HYDROcodone bitartrate 10 MG / acetaminophen 500 MG Oral Tablet

Details

Generic Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Brand Name: Hydrocodone Bitartrate And Acetaminophen

Substance Name(s):
HYDROCODONE BITARTRATE
ACETAMINOPHEN

WARNINGS

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 4000 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 4000 milligrams of acetaminophen per day, even if they feel well. Hypersensitivity/anaphylaxis: There have been post-marketing reports of hypersensitivity and anaphylaxis associated with 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, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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 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: Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III 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 ).

DRUG INTERACTIONS

Drug Interactions: Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

OVERDOSAGE

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms: Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment: A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For hydrocodone overdose, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

DESCRIPTION

Hydrocodone bitartrate and acetaminophen is 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: This is an image of the structural formula of Hydrocodone bitartrate. This is an image of the structural formula of Acetaminophen. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg Each tablet contains: Hydrocodone Bitartrate …………. 2.5 mg Acetaminophen ……………………. 500 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red #3, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sucrose. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg Each tablet contains: Hydrocodone Bitartrate …………….. 5 mg Acetaminophen ……………………….. 325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and sugar spheres which are composed of starch derived from corn, FD&C Red #40, FD&C Yellow #6, and sucrose. Meets USP Dissolution Test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg Each tablet contains: Hydrocodone Bitartrate …………. 5 mg Acetaminophen ……………………. 500 mg In addition each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg Each tablet contains: Hydrocodone Bitartrate …………. 7.5 mg Acetaminophen ……………………. 325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid. Meets USP Dissolution Test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg Each tablet contains: Hydrocodone Bitartrate …………. 7.5 mg Acetaminophen ……………………. 500 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue #1, FD&C Yellow #5, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sucrose. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg Each tablet contains: Hydrocodone Bitartrate …………. 7.5 mg Acetaminophen ……………………. 650 mg In addition each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg Each tablet contains: Hydrocodone Bitartrate …………. 7.5 mg Acetaminophen ……………………. 750 mg In addition each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg Each tablet contains: Hydrocodone Bitartrate ………… 10 mg Acetaminophen ……………………. 325 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Each tablet contains: Hydrocodone Bitartrate ………… 10 mg Acetaminophen ……………………. 500 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, D&C Red #30 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg Each tablet contains: Hydrocodone Bitartrate ………… 10 mg Acetaminophen ……………………. 650 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg Each tablet contains: Hydrocodone Bitartrate ………… 10 mg Acetaminophen ……………………. 660 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1.

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg are supplied as white with bright pink specks, capsule-shaped, scored tablets, debossed “3591” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 100, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg are supplied as white with orange specks, capsule-shaped, scored tablets, debossed “3604” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 10, 30, 60, 90, 100, 120, 180, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg are supplied as white, capsule-shaped, scored tablets, debossed “3592” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 20, 30, 50, 60, 90, 100, 120, 180, 240, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg are supplied as light orange, oval-shaped, scored tablets, debossed “3605” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 10, 90, 100, 120, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg are supplied as white with green specks, capsule-shaped, scored tablets, debossed “3594” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 30, 60, 90, 100, 120, 180, 240, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg are supplied as white, modified capsule-shaped, scored tablets, debossed “3595” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 100, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg are supplied as white capsule-shaped, scored tablets, debossed “3596” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 60, 90, 100, 120, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg are supplied as light yellow, modified capsule-shaped, scored tablets, debossed “3601” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 60, 90, 100, 120, 150, 180, 240, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg are supplied as pink, capsule-shaped tablets, debossed “3600” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 30, 60, 90, 100, 120, 150, 180, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg are supplied as light blue, capsule-shaped, scored tablets, debossed “3597” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 30, 60, 90, 100, 120, 180, 500 and 1000. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg are supplied as white oval-shaped, scored tablets, debossed “3598” on one side and debossed “V” on the reverse side. The tablets are supplied in containers of 100, 500 and 1000. Storage: 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 CIII Narcotic.

GERIATRIC USE

Geriatric Use: Clinical studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 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.

INDICATIONS AND USAGE

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

PEDIATRIC USE

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

PREGNANCY

Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

NUSRING MOTHERS

Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

BOXED WARNING

INFORMATION FOR PATIENTS

Information for Patients/Caregivers: 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. Hydrocodone, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. 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.

DOSAGE AND ADMINISTRATION

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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg 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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg 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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg 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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg 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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg 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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg 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. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg 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.