Oxacillin

Oxacillin Manufacturers

• Teva Parenteral Medicines, Inc.
  

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  Oxacillin | Teva Parenteral Medicines, Inc.

  

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  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (See PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP

  Drug
  

  Adults
  

  Infants and Children < 40 kg (88 lbs)
  

  Other Recommendat ons
  

  Oxacillin
  

  250 to 500 mg IM or IV every 4 to 6
  hours (mild to moderate infections)
  

  50 mg/kg/day IM or IV in equally divided
  doses every 6 hours (mild to moderate infections)
  

  1 gram IM or IV
  every 4 to 6 hours (severe infections)
  

  100 mg/kg/day IM or IV in equally divided doses
  every 4 to 6 hours (severe infections)
  

  Premature and Neonates 25 mg/kg/day IM or IV
  

  Directions for use

  For Intramuscular Use

  Use Sterile Water for Injection, USP. Add 5.7 mL to the 1 gram vial and 11.5 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70°F or for one week under refrigeration (40° F).

  For Direct Intravenous Use

  Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately10 minutes.

  For Administration by Intravenous Drip

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP

  Concentration mg/mL
  

  Sterile
  water  for Injection
  

  0.9% sodium chloride
  Injection, USP
  

  M/6 Molar
  Sodium
  Lactate Solution
  

  5% Dextrose 
  in water
  

  5% Dextrose in 0.45%
  sodium chloride
  

  10% Invert Sugar
  Injection, USP
  

  Lactated
  Ringers Solution
  

  ROOM TEMPERATURE (25° C)
  

  10 to100
  

  4 Days
  

  4 Days
  

  10 to 30
  

  24 Hrs
  

  24 Hrs
  

  0.5 to 2
  

  6 Hrs
  

  6 Hrs
  

  6 Hrs
  

  REFRIGERATION (4° C)
  

  10 to 100
  

  7 Days
  

  7 Days
  

  10 to 30
  

  4 Days
  

  4 Days
  

  4 Days
  

  4 days
  

  4 Days
  

  FROZEN (-15° C)
  

  50 to 100
  

  30 Days
  

  250/1.5 mL
  

  30 Days
  

  100
  

  30 Days
  

  10 to 100
  

  30 Days
  

  30 Days
  

  30 Days
  

  30 days
  

  30 Days
  

  Stability studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period.

  IV Solution

  5% Dextrose in Normal Saline

  10% D-Fructose in Water

  10% D-Fructose in Normal Saline

  Lactated Potassic Saline Injection

  10% Invert Sugar in Normal Saline

  10% Invert Sugar Plus 0.3% Potassium Chloride in Water

  Travert 10% Electrolyte #1

  Travert 10% Electrolyte #2

  Travert 10% Electrolyte #3

  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.

  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

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

  Do not add supplementary medication to Oxacillin for Injection, USP.

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• Auromedics Pharma Llc
  

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  Oxacillin | Auromedics Pharma Llc

  

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  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.
  
  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
  
  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
  
  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  
  
  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION Drug Adults Infants and Children
  <40 kg (88 lbs) Other Recommendations    Oxacillin
     250 to 500 mg IM or IV
     every 4 to 6 hours (mild to
     moderate infections)
     50 mg/kg/day IM or IV in equally
     divided doses every 6 hours
     (mild to moderate infections)
   
     1 gram IM or IV every 4 to
     6 hours (severe infections)
     100 mg/kg/day IM or IV in
     equally divided doses every 4 to
     6 hours (severe infections)
     Premature and Neonates
     25 mg/kg/day IM or IV
  Directions for Use For Intramuscular Use
  

  Use Sterile Water for Injection, USP. Add 11.5 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70°F or for one week under refrigeration (40°F).

  For Direct Intravenous Use
  

  Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.

  For Administration by Intravenous Drip
  

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP Concentration
  mg/mL Sterile
  Water for
  Injection USP 0.9% Sodium
  Chloride Injection USP (Isotonic) Sodium
  Lactate Solution USP (M/6 Molar) Dextrose
  Injection USP (5%) Dextrose
  and Sodium Chloride Injection USP
  (5% Dextrose and
  0.45% NaCl) Invert
  Sugar Injection USP (10%) Lactated
  Ringer’s
  Injection USP ROOM TEMPERATURE (25°C)
     10-100
  4 Days
  4 Days
   
   
   
   
   
     10-30
   
   
  24 Hrs
   
  24 Hrs
   
   
     0.5-2
   
   
   
  6 Hrs
   
  6 Hrs
  6 Hrs
  REFRIGERATION (4°C)
     10-100
  7 Days
  7 Days
   
   
   
   
   
     10-30
   
   
  4 Days
  4 Days
  4 Days
  4 Days
  4 Days
  FROZEN (-15°C)
     50-100
  30 Days
   
   
   
   
   
   
     250/1.5 mL
  30 Days
   
   
   
   
   
   
     100
   
  30 Days
   
   
   
   
   
     10-100
   
   
  30 Days
  30 Days
  30 Days
  30 Days
  30 Days
  
  

  Stability studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period.
  
  IV Solution
  
  5% Dextrose in Normal Saline
  10% D-Fructose in Water
  10% D-Fructose in Normal Saline
  Lactated Potassic Saline Injection
  10% Invert Sugar in Normal Saline
  10% Invert Sugar Plus 0.3% Potassium Chloride in Water
  Travert 10% Electrolyte #1
  Travert 10% Electrolyte #2
  Travert 10% Electrolyte #3
  
  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.
  
  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Do not add supplementary medication to Oxacillin for Injection, USP.

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• Sandoz Inc
  

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  Oxacillin | Almatica Pharma Inc.

  

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  Hypertension

  The initial dose of TENORMIN is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to TENORMIN 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

  TENORMIN may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.

  Angina Pectoris

  The initial dose of TENORMIN is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to TENORMIN 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.

  Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.

  Acute Myocardial Infarction

  In patients with definite or suspected acute myocardial infarction, treatment with TENORMIN I.V. Injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg TENORMIN over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. TENORMIN I.V. Injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of TENORMIN I.V. Injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.

  In patients who tolerate the full intravenous dose (10 mg), TENORMIN Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, TENORMIN can be given orally either 100 mg once daily or 50 mg twice a day for a further 6-9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, TENORMIN should be discontinued. (See full prescribing information prior to initiating therapy with TENORMIN Tablets.)

  Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given TENORMIN Tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).

  Although the demonstration of efficacy of TENORMIN is based entirely on data from the first seven postinfarction days, data from other beta blocker trials suggest that treatment with beta blockers that are effective in the postinfarction setting may be continued for one to three years if there are no contraindications.

  TENORMIN is an additional treatment to standard coronary care unit therapy.

  Elderly Patients or Patients with Renal Impairment

  TENORMIN is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.

  No significant accumulation of TENORMIN occurs until creatinine clearance falls below 35 mL/min/1.73m2. Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.

  The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:

  Creatinine Clearance

  (mL/min/1.73m2)

  Atenolol

  Elimination Half-Life

  (h)

  Maximum Dosage

  15-35

  16-27

  50 mg daily

  <15

  >27

  25 mg daily

  Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of TENORMIN: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose ("trough" blood pressure) to ensure that the treatment effect is present for a full 24 hours.

  Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.

  Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

  Cessation of Therapy in Patients with Angina Pectoris

  If withdrawal of TENORMIN therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.

  Hypertension

  The initial dose of TENORMIN is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to TENORMIN 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

  TENORMIN may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.

  Angina Pectoris

  The initial dose of TENORMIN is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to TENORMIN 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.

  Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.

  Acute Myocardial Infarction

  In patients with definite or suspected acute myocardial infarction, treatment with TENORMIN I.V. Injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg TENORMIN over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. TENORMIN I.V. Injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of TENORMIN I.V. Injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.

  In patients who tolerate the full intravenous dose (10 mg), TENORMIN Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, TENORMIN can be given orally either 100 mg once daily or 50 mg twice a day for a further 6-9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, TENORMIN should be discontinued. (See full prescribing information prior to initiating therapy with TENORMIN Tablets.)

  Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given TENORMIN Tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).

  Although the demonstration of efficacy of TENORMIN is based entirely on data from the first seven postinfarction days, data from other beta blocker trials suggest that treatment with beta blockers that are effective in the postinfarction setting may be continued for one to three years if there are no contraindications.

  TENORMIN is an additional treatment to standard coronary care unit therapy.

  Elderly Patients or Patients with Renal Impairment

  TENORMIN is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.

  No significant accumulation of TENORMIN occurs until creatinine clearance falls below 35 mL/min/1.73m2. Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.

  The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:

  Creatinine Clearance

  (mL/min/1.73m2)

  Atenolol

  Elimination Half-Life

  (h)

  Maximum Dosage

  15-35

  16-27

  50 mg daily

  <15

  >27

  25 mg daily

  Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of TENORMIN: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose ("trough" blood pressure) to ensure that the treatment effect is present for a full 24 hours.

  Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.

  Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

  Cessation of Therapy in Patients with Angina Pectoris

  If withdrawal of TENORMIN therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.

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• Sandoz Inc
  

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  Oxacillin | Minitube Of America, Inc.

  

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  Dissolve each vial of freeze-dried product with 10.5 ml of solvent.

  Use aseptic technique during reconstitution and when removing aliquots from the vial.  Adequately clean and disinfect the vial closure prior to each entry with a sterile needle.

  Mix gently during reconstitution. 

  PLUSET is to be given by intramuscular injection only.  

  The following treatment schedule is recommended for the induction of superovulation in the cow:                     

  The total recommended dose is 800 to 1000 IU in decreasing doses for 4 to 5 days. Considering the variability between animals and taking into account breed, age and reproductive status the dosing schedule should be adjusted appropriately. It is therefore recommended to seek veterinary advice on appropriate dosing patterns. For heifers and beef cows a total dose of 800 IU is recommended. For dairy cows the dose could be increased to 1000 IU taking into account increasing age, parity number and dairy production.

  Recommended schedule for 800 IU in 4 days:

  Day 1*

  08:00 hrs

  3.0 ml i.m.

  (150 IU FSH + 150 IU LH)

  20:00 hrs

  3.0 ml i.m.

  (150 IU FSH + 150 IU LH)

  Day 2

  08:00 hrs

  2.5 ml i.m.

  (125 IU FSH + 125 IU LH)

  20:00 hrs

  2.5 ml i.m.

  (125 IU FSH + 125 IU LH)

  Day 3**

  08:00 hrs

  1.5 ml i.m.

  (75 IU FSH + 75 IU LH)

  20:00 hrs

  1.5 ml i.m

  (75 IU FSH + 75 IU LH)

  Day 4

  08:00 hrs

  1.0 ml i.m.

  (50 IU FSH + 50 IU LH)

  20:00 hrs

  1.0 ml i.m.

  (50 IU FSH + 50 IU LH)

  Recommended schedule for 1000 IU in 5 days:

  Day 1*

  08:00 hrs

  3.0 ml i.m.

  (150 IU FSH + 150 IU LH)

  20:00 hrs

  3.0 ml i.m.

  (150 IU FSH + 150 IU LH)

  Day 2

  08:00 hrs

  2.5 ml i.m.

  (125 IU FSH + 125 IU LH)

  20:00 hrs

  2.5 ml i.m.

  (125 IU FSH + 125 IU LH)

  Day 3**

  08:00 hrs

  2.0 ml i.m.

  (100 IU FSH + 100 IU LH)

  20:00 hrs

  2.0 ml i.m

  (100 IU FSH + 100 IU LH)

  Day 4

  08:00 hrs

  1.5 ml i.m.

  (75 IU FSH + 75 IU LH)

  20:00 hrs

  1.5 ml i.m.

  (75 IU FSH + 75 IU LH)

  Day 5

  08:00 hrs

  1.0 ml i.m.

  (50 IU FSH + 50 IU LH)

  20:00 hrs

  1.0 ml i.m.

  (50 IU FSH + 50 IU LH)

  * Corresponds to the 11th day of the oestrus cycle.

  ** A luteolytic dose of prostaglandin F2 alpha should be administered intramuscularly at 60 and/or 72 hours after the beginning of superovulation treatment.

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• Sandoz Inc
  

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  Oxacillin | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

  

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  The application frequency for Imiquimod Cream is different for each indication.
  Imiquimod is not for oral, ophthalmic, or intravaginal use.

  2.1 Actinic Keratosis

  Imiquimod Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Imiquimod Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Imiquimod Cream should be applied to the contiguous treatment area at each application. Imiquimod Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Imiquimod Cream therapy.

  It is recommended that patients wash their hands before and after applying Imiquimod Cream.

  Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes).

  Contact with the eyes, lips and nostrils should be avoided.

  Local skin reactions in the treatment area are common. [see Adverse Reactions (6.1, 6.5)] A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.
  However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

  Imiquimod Cream is packaged in single-use packets, with 24 packets supplied per box.

  Patients should be prescribed no more than 36 packets for the 16-week treatment period.
  Unused packets should be discarded. Partially-used packets should be discarded and not reused.

  2.3 External Genital Warts

  Imiquimod Cream should be applied 3 times per week to external genital/perianal warts. Imiquimod Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Imiquimod Cream should be applied prior to normal sleeping hours and left on the skin for 6 -10 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Imiquimod Cream therapy.

  It is recommended that patients wash their hands before and after applying Imiquimod Cream.

  A thin layer of Imiquimod Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water.

  Local skin reactions at the treatment site are common. [see Adverse Reactions (6.3, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

  Imiquimod Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2; use of excessive amounts of cream should be avoided.

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• Sandoz Inc
  

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  Oxacillin | Sandoz Inc

  

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  The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer term of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (See PRECAUTIONS: General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP

  Drug

  Adults

  Infants and Children
  <40 kg (88 lbs)

  Other Recommendations

  Oxacillin

  250 to 500 mg IV every 4 to 6 hours (mild to moderate infections)

  50 mg/kg/day IV in equally divided doses every 6 hours (mild to moderate infections)

  1 gram IV every 4 to 6 hours (severe infections)

  100 mg/kg/day IV in equally divided doses every 4 to 6 hours (severe infections)

  Premature and Neonates 25 mg/kg/day IV

  Directions for use For Administration by Intravenous Drip

  Reconstitute as directed below (Pharmacy Bulk Package) prior to further dilution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP* * IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that a product should be used as soon after preparation as feasible.

  Concentration

  mg/mL

  Sterile

  Water for

  Injection,

  USP

  0.9%

  Sodium

  Chloride

  Injection,

  USP

  Sodium

  Lactate

  Injection,

  USP

  (M/6

  Sodium

  Lactate)

  5%

  Dextrose

  Injection,

  USP

  5%

  Dextrose

  and

  0.45%

  Sodium

  Chloride

  Injection,

  USP

  10%

  Invert

  Sugar

  Injection,

  USP

  Lactated

  Ringers

  Injection,

  USP

  ROOM TEMPERATURE (25°C)

  10-100

  4 Days

  4 Days

  10-30

  24 Hrs

  24 Hrs

  0.5-2

  6 Hrs

  6 Hrs

  6 Hrs

  REFRIGERATION (4°C)

  10-100

  7 Days

  7 Days

  10-30

  4 Days

  4 Days

  4 Days

  4 Days

  4 Days

  FROZEN (-15°C)

  50-100

  30 Days

  250/1.5 mL

  30 Days

  100

  30 Days

  10-100

  30 Days

  30 Days

  30 Days

  30 Days

  30 Days

  Stability

  Studies on Oxacillin Sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° F) during a 6-hour period.

  IV Solution

  5% Dextrose in Normal Saline

  10% D-Fructose in Water

  10% D-Fructose in Normal Saline

  Lactated Potassic Saline Injection

  10% Invert Sugar in Normal Saline

  10% Invert Sugar Plus 0.3% Potassium Chloride in Water

  Travert 10% Electrolyte #1

  Travert 10% Electrolyte #2

  Travert 10% Electrolyte #3

  Only those solutions listed above should be used for the intravenous infusion of Oxacillin Sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.

  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

  Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams Oxacillin Sodium and is designed for use in the pharmacy in preparing IV admixtures. Add 93 mL Sterile Water for Injection, USP or Sodium Chloride Injection, USP 0.9%. The resulting solution will contain 100 mg oxacillin per mL and will require further dilution.

  CAUTION: NOT TO BE DISPENSED AS A UNIT.

  Directions For Proper Use of Pharmacy Bulk Package 1. The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents. 2. Use of this product is restricted to a suitable work area, such as a laminar flow hood. 3. Once this container closure has been punctured, withdrawal of the contents should be completed without delay. If prompt fluid transfer cannot be accomplished, discard the contents no later than 4 hours after initial closure puncture. This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle. 4. A plastic ball attached to the pharmacy bulk package provides a suitable hanging device while dispensing contents.

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

  HOW SUPPLIED

  Oxacillin for Injection, USP, is available in a Pharmacy Bulk Package bottle which contains oxacillin sodium monohydrate equivalent to 10 grams oxacillin.

  NDC 0781-9113-95 10 grams Pharmacy Bulk Package bottle, Packaged in carton of ten Pharmacy Bulk Package bottles.

  Storage

  Store the dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

  NOVAPLUS is a registered trademark of Novation, LLC.

  02-2015M

  46153874

  Manufactured in Austria by Sandoz GmbH

  for Sandoz Inc., Princeton, NJ 08540

  Close
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  More Info
• Sandoz Inc
  

  ×

  Oxacillin | Sandoz Inc

  

  ---

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations

  Oxacillin

  250 to 500 mg IM or IV every 4 to 6 hours (mild to moderate infections)

  50 mg/kg/day IM or IV in equally divided doses every 6 hours (mild to moderate infections)

  1 gram IM or IV every 4 to 6 hours (severe infections)

  100 mg/kg/day IM or IV in equally divided doses every 4 to 6 hours (severe infections)

  Premature and Neonates 25 mg/kg/day IM or IV

  Directions for use For Intramuscular Use

  Use Sterile Water for Injection, USP. Add 5.4 mL to the 1 gram vial and 10.6 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70° F or for one week under refrigeration (40° F).

  For Direct Intravenous Use

  Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.

  For Administration by Intravenous Drip

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP Concentration
  mg/mL Sterile
  Water
  for
  Injection,
  USP 0.9%
  Sodium
  Chloride
  Injection,
  USP M/6
  Molar
  Sodium
  Lactate
  Solution 5%
  Dextrose
  in
  Water 5%
  Dextrose
  in
  0.45%
  Sodium
  Chloride 10%
  Invert
  Sugar
  Injection,
  USP Lactated
  Ringers
  Solution

  ROOM TEMPERATURE (25°C)

  10 to 100

  4 Days

  4 Days

  10 to 30

  24 Hrs

  24 Hrs

  0.5 to 2

  6 Hrs

  6 Hrs

  6 Hrs

  REFRIGERATION (4°C)

  10 to 100

  7 Days

  7 Days

  10 to 30

  4 Days

  4 Days

  4 Days

  4 Days

  4 Days

  FROZEN (-15°C)

  50 to 100

  30 Days

  250/1.5 mL

  30 Days

  100

  30 Days

  10 to 100

  30 Days

  30 Days

  30 Days

  30 Days

  30 Days

  Stability studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° F) during a 6-hour period.

  IV Solution

  5% Dextrose in Normal Saline

  10% D-Fructose in Water

  10% D-Fructose in Normal Saline

  Lactated Potassic Saline Injection

  10% Invert Sugar in Normal Saline

  10% Invert Sugar Plus 0.3% Potassium Chloride in Water

  Travert 10% Electrolyte #1

  Travert 10% Electrolyte #2

  Travert 10% Electrolyte #3

  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.

  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

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

  Do not add supplementary medication to oxacillin for injection, USP.

  Close
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  More Info
• Sandoz Inc
  

  ×

  Oxacillin | Sandoz Inc

  

  ---

  The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations

  Oxacillin

  250 to 500 mg IV every 4 to 6 hours (mild to moderate infections)

  50 mg/kg/day IV in equally divided doses every 6 hours (mild to moderate infections)

  Oxacillin

  1 gram IV every 4 to 6 hours (severe infections)

  100 mg/kg/day IV in equally divided doses every 4 to 6 hours (severe infections)

  Premature and Neonates 25 mg/kg/day IV

  Directions for use For Administration by Intravenous Drip

  Reconstitute as directed below (Pharmacy Bulk Package) prior to further dilution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP Concentration
  mg/mL Sterile
  Water
  for
  Injection,
  USP 0.9%
  Sodium
  Chloride
  Injection,
  USP M/6
  Molar
  Sodium
  Lactate
  Solution 5%
  Dextrose
  in
  Water 5%
  Dextrose
  in
  0.45%
  Sodium
  Chloride 10%
  Invert
  Sugar
  Injection,
  USP Lactated
  Ringers
  Solution

  ROOM TEMPERATURE (25°C)

  10 to 100

  4 Days

  4 Days

  10 to 30

  24 Hrs

  24 Hrs

  0.5 to 2

  6 Hrs

  6 Hrs

  6 Hrs

  REFRIGERATION (4°C)

  10 to 100

  7 Days

  7 Days

  10 to 30

  4 Days

  4 Days

  4 Days

  4 Days

  4 Days

  FROZEN (-15°C)

  50 to 100

  30 Days

  250/1.5 mL

  30 Days

  100

  30 Days

  10 to 100

  30 Days

  30 Days

  30 Days

  30 Days

  30 Days

  Stability studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° F) during a 6-hour period.

  IV Solution

  5% Dextrose in Normal Saline

  10% D-Fructose in Water

  10% D-Fructose in Normal Saline

  Lactated Potassic Saline Injection

  10% Invert Sugar in Normal Saline

  10% Invert Sugar Plus 0.3% Potassium Chloride in Water

  Travert 10% Electrolyte #1

  Travert 10% Electrolyte #2

  Travert 10% Electrolyte #3

  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.

  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

  Pharmacy Bulk Package

  This glass Pharmacy Bulk Package bottle contains 10 grams Oxacillin Sodium and is designed for use in the pharmacy in preparing IV admixtures. Add 93 mL Sterile Water for Injection, USP or Sodium Chloride Injection, USP 0.9%. The resulting solution will contain 100 mg oxacillin per mL and will require further dilution.

  CAUTION: NOT TO BE DISPENSED AS A UNIT.

  Directions for Proper Use of Pharmacy Bulk Package 1. The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents. 2. Use of this product is restricted to a suitable work area, such as a laminar flow hood. 3. Once this container closure has been punctured, withdrawal of the contents should be completed without delay. If prompt fluid transfer cannot be accomplished, discard the contents no later than 4 HOURS after initial closure puncture. This time limit should begin with the introduction of solvent for diluent into the Pharmacy Bulk Package.

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

  Do not add supplementary medication to Oxacillin for Injection, USP.

  HOW SUPPLIED

  Oxacillin for Injection, USP, is available in a Pharmacy Bulk Package bottle which contains oxacillin sodium monohydrate equivalent to 10 grams oxacillin.

  NDC 0781-3103-95 10 grams Pharmacy Bulk Package bottle, Packaged in carton of ten Pharmacy Bulk Package bottles.

  Storage

  Store the dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

  REFERENCES 1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Tenth Edition. CLSI Document M07-A10. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. 2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. CLSI Document M100-S25. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. 3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard Twelfth Edition. CLSI Document M02-A12. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

  09-2015M

  46171124

  Manufactured in Austria by Sandoz GmbH

  for Sandoz Inc., Princeton, NJ 08540

  Product of Italy

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  No Recall

  More Info
• Sagent Pharmaceuticals
  

  ×

  Oxacillin | Sagent Pharmaceuticals

  

  ---

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations Oxacillin 250 to 500 mg IM or
  IV every 4 to 6 hours
  (mild to moderate
  infections) 50 mg/kg/day IM or
  IV in equally divided
  doses every 6 hours
  (mild to moderate
  infections) Oxacillin 1 gram IM or IV
  every 4 to 6 hours
  (severe infections) 100 mg/kg/day IM
  or IV in equally
  divided doses every
  4 to 6 hours
  (severe infections) Premature and
  Neonates 25 mg/kg/day
  IM or IV Directions for Use For Intramuscular Use

  Use Sterile Water for Injection, USP. Add 5.7 mL to the 1 gram vial and 11.5 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70°F or for one week under refrigeration (40°F).

  For Direct Intravenous Use

  Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.

  For Administration by Intravenous Drip

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP Concentration mg/mL Sterile
  Water for
  Injection Sodium Chloride Injection 0.9% M/6 Molar
  Sodium
  Lactate
  Injection Dextrose
  Injection 5% 5% Dextrose
  in 0.45%
  NaCI 10%
  Invert
  Sugar Lactated
  Ringers
  Solution ROOM TEMPERATURE (25º C) 10-100 4 Days 4 Days 10-30 24 Hrs 24 Hrs 0.5-2 6 Hrs 6 Hrs 6 Hrs REFRIGERATION (4º C) 10-100 7 Days 7 Days 10-30 4 Days 4 Days 4 Days 4 Days 4 Days FROZEN (-15º C) 50-100 30 Days 250/1.5 mL 30 Days 100 30 Days 10-100 30 Days 30 Days 30 Days 30 Days 30 Days

  Stability studies on Oxacillin Sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° F) during a 6-hour period.

  IV Solution

  5% Dextrose in Normal Saline

  10% D-Fructose in Water

  10% D-Fructose in Normal Saline

  10% Invert Sugar in Normal Saline

  10% Invert Sugar Plus 0.3% Potassium Chloride in Water

  Only those solutions listed above should be used for the intravenous infusion of Oxacillin Sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.

  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

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

  Do not add supplementary medication to Oxacillin for Injection, USP.

  Close
  No Recall

  More Info
• Sagent Pharmaceuticals
  

  ×

  Oxacillin | Sagent Pharmaceuticals

  

  ---

  The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations Oxacillin 250 to 500 mg IV
  every 4 to 6 hours (mild to moderate infections) 50 mg/kg/day IV in equally divided
  doses every 6 hours
  (mild to moderate
  infections) Oxacillin 1 gram IV every 4 to 6 hours (severe infections) 100 mg/kg/day IV in equally divided doses every 4 to 6 hours
  (severe infections) Premature and
  Neonates 25 mg/kg/day IV

  Close
  No Recall

  More Info
• Auromedics Pharma Llc
  

  ×

  Oxacillin | Auromedics Pharma Llc

  

  ---

  
  

  The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

  
  
  

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.
  
  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
  
  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
  
  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  
  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations    Oxacillin
     250 to 500 mg IV
     every 4 to 6 hours (mild
     to moderate infections)
     50 mg/kg/day IV in
     equally divided doses every 6
     hours (mild to moderate infections)
   
     1 gram IV every 4
     to 6 hours (severe infections)
     100 mg/kg/day IV in
     equally divided doses every 4 to
     6 hours (severe infections)
     Premature and Neonates 25 mg/kg/day IV
  Directions for Use
  

  For Administration by Intravenous Drip
  
  Reconstitute as directed below (Pharmacy Bulk Package) prior to further dilution.

  
  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP* Concentration
  mg/mL Sterile
  Water for
  Injection USP 0.9% Sodium
  Chloride Injection USP (Isotonic) Sodium
  Lactate Solution USP (M/6 Molar) Dextrose
  Injection USP (5%) Dextrose
  and Sodium Chloride Injection USP
  (5% Dextrose and
  0.45% NaCl) Invert
  Sugar Injection USP (10%) Lactated
  Ringer’s
  Injection USP *IMPORTANT:This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that a product should be used as soon after preparation as feasible.
  ROOM TEMPERATURE (25°C)
     10-100
  4 Days
  4 Days
   
   
   
   
   
     10-30
   
   
  24 Hrs
   
  24 Hrs
   
   
     0.5-2
   
   
   
  6 Hrs
   
  6 Hrs
  6 Hrs
  REFRIGERATION (4°C)
     10-100
  7 Days
  7 Days
   
   
   
   
   
     10-30
   
   
  4 Days
  4 Days
  4 Days
  4 Days
  4 Days
  FROZEN (-15°C)
     50-100
  30 Days
   
   
   
   
   
   
     250/1.5 mL
  30 Days
   
   
   
   
   
   
     100
   
  30 Days
   
   
   
   
   
     10-100
   
   
  30 Days
  30 Days
  30 Days
  30 Days
  30 Days
  Stability
  

  Studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period. 
  
  IV Solution
  
  5% Dextrose in Normal Saline
  10% D-Fructose in Water
  10% D-Fructose in Normal Saline
  Lactated Potassic Saline Injection
  10% Invert Sugar in Normal Saline
  10% Invert Sugar Plus 0.3% Potassium Chloride in Water 
  Travert 10% Electrolyte #1 
  Travert 10% Electrolyte #2 
  Travert 10% Electrolyte #3 
  
  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use. 
  
  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

  Pharmacy Bulk Package
  

  This Pharmacy Bulk Package glass bottle contains 10 grams oxacillin sodium and is designed for use in the pharmacy in preparing IV admixtures. Add 93 mL Sterile Water for Injection, USP or Sodium Chloride Injection, USP 0.9%. The resulting solution will contain 100 mg oxacillin per mL and will require further dilution.
  
  CAUTION: NOT TO BE DISPENSED AS A UNIT.

  Directions for Proper Use of Pharmacy Bulk Package
  The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of this product is restricted to a suitable work area, such as a laminar flow hood. Once a sterile transfer device has been inserted into the container closure withdrawal of the contents should be completed without delay. The container closure may be penetrated only one time after reconstitution if prompt fluid transfer cannot be accomplished, discard the contents no later than 4 hours after initial closure puncture. This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle. A plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing contents.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Do not add supplementary medication to Oxacillin for Injection, USP.

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• Auromedics Pharma Llc
  

  ×

  Oxacillin | Auromedics Pharma Llc

  

  ---

  
  

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.
  
  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
  
  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
  
  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  
  
  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION Drug Adults Infants and Children
  <40 kg (88 lbs) Other Recommendations    Oxacillin
     250 to 500 mg IM or IV
     every 4 to 6 hours (mild to
     moderate infections)
     50 mg/kg/day IM or IV in equally
     divided doses every 6 hours
     (mild to moderate infections)
   
     1 gram IM or IV every 4 to
     6 hours (severe infections)
     100 mg/kg/day IM or IV in
     equally divided doses every 4 to
     6 hours (severe infections)
     Premature and Neonates
     25 mg/kg/day IM or IV
  Directions for Use For Intramuscular Use
  

  Use Sterile Water for Injection, USP. Add 5.7 mL to the 1 gram vial and 11.5 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70°F or for one week under refrigeration (40°F).

  For Direct Intravenous Use
  

  Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.

  For Administration by Intravenous Drip
  

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP Concentration
  mg/mL Sterile
  Water for
  Injection USP 0.9% Sodium
  Chloride Injection USP (Isotonic) Sodium
  Lactate Solution USP (M/6 Molar) Dextrose
  Injection USP (5%) Dextrose
  and Sodium Chloride Injection USP
  (5% Dextrose and
  0.45% NaCl) Invert
  Sugar Injection USP (10%) Lactated
  Ringer’s
  Injection USP ROOM TEMPERATURE (25°C)
     10-100
  4 Days
  4 Days
   
   
   
   
   
     10-30
   
   
  24 Hrs
   
  24 Hrs
   
   
     0.5-2
   
   
   
  6 Hrs
   
  6 Hrs
  6 Hrs
  REFRIGERATION (4°C)
     10-100
  7 Days
  7 Days
   
   
   
   
   
     10-30
   
   
  4 Days
  4 Days
  4 Days
  4 Days
  4 Days
  FROZEN (-15°C)
     50-100
  30 Days
   
   
   
   
   
   
     250/1.5 mL
  30 Days
   
   
   
   
   
   
     100
   
  30 Days
   
   
   
   
   
     10-100
   
   
  30 Days
  30 Days
  30 Days
  30 Days
  30 Days
  
  

  Stability studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period.
  
  IV Solution
  
  5% Dextrose in Normal Saline
  10% D-Fructose in Water
  10% D-Fructose in Normal Saline
  Lactated Potassic Saline Injection
  10% Invert Sugar in Normal Saline
  10% Invert Sugar Plus 0.3% Potassium Chloride in Water
  Travert 10% Electrolyte #1
  Travert 10% Electrolyte #2
  Travert 10% Electrolyte #3
  
  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.
  
  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Do not add supplementary medication to Oxacillin for Injection, USP.

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• Auromedics Pharma Llc
  

  ×

  Oxacillin | Auromedics Pharma Llc

  

  ---

  
  

  The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

  
  
  

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.
  
  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
  
  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
  
  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  
  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations    Oxacillin
     250 to 500 mg IV
     every 4 to 6 hours (mild
     to moderate infections)
     50 mg/kg/day IV in
     equally divided doses every 6
     hours (mild to moderate infections)
   
     1 gram IV every 4
     to 6 hours (severe infections)
     100 mg/kg/day IV in
     equally divided doses every 4 to
     6 hours (severe infections)
     Premature and Neonates 25 mg/kg/day IV
  Directions for Use
  

  For Administration by Intravenous Drip
  
  Reconstitute as directed below (Pharmacy Bulk Package) prior to further dilution.

  
  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP* Concentration
  mg/mL Sterile
  Water for
  Injection USP 0.9% Sodium
  Chloride Injection USP (Isotonic) Sodium
  Lactate Solution USP (M/6 Molar) Dextrose
  Injection USP (5%) Dextrose
  and Sodium Chloride Injection USP
  (5% Dextrose and
  0.45% NaCl) Invert
  Sugar Injection USP (10%) Lactated
  Ringer’s
  Injection USP *IMPORTANT:This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that a product should be used as soon after preparation as feasible.
  ROOM TEMPERATURE (25°C)
     10-100
  4 Days
  4 Days
   
   
   
   
   
     10-30
   
   
  24 Hrs
   
  24 Hrs
   
   
     0.5-2
   
   
   
  6 Hrs
   
  6 Hrs
  6 Hrs
  REFRIGERATION (4°C)
     10-100
  7 Days
  7 Days
   
   
   
   
   
     10-30
   
   
  4 Days
  4 Days
  4 Days
  4 Days
  4 Days
  FROZEN (-15°C)
     50-100
  30 Days
   
   
   
   
   
   
     250/1.5 mL
  30 Days
   
   
   
   
   
   
     100
   
  30 Days
   
   
   
   
   
     10-100
   
   
  30 Days
  30 Days
  30 Days
  30 Days
  30 Days
  Stability
  

  Studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period. 
  
  IV Solution
  
  5% Dextrose in Normal Saline
  10% D-Fructose in Water
  10% D-Fructose in Normal Saline
  Lactated Potassic Saline Injection
  10% Invert Sugar in Normal Saline
  10% Invert Sugar Plus 0.3% Potassium Chloride in Water 
  Travert 10% Electrolyte #1 
  Travert 10% Electrolyte #2 
  Travert 10% Electrolyte #3 
  
  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use. 
  
  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

  Pharmacy Bulk Package
  

  This Pharmacy Bulk Package glass bottle contains 10 grams oxacillin sodium and is designed for use in the pharmacy in preparing IV admixtures. Add 93 mL Sterile Water for Injection, USP or Sodium Chloride Injection, USP 0.9%. The resulting solution will contain 100 mg oxacillin per mL and will require further dilution.
  
  CAUTION: NOT TO BE DISPENSED AS A UNIT.

  Directions for Proper Use of Pharmacy Bulk Package
  The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Use of this product is restricted to a suitable work area, such as a laminar flow hood. Once a sterile transfer device has been inserted into the container closure withdrawal of the contents should be completed without delay. The container closure may be penetrated only one time after reconstitution if prompt fluid transfer cannot be accomplished, discard the contents no later than 4 hours after initial closure puncture. This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle. A plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing contents.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Do not add supplementary medication to Oxacillin for Injection, USP.

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• Sagent Pharmaceuticals
  

  ×

  Oxacillin | Sagent Pharmaceuticals

  

  ---

  The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations Oxacillin 250 to 500 mg IV
  every 4 to 6 hours (mild to moderate infections) 50 mg/kg/day IV in equally divided
  doses every 6 hours
  (mild to moderate
  infections) Oxacillin 1 gram IV every 4 to 6 hours (severe infections) 100 mg/kg/day IV in equally divided doses every 4 to 6 hours
  (severe infections) Premature and
  Neonates 25 mg/kg/day IV

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• Sagent Pharmaceuticals
  

  ×

  Oxacillin | Sagent Pharmaceuticals

  

  ---

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug Adults Infants and Children
  <40 kg (88 lbs) Other
  Recommendations Oxacillin 250 to 500 mg IM or
  IV every 4 to 6 hours
  (mild to moderate
  infections) 50 mg/kg/day IM or
  IV in equally divided
  doses every 6 hours
  (mild to moderate
  infections) Oxacillin 1 gram IM or IV
  every 4 to 6 hours
  (severe infections) 100 mg/kg/day IM
  or IV in equally
  divided doses every
  4 to 6 hours
  (severe infections) Premature and
  Neonates 25 mg/kg/day
  IM or IV

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• Baxter Healthcare Corporation
  

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  Oxacillin | Adler-stern Pharmaceuticals,llc

  

  ---

  clean and dry affected area

  remove patch from backing and apply to affected area

  use only one patch at a time, and maximum of four patches/day

  leave patch on affected area for up to 8 hours

  do not use patches for longer than five consecutive days

  children under 12 should consult physician prior to use

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• Agila Specialties Private Limited
  

  ×

  Oxacillin | Agila Specialties Private Limited

  

  ---

  The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.

  Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.

  Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.

  Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (See PRECAUTIONS-General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury.

  With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

  RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP Drug
  Adults
  Infants and Children < 40 kg (88 lbs)
  Other Recommendations
  Oxacillin
  250 to 500 mg IM or IV every 4 to 6
  hours (mild to moderate infections)
  50 mg/kg/day IM or IV in equally divided
  doses every 6 hours (mild to moderate infections)
  
  
  1 gram IM or IV
  every 4 to 6 hours (severe infections)
  100 mg/kg/day IM or IV in equally divided doses
  every 4 to 6 hours (severe infections)
  Premature and Neonates 25 mg/kg/day IM or IV
  

  Directions for use

  For Intramuscular Use

  Use Sterile Water for Injection, USP. Add 5.7 mL to the 1 gram vial and 11.5 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70°F or for one week under refrigeration (40° F).

  For Direct Intravenous Use

  Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately10 minutes.

  For Administration by Intravenous Drip

  Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution.

  STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP Concentration mg/mL
  Sterile
  water  for Injection
  0.9% sodium chloride
  Injection, USP
  M/6 Molar
  Sodium
  Lactate Solution
  5% Dextrose 
  in water
  5% Dextrose in 0.45%
  sodium chloride
  10% Invert Sugar
  Injection, USP
  Lactated
  Ringers Solution
  
  ROOM TEMPERATURE (25° C)
  10 to100
  4 Days
  4 Days
  
  
  
  
  
  10 to 30
  
  
  24 Hrs
  
  24 Hrs
  
  
  0.5 to 2
  
  
  
  6 Hrs
  
  6 Hrs
  6 Hrs
  
  REFRIGERATION (4° C)
  10 to 100
  7 Days
  7 Days
  
  
  
  
  
  10 to 30
  
  
  4 Days
  4 Days
  4 Days
  4 days
  4 Days
  
  FROZEN (-15° C)
  50 to 100
  30 Days
  
  
  
  
  
  
  250/1.5 mL
  30 Days
  
  
  
  
  
  
  100
  
  30 Days
  
  
  
  
  
  10 to 100
  
  
  30 Days
  30 Days
  30 Days
  30 days
  30 Days
  

  Stability studies on oxacillin sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70°F) during a 6-hour period.

  IV Solution

  5% Dextrose in Normal Saline

  10% D-Fructose in Water

  10% D-Fructose in Normal Saline

  Lactated Potassic Saline Injection

  10% Invert Sugar in Normal Saline

  10% Invert Sugar Plus 0.3% Potassium Chloride in Water

  Travert 10% Electrolyte #1

  Travert 10% Electrolyte #2

  Travert 10% Electrolyte #3

  Only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.

  If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

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

  Do not add supplementary medication to oxacillin for injection, USP.

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  No Recall

  More Info