KADIAN- morphine sulfate capsule, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Pieejams no:

Lake Erie Medical DBA Quality Care Products LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

KADIAN is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use KADIAN is not for use: ¯ As an as-needed (prn) analgesic ¯ For pain that is mild or not expected to persist for an extended period of time ¯ For acute pain ¯ For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the KADIAN 100 mg and 200 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer. KADIAN is contraindicated in patients with - Significant respiratory depression - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - Known or susp

Produktu pārskats:

KADIAN capsules contain white to off-white or tan colored polymer coated extended-release pellets of morphine sulfate and are available in nine dose strengths. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and moisture.  Dispense in a sealed tamper-evident, childproof, light-resistant container.

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

KADIAN- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
Medication Guide
KADIAN® (key-dee-uhn)
(morphine sulfate) extended-release capsules, CII
KADIAN is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to treat
moderate to severe around-the-clock pain.
Important information about KADIAN:
•
Get emergency help right away if you take too much KADIAN (overdose).
KADIAN overdose
can cause life-threatening breathing problems that can lead to death.
•
Never give anyone else your KADIAN. They could die from taking it.
Store KADIAN away from
children and in a safe place to prevent stealing or abuse. Selling or
giving away KADIAN is
against the law.
Do not take KADIAN if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking KADIAN, tell your healthcare provider if you have a
history of:
•
head injury, seizures
•
liver, kidney, thyroid
problems
•
problems urinating
•
pancreas or
gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction, or
mental health problems.
Tell your healthcare provider if you are:
•
pregnant or planning to become pregnant. KADIAN may harm your unborn
baby.
•
breastfeeding. KADIAN passes into breast milk and may harm your baby.
•
taking prescription or over-the-counter medicines, vitamins, or herbal
supplements.
When taking KADIAN:
•
Do not change your dose. Take KADIAN exactly as prescribed by your
healthcare provider.
•
Take your prescribed dose at the same time every day. Do not take more
than your prescribed dose
in 24 hours. If you miss a dose, take KADIAN as soon as possible and
then take your next dose 12
or 24 hours later as directed by your healthcare provider. If it is
almost time for your next dose,
skip the missed dose and go back to your regular dosing schedule.
•
Swallow KADIAN whole. Do not cut, break, chew, crush, dissolve, or
inject KADIAN.
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Produkta apraksts

KADIAN- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KADIAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR KADIAN.
KADIAN® (MORPHINE SULFATE) EXTENDED-RELEASE CAPSULES, FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 1941
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY
DEPRESSION, AND ACCIDENTAL EXPOSURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
KADIAN CONTAINS PELLETS OF MORPHINE SULFATE, A SCHEDULE II CONTROLLED
SUBSTANCE. MONITOR FOR SIGNS OF
MISUSE, ABUSE, AND ADDICTION DURING KADIAN THERAPY. (5.1, 9)
FATAL RESPIRATORY DEPRESSION MAY OCCUR, WITH HIGHEST RISK AT
INITIATION AND WITH DOSE INCREASES. INSTRUCT
PATIENTS ON PROPER ADMINISTRATION OF KADIAN CAPSULES TO REDUCE THE
RISK. (5.2)
ACCIDENTAL INGESTION OF KADIAN CAN RESULT IN FATAL OVERDOSE OF
MORPHINE, ESPECIALLY IN CHILDREN. (5.3)
INDICATIONS AND USAGE
KADIAN is an opioid agonist product indicated for the management of
moderate to severe pain when a continuous, around-
the-clock opioid analgesic is needed for any extended period of time
(1)
Limitations of Use
KADIAN is not for use:
-As an as-needed (prn) analgesic (1)
-For pain that is mild or not expected to persist for an extended
period of time (1)
-For acute pain (1)
-For postoperative pain, unless the patient is already receiving
chronic opioid therapy prior to surgery, or if the
postoperative pain is expected to be moderate to severe and persist
for an extended period of time (1)
KADIAN 100 mg and 200 mg capsules are only for patients in whom
tolerance to an opioid of comparable potency is
established. (1)
DOSAGE AND ADMINISTRATION
Individualize dosing based on patient’s prior analgesic treatment
experience, and titrate as needed to provide adequate
analgesia and minimize adverse reactions. (2.1, 2.2)
Instruct patients to swallow KADIAN capsules intact, or to sprinkle
the capsule contents on applesauce an