Hydrocodone Bitartrate and Acetaminophen Tablets

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Overview

What is Hydrocodone Bitartrate and Acetaminophen Tablets?

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration.

WARNING: May be habit-forming

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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:

Hydrocodone Bitartrate, USP ........................ 7.5 mg

Acetaminophen, USP .................................... 500 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose.

Meets USP Dissolution Test 1.

What does Hydrocodone Bitartrate and Acetaminophen Tablets look like?

What are the available doses of Hydrocodone Bitartrate and Acetaminophen Tablets?

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What should I talk to my health care provider before I take Hydrocodone Bitartrate and Acetaminophen Tablets?

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How should I use Hydrocodone Bitartrate and Acetaminophen Tablets?

Hydrocodone bitartrate and acetaminophen tablets, USP 7.5 mg / 500 mg 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 is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

What interacts with Hydrocodone Bitartrate and Acetaminophen Tablets?

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What are the warnings of Hydrocodone Bitartrate and Acetaminophen Tablets?

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What are the precautions of Hydrocodone Bitartrate and Acetaminophen Tablets?

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What are the side effects of Hydrocodone Bitartrate and Acetaminophen Tablets?

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What should I look out for while using Hydrocodone Bitartrate and Acetaminophen Tablets?

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product.

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 Tablets?

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

How should I store and handle Hydrocodone Bitartrate and Acetaminophen Tablets?

Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container with a child-resistant closure.Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container with a child-resistant closure.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.They are available as follows:Bottles of 100: NDC 53746-112-01Bottles of 500: NDC 53746-112-05Bottles of 1000: NDC 53746-112-10Storage:Dispense in a tight, light-resistant container with a child-resistant closure.A Schedule CIII Narcotic.

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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.

Pharmacokinetics

The behavior of the individual components is described below.

Hydrocodone:

Acetaminophen:

Non-Clinical Toxicology

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product.

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

Do not eat or drink dairy products within one hour of fluoride administration. Incompatability of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Special Risk Patients:

Cough Reflex:

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:

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.

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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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Review

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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