Codeine-Chlorpheniramine

Codeine-Chlorpheniramine is a combination medication used for the relief of cough and symptoms associated with upper respiratory tract allergies or common cold in patients 18 years of age and older.

• Codeine-Chlorpheniramine is available under the following different brand names: Tuzistra XR, Tuxarin ER

Common side effects of Codeine-Chlorpheniramine include:

• nausea and vomiting
• constipation
• abdominal bloating
• abdominal pain
• blurred vision
• double vision
• visual disturbances
• confusion
• dizziness
• depression
• drowsiness
• sedation
• headache
• euphoria
• facial dyskinesia
• feeling faint
• lightheadedness
• a general feeling of discomfort or illness (malaise)
• excitability
• nervousness
• agitation
• restlessness
• drowsiness
• insomnia
• abnormal movement (dyskinesia)
• irritability
• tremor

Serious side effects of Codeine-Chlorpheniramine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• skin redness
• rash that spreads and causes blistering and peeling
• breathing that may stop
• slow breathing with long pauses
• blue-colored lips
• difficult to wake up
• noisy breathing
• sighing
• shallow breathing
• breathing that stops during sleep
• chest pain
• fast or pounding heartbeats
• lightheadedness
• fainting
• confusion
• extreme drowsiness
• unusual thoughts or behavior
• painful or difficult urination
• severe constipation
• nausea
• upper stomach pain
• itching
• loss of appetite
• dark urine
• clay-colored stools
• yellowing of the skin or eyes (jaundice)
• vomiting
• loss of appetite
• dizziness
• worsening tiredness
• weakness
• agitation
• hallucinations
• fever
• sweating
• shivering
• muscle stiffness
• twitching
• loss of coordination
• diarrhea

Rare side effects of Codeine-Chlorpheniramine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Extended-release oral suspension: Schedule III

• (14.7 mg/2.8 mg)/5 mL (equivalent to 20 mg codeine phosphate and 4 mg chlorpheniramine maleate)

Tablet, extended-release: Schedule III

• 40 mg/5.6 mg (equivalent to 54.3 mg codeine phosphate and 8 mg chlorpheniramine maleate)

Cough and Cold

Adult dosage

• Suspension: 10 mL orally every 12 hours; not to exceed 2 doses (20 mL) in 24 hours
• Tablet: 1 tablet orally every 12 hours; not to exceed 2 doses/24 h

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Codeine-Chlorpheniramine has severe interactions with the following drug:
  • alvimopan
• Codeine-Chlorpheniramine has serious interactions with at least 55 other drugs.
• Codeine-Chlorpheniramine has moderate interactions with at least 294 other drugs.
• Codeine-Chlorpheniramine has minor interactions with at least 27 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known hypersensitivity to codeine, chlorpheniramine, or product components
• Children younger than 12 years
• Postoperative management in children younger than 18 years following tonsillectomy and/or adenoidectomy
• Patients with significant respiratory depression and acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors or its use within the last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• People known to be hypersensitive to other opioids exhibiting cross-sensitivity to codeine

Effects of drug abuse

• Overdose
• Death

Short-Term Effects

• See "What Are Side Effects Associated with Using Codeine-Chlorpheniramine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Codeine-Chlorpheniramine?"

Cautions

• Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (ie, multiple copies of the gene for CYP2D6 or high morphine concentrations)
• Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine
• Avoid use in adolescents 12-18 years of age who have other risk factors that may increase sensitivity to respiratory depressant effects of codeine unless benefits outweigh risks; risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression; when prescribing codeine for adolescents, healthcare providers should choose lowest effective dose for shortest period and inform patients and caregivers about risks and the signs of morphine overdose
• Produces dose-related respiratory depression (fatalities reported) by directly acting on the brain stem respiratory centers; may produce irregular and periodic breathing
• At least one death was reported in a nursing infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine; breastfeeding not recommended during treatment
• Potential for dependence and abuse
• Avoid use with head injuries; opioids produce adverse reactions that may obscure the clinical course of patients with head injuries
• Codeine and chlorpheniramine produce drowsiness and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks (driving, operating machinery)
• Long-term use of opioids, including codeine, may result in constipation or obstructive bowel disease
• Caution with acute abdominal conditions because the codeine may obscure the diagnosis or clinical course of patients with acute abdominal conditions; concurrent use of other anticholinergics with codeine may produce paralytic ileus
• Caution in elderly or debilitated patients and those with asthma, persistent or chronic cough, hypothyroidism, Addison disease, prostatic hypertrophy, or urethral stricture
• Both codeine and chlorpheniramine are extensively metabolized by the liver; caution with severe hepatic impairment
• Concomitant use of opioids, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; because of these risks, avoid the use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol
• Avoid in patients with head injury, intracranial lesions, or increased intracranial pressure
• Avoid concurrent use of alcohol or other central nervous system depressants
• Measure dose only with an accurate mL-measuring device

Pregnancy and Lactation

• Codeine
  • As with all opioids, administration of codeine to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used
  • Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent
  • Withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever
• Labor and delivery
  • Use of codeine during labor may lead to respiratory depression in the neonate; opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate; use is not recommended in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression
• Chlorpheniramine
  • A retrospective study found a small, but statistically significant, association between maternal use of chlorpheniramine and inguinal hernia and eye or ear anomalies in children
• Lactation
  • Codeine and its active metabolite, morphine, are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk; women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants
  • Use caution if administered to a nursing woman; prescribe the lowest dose for the shortest period to achieve the desired effect; inform mothers when to seek immediate medical care and how to identify signs and symptoms of neonatal toxicity (eg, drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone)
  • In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent
  • There is no information on the effects of codeine milk production; because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, breastfeeding is not recommended during treatment