PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Boleh didapati daripada:

Nostrum Laboratories, Inc.

INN (Nama Antarabangsa):

PROMETHAZINE HYDROCHLORIDE

Komposisi:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Promethazine Hydrochloride and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use - Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) and Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) and Use in Specific Populations (8.4) ]. - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Promethazine Hydrochloride and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outw

Ringkasan produk:

Promethazine Hydrochloride and Codeine Phosphate Oral Solution, 6.25 mg and 10 mg per 5 mL, is supplied in a clear green, pineapple flavored oral solution and is available as follows: NDC 70408-185-31 4 fl. oz. (118 mL) NDC 70408-185-34 16 fl. oz. (473 mL) Keep bottles tightly closed. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container as defined in the USP with a child-resistant closure. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters.  Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION
Nostrum Laboratories, Inc.
----------
MEDICATION GUIDE
Promethazine (proe METH a zeen) Hydrochloride and Codeine (KOE deen)
Phosphate Oral Solution C-V
What is the most important information I should know about
Promethazine Hydrochloride and Codeine
Phosphate Oral Solution?
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is not
for children under 18 years of
age.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution can
cause serious side effects,
including:
•
Addiction, abuse and misuse. Taking Promethazine Hydrochloride and
Codeine Phosphate Oral
Solution or other medicines that contain an opioid can cause
addiction, abuse, and misuse, which
can lead to overdose and death. This can happen even if you take
Promethazine Hydrochloride and
Codeine Phosphate Oral Solution exactly as prescribed by your
healthcare provider. Your risk of
addiction, abuse, and misuse is increased if you or a family member
has a history of drug or
alcohol abuse or addiction, or mental health problems.
•
Do not share your Promethazine Hydrochloride and Codeine Phosphate
Oral Solution with
other people.
•
Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in
a safe place
away from children.
•
Life-threatening breathing problems (respiratory depression).
Promethazine Hydrochloride and
Codeine Phosphate Oral Solution can cause breathing problems
(respiratory depression) that can
happen at any time during treatment and can lead to death. Your risk
of breathing problems is
greatest when you first start taking Promethazine Hydrochloride and
Codeine Phosphate Oral
Solution, are taking other medicines that can cause breathing
problems, have certain lung
problems, are elderly or have certain other health problems. Children
are at higher risk for
respiratory depression. Breathing problems can happen even if you take
Promethazine
Hydrochloride and Codeine Phosphate Oral Solution exactly as
presc

Ciri produk

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION
NOSTRUM LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROMETHAZINE HYDROCHLORIDE AND
CODEINE PHOSPHATE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION.
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 1952
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK
FACTORS
FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE
AND
RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS
WITH DRUGS
AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH
BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION EXPOSES
USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND MONITOR CLOSELY FOR THESE BEHAVIORS AND CONDITIONS.
(5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR WHEN USED IN PATIENTS AT HIGHER RISK. (5.2)
ACCIDENTAL INGESTION OF PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE ORAL SOLUTION, ESPECIALLY
BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF CODEINE. (5.2)
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED CODEINE;
MOST CASES FOLLOWED TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF
THE CHILDREN HAD EVIDENCE OF
BEING AN ULTRA-RAPID METABOLIZER OF CODEINE DUE TO A CYP2D6
POLYMORPHISM. (5.3) PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION IS CONTRAINDICATED
IN CHILDREN YOUNGER THAN 12
YEARS OF AGE AND IN CHILDREN YOUNG