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Tussionex Pennkinetic Side Effects

Generic Name: chlorpheniramine / hydrocodone

Note: This document contains side effect information about chlorpheniramine / hydrocodone. Some of the dosage forms listed on this page may not apply to the brand name Tussionex Pennkinetic.

For the Consumer

Applies to chlorpheniramine / hydrocodone: oral capsule extended release, oral suspension extended release

Other dosage forms:

Oral route(Suspension, Extended Release)

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and MisuseHydrocodone polistirex/chlorpheniramine polistirex exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone polistirex/chlorpheniramine polistirex 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 hydrocodone polistirex/chlorpheniramine polistirex, prescribe hydrocodone polistirex/chlorpheniramine polistirex 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 treatmentLife-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone polistirex/chlorpheniramine polistirex. Monitor for respiratory depression, especially during initiation of hydrocodone polistirex/chlorpheniramine polistirex or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone polistirex/chlorpheniramine polistirex, especially by children, can result in a fatal overdose of hydrocodone polistirex.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone polistirex/chlorpheniramine polistirex. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone polistirex/chlorpheniramine polistirex.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone polistirex/chlorpheniramine polistirex with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone polistirex/chlorpheniramine polistirex in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant 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 hydrocodone polistirex/chlorpheniramine polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone polistirex/chlorpheniramine polistirex. The co-ingestion of alcohol with hydrocodone polistirex/chlorpheniramine polistirex may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal SyndromeHydrocodone polistirex/chlorpheniramine polistirex is not recommended for use in pregnant women. Prolonged use of hydrocodone polistirex/chlorpheniramine polistirex 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 hydrocodone polistirex/chlorpheniramine polistirex 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 .

Along with its needed effects, chlorpheniramine / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / hydrocodone:

More Common

  • Lightheadedness, dizziness, or fainting
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence Not Known

  • Agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • change in the ability to see colors, especially blue or yellow
  • chills
  • confusion
  • constipation
  • constricted, pinpoint, or small pupils (black part of the eye)
  • cough
  • cough producing mucus
  • dark urine
  • decrease in frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult, painful, or troubled breathing
  • difficulty in passing urine (dribbling)
  • difficulty swallowing
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • double vision
  • feeling sad or empty
  • fever
  • general feeling of tiredness or weakness
  • headache
  • hives, itching, skin rash
  • hoarseness
  • indigestion
  • irregular, fast or slow, or shallow breathing
  • irritability
  • lack of appetite
  • loss of consciousness
  • loss of interest or pleasure
  • lower back or side pain
  • muscle aches
  • nausea
  • nervousness
  • overactive reflexes
  • pain or cramping in the stomach
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • restlessness
  • seeing double
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness and unsteady walk
  • shivering
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stuffy or runny nose
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking
  • trouble concentrating
  • trouble sleeping
  • twitching
  • uncontrolled movements of the face
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting
  • yellow eyes or skin

Some side effects of chlorpheniramine / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Constipation
  • dry mouth

Incidence Not Known

  • Back pain
  • decreased appetite
  • difficulty in moving
  • drowsiness
  • false or unusual sense of well-being
  • fear or nervousness
  • sleepiness
  • feeling of warmth
  • increased sweating
  • joint pain
  • muscle pain or stiffness
  • redness of the face, neck, arms and occasionally, upper chest
  • trouble getting pregnant

For Healthcare Professionals

Applies to chlorpheniramine / hydrocodone: oral capsule extended release, oral liquid, oral suspension extended release

General

The more commonly reported adverse effects have included, sedation, somnolence, mental clouding, dizziness, nausea and vomiting.[Ref]

Respiratory

Frequency not reported: Dose-related respiratory depression including fatal respiratory depression, dryness of the pharynx, dryness of respiratory passages, laryngismus, wheezing, breathing trouble[Ref]

Nervous system

Frequency not reported: Sedation, somnolence, drowsiness, lethargy, mental and physical impairment, dizziness, headache, facial dyskinesia, feeling faint, lightheadedness, tremor[Ref]

Psychiatric

Frequency not reported: Mental clouding, confusion, anxiety, fear, dysphoria, psychic dependence, mood changes, euphoria, agitation, irritability

Gastrointestinal

Frequency not reported: Nausea, vomiting, constipation, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, loss of appetite[Ref]

Cardiovascular

Frequency not reported: Chest tightness

Dermatologic

Frequency not reported: Skin rash, pruritus, erythema, urticaria, excessive perspiration[Ref]

Genitourinary

Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy[Ref]

Ocular

Frequency not reported: Blurred, double, or other visual disturbances

References

1. "Product Information. Tussionex PennKinetic (chlorpheniramine-hydrocodone)." UCB Pharma Inc, Smyrna, GA.

2. "Product Information. TussiCaps (chlorpheniramine-hydrocodone)." ECR Pharmaceuticals, Richmond, VA.

3. "Product Information. Vituz (chlorpheniramine-hydrocodone)." Hawthorn Pharmaceuticals, Madison, MS.

4. "Product Information. HyTan (chlorpheniramine-hydrocodone)." Prasco Laboratories, Cincinnati, OH.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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