Hydrogen Peroxide Solution

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Hydrogen Peroxide Solution Recall

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Side Effects & Adverse Reactions

For external use only

in the eyes or apply over large areas of the body
longer than 1 week

deep or pucture wounds, animal bites or serious burns

the condition persists or gets worse
sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, or fever develops

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

first aid to help prevent the risk of infection in minor cuts, scrapes and burns
aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Hydrogen Peroxide Solution Manufacturers

H-e-b

Hydrogen Peroxide Solution | H-e-b

First Aid Antiseptic:
clean the affected area apply a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age: mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Better Living Brands Llc

Hydrogen Peroxide Solution | Better Living Brands Llc

First Aid Antiseptic:
clean the affected area apply a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Cardinal Health

Hydrogen Peroxide Solution | Cardinal Health

First Aid Antiseptic:
clean the affected area apply a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Foodhold U.s.a., Llc

Hydrogen Peroxide Solution | Foodhold U.s.a., Llc

First Aid Antiseptic:
clean the affected area apply a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Valu Merchandisers, Co

Hydrogen Peroxide Solution | Valu Merchandisers, Co

First Aid Antiseptic:
clean the affected area apply a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age: mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Salado Sales, Inc

Hydrogen Peroxide Solution | Salado Sales, Inc

First Aid Antiseptic:
clean the affected area spray a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Publix Super Markets, Inc

Hydrogen Peroxide Solution | Publix Super Markets, Inc

First Aid Antiseptic:
clean the affected area spray a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall
Jiangsu Province Jianerkang Medical Dressing Co. ,ltd.

Hydrogen Peroxide Solution | Jiangsu Province Jianerkang Medical Dressing Co. ,ltd.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Dolgencorp, Llc

Hydrogen Peroxide Solution | Dolgencorp, Llc

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent 9oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Duane Reade

Hydrogen Peroxide Solution | Duane Reade

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent 9oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Demoulas Super Markets, Inc

Hydrogen Peroxide Solution | Demoulas Super Markets, Inc

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Target Corp

Hydrogen Peroxide Solution | Target Corp

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Meijer Distribution, Inc

Hydrogen Peroxide Solution | Meijer Distribution, Inc

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Walgreens Co.

Hydrogen Peroxide Solution | Walgreens Co.

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Kmart Corp

Hydrogen Peroxide Solution | Kmart Corp

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
The Great Atlantic + Pacific Tea Company

Hydrogen Peroxide Solution | The Great Atlantic + Pacific Tea Company

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral debriding agent (oral rinse): adults and children 2 years of age and over:
•mix with an equal amount of water
•swish around in the mouth over the affected area for at least 1 minute and then spit out
•use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult a dentist or doctor

No Recall
Western Family

Hydrogen Peroxide Solution | Western Family

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

No Recall
Dza Brands,

Hydrogen Peroxide Solution | Dza Brands,

Directions

•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

No Recall
Supervalu, Inc

Hydrogen Peroxide Solution | Wakefern Food Corporation

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours
Weight (lb)

Age (yr)

Dose (mL or tsp)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Army + Air Force Exchange Service

Hydrogen Peroxide Solution | Army + Air Force Exchange Service

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral Debriding agent: adults and children 2 years of age and over:
• mix with equal amount of water
• swish around in the mouth over the affected area for at least 1 minute and then spit out
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.

• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor

No Recall
Chain Drug Consortium, Llc

Hydrogen Peroxide Solution | Chain Drug Consortium, Llc

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral Debriding agent: adults and children 2 years of age and over:
• mix with equal amount of water
• swish around in the mouth over the affected area for at least 1 minute and then spit out
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.

• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor

No Recall
Hydrox Laboratories

Hydrogen Peroxide Solution | Hydrox Laboratories

First aid antiseptic:
clean the affected area apply a small amount of product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first
Oral debriding agent (oral rinse):
adults and children 2 years of age and over:
mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor

No Recall
Rite Aid

Hydrogen Peroxide Solution | Rite Aid

Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first
Oral debriding agent (oral rinse): adults and children 2 years of age and over:
• mix with an equal amount of water
• swish around in the mouth over the affected area for at least 1 minute and then spit out
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

No Recall
Pioneer Associates

Hydrogen Peroxide Solution | Pioneer Associates

Directions

first aid antiseptic:
clean affected area apply small amount of product on affected area 1-3 times a day may be covered with a sterile bandage if bandaged, let dry first
oral debriding agent (oral rinse):
adults and children 2 years of age and over: mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor

No Recall
Shopko Stores Operating Co, Llc

Hydrogen Peroxide Solution | Shopko Stores Operating Co, Llc

First Aid
clean the affected area apply a small amount of product on the affected area 1 to 3 tmes a day may be covered with a sterile bandage if bandage, let dry first
Oral debriding agent adults and children over 2 years of age:
mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in use children under 2 years of age: consult a dentist, doctor

No Recall
Cvs Pharmacy, Inc

Hydrogen Peroxide Solution | Cvs Pharmacy, Inc

clean the affected area apply a small amount of product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first

No Recall
Mckesson Medical-surgical Inc.

Hydrogen Peroxide Solution | Mckesson Medical-surgical Inc.

First aid antiseptic:
Clean the affected area Apply a small amount of product on the area 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first Oral debriding agent (oral rinse): adults and children 2 years of age and over:
Mix with an equal amount of water Swish around in the mouth over the affected area for at least 1 minute and then spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: consult a dentist or doctor

No Recall
Laboratorios Jaloma, S.a. De C.v.

Hydrogen Peroxide Solution | Laboratorios Jaloma, S.a. De C.v.

Directions * clean the affected area * apply a small

amount of this product on the area 1 to 3 times daily * may be

covered with a sterile bandage * if bandaged, let dry first

No Recall
Mckesson Medical-surgical Inc.

Hydrogen Peroxide Solution | Mckesson Medical-surgical Inc.

  First aid antiseptic:
Clean the affected area Apply a small amount of product on the area 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first   Oral debriding agent (oral rinse):
  adults and children 2 years of age and over:
Mix with an equal amount of water Swish around in the mouth over the affected area for at least 1 minute and then spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: consult a dentist or doctor

No Recall
Vi-jon

Hydrogen Peroxide Solution | Fresenius Kabi Usa, Llc

2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin in 5% dextrose injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.

These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

Type of Infection*

Dosed Every 24 hours

Duration (days)†

Nosocomial Pneumonia

750 mg

7 to 14

Community-Acquired Pneumonia‡

500 mg

7 to 14

Community-Acquired Pneumonia§

750 mg

5

Acute Bacterial Sinusitis

750 mg

5

500 mg

10 to 14

Acute Bacterial Exacerbation of Chronic Bronchitis

500 mg

7

Complicated Skin and Skin Structure Infections (SSSI)

750 mg

7 to 14

Uncomplicated SSSI

500 mg

7 to 10

Chronic Bacterial Prostatitis

500 mg

28

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶

750 mg

5

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#

250 mg

10

Uncomplicated Urinary Tract Infection

250 mg

3

Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,β
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,β

500 mg

see Table 2 below (2.2)

60β
60β

Plague, adult and pediatric patients > 50 kgα
Pediatric patients < 50 kg and ≥ 6 months of age

500 mg

See Table 2 below (2.2)

10 to 14

10 to 14

* Due to the designated pathogens [see Indications and Usage (1)].

† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].

¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

β The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
α Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

           Table 2: Dosage in Pediatric Patients ≥ 6 months of age

Type of Infection*

Dose

Freq.

Once

Every

Duration†

Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg

500 mg

24 hr

60 days§

Pediatric patients < 50 kg and
≥ 6 months of age

8 mg/kg

(not to exceed 250 mg per dose)

12 hr

60 days§

Plague¶
Pediatric patients > 50 kg

500 mg

24 hr

10 to 14 days

Pediatric patients < 50 kg and
≥ 6 months of age

8 mg/kg

(not to exceed 250 mg per dose)

12 hr

10 to 14 days

* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14).

†   Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡   Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

§    The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min)

Dosage in Normal Renal Function Every 24 hours

Creatinine Clearance 20 to 49 mL/min

Creatinine Clearance 10 to 19 mL/min

Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)

750 mg

750 mg every 48 hours

750 mg initial dose, then 500 mg every 48 hours

750 mg initial dose, then 500 mg every 48 hours

500 mg

500 mg initial dose, then 250 mg every 24 hours

500 mg initial dose, then 250 mg every 48 hours

500 mg initial dose, then 250 mg every 48 hours

250 mg

No dosage adjustment required

250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required

No information on dosing adjustment is available

2.4 Drug Interaction with Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin in 5% dextrose injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration Instructions
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin in 5% dextrose injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin in 5% dextrose injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Hydration for Patients Receiving Levofloxacin in 5% Dextrose Injection

Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
2.6 Preparation of Intravenous Product
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Because only limited data are available on the compatibility of levofloxacin in 5% dextrose injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix Solution in Single-Use Flexible Containers or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin in 5% dextrose injection with an infusion solution compatible with levofloxacin in 5% dextrose injection and with any other drug(s) administered via this common line.

Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)

Levofloxacin in 5% dextrose injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 50 mL premixed flexible container contains 250 mg/50 mL of levofloxacin solution. The 100 mL premixed flexible container contains 500 mg/100 mL of levofloxacin solution. The 150 mL premixed flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.

Instructions for the Use of Levofloxacin Injection Premix in Single-Use Flexible Containers:

1. Tear outer wrap at the notch and remove solution container.

2. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised.

3. Do not use if the solution is cloudy or a precipitate is present.

4. Use sterile equipment.

5. WARNING: Do not admix with other drugs or additives. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration:

1. Close flow control clamp of administration set.

2. Remove cover from port at bottom of container.

3. 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.

4. Suspend container from hanger.

5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers.

6. Open flow control clamp to expel air from set. Close clamp.

7. Regulate rate of administration with flow control clamp.
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin in 5% dextrose injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.

These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

Type of Infection*

Dosed Every 24 hours

Duration (days)†

Nosocomial Pneumonia

750 mg

7 to 14

Community-Acquired Pneumonia‡

500 mg

7 to 14

Community-Acquired Pneumonia§

750 mg

5

Acute Bacterial Sinusitis

750 mg

5

500 mg

10 to 14

Acute Bacterial Exacerbation of Chronic Bronchitis

500 mg

7

Complicated Skin and Skin Structure Infections (SSSI)

750 mg

7 to 14

Uncomplicated SSSI

500 mg

7 to 10

Chronic Bacterial Prostatitis

500 mg

28

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶

750 mg

5

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#

250 mg

10

Uncomplicated Urinary Tract Infection

250 mg

3

Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,β
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,β

500 mg

see Table 2 below (2.2)

60β
60β

Plague, adult and pediatric patients > 50 kgα
Pediatric patients < 50 kg and ≥ 6 months of age

500 mg

See Table 2 below (2.2)

10 to 14

10 to 14

* Due to the designated pathogens [see Indications and Usage (1)].

† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].

¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

β The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
α Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

           Table 2: Dosage in Pediatric Patients ≥ 6 months of age

Type of Infection*

Dose

Freq.

Once

Every

Duration†

Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg

500 mg

24 hr

60 days§

Pediatric patients < 50 kg and
≥ 6 months of age

8 mg/kg

(not to exceed 250 mg per dose)

12 hr

60 days§

Plague¶
Pediatric patients > 50 kg

500 mg

24 hr

10 to 14 days

Pediatric patients < 50 kg and
≥ 6 months of age

8 mg/kg

(not to exceed 250 mg per dose)

12 hr

10 to 14 days

* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14).

†   Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡   Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

§    The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min)

Dosage in Normal Renal Function Every 24 hours

Creatinine Clearance 20 to 49 mL/min

Creatinine Clearance 10 to 19 mL/min

Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)

750 mg

750 mg every 48 hours

750 mg initial dose, then 500 mg every 48 hours

750 mg initial dose, then 500 mg every 48 hours

500 mg

500 mg initial dose, then 250 mg every 24 hours

500 mg initial dose, then 250 mg every 48 hours

500 mg initial dose, then 250 mg every 48 hours

250 mg

No dosage adjustment required

250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required

No information on dosing adjustment is available

2.4 Drug Interaction with Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin in 5% dextrose injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration Instructions
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin in 5% dextrose injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin in 5% dextrose injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Hydration for Patients Receiving Levofloxacin in 5% Dextrose Injection

Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
2.6 Preparation of Intravenous Product
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Because only limited data are available on the compatibility of levofloxacin in 5% dextrose injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix Solution in Single-Use Flexible Containers or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin in 5% dextrose injection with an infusion solution compatible with levofloxacin in 5% dextrose injection and with any other drug(s) administered via this common line.

Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)

Levofloxacin in 5% dextrose injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 50 mL premixed flexible container contains 250 mg/50 mL of levofloxacin solution. The 100 mL premixed flexible container contains 500 mg/100 mL of levofloxacin solution. The 150 mL premixed flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.

Instructions for the Use of Levofloxacin Injection Premix in Single-Use Flexible Containers:

1. Tear outer wrap at the notch and remove solution container.

2. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised.

3. Do not use if the solution is cloudy or a precipitate is present.

4. Use sterile equipment.

5. WARNING: Do not admix with other drugs or additives. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration:

1. Close flow control clamp of administration set.

2. Remove cover from port at bottom of container.

3. 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.

4. Suspend container from hanger.

5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers.

6. Open flow control clamp to expel air from set. Close clamp.

7. Regulate rate of administration with flow control clamp.

No Recall
Henry Schein Inc.

Hydrogen Peroxide Solution | Henry Schein Inc.

First Aid Antiseptic clean the affected area apply a small amount of product on the area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first
Oral Debriding Agent (oral rinse):

Adults and children 2 years of age & over:
mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor

No Recall
Ndc, Inc.

Hydrogen Peroxide Solution | Ndc, Inc.

First Aid Antiseptic clean the affected area apply a small amount of product on the area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first
Oral Debriding Agent (oral rinse):

Adults and children 2 years of age & over:
mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: consult a dentist or doctor

No Recall
Family Dollar

Hydrogen Peroxide Solution | Family Dollar

clean the affected area spray a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first

No Recall
Sound Body

Hydrogen Peroxide Solution | Sound Body

clean the affected area spray a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first

No Recall
Geiss, Destin & Dunn, Inc

Hydrogen Peroxide Solution | Geiss, Destin & Dunn, Inc

First Aid Antiseptic:
clean the affected area spray a small amount of the product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandage, let dry first
Oral Debriding Agent:
adults, children over 2 years of age mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist or doctor

No Recall