PALLADONE SR 4 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
HYDROMORPHONE HYDROCHLORIDE
Available from:
RAFA LABORATORIES LTD
ATC code:
N02AA03
Pharmaceutical form:
CAPSULES SLOW RELEASE
Composition:
HYDROMORPHONE HYDROCHLORIDE 4 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
BARD PHARMACEUTICALS LTD, U.K.
Therapeutic group:
HYDROMORPHONE
Therapeutic area:
HYDROMORPHONE
Therapeutic indications:
For the relief of severe pain in cancer.
Authorization number:
110 19 28724 00
Authorization date:
2013-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

28-05-2009

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םושיר

םינולע

טנרטניאל םינולע

\Palladone sr.doc

דומע

ךותמ

ע עבקנ הז ןולע טמרופ

"

רשואו קדבנ ונכותו תואירבה דרשמ י

םיחקורה תונקת יפל ןכרצל ןולע

םירישכת

משתה

"

1986

אפור םשרמב תבייח וז הפורת

הפורתב שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק

ןודלפ

SR

רקובמ רורחשב תוסומכ

ליעפה רמוחה בכרה

:

הליכמ תוסומכ לכ

Hydromorphone hydrochloride 4, 8, 24 mg

תיאופר תוליעפ

:

ןטרסה תלחממ םיעבונה םישק םיבאכ ךוכישל תדעוימ הפורתה

רישכתב שמתשהל ןיא יתמ

?

הקינמ וא ןוירהב ךניה רשאכ רישכתב ישמתשת לא

םירחאה הפורתה יביכרממ דחאל וא ןופרומורדיהל תושיגר העודי םא רישכתב שמתשהל ןיא

שמתשהל ןיא יתמישנ יוכיד לש םיבצמב הפורתב

המוק וא םירומח םילושלש

לופיטה תלחתה ינפל אפורב ץעוויהל ילבמ הפורתב שמתשהל ןיא לבוס ךניה םא

דוקפתב יוקילמ רבעב תלבס וא ת

המישנה תכרעמ

ןוגכ המטסא

ו בלה

םדה ילכ וא

דבכה

הרמה סיכ

הילכה

ןתשה תכרעמ

לוכיעה תכרעמ

וא ןוגכ לושלש וא סוקל

סירתה תטולב

דיאורית

תטולב תינומרעה

לבוס ךניה םא ןכו

תותיוועמ רבעב תלבס וא ת

שארב העיגפ וא תיחומ ךות הערפה וא ץבש

ןוסידא תלחמ

םזילוהוכלא

דומע תמקע הרדשה

תופורתב וא םימסב תולת וא

ךלש םוי םויה ייח לע הפורתה עיפשת ךיא

?

הפורתב שומישה בכרב הגיהנב תוריהז בייחמ ןכ לעו תונרעב םוגפל לולע וז

תוליעפ לכבו תונכוסמ תונוכמ תלעפהב תונריע תבייחמה

המודכו שיבכה תברקב םיקחשממ וא םיינפוא לע הביכרמ םריהזהל שי םידליל רשאב

הפורתה םע לופיטה תפוקתב םיפירח תואקשמ וא תוניי תותשל ןיא

תורהזא

:

ךשוממ שומיש תולתל םורגל לולע

אפורב ץעוויהל ילב תימואתפ הרוצב וז הפורת לוטיל קיספהל ןיא

שיגר ךניה םא

הפורתה תליטנ ינפל אפורל ךכ לע עידוהל ךילע איהשלכ הפורתל וא אוהשלכ ןוזמל ה

דמוע ךניה םא

חותינ רובעל ת

ילטנד ללוכ

אפורל חוודל שי המדרהב הכורכה הלועפ לכ וא

ייניש אפור וז הפורת תליטנ לע ם

ךשמב הפורתב שמתשהל ץלמומ אל

חותינ רחאל תועש

תויתפורת ןיב תובוגת

:

לטונ ךניה םא

תפסונ הפורת ת

יא וא םינוכיס עונמל ידכ לפטמה אפורל חוודל ךילע תרחא הפורתב לופיטה התע הז תרמג םא וא

םיעבונה תוליעי תויתפורת ןיב תובוגתמ

דחוימב

ת יבגל תואבה תוצובקהמ תופור

תיזכרמה םיבצעה תכרעמ לע תועיפשמה תופורת

ןוגכ

העגרהל תופורת

הנישל

ןוסניקרפל

היספליפאל

תויגרלא דגנ

םייטוקרנ םיבאכ יככשמו םיחותינל םימידרמ םירמוח

ימלוב ללוכ ןואכיד דגנ תופורת םיילקיצירטו זדיסקואונימאונומ

א תויגרנילוכיטנא תופורת תיגרנילוכיטנא הלועפ תולעב ו

ןטב תותיווע דגנ םירישכת ןוגכ

תייפרהל תופורתו םירירש

אדו

לטונ ךניהש תופורתה רתי םא אפורה םע י

הז רישכתל תודגונמ ןניא ת

יאוול תועפות

:

הפורתה לש היוצרה תוליעפל ףסונב

ןוגכ יאוול תועפשה עיפוהל תולולע הב שומישה ןמזב

תוריצע

הליחב

תואקה

םונמנ

תרוחרחס

וא תופייע תרבגומ השלוח

נה תועפותה םא

"

ו תוכשמתמ ל

אפורל תונפל שי תודירטמ וא

תדחוימ תוסחייתה תובייחמה תועפות

המישנ יישק וא רצוק

וא יוריג רועב החירפ

רתי תעזה

לובלב

קומע םונמנ

בלה בצקב תורידס יאו תותיווע

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קספה

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אפורל י דימ

שיגרמ ךניה ובש הרקמ לכב

הז ןולעב וניוצ אלש יאוול תועפות ה

דימ אפורה םע ץעייתהל ךילע תיללכה ךתשגרהב יוניש לח םא וא

ןונימ

:

אפורה תוארוה יפל ןונימ דבלב

תצלמומה הנמה לע רובעל ןיא

ליגל תחתמ תוקוניתו םידליל ללכ ךרדב תדעוימ הניא וז הפורת

םינש

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םושיר

םינולע

טנרטניאל םינולע

\Palladone sr.doc

דומע

ךותמ

לע עבקנש יפכ םיבוצק םינמזב וז הפורתב שמתשהל שי

לפטמה אפורה ידי

בוצק ןמזב וז הפורת לוטיל תחכש םא

תרכזנשכ דימ הנמ לוטיל שי

תונמ יתש לוטיל ןיא ןפוא םושב ךא דחיב

שומישה ןפוא

:

דימ עולבלו רקו ךר ןוזמ לע הנכות תא רזפלו חותפל וא םימ םע התומלשב הסומכה תא עולבל ןתינ

הרקמ לכב וא הרוגסה הסומכה תא סועלל ןיא םיריגרגה תא

התעילבל שורדה ןמזל רבעמ הפב הפורתה תא קיזחהל ןיא

לכות דציכ

/

לופיטה תחלצהל עייסל י

?

א םילשהל ךילע לע ץלמוהש לופיטה ת

אפורה ידי

אפור םע תוצעייתה אלל הפורתב לופיטה קיספהל ןיא ךתואירב בצמב רופיש לח םא םג

זא םגו יתגרדה ןפואב קר

הלערה ענמ

!

ו םידלי לש םדי גשיהל ץוחמ רוגס םוקמב רומשל שי תרחא הפורת לכו וז הפורת

הלערה ענמת ךכ ידי לעו תוקונית וא

נמ תלטנ םא םא וא רתי ת הפורתה ןמ דלי עלב תועטב

הנפ

תיב לש ןוימ רדחל דימ י

םילוח

ךתיא הפורתה תזירא אבהו

האקהל םורגת לא אפורמ תשרופמ הארוה אלל

ךתלחמב לופיטל המשרנ וז הפורת

רחא הלוחב

קיזהל הלולע איה ת

ךיבורקל וז הפורת ןתית לא

ךירכמ וא ךינכש

חב תופורת לוטיל ןיא ךשו

הנמהו תיוותה קודב םעפ לכב לטונ ךניהש

הפורת ת

ביכרה

קוקז ךניה םא םייפקשמ י

םהל ה

הנסחא

רירק םוקמ

הזיראה יאנת יפל םג

םיצלמומה הנסחא

דבלב תלבגומ הפוקתל תורמשנ תופורת

לש הגופתה ךיראתל בל םישל אנ רישכתה

קפס לש הרקמ לכב

ל קפיסש חקורב ץעוויהל ךילע הפורתה תא ך

הזירא התואב תונוש תופורת ןסחאל ןיא

סמ

'

הפורתה םושיר

:

ןודלפ

"

110-19-28724

ןודלפ

"

110-20-28725

ןודלפ

"

110-22-28727

לש ןוישרב רצוימ

Napp

הילגנא

Doctor Leaflet

Palladone SR Capsules

Narcotic prescription required

Composition

Each capsule contains: Hydromorphone hydrochloride 4, 8, or 24 mg incorporated in a

controlled-release system

Action

Hydromorphone is a semisynthetic opioid agonist analgesic that acts primarily at the mu

opiate receptor. Opiate receptors in the central nervous system mediate analgesic activity.

Opioid agonists occupy the same receptors as endogenous opioid peptides (enkephalins or

endorphins), and both may alter the central release of neurotransmitters from afferent

nerves sensitive to noxious stimuli. Opioid antagonists block the opiate receptor, inhibit

the pharmacological activity of the agonist and will precipitate withdrawal in dependent

patients.

Hydromorphone has similar pharmacological and pharmacokinetic properties to morphine

to which it is chemically related. However, it is approximately 7.5 times more potent on a

mg for mg basis when administered orally. Hydromorphone is recognized by the World

Health Organization as an alternative opioid to morphine for cancer pain. This is

important since one of the cornerstones of cancer pain management is opioid rotation.

Opioid rotation consists of switching a patient from one opioid to another in order to

achieve adequate analgesia with few side effects. In particular, hydromorphone may have

a better side effect profile than morphine in some individuals, producing less severe

constipation and vomiting.

Palladone SR capsules incorporate hydromorphone in a controlled-release system which

allows the patient to take the preparation on a 12-hourly basis. The hydromorphone is

gradually released and absorbed with controlled bioavailability. Analgesics for severe

cancer pain should be administered around-the-clock (and not on an as-needed basis).

Thus, Palladone SR capsules have a significant advantage compared with other,

conventional forms of hydromorphone in the relief of severe cancer pain, for those patients

who are able to take an oral preparation.

Indications

Palladone SR capsules are indicated for the relief of severe pain in cancer.

Contraindications

Hydromorphone is contraindicated in patients with known hypersensitivity to its effect. It

is contraindicated in respiratory depression, coma, diarrhea caused by poisoning or

associated with pseudomembranous colitis caused by cephalosporins, lincomycins or

Ref:ww-\rishum\docleaf\Palladone sr

penicillins. Hydromorphone is not recommended for use in obstetric analgesia and in

pediatrics.

Warnings

Drug Dependence

Hydromorphone, like all opioid analgesics, may cause physical dependence whereby the

body adapts itself to the drug. This involves physiological changes which explain two

phenomena frequently seen with long-term opioid treatment: tolerance and the withdrawal

syndrome.

Tolerance is defined as the need to administer a higher dose of the opioid to maintain the

same level of analgesia. For most patients, the first indication of tolerance is a decrease in

the duration of analgesia for a given dose and the appearance of breakthrough pain.

Tolerance may be confused with an increase in the pain intensity of the disease itself

(which is the most common reason an increase in dosage is indicated). Irrespective of the

underlying cause, it is recommended that the dose be increased and the patient re-titrated

until the pain is again controlled.

Withdrawal symptoms, sometimes called the opioid abstinence syndrome, are those

manifested by a patient upon cessation of treatment or rapid reduction of dosage.

If a reduction in dosage is required, the opioid abstinence syndrome can usually be avoided

by gradually decreasing the dosage in the following fashion. Half the prior daily dosage

should be given for the first 2 days. This should be reduced by 25% every 2 days

thereafter, until the total dosage is 30 mg/day in oral morphine equivalents. The drug may

be discontinued after 2 days at this dosage level.

Physical dependence does not imply psychological dependence. Psychological

dependence is a pattern of compulsive drug use characterized by a craving for an opioid

and the need to use the opioid for effects other than pain relief. This type of dependence is

extremely rare in patients taking opioids for the relief of severe pain. This must not be

confused with the behavior of patients whose pain is inadequately treated, who will also

manifest drug-seeking behavior. For these patients titration to pain-controlling dosage is

required.

Head Injury

Because of the tendency of hydromorphone to produce respiratory depression and its

capacity to elevate cerebrospinal fluid pressure, it should be used with extreme caution, if

at all, in the presence of head injury, other intracranial lesions or a pre-existing increase in

intracranial pressure since both of these adverse reactions may be markedly exaggerated.

Opioid agonists like hydromorphone may interfere with evaluation of CNS functions,

especially relative to consciousness levels, pupillary changes, and respiratory depression,

thereby masking the clinical course of patients with head injuries. In such cases,

hydromorphone must be used with extreme caution and only when it is absolutely

essential.

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Paralytic Ileus

Palladone SR capsules should not be used where there is the possibility of paralytic ileus

occurring. Should paralytic ileus be suspected or occur during use, Palladone SR capsules

should be discontinued immediately.

Cordotomy

Patients about to undergo cordotomy or other pain-relieving surgical procedures should be

transferred to immediate release hydromorphone prior to surgery. If further treatment with

Palladone SR capsules is indicated then the dosage should be adjusted to the new post-

operative requirement.

Asthma and other Respiratory Conditions

Hydromorphone should be used with extreme caution, if at all, in patients with acute

asthma, chronic obstructive pulmonary disease or cor-pulmonale, a decreased respiratory

reserve (as in emphysema, kyphoscoliosis or severe obesity), hypoxia or hypercapnia.

Even therapeutic doses of opioids may decrease respiratory drive while simultaneously

increasing airway resistance to the point of apnea.

Cardiovascular Effects

Opioids may produce orthostatic hypotension in ambulatory patients. Opioids may also

cause severe hypotension in individuals whose ability to maintain their blood pressure has

already been compromised by depleted blood volume or concurrent administration of other

drugs such as phenothiazines or certain anesthetics.

Use in Pregnancy and Labor

Hydromorphone crosses the placental barrier. Because of possible adverse effects on fetal

development, hydromorphone is not recommended for use during pregnancy. Use during

labor is not recommended (see Contraindications). It may lead to respiratory depression,

especially in the premature neonate.

Use in Breastfeeding

It is not known whether hydromorphone is excreted in human milk. However, because

many drugs are excreted in human milk and because of the potential for adverse effects in

infants, nursing should be discontinued if hydromorphone is absolutely indicated.

Use in Pediatrics

Hydromorphone is not recommended for use in children under 12 years.

Use in the Elderly

Hydromorphone should be used with caution in the elderly. The elderly may require a

lower dosage than adults to achieve adequate analgesia. Some elderly patients may be

sensitive to the respiratory depressant effect of hydromorphone and should be monitored

closely during therapy initiation and any subsequent dosage increase.

Adverse Reactions

Ref:ww-\rishum\docleaf\Palladone sr

The most serious adverse reactions to hydromorphone are respiratory depression and, to a

lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.

The most frequent adverse reactions include lightheadedness, dizziness, miosis,

drowsiness, sedation, constipation, nausea, vomiting and sweating. Other adverse

reactions include mental clouding, lethargy, impairment of mental and physical

performance, anxiety, fear, euphoria, confusion, dysphoria, psychic dependence, mood

changes, weakness, dry mouth, biliary tract spasm, ureteral spasm, spasm of vesical

sphincters and urinary retention, hesitancy oliguria, decreased libido, pruritus and urticaria.

In some individuals, hydromorphone may cause less constipation or emesis than morphine

preparations. When nausea and vomiting or constipation are troublesome, Palladone SR

capsules can be readily combined with anti-emetics or laxatives.

Precautions

Use with caution in patients with Addison’s disease, cardiac arrhythmia, cardiovascular

disease, cerebral arteriosclerosis, history of drug abuse or dependence, ulcerative colitis,

gall bladder and hepato-renal impairment, prostatic hypertrophy, urethral stricture,

respiratory disease, hypothyroidism, convulsive disorders, and acute alcoholism. The

administration of opioids may obscure the diagnosis or clinical course of patients with

acute abdominal conditions.

Palladone SR capsules are not recommended in the first 24 hours post-operatively. After

this time, they should be used with caution particularly following abdominal surgery.

Opioid agonist-induced increase in intraluminal pressure may endanger surgical

anastomosis.

Persons who perform potentially hazardous tasks requiring mental alertness and/or

physical coordination should be warned about possible CNS adverse effects (e.g. driving

may be affected). As with all opioids, a reduction in dosage may be advisable in the

elderly and in debilitated patients (see Warnings).

Drug Interactions

Because of potential adverse interactions, hydromorphone should be used with extreme

caution in individuals who are concurrently receiving other narcotic analgesics, general

anesthetics, phenothiazines, tranquilizers, antihistamines, sedative hypnotics, tricyclic

antidepressants and other CNS depressants including alcohol, anticholinergics and

neuromuscular blocking agents. Respiratory depression, hypotension, profound sedation,

coma, severe constipation, or urinary retention may result.

Caution should be exercised if hydromorphone is to be used concurrently with monoamine

oxidase inhibitors (e.g., phenelzine), and within two weeks of their discontinuation, since

severe reactions have been reported with other opioid analgesics, especially pethidine. In

such patients, it is recommended that a small test dose of hydromorphone (25% of the

usual dose) or several small incremental test doses over a period of several hours should be

administered first, to permit observation of any interaction.

Ref:ww-\rishum\docleaf\Palladone sr

Administration of a mixed agonist/antagonist opioid analgesic (e.g., pentazocine,

buprenorphine) to a patient receiving therapy with a pure agonist opioid such as

hydromorphone may reduce the analgesic effect, or precipitate withdrawal.

Similarly, administration of an opioid antagonist like naltrexone can precipitate withdrawal

in patients receiving hydromorphone.

Laboratory and Diagnostic Interference

Plasma amylase and lipase concentrations may be increased in the presence of

hydromorphone. Because of the induction by hydromorphone of spasms of the sphincter

of Oddi and increased biliary tract pressure, determinations of these enzymes may remain

unreliable 24 hours post-medication.

Dosage and Administration

A. General Recommendations

For the correct and effective use of hydromorphone it is critical to adjust the dosing

regimen for each patient individually. The following dosage recommendations are,

therefore, only suggested approaches to what is actually a series of clinical decisions in the

management of the pain of an individual patient. The dosage of hydromorphone is

individualized according to the patient's pain, metabolism, previous history of analgesic

therapy, and response to hydromorphone.

Palladone SR 4, 8, and 24 mg capsules should be taken on a regular 12-hourly schedule, at

the minimum dose required to achieve acceptable analgesia. Palladone SR capsules should

be swallowed whole or may be opened and their contents sprinkled onto cold, soft food.

Palladone SR capsules are available in three dosage strengths that can be combined to

obtain the precise dose for each individual. Four mg of oral hydromorphone has an

analgesic efficacy equivalent to 30 mg morphine sulphate given orally.

B. Initial Dosage

Opioid-Naive Patients

In opioid-naive patients, for ease of titration, the initial daily dosage of hydromorphone

can be established using hydromorphone immediate-release capsules, using a 4-hourly

schedule. The total daily dose should then be divided in two and administered as

Palladone SR capsules 12-hourly.

Alternatively, opioid-naive patients can be started directly on Palladone SR capsule

therapy. These patients should initially receive a conservative dose of 4 mg 12-hourly, in

order to avoid overdosage. The majority of patients will then require an upward titration.

(Appropriate use of the 24 mg capsules must be decided by careful evaluation of each

clinical situation.)

Conversion From Other Opioid Analgesics

If a patient has been receiving opioid-containing medications prior to Palladone SR

capsules, standard conversion ratio estimates (see below) should be used to convert the

previous 24-hour opioid use to an oral hydromorphone equivalent. Calculate the total daily

Ref:ww-\rishum\docleaf\Palladone sr

dosage of each opioid (mg). Multiply the daily dose of each prior opioid by the

appropriate multiplication factor from the table for oral and/or parenteral forms, adding the

results to obtain the equivalent total daily hydromorphone oral dose. Then, divide by 2 to

compute the hydromorphone q12h dose. Round to a dose that is appropriate for the

Palladone SR capsule strengths/combinations available.

For example, in a patient taking 120mg oral morphine daily (60 mg MCR twice daily) who

is being switched to hydromorphone:

120 X 0.13 = 15.6 mg daily oral hydromorphone

15.6 ÷ 2 = 7.8 mg q12 hours.

The patient should receive an 8 mg Palladone SR capsule twice daily.

Patients receiving immediate release hydromorphone on a regular basis will find it more

convenient to continue treatment with Palladone SR capsules, which are administered at

12-hourly intervals. Note: When converting between immediate release and slow release

hydromorphone, the total daily dosage of hydromorphone remains the same.

Multiplication Factors for Converting from Other Opioids to Oral Hydromorphone

(mg/day prior opioid x factor = mg/day oral hydromorphone)

_________________________________________________________________________

Prior Opioid

Oral

Parenteral

morphine

0.13

methadone

pethidine

0.013

0.05

pentazocine

0.02

0.06

codeine

0.02

oxycodone

0.13

buprenorphine

4.67 (sublingual)

fentanyl

_________________________________________________________________________

*Transdermal fentanyl: Eighteen hours following the removal of the transdermal fentanyl

patch, treatment with Palladone SR capsules can be initiated. Although there has been no

systematic assessment of such conversion, a conservative dose of 4 mg q12 hours should

be initially substituted for each 25 ug fentanyl transdermal patch. The patient should be

closely monitored for early titration as there is limited clinical experience with this

conversion.

The conversion table is only meant to serve as a guide. It should be noted that the above

table is based on a hydromorphone:morphine ratio of 7.5:1. However, recent studies have

indicated that during chronic morphine dosing, the ratio may approximate 4:1. Therefore,

the above table presents a conservative

starting dose, and consideration should be given to

early upward titration in a significant portion of patients. In the rare patient receiving very

large opioid doses, consideration should be given to the potential for incomplete cross

tolerance. When converting these patients to hydromorphone therapy, the starting dose

estimated by the conversion ratio may need to be decreased. In all circumstances, the

patient's response following conversion from other opioids must be carefully monitored

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and the dosage of Palladone SR capsules adjusted accordingly. (Note: The table should not

be used for converting patients from hydromorphone to other opioids.)

C. Titration to Pain Control

Adjustments of the initial dosage should be made to obtain an appropriate balance between

pain relief and opioid adverse experiences. The optimal dose is that which maintains

adequate analgesia for 12 hours with no or controllable side effects. If the initial dose

provides inadequate analgesia, patients should be assessed following incremental increases

in dosage. As a guideline the total daily hydromorphone dose can be increased by 25% to

50% of the current dose. As there is no upper limit to the amount of hydromorphone that

may be given in intractable oncologic pain, the quantity administered should be that which

produces adequate analgesia. Adequate analgesia is generally considered to be mild or no

pain with the regular use of no more than two doses of supplemental analgesia per 24

hours. Rescue medication should be available (see Supplemental Analgesia).

If significant adverse events occur before the therapeutic goal of mild or no pain is

achieved, the events should be treated aggressively. Once adverse events are under

control, upward titration can continue to an acceptable level of pain control. If the adverse

experiences cannot be controlled or tolerated, opioid rotation should be considered.

D. Supplemental Analgesia

Most cancer patients given around-the-clock therapy with controlled-release oral opioids

will need to have immediate-release medication available for “rescue” from breakthrough

pain or to prevent incident pain (the latter occurs predictably during certain patient

activities). The most logical rescue medication is immediate release hydromorphone. The

supplemental analgesic should be prescribed at 1/4 to 1/3 of the 12-hour Palladone SR

dose. The rescue medication is dosed every 4 hours as needed for breakthrough pain and

administered one hour before anticipated incident pain. If more than two doses of rescue

medication are needed within 24 hours, the dose of Palladone SR should be titrated

upward.

E. Maintenance of Therapy

During the course of treatment the patient may experience a recurrence of pain due to an

increase in the level of pain because of disease progression or due to the development of

tolerance. Regardless of the reason, the hydromorphone dose should be increased and the

patient re-titrated as outlined above in order to re-establish pain control.

Patients about to undergo any pain-relieving surgical procedure should be transferred to

immediate release hydromorphone prior to surgery. Following surgery if further treatment

with Palladone SR capsules is indicated, the dosage should be adjusted to the new post-

operative requirement.

F. Cessation of Therapy

Dose Tapering

When the patient no longer requires chronic therapy with Palladone SR capsules, the

dosage should be slowly tapered, as described above (see Drug Dependence, Warnings). If

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signs of withdrawal appear, tapering should be stopped. The dose should be slightly

increased until the signs and symptoms disappear. Tapering should then begin again but

with longer periods of time between each dose reduction.

Conversion from Palladone SR to Parenteral Opioids

A 1:5 ratio of oral to parenteral hydromorphone equivalence is suggested. To avoid

overdose, initiate treatment with ½ of the estimated equianalgesic dose of parenteral opioid

and titrate the dose based upon the patient’s response.

Overdosage

Manifestations

Hydromorphone overdosage is initially characterized by sedation, confusion and delirium.

If such symptoms become apparent, Palladone SR capsules should be withdrawn and the

patient monitored. Later manifestations of serious hydromorphone overdosage include pin-

point pupils, CNS depression ranging from extreme somnolence progressing to stupor or

coma, respiratory depression which may progress to Cheyne-Stokes respiration and/or

cyanosis, cold, clammy skin and/or hypothermia, flaccid skeletal muscles, and sometimes

bradycardia and hypotension. In severe cases, circulatory failure, cardiac arrest and death

may occur.

Treatment

The treatment of overdosage consists of induced emesis or gastric lavage (in the conscious

patient) and establishment of adequate respiration through the provision of a patent airway

and institution of assisted or controlled ventilation. If depressed respiration is associated

with muscular rigidity, an I.V. neuromuscular blocking agent may be required.

If necessary, administer an opioid antagonist, preferably naloxone (0.4 mg in 10 ml saline

using small bolus injections that are titrated against the respiratory rate). Because the

duration of action of hydromorphone exceeds that of the administered naloxone, the patient

should be kept under observation in order to ascertain whether additional doses of the

antagonist are required. An antagonist should not be administered in the absence of

significant respiratory or cardiovascular depression.

Note: In individuals who are physically dependent upon hydromorphone, the

administration of the usual dose of naloxone will precipitate an acute withdrawal

syndrome. The severity of the syndrome is dependent upon the degree of physical

dependence and the dose of naloxone given. If at all possible, avoid the use of an

antagonist in such individuals. If, however, absolutely necessary, administer the naloxone

with extreme caution, using only 10-20% of the usual initial dose given.

Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as

required.

A 0.02% aqueous solution of potassium permanganate may be used for lavage.

Observe the patient for a rise in temperature or pulmonary complications that may require

antibiotic therapy.

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Pharmaceutical Precautions

Store at or below 25

Presentation

Palladone SR 4 mg

14 pale blue-capped capsules

Palladone SR 8 mg

14 pink-capped capsules

Palladone SR 24 mg

14 blue-capped capsules

Rafa Laboratories Ltd. P O Box 405, Jerusalem 91003

Tel: 02-5893939 Fax: 02-5870282 e-mail: med.info@rafa-lab.co.il

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