Lorcet 10/650

Lorcet 10/650

Lorcet 10/650 Recall

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Questions & Answers

Side Effects & Adverse Reactions

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 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

Lorcet® 10/650 tablets contain hydrocodone, an opioid agonist, and are a Schedule III controlled substance. Opioid agonists have thepotential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

Lorcet® 10/650 can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Lorcet® 10/650 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

Lorcet® 10/650 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 are 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 4,5 ⟨-epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

hydrocodone bitartrate chemical structure

C18H21NO3 • C4H6O6 • 2 ½ H2O M.W. 494.490

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 chemical structure

C8H9NO2 MW = 151.16

Each Lorcet® 10/650 tablet for oral administration contains:

Hydrocodone Bitartrate...................................10 mg

WARNING: May be habit-forming.

Acetaminophen.............................................650 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and FD&C Blue #1 Lake.

This product complies with Dissolution Test 1.

Lorcet 10/650 Manufacturers


  • Rx Pak Division Of Mckesson Corporation
    Lorcet 10/650 (Hydrocodone Bitartrate, Acetaminophen) Tablet [Rx Pak Division Of Mckesson Corporation]
  • Forest Laboratories, Inc.
    Lorcet 10/650 (Hydrocodone Bitartrate And Acetaminophen) Tablet [Forest Laboratories, Inc.]

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