Last reviewed 2026-04-20 · How we verify

Tussionex Pennkinetic (HYDROCODONE)

Tussionex Pennkinetic works by binding to opioid receptors in the brain, which helps to reduce pain and congestion.

At a glance

Mechanism of action

Mechanismof Action. Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (u) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play role in the analgesic effects of this drug. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.

Approved indications

• Allergic rhinitis
• Common cold
• Cough
• Nasal congestion
• Nasal discharge
• Pain
• Rhinitis

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS Addiction, Abuse, and Misuse Because the use of hydrocodone bitartrate and acetaminophen tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydrocodone bitartrate and acetaminophen tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone [see WARNINGS ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of hydrocodone bitartrate and acetaminophen tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS ; PRECAUTIONS, Drug Interactions ] . Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ]. Cytochrome P450 3A4 Interaction The concomitant use of hydrocodone bitartrate and acetaminophen tablets with all Cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions 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 concentrations. Monitor patients receiving hydrocodone bitartrate and acetaminophen tablets and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY ; WARNINGS ; PRECAUTIONS, Drug Interactions ]. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS ; OVERDOSAGE ].

Common side effects

• Constipation
• Nausea
• Somnolence
• Fatigue
• Headache
• Dizziness
• Dry mouth
• Vomiting
• Pruritus
• Abdominal pain
• Edema peripheral
• Upper respiratory tract infection

Drug interactions

• isocarboxazid
• linezolid
• naltrexone
• phenelzine
• rasagiline
• selegiline
• tranylcypromine

Key clinical trials

• Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2,PHASE3)
• Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients (PHASE2)
• Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (NA)
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
• Post-operative Pain Management in Children With Supracondylar Humerus Fractures (PHASE4)
• 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (PHASE2)
• SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management (PHASE4)
• Use of Driving Tests to Evaluate Patient Performance on Oral Opioids

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tussionex Pennkinetic CI brief — competitive landscape report
• Tussionex Pennkinetic updates RSS · CI watch RSS
• Teva portfolio CI