PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

CODEINE PHOSPHATE

Composition:

CODEINE PHOSPHATE 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine HCl 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: Promethazine HCl and codeine phosphate oral solution is contraindicated for: Promethazine HCl and codeine phosphate oral solution is also contraindicated in patients with: Risk Summary Promethazine HCl and codeine phosphate 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), Clinical Considerations ]. There are no available data with promethazine HCl and codeine phosphate 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

Product summary:

Promethazine HCl and Codeine Phosphate Oral Solution, 6.25 mg and 10 mg per 5 mL, is a purple to reddish purple solution, supplied as: 4 fl oz (118 mL) - NDC 50383-804-04 16 fl oz (473 mL) - NDC 50383-804-16 Keep bottles tightly closed. Store at 20°-25° C (68°-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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CODEINE PHOSPHATE SOLUTION
Akorn
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MEDICATION GUIDE
MEDICATION GUIDE
Promethazine (proe METH a zeen) Hydrochloride and
Codeine (KOE deen) Phosphate Oral Solution,
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
prescribed by your healthcare
provider.
Call your healthcare provider or get emergency medica

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
[PROMETHAZINE HCL AND
CODEINE PHOSPHATE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION.
PROMETHAZINE HCL 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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RECENT MAJOR CHANGES
Boxed Warning 08/2017 and 05/2018
Indications and Usage (1) 05/2018
Dosage and Administration (2.1, 2.3) 05/2018
Contraindications (4) 08/2017 and 05/2018
PROMETHAZINE HCL 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 HCL 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) PR