FIRST®- Lansoprazole Rx

Lansoprazole 3 mg/mL in FIRST® -PPI Suspension Compounding Kit

FOR PRESCRIPTION COMPOUNDING ONLY

DESCRIPTION

Each FIRST® - Lansoprazole Compounding Kit is comprised of 0.27 grams of lansoprazole powder USP and 90 mL of FIRST® - PPI Suspension containing benzyl alcohol, FD&C red # 40, flavor, hydroxyethylcellulose, purified water, saccharin sodium, simethicone emulsion, sodium bicarbonate, sodium citrate (dihydrate), sorbitol solution, and sucralose.* When compounded, the final product provides an homogeneous suspension containing 3 mg per mL of lansoprazole in FIRST® - PPI Suspension comparable to the active ingredient contained in Simplified Lansoprazole Suspension (SLS).**

How Supplied and Compounding Directions

TO THE PHARMACIST

Everything you need to make this Rx is included...

1. FIRST® - Lansoprazole Compounding Kit contains pre-measured lansoprazole powder and FIRST® - PPI Suspension.

2. Important - Remove the cap from the bottle containing lansoprazole powder. Tap the top of the induction seal liner to loosen any powder which may have adhered to the liner. Carefully and slowly peel back the inner foil seal liner from the bottle. Using the enclosed tool, scrape any lansoprazole powder from the seal into the bottle. Again using the tool, loosen the powder from the inside lower edges of the bottle.

3. Shake the FIRST® - PPI Suspension for a few seconds. Open the suspension bottle and empty about half the contents of the FIRST® - PPI Suspension into the  lansoprazole powder bottle. Replace the cap and shake the lansoprazole powder bottle vertically for approximately 60 seconds. Empty the remaining FIRST® - PPI Suspension into the lansoprazole powder bottle. Replace the cap and shake the lansoprazole powder bottle vertically for approximately 60 seconds.

4. It is not uncommon to observe clumps of lansoprazole powder in freshly prepared lansoprazole suspension. After a brief time these clumps will disappear once the powder is well wetted.

5. Instruct the patient to shake well before each use.

WARNING:

Bone Fractures. People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.

Low magnesium levels in the body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment.

FIRST® - Lansoprazole Compounding Kit components have a two-year expiration date.** Prior to compounding, store FIRST® - Lansoprazole Compounding Kit at room temperature 15º- 30ºC (59º- 86ºF).

Based on real time temperature and humidity testing, compounded FIRST®- Lansoprazole product is stable for at least 30 days at room temperature 15º- 30ºC (59º- 86ºF), as well as at refrigerated temperature 2º- 8ºC (36º- 46ºF) [see USP].** It is recommended that the final compounded formulation be stored at refrigerated temperature 2º- 8ºC (36º- 46ºF).

FIRST® - PPI Suspension meets the requirements for total aerobic microbial count of not more than 100 cfu/mL, as well as for the absence of the specified microorganisms Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella spp, when tested as described in the current USP under < 61> Microbial Enumeration Tests and <62> Tests for Specified Microorganisms. FIRST® - PPI Suspension also meets the requirements as described in the current USP under <51> Antimicrobial Effectiveness Testing for Category 3 products.

When compounded and stored according to instructions, acid neutralizing capacity is maintained for at least 30 days.**

For oral use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. Compounded product, as dispensed, is stable for at least 30 days at room temperature, as well as at refrigerated temperature. It is recommended that the final compounded formulation be stored at refrigerated temperature.

How Supplied

FIRST - Lansoprazole Compounding Kits are available as follows:

3 FL OZ (90 mL) as dispensed       (NDC 65628-080-03)

5 FL OZ (150 mL) as dispensed       (NDC 65628-080-05)

10 FL OZ (300 mL) as dispensed       (NDC 65628-080-10)

*       Certificate of analysis on file

**       Data and documentation on file

Rx ONLY

Issued: December 2011

U.S. Patent Pending

Distributed By:

CUTISPHARMA, INC.

SMART PRODUCTS FOR SMART PEOPLE 

Woburn, MA 01801, USA www.cutispharma.com

PRINCIPAL DISPLAY PANEL

NDC 65628-080-03       Rx Only
FIRST® - Lansoprazole
Lansoprazole 3 mg/mL in FIRST® - PPI
Suspension Compounding Kit
Equivalent to active ingredient (Lansoprazole) contained in Simplified Lansoprazole
Suspension (SLS)
FOR PRESCRIPTION COMPOUNDING ONLY
Each kit contains:
Active Ingredients:
Lansoprazole 0.27 g
Inactive Ingredients:
Benzyl alcohol, FD&C red #40, flavor, hydroxyethylcellulose,
purified water, saccharin sodium, simethicone emulsion,
sodium bicarbonate, sodium citrate (dihydrate), sorbitol
solution, sucralose
3 FL OZ (90 mL) as dispensed