What is Tussionex Pennkinetic?
Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension is a prescription medication primarily indicated for the relief of cough and upper respiratory symptoms associated with allergies or colds in adults and children aged 6 years and older.
Each 5 mL of Tussionex Pennkinetic Extended-Release Suspension provides 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate. Hydrocodone is a narcotic antitussive, and chlorpheniramine is an antihistamine. The extended-release suspension is designed for oral use, with controlled release facilitated by the Pennkinetic System, an extended-release drug delivery system.
Hydrocodone is a semisynthetic narcotic antitussive and analgesic. Its mechanism of action is qualitatively similar to codeine. Hydrocodone is believed to act directly on the cough center, and in excessive doses, it can depress respiration, leading to miosis, euphoria, and physical and psychological dependence.
Chlorpheniramine is an antihistamine with additional anticholinergic and sedative properties. It inhibits histamine release, preventing capillary dilation and edema of the respiratory mucosa.
Indications and Usage
Tussionex Pennkinetic Extended-Release Suspension is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children aged 6 years and older.
Dosage and Administration
Tussionex Pennkinetic Extended-Release Suspension is supplied as a gold-colored suspension in a 4 oz amber plastic bottle containing 115 mL. Each bottle includes a plastic dosing spoon calibrated for measuring 2.5 mL and 5 mL doses.
It is crucial to measure Tussionex with an accurate measuring device. A dosing spoon is provided with the 4 oz (115 mL) packaged product, calibrated for 2.5 mL and 5 mL doses. The recommended dosages are as follows:
Adults and Children 12 Years and Older
- 5 mL every 12 hours; do not exceed 10 mL in 24 hours.
- Children 6-11 Years of Age
- 2.5 mL every 12 hours; do not exceed 5 mL in 24 hours.
Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children under 6 years of age.
Tussionex is contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine. It is also contraindicated in children under 6 years of age due to the risk of fatal respiratory depression.
Risk from Concomitant Use with Benzodiazepines or other CNS Depressants
Concomitant use of opioids, including Tussionex, with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients taking benzodiazepines, other CNS depressants, or alcohol should avoid opioid cough medications.
Observational studies suggest an increased risk of drug-related mortality with concomitant use of opioid analgesics and benzodiazepines. Similar risks are expected with opioid cough medications.
Patients and caregivers should be informed about the risks of respiratory depression and sedation when using Tussionex with benzodiazepines, alcohol, or other CNS depressants.
As with all narcotics, Tussionex can cause dose-related respiratory depression by directly affecting brain stem respiratory centers. Caution is advised in postoperative use, pulmonary disease, or whenever ventilatory function is depressed. Naloxone hydrochloride can be used as an antagonist if respiratory depression occurs.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of narcotics may be exaggerated in the presence of head injury, intracranial lesions, or increased intracranial pressure.
Acute Abdominal Conditions
Narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Obstructive Bowel Disease
Chronic use of narcotics may result in obstructive bowel disease, especially in patients with underlying intestinal motility disorders.
Tussionex is contraindicated in children under 6 years of age. Caution is advised in pediatric patients aged 6 and older due to the sensitivity of the respiratory center to narcotic cough suppressants.
Caution is advised in prescribing Tussionex to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.
Special Risk Patients
Tussionex should be used with caution in elderly or debilitated patients, those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture.
Information for Patients
Concomitant Use with Benzodiazepines or Other CNS Depressants
Patients and caregivers should be informed of the potentially fatal additive effects when Tussionex is used with benzodiazepines or other CNS depressants, including alcohol. Concomitant use should be avoided.
Neurological Adverse Reactions
Patients should be advised that Tussionex may cause marked drowsiness and impair mental and/or physical abilities. Driving or operating machinery during treatment should be avoided.
Patients should not dilute Tussionex with other fluids or mix it with other drugs, as this may alter absorption rates and increase toxicity. Accurate measuring devices should be used to prevent overdosage.
Hydrocodone suppresses the cough reflex, and caution is advised when Tussionex is used postoperatively or in patients with pulmonary disease.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and reproductive studies for Tussionex Pennkinetic Extended-Release Suspension have not been conducted.
Teratogenic Effects – Pregnancy Category C
Hydrocodone has shown teratogenic effects in hamsters at doses 700 times the human dose. Adequate and well-controlled studies in pregnant women are lacking. Tussionex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Babies born to mothers who have been regularly taking opioids prior to delivery may be physically dependent, exhibiting withdrawal signs such as irritability, excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever.
Labor and Delivery
As with all narcotics, the administration of Tussionex to the mother shortly before delivery may result in respiratory depression in the newborn, especially with higher doses.
It is unknown whether Tussionex is excreted in human milk. Due to potentially serious adverse reactions in nursing infants, the decision to discontinue nursing or discontinue the drug should consider the importance of the drug to the mother.
Tussionex is contraindicated in children under 6 years of age and should be used with caution in those aged 6 and older. The respiratory center in pediatric patients is sensitive to the depressant action of narcotic cough suppressants.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently. Dose selection in the elderly should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or drug therapy.
Serious overdosage with hydrocodone can result in respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, bradycardia, hypotension, and, in severe cases, circulatory collapse, cardiac arrest, and death.
Primary attention should focus on reestablishing adequate respiratory exchange through maintaining a patent airway and instituting assisted or controlled ventilation. Naloxone hydrochloride is a specific antidote for respiratory depression resulting from hydrocodone overdosage. Adequate respiration should be maintained with repeated doses of the antagonist as needed.
If you experience signs of an allergic reaction to Tussionex PennKinetic, including hives, difficulty breathing, or swelling of the face, lips, tongue, or throat, seek emergency medical help immediately.
Hydrocodone, like other narcotic medications, can slow down your breathing, potentially leading to a life-threatening situation if breathing becomes too weak.
Notify someone caring for you to seek emergency medical attention if you exhibit slow breathing with extended pauses, or your lips turn blue.
Discontinue the use of this medication and contact your doctor promptly if you encounter:
1. Severe drowsiness
2. Noisy or shallow breathing, or sighing
3. Severe constipation
4. Feeling light-headed, with a risk of fainting
5. A slow heart rate or weak pulse
7. Symptoms of adrenal gland problems, such as nausea, vomiting, loss of appetite, dizziness, weakness, or fatigue.
Older adults may be more susceptible to side effects like dry mouth, constipation, and confusion.
Common side effects of Tussionex PennKinetic may include:
1. Difficulty breathing
4. Nausea and vomiting
5. Reduced or no urination
This list is not exhaustive, and other side effects may occur. If you notice any adverse reactions, contact your doctor for medical advice. Report side effects to the FDA at 1-800-FDA-1088.
Combining certain drugs simultaneously may pose safety risks, as some medications can influence the blood levels of others, leading to increased side effects or reduced effectiveness.
Using Tussionex PennKinetic alongside substances that depress respiratory function can result in serious side effects or even fatalities. Prior to taking opioid medication, sleeping aids, muscle relaxants, or drugs for anxiety or seizures, consult your doctor.
Ensure your doctor is informed about all your medications, particularly:
• Antibiotics or antifungal drugs
• Antiviral medications for hepatitis or HIV
• Asthma treatments
• Bladder or urinary medications
• Blood pressure medications
• Diuretics or “water pills”
• Medications for stomach ulcers, motion sickness, or irritable bowel syndrome
• Medications for Parkinson’s disease
This list is not exhaustive, and numerous other drugs may interact with hydrocodone and chlorpheniramine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all potential drug interactions are detailed in this overview.
Store Tussionex at 20 to 25°C (68 to 77°F) with excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].
Tussionex Pennkinetic Extended-Release Suspension is manufactured for UCB, Inc., located in Smyrna, GA 30080.