INFO - On Ultram ER (tramadol HCl extended-release) from the manufacturer

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Ultram ER (tramadol HCl extended-release)

Excerpts:

ULTRAM® ER, like other opioids, can be abused or cause dependence.

People who are suicidal or have a history of drug addiction should not

take ULTRAM® ER. Do not take more than the recommended dose of

ULTRAM® ER. Taking more than the recommended dose of ULTRAM® ER,

alone or in combination with alcohol or medications such as

tranquilizers, hypnotics or other opioids, can cause respiratory

depression, seizures, overdose and possibly death.

http://www.ultram-er.com/ultram-er/isi.html

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CLINICAL PHARMACOLOGY

Mechanism of Action

ULTRAM ER is a centrally acting synthetic opioid analgesic. Although

its mode of action is not completely understood,

from animal tests, at least two complementary mechanisms appear

applicable: binding of parent and M1 metabolite

to ì-opioid receptors and weak inhibition of reuptake of

norepinephrine and serotonin.

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DRUG ABUSE AND ADDICTION

ULTRAM ER is a mu-agonist opioid. Tramadol, like other opioids used in

analgesia, can be abused and is

subject to criminal diversion.

Drug addiction is characterized by compulsive use, use for non-medical

purposes, and continued use despite harm or

risk of harm. Drug addiction is a treatable disease, utilizing a

multi-disciplinary approach, but relapse is common.

" Drug-seeking " behavior is very common in addicts and drug abusers.

Drug-seeking tactics include emergency calls

or visits near the end of office hours, refusal to undergo appropriate

examination, testing or referral, repeated " loss "

of prescriptions, tampering with prescriptions and reluctance to

provide prior medical records or contact information

for other treating physician(s). " Doctor shopping " to obtain

additional prescriptions is common among drug abusers

and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence

and tolerance. Physicians should be aware

that addiction may not be accompanied by concurrent tolerance and

symptoms of physical dependence in all addicts.

In addition, abuse of opioids can occur in the absence of true

addiction and is characterized by misuse for non-medical

purposes, often in combination with other psychoactive substances.

ULTRAM ER, like other opioids, may be diverted

for non-medical use. Careful record-keeping of prescribing

information, including quantity, frequency, and renewal

requests is strongly advised.

Proper assessment of the patient, proper prescribing practices,

periodic re-evaluation of therapy, and proper

dispensing and storage are appropriate measures that help to limit

abuse of opioid drugs.

ULTRAM ER is intended for oral use only. The crushed tablet poses a

hazard of overdose and death. This risk is

increased with concurrent abuse of alcohol and other substances. With

parenteral abuse, the tablet excipients can be

expected to result in local tissue necrosis, infection, pulmonary

granulomas, and increased risk of endocarditis and

valvular heart injury. Parenteral drug abuse is commonly associated

with transmission of infectious diseases such as

hepatitis and HIV.

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Labor and Delivery

ULTRAM ER should not be used in pregnant women prior to or during

labor unless the potential benefits outweigh the

risks. Safe use in pregnancy has not been established. Chronic use

during pregnancy may lead to physical dependence

and post-partum withdrawal symptoms in the newborn (see DRUG ABUSE AND

ADDICTION). Tramadol has been

shown to cross the placenta. The mean ratio of serum tramadol in the

umbilical veins compared to maternal veins was

0.83 for 40 women treated with tramadol HCl during labor.

The effect of ULTRAM ER, if any, on the later growth, development, and

functional maturation of the child is unknown.

http://www.ultram-er.com/ultram-er/shared/pi/ultramer.pdf

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