Doctor Pharmacy

Brand Name:

WATSON 540 (Acetaminophen and Hydrocodone 500 mg / 10 mg)

Pill imprint WATSON 540 has been identified as Acetaminophen and hydrocodone bitartrate 500 mg / 10 mg.

Acetaminophen/hydrocodone is used in the treatment of back pain; pain; rheumatoid arthritis; cough and belongs to the drug class narcotic analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/hydrocodone 500 mg / 10 mg has a potential for abuse less than the drugs in schedules 1 and 2. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence.

Imprint:

WATSON 540

Strength:

500 mg / 10 mg

Color:

Blue

Shape:

Elliptical / Oval

Availability:

Prescription only

Drug Class:

Narcotic analgesic combinations

Pregnancy Category:

C - Risk cannot be ruled out

CSA Schedule:

3 - Moderate abuse potential

Manufacturer:

Watson Laboratories, Inc.

National Drug Code (NDC):

00591-0540

Inactive Ingredients:

croscarmellose sodium
crospovidone
magnesium stearate
microcrystalline cellulose
povidone
corn starch
stearic acid
aluminum oxide
FD&C Blue No. 2

Side Effects:

Some side effects of acetaminophen / hydrocodone may not be reported. Always consult your doctor or healthcare specialist for medical advice.

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral syrup, oral tablet.

Along with its needed effects, acetaminophen / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / hydrocodone:

Incidence not known:

    Back, leg, or stomach pains
    black, tarry stools
    bleeding gums
    blood in the urine or stools
    blood in vomit
    bluish lips or skin
    chills
    choking
    cough or hoarseness
    dark urine
    decrease in the frequency of urination
    decrease in urine volume
    difficult or troubled breathing
    difficulty in passing urine (dribbling)
    difficulty with breathing
    difficulty with swallowing
    dizziness
    fast heartbeat
    fever
    fever with or without chills
    general body swelling
    general feeling of tiredness or weakness
    headache
    hives
    irregular, fast or slow, or shallow breathing
    itching
    light-colored stools
    loss of appetite
    lower back or side pain
    nausea or vomiting
    nosebleeds
    not breathing
    painful or difficult urination
    pale or blue lips, fingernails, or skin
    pale skin
    pinpoint red spots on the skin
    puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    severe or continuing stomach pain
    shortness of breath or troubled breathing
    skin rash
    sore throat
    sore tongue
    sores, ulcers, or white spots on the lips or in the mouth
    tightness in the chest
    unable to speak
    unusual bleeding or bruising
    unusual tiredness or weakness
    upper right abdominal or stomach pain
    wheezing
    yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / hydrocodone:

Symptoms of overdose:

    Bloody or cloudy urine
    change in consciousness
    chest pain or discomfort
    cold and clammy skin
    decreased awareness or responsiveness
    extreme drowsiness
    general feeling of discomfort or illness
    increased sweating
    irregular heartbeat
    lightheadedness, dizziness, or fainting
    loss of consciousness
    no blood pressure or pulse
    no muscle tone or movement
    not breathing
    severe sleepiness
    slow or irregular heartbeat
    stopping of heart
    sudden decrease in the amount of urine
    unconsciousness
    unpleasant breath odor
    vomiting of blood

Some side effects of acetaminophen / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

    Drowsiness
    relaxed and calm
    sleepiness

Incidence not known:

    Belching
    changes in mood
    difficulty having a bowel movement (stool)
    fear or nervousness
    feeling of indigestion
    hearing loss
    impaired hearing
    pain in the chest below the breastbone
    unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Pregnancy and Breastfeeding Warnings:

Acetaminophen / hydrocodone Pregnancy Warnings:

FDA pregnancy category: C Acetaminophen-hydrocodone should only be given during pregnancy when benefit outweighs risk.

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Acetaminophen / hydrocodone Breastfeeding Warnings:

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (acetaminophen and hydrocodone) Excreted into animal milk: Yes (acetaminophen and hydrocodone) There have been reports of rash, drowsiness, limpness, and lethargy in breastfed infants of mothers taking acetaminophen-hydrocodone.

Dosage:

This dosage information may not include all the information needed to use Acetaminophen / Hydrocodone safely and effectively. See additional information for Acetaminophen / Hydrocodone.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Pain

Usual Geriatric Dose for:

Pain

Usual Pediatric Dose for:

Cough
Pain

Additional dosage information:

    Renal Dose Adjustments
    Liver Dose Adjustments
    Dose Adjustments
    Precautions
    Dialysis
    Other Comments

Usual Adult Dose for Pain:

Initial dose:

1 tablet (acetaminophen/hydrocodone 500 mg-5 mg) orally every 6 hours as needed or
10 mL (acetaminophen/hydrocodone 333 mg-5 mg) oral elixir every 6 hours as needed or
15 mL (acetaminophen/hydrocodone 325 mg-10 mg) oral solution every 4 to 6 hours as needed or
15 mL (acetaminophen/hydrocodone 500 mg-10 mg) oral elixir every 4 to 6 hours as needed.
11.25 mL (acetaminophen/hydrocodone 300 mg-10 mg) oral elixir every 4 to 6 hours as needed.

Many different combination dosage forms of acetaminophen-hydrocodone are commercially available. In general, combinations with 5 mg of hydrocodone are given 1 to 2 doses every 4 to 6 hours, up to 8 doses per day. Combinations containing 7.5 or 10 mg of hydrocodone are given once every 4 to 6 hours, up to 5 or 6 doses per day (depending on how much acetaminophen they contain).

Usual Geriatric Dose for Pain:

Initial dose: 1 tablet (acetaminophen/hydrocodone 500 mg-2.5 mg) orally every 6 hours as needed or 5 mL (acetaminophen/hydrocodone 167 mg-2.5 mg) oral elixir every 6 hours as needed.

Usual Pediatric Dose for Cough:

Antitussive (doses based on hydrocodone):
Children: 0.6 mg/kg/day or 20 mg/m2/day divided in 3 to 4 doses/day
Less than 2 years: Do not exceed 1.25 mg/single dose
2 to 12 years: Do not exceed 5 mg/single dose
Greater than 12 years: Do not exceed 10 mg/single dose

Analgesic: Children: Dose has not been well established:
Opioid-naive patients (dose based on hydrocodone):
Children and Adults less than 50 kg: Usual initial dose: 0.1 to 0.2 mg/kg every 3 to 4 hours
Children and Adults greater than or equal to 50 kg: Usual initial dose: 5 to 10 mg every 3 to 4 hours

Usual Pediatric Dose for Pain:

Antitussive (doses based on hydrocodone):
Children: 0.6 mg/kg/day or 20 mg/m2/day divided in 3 to 4 doses/day
Less than 2 years: Do not exceed 1.25 mg/single dose
2 to 12 years: Do not exceed 5 mg/single dose
Greater than 12 years: Do not exceed 10 mg/single dose

Analgesic: Children: Dose has not been well established:
Opioid-naive patients (dose based on hydrocodone):
Children and Adults less than 50 kg: Usual initial dose: 0.1 to 0.2 mg/kg every 3 to 4 hours
Children and Adults greater than or equal to 50 kg: Usual initial dose: 5 to 10 mg every 3 to 4 hours

Renal Dose Adjustments:

Dosage adjustments in patients with renal dysfunction should be done cautiously.

Liver Dose Adjustments:

Dosage adjustments in patients with liver dysfunction should be done cautiously.

Dose Adjustments:

Dosage can be titrated to achieve desired effect. Selected patients may benefit from formulations that provide more acetaminophen or more hydrocodone per dose.

In children, whenever possible calculate dose using weight.

Precautions:

Hydrocodone, particularly in large doses, may cause life-threatening respiratory depression. Treatment includes maintenance of the airway, artificial ventilation if necessary, and the opiate antagonist, naloxone. The usual adult dose of naloxone is 1 to 2 mg every 2 to 3 minutes as necessary. The dose can be administered intravenously (preferred), intramuscularly, subcutaneously and sublingually.

Hydrocodone, like other analgesics, should be administered with caution to patients with head injuries, acute undiagnosed abdominal pain, acute alcoholism, delirium tremens, hypothyroidism, severe renal disease, severe liver disease, pulmonary disease, myxedema (or hypothyroidism), CNS depression, coma, toxic psychosis, Addison's disease, gall bladder disease, prostatic hypertrophy, urethral stricture, kyphoscoliosis, and general debilitation. Hydrocodone should also be administered with caution to patients following gastrointestinal surgery.

Hydrocodone, like other narcotic analgesics, may be habit forming.

Hydrocodone may impair the mental abilities necessary for potentially hazardous tasks such as driving or operating machinery.

The CNS depressant effects of hydrocodone may be increased by other CNS depressants such as alcohol, sedatives, hypnotics, tranquilizers, phenothiazines, and general anesthetics.
Dialysis

Dosage adjustments in dialysis patients should be done cautiously.