Medical Editor: John P. Cunha, DO, FACOEP
What Is Apadaz?
Apadaz (benzhydrocodone and acetaminophen tablets) is a combination of a prodrug of the opioid agonist hydrocodone and a non-narcotic pain reliever and fever reducer indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
What Are Side Effects of Apadaz?
Common side effects of Apadaz include:
- dizziness, and
Dosage for Apadaz
The dose of Apadaz is individualized based on:
- the severity of pain,
- patient response,
- prior analgesic experience, and
- risk factors for addiction, abuse, and misuse
The initial dose of Apadaz is 1 or 2 tablets every 4 to 6 hours as needed for pain.
What Drugs, Substances, or Supplements Interact with Apadaz?
Apadaz may interact with:
- macrolide antibiotics,
- azole antifungals,
- protease inhibitors,
- benzodiazepines and other sedatives/hypnotics,
- muscle relaxants,
- general anesthetics,
- other opioids,
- selective serotonin reuptake inhibitors (SSRIs),
- serotonin and norepinephrine reuptake inhibitors (SNRIs),
- tricyclic antidepressants (TCAs),
- 5-HT3 receptor antagonists,
- drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol),
- monoamine oxidase inhibitors(MAOIs),
- opioid analgesics,
- muscle relaxants,
- diuretics, and
Tell your doctor all medications and supplements you use.
Apadaz During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Apadaz; prolonged use of opioid analgesics during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. The medications in Apadaz pass into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Apadaz.
Our Apadaz (benzhydrocodone and acetaminophen tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines and other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis and Other Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of APADAZ was evaluated in six Phase 1 studies in which a total of 200 healthy adult subjects receive at least one oral dose of APADAZ. The most common AEs (>5%) reported across these studies were: nausea (21.5%), somnolence (18.5%), vomiting (13.0%), constipation (12.0%), pruritus (11.5%), dizziness (7.5%), and headache (6.0%).
The following adverse reactions occurred with an incidence of 1% to 5% in single-dose or repeateddose clinical trials of APADAZ.
Gastrointestinal disorder: abdominal distension, abdominal pain, flatulence
General disorders and administration site conditions: asthenia
Nervous system disorders: presyncope, tremor
Respiratory, thoracic and mediastinal disorders: dyspnea
Vascular disorders: hot flush, hypotension
Adverse reactions occurring at less than 1%: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in APADAZ clinical trials.
Eye disorders: eye pruritus
Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease, haematemesis
General disorders and administration site conditions: chest discomfort
Infections and infestations: rhinitis
Nervous system disorders: hypoesthesia, syncope
Psychiatric disorders: agitation, euphoric mood, nightmare
The following adverse reactions have been identified during post-approval use of hydrocodone.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more oftenfollowing greater than one month of use.
Anaphylaxis has been reported with ingredients contained in APADAZ.
Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Apadaz (Benzhydrocodone and Acetaminophen)