Doribax

Doribax Manufacturers

• Janssen Pharmaceuticals, Inc.
  

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  Doribax | Janssen Pharmaceuticals, Inc.

  

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  2.1 Recommended Dosage

  The recommended dosage of DORIBAX® is 500 mg administered every 8 hours by intravenous infusion over one hour in patients ≥18 years of age. The recommended dosage and administration by infection is described in Table 1:

  Table 1: Dosage of DORIBAX® by Infection Infection Dosage Frequency Infusion Time
  (hours) Duration * Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated. † Duration can be extended up to 14 days for patients with concurrent bacteremia. Complicated intra-abdominal infection 500 mg every 8 hours 1 5–14 days* Complicated UTI, including pyelonephritis 500 mg every 8 hours 1 10 days*† 2.2 Patients with Renal Impairment Table 2: Dosage of DORIBAX® in Patients with Renal Impairment Estimated CrCl (mL/min) Recommended Dosage Regimen of DORIBAX® * [see Preparation of 250 mg DORIBAX ® dose using the 250 mg vial and Preparation of 250 mg DORIBAX ® dose using the 500 mg vial ( 2.3)] > 50 No dosage adjustment necessary ≥ 30 to ≤ 50 250 mg* administered intravenously (over 1 hour) every 8 hours > 10 to < 30 250 mg* administered intravenously (over 1 hour) every 12 hours

  The following formula may be used to estimate CrCl. The serum creatinine used in the formula should represent a steady state of renal function.

  Males: Creatinine clearance (mL/min) = weight (kg) × (140 - age in years) 72 × serum creatinine (mg/dL)   Females: Creatinine clearance (mL/min) = 0.85 × value calculated for males

  DORIBAX® is hemodialyzable; however, there is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

  2.3 Preparation of Solutions

  DORIBAX® does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparation of the infusion solution.

  To prepare DORIBAX infusions in Baxter Minibag Plus™ infusion bags consult the infusion bag manufacturer's instructions.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. DORIBAX infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.

  Preparation of 500 mg DORIBAX® dose using the 500 mg vial

  Constitute the 500 mg vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is approximately 50 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is approximately 4.5 mg/mL.

  Preparation of 250 mg DORIBAX® dose using the 250 mg vial

  Constitute the 250 mg vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is approximately 25 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing either 50 or 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is approximately 4.2 mg/mL (50 mL infusion bag) or approximately 2.3 mg/mL (100 mL infusion bag).

  Preparation of 250 mg DORIBAX® dose using the 500 mg vial

  Constitute the 500 mg vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is approximately 50 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. Remove 55 mL of this solution from the bag and discard. Infuse the remaining solution, which contains 250 mg (approximately 4.5 mg/mL). 2.4 Compatibility

  The compatibility of DORIBAX® with other drugs has not been established. DORIBAX® should not be mixed with or physically added to solutions containing other drugs.

  2.5 Storage of Constituted Solutions

  Upon constitution with sterile water for injection or 0.9% sodium chloride (normal saline) injection, DORIBAX suspension in the vial may be held for 1-hour prior to transfer and dilution in the infusion bag.

  Following dilution of the suspension with normal saline or 5% dextrose, DORIBAX infusions stored at room temperature or under refrigeration should be completed according to the times in Table 3.

  Table 3: Storage and Stability Times of Infusion Solutions Prepared in Normal Saline or 5% Dextrose Infusion prepared in Stability Time at Room Temp.
  (includes room temperature storage and infusion time) Stability time at 2–8°C (Refrigeration)
  (includes refrigerator storage and infusion time) Normal saline 12 hours 72 hours 5% Dextrose 4 hours 24 hours

  Constituted DORIBAX suspension or DORIBAX infusion should not be frozen. This storage information applies also to DORIBAX® diluted in Baxter Minibag Plus™.

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• Shionogi Inc.
  

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  Doribax | Par Pharmaceutical, Inc.

  

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  Propafenone HCl Extended Release Capsules can be taken with or without food. Do not crush or further divide the contents of the capsule.

  The dose of propafenone ER capsules must be individually titrated on the basis of response and tolerance. Initiate therapy with propafenone ER capsules 225 mg given every 12 hours. Dosage may be increased at a minimum of 5 day interval to 325 mg given every 12 hours. If additional therapeutic effect is needed, the dose of propafenone ER capsules may be increased to 425 mg given every 12 hours.

  In patients with hepatic impairment or those with significant widening of the QRS complex or second or third degree AV block, consider reducing the dose.

  The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with the simultaneous administration of propafenone may significantly increase the concentration of propafenone and thereby increase the risk of proarrhythmia and other adverse events. Therefore, avoid simultaneous use of propafenone ER capsules with both a CYP2D6 inhibitor and a CYP3A4 inhibitor. [SEE WARNINGS AND PRECAUTIONS (5.2) AND DRUG INTERACTIONS (7.1)].

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