TRAMADOL HCL ER- tramadol hcl tablet, extended release TRAMADOL HYDROCHLORIDE tablet, extended release TRAMADOL HYDROCHLORIDE

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

Available from:

DIRECT RX

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride extended-release tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time Tramadol hydrochloride extended-release tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride extended-release tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride extended-release tablets may worsen central nervous system and respiratory depression in these patients. - Tramadol hydrochloride extended-release tablet 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 c

Product summary:

Tramadol hydrochloride extended-release tablets are supplied in the following package and dose strength forms: 100 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “531” with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap ……………... NDC 47335-859-83 Bottles of 100's with Child Resistant Cap ……………. NDC 47335-859-88 Bottles of 100's with Non Child Resistant Cap ……… NDC 47335-859-08 Bottles of 1000's with Non Child Resistant Cap …….. NDC 47335-859-18 200 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “533” with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap ……………... NDC 47335-860-83 Bottles of 100's with Child Resistant Cap ……………. NDC 47335-860-88 Bottles of 100's with Non Child Resistant Cap ……… NDC 47335-860-08 Bottles of 1000's with Non Child Resistant Cap …….. NDC 47335-860-18 300 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “537” with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap ……………... NDC 47335-861-83 Bottles of 100's with Child Resistant Cap ……………. NDC 47335-861-88 Bottles of 100's with Non Child Resistant Cap ……… NDC 47335-861-08 Bottles of 1000's with Non Child Resistant Cap …….. NDC 47335-861-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container. Warning: keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAMADOL HCL ER- TRAMADOL HCL TABLET, EXTENDED RELEASE
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
DIRECT RX
----------
Medication Guide
Tramadol Hydrochloride Extended-Release Tablets , CIV
(tram' a dol hye'' droe klor' ide)
Tramadol hydrochloride extended-release tablets are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require daily around-the-clock, long-term treatment with an
opioid, when other pain treatments
such as non-opioid pain medicines or immediate-release opioid
medicines do not treat your pain well
enough or you cannot tolerate them.
A long-acting (extended-release) opioid pain medicine that can put you
at risk for overdose and death.
Even if you take your dose correctly as prescribed you are at risk for
opioid addiction, abuse, and misuse
that can lead to death.
Not for use to treat pain that is not around-the-clock.
Important information about tramadol hydrochloride extended-release
tablets:
Get emergency help right away if you take too much tramadol
hydrochloride extended-release tablets
(overdose) . When you first start taking tramadol hydrochloride
extended-release tablets, when your dose
is changed, or if you take too much (overdose), serious or
life-threatening breathing problems that can
lead to death may occur.
Taking tramadol hydrochloride extended-release tablets with other
opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
Never give anyone else your tramadol hydrochloride extended-release
tablets. They could die from taking
it. Selling or giving away tramadol hydrochloride extended-release
tablets is against the law.
Store tramadol hydrochloride extended-release tablets securely, out of
sight and reach of children, and in
a location not accessible by others, including visitors to t

Summary of Product characteristics

TRAMADOL HCL ER- TRAMADOL HCL TABLET, EXTENDED RELEASE
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
DIRECT RX
----------
TRAMADOL HYDROCHLORIDE
DESCRIPTION SECTION
Tramadol hydrochloride is a centrally acting synthetic analgesic in an
extended-release
formulation. The chemical name is (±)cis-2-[(dimethylamino)
methyl]-1-(3-
methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
Figure 1
The molecular weight of tramadol hydrochloride is 299.84. It is a
white, crystalline
powder that is freely soluble in water and methanol, very slightly
soluble in acetone and
has a pKa of 9.41. The n-octanol/water log partition coefficient
(logP) is 1.35 at pH 7.
Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg
or 300 mg of
tramadol hydrochloride, USP in an extended-release formulation. The
tablets are white in
color and contain the inactive ingredients pregelatinized maize
starch, hypromellose,
mannitol, magnesium stearate, cellulose acetate and polyethylene
glycol.
Imprinting ink contains, shellac glaze, iron oxide black, N-butyl
alcohol, ammonium
hydroxide and propylene glycol.
CLINICAL PHARMACOLOGY SECTION
12.1 Mechanism of Action
Tramadol hydrochloride tablets contains tramadol, an opioid agonist
and inhibitor of
norepinephrine and serotonin re-uptake. Although the mode of action is
not completely
understood, the analgesic effect of tramadol is believed to be due to
both binding to μ-
opioid receptors and weak inhibition of re-uptake of norepinephrine
and serotonin.
Opioid activity is due to both low affinity binding of the parent
compound and higher
affinity binding of the O-demethylated metabolite M1 to μ-opioid
receptors. In animal
models, M1 is up to 6 times more potent than tramadol in producing
analgesia and 200
times more potent in μ-opioid binding. Tramadol-induced analgesia is
only partially
antagonized by the opioid antagonist naloxone in several animal tests.
The relative
contribution of