ZYTRAM XL Controlled release tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ZYTRAM XL Tramadol Hydrochloride Controlled Release Tablets.

Indications and clinical use

ZYTRAM XL (tramadol hydrochloride controlled release tablets) is indicated for the management of moderate to moderately severe pain in adults who require continuous treatment for several days or more. ...

Contraindications

ZYTRAM XL is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete ...

Warnings and precautions

General Patients should be instructed not to give ZYTRAM XL to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death. ...

Adverse reactions

8.1 Adverse Reaction Overview Adverse effects of ZYTRAM XL are similar to those of other opioid analgesics, and represent an extension of pharmacological effects of the drug class. The major hazards associated ...

Drug interactions

9.1 Serious Drug Interactions Box Risks from concomitant use of opioids and benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory ...

Dosage and administration

4.1 Dosing Considerations All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. For the management of chronic non-cancer, nonpalliative ...

Overdosage

For management of a suspected drug overdose, contact your regional poison control centre immediately. Deaths due to overdose have been reported with abuse and misuse of tramadol, by ingesting, inhaling, ...

Action and clinical pharmacology

10.1 Mechanism of Action Tramadol 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 ...

Storage and stability

Store ZYTRAM XL tablets at room temperature (15°C 30°C). Protect from light, moisture and high humidity. Disposal ZYTRAM XL should never be disposed of in household trash. Disposal via a pharmacy ...

Special handling instructions

ZYTRAM XL should be kept in a safe place, such as under lock and out of the sight and reach of children before, during and after use. ZYTRAM XL should not be used in front of children, since they may copy ...

Dosage forms, composition and packaging

Table 1. Dosage Forms, Strengths, Composition and Packaging: Route of Administration Dosage Form/Strength/Composition Non-medicinal Ingredients Oral Controlled release tablets/75 mg, 100 mg, 150 ...

Pharmaceutical information

Drug Substance Proper name: Tramadol Hydrochloride Chemical name: (1 RS, 2 RS)- 2-[(dimethylamino)methyl]- 1-(3- methoxyphenyl) cyclohexanol hydrochloride Molecular formula and molecular mass: C16 ...

Clinical trials

14.1 Trial Design and Study Demographics ZYTRAM XL (tramadol hydrochloride controlled release tablets) was demonstrated to be effective in the treatment of various types of chronic pain, such as osteoarthritis ...

Toxicology

General Toxicology After a single oral administration in mice, rats, guinea pigs, rabbits and dogs, the LD50 of tramadol was 228-850 mg/kg; after s.c. injection in mice, rats and guinea pigs ...

Serious warnings and precautions box

Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the risks of overdose and death with extended-release opioid formulations, ...

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