Lortab

Lortab

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Questions & Answers

Side Effects & Adverse Reactions

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 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue LORTAB ELIXIR immediately and seek medical care if they experience these symptoms. Do not prescribe LORTAB ELIXIR for patients with acetaminophen allergy.

Respiratory Depression

At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS, Pediatric Use). If use of LORTAB ELIXIR in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Misuse Abuse and Diversion of Opioids

LORTAB ELIXIR contains hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

LORTAB ELIXIR can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing LORTAB ELIXIR in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

LORTAB ELIXIR is indicated for the relief of moderate to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

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

WARNING: May be habit-forming (see PRECAUTIONS, Information for Patients/Caregivers, and DRUG ABUSE AND DEPENDENCE). 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:

Hydrocodone Bitartrate 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:

Acetaminophen Structural Formula

LORTAB ELIXIR (hydrocodone bitartrate and acetaminophen oral solution) contains :

PerPer
5 mL15 mL
Hydrocodone Bitartrate ......................3.33 mg10 mg
Acetaminophen ..................................100 mg300 mg
Alcohol ..............................................7%7%

In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.

Lortab Manufacturers


  • Akorn, Inc.
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Syrup [Akorn, Inc.]
  • Stat Rx Usa Llc
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [Stat Rx Usa Llc]
  • Cardinal Health
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [Cardinal Health]
  • Cardinal Health
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [Cardinal Health]
  • Physicians Total Care, Inc.
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Syrup [Physicians Total Care, Inc.]
  • Cardinal Health
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [Cardinal Health]
  • A-s Medication Solutions Llc
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [A-s Medication Solutions Llc]
  • Rx Pak Division Of Mckesson Corporation
    Lortab (Hydrocodone Bitartrate, Acetaminophen) Tablet [Rx Pak Division Of Mckesson Corporation]
  • Rx Pak Division Of Mckesson Corporation
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Tablet [Rx Pak Division Of Mckesson Corporation]
  • Rx Pak Division Of Mckesson Corporation
    Lortab (Hydrocodone Bitartrate, Acetaminophen) Tablet [Rx Pak Division Of Mckesson Corporation]
  • Ecr Pharmaceuticals
    Lortab (Hydrocodone Bitartrate And Acetaminophen) Syrup [Ecr Pharmaceuticals]

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