DESCRIPTION SECTION

DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table.

Each hydrocodone bitartrate and acetaminophen tablet contains:

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.

Meets USP Dissolution Test 1.

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INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings], reserve Hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

· Have not been tolerated, or are not expected to be tolerated,

· Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

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CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with:

• Significant respiratory depression [seeWARNINGS]

• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [seeWARNINGS]

• Known or suspected gastrointestinal obstruction, including paralytic ileus [seeWARNINGS]

• Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see**WARNINGS****,**ADVERSE REACTIONS]

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ADVERSE REACTIONS SECTION

ADVERSE REACTIONS

The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and Tablets. 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.
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.****
** Other adverse reactions include**

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Central Nervous System

Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

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****Gastrointestinal System

constipation.

Genitourinary System

Ureteral spasm, spasm of vesical sphincters and urinary retention.
Special Senses

Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Dermatological

Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions.
Hematological - Thrombocytopenia, agranulocytosis.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life- threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
• Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
• Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets.

• Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time.

• Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings].

• Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

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OVERDOSAGE SECTION

OVERDOSAGE

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

Clinical Presentation

Acute overdose with hydrocodone bitartrate and acetaminophen tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypoglycemia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Acetaminophen

Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post- ingestion.

Treatment of Overdose

Hydrocodone

In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures.

Opioid antagonists, such as naloxone are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.

Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone bitartrate and acetaminophen tablets in hydrocodone bitartrate and acetaminophen tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Acetaminophen

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

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SPL MEDGUIDE SECTION

MEDICATION GUIDE

Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen

Hydrocodone Bitartrate and Acetaminophen Tablets are:

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** •** A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

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** Important information about hydrocodone bitartrate and acetaminophen tablets:**
• Get emergency help or call 911 right away if you take too much hydrocodone bitartrate and acetaminophen tablets (overdose). When you first start taking

hydrocodone bitartrate and acetaminophen tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose..
• Taking hydrocodone bitartrate and acetaminophen tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death.
• Never give anyone else your Hydrocodone Bitartrate and Acetaminophen Tablets. They could die from taking it. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Tablets are against the law.
• Store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

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Do not take hydrocodone bitartrate and acetaminophen tablets if you have:
• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines.
• Known hypersensitivity to hydrocodone or acetaminophen,or any ingredient in hydrocodone and acetaminophen tablets.

Before taking hydrocodone bitartrate and acetaminophen tablets, tell your healthcare provider if you have a history of:
• head injury, seizures
• liver, kidney, thyroid problems
• problems urinating
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take hydrocodone bitartrate and acetaminophen tablets, do not take more of hydrocodone bitartrate and acetaminophen tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking hydrocodone bitartrate and acetaminophen tablets *Pregnant or planning to becomepregnant. Use of hydrocodone bitartrate and acetaminophen tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

Breastfeeding*.******Hydrocodone bitartrate and acetaminophen tablets passes into breast milk and may harm your baby.Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.

• living in a household where there are small children or someone who has abused street or prescription drugs
  Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydrocodone bitartrate and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.

When taking hydrocodone bitartrate and acetaminophen tablets:
• Do not change your dose. Take hydrocodone Bitartrate and acetaminophen tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for shortest time needed take your prescribed dose every four to six hours as needed for pain
**.**For acute (short-term) pain, you may only need to take hydrocodone Bitartrate and acetaminophen tablets for a few days. You may have some hydrocodone Bitartrate and acetaminophen tablets left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused hydrocodone Bitartrate and acetaminophen tablets.
• Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking hydrocodone bitartrate and acetaminophen tablets regularly, do not stop taking hydrocodone bitartrate and acetaminophen tablets without talking to your healthcare provider.

• Dispose of expired, unwanted, or unused hydrocodone bitartrate and acetaminophen tablets by promptly flushing down the toilet, if a drug take- back option is not readily available.Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking hydrocodone bitartrate and acetaminophen tablets DO NOT:
• Drive or operate heavy machinery, until you know how hydrocodone bitartrate and acetaminophen tablets affects you. Hydrocodone bitartrate and acetaminophen tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydrocodone bitartrate and acetaminophen tablets may cause you to overdose and die.

The possible side effects of hydrocodone bitartrate and acetaminophen tablets:
• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:
• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of hydrocodone bitartrate and acetaminophen tablets. Call your healthcare provider for medical advice about side effects. You may also request medical information or to report suspected adverse reactions, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088.** For more information go to dailymed.nlm.nih.gov**

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What are the ingredients in Hydrocodone Bitartrate and Acetaminophen Tablets?
Active Ingredients:hydrocodone bitartrate and acetaminophen
**Inactive ingredients:**colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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**Dispense with Medication Guide available at **https://www.aurobindousa.com/medication-guides/

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Distributed by:
** Aurobindo Pharma USA, Inc.**
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Revised: 12/2023

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