PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals, Inc

INN (mednarodno ime):

PROMETHAZINE HYDROCHLORIDE

Sestava:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 Promethazine with Codeine Oral Solution is contraindicated for: Promethazine with Codeine Oral Solution is also contraindicated in patients with: Risk Summary Promethazine with Codeine Oral Solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.19) and Clinical Considerations ]. There are no available data with Promethazine with Codeine Oral Solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Published studies with codeine have reported inconsistent findings and have important methodological limitations (see Data ). There are reports of respiratory depression when codei

Povzetek izdelek:

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: 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

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
Preferred Pharmaceuticals, Inc
----------
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

Lastnosti izdelka

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
PREFERRED PHARMACEUTICALS, INC
----------
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._
•
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•
•
•
•
•
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•
RECENT MAJOR CHANGES
Boxed Warning 08/2017 and 06/2018
Indications and Usage (1) 06/2018
Dosage and Administration (2.1, 2.3) 06/2018
®
®
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 Solut