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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

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Overview

What is HYDROCODONE BIT/APAP?

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 BIT/APAP look like?



What are the available doses of HYDROCODONE BIT/APAP?

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What should I talk to my health care provider before I take HYDROCODONE BIT/APAP?

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How should I use HYDROCODONE BIT/APAP?

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 the pain and the 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 BIT/APAP?

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 BIT/APAP?

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Hypersensitivity/anaphylaxis

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Respiratory Depression

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Head Injury and Increased Intracranial Pressure

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Acute Abdominal Conditions

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What are the precautions of HYDROCODONE BIT/APAP?

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  • Do not take Hydrocodone Bitartrate and Acetaminophen Tablets USP if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing stop taking Hydrocodone Bitartrate and Acetaminophen Tablets USP and contact your healthcare provider immediately.
  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.




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Laboratory Tests

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Drug/Laboratory Test Interactions

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Carcinogenesis, Mutagenesis, Impairment of Fertility

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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What are the side effects of HYDROCODONE BIT/APAP?

The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

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Central Nervous System

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Gastrointestinal System

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Genitourinary System

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Respiratory Depression

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Special Senses –

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What should I look out for while using HYDROCODONE BIT/APAP?

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 BIT/APAP?

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


How should I store and handle HYDROCODONE BIT/APAP?

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied in Unit-of-Use Bottles 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 in Unit-of-Use Bottles 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 include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory 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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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