PAI PROMETHAZINE VC WITH CODEINE ORAL SOLUTION Germany (1 Pint/16 oz)

Promethazine VC with Codeine Oral Solution is a combination of codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist, indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Promethazine is an antihistamine, Phenylephrine is a decongestant and Codeine is an opioid cough suppressant. JUUL PODS NEAR ME

Uses advised against Not indicated for pediatric patients under 18 years of age.Promethazine 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 are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI). Not indicated for patients with narrow angle glaucoma, patients with difficulty urinating,
patients with paralytic ileus (bowel obstruction). Not indicated for patients with allergic reactions to codeine or certain other opioid medications. Benzodiazepines or other medicines which can cause drowsiness or sleepiness should not be taken during treatment with Promethazine VC with Codeine.

Precautionary Statements – Prevention Obtain special instructions before use.
Do not handle until all safety precautions have been read and understood.
Use personal protective equipment as required.
Precautionary Statements – Response
If exposed or concerned: Get medical advice/attention.
Precautionary Statements – Storage
Store locked up.
Precautionary Statements – Disposal
Dispose of contents/container to an approved waste disposal plant.
Hazards not otherwise classified (HNOC)
Not available.
Other Information
Not available

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.

• Promethazine VC with Codeine 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 VC with Codeine 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) Promethazine VC 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. ( 4) Avoid the use of Promethazine VC 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.
• 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. ( 5.4)
• Ensure accuracy when prescribing, dispensing, and administering Promethazine VC with Codeine Oral Solution. Dosing errors can result in accidental overdose and death. ( 2.1, 5.7)
• The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of Promethazine VC with Codeine Oral Solution in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor. ( 5.9, 7.1, 7.2, 7.3)
• 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. Avoid the use of Promethazine VC with Codeine Oral Solution in patients taking benzodiazepines, other CNS depressants, or alcohol. ( 5.10, 7.4)
• Promethazine VC with Codeine Oral Solution is not recommended for use in pregnant women. Prolonged use of Promethazine VC with Codeine Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If Promethazine VC with Codeine Oral Solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ( 5.20, 8.1)