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DOSAGE AND ADMINISTRATION
Daily doses of ZOHYDRO ER, 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.
Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Individualize dosing based on severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. Instruct patients to swallow ZOHYDRO ER intact and not to cut, break, chew, crush, or dissolve the capsules (risk of potentially fatal overdose).
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 titration of ZOHYDRO ER may occur every 3 to 7 days, using increments of 10 mg every 12 hours (i.e., 20 mg per day).
Patients with Severe Hepatic Impairment: Initiate dosing with 10 mg every
12 hours and titrate carefully, while monitoring for respiratory depression, sedation, and hypotension. No adjustment in starting dose with ZOHYDRO
ER is required in patients with mild or moderate hepatic impairment. (2.4)
Do not abruptly discontinue ZOHYDRO ER in a physically dependent patient.
Significant respiratory depression.
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
Known or suspected gastrointestinal obstruction, including paralytic ileus.
Hypersensitivity to hydrocodone or to any other components of ZOHYDRO
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
ZOHYDRO ER contains hydrocodone, a Schedule II controlled substance. As an opioid, it exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as it deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ZOHYDRO ER, and monitor all patients receiving ZOHYDRO ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of ZOHYDRO ER for the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as ZOHYDRO ER, but use in such patients necessitates intensive counseling about the risks and proper use of ZOHYDRO along with intensive monitoring for signs of addiction, abuse, and misuse.
The following serious adverse reactions are discussed elsewhere in the labeling:
• Addiction, Abuse, and Misuse [see Warnings and Precautions.
• Life-Threatening Respiratory Depression [see Warnings and Precautions.
• Neonatal Opioid Withdrawal Syndrome
• Interactions with Benzodiazepines and Other CNS Depressants.
• Adrenal Insufficiency.
• Severe Hypotension.
• Gastrointestinal Adverse Reactions.