Hydrocodone bitartrate

What is Hydrocodone bitartrate?

• Hydrocodone bitartrate (ZOHYDRO ER) is an opioid agonist used to treat severe pain of a prolonged duration, if other measures are not sufficient.

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Hydrocodone

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What are the uses of this medicine?

• This medicine is a pain medicine that contains an opioid (narcotic) that is used to treat pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Limitations of Use:

• A long acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not for use to treat pain that is not around-the-clock.

How does this medicine work?

• Hydrocodone is a semi-synthetic opioid agonist with relative selectivity for the mu-opioid (µ) receptor, although it can interact with other opioid receptors at higher doses.
• Hydrocodone acts as a full agonist, binding to and activating opioid receptors at sites in the peri-aquaductal and peri-ventricular gray matter, the ventro-medial medulla and the spinal cord to produce analgesia.
• The analgesia, as well as the euphoriant, respiratory depressant and physiologic dependence properties of μ agonist opioids like hydrocodone, result principally from agonist action at the μ receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus
• Hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartrate or any other ingredients in ZOHYDRO ER

What drug interactions can this medicine cause?

• Concomitant use of alcohol with ZOHYDRO ER can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone.
• The concomitant use of ZOHYDRO ER with other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol, can increase the risk of respiratory depression, profound sedation, coma, or death.
• The use of MAO inhibitors or tricyclic antidepressants with ZOHYDRO ER may increase the effect of either the antidepressant or ZOHYDRO ER.
• Avoid Concomitant use of Mixed agonists/antagonists and partial agonist analgesics with ZOHYDRO ER because they may reduce analgesic effect of ZOHYDRO ER or precipitate withdrawal symptoms.

Is this medicine FDA approved?

• Initial U.S. Approval: 1943

How should this medicine be used?

Recommended Dosage:

• ZOHYDRO ER 50 mg capsules, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.
• For opioid-naïve and opioid non-tolerant patients, initiate with 10 mg capsules orally every 12 hours.
• To convert to ZOHYDRO ER from another opioid, use available conversion factors to obtain estimated dose.
• Dose can be increased every 3 to 7 days, using increments of 10 mg every 12 hours (i.e., 20 mg per day).
• Do not abruptly discontinue ZOHYDRO ER in a physically dependent patient.

Administration

• Do not change your dose. Take ZOHYDRO ER exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.
• Swallow ZOHYDRO ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject ZOHYDRO ER because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking ZOHYDRO ER without talking to your healthcare provider.
• After you stop taking ZOHYDRO ER, flush any unused capsules down the toilet.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg

This medicine is available in fallowing brand namesː

• ZOHYDRO ER

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain
• pruritus
• edema peripheral
• upper respiratory tract infection
• muscle spasms
• urinary tract infection
• back pain
• tremor.

What special precautions should I follow?

• Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on ZOHYDRO ER therapy. If coadministration is required, consider dose reduction of one or both drugs.
• Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor closely because of increased risk for life-threatening respiratory depression.
• ZOHYDRO ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor during dose initiation and titration.
• Monitor patients taking ZOHYDRO ER who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with ZOHYDRO ER.
• Concomitant use of CYP3A4 inhibitors may increase opioid effects.
• Drive or operate heavy machinery, until you know how ZOHYDRO ER affects you. ZOHYDRO ER can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ZOHYDRO ER may cause you to overdose and die.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• progressing to stupor or coma
• skeletal muscle flaccidity
• cold and clammy skin
• constricted pupils
• pulmonary edema
• bradycardia
• hypotension
• death
• hypoxia

Management of overdosage:

• Management is done by protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema accompanying overdose as indicated.
• Cardiac arrest or arrhythmias will require advanced life support techniques.
• The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose.
• ZOHYDRO ER will continue to release hydrocodone and add to the hydrocodone load for 24 to 48 hours or longer following ingestion necessitating prolonged monitoring.
• In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• ZOHYDRO ER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Prolonged use of ZOHYDRO ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

Can this medicine be used in children?

• The safety and effectiveness of ZOHYDRO ER in pediatric patients below the age of 18 years have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: HYDROCODONE BITARTRATE

Inactive ingredients: HYPROMELLOSES SILICON DIOXIDE TALC TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 FERRIC OXIDE YELLOW FD&C RED NO. 3 FERROSOFERRIC OXIDE FERRIC OXIDE RED GELATIN SUCROSE STARCH, CORN AMMONIO METHACRYLATE COPOLYMER TYPE B

Who manufactures and distributes this medicine?

• Packager: Zogenix, Inc.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
• Dispense in tight container as defined in the USP, with a child-resistant closure.
• Advise patients to dispose of any unused capsules from a prescription as soon as they are no longer needed in accordance with local State guidelines and/or regulations

• Dailymed label info on Hydrocodone bitartrate
• FDA Hydrocodone bitartrate

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