Popular Searches:

drugs

viagra

diet pills
drugs prescription drugs weight loss drugs drugs online discount drugs drugstore drugs for depression online drugstore online drugs canadian drugs cheap drugs nc drugs facilities fertility drugs canada drugs brands only drugs acyclovir adipex ambien antibiotic carisoprodol celebrex didrex diet pills discount xenical hydrocodone ionamin lortab meridia online soma paxil penis enlargement phentermine prevacid prilosec propecia prozac renova retin-a senior health soma sonata tenuate tramadol ultram valium valtrex vaniqa viagra vicodin vioxx vitamin wagering weight weight loss wellbutrin women health xanax xenical xenical online zocor zoloft zovirax zyban zyrtec
A1, A2, B, C1, C2, D, E, F, G-H, I-K, L, M, N, O, P1, P2, Q-R, S, T, U-V, W-Z

Cancidas Indications, Dosage, Storage, Stability - Caspofungin acetate

Cancidas Indications, Dosage, Storage, Stability - Caspofungin acetate

INDICATIONS AND USAGE

CANCIDAS is indicated for the treatment of:

DOSAGE AND ADMINISTRATION

General Recommendations

Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose.

Esophageal Candidiasis

50 mg daily should be administered by slow IV infusion over approximately 1 hour. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered (see CLINICAL STUDIES). A 70-mg loading dose has not been studied with this indication.

Invasive Aspergillosis

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. CANCIDAS should be administered by slow IV infusion of approximately 1 hour. Duration of treatment should be based upon the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response. Do not mix or co-infuse CANCIDAS with other medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE). The efficacy of a 70 mg dose regimen in patients who are not clinically responding to the 50 mg daily dose is not known. Limited safety data suggests that an increase in dose to 70 mg daily is well tolerated. The safety and efficacy of doses above 70 mg have not been adequately studied.

Hepatic Insufficiency

Patients with mild hepatic insufficiency (Child-Pugh score 5 to 6) do not need a dosage adjustment. However, for patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), after the initial 70-mg loading dose, CANCIDAS 35 mg daily is recommended. There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score >9) (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations.).

Concomitant Medication with Inducers of Drug Clearance

Patients on rifampin should receive 70 mg of CANCIDAS daily. Patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS daily (see PRECAUTIONS, Drug Interactions).

Preparation of Cancidas for use: Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE α-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose.

Preparation of the 70-mg Day 1 loading-dose infusion for Invasive Aspergillosis

1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.

2. Aseptically add 10.5 mL of 0.9% Sodium Chloride Injection to the vial.a This reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).b

3. Aseptically transfer 10 mLc of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9% Sodium Chloride Injection.d (If a 70-mg vial is unavailable, see below: Alternative Infusion Preparation Methods, Preparation of 70-mg Day 1 loading dose from two 50-mg vials.)

Preparation of the daily 50-mg infusion

1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.

2. Aseptically add 10.5 mL of 0.9% Sodium Chloride Injection to the vial.a This reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).b

3. Aseptically transfer 10 mLc of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9% Sodium Chloride Injection.d (If a reduced infusion volume is medically necessary, see below: Alternative Infusion Preparation Methods, Preparation of 50-mg daily doses at reduced volume.)

Alternative Infusion Preparation Methods

Preparation of 70-mg Day 1 loading dose from two 50-mg vials for Invasive Aspergillosis

Reconstitute two 50-mg vials with 10.5 mL of diluent each (see Preparation of the daily 50-mg infusion). Aseptically transfer a total of 14 mL of the reconstituted CANCIDAS from the two vials to 250 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s Injection.

Preparation of 50-mg daily doses at reduced volume

When medically necessary, the 50-mg daily doses can be prepared by adding 10 mL of reconstituted CANCIDAS to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s Injection (see Preparation of the daily 50-mg infusion).

Preparation of a 35-mg daily dose for patients with moderate Hepatic Insufficiency

Reconstitute one 50-mg vial (see above: Preparation of the daily 50-mg infusion). Aseptically transfer 7 mL of the reconstituted CANCIDAS from the vial to 250 mL of 0.9% Sodium Chloride Injection or, if medically necessary, to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s Injection.

Preparation notes:

a The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.

b Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.

c CANCIDAS is formulated to provide the full labeled vial dose (70 mg or 50 mg) when 10 mL is withdrawn from the vial.

d This infusion solution must be used within 24 hours, during which time it should be kept at ≤25°C (≤77°F).

 

TABLE 5 : CANCIDAS Concentrations

Dose

Reconstituted Solution Concentration

Infusion Volume

Infusion Solution Concentration

70-mg initial dose

7.2 mg/mL

260 mL

0.28 mg/mL

50-mg daily dose

5.2 mg/mL

260 mL

0.20 mg/mL

70-mg initial dose* (from two 50 mg vials)

5.2 mg/mL

264 mL

0.28 mg/mL

50-mg daily dose* (reduced volume)

5.2 mg/mL

110 mL

0.47 mg/mL

35-mg daily dose*

5.2 mg/mL

257 mL

0.14 mg/mL

(from one 50 mg vial) for Moderate

or

or

or

Hepatic Insufficiency

5.2 mg/mL

107 mL

0.34 mg/mL

*See preceding text for these special situations

*See preceding text for these special situations

HOW SUPPLIED

No. 3822 — CANCIDAS 50 mg is a white to off-white powder/cake for infusion in a vial labeled with a red aluminum band and a plastic cap.

NDC 0006-3822-10 one single-use vial.

No. 3823 — CANCIDAS 70-mg is a white to off-white powder/cake for infusion in a vial with a yellow/orange aluminum band and a plastic cap.

NDC 0006-3823-10 one single-use vial.

Storage Vials

The lyophilized vials should be stored refrigerated at 2° to 8°C (36° to 46°F)

Reconstituted concentrate

Reconstituted CANCIDAS may be stored at ≤25°C (≤77°F) for one hour prior to the preparation of the patient infusion solution.

Diluted Product

The final patient infusion solution in the IV bag or bottle can be stored at ≤ 25°C (≤ 77°F) for 24 hours or at 2 to 8°C (36 to 46°F) for 48 hours.
.

MERCK & CO., INC., Whitehouse Station, NJ 08889,USA

Revised Apr 02, 2003

top


Popular Searches:

weight loss

ultram

penis enlargement

hydrocodone

antibiotic