Cleocin

Cleocin Manufacturers

• Physicians Total Care, Inc.
  

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  Cleocin | Physicians Total Care, Inc.

  

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  If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in CLEOCIN PEDIATRIC Flavored Granules.

  Serious infections: 8–12 mg/kg/day (4–6 mg/lb/day) divided into 3 or 4 equal doses.

  Severe infections: 13–16 mg/kg/day (6.5–8 mg/lb/day) divided into 3 or 4 equal doses.

  More severe infections: 17–25 mg/kg/day (8.5–12.5 mg/lb/day) divided into 3 or 4 equal doses.

  In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

  Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN PEDIATRIC.

  NOTE: In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin.

  Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.

  Storage Conditions: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

  Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.

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• Pharmacia And Upjohn Company
  

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  Cleocin | Torrent Pharmaceuticals Limited

  

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  2.1 General Dosing Recommendations

  Levetiracetam extended-release tablet is administered once daily.

  Treatment should be initiated with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended once daily dose of 3000 mg.

  2.2 Adult Patients with Impaired Renal Function

  Levetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                      [140-age (years)] x weight (kg)

       CLcr=      ----------------------------------------- (x  0.85 for female patients)

                         72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:  

                                                    CLcr (mL/min)

       CLcr (mL/min/1.73m2)=  ---------------------------- x 1.73

                                                    BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

  Group
  Creatinine 
  Clearance 
  (mL/min/1.73m2) 
  Dosage 
  (mg) 
  Frequency
  Normal 
  > 80 
  1000 to 3000
  Every 24 hours
  Mild 
  50 to 80 
  1000 to 2000
  Every 24 hours 
  Moderate 
  30 to 50 
  500 to 1500 
  Every 24 hours 
  Severe 
  < 30 
  500 to 1000 
  Every 24 hours 
  

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• Pharmacia And Upjohn Company
  

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  Cleocin | Apotex Corp

  

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  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  2.1 Hypercalcemia of Malignancy
  

  The maximum recommended dose of Zoledronic acid Injection in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L]) is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients who receive Zoledronic acid Injection should have serum creatinine assessed prior to each treatment.
  
  Dose adjustments of Zoledronic acid Injection are not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment prior to initiation of therapy (serum creatinine less than 400 mcmol/L or less than 4.5 mg/dL).
  
  Patients should be adequately rehydrated prior to administration of Zoledronic acid Injection [see Warnings and Precautions (5.2)].
  
  Consideration should be given to the severity of, as well as the symptoms of, tumor-induced hypercalcemia when considering use of Zoledronic acid Injection. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia.
  
  Retreatment with Zoledronic acid Injection 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. Renal function must be carefully monitored in all patients receiving Zoledronic acid Injection and serum creatinine must be assessed prior to retreatment with Zoledronic acid Injection [see Warnings and Precautions (5.2)].

  2.2 Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors

  The recommended dose of Zoledronic acid Injection in patients with multiple myeloma and metastatic bone lesions from solid tumors for patients with creatinine clearance (CrCl)  greater than 60 mL/min is 4 mg infused over no less than 15 minutes every 3 to 4 weeks. The optimal duration of therapy is not known.
  
  Upon treatment initiation, the recommended Zoledronic acid Injection doses for patients with reduced renal function (mild and moderate renal impairment) are listed in Table 1. These doses are calculated to achieve the same area under the curve (AUC) as that achieved in patients with creatinine clearance of 75 mL/min. CrCl is calculated using the Cockcroft-Gault formula [see  Warnings and Precautions (5.2)].

  Table 1: Reduced Doses for Patients with Baseline CrCl Less than or Equal to 60 mL/min

  Baseline Creatinine Clearance (mL/min)
  Zoledronic acid Injection Recommended Dose*
  greater than 60
  4 mg
  50 - 60
  3.5 mg
  40 - 49
  3.3 mg
  30 - 39
  3 mg
  *Doses calculated assuming target AUC of 0.66(mg•hr/L) (CrCl = 75 mL/min)
  

  During treatment, serum creatinine should be measured before each Zoledronic acid Injection dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:

             For patients with normal baseline creatinine, increase of 0.5 mg/dL

           For patients with abnormal baseline creatinine, increase of 1.0 mg/dL

  
  

  In the clinical studies, Zoledronic acid Injection treatment was resumed only when the creatinine returned to within 10% of the baseline value. Zoledronic acid Injection should be reinitiated at the same dose as that prior to treatment interruption.
  
  Patients should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of Vitamin D daily.

  2.3 Preparation of Solution
  

  Zoledronic acid Injection must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs.
  
  4 mg/5 mL Single-Use Vial
  
  Vials of Zoledronic acid Injection concentrate for infusion contain overfill allowing for the withdrawal of 5 mL of concentrate (equivalent to 4 mg zoledronic acid). This concentrate should immediately be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, following proper aseptic technique, and administered to the patient by infusion. Do not store undiluted concentrate in a syringe, to avoid inadvertent injection.
  
  To prepare reduced doses for patients with baseline CrCl less than or equal to 60 mL/min, withdraw the specified volume of the Zoledronic acid Injection concentrate from the vial for the dose required (see Table 2).
  
  Table 2: Preparation of Reduced Doses – Zoledronic acid Injection Concentrate

  
  Remove and Use
  Zoledronic acid Injection Volume (mL)
  Dose (mg)
  4.4
  3.5
  4.1
  3.3
  3.8
  3.0
  

  The withdrawn concentrate must be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP.
  
  If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2°C-8°C (36°F-46°F). The refrigerated solution should then be equilibrated to room temperature prior to administration. The total time between dilution, storage in the refrigerator, and end of administration must not exceed 24 hours.

  2.4 Method of Administration

  Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zoledronic acid Injection should not exceed 4 mg and the duration of infusion should be no less than 15 minutes [see Warnings and Precautions (5.3)]. In the trials and in postmarketing experience, renal deterioration, progression to renal failure and dialysis, have occurred in patients, including those treated with the approved dose of 4 mg infused over 15 minutes. There have been instances of this occurring after the initial Zoledronic acid Injection dose.

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• U.s. Pharmaceuticals
  

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  Cleocin | U.s. Pharmaceuticals

  

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  The recommended dose is one CLEOCIN Vaginal Ovule (containing clindamycin phosphate equivalent to 100 mg clindamycin per 2.5 g suppository) intravaginally per day, preferably at bedtime, for 3 consecutive days.

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