Abstral Sublingual 100MG , two hundred microgram, three hundred microgram, four hundred microgram, six hundred microgram, 800 microgram sublingual tablets

2. Qualitative and quantitative composition
every sublingual tablet carries:

one hundred micrograms fentanyl (as citrate)

2 hundred micrograms fentanyl (as citrate)

300 micrograms fentanyl (as citrate)

four hundred micrograms fentanyl (as citrate)

six hundred micrograms fentanyl (as citrate)

800 micrograms fentanyl (as citrate)

For the whole list of excipients, see section 6.1.

three. Pharmaceutical form
Sublingual tablet

a hundred microgram sublingual pill is a white spherical tablet

2 hundred microgram sublingual tablet is a white oval-shaped pill

three hundred microgram sublingual pill is a white triangle-shaped pill

four hundred microgram sublingual tablet is a white diamond-formed pill

six hundred microgram sublingual pill is a white “D”-fashioned pill

800 microgram sublingual tablet is a white tablet–shaped tablet

four. medical particulars
four.1 therapeutic indicators
management of step forward ache in person patients the usage of opioid remedy for continual cancer pain. breakthrough pain is a brief exacerbation of otherwise managed continual historical past ache.

four.2 Posology and method of management
Abstral Sublingual 100MG, must only be administered to patients who are taken into consideration tolerant to their opioid therapy for persistent cancer ache. sufferers can be taken into consideration opioid tolerant in the event that they take as a minimum 60 mg of oral morphine daily, as a minimum 25 micrograms of transdermal fentanyl in keeping with hour, at least 30 mg of oxycodone daily, as a minimum eight mg of oral hydromorphone every day or an equianalgesic dose of another opioid for a week or longer.

technique of management:

Abstral Sublingual 100MG drugs ought to be administered without delay under the tongue at the inner most element. Abstral sublingual capsules must not be swallowed, but allowed to completely dissolve within the sublingual hollow space without chewing or sucking. patients have to be suggested now not to eat or drink anything until the sublingual pill is completely dissolved.

In patients who’ve a dry mouth water may be used to moisten the buccal mucosa earlier than taking Abstral.

Dose titration:

The object of dose titration is to discover an best upkeep dose for ongoing treatment of breakthrough ache episodes. This premiere dose should offer ok analgesia with an appropriate level of negative reactions.

The most efficient dose of Abstral can be determined by means of upward titration, on an character patient basis. several doses are available for use at some stage in the dose titration section. The initial dose of Abstral used should be 100 micrograms, titrating upwards as vital thru the range of available dosage strengths.

sufferers ought to be cautiously monitored till an surest dose is reached.

Switching from different fentanyl containing products to Abstral must not arise at a 1:1 ratio due to one of a kind absorption profiles. If sufferers are switched from some other fentanyl containing product, a brand new dose titration with Abstral is needed.

the subsequent dose regimen is usually recommended for titration, despite the fact that in all instances the physician ought to recollect the scientific want of the patient, age and concomitant illness.

All sufferers must start remedy with a single one hundred microgram sublingual tablet. If good enough analgesia isn’t always received within 15-half-hour of administration of a unmarried sublingual tablet, a supplemental (second) 100 microgram sublingual tablet may be administered. If adequate analgesia is not acquired inside 15-30 minutes of the first dose an boom in dose to the following maximum tablet power should be taken into consideration for the next episode of breakthrough ache (talk over with discern underneath).

Dose escalation should maintain in a stepwise way till adequate analgesia with tolerable unfavorable reactions is performed. The dose power for the supplemental (second) sublingual pill ought to be accelerated from 100 to 200 micrograms at doses of four hundred micrograms and better. that is illustrated within the schedule under. No extra than two (2) doses have to be administered for a single episode of leap forward pain in the course of this titration section.