Re: Lupron Depo vs Lupron Depo-PED

[Guest guest]

Dear Tim,

Back in pharm tech school in 1984-1989 I was taught by a pharmacist who

is my idol to this day. He told me that most PEDS formulas are such

mainly because they do not contain benzyl alcohol and secondly because

of max strength or concentration to prevent overdosing. So those we my

first and second guesses. He also told us WHY! I pass it on to my

students as well.

But I had to prove it for you. I knew you were not about to take

my 'word' on it. So I gave it my best search ever. I had to go to abou

7 sites to find it. Since I knew what I was looking for it was easy.

But the person only looking for strength maynot find it.

Here is a bit of background on the drug/hormone analog for those

memebers/readers who are not familiar with it:

" Initially, LUPRON DEPOT, like other LH-RH agonists, causes increases

in serum levels of testosterone to approximately 50% above baseline

during the first week of treatment for prostate cancer. " Since this

increase in testoserone allows feedback to the hypothalamus, the master

gland or pituitary basically shuts off the message to the testes to

make testosterone. Testosterone can feed the protstate cancer. The

messages are two hormones from the pitutiary gland to the testes

called; luteinizing hormone and follicle-stimulating hormone.

Eventually these hormone levels drop and no testosterone is made.

As an Antineoplastic (anti Cancer) it is a Gonadotropin-releasing

hormone (GnRH) analog

Leuprolide is a synthetic nonapeptide analog of naturally occurring

gonadotropin releasing hormone (GnRH or LHRH). "

My words: In precocious puberty, (early puberty usually before age 8)

the fall in LH and FSH leads to the ovaries making less estrogen and

the testes making less testosterone, thus slowing the progression of

puberty.

1. Adult LUPRON DEPOT is usually given IM Depot while Pediatric is

usually given subcutaneously. IM has a 4 hour onset and the Ped is a 1

week onset

2. Another difference is in dosing:

Prostate Cancer Adult LUPRON DEPOT CAP: 1 mg subcutaneously daily or

7.5 mg I.M. monthly (depot injection). Or 22.5 mg I.M. q 3 months, 30

mg I.M. q 4 months, or one 72-mg implant q 12 months.

For endometriosis Adult LUPRON DEPOT can also be given 3.75 mg I.M.

monthly or 11.25 mg I.M. q 3 months as a single dose. Recommended

duration is 6 months or less.

Pediatric Use: See LUPRON DEPOT-PED CPP (leuprolide acetate for depot

suspension) labeling for the safety and effectiveness of the monthly

formulation in children with central precocious puberty.

Testosterone and estradiol are reduced to prepubertal levels in males

and females, respectively, and a reduction of gonadotropins will allow

for normal physical and psychological growth and development. Natural

maturation occurs when gonadotropins return to pubertal levels

following discontinuation of leuprolide.

Supplied 5mg/1ml

Adult for CAP 7.5, 22.5 and 30 mg

Ped for CPP 7.5 , 11.25 and 15 mg

3. I found that the Adult Lepron has benzyl alcohol, a preservative

that is customarily NOT found in children's formulas. Further the

children's formula does not have a warning for it (since it is not in

it!) This additive is the MAIN difference between adult and peds

formulation of Lupron as well as many other products.

" Lepron Peds.

The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg

prefilled dualchamber syringe contains leuprolide acetate (7.5/11.25/15

mg), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids

copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The

second chamber of diluent contains carboxymethylcellulose sodium (5

mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection,

USP, and glacial acetic

acid, USP to control pH. During the manufacture of LUPRON DEPOT-PED,

acetic acid is lost, leaving the peptide.

LUPRON DEPOT-PED is packaged as follows:

Kit with prefilled dual-chamber syringe 7.5 mg NDC 0300-2108-01

Kit with prefilled dual-chamber syringe 11.25 mg NDC 0300-2282-01

Kit with prefilled dual-chamber syringe 15 mg NDC 0300-2440-01 "

" LUPRON INJECTION is a s erile, aqueous solu ion in ended for daily

subcu aneous injec ion. I is available in a 2.8 mL mul iple dose vial

con aining leuprolide ace a e (5 mg/mL), sodium chloride, USP (6.3

mg/mL) for onici y adjus men , benzyl alcohol, NF as a preserva ive (9

mg/mL), and water for injec ion, USP. The pH may have been adjus ed wi

h sodium hydroxide, NF and/or ace ic acid, NF. "

" PRECAUTIONS

Patients with known allergies to benzyl alcohol, an ingredient of the

vehicle of LUPRON INJECTION, may present symptoms of hypersensitivity,

usually local, in the form of erythema and induration at the injection

site. "

Here are some references:

http://books.google.com/books?

id=KaegPx6LK2sC & pg=PA558 & lpg=PA558 & dq=Lupron+7.5mg+(for+adults)

+and+PED & source=web & ots=GOcWjad1Vs & sig=yXaIBLNNC9V5qPNl_Sx4NYJOywI & hl=en

& sa=X & oi=book_result & resnum=2 & ct=result#PPA559,M1

http://medical-dictionary.thefreedictionary.com/Lupron

Clinician's Pocket Reference by Leonard G. Gomella, A. Haist

Page 558-559

http://www.rxmed.com/b.main/b2.pharmaceutical/b2.1.monographs/CPS-%

20Monographs/CPS-%20(General%20Monographs-%20L)/LUPRON%20DEPOT.html

http://drugs-about.com/drugs/lupron/lupron-pediatric.pdf

I am including some thing I found for you on Benzyl Alcohol and

neonates:

" Benzyl Alcohol as Preservative for Intravenous Solutions

Benzyl alcohol is commonly used as an antibacterial agent in a variety

of formulations including bacteriostatic sodium chloride and

bacteriostatic water. Although benzyl alcohol toxicity has been

recognized, the concentration necessary for antibacterial action

appears to be much lower than the concentration that would be dangerous

to adults. Prior to these reports, little was known about the toxic

effects of benzyl alcohol in neonates.

The possible toxic effects of benzyl alcohol in neonates were noted

when several premature infants in neonatal intensive care units

developed similar clinical syndromes, referred to as the " gasping

syndrome, " characterized by deterioration of multiple organ systems and

eventual death.

http://pedsinreview.aappublications.org/cgi/content/abstract/6/5/139

" Newborns, especially if critically ill, may not metabolize benzyl

alcohol as readily as adults. Reports in the early 1980's of sixteen

neonatal deaths associated with the use of saline flush solutions

containing benzyl alcohol preservative led to recommendations to avoid

its use in neonates. "

http://en.wikipedia.org/wiki/Benzyl_alcohol

I do hope that this helps.

May I ask you what triggered your astute curiosity?

Respectfully,

Jeanetta Mastron CPhT BS

Pharm Tech Educator

Founder/Owner of this site

>

> i can not find the answer im looking for thought maybe someone on

here

> could help. What is the difference between Lupron 7.5mg (for adults)

and

> 7.5 mg PED? if anyone has some in site to this please let me know on

or

> off the list Thanks in advance

> --Tim

>

[Guest guest]

Thank you, working in medical oncology, and now back to retail, i wanted

to know if there was a reason for the 2 different drugs with the same

dose, weather or not it was for the company to have 2 brand name drugs

for different FDA reason ie zyban & wellbutrin Your the best i know that

i can always get the answer i need on here. IS there another list that

is more like questions and answer i would hate to impead on the learning

process with sometime stupid questions? just wondering keep up the good work

-- B. Macleod CPhT