the following table (Table 4).Table 4.  Recommended Dosage Regimen of FACTIVEThe clinical decision regarding the use of a 5 or 7 day regimen should be guided by results of the initial sputum culture.

   INDICATION  DOSE / DURATION  *MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.  Acute bacterial exacerbation of chronic  One 320 mg tablet daily for 5 days  bronchitis    Community-acquired pneumonia (of mild to moderate severity)  due to known or suspected S. pneumoniae,    H. influenzae, M. pneumoniae, or C.  One 320 mg tablet daily for 5 days  pneumoniae infection    due to known or suspected MDRSP*, K.  One 320 mg tablet daily for 7 days  pneumoniae, or M. catarrhalis infection  

  The recommended dose and duration of FACTIVE should not be exceeded (see Table 2).

  Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance ≤40 mL/min. Table 5 provides dosage guidelines for use in patients with renal impairment.Table 5.  Recommended Doses for Patients with Renal Impairment

   Creatinine Clearance (mL/min)  Dose  >40  See Usual Dosage  ≤40  160 mg every 24 hours

  Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160 mg every 24 hours.

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Creatinine Clearance Formula

  Women: 0.85 x the value calculated for men

  Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.

  Use in Elderly: No dosage adjustment is recommended.

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• Doxazosin
  

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  Doxazosin

  

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  2.1 Recommended Dosing

  Cardene I.V. is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

  Dosage as a Substitute for Oral Nicardipine Therapy

  The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

  Oral Cardene Dose

  Equivalent I.V. Infusion Rate

  20 mg q8h

  0.5 mg/hr = 5 mL/hr

  30 mg q8h

  1.2 mg/hr = 12 mL/hr

  40 mg q8h

  2.2 mg/hr = 22 mL/hr

  Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

  Initiate therapy at 50 mL/hr (5 mg/hr).  If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

  Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

  Drug Discontinuation and Transition to an Oral Antihypertensive Agent

  Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

  If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.

  If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

  Special Populations

  Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.3 , 5.4  and 5.5.)]

  2.2 Monitoring

  The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment.  With constant infusion, blood pressure begins to fall within minutes.  It reaches about 50% of its ultimate decrease in about 45 minutes.

  Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment.  If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 30‑50 mL/hr (3 - 5 mg/hr) and adjusted to maintain desired blood pressure.

  2.3 Instructions for Administration

  Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.6 )].

  Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

  Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact.  If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

  Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container.  Do not add supplementary medication to the bag. Protect from light until ready to use.

  Do not use plastic containers in series connections.  Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

  Preparation for administration

  1.        Suspend container from eyelet support.

  2.        Remove protector from outlet port at bottom of container.

  3.        Attach administration set.  Refer to complete directions accompanying set.

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• Good Sense Daytime
  

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  Good Sense Daytime

  

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  2.1  Important Administration Instructions

  For intracheal administration only.

  CUROSURF should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. Before administering CUROSURF, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering CUROSURF. Allow the infant to stabilize before proceeding with dosing.

  Administer CUROSURF either:

  Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter after briefly disconnecting the endotracheal tube from the ventilator; or Intratracheally in a single aliquot through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

  2.2  Recommended Dosage

  The initial recommended dose is 2.5 mL/kg birth weight (see Table 1), administered as one or two aliquots depending upon the instillation procedure [see Dosage and Administration (2.3)].

  Up to two repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dosage (sum of the initial and up to two repeat doses) is 5 mL/kg.  

   Table 1:  CUROSURF Weight-Based Dosing Chart for Rescue Treatment of RDS

  Weight

  (grams)

  Initial Dose

  2.5 mL/kg

  Repeat Dose

  1.25 mL/kg

  Weight

  (grams)

  Initial Dose

  2.5 mL/kg

  Repeat Dose

  1.25 mL/kg

  Each Dose (mL)

  Each Dose (mL)

  600-650

  1.60

  0.80

  1301-1350

  3.30

  1.65

  651-700

  1.70

  0.85

  1351-1400

  3.50

  1.75

  701-750

  1.80

  0.90

  1401-1450

  3.60

  1.80

  751-800

  2.00

  1.00

  1451-1500

  3.70

  1.85

  801-850

  2.10

  1.05

  1501-1550

  3.80

  1.90

  851-900

  2.20

  1.10

  1551-1600

  4.00

  2.00

  901-950

  2.30

  1.15

  1601-1650

  4.10

  2.05

  951-1000

  2.50

  1.25

  1651-1700

  4.20

  2.10

  1001-1050

  2.60

  1.30

  1701-1750

  4.30

  2.15

  1051-1100

  2.70

  1.35

  1751-1800

  4.50

  2.25

  1101-1150

  2.80

  1.40

  1801-1850

  4.60

  2.30

  1151-1200

  3.00

  1.50

  1851-1900

  4.70

  2.35

  1201-1250

  3.10

  1.55

  1901-1950

  4.80

  2.40

  1251-1300

  3.20

  1.60

  1951-2000

  5.00

  2.50

  2.3  Preparation of the CUROSURF Suspension

  Remove the vial of CUROSURF suspension from a refrigerator at +2 to +8°C (36 to 46°F) and slowly warm the vial to room temperature before use. Visually inspect the CUROSURF suspension for discoloration prior to administration. The color of the CUROSURF suspension should be white to creamy white. Discard the CUROSURF vial if the suspension is discolored. Gently turn the vial upside-down, in order to obtain a uniform suspension. DO NOT SHAKE. Locate the notch (FLIP UP) on the colored plastic cap and lift the notch and pull upwards. Pull the plastic cap with the aluminum portion downwards. Remove the whole ring by pulling off the aluminum wrapper. Remove the rubber cap to extract content. Unopened, unused vials of CUROSURF suspension that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Do not warm to room temperature and return to refrigerated storage more than once. Protect from light.

  2.4  Administration

  For endotracheal tube instillation using a 5 French end-hole catheter

  Slowly withdraw the entire contents of the vial of CUROSURF suspension into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Enter each single-use vial only once. Attach the pre-cut 8-cm 5 end-hole French catheter to the syringe. Fill the catheter with CUROSURF suspension. Discard excess CUROSURF through the catheter so that only the dose to be given remains in the syringe. When administering CUROSURF using a 5 French end-hole catheter, administer in two divided aliquots: For the first dose: 1.25 mL/kg (birth weight) per aliquot

   For each repeated dose: 0.635 mL/kg (birth weight) per aliquot

  First aliquot of CUROSURF suspension: Position the infant in a neutral position (head and body in alignment without inclination), with either the right or left side dependent. Immediately before CUROSURF administration, change the infant’s ventilator settings to a rate of 40-60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO2 > 92%. Briefly disconnect the endotracheal tube from the ventilator. Insert the pre-cut 5 French catheter into the endotracheal tube and instill the first aliquot of CUROSURF suspension. After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for one minute. Second aliquot of CUROSURF suspension: When the infant is stable, reposition the infant such that the other side is dependent. Administer the remaining aliquot using the same procedures as the first aliquot. After completion of the dosing procedure, resume usual ventilator management and clinical care. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur. Post dosing, consider maintenance of PaO2 of about 55 mmHg, PaCO2 of 35-45, and pH > 7.3 [see Clinical Studies (14.1)].

  For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube

  Slowly withdraw the entire contents of the vial of CUROSURF suspension into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Do not attach 5 French end-hole catheter. Remove the needle and discard excess CUROSURF so that only the dose to be given remains in the syringe. Keep the infant in a neutral position (head and body in alignment without inclination). Administer CUROSURF suspension through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation. After completion of this dosing procedure, ventilator management may require transient increases in FiO2 , ventilator rate, or PIP. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.

  2.1  Important Administration Instructions

  For intracheal administration only.

  CUROSURF should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. Before administering CUROSURF, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering CUROSURF. Allow the infant to stabilize before proceeding with dosing.

  Administer CUROSURF either:

  Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter after briefly disconnecting the endotracheal tube from the ventilator; or Intratracheally in a single aliquot through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

  2.2  Recommended Dosage

  The initial recommended dose is 2.5 mL/kg birth weight (see Table 1), administered as one or two aliquots depending upon the instillation procedure [see Dosage and Administration (2.3)].

  Up to two repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dosage (sum of the initial and up to two repeat doses) is 5 mL/kg.  

   Table 1:  CUROSURF Weight-Based Dosing Chart for Rescue Treatment of RDS

  Weight

  (grams)

  Initial Dose

  2.5 mL/kg

  Repeat Dose

  1.25 mL/kg

  Weight

  (grams)

  Initial Dose

  2.5 mL/kg

  Repeat Dose

  1.25 mL/kg

  Each Dose (mL)

  Each Dose (mL)

  600-650

  1.60

  0.80

  1301-1350

  3.30

  1.65

  651-700

  1.70

  0.85

  1351-1400

  3.50

  1.75

  701-750

  1.80

  0.90

  1401-1450

  3.60

  1.80

  751-800

  2.00

  1.00

  1451-1500

  3.70

  1.85

  801-850

  2.10

  1.05

  1501-1550

  3.80

  1.90

  851-900

  2.20

  1.10

  1551-1600

  4.00

  2.00

  901-950

  2.30

  1.15

  1601-1650

  4.10

  2.05

  951-1000

  2.50

  1.25

  1651-1700

  4.20

  2.10

  1001-1050

  2.60

  1.30

  1701-1750

  4.30

  2.15

  1051-1100

  2.70

  1.35

  1751-1800

  4.50

  2.25

  1101-1150

  2.80

  1.40

  1801-1850

  4.60

  2.30

  1151-1200

  3.00

  1.50

  1851-1900

  4.70

  2.35

  1201-1250

  3.10

  1.55

  1901-1950

  4.80

  2.40

  1251-1300

  3.20

  1.60

  1951-2000

  5.00

  2.50

  2.3  Preparation of the CUROSURF Suspension

  Remove the vial of CUROSURF suspension from a refrigerator at +2 to +8°C (36 to 46°F) and slowly warm the vial to room temperature before use. Visually inspect the CUROSURF suspension for discoloration prior to administration. The color of the CUROSURF suspension should be white to creamy white. Discard the CUROSURF vial if the suspension is discolored. Gently turn the vial upside-down, in order to obtain a uniform suspension. DO NOT SHAKE. Locate the notch (FLIP UP) on the colored plastic cap and lift the notch and pull upwards. Pull the plastic cap with the aluminum portion downwards. Remove the whole ring by pulling off the aluminum wrapper. Remove the rubber cap to extract content. Unopened, unused vials of CUROSURF suspension that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Do not warm to room temperature and return to refrigerated storage more than once. Protect from light.

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• Zyflo
  

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  Zyflo

  

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  The recommended dosage of ZYFLO for the symptomatic treatment of patients with asthma is one 600-mg tablet four times a day for a total daily dose of 2400 mg. For ease of administration, ZYFLO may be taken with meals and at bedtime. Hepatic transaminases should be evaluated prior to initiation of ZYFLO and periodically during treatment (see PRECAUTIONS, Hepatic).

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• Bethkis
  

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  Bethkis

  

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  2.1 Dosing Information

  The recommended dosage for patients six years of age and older is to administer one single-use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart.

  The 300 mg/4 mL dose of BETHKIS is the same for patients regardless of age or weight. BETHKIS has not been studied in patients less than six years old.

  2.2 Administration

  BETHKIS is administered by oral inhalation. Do not use by any other route.

  BETHKIS is administered by inhalation using a hand‑held PARI LC PLUS Reusable Nebulizer with a PARI Vios Air compressor over an approximately 15 minute period and until sputtering from the output of the nebulizer has occurred for at least one minute.

  Further patient instructions on how to administer BETHKIS are provided in the PATIENT COUNSELING INFORMATION (17) and the PATIENT’S INSTRUCTIONS FOR USE.

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• Cardene Iv
  

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  Cardene Iv

  

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  2.1 Recommended Dosing

  Cardene I.V. is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

  Dosage as a Substitute for Oral Nicardipine Therapy

  The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

   Oral Cardene Dose  Equivalent I.V. Infusion Rate  20 mg q8h  0.5 mg/hr = 2.5 mL/hr  30 mg q8h  1.2 mg/hr = 6 mL/hr  40 mg q8h  2.2 mg/hr = 11 mL/hr

  Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

  Initiate therapy at 25 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved.

  Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 15 mL/hr (3 mg/hr).

  Drug Discontinuation and Transition to an Oral Antihypertensive Agent

  Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

  If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.

  If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

  Special Populations

  Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.3, 5.4 and 5.5.)]

  2.2 Monitoring

  The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment.  With constant infusion, blood pressure begins to fall within minutes.  It reaches about 50% of its ultimate decrease in about 45 minutes.

  Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment.  If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 15‑25 mL/hr (3 - 5 mg/hr) and adjusted to maintain desired blood pressure.

  2.3 Instructions for Administration

  Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.6 )].

  Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

  Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact.  If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

  Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container.  Do not add supplementary medication to the bag. Protect from light until ready to use.

  Do not use plastic containers in series connections.  Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

  Preparation for administration

  1.        Suspend container from eyelet support.

  2.        Remove protector from outlet port at bottom of container.

  3.        Attach administration set.  Refer to complete directions accompanying set.

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• Zyflo Cr
  

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  Zyflo Cr

  

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  The recommended dosage of ZYFLO CR for the treatment of patients with asthma is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. Tablets should not be chewed, cut or crushed. If a dose is missed, the patient should take the next dose at the scheduled time and not double the dose. Assess hepatic function enzymes prior to initiation of ZYFLO CR and periodically during treatment [see Contraindications (4), Warnings and Precautions (5), and Use in Specific Populations (8.7)].

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