CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE- carisoprodol, aspirin and codeine phosphate tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Inapatikana kutoka:

Eon Labs, Inc.

INN (Jina la Kimataifa):

CARISOPRODOL

Tungo:

CARISOPRODOL 200 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitations of Use Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see DOSAGE AND ADMINISTRATION ). Carisoprodol, Aspirin and Codeine Phosphate Tablets are contraindicated for: • All children younger than 12 years of age (see WARNINGS) • Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ). Carisoprodol, Aspirin and Codeine Phosphate Tablets are also contraindicated in patients with: Carisoprodol, Aspirin, and Codeine Phosphate Tablets contains codeine. Codeine in combination with carisoprodol and aspirin is a Schedule III

Bidhaa muhtasari:

Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as: Carisoprodol 200 mg, Aspirin 325 mg and Codeine Phosphate 16 mg, round, two-layered yellow and white tablets; imprinted "E 749" and are available in bottles of 100, 500, and 1000. NDC 0185-0749-01, bottles of 100 tablets NDC 0185-0749-05, bottles of 500 tablets NDC 0185-0749-10, bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Rev. August 2018 MF0749REV08/18

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

PHOSPHATE TABLET
Eon Labs, Inc.
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MEDICATION GUIDE
Medication Guide
Carisoprodol (kar-eye-soe-PROE-dol), Aspirin (ASS-per-in), and Codeine
Phosphate (koe-DEEN
fos-feyt) Tablets, CIII
Carisoprodol, Aspirin, and Codeine Phosphate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is indicated for the relief
of discomfort associated with acute, painful musculoskeletal
conditions in adults, when other pain
treatments such as non-opioid pain medicines do not treat your pain
well enough or you cannot
tolerate them.
•
An 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.
Carisoprodol, Aspirin and Codeine Phosphate Tablets should only be
used for up to 2 or 3 weeks. It
is not known if Carisoprodol, Aspirin and Codeine Phosphate Tablets is
effective when used for
longer periods.
Important information about Carisoprodol, Aspirin, and Codeine
Phosphate Tablets:
•
Get emergency help right away if you take too much Carisoprodol,
Aspirin, and Codeine Phosphate
Tablets (overdose). When you first start taking Carisoprodol, Aspirin,
and Codeine Phosphate
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 Carisoprodol, Aspirin, and Codeine Phosphate 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 Carisoprodol, Aspirin, and Codeine
Phosphate Tablets. They could die
from taking it. Store Carisoprodol, Aspirin, and Codeine Phosphate
Tablets away from children and
in a safe place to prevent stealing or abuse. Selling or giving away
Carisoprodol, Aspirin, and
Codeine Phosphate Tablets is against the law.
Important Informatio

Tabia za bidhaa

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE- CARISOPRODOL, ASPIRIN AND
CODEINE
PHOSPHATE TABLET
EON LABS, INC.
----------
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS USP, CIII
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE. RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF
CODEINE AND OTHER RISK FACTORS FOR LIFE- THREATENING RESPIRATORY
DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME;
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS EXPOSE PATIENTS
AND OTHER USERS TO
THE RISKS OF OPIOID ADDICTION, ABUSE AND MISUSE, WHICH CAN LEAD TO
OVERDOSE AND DEATH.
ASSESS EACH PATIENT’S RISK PRIOR TO PRESCRIBING CARISOPRODOL,
ASPIRIN AND CODEINE
PHOSPHATE TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE
DEVELOPMENT OF THESE
BEHAVIORS AND CONDITIONS (SEE WARNINGS).
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE,
AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A REMS
FOR THESE
PRODUCTS(SEE WARNINGS). UNDER THE REQUIREMENTS OF THE REMS, DRUG
COMPANIES WITH
APPROVED OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION
PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR
RESPIRATORY DEPRESSION,
ESPECIALLY DURING INITIATION OF CARISOPRODOL, ASPIRIN AND CODEINE
PHOSPHATE TABLETS OR
FOLLOWING A DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF CARISOPRODOL, ASPIRIN AND
CODEINE PHOSPHATE
TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
C