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– causes sedative effect, has antiemetic effect. It has also pronounced to be an adrenoblocking remedy, which moderates peripheral and central anticholinergic action. The effect starts already in 20 minutes after ingestion and lasts up to 6 hours, sometimes up to 12 hours.
The drug is used to cure some allergic diseases and reactions such as: rash, itching, eczema, drug rash, serum sickness, Quincke’s edema, hay fever, anaphylactic shock, bronchial obstructive syndrome (as part of complex therapy).
Also it is prescribed for the treatment of skin diseases (including eczema, neurodermatitis, diathesis, contact dermatitis and toxicodermia).

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Before using this medicine

If you are allergic to any drugs like this one, any other drugs, foods, or other substances.

Tell your doctor about the allergy and what signs you had,

like rash;

hives;

itching;

shortness of breath;

cough;

swelling of face,

tongue,throat;

or any other signs.

If you have any of these health problems;

Lung or breathing problems like asthma,

trouble breathing, or sleep apnea,

high levels of carbon dioxide in the blood,

stomach or bowel

block or narrowing.

Overdose

If you think there has been an overdose, call your poison control center or get medical care right away.

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HOW IS THIS DRUG BEST TAKEN?

Read all information given to you.

Follow all instructions closely.

drink with or without food.

Take with food if it causes an upset stomach.

Measure liquid doses carefully.

Use the measuring device that comes with this drug.

If there is none, ask the pharmacist for a device to measure this drug.

HOW DO I STORE AND/OR THROW OUT THIS DRUG?

Store at room temperature.

Protect from light.

Store in a dry place.

Do not store in a bathroom.

Always keep all drugs in a safe place.

Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs.

Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs.

There may be drug take-back programs in your area.

WHAT DO I DO IF I MISS A DOSE?

If you take this drug on a regular basis, take a missed dose as soon as you think about it.

If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

Do not take 2 doses at the same time or extra doses.

Many times this drug is taken on an as needed basis.

Do not take more often than told by the doctor.

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• 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

  Addiction, Abuse, and Misuse

  Promethazine HCl and codeine phosphate oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

  Reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

  Assess each patient’s risk prior to prescribing promethazine HCl and codeine phosphate oral solution, prescribe promethazine HCl and codeine phosphate oral solution for the shortest duration that is consistent with individual patient treatment goals,

  monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment. [see WARNINGS AND PRECAUTIONS (5.1)]

  Life-Threatening Respiratory Depression

  Serious, life-threatening, or fatal respiratory depression may occur with use of promethazine HCl and codeine phosphate oral solution.

  Monitor for respiratory depression, especially during initiation of promethazine HCl and codeine phosphate oral solution therapy or when used in patients at higher risk [see WARNINGS AND PRECAUTIONS (5.2)].

  Accidental Ingestion

  Accidental ingestion of even one dose of promethazine HCl and codeine phosphate oral solution, especially by children, can result in a fatal overdose of codeine [see WARNINGS AND PRECAUTIONS (5.2)].

  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 [see WARNINGS AND PRECAUTIONS (5.3)].

  Promethazine HCl and codeine phosphate 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 (4)].

  Avoid the use of promethazine HCl and codeine phosphate 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.

  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 AND PRECAUTIONS (5.4).

  Risk of Medication Errors

  Ensure accuracy when prescribing, dispensing, and administering promethazine HCl and codeine phosphate oral solution. Dosing errors can result in accidental overdose and death.

  Always use an accurate milliliter measuring device when measuring and administering promethazine HCl and codeine phosphate oral solution [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.7)].

  Interactions with Drugs Affecting Cytochrome P450 Isoenzymes

  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 HCl and codeine phosphate oral solution in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor [see Warnings and

  Precautions (5.9), DRUG INTERACTIONS (7.1, 7.2, 7.3)].

  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.

  Avoid the use of promethazine HCl and codeine phosphate oral solution in patients taking benzodiazepines, other CNS depressants, or alcohol. [see WARNING AND PRECAUTIONS (5.10), DRUG INTERACTIONS (7.4)]

  Neonatal Opioid Withdrawal Syndrome

  Promethazine HCl and codeine phosphate oral solution is not recommended for use in pregnant women [see USE IN SPECIFIC POPULATIONS (8.1)].

  Prolonged use of promethazine HCl and codeine phosphate oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

  If promethazine HCl and codeine phosphate oral solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatalopioid withdrawal syndrome and ensure that appropriate treatment will be available 

  How promethazine / codeine works

  Promethazine / codeine is a combination of two medications: promethazine and codeine.

  Promethazine is a phenothiazine medication that blocks the signals in your brain and body causing you to experience cold and allergy symptoms like a runny nose and sneezing. Codeine is an opioid medication that works in your brain to lessen your urge to cough.

  What is promethazine / codeine used for?

  • Respiratory symptoms caused by allergies or the common cold, including cough, runny nose, and sneezing

  Promethazine / codeine dosage forms

  

  Ml Of Syrup

  6.25mg/10mg/5ml

  Typical dosing for promethazine / codeine

  Adults over 18 years old: The typical dose is 5 mL (1 teaspoonful) by mouth every 4 to 6 hours as needed. Do not take more than 30 mL (6 teaspoonfuls) in a day.

  Promethazine / codeine is not recommended for use in children under 18 years old.