PROMETHAZINE VC WITH CODEINE- promethazine and phenylephrine hydrochloride and codeine phosphate solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J), PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Mevcut itibaren:

Par Pharmaceutical

INN (International Adı):

CODEINE PHOSPHATE

Kompozisyon:

CODEINE PHOSPHATE 10 mg in 5 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Promethazine VC with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, 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 VC with Codeine Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough h

Ürün özeti:

Promethazine VC with Codeine Oral Solution (promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate 6.25 mg/5 mL, 5 mg/5 mL, 10 mg/5 mL; and 7% alcohol) is a clear, reddish-orange oral solution supplied as: NDC 0603-1588-54 4 fluid ounce (118 mL) bottle NDC 0603-1588-58 1 pint (473 mL) bottle Keep bottles tightly closed. Store at 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature] Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. 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. DEA Order Form Required

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

PROMETHAZINE VC WITH CODEINE- PROMETHAZINE AND PHENYLEPHRINE
HYDROCHLORIDE AND
CODEINE PHOSPHATE SOLUTION
Par Pharmaceutical
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MEDICATION GUIDE
PROMETHAZINE (proe METH a zeen) VC WITH CODEINE (KOE deen) ORAL
SOLUTION
(promethazine hydrochloride, phenylephrine hydrochloride, and codeine
phosphate)
oral solution, CV
What is the most important information I should know about
PROMETHAZINE VC WITH CODEINE
ORAL SOLUTION?
PROMETHAZINE VC WITH CODEINE ORAL SOLUTION is not for children under
18 years of age.
PROMETHAZINE VC WITH CODEINE ORAL SOLUTION can cause serious side
effects, including:
•
Addiction, abuse and misuse. Taking PROMETHAZINE VC WITH CODEINE 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 VC
WITH CODEINE 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 VC WITH CODEINE ORAL SOLUTION with
other people.
•
Keep PROMETHAZINE VC WITH CODEINE ORAL SOLUTION in a safe place away
from children.
•
Life-threatening breathing problems (respiratory depression).
PROMETHAZINE VC WITH
CODEINE 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 VC WITH CODEINE 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 VC WITH
CODEINE ORAL SOLUTION exactly as prescribed by your healthcare
provider.
Call your healthcare provider or get emergency medical help right away
if anyone taking
PROMETHAZINE

Ürün özellikleri

PROMETHAZINE VC WITH CODEINE- PROMETHAZINE AND PHENYLEPHRINE
HYDROCHLORIDE AND
CODEINE PHOSPHATE SOLUTION
PAR PHARMACEUTICAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROMETHAZINE VC WITH CODEINE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PROMETHAZINE VC WITH CODEINE
ORAL SOLUTION.
PROMETHAZINE VC WITH CODEINE ORAL SOLUTION (PROMETHAZINE
HYDROCHLORIDE, PHENYLEPHRINE
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 VC WITH CODEINE 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 VC WITH CODEINE 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 VC
WITH CODEINE ORAL SOLUTION IS CONTRAINDICATED IN CHILDREN YOUNGER THAN
12 YEARS OF AGE AND IN CHILDREN
YOUNGER THAN 18 YEARS OF AGE FOLLOWING T