PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

NuCare Pharmaceuticals,Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Promethazine with Codeine Oral Solution is contraindicated in pediatric patients less than 12 years of age. (See WARNINGS - Ultra- Rapid Metabolism of Codeine and Respiratory Depression ). Promethazine with Codeine Oral Solution is contraindicated for post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (See WARNINGS - Ultra- Rapid Metabolism of Codeine and Respiratory Depression ). 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. Prom

leaflet_short:

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 68071-1606-4 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

מצב אישור:

Abbreviated New Drug Application

עלון מידע

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. Do
not drive a
car or operate machinery until you know how Promethazine with Codeine
Oral Solution
affects you. Promethazine with Codeine Oral Solution can slow your
thinking and
motor skills, and may affect your vision.
•
Do not give Promethazine with Codeine Oral Solution to children under
12 years of age
or to a child younger than 18 years of age 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.
•
Avoid giving Promethazine with Codeine Oral Solution to children
between 12 to 18
years of age who have other risk factors for breathing problems.
Children with these
risk factors may be more sensitive to breathing problems (respiratory
depression) if they
take Promethazine with Codeine Oral Solution:
•
recently had surgery
•
have obstructive sleep apnea
•
are obese
•
have other medical conditions that can cause difficulty breathing,
such as
neuromuscular problems
•
take other medicines that cause breathing problems
•
have severe lung problems
•
You should not breastfeed during treatment with Promethazine with
Codeine Oral
Solution.
•
When you take Promethazine with Codeine Oral Solution, some if it
changes
into morphine in your body.
•
In some women, this happens very quickly. Codei

מאפייני מוצר

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
NUCARE PHARMACEUTICALS,INC.
----------
PROMETHAZINE WITH CODEINE ORAL SOLUTION
(PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION)
CV
RX ONLY
WARNING: ULTRA RAPID METABOLISM OF CODEINE AND OTHER RISK
FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE-THREATENING
RESPIRATORY DEPRESSION IN CHILDREN
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED
CODEINE. MOST OF THE REPORTED CASES OCCURRED FOLLOWING TONSILLECTOMY
AND/OR
ADENOIDECTOMY, AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING AN
ULTRA-RAPID METABOLIZER
OF CODEINE DUE TO A CYP2D6 POLYMORPHISM. 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 (SEE
CONTRAINDICATIONS). AVOID THE USE OF PROMETHAZINE WITH CODEINE ORAL
SOLUTION IN
ADOLESCENTS 12 TO 18 YEARS OF AGE WHO HAVE OTHER RISK FACTORS THAT MAY
INCREASE THEIR
SENSITIVITY TO THE RESPIRATORY DEPRESSANT EFFECTS OF CODEINE. (SEE
WARNINGS - ULTRA-RAPID
METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).
PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES
HAVE BEEN REPORTED WITH
USE OF PROMETHAZINE IN PEDIATRIC PATIENTS. CHILDREN MAY BE
PARTICULARLY SENSITIVE TO THE
ADDITIVE RESPIRATORY DEPRESSANT EFFECTS WHEN PROMETHAZINE IS COMBINED
WITH OTHER
RESPIRATORY DEPRESSANTS, INCLUDING CODEINE. (SEE WARNINGS -
PROMETHAZINE AND
RESPIRATORY DEPRESSION IN CHILDREN).
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, PR