Edarbyclor

Edarbyclor Manufacturers

• Takeda Pharmaceuticals America, Inc.
  

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  Edarbyclor | Takeda Pharmaceuticals America, Inc.

  

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  2.1 Dosing Information

  The recommended starting dose of Edarbyclor is 40/12.5 mg taken orally once daily. Most of the antihypertensive effect is apparent within 1 to 2 weeks. The dosage may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve blood pressure goals. Edarbyclor doses above 40/25 mg are probably not useful.

  Edarbyclor may be used to provide additional blood pressure lowering for patients not adequately controlled on ARB or diuretic monotherapy treatment. Patients not controlled with azilsartan medoxomil 80 mg may have an additional systolic / diastolic clinic blood pressure reduction of 13/6 mm Hg when switched to Edarbyclor 40/12.5 mg. Patients not controlled with chlorthalidone 25 mg may have an additional clinic blood pressure reduction of 10/7 mm Hg when switched to Edarbyclor 40/12.5 mg.

  Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals.

  Patients titrated to the individual components (azilsartan medoxomil and chlorthalidone) may instead receive the corresponding dose of Edarbyclor.

  Edarbyclor may be taken with or without food [see Clinical Pharmacology (12.3)].

  Edarbyclor may be administered with other antihypertensive agents as needed.

  2.2 Prior to Dosing

  Correct any volume depletion prior to administration of Edarbyclor, particularly in patients with impaired renal function or those treated with high doses of diuretics [see Warnings and Precautions (5.2)].

  Patients who experience dose-limiting adverse reactions on chlorthalidone may be switched to Edarbyclor, initially with a lower dose of chlorthalidone [see Warnings and Precautions (5.4)].

  2.3 Handling Instructions

  As Edarbyclor is moisture sensitive, dispense and store Edarbyclor in its original container to protect Edarbyclor from light and moisture.

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• Arbor Pharmaceuticals Ireland Limited
  

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  Edarbyclor | Apotex Corp

  

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  Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

  2.1 Dosage in Adults

  The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.

  Table 1: Adult Dosage Guidelines

  Infection Dose Frequency Usual Durations1 Urinary Tract
  Acute Uncomplicated Cystitis 250–500 mg
  250 mg every 12 hours
  every 12 hours 7 to 14 days 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500–750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal2 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and
  Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (post­ exposure)3 500 mg every 12 hours 60 days Plague 3 500–750 mg every 12 hours 14 days

  1. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
  2. Used in conjunction with metronidazole.
  3. Begin drug administration as soon as possible after suspected or confirmed exposure.

  Conversion of IV to Oral Dosing in Adults
  Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

  Table 2: Equivalent AUC Dosing Regimens

  Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours
  2.2 Dosage in Pediatric Patients

  Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.

  Table 3: Pediatric Dosage Guidelines

  Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10–21 days1 Inhalational Anthrax (Post­Exposure)2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague2,3 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 hours 10–21 days

  1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  2. Begin drug administration as soon as possible after suspected or confirmed exposure.
  3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

  2.3 Dosage Modifications in Patients with Renal Impairment

  Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.

  Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function
  

  Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30–50 250–500 mg every12 hours 5–29 250–500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250–500 mg every 24 hours (after dialysis)

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

  
  Women – 0.85 x the value calculated for men.

  The serum creatinine should represent a steady state of renal function.

  In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).

  2.4 Important Administration Instructions

  With Multivalent Cations
  Administer ciprofloxacin at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

  With Dairy Products
  Concomitant administration of ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products.

  Hydration of Patients Receiving Ciprofloxacin
  Assure adequate hydration of patients receiving ciprofloxacin to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

  Instruct the patient of the appropriate ciprofloxacin administration [see Patient Counseling Information (17)].

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