CODEINE SULFATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CODEINE SULFATE (UNII: 11QV9BS0CB) (CODEINE - UNII:Q830PW7520)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

CODEINE SULFATE

Sammensetning:

CODEINE SULFATE 60 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Codeine sulfate is an opioid analgesic indicated for the relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate. Codeine sulfate is contraindicated in patients with known hypersensitivity to codeine or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine. Codeine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Codeine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Codeine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. Enter section text here Codeine sulfate is an opioid agonist and is a Schedule II controlled substance. Codeine sulfate 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

Produkt oppsummering:

Codeine Sulfate NDC 54868-2541-0: Bottles of 10 Tablets NDC 54868-2541-1: Bottles of 30 Tablets NDC 54868-2541-2: Bottles of 60 Tablets Storage Store at Controlled Room Temperature, 15º to 30ºC (59º to 86ºF). Protect from moisture and light. Dispense in well-closed container as defined in the USP/NF. All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

Autorisasjon status:

New Drug Application

Preparatomtale

CODEINE SULFATE - CODEINE SULFATE TABLET
PHYSICIANS TOTAL CARE, INC.
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1 INDICATIONS AND USAGE
Codeine sulfate is an opioid analgesic indicated for the relief of
mild to moderately severe pain where
the use of an opioid analgesic is appropriate.
2 DOSAGE AND ADMINISTRATION
Selection of patients for treatment with codeine sulfate should be
governed by the same principles that
apply to the use of similar opioid analgesics. Physicians should
individualize treatment in every case,
using non-opioid analgesics, opioids on an as needed basis and/or
combination products, and chronic
opioid therapy in a progressive plan of pain management.
2.1 Individualization of Dosage
As with any opioid drug product, adjust the dosing regimen for each
patient individually, taking into
account the patient’s prior analgesic treatment experience. In the
selection of the initial dose of codeine
sulfate, attention should be given to the following:
• the total daily dose, potency and specific characteristics of the
opioid the patient has been taking
previously;
• the reliability of the relative potency estimate used to calculate
the equivalent codeine sulfate dose
needed;
• the patient’s degree of opioid tolerance;
• the general condition and medical status of the patient;
• concurrent medications;
• the type and severity of the patient’s pain;
• risk factors for abuse, addiction or diversion, including a prior
history of abuse, addiction or
diversion.
The following dosing recommendations, therefore, can only be
considered suggested approaches to
what is actually a series of clinical decisions over time in the
management of the pain of each individual
patient.
Continual re-evaluation of the patient receiving codeine sulfate is
important, with special attention to the
maintenance of pain control and the relative incidence of side effects
associated with therapy. During
chronic therapy, especially for noncancer-related pain, the continued
need for the use of opioid
analgesics should be re-assessed as appropriate.
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