Apadaz

Apadaz is a prescription medication used to treat acute and severe pain. It is a single product containing 2 medications: benzhydrocodone and acetaminophen.

Benzhydrocodone belongs to a group of drugs called opiate analgesics (narcotic pain relievers). These relieve pain by changing the way the brain responds to pain. Acetaminophen belongs to a group of drugs called analgesics (pain relievers). These relieve pain by changing the way the body senses pain. 

This medication comes in tablet form and is taken up to 6 times a day. Do not take more than 12 tablets in 24 hours. 

Common side effects of Apadaz include nausea, tiredness, vomiting, constipation, itching, dizziness and headache.

Apadaz can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Apadaz affects you.

Apadaz is a prescription medication that is intended 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Apadaz. See the “Apadaz Precautions” section.

Common side effects of Apadaz include the following:

• nausea
• feeling very tired
• vomiting
• constipation
• itchiness
• dizziness
• headache

This is not a complete list of Apadaz side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• Alcohol and other sedating medications such as:
  • barbiturate medications including butalbital, pentobarbital (Nembutal), phenobarbital (Luminal)
  • benzodiazepine medications including clonazepam (Klonopin), diazepam (Diastat), lorazepam (Ativan), midazolam (Versed), alprazolam (Xanax), temazepam (Restoril)
  • hypnotic medications including eszopiclone (Lunesta), zeleplon (Sonata), zolpidem (Ambien)
  • first generation antihistamine medications including diphenhydramine (Benedryl), doxylamine (Diclectin), promethazine (Phenergan), hydroxyzine (Vistaril), chlorpheniramine (Chlor-Trimeton)
  • muscle relaxant medications including baclofen (Lioresal), carisoprodol (Somadril), cyclobenzaprine (Flexeril), methocarbamol (Robaxin), tizanidine (Zanaflex), gabapentin (Neurontin), pregabalin (Lyrica)
  • opioid pain relieving medications including tramadol (Ultram), morphine (MS Contin), hydromorphone (Dilaudid), oxymorphone (Opana), oxycodone (Oxycontin), hydrocodone (Vantrela), fentanyl (Duragesic), codeine, meperidine (Demerol)
  • antidepressant medications including amitriptyline (Elavil), trazodone (Oleptro), mirtazapine (Remeron), doxepin (Sinequan), nortriptyline (Pamelor), nefazodone (Serzone)
  • antipsychotic medications including olanzepine (Zyprexa), clozapine (Clozaril), haloperidol (Haldol), fluphenazine (Prolixin), quetiapine (Seroquel), prochlorperazine (Compazine)
• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)
• monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), rasagiline (Azilect)
• mixed opioid agonists/antagonists such as butorphanol, nalbuphine, pentazocine (Talwin), buprenorphine (Belbuca)
• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), triamterene (Dyrenium, Dyazide, Maxzide)
• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

This is not a complete list of Apadaz drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Apadaz including the following:

• Apadaz and other opioid medications expose patients to the risks of addiction, abuse and misuse. Addiction can occur even when Apadaz is used appropriately. These risks are higher in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (example: depression). 
• At high doses or in sensitive patients, Apadaz may produce respiratory depression. Apadaz also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. The respiratory depressant effects of hydrocodone may be exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Apadaz may also produce adverse reactions that may obscure the clinical course of patients with head injuries.
• Apadaz use during pregnancy can cause opioid withdrawal syndrome in the newborn baby. This may be life-threatening to the newborn baby. Tell your healthcare provider right away if you are pregnant or plan to become pregnant while taking Apadaz. 
• Apadaz may cause serious skin reactions. Tell your healthcare provider right away if you notice any signs of a hypersensitivty reaction, such as rash, swelling around the face, mouth or throat, itching and difficulty breathing. 
• Apadaz may increase the number of seizures that patients with seizure disorders have. Tell your healthcare provider right away if you have a seizure disorder and have a change in the number of seizures you experience. 
• Apadaz may cause withdrawal symptoms after stopping this medicine. Tell your healthcare provider right away if you have signs or symptoms of withdrawal such as anxiety, tiredness, sweating, vomiting, feeling more sad than normal, seizures and hallucinations. 
• Apadaz may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
• Apadaz suppresses the cough reflex; caution should be exercised when Apadaz is used postoperatively and in patients with pulmonary disease.
• Apadaz should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.

Apadaz can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Apadaz affects you.

Do not take Apadaz if you:

• are allergic to Apadaz or to any of its ingredients or are allergic to any other opioid medication
• have acute or severe asthma
• have significant respiratory depression
• have a known or suspected obstruction in your stomach or GI tract

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Apadaz, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Apadaz, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Apadaz or to any of its ingredients or are allergic to any other opioid medication
• have a personal or family history of addiction
• have or have ever had low blood pressure
• have or have ever had difficulty urinating
• have or have ever had seizures
• have or have ever had thyroid disease
• have or have ever had gall bladder disease
• have or have ever had pancreas disease
• have or have ever had liver disease
• have or have ever had kidney disease
• have a history of asthma or conditions that cause trouble breathing
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Apadaz falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Apadaz has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Apadaz, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Apadaz exactly as prescribed.

Apadaz comes in tablet form and is taken every 4 to 6 hours. The lowest effective dose should be used for the shortest time period possible.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Apadaz at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dosage of Apadaz should be adjusted according to the severity of the pain and response of the patient. However, it is important to remember that tolerance to Apadaz can develop with continued use and that the incidence of adverse effects is dose-related.

If you take too much Apadaz, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Apadaz is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Apadaz at room temperature.
• Protect from exposure to light.
• Keep this and all medicines out of the reach of children.

Apadaz exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.

Accidental ingestion of Apadaz,especially by children, can result in a fatal overdose of hydrocodone.

Prolonged use of Apadaz during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone from Apadaz. 

Apadaz contains acetaminophen. 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

Concomitant use of opioids with benzodiazepines orother central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.