PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine with Codeine 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 and/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 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 has been made. Promethazine with C

Product summary:

Promethazine with Codeine Oral Solution (Promethazine HCl and Codeine Phosphate Oral Solution), 6.25 mg and 10 mg per 5 mL, is a clear, purple solution, supplied as: NDC 0603-1585-54                4 fluid ounce (118 mL) bottle NDC 0603-1585-58                1 Pint (473 mL) bottle 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 (USP/NF) 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. DEA Order Form Required

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
Par Pharmaceutical
----------
MEDICATION GUIDE
PROMETHAZINE WITH CODEINE (proe METH a zeen with KOE deen) ORAL
SOLUTION
(promethazine hydrochloride and codeine phosphate)
oral solution, C-V
What is the most important information I should know about
PROMETHAZINE WITH CODEINE
ORAL SOLUTION?
PROMETHAZINE WITH CODEINE ORAL SOLUTION is not for children under 18
years of age.
PROMETHAZINE WITH CODEINE ORAL SOLUTION can cause serious side
effects, including:
•
Addiction, abuse and misuse. Taking PROMETHAZINE 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
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 WITH CODEINE ORAL SOLUTION with other
people.
•
Keep PROMETHAZINE WITH CODEINE ORAL SOLUTION in a safe place away from
children.
•
Life-threatening breathing problems (respiratory depression).
PROMETHAZINE 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 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 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 WITH CODEINE ORAL SOLUTION, or your breastfeeding baby,
has any of the
symptoms

Summary of Product characteristics

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
PAR PHARMACEUTICAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROMETHAZINE WITH CODEINE ORAL SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PROMETHAZINE WITH CODEINE ORAL SOLUTION
.
PROMETHAZINE WITH CODEINE 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 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 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 with Codeine Oral Solution is
contraindicated in children younger than 12 years of age and in
children younger than 18 years of age following
tonsillectomy and/or adenoidectomy. (4) Avoid the use of Promethazine