HYDROCODONE BITARTRATE AND ACETAMINOPHEN

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Overview

What is HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

Hydrocodone Bitartrate and Acetaminophen Tablets 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: 4,5α-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:

Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains:

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

The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake 12%.

Meets USP Dissolution Test 1.

What does HYDROCODONE BITARTRATE AND ACETAMINOPHEN look like?

What are the available doses of HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

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What should I talk to my health care provider before I take HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

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How should I use HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

Dosage should be adjusted according to the severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage for Hydrocodone Bitartrate and Acetaminophen Tablets USP is:

What interacts with HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

What are the warnings of HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

Respiratory Depression

Head Injury and Increased Intracranial Pressure

Acute Abdominal Conditions

What are the precautions of HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

General

Special Risk Patients

Cough Reflex

Information for Patients

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

Drug Interactions

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Teratogenic Effects.

Pregnancy Category C

Nonteratogenic Effects

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

What are the side effects of HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

Central Nervous System

Gastrointestinal System

Genitourinary System

Respiratory Depression

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Special Senses –

Dermatological

The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the section.

What should I look out for while using HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

What might happen if I take too much HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

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

How should I store and handle HYDROCODONE BITARTRATE AND ACETAMINOPHEN?

GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows:Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure.Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows:Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.

The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Non-Clinical Toxicology

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

Drug Interactions

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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