Info on Avinza

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Drugs Approved by the FDA

Drug

Name: Avinza (morphine sulfate)

The

following information is obtained from various newswires, published medical

journal articles, and medical conference presentations.

Company:

Elan Corporation

Approval Status: Approved March 2002

Treatment for: Chronic pain

General

Information

Avinza was approved by the FDA in

March 2002 for the treatment of moderate to severe chronic pain in patients

that require continuous, around-the-clock therapy for an extended period of

time. A once-daily dose of Avinza in the extended

release capsule formulation provides relief from pain for a 24-hour period. Avinza is available in 30, 60, 90 and 120 mg capsules.

This

product was developed by Elan Corporation and will be

marketed in the U.S.

and Canada by Ligand Pharmaceuticals.

Clinical

Results

Controlled

and open-label clinical trials were conducted to test the safety and efficacy

of Avinza. A total of approximately 140 healthy

subjects and 560 subjects with chronic, moderate-to-severe pain from malignant

and non-malignant disease sources were involved in these studies. The duration

of the controlled clinical studies ranged from seven days to up to four weeks.

Subjects in the open-label studies were observed for six to 12 months.

In one

study, 295 subjects with chronic pain from osteoarthritis received either

placebo or once-daily treatment with Avinza 30 mg in

the morning or evening. Results showed that Avinza

was significantly more effective at reducing pain than placebo.

Pharmacokinetic

studies indicated that the amount of morphine absorbed from Avinza

extended-release formulation was similar to that absorbed from other oral

morphine formulations. Furthermore, the pharmacokinetics of Avinza

were shown to be dose-proportional for both healthy

subjects and subjects with moderate-to-severe pain.

Side

Effects

The

most common side effects reported by subjects in clinical trials were:

o

constipation

o

nausea

o

somnolence

o

vomiting

o

headache

These

side effects were dose-dependent.

Mechanism

of Action

Avinza is made up of two components:

an immediate-release component that rapidly achieves plateau morphine

concentrations in plasma, and an extended-release component that maintains

plasma concentrations throughout the 24-hour dosing interval. Avinza creates and maintains the plateau-like plasma

concentration profile after steady-state plasma morphine concentrations have

been achieved.

Do not take AVINZA if your healthcare provider did not prescribe AVINZA

for you or if:

· you

have severe asthma or severe lung problems.

· you

have had a severe allergic reaction to

morphine. A severe allergic reaction includes a severe rash,

hives, breathing problems, or dizziness.

Your healthcare provider should know about all your

medical conditions before deciding if AVINZA is right for you and what dose is best. Only you and your

healthcare provider can decide if AVINZA is right for you.

Tell your healthcare provider about all of your medical problems, especially the ones listed below:

· trouble breathing or lung problems

· recent head injury or

concussion

· liver or kidney problems

· adrenal gland problems, such as 's disease

· convulsions or

seizures

· alcoholism

· hallucinations or

other severe mental problems

· past or present substance abuse or

drug addiction

Tell your healthcare provider about all the medicines

you take, including prescription and non-prescription

medicines, vitamins, and herbal supplements. They may cause serious medical problems

when taken with AVINZA, especially

if they cause drowsiness.

How Should You Take AVINZA?

· Follow your healthcare provider's directions exactly. Your healthcare provider may change your dose based on your reactions to the medicine. Do not

change your dose unless your healthcare provider tells you to change it. Do

not take AVINZA more often than prescribed.

· Try to take AVINZA at the

same time each day.

· Do

not crush, dissolve, or chew the contents (beads) of the capsules

before swallowing.

If the capsule beads are not swallowed whole, your body will absorb too much medicine at one time. This can lead to serious problems, including overdose and death.

· AVINZA

capsules may be opened and the entire bead

contents sprinkled on a small amount of applesauce immediately prior to eating.

· If

you miss a dose, take it as soon as possible. If it is

almost time for your next dose, skip the

missed dose and go back to your regular dosing

schedule. Do not take 2 doses at once unless

instructed by your healthcare provider. If uncertain about your dosing, call

your healthcare provider.

· In case of overdose, call your local emergency number or poison control center right away.

· Regularly

review your pain symptoms with your healthcare provider.

· Consult

your healthcare provider for instructions on how to stop taking this medicine slowly to avoid

uncomfortable symptoms. You should not stop taking AVINZA all at once if you have been taking

it for more than a few days.

· If you are

instructed to stop taking AVINZA, flush the unused

capsules down the toilet.

What Should You Avoid While

Taking AVINZA?

· Do

not drive, operate heavy machinery, or

participate in any other possibly dangerous activities until

you know how you react to this medicine. AVINZA can make you drowsy.

· Do

not drink alcohol while using AVINZA. It may

increase the chance of having dangerous side effects.

· Do

not take other medicines without your

healthcare provider's approval. Other medicines

include prescription and non-prescription medicines, vitamins, and supplements.

Be especially careful about products that make you

drowsy.

Call Your Healthcare Provider

Or Get Medical Help Right Away If

· your breathing slows down or becomes

difficult

·you feel faint,

dizzy, confused, or have any other unusual symptoms

What are the Possible Side

Effects of AVINZA?

Some of the common side effects of AVINZA

are constipation, nausea, drowsiness, and itching. Some of these side effects may decrease with continued use. These

are not all the possible side effects of AVINZA.

Constipation is a common side effect of opioids, including AVINZA.

You may wish to discuss steps to prevent or relieve constipation with your healthcare provider.

There is a risk of abuse or addiction with narcotic painkillers. If you have

abused drugs in the past, you may have a higher chance of developing an abuse problem or addiction again while using AVINZA. It is not known how often patients

with continuing (chronic) pain become

addicted to narcotics, but the risk has been

reported to be small.

This leaflet summarizes the most important

information about AVINZA. If you

would like more information, talk with your healthcare provider or pharmacist.

Hugs,

Deanna

[Guest guest]

Now why couldn't I find that? lol. Thank you Deanna. It sounds terrible reading about it but I haven't felt this good in years and haven't had any of the side affects at all. I guess since it is new they must not know what it does to things like your liver over the course of years?

a C