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

Available from:

Akorn

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP 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: Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution is contraindicated for: Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution is also contraindicated in patients with: Risk Summary Promethazine HCl, phenylephrine 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 (5.20), Clinical Considerations ]. There are no available data with promethazine HCl, phenylephrine HCl and codeine phosphate oral solution use in pregnant women to inform a drug-associated risk for adverse developmental

Product summary:

Promethazine HCl, Phenylephrine HCl, and Codeine Phosphate Oral Solution, USP, is a yellow-orange, fruit-flavored oral solution contains promethazine HCl 6.25 mg, phenylephrine HCl 5 mg, codeine phosphate 10 mg; and alcohol 7%, supplied as: 16 fl. oz. (473 mL) bottle - NDC 50383-805-16 4 fl. oz. (118 mL) bottle - NDC 50383-805-04 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

PHOSPHATE- PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND
CODEINE
PHOSPHATE SOLUTION
Akorn
----------
MEDICATION GUIDE
MEDICATION GUIDE
Promethazine (proe METH a zeen) Hydrochloride,
Phenylephrine (fen il EF rin) Hydrochloride and Codeine
(KOE deen) Phosphate Oral Solution,
What is the most important information I should know about
Promethazine Hydrochloride,
Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?
Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine
Phosphate Oral Solution is not
for children under 18 years of age.
Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine
Phosphate Oral Solution can
cause serious side effects, including:
•
Addiction, abuse and misuse. Taking Promethazine Hydrochloride,
Phenylephrine 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, Phenylephrine 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.
o
Do not share your Promethazine Hydrochloride, Phenylephrine
Hydrochloride and Codeine
Phosphate Oral Solution with other people.
o
Keep Promethazine Hydrochloride, Phenylephrine Hydrochloride and
Codeine Phosphate Oral
Solution in a safe place away from children.
•
Life-threatening breathing problems (respiratory depression).
Promethazine Hydrochloride,
Phenylephrine 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,
Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, are
taking other medicines
that can ca

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND
CODEINE PHOSPHATE- PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROMETHAZINE HCL,
PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PROMETHAZINE HCL, PHENYLEPHRINE HCL
AND CODEINE
PHOSPHATE ORAL SOLUTION.
PROMETHAZINE HCL, PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL
SOLUTION, USP, 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._
•
•
•
•
•
•
•
•
•
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 HCL, PHENYLEPHRINE 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, PHENYLEPHRINE 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