ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520)

Հասանելի է:

RedPharm Drug Inc.

INN (Միջազգային անվանումը):

ACETAMINOPHEN

Կազմը:

ACETAMINOPHEN 300 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications. Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Clinical studies of lorazepam generally were not adequate

Ապրանքի ամփոփագիր:

Lorazepam Tablets USP are available in the following dosage strengths: 0.5 mg: white, scored, round flat faced beveled edge, debossed with 240 over 0.5 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000. 1 mg: white, scored, round flat faced beveled edge, debossed with 241 over 1 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000. 2 mg: white, scored, round flat faced beveled edge, debossed with 242 over 2 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Revised: June 2008 0608B 173019

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ACETAMINOPHEN AND CODEINE PHOSPHATE - ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
REDPHARM DRUG INC.
----------
LORAZEPAM TABLET
PRECAUTIONS
GENERAL
Acetaminophen and codeine phosphate tablets should be prescribed with
caution in certain special-risk
patients, such as the elderly or debilitated, and those with severe
impairment of renal or hepatic
function, head injuries, elevated intracranial pressure, acute
abdominal conditions, hypothyroidism,
urethral stricture, Addison's disease, or prostatic hypertrophy.
Ultra-Rapid Metabolizers of Codeine
Some individuals may be ultra-rapid metabolizers due to a specific
CYP2D6 2x2 genotype. These
individuals convert codeine into its active metabolite, morphine, more
rapidly and completely than other
people. This rapid conversion results in higher than expected serum
morphine levels. Even at labeled
dosage regiments, individuals who are ultra-rapid metabolizers may
experience overdose symptoms
such as extreme sleepiness, confusion or shallow breathing.
The prevalence of this CYP2D6 phenotype varies widely and has been
estimated at 0.5 to 1% in
Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians,
3% in African Americans, and 16
to 28% in North Africans, Ethiopians and Arabs. Data is not available
for other ethnic groups.
When physicians prescribe codeine-containing drugs, they should choose
the lowest effective dose for
the shortest period of time and should inform their patients about
these risks and the signs of morphine
overdose (see PRECAUTIONS, NURSING MOTHERS).
INFORMATION FOR PATIENTS
Caution patients that some people have a variation in a liver enzyme
and change codeine into morphine
more rapidly and completely than other people. These people are
ultra-rapid metabolizers and are more
likely to have higher-than-normal levels of morphine in their blood
after taking codeine which can
result in overdose symptoms such as extreme sleepiness, confusion, or
shallow breathing. In most
cases, it is unknown if someone is an ultra-rapid codeine metabolizer.
Nurs