Chloraprep One-step

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Chloraprep One-step Recall

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Side Effects & Adverse Reactions

For external use only. Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY:

solution contains alcohol and gives off flammable vapors
avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
do not allow solution to pool
remove wet materials from prep area

Do not use

on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
for lumbar puncture or in contact with the meninges
on open skin wounds or as a general skin cleanser

When using this product

keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
for lumbar puncture or in contact with the meninges
on open skin wounds or as a general skin cleanser

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

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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

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

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History

There is currently no drug history available for this drug.

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Other Information

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Chloraprep One-step Manufacturers

Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm 2). remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away. if using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up too 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2) remove applicator from package; do not touch applicator tip hold the sponge tip down and pinch the barrel of the applicator only once to activate the ampule and release the antiseptic wet the sponge tip by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for approximately 30 seconds. Allow the area to air dry for approximately 30 seconds. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for approximately 2 minutes. Allow the area to air dry for approximately 1 minute. do not blot or wipe away discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2) remove applicator from package; do not touch sponge hold the applicator horizontally with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute. Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area using one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2) tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area. completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute. Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area using three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm 2) tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area. completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds (use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes (use each swabstick sequentially within the 2 minutes). Allow the area to air dry for approximately 1 minute. Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm 2) remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes of the sponge for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away. If using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 cm 2) remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use gentle back-and-forth strokes for 2 minutes do not allow the solution to pool; tuck prep towels to absorb solution, and then remove allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 8.4 in. × 8.4 in. (457 cm 2) remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes do not allow solution to pool; tuck prep towels to absorb solution, and then remove allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Teva Parenteral Medicines, Inc.

2.2 Colorectal Single Agent Regimens 1 and 2
Administer irinotecan hydrochloride injection as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3.

A reduction in the starting dose by one dose level of irinotecan hydrochloride injection may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin > 2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients.
Table 3. Single-Agent Regimens of Irinotecan Hydrochloride Injection and Dose Modifications a Subsequent doses may be adjusted as high as 150 mg/m2 or to as low as 50 mg/m2 in 25 to 50 mg/m2 decrements depending upon individual patient tolerance.
b Subsequent doses may be adjusted as low as 200 mg/m2 in 50 mg/m2 decrements depending upon individual patient tolerance.
c Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit.

Regimen 1 (weekly)a

125 mg/m2 intravenous infusion over 90 minutes, days 1,8,15,22 then 2-week rest

Starting Dose and Modified Dose Levelsc (mg/m2)

Starting Dose

Dose Level -1

Dose Level -2

125

100

75

Regimen 2 (every 3 weeks)b

350 mg/m2 intravenous infusion over 90 minutes, once every 3 weeksc

Starting Dose and Modified Dose Levels (mg/m2)

Starting Dose

Dose Level -1

Dose Level -2

350

300

250

Dose Modifications

Based on recommended dose-levels described in Table 3, Single-Agent Regimens of Irinotecan Hydrochloride Injection and Dose Modifications, subsequent doses should be adjusted as suggested in Table 4, Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity.
Table 4: Recommended Dose Modifications for Single-Agent Schedulesa a All dose modifications should be based on the worst preceding toxicity
b National Cancer Institute Common Toxicity Criteria (version 1.0)
c Pretreatment
d Excludes alopecia, anorexia, asthenia
A new cycle of therapy should not begin until the granulocyte count has recovered to ≥ 1500/mm3, and the platelet count has recovered to ≥ 100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing irinotecan hydrochloride injection.

Worst Toxicity NCI Gradeb (Value)

During a Cycle of Therapy

At the Start of the Next Cycles of Therapy (After Adequate Recovery), Compared with the Starting Dose in the Previous Cyclea

Weekly

Weekly

Once Every 3 Weeks

No toxicity

Maintain dose level

↑ 25 mg/m2 up to a maximum dose of 150 mg/m2

Maintain dose level

Neutropenia

1 (1500 to

1999/mm3)

Maintain dose level

Maintain dose level

Maintain dose level

2 (1000 to

1499/mm3)

↓ 25 mg/m2

Maintain dose level

Maintain dose level

3 (500 to 999/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

4 (< 500/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Neutropenic fever

Omit dose until resolved, then ↓ 50 mg/m2 when resolved

↓ 50 mg/m2

↓ 50 mg/m2

Other hematologic toxicities

Dose modifications for leukopenia, thrombocytopenia, and anemia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea

1 (2 to 3 stools/day > pretxc)

Maintain dose level

Maintain dose level

Maintain dose level

2 (4 to 6 stools/day > pretx)

↓ 25 mg/m2

Maintain dose level

Maintain dose level

3 (7 to 9 stools/day > pretx)

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

4 (≥ 10 stools/day > pretx)

Omit dose until resolved to ≤ grade 2 then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Other nonhematologicd toxicities

1

Maintain dose level

Maintain dose level

Maintain dose level

2

↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

3

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

4

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2
2.3 Dosage in Patients with Reduced UGT1A1 Activity
When administered in as a single-agent, a reduction in the starting dose by at least one level of irinotecan hydrochloride injection should be considered for patients known to be homozygous for the UGT1A1*28 allele [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)]. However, the precise dose reduction in this patient population is not known, and subsequent dose modifications should be considered based on individual patient tolerance to treatment (see Tables 1 to 4).
2.4 Premedication
It is recommended that patients receive premedication with antiemetic agents. In clinical studies of the weekly dosage schedule, the majority of patients received 10 mg of dexamethasone given in conjunction with another type of antiemetic agent, such as a 5-HT3 blocker (e.g., ondansetron or granisetron). Antiemetic agents should be given on the day of treatment, starting at least 30 minutes before administration of irinotecan hydrochloride injection. Physicians should also consider providing patients with an antiemetic regimen (e.g., prochlorperazine) for subsequent use as needed.

Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms.
2.5 Preparation of Infusion Solution
Inspect vial contents for particulate matter and discoloration and repeat inspection when drug product is withdrawn from vial into syringe.

Irinotecan hydrochloride injection 20 mg/mL is intended for single use only and any unused portion should be discarded.

Irinotecan hydrochloride injection must be diluted prior to infusion. Irinotecan hydrochloride injection should be diluted in 5% Dextrose Injection, USP, (preferred) or 0.9% Sodium Chloride Injection, USP, to a final concentration range of 0.12 mg/mL to 2.8 mg/mL. Other drugs should not be added to the infusion solution.

The solution is physically and chemically stable for up to 24 hours at room temperature and in ambient fluorescent lighting. Solutions diluted in 5% Dextrose Injection, USP, and stored at refrigerated temperatures (approximately 2° to 8°C, 36° to 46°F), and protected from light are physically and chemically stable for 48 hours. Refrigeration of admixtures using 0.9% Sodium Chloride Injection, USP, is not recommended due to a low and sporadic incidence of visible particulates. Freezing irinotecan hydrochloride injection and admixtures of irinotecan hydrochloride injection may result in precipitation of the drug and should be avoided.

The irinotecan hydrochloride injection solution should be used immediately after reconstitution as it contains no antibacterial preservative. Because of possible microbial contamination during dilution, it is advisable to use the admixture prepared with 5% Dextrose Injection, USP, within 24 hours if refrigerated (2° to 8°C, 36° to 46°F). In the case of admixtures prepared with 5% Dextrose Injection, USP, or Sodium Chloride Injection, USP, the solutions should be used within 4 hours if kept at room temperature. If reconstitution and dilution are performed under strict aseptic conditions (e.g., on Laminar Air Flow bench), irinotecan hydrochloride injection solution should be used (infusion completed) within 12 hours at room temperature or 24 hours if refrigerated (2° to 8°C, 36° to 46°F).
2.6 Safe Handling
Care should be exercised in the handling and preparation of infusion solutions prepared from irinotecan hydrochloride injection. The use of gloves is recommended. If a solution of irinotecan hydrochloride injection contacts the skin, wash the skin immediately and thoroughly with soap and water. If irinotecan hydrochloride injection contacts the mucous membranes, flush thoroughly with water. Several published guidelines for handling and disposal of anticancer agents are available.
2.7 Extravasation
Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sterile water and applications of ice are recommended.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 13.2 in. × 13.2 in. (1126 cm 2). remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wing only once to activate the ampules and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use gentle back-and-forth strokes for 2 minutes do not allow solution to pool; tuck prep towels to absorb solution, and then remove allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in. (457 cm 2) remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes do not allow solution to pool; tuck prep towels to absorb solution, and then remove allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step | Carefusion 213 Llc

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. use in a well ventilated area maximal treatment area for one applicator is approximately 13.2 in. x 13.2 in. (1126 cm 2). remove applicator from package; do not touch sponge hold applicator with the sponge down. Pinch wing only once to activate the ampules and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes do not allow solution to pool; tuck prep towels to absorb solution, and then remove allow solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

No Recall
Carefusion 213 Llc

Chloraprep One-step |

2.1 Recommended Dosing
The recommended dosage is one 60 mg raloxifene hydrochloride tablet daily, which may be administered any time of day without regard to meals [see Clinical Pharmacology (12.3)].

For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [see Clinical Studies (14.3, 14.4)].
2.2 Recommendations for Calcium and Vitamin D Supplementation
For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400-800 IU daily. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplements. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

No Recall