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Description

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Norco®
(buy hydrocodone acetaminophen hydrocodone acetaminophen and bitartrate) 10mg/325 mg, Tablets for Oral Administration

DESCRIPTION

NORCO® (Hydrocodone bitartrate and acetaminophen) is supplied in tablet form for oral administration.

buy hydrocodone acetaminophen 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:

 

 

Hydrocodone bitartrate - Structural Formula Illustration

 

Acetaminophen, 4´-hydroxy acetani lide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

 

 

Acetaminophen - Structural Formula Illustration

 

NORCO®, for oral administration is available in the following strengths:

Hydrocodone

Bitartrate Acetaminophen

NORCO® 7.5/325 7.5 mg 325 mg
NORCO® 10/325 10 mg 325 mg

In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid; the 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake, the 10 mg/325 mg tablets include

FDA warnings

  • This drug has black box warnings. A black box warning is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
  • May cause addiction, abuse, and misuse. Taking this drug increases your risk of opioid (narcotic) addiction, abuse, and misuse. This could lead to overdose and death. Talk to your doctor if you are concerned about the habit-forming properties of this drug.
  • May slow or stop breathing. Hydrocodone in high doses may affect the parts of your brain that control your breathing. If you have trouble breathing, call your doctor or get emergency medical help right away.
  • Accidental ingestion by children. Swallowing even one dose of this medication could be fatal to a child. Keep away from children.
  • May cause withdrawal symptoms in newborn infants. If you use this medication during pregnancy, your baby may have life-threatening problems after it’s born. This is called neonatal opioid withdrawal syndrome. Problems in your newborn are more likely if you take this medication for a long period of time during pregnancy. Talk to your doctor if you are pregnant or planning to become pregnant.buy hydrocodone acetaminophen Drug interactions. Hydrocodone and acetaminophen are broken down by your liver. If you take these drugs with another drug that can affect your liver, hydrocodone and acetaminophen could build up in your body and cause more breathing problems and other side effects. Your doctor may need to change or stop this medication or your other medications. buy hydrocodone acetaminophen
  • May cause liver failure. Taking too much acetaminophen can cause liver failure. Sometimes, this results in the need for liver transplant, or death. Most reported cases of liver injury have occurred when a person took more than 4,000 mg of acetaminophen per day, usually together with more than one product containing acetaminophen. The risk of liver failure is higher in people who already have liver disease, and people who drink alcohol while taking acetaminophen.
  • Use with central nervous system (CNS) depressants. Taking opioids with CNS depressants, such as benzodiazepines or alcohol, may result in excessive sedation, slow breathing, coma, and death.

Other warnings

  • Severe allergic reaction warning: This medication may cause a severe, potentially life-threatening allergic reaction. The reaction can occur very quickly. Symptoms may include:
    • trouble breathing
    • swelling of your face, throat, and mouth
    • rash
    • itching
    • vomiting

If this occurs, stop taking this medication and call your doctor right away or get emergency medical help.

  • Adrenal gland problems warning: This medication may cause your adrenal glands to not work as well. Symptoms may include:
  • Drug Description

    Find Lowest Prices on

    Norco®
    (hydrocodone acetaminophen and bitartrate) 10mg/325 mg, Tablets for Oral Administration

    DESCRIPTION

    NORCO® (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:

     

     

    Hydrocodone bitartrate - Structural Formula Illustration

     

    Acetaminophen, 4´-hydroxy acetani lide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

     

     

    Acetaminophen - Structural Formula Illustration

     

    NORCO®, for oral administration is available in the following strengths:

    Hydrocodone

    Bitartrate Acetaminophen

    NORCO® 7.5/325 7.5 mg 325 mg
    NORCO® 10/325 10 mg 325 mg

    In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid; the 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake, the 10 mg/325 mg tablets include D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.

    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.

    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.

    HOW SUPPLIED

    NORCO® 7.5/325 is available as capsule-shaped, light orange tablets bisected on one side and debossed with “NORCO® 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied as follows:

    Bottles of 30
    Bottles of 100
    Bottles of 500

    NORCO 10/325 is available as capsule-shaped, yellow tablets bisected on one side and debossed with  “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied as follows:

    Bottles of 100
    Bottles of 500

    Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

    Dispense in a tight, light-resistant container with a child resistant closure.

    Watson Pharma, Inc., A Subsidiary of Watson, Pharmaceuticals, Inc., Corona, CA 92880 USA 14716. Revised: July 2007. Cardinal Health, Zanesville, OH 43701.

    QUESTION

    Medically speaking, the term “myalgia” refers to what type of pain?See Answer

    Side Effects & Drug Interactions

    SIDE EFFECTS

    The most frequently reported adverse reactions are 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

    Central Nervous System: Drowsi ness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

    Gastrointestinal System: Prolonged administration of NORCO® may produce constipation.

    Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

    Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

    Special Senses : Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

    Dermatological: Skin rash, pruritus.

    The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopeniaagranulocytosis. Potential effects of high dosage are listed in the OVERDOSAGE section.

    Drug Abuse And Dependence

    Controlled Substance

    NORCO® is classified as a Schedule III controlled substance.

    Abuse and Dependence

    Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when NORCO® is used for a short time for the treatment of pain.

    Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

    DRUG INTERACTIONS

    Patients receiving other narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with NORCO® 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.

    Drug/Laboratory Test Interactions

    Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

    Warnings

    WARNINGS

    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 pre-existing 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.

    Precautions

    PRECAUTIONS

    General

    Special Risk Patients

    As with any narcotic analgesic agent, NORCO® should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

    Cough reflex

    Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when NORCO® is used postoperatively and in patients with pulmonary disease.

    Laboratory Tests

    In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

    There are no adequate and well-controlled studies in pregnant women. NORCO® 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.

    Labor And Delivery

    As with all narcotics, administration of this product to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

    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.buy hydrocodone acetaminophen 5 325

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Clinical studies of hydrocodone bitartrate 5 mg and acetaminophen 500 mg 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.buy hydrocodone acetaminophen

    Overdosage & Contraindications

    OVERDOSE

    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 respirationcyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apneacirculatory collapse, cardiac arrest and death may occur.buy hydrocodone acetaminophen 5 325

    Acetaminophen

    In acetaminophen overdosage: dosedependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia 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.buy hydrocodone acetaminophen 5 325

    In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

    Treatment

    A single or multiple 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. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

    Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.

    Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.buy hydrocodone acetaminophen

    A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

    If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.buy hydrocodone acetaminophen

    Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

    The toxic dose for adults for acetaminophen is 10 g.

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