Cordran

Cordran Manufacturers

• Aqua Pharmaceuticals
  

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  Cordran | Aqua Pharmaceuticals

  

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  For moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day. For dry, scaly lesions, the ointment is applied as a thin film to affected areas 2 or 3 times daily.

  Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

  Cordran® (flurandrenolide, USP) should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

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• Aqua Pharmaceuticals
  

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  Cordran | Aqua Pharmaceuticals

  

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  Shake well before using. A small quantity of Cordran Lotion should be rubbed gently into the affected area 2 or 3 times daily.

  Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

  Cordran Lotion should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

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• Actavis Pharma, Inc.
  

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  Cordran | Glaxosmithkline Llc

  

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  2.1 Important Administration Instructions • CEFTIN tablets and CEFTIN for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)]. • Administer CEFTIN tablets or oral suspension as described in the appropriate dosage guidelines [see Dosage and Administration (2.2, 2.3, 2.4)]. • Administer CEFTIN tablets with or without food. • Administer CEFTIN for oral suspension with food. • Pediatric patients (aged 13 years and older) who cannot swallow the CEFTIN tablets whole should receive CEFTIN for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)]. 2.2 Dosage for CEFTIN Tablets

  Administer CEFTIN tablets as described in the dosage guidelines table below with or without food.

  Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for CEFTIN Tablets

  Infection

  Dosage

  Duration

  (Days)

  Adults and Adolescents (13 years and older)

  Pharyngitis/tonsillitis (mild to moderate)

  250 mg every 12 hours

  10

  Acute bacterial maxillary sinusitis (mild to moderate)

  250 mg every 12 hours

  10

  Acute bacterial exacerbations of chronic bronchitis (mild to moderate)

  250 or 500 mg every 12 hours

  10a

  Secondary bacterial infections of acute bronchitis

  250 or 500 mg every 12 hours

  5 to 10

  Uncomplicated skin and skin-structure infections

  250 or 500 mg every 12 hours

  10

  Uncomplicated urinary tract infections

  250 mg every 12 hours

  7 to 10

  Uncomplicated gonorrhea

  1,000 mg

  single dose

  Early Lyme disease

  500 mg every 12 hours

  20

  Pediatric Patients younger than 13 years (who can swallow tablets whole)b

  Acute bacterial otitis media

  250 mg every 12 hours

  10

  Acute bacterial maxillary sinusitis

  250 mg every 12 hours

  10

  a The safety and effectiveness of CEFTIN administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

  b When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.

  2.3 Dosage for CEFTIN for Oral Suspension

  Administer CEFTIN for oral suspension as described in the dosage guidelines table below with food.

  Table 2. Pediatric Patients (3 months to 12 years) Dosage Guidelines for CEFTIN for Oral Suspension

  Infection

    Recommended Daily Dosea   Maximum Daily Dose   Duration (Days)

  Pharyngitis/tonsillitis

    20 mg/kg   500 mg

  10

  Acute bacterial otitis media

    30 mg/kg   1,000 mg

  10

  Acute bacterial maxillary sinusitis

    30 mg/kg   1,000 mg

  10

  Impetigo

    30 mg/kg   1,000 mg

  10

  a Recommended daily dose given twice daily divided in equal doses.

  2.4 Preparation and Administration of CEFTIN for Oral Suspension

  Prepare a suspension at the time of dispensing as follows:

  1. Shake the bottle to loosen the powder. 2. Remove the cap. 3. Add the total amount of water for reconstitution (Table 3) and replace the cap. 4. Invert the bottle and vigorously rock the bottle from side to side so that water rises through the powder. 5. Once the sound of the powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction. Table 3. Amount of Water Required for Reconstitution of Labeled Volumes of CEFTIN for Oral Suspension

  Oral Suspension

  Amount of Water Required for Reconstitution

  Labeled Volume after Reconstitution

  125 mg/5 mL

  37 mL

    100 mL

  250 mg/5 mL

  19 mL

    50 mL

  35 mL

    100 mL • Shake the oral suspension well before each use. • Replace cap securely after each opening. • Store the reconstituted suspension refrigerated between 2° and 8°C (36° and 46°F). • Discard the reconstituted suspension after 10 days. 2.5 Dosage in Patients with Impaired Renal Function

  A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3)].

  Table 4. Dosing in Adults with Renal Impairment

  Creatinine Clearance (mL/min)

  Recommended Dosage

  ≥30

  No dosage adjustment

  10 to ˂30

  Standard individual dose given every 24 hours

  ˂10 (without hemodialysis)

  Standard individual dose given every 48 hours

  Hemodialysis

  A single additional standard dose should be given at the end of each dialysis

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