PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NuCare Pharmaceuticals,Inc.

INN (इंटरनेशनल नाम):

PROMETHAZINE HYDROCHLORIDE

रचना:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine sulfate is contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS - Death Related to Ultra- Rapid Metabolism of Codeine to Morphine ). Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine hydrochloride is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Prometha

उत्पाद समीक्षा:

Promethazine with Codeine Oral Solution, a clear purple solution with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (120 mL) NDC 68071-4037-4 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. DEA Order Form Required

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Promethazine (proe meth’ a zeen) with Codeine (koe’ deen) Oral
Solution C-V
(Promethazine Hydrochloride and Codeine Phosphate Oral Solution)
What is the most important information I should know about
Promethazine with Codeine Oral
Solution?
•
Taking Promethazine with Codeine Oral Solution with benzodiazepines,
or other central
nervous system depressants, including alcohol can cause severe
drowsiness, breathing
problems (respiratory depression), coma, and death.
•
Promethazine with Codeine Oral Solution can cause you to be drowsy.
Avoid driving a
car or operating machinery during treatment with Promethazine with
Codeine Oral
Solution.
•
Do not give Promethazine with Codeine Oral Solution to children who
are under 6 years
of age. It may harm them.
•
Do not give Promethazine with Codeine Oral Solution to a child to
treat pain after
tonsillectomy or adenoidectomy surgery.
•
When you take Promethazine with Codeine Oral Solution, some of it
changes
into morphine in your body.
•
In some children and adults this happens very quickly, and can cause
you to stop
breathing and cause death due to an overdose.
•
Women who breastfeed should talk to their healthcare provider before
taking
Promethazine with Codeine Oral Solution.
•
When you take Promethazine with Codeine Oral Solution, some of it
changes
into morphine in your body.
•
In some women, this happens very quickly. Codeine and morphine pass
into
your breast milk. A large amount of morphine can cause your baby to
die.
•
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 below:
•
increased sleepiness
•
shallow breathing
•
confusion
•
limpness
•
difficulty breathing
•
your baby has difficulty breastfeeding
•
Keep Promethazine with Codeine Oral Solution in a safe place away from
children.
Accidental use by a child is a medical emergency and can cause deat

उत्पाद विशेषताएं

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
NUCARE PHARMACEUTICALS,INC.
----------
PROMETHAZINE WITH CODEINE ORAL SOLUTION
(PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION)
CV
RX ONLY
WARNING: RESPIRATORY DEPRESSION IN CHILDREN; DEATH RELATED TO
ULTRA RAPID METABOLISM OF CODEINE TO MORPHINE AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS RESPIRATORY DEPRESSION IN CHILDREN
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE IS
CONTRAINDICATED
IN PEDIATRIC PATIENTS LESS THAN 6 YEARS OF AGE. CONCOMITANT
ADMINISTRATION OF PROMETHAZINE
PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH
RESPIRATORY
DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES,
HAVE BEEN REPORTED
WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN
2 YEARS OF AGE. A
WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE
RESULTED IN
RESPIRATORY DEPRESSION IN THESE PATIENTS. DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO
RECEIVED CODEINE
FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING
ULTRA-RAPID
METABOLIZERS OF CODEINE DUE TO A CYP2D6 POLYMORPHISM. RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS)
DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY DEPRESSION,
COMA, AND DEATH (SEE WARNINGS, PRECAUTIONS - DRUG INTERACTIONS). AVOID
USE OF
OPIOID COUGH MEDICATIONS IN PATIENTS TAKING BENZODIAZEPINES, OTHER CNS
DEPRESSANTS, OR
ALCOHOL.
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Promethazine hydrochloride 6.25 mg;
codeine phosphate 10 mg in a flavored syrup base with a pH between 4.4
and 5.2. Alcohol 7%.
Inactive ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C
r