Hydrocodone Bitartrate and Acetaminophen (Vicodin ES)
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Hydrocodone Bitartrate and Acetaminophen (Vicodin ES)

Vicodin ES®
(hydrocodone bitartrate and acetaminophen) Tablets, USP
7.5 mg/750 mg

DRUG 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:

Vicodin ES (hydrocodone bitartrate and acetaminophen)

C18H21NO3·C4H6O6·2½H2O     M.W.= 494.50

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:

Vicodin ES

C8H9NO2    M.W. 151.16

Each VICODIN ES (hydrocodone bitartrate and acetaminophen) Tablet contains:
Hydrocodone Bitartrate 7.5 mg
Acetaminophen 750 mg

In addition each tablet contains the following inactive ingredients: Colloidal silicon dioxide, pregelatinized starch, magnesium stearate, croscarmellose sodium, povidone, and stearic acid.

Meets USP Dissolution Test 2.

What are the possible side effects of acetaminophen and hydrocodone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, fear, unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with urination; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Vicodin ES »

What are the precautions when taking hydrocodone bitartrate and acetaminophen (Vicodin ES)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as morphine, codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as...

Read All Potential Precautions of Vicodin ES »

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

VICODIN ES (hydrocodone bitartrate and acetaminophen) Tablets are indicated for the relief of moderate to moderately severe pain.

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 5 tablets.

HOW SUPPLIED

White, oval-shaped, faceted edged tablet bisected on one side and imprinted with "VICODIN ES (hydrocodone bitartrate and acetaminophen) " on the other side.

Bottles of 100-NDC #0074-1973-14
Bottles of 500-NDC #0074-1973-54

Hospital Unit Dosage Package - 100 tablets (4 x 25 tablets) - NDC #0074-1973-12.

Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

A Schedule Vicodin ES (hydrocodone bitartrate and acetaminophen) Controlled Drug Substance.
©Abbott 03-5541-R3-Revised November, 2006
ABBOTT ABBOTT Laboratories  LABORATORIES
NORTH CHICAGO, IL 60064, U.S.A.
FDA revision date: 12/26/06

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

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

Gastrointestinal System: Prolonged administration of VICODIN ES (hydrocodone bitartrate and acetaminophen) Tablets 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 the brain stem respiratory center. (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, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the OVERDOSAGE section.

DRUG ABUSE AND DEPENDENCE

Misuse, Abuse, and Diversion of Opioids : VICODIN ES (hydrocodone bitartrate and acetaminophen) contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. VICODIN ES (hydrocodone bitartrate and acetaminophen) , and other opioids, used in analgesia can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

"Drug seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid 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. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. VICODIN ES® (hydrocodone bitartrate and acetaminophen) (hydrocodone bitartrate 7.5 mg and acetaminophen 750 mg), like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Read the Vicodin ES (hydrocodone bitartrate and acetaminophen) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with VICODIN ES (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.

Drug/Laboratory Test Interactions: Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

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 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: VICODIN ES (hydrocodone bitartrate and acetaminophen) contains 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.

VICODIN ES (hydrocodone bitartrate and acetaminophen) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing VICODIN ES in situations where the physician or pharmacist is concerned about an increased risk of misues, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

PRECAUTIONS

General

Special Risk Patients: As with any narcotic analgesic agent, VICODIN ES (hydrocodone bitartrate and acetaminophen) Tablets 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 VICODIN ES (hydrocodone bitartrate and acetaminophen) Tablets are 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. VICODIN ES (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.

Labor and Delivery: As with all narcotics, administration of VICODIN ES Tablets 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.

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

Geriatric Use: Clinical studies of VICODIN ES® (hydrocodone bitartrate and acetaminophen) (hydrocodone bitartrate 7.5 mg and acetaminophen 750 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 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.

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

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 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 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.

In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and 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 endo-tracheal 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. 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.

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

The toxic dose for adults for acetaminophen is 10 g.

CONTRAINDICATIONS

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.

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

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 hypothalmic 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: Following a 10mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ±5.2ng/mL. Maximum serum levels were achieved at 1.3 ±0.3 hours and the half-life was determined to be 3.8 ±0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α - and 6-β - hydroxy- metabolites. See OVERDOSAGE for toxicity information.

Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information.

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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.

Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Vicodin ES Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYDROCODONE/ACETAMINOPHEN - ORAL

(HYE-droe-KOE-done/a-SEET-a-MIN-oh-fen)

COMMON BRAND NAME(S): Lorcet, Lortab, Norco, Vicodin

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.

Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

USES: This combination medication is used to relieve moderate to severe pain. It contains a narcotic pain reliever (hydrocodone) and a non-narcotic pain reliever (acetaminophen). Hydrocodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.

HOW TO USE: See also Warning section.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

If you are using a liquid form of this medication, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting narcotic medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other non-narcotic pain relievers (such as naproxen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using this product safely with other drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

Disclaimer

Vicodin ES Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, severe stomach/abdominal pain, difficulty urinating.

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Vicodin ES (hydrocodone bitartrate and acetaminophen) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as morphine, codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Liquid products may contain sugar and alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, urinary problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This medication passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Disclaimer

Vicodin ES Consumer (continued)

DRUG INTERACTIONS: See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist/antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness, dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as morphine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, unusual sweating, slow breathing, slow heartbeat, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2012. Copyright(c) 2012 First Databank, Inc.

Vicodin ES Patient Information Including Side Effects

Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone

Generic Name: acetaminophen and hydrocodone (Pronunciation: a SEET a MIN oh fen and hye droe KOE done)

What is acetaminophen and hydrocodone (Vicodin ES)?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.

Acetaminophen-Hydrocodone 325 mg-10 mg-QUA

oval, yellow, imprinted with LOGO, 36 01

Acetaminophen-Hydrocodone 325 mg-10 mg-WAT

oblong, yellow, imprinted with Watson 853

Acetaminophen-Hydrocodone 325 mg-5 mg-WAT

oblong, white/orange specks, imprinted with 3202, WATSON

Acetaminophen-Hydrocodone 325 mg-7.5 mg-WAT

oblong, orange, imprinted with WATSON, 3203

Acetaminophen-Hydrocodone 500 mg-5 mg-MAL

oblong, white, imprinted with M 357

Acetaminophen-Hydrocodone 500 mg-7.5 mg-MAL

oblong, white, imprinted with M 358

Acetaminophen-Hydrocodone 650 mg-10 mg-MAL

oblong, blue, imprinted with M 361

Acetaminophen-Hydrocodone 650 mg-10 mg-WAT

oblong, green, imprinted with WATSON 503

Acetaminophen-Hydrocodone 650 mg-7.5 mg-MAL

oblong, white, imprinted with M 359

Acetaminophen-Hydrocodone 660 mg-10 mg-AND

oblong, white, imprinted with Logo 567

Acetaminophen-Hydrocodone 750 mg-10 mg-WAT

oval, yellow, imprinted with WATSON 3228

Acetaminophen-Hydrocodone 750 mg-7.5 mg-MAL

oblong, white, imprinted with M 360

Anexsia 5-500

round, white, imprinted with ANEXSIA, MPC 207

APAP-HC 10-500 mg-WAT

oblong, blue, imprinted with WATSON 540

APAP-HC 10-500-WAT

elliptical, white, imprinted with WATSON 540

APAP-HC 10-650 mg-WAT

oblong, green, imprinted with WATSON 503

APAP-HC 2.5-500 mg-WAT

oblong, white, imprinted with WATSON 388

APAP-HC 5-500 mg-WAT

oblong, white, imprinted with WATSON 349

APAP-HC 5-500-WAT

oblong, white, imprinted with WATSON 349

APAP-HC 7.5-500 mg

oblong, white, imprinted with WATSON 385

APAP-HC 7.5-500 mg-WAT

oblong, white, imprinted with WATSON 385

APAP-HC 7.5-650 mg

oblong, pink, imprinted with WATSON 502

APAP-HC 7.5-750 mg-WAT

oblong, white, imprinted with WATSON 387

APAP-HC 7.5-750-WAT

oblong, white, imprinted with WATSON 387

APAP-Hydrocodone 660 mg-10 mg-MAL

oblong, white, imprinted with M362

Hydrocodone-APAP 5mg-325mg-MAL

oblong, white, imprinted with M365

Lorcet Plus 7.5-650

oblong, white, imprinted with 201, UU

Lortab 10-500 mg

oblong, pink, imprinted with 910, UCB

Lortab 5-500

oblong, white/blue specks, imprinted with ucb, 902

Lortab 7.5-500 mg

oblong, white, imprinted with 903, UCB

Maxidone 10-750 mg

oval, yellow, imprinted with MAXIDONE 634

Norco 10-325

oblong, yellow, imprinted with NORCO 539

Norco 5-325 mg

oblong, white/orange specks, imprinted with 913, WATSON

Norco 7.5-325 mg

oblong, orange, imprinted with NORCO 729

Stagesic 500 mg-5 mg Cap

white, imprinted with Stagesic

Vicodin ES

oblong, white, imprinted with VICODIN ES

Xodol 300 mg-10 mg

oblong, white, imprinted with 10 300, TP

Zydone 400 mg-10 mg

octagonal, red, imprinted with E, 10

Zydone 400 mg-5 mg

octagonal, yellow, imprinted with E, 5

Zydone 400 mg-7.5 mg

octagonal, blue, imprinted with E, 7.5

What are the possible side effects of acetaminophen and hydrocodone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, fear, unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with urination; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • anxiety, dizziness, drowsiness;
  • mild nausea, vomiting, upset stomach, constipation;
  • headache, mood changes;
  • blurred vision;
  • ringing in your ears; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Vicodin ES (hydrocodone bitartrate and acetaminophen) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about acetaminophen and hydrocodone?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Vicodin ES Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking acetaminophen and hydrocodone?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or hydrocodone.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

To make sure you can safely take acetaminophen and hydrocodone, tell your doctor if you have any of these other conditions:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • a history of head injury or brain tumor;
  • low blood pressure;
  • a stomach or intestinal disorder;
  • underactive thyroid;
  • Addison's disease or other adrenal gland disorder;
  • curvature of the spine;
  • mental illness; or
  • a history of drug or alcohol addiction.

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share acetaminophen and hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen and hydrocodone?

Take exactly as prescribed. Never take acetaminophen and hydrocodone in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and hydrocodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and hydrocodone.

Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Vicodin ES Patient Information including If I Miss a Dose

What happens if I miss a dose?

Since acetaminophen and hydrocodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

What should I avoid while taking acetaminophen and hydrocodone?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What other drugs will affect acetaminophen and hydrocodone?

Do not take acetaminophen and hydrocodone with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and other drugs may interact with acetaminophen and hydrocodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and hydrocodone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01. Revision date: 8/11/2011.

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