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Drug Facts | TRAMADOL HYDROCHLORIDE [Alivio Medical Products, LLC] | BioPortfolio

13:38 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Each capsule contains:

Tramadol Hydrochloride, USP ..........50 mg

Usual Dosage:  For dosage and other prescribing

information, see accompanying insert.

Store at 20 to 25 C (68 to 77 F); excursions

permitted to 15 to 30 C (59 to 86 F)[See

USP Controlled Room Temperature]

Dispense in a tight container as defined in

the USP.

Keep out of reach of children.

DESCRIPTION

Tramadol hydrochloride tablets, USP are a centrally acting analgesic.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS    Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid

analgesic.

CLINICAL STUDIES

Tramadol hydrochloride has been given in single oral doses pf 50, 75 and 100 mg to patients with pain

following surgical procedures and pain following oral surgery (extraction if impacted molars).

INDICATIONS AND USAGE

Tramadol hydrochloride tablets, USP are indicated for the management of moderate to

moderately severe pain in adults.

CONTRAINDICATIONS

Tramadol hydrochloride tablets, USP should not be administered to patients who have previously

demonstrated hypersensitivity to tramadol, any other component of this product or opoids.

WARNINGS

Seizure Risk   Seizures have been reported in patients receiving Tramadol hydrochloride within the

recommended dosage range.

PRECAUTIONS

Acute Abdominal Conditions   The administration of tramadol hydrochloride may complicate the clinical assessment

of patients with acute abdominal conditions

ADVERSE REACTIONS

Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label

extension periods in U.S. clinical studies of chronic nonmalignant pain.

DRUG ABUSE AND DEPENDENCE.

Abuse   Tramadol has mu-opoid agonist activity.

OVERDOSAGE

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to

stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures,

bradycardia, hypotension, cardiac arrest, and death.

DOSAGE AND ADMINISTRATION

Adults (17 years of age and older)    For patients with moderate to moderately severe chronic pain not

requiringrapid onset of analgesic effect, the tolerability of tramadol hydrochloride, USP can be improved by

initiating therapy with a titration regimen:

Manufacturer

Alivio Medical Products, LLC

Active Ingredients

Source

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Clinical Trials [2329 Associated Clinical Trials listed on BioPortfolio]

Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets

The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®. In o...

An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain

The purpose of this study is to find the clinical dose range of an active ingredient of JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient analgesic ef...

Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac

The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combinatio...

Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants

The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in ...

A Comparative Study on Tramadol 37.5mg/Acetaminophen 325mg Tablets Maintenance Versus Non-steroidal Anti-inflammatory Drugs(NSAIDs) Maintenance in Patients With Knee Osteoarthritis

The purpose of this study is to compare the effectiveness of tramadol 37.5mg/acetaminophen 325mg maintenance with that of NSAID maintenance in patients whose pain was relieved after the ad...

PubMed Articles [246 Associated PubMed Articles listed on BioPortfolio]

Tramadol hydrochloride: An alternative to conventional local anaesthetics for intraoral procedures- a preliminary study.

To evaluate and compare the soft tissue anaesthesia produced by tramadol hydrochloride on gingival tissues in maxilla.

A Disposition Kinetic Study of Tramadol in Intoxicated Rats Induced by Ethanol and Acetaminophen in Perfused Rat Liver Model.

Damage to the liver can lead to changes in the metabolism of tramadol. In this study, the rate of tramadol metabolites in rats with damaged liver induced by ethanol and acetaminophen were assessed in ...

Serotonin and norepinephrine transporter occupancy of tramadol in non-human primate using positron emission tomography.

Tramadol, a centrally acting analgesic drug, has relatively high affinity to serotonin transporter (5-HTT) and norepinephrine transporter (NET) in addition to μ-opioid receptor. Based on this charact...

Seizures in tramadol overdoses reported in the ToxIC registry: predisposing factors and the role of naloxone.

Tramadol prescriptions have increased as fewer schedule II and III drugs are prescribed. There has been a concomitant increase in overdoses and adverse events recorded in the National Poison Data Syst...

An overview of tramadol and its usage in pain management and future perspective.

Patients with chronic non-malignant pain report impairment of physical and social life along with psychological state affecting their overall quality of life. The purpose of managing pain is to reduce...

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