Posology : מינונים

4.2 Posology and method of administration

Posology
The analgesic efficacy of Targin® is equivalent to oxycodone hydrochloride prolonged-release formulations.
The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient. Unless otherwise prescribed, Targin® should be administered as follows:

Adults
The usual starting dose for an opioid naïve patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals (Targin® 10).

Lower strength (Targin® 5) is available to facilitate dose titration when initiating opioid therapy and for individual dose adjustment.

Patients already receiving opioids may be started on higher doses depending on their previous opioid experience.

The maximum daily dose of Targin® is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. For patients requiring higher doses of Targin®, administration of supplemental prolonged-release oxycodone hydrochloride at the same time intervals should be considered. In the case of supplemental oxycodone hydrochloride dosing, the beneficial effect of naloxone hydrochloride on bowel function may be impaired.

After complete discontinuation of therapy with Targin® with a subsequent switch to another opioid a worsening of the bowel function can be expected.

Some patients taking these prolonged-release tablets according to a regular time schedule require immediate release analgesics as "rescue" medication for breakthrough pain. Targin® is a prolonged-release formulation and therefore not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should approximate one sixth of the equivalent daily dose of oxycodone hydrochloride. The need for more than two ”rescues” per day is usually an indication that the dosage requires upward adjustment. This adjustment should be made every 1-2 days in steps of Targin® 5 twice daily, or where necessary Targin® 10 twice daily until a stable dose is reached. The aim is to establish a patient-specific twice daily dose that will maintain adequate analgesia and make use of as little rescue medication as possible for as long as pain therapy is necessary.


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Targin® is taken at the determined dosage twice daily according to a fixed time schedule. While symmetric administration (the same dose mornings and evenings) subject to a fixed time schedule (every 12 hours) is appropriate for the majority of patients, some patients, depending on the individual pain situation, may benefit from asymmetric dosing tailored to their pain pattern. In general, the lowest effective analgesic dose should be selected.

In non-malignant pain therapy, daily doses of up to 40 mg/20 mg oxycodone hydrochloride/naloxone hydrochloride are usually sufficient, but higher doses may be needed.


Elderly patients
As for younger adults the dosage should be adjusted to the intensity of the pain and the sensitivity of the individual patient.

Patients with impaired hepatic function
A clinical trial has shown that plasma concentrations of both oxycodone and naloxone are elevated in patients with hepatic impairment. Naloxone concentrations were affected to a higher degree than oxycodone (see section 5.2). The clinical relevance of a relative high naloxone exposure in hepatic impaired patients is yet not known. Caution must be exercised when administering Targin® to patients with mild hepatic impairment (see section 4.4). In patients with moderate and severe hepatic impairment Targin® is contraindicated (see section 4.3).

Patients with impaired renal function
A clinical trial has shown that plasma concentrations of both oxycodone and naloxone are elevated in patients with renal impairment (see section 5.2). Naloxone concentrations were affected to a higher degree than oxycodone. The clinical relevance of a relative high naloxone exposure in renal impaired patients is yet not known. Caution should be exercised when administering Targin® to patients with renal impairment (see section 4.4).

Paediatric population
The safety and efficacy of Targin® in children aged below 18 years has not been established. No data are available.

Method of administration
Oral use.

Targin® prolonged-release tablets are taken in the determined dosage twice daily in a fixed time schedule.

The prolonged-release tablets may be taken with or without food with sufficient liquid. These tablets must be swallowed whole, and not broken, chewed or crushed (see section 4.4).

Treatment goals and discontinuation

Before initiating treatment with Targin®, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When the patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).

Duration of use

Targin® should not be administered for longer than absolutely necessary.