Chlorpheniramine and codeine

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ask a doctor before giving this medicine to a child younger than 12 years old. Do not give this medicine to anyone under 18 who recently had surgery to remove the tonsils or adenoids.

You should not use antihistamine medication to make a child sleepy.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use chlorpheniramine and codeine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

You should not use antihistamine medication to make a child sleepy.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid to freeze.

Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop using chlorpheniramine and codeine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• a slow heart rate or weak pulse;

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• painful or difficult urination;

• tremor, uncontrolled muscle movements; or

• confusion, ringing in your ears.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

• dizziness, drowsiness;

• general ill feeling;

• mood changes, feeling agitated or irritable;

• headache, feeling light-headed;

• feeling restless, nervous, or excited;

• sleep problems (insomnia);

• constipation;

• nausea, vomiting, stomach pain, bloating;

• blurred vision, double vision; or

• dry mouth, nose, or throat.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to chlorpheniramine / codeine: oral liquid, oral suspension, oral suspension extended release, oral tablet

Cardiovascular

Codeine or Chlorpheniramine:
Frequency not reported: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope[Ref]

Nervous system

Codeine or Chlorpheniramine:
Frequency not reported: Weakness, dizziness, drowsiness, sedation, headache, facial dyskinesia, lightheadedness, somnolence, dyskinesia, tremor[Ref]

Gastrointestinal

Codeine or Chlorpheniramine:
Frequency not reported: Nausea, vomiting, constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, diarrhea, gastro-esophageal reflux, gastrointestinal hypomotility[Ref]

Respiratory

Codeine:
Frequency not reported: Respiratory depression, dryness of the pharynx and respiratory passages, laryngismus, atelectasis, wheezing, troubled breathing, hiccups[Ref]

Endocrine

Codeine or Chlorpheniramine:
Frequency not reported: Decreased lactation, early menses, gynecomastia, increased libido, pheochromocytoma stimulation[Ref]

Dermatologic

Codeine or Chlorpheniramine:
Frequency not reported: Redness or flushing of face, skin rash, pruritus, erythema, urticaria, excessive perspiration, dermatitis[Ref]

Hypersensitivity

Codeine or Chlorpheniramine:
Frequency not reported: Allergic laryngospasm, nasal stuffiness, bronchospastic allergic reaction, hives, itching, swelling of face[Ref]

Ocular

Codeine or Chlorpheniramine:
Frequency not reported: Blurred vision, diplopia, visual disturbances, hypermetropia, lacrimation increased, mydriasis, photophobia[Ref]

General

The more commonly reported adverse effects have included nausea, vomiting, constipation, blurred vision, confusion, dizziness, depression, drowsiness, headache, lightheadedness, insomnia, irritability, and tremor.[Ref]

Other

Codeine or Chlorpheniramine:
Frequency not reported: Asthenia, feeling of relaxation, unusual tiredness, labyrinthitis, tinnitus, vertigo[Ref]

Metabolic

Codeine or Chlorpheniramine:
Frequency not reported: Changes in glucose utilization, glycosuria, hypoglycemia, increased appetite, loss of appetite[Ref]

Psychiatric

Codeine:
Frequency not reported: Drug dependence, confusion, depression, euphoria, false sense of well-being, excitability, nervousness, agitation, restlessness, insomnia, irritability[Ref]

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

Immediate-release (suspension, liquid, tablets):
1 dose orally every 4 to 6 hours as needed
-Chlorpheniramine: Single dose: up to 4 mg; Maximum dose: 24 mg/24 hours
-Codeine: Single dose: up to 20 mg; Maximum dose: 120 mg/24 hours
Maximum doses should not exceed maximum dose of either of the single ingredient doses

Extended-release suspension: chlorpheniramine polistirex 2.8 mg/codeine polistirex 14.7 mg per 5 mL (equivalent to chlorpheniramine maleate 4 mg/codeine phosphate 20 mg per 5 mL)
10 mL orally every 12 hours
Maximum dose: 20 mL/24 hours

Comments:
-Liquid preparations should be measured with an accurate milliliter measuring device.
-Shake oral suspensions well before measuring dose.

Uses: For the temporary relief of cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants; temporarily decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Use with caution, especially in patients with severe renal impairment

Use with caution, especially in patients with severe hepatic impairment