Medicinal Products

ABSTRAL 200 micrograms

Generic drug of the therapeutic class: Analgesics
Active ingredients: Fentanyl
laboratory: Prostrakan Limited

Sublingual tablet
Case of 30
All forms

Indication

Treatment of paroxysmal pain attacks in adult patients using opioids to treat chronic pain of cancer. Paroxysmal pain is a transient exacerbation of chronic pain that is otherwise controlled by DMARD.

Dosage ABSTRAL 200 micrograms Sublingual Tablet Case of 30

ABSTRAL is reserved for patients considered to be tolerant to the underlying morphine treatment of chronic cancer pain. Patients receiving at least 60 mg of morphine per day orally, at least 25 μg of fentanyl per hour transdermally, at least 30 mg of oxycodone per day orally, or at least 8 mg per day, may be considered as tolerant to opioids. mg of hydromorphone daily or an equianalgesic dose of another morphine for a minimum of one week.

Administration mode

ABSTRAL sublingual tablets should be placed directly under the tongue as far as possible. ABSTRAL sublingual tablets should not be swallowed, but melt completely under the tongue without being chewed or sucked. Patients should be informed that they should not eat or drink until complete dissolution of the sublingual tablet.

Patients with dry mouth may use water to moisten the oral mucosa before taking ABSTRAL.

Titration of the dose:

The objective of the dose titration is to identify an optimal maintenance dose for the treatment of breakthrough pain. This optimal dose should allow adequate analgesia with an acceptable rate of adverse effects.

The optimal dose of ABSTRAL should be determined for each patient by progressive titration. Several assays are available and can be used during the titration phase. The initial dose of ABSTRAL used should be 100 μg, with dosage increase if necessary, in the range of available dosages.

Patients should be carefully monitored until an optimal dose has been achieved. Substitution of ABSTRAL with other products containing fentanyl should not be made in a ratio of 1/1 as the different products have different absorption profiles. Any replacement of another product containing fentanyl with ABSTRAL must result in a new titration.

The following dosing regimen is recommended for titration. However, the physician must always consider the patient's clinical needs, age, and concomitant illness.

All patients should initiate treatment with a single 100 μg sublingual tablet.

If adequate analgesia is not achieved within 15 to 30 minutes after administration of the sublingual tablet:

an additional sublingual tablet of 100 μg can be administered;

- For the treatment of the next paroxysmal pain attack, consider administering the higher dosage (see Figure below).

The dose increase should be continued in stages until adequate analgesia is achieved with tolerable adverse events. For initial doses of 400 μg and above, the dosage of the additional sublingual tablet should be 200 μg. This is illustrated by the table below.

During the titration phase, the patient can not receive more than two doses for a single paroxysmal pain episode.

ABSTRAL TITRATION METHOD

Assay (in μg) of the first sublingual tablet with paroxysmal pain

Assay (in μg) of the second sublingual tablet, to be administered as needed 15 to 30 minutes after the first tablet

100

100

200

100

300

100

400

200

600

200

800

-

If the highest dose for effective analgesia causes adverse effects that are considered unacceptable, an intermediate dose may be administered (using the 100 μg tablet as appropriate).

During the titration phase, patients should be informed of the possibility of using multiple 100 μg and / or 200 μg tablets as a single dose. The number of tablets administered for the treatment of a single paroxysmal pain episode must not exceed four (4).

The efficacy and safety of doses above 800 μg have not been evaluated in clinical studies in patients.

In order to minimize the risk of adverse events related to opioids and to determine the appropriate dose, patients should be placed under strict medical supervision during the titration process.

During the titration phase, patients must wait at least 2 hours before treating another paroxysmal pain episode with ABSTRAL.

Maintenance treatment:

When the appropriate dose, which may be greater than one tablet, has been determined, it should continue to be used. Consumption should be limited to four doses of ABSTRAL per day.

During the maintenance period, patients must wait at least 2 hours before treating another bout of paroxysmal pain with ABSTRAL.

Readjustment of the dose:

If a marked change in response is observed (analgesia or adverse effects), a new dose adjustment may be necessary to maintain an optimal dose.

If the patient has more than four paroxysmal breakthroughs per day for more than four consecutive days, the dose of long-acting opioid used to treat chronic pain should be re-evaluated. In case of modification of this opioid or its dosage, the dose of ABSTRAL must be reevaluated and possibly readapted to guarantee the use of an optimal dose.

Any new dose adjustment of any analgesic must be performed under medical supervision.

Stop treatment:

When morphine treatment is no longer required, the dose of ABSTRAL should be taken into account before any progressive reduction of opioids, in order to minimize the potential withdrawal syndrome.

In patients continuing the morphine treatment of chronic pain for which treatment of breakthrough pain is no longer necessary, ABSTRAL can usually be stopped immediately.

Use in children and adolescents:

Given the lack of safety data and efficacy for this population, ABSTRAL should not be used in patients younger than 18 years of age.

Use in the elderly:

The titration of the dose should be particularly careful and the possible appearance of signs of fentanyl toxicity should be strictly monitored (see Warnings and Precautions ).

Use in patients with hepatic or renal insufficiency:

The possible occurrence of signs of fentanyl toxicity should be strictly monitored in patients with hepatic or renal disorders (see Warnings and Precautions ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

The use of ABSTRAL is contraindicated in subjects who have never received morphine treatment because of the risk of life-threatening respiratory depression.

Severe respiratory depression or severe obstructive pulmonary diseases.

Abstral side effects

The expected side effects with ABSTRAL are the typical adverse effects of opioids that will decrease in intensity with continued treatment. The most serious potential adverse reactions associated with opioids are respiratory depression (which may lead to respiratory arrest), hypotension, and shock.

ABSTRAL's clinical studies were designed to assess the safety and efficacy in the treatment of breakthrough cancer-related breakthrough pain; at the same time, all patients received opioids such as sustained release morphine, sustained release oxycodone or transdermal fentanyl for their chronic pain. It is therefore not possible to clearly distinguish the effects of ABSTRAL alone.

The most common side effects reported with ABSTRAL are typical adverse effects of opioids such as nausea, constipation, somnolence and headache.

Tabulated summary of adverse effects of ABSTRAL:

Treatment-related adverse events reported in studies evaluating the safety and efficacy of ABSTRAL in patients and in the context of pharmacovigilance are listed below by system organ class and frequency (very common: ≥ 1/10, frequent: ≥ 1/100, <1/10, infrequent: ≥ 1/1000, <1/100, indeterminate frequency (can not be estimated from available data)) . Within each frequency group, adverse effects are presented in order of decreasing severity).

The possibility of establishing a relationship between ABSTRAL dose and adverse events observed in clinical studies is limited by the titration regimens used in these studies.

Class of organ system

Side effects, by frequency

Very common

≥ 1/10

Frequent

≥ 1/100, <1/10

Rare

≥ 1/1000, <1/100

Not known (can not be estimated from the available data)

Immune system disorders

hypersensitivity

Metabolism and nutrition disorders

Anorexia

Decreased appetite

Psychiatric disorders

Depression

Paranoia

Confusional state

disorientation

Changes in mental state

Anxiety

Euphoria

dysphoria

Emotional lability
Attention disorders

Nervous system disorders

Dizziness

headaches

Drowsiness

Amnesia

parosmia

dysgeusia

tremor

Lethargy

Hypoaesthesia

Insomnia

Sleeping troubles

Eye disorders

Blurred vision

Heart conditions

tachycardia

bradycardia

Vascular disorders

hypotension

Respiratory disorders,

thoracic and mediastinal

Dyspnea

Oropharyngeal pain

Feeling of constriction of the throat

Gastrointestinal disorders

nausea

stomatitis

vomiting

Constipation

Oral dryness

Oral ulcer

Gingival ulceration

Lip ulcer

Delayed gastric emptying

Abdominal pain

Dyspepsia

Gastric discomfort

Affection of language

Foot-and-mouth disease

[1] Edema of the tongue

Skin and subcutaneous tissue disorders

Hyperhidrosis

Cutaneous lesion

rash

Allergic pruritus

itching

Night sweats

Increased tendency to bruise

Musculoskeletal and systemic disorders

arthralgia

Musculoskeletal stiffness

Joint stiffness

Disorders of reproductive organs and breast

Erectile dysfunction

General disorders and administration site conditions

Tired

Withdrawal syndrome

Asthenia

Discomfort

Injury, poisoning and procedural complications

Accidental overdose

ANSM alert of 25/09/13:

In the case of oral administration: pain and irritation of the oral mucosa, ulcer, deterioration of the dental state (caries, partial or total loss of teeth).

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