Fluphenazine Hydrochloride

Fluphenazine Hydrochloride

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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 4,000 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 4,000 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 the 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 Hydrocodone Bitartrate and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets 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.

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 pre-existing 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 – Hydrocodone bitartrate and acetaminophen tablets 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.

Hydrocodone bitartrate and acetaminophen tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets 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

Hydrocodone bitartrate and acetaminophen tablets are 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 Tablets are supplied in tablet form for oral administration.

*WARNING: May be habit-forming. (See PRECAUTIONS, Information for Patients, 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

Each Hydrocodone Bitartrate and Acetaminophen 5 mg/300 mg tablet contains:
Hydrocodone Bitartrate* ...... 5 mg
   *WARNING: May be habit-forming.
Acetaminophen ................. 300 mg

Each Hydrocodone Bitartrate and Acetaminophen 7.5 mg/300 mg tablet contains:
Hydrocodone Bitartrate* ...... 7.5 mg
   *WARNING: May be habit-forming.
Acetaminophen ................. 300 mg

Each Hydrocodone Bitartrate and Acetaminophen 10 mg/300 mg tablet contains:
Hydrocodone Bitartrate* ...... 10 mg
   *WARNING: May be habit-forming.
Acetaminophen ................. 300 mg

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

This product complies with USP Dissolution Test 2.

Fluphenazine Hydrochloride Manufacturers


  • American Health Packaging
    Fluphenazine Hydrochloride Tablet, Film Coated [American Health Packaging]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Fluphenazine Hydrochloride Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • State Of Florida Doh Central Pharmacy
    Fluphenazine Hydrochloride Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • App Pharmaceuticals, Llc
    Fluphenazine Hydrochloride Injection, Solution [App Pharmaceuticals, Llc]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Lannett Company, Inc.
    Fluphenazine Hydrochloride Tablet, Film Coated [Lannett Company, Inc.]
  • Remedyrepack Inc.
    Fluphenazine Hydrochloride Tablet, Film Coated [Remedyrepack Inc. ]
  • Sandoz Inc
    Fluphenazine Hydrochloride Tablet, Film Coated [Sandoz Inc]
  • Mylan Pharmaceuticals Inc.
    Fluphenazine Hydrochloride Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Mylan Institutional Inc.
    Fluphenazine Hydrochloride Tablet, Film Coated [Mylan Institutional Inc.]
  • Clinical Solutions Wholesale
    Fluphenazine Hydrochloride Tablet, Film Coated [Clinical Solutions Wholesale]
  • Tya Pharmaceuticals
    Fluphenazine Hydrochloride Tablet, Film Coated [Tya Pharmaceuticals]

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