Dextromethorphan and promethazine

Call your doctor immediately if you experience uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use dextromethorphan and promethazine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dextromethorphan and promethazine before the MAO inhibitor has cleared from your body.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Do not use dextromethorphan and promethazine if you have asthma or other lung disease.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking dextromethorphan and promethazine, tell your doctor if you are allergic to any drugs, or if you have emphysema or chronic bronchitis. You may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

Before taking dextromethorphan and promethazine, tell your doctor if you have:

• epilepsy or another seizure disorder;

• emphysema or chronic bronchitis;

• sleep apnea (breathing stops during sleep);

• glaucoma;

• a stomach ulcer or digestive obstruction;

• bone marrow disorder;

• problems with urination;

• high blood pressure or heart disease; or

• liver disease.

If you have any of these conditions, you may not be able to use dextromethorphan and promethazine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether this medication passes into breast milk or if it could harm an unborn baby. Do not use dextromethorphan and promethazine without telling your doctor if you are breast-feeding a baby.

Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cough medicine within the past few days.

Store dextromethorphan and promethazine at room temperature, away from heat, light, and moisture.

Usual Adult Dose for Allergic Rhinitis:

5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

Usual Adult Dose for Cold Symptoms:

5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

Usual Adult Dose for Cough:

5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

Usual Pediatric Dose for Allergic Rhinitis:

12 years or older:
5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

6 years to 11 years:
2.5 to 5 mL orally every 4 to 6 hours, not to exceed 20 mL in 24 hours.

2 years to 5 years:
1.25 to 2.5 mL orally every 4 to 6 hours, not to exceed 10 mL in 24 hours.

Usual Pediatric Dose for Cold Symptoms:

12 years or older:
5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

6 years to 11 years:
2.5 to 5 mL orally every 4 to 6 hours, not to exceed 20 mL in 24 hours.

2 years to 5 years:
1.25 to 2.5 mL orally every 4 to 6 hours, not to exceed 10 mL in 24 hours.

Usual Pediatric Dose for Cough:

12 years or older:
5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

6 years to 11 years:
2.5 to 5 mL orally every 4 to 6 hours, not to exceed 20 mL in 24 hours.

2 years to 5 years:
1.25 to 2.5 mL orally every 4 to 6 hours, not to exceed 10 mL in 24 hours.

Applies to dextromethorphan / promethazine: oral syrup

General

The most common adverse reaction is somnolence.

Nervous system

Dextromethorphan:
Frequency not reported: Drowsiness, dizziness

Promethazine:
Frequency not reported: Drowsiness, dizziness, sedation, somnolence, tremors, convulsive seizures, extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion, incoordination, neuroleptic malignant syndrome, serotonin syndrome, abnormal movements[Ref]

Respiratory

Promethazine:
Frequency not reported: Asthma, nasal stuffiness, respiratory depression (potentially fatal), apnea[Ref]

Gastrointestinal

Dextromethorphan:
Frequency not reported: Gastrointestinal disturbances

Promethazine:
Frequency not reported: Dry mouth, nausea, vomiting[Ref]

Psychiatric

Promethazine:
Frequency not reported: Disorientation, euphoria, nervousness, insomnia, excitation, catatonic-like states, hysteria, hallucinations, confusion, nightmares, delirium agitated behavior, hyperexcitability

Cardiovascular

Promethazine:
Frequency not reported: Increased or decreased blood pressure, tachycardia, bradycardia, faintness[Ref]

Hepatic

Promethazine:
Frequency not reported: Jaundice[Ref]

Hematologic

Promethazine:
Frequency not reported: Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis[Ref]

Dermatologic

Promethazine:
Frequency not reported: Dermatitis, photosensitivity, urticaria[Ref]

Hypersensitivity

Promethazine:
Frequency not reported: Angioneurotic edema[Ref]

Other

Promethazine:
Frequency not reported: Lassitude, tinnitus, fatigue[Ref]

Ocular

Promethazine:
Frequency not reported: Blurred vision, diplopia[Ref]

Some side effects of dextromethorphan / promethazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

12 years or older:
5 mL orally every 4 to 6 hours, not to exceed 30 mL in 24 hours.

6 years to 11 years:
2.5 to 5 mL orally every 4 to 6 hours, not to exceed 20 mL in 24 hours.

2 years to 5 years:
1.25 to 2.5 mL orally every 4 to 6 hours, not to exceed 10 mL in 24 hours.

Data not available

Dextromethorphan-promethazine has been assigned to pregnancy category C by the FDA. Animal studies have failed to revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Dextromethorphan-promethazine is only recommended for use during pregnancy when benefit outweighs risk.