Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Unit Dose Services
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
Product: 50436-1029 NDC: 50436-1029-1 120 mL in a BOTTLE
Abbreviated New Drug Application
Unit Dose Services ---------- 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. Codeine and mo Прочитать полный документ
PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION UNIT DOSE SERVICES ---------- 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, PRECAUTIONS Прочитать полный документ