Nighttime

Nighttime Manufacturers

• Hannaford Brothers Company
  

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  Nighttime | Hannaford Brothers Company

  

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  take only as recommended – see Liver warning use dose cup do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

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• Western Family Foods Inc
  

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  Nighttime | Western Family Foods Inc

  

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  adults and children 12

  years and over take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years do not use

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• Salado Sales, Inc.
  

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  Nighttime | Salado Sales, Inc.

  

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  do not take more than directed
  (see overdose warning) do not take more than 8 liquid caps in 24 hours adults and children 12 years and over: 2 liquid caps with water every 6 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

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• Publix Super Markets Inc
  

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  Nighttime | Publix Super Markets Inc

  

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  • take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs

  adults & children 12 yrs & over

  30 mL (2 TBSP) every 6 hrs

  children 4 to under 12 yrs

  ask a doctor

  children under 4 yrs

  do not use

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• Publix Super Markets Inc
  

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  Nighttime | Sun Pharmaceutical Industries, Inc.

  

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  Dexmethylphenidate hydrochloride tablets are administered twice daily, at least 4 hours apart. Dexmethylphenidate hydrochloride tablets may be administered with or without food.
  
  Dosage should be individualized according to the needs and responses of the patient.
  
  Patients New to Methylphenidate
  
  The recommended starting dose of dexmethylphenidate hydrochloride tablets for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).

  
  

  Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.

  
  

  Patients Currently Using Methylphenidate

  
  

  For patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride tablets is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).

  
  

  Maintenance/Extended Treatment

  
  

  There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

  
  

  Dose Reduction and Discontinuation
  
  If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
  
  If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.

  
  

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• Cvs Pharmacy
  

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  Nighttime | Hospira, Inc.

  

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  The recommended adult and pediatric dosages and routes of administration are outlined in the following table 10. MAXIPIME should be administered intravenously over approximately 30 minutes.

  Table 10: Recommended Dosage Schedule for MAXIPIME in Patients with CrCL Greater Than 60 mL/min† †Adjust dose in patients with CrCL less than or equal to 60 mL/min
  *including cases associated with concurrent bacteremia
  **or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.
  ***Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the intramuscular route is considered to be a more appropriate route of drug administration.
  §For Pseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years)

  Site and Type of Infection

  Dose

  Frequency

  Duration
  (days)

  Adults 

  Moderate to Severe Pneumonia due to S. pneumoniae*,
  P. aeruginosa§, K. pneumoniae, or Enterobacter species

  1 to 2 g IV

  Every 8 to 12 hours

  10

  Empiric therapy for febrile neutropenic patients (See
  INDICATIONS AND USAGE and CLINICAL STUDIES.)

  2 g IV

  Every 8 hours

  7**

  Mild to Moderate Uncomplicated or Complicated Urinary
  Tract Infections, including pyelonephritis, due to E. coli,
  K. pneumoniae, or P. mirabilis*

  0.5 to 1 g
  IV/IM***

  Every 12 hours

  7 to 10

  Severe Uncomplicated or Complicated Urinary Tract
  Infections, including pyelonephritis, due to E. coli or
  K. pneumoniae*

  2 g IV

  Every 12 hours

  10

  Moderate to Severe Uncomplicated Skin and Skin
  Structure Infections due to S. aureus or S. pyogenes

  2 g IV

  Every 12 hours

  10

  Complicated Intra-abdominal Infections (used in
  combination with metronidazole) caused by E. coli,
  viridans group streptococci, P. aeruginosa§,
  K. pneumoniae, Enterobacter species, or
  B. fragilis. (See CLINICAL STUDIES.)

  2 g IV

  Every 8 to 12 hours

  7 to 10

  Pediatric Patients (2 months up to 16 years)
  The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above.

  Patients with Hepatic Impairment

  No adjustment is necessary for patients with hepatic impairment.

  Patients with Renal Impairment

  In patients with creatinine clearance less than or equal to 60 mL/min, the dose of MAXIPIME should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of MAXIPIME should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of MAXIPIME in patients with renal impairment are presented in Table 11.

  When only serum creatinine is available, the following formula (Cockcroft and Gault equation)4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

  Males: Creatinine Clearance (mL/min) =           Weight (kg) x (140–age)           
                                                                            72 × serum creatinine (mg/dL)

  Females: 0.85 × above value

  Table 11: Recommended Dosing Schedule for MAXIPIME in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) * On hemodialysis days, cefepime should be administered following hemodialysis. Whenever possible, cefepime should be administered at the same time each day.

  Creatinine
  Clearance (mL/min)

  Recommended Maintenance Schedule

  Greater than 60
  Normal
  recommended
  dosing schedule

  500 mg
  every 12 hours

  1 g
  every 12 hours

  2 g
  every 12 hours

  2 g
  every 8 hours

  30 to 60

  500 mg
  every 24 hours

  1 g
  every 24 hours

  2 g
  every 24 hours

  2 g
  every 12 hours

  11 to 29

  500 mg
  every 24 hours

  500 mg
  every 24 hours

  1 g
  every 24 hours

  2 g
  every 24 hours

  Less than 11

  250 mg
  every 24 hours

  250 mg
  every 24 hours

  500 mg
  every 24 hours

  1 g
  every 24 hours

  CAPD

  500 mg
  every 48 hours

  1 g
  every 48 hours

  2 g
  every 48 hours

  2 g
  every 48 hours

  Hemodialysis*

  1 g on day 1, then 500 mg every 24 hours thereafter

  1 g
  every 24 hours

  In patients undergoing continuous ambulatory peritoneal dialysis, MAXIPIME may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 11).

  In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of MAXIPIME for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.

  MAXIPIME should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 11).

  Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients (see CLINICAL PHARMACOLOGY), changes in the dosing regimen proportional to those in adults (see Tables 10 and 11) are recommended for pediatric patients.

  Administration

  For Intravenous Infusion, Dilute with a suitable parenteral vehicle prior to intravenous infusion. Constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.

  Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.

  ADD-Vantage™ vials are to be constituted only with 50 mL or 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection in ADD-Vantage flexible diluent containers. (See ADD-Vantage Vial Instructions for Use.)

  Intramuscular Administration: For intramuscular administration, MAXIPIME (cefepime hydrochloride) should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol (refer to Table 12).

  Preparation of MAXIPIME solutions is summarized in Table 12.

  Table 12: Preparation of Solutions of MAXIPIME

  Single-Dose Vials for
  Intravenous/Intramuscular
  Administration

  Amount of Diluent
  to be added (mL)

  Approximate Available 
  Volume (mL)

   
  Approximate
  Cefepime
  Concentration
  (mg/mL)

  cefepime vial content
  500 mg (IV)
  500 mg (IM)
  1 g (IV)
  1 g (IM)
  2 g (IV)

   
  5
  1.3
  10
  2.4
  10

   
  5.6
  1.8
  11.3
  3.6
  12.5

   
  100
  280
  100
  280
  160

  ADD-Vantage
  1 g vial
  1 g vial
  2 g vial
  2 g vial

   
  50
  100
  50
  100

   
  50
  100
  50
  100

   
  20
  10
  40
  20

  Compatibility and Stability

  Intravenous: MAXIPIME is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol™-R, and Normosol™-M in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or 7 days in a refrigerator 2°C to 8°C (36°F to 46°F). MAXIPIME in ADD-Vantage vials is stable at concentrations of 10 to 40 mg per mL in 5% Dextrose Injection or 0.9% Sodium Chloride Injection for 24 hours at controlled room temperature 20°C to 25°C or 7 days in a refrigerator 2°C to 8°C.

  MAXIPIME admixture compatibility information is summarized in Table 13.

  Table 13: Cefepime Admixture Stability NS = 0.9% Sodium Chloride Injection
  D5W = 5% Dextrose Injection
  na = not applicable
  RT/L = Ambient room temperature and light

  Stability Time for
   

  MAXIPIME
  Concentration

  Admixture and
  Concentration

  IV Infusion
  Solutions

  RT/L
  (20° to 25°C)

  Refrigeration
  (2° to 8°C)

  40 mg/mL

  Amikacin
  6 mg/mL

  NS or D5W

  24 hours

  7 days

  40 mg/mL

  Ampicillin
  1 mg/mL

  D5W

  8 hours

  8 hours

  40 mg/mL

  Ampicillin
  10 mg/mL

  D5W

  2 hours

  8 hours

  40 mg/mL

  Ampicillin
  1 mg/mL

  NS

  24 hours

  48 hours

  40 mg/mL

  Ampicillin
  10 mg/mL

  NS

  8 hours

  48 hours

  4 mg/mL

  Ampicillin
  40 mg/mL

  NS

  8 hours

  8 hours

  4 to 40 mg/mL

  Clindamycin
  Phosphate
  0.25 to 6 mg/mL

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Heparin
  10 to 50 units/mL

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Potassium Chloride
  10 to 40 mEq/L

  NS or D5W

  24 hours

  7 days

  4 mg/mL

  Theophylline
  0.8 mg/mL

  D5W

  24 hours

  7 days

  1 to 4 mg/mL

  na

  Aminosyn™ II
  4.25% with
  electrolytes and calcium

  8 hours

  3 days

  0.125 to
  0.25 mg/mL

  na

  Inpersol™
  with 4.25% dextrose

  24 hours

  7 days

  Solutions of MAXIPIME, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction. However, if concurrent therapy with MAXIPIME is indicated, each of these antibiotics can be administered separately.

  Intramuscular: MAXIPIME (cefepime hydrochloride) constituted as directed is stable for 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or for 7 days in a refrigerator 2°C to 8°C (36°F to 46°F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.

  NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION. IF PARTICULATE MATTER IS EVIDENT IN RECONSTITUTED FLUIDS, THE DRUG SOLUTION SHOULD BE DISCARDED.

  As with other cephalosporins, the color of MAXIPIME powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

  INSTRUCTIONS FOR USE 

  These instructions for use should be made available to the individuals who perform the reconstitution steps.

  To Open:

  Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container:

  (Use Aseptic Technique)

  1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

  a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.)

  NOTE: Once the breakaway cap has been removed, do not access vial with syringe.

                               

  b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)

  2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go.

  NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.)

  3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

  4. Label appropriately.

                                
  To Reconstitute the Drug:

  1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

  2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)

  3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

  4. Mix container contents thoroughly and use within the specified time.

  5. Look through the bottom of the vial to verify that the stopper has been removed and complete mixing has occurred. (SEE FIGURE 7.)

  If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.

  Preparation for Administration:

  (Use Aseptic Technique)

  1. Confirm the activation and admixture of vial contents.

  2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

  3. Close flow control clamp of administration set.

  4. Remove cover from outlet port at bottom of container.

  5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.

  6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

  7. Squeeze and release drip chamber to establish proper fluid level in chamber.

  8. Open flow control clamp and clear air from set. Close clamp.

  9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

  10. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

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