ABSTRAL 200mcg Tablets/Sublingual

What is ABSTRAL 200mcg

ABSTRAL 200mcg is a prescription opioid analgesic formulated as sublingual tablets containing fentanyl citrate. It is specifically indicated for the management of breakthrough cancer pain in patients who are already receiving and are tolerant to around-the-clock opioid therapy. Breakthrough pain refers to transient, intense episodes of pain that "break through" regular pain control measures.

• ABSTRAL contains fentanyl, a synthetic opioid approximately 50 to 100 times more potent than morphine.
• The sublingual route allows the tablet to dissolve under the tongue, enabling rapid absorption into the bloodstream and fast onset of pain relief.
• This formulation is designed for quick relief of acute pain episodes rather than for baseline chronic pain management.
• ABSTRAL 200mcg is available in blister packs containing 10 tablets, ensuring ease of handling and dosing control.
• Because of its potency and risk profile, ABSTRAL should only be used by patients who are opioid tolerant—meaning they have been taking opioid medications regularly and at sufficient doses.
• It is not suitable for opioid-naive patients or for managing pain unrelated to cancer breakthrough episodes.
• ABSTRAL should be used under close medical supervision to monitor effectiveness and potential adverse effects.

In summary, ABSTRAL 200mcg is an effective rapid-onset analgesic option for opioid-tolerant cancer patients experiencing episodic breakthrough pain, improving their quality of life by providing timely and potent pain relief.

How to use ABSTRAL 200mcg

Proper administration of ABSTRAL 200mcg is critical to ensure safety and optimal pain control. Key instructions include:

• Route of administration: Place the tablet under the tongue and allow it to dissolve completely without chewing, swallowing, or sucking on it.
• Do not eat or drink: Avoid eating or drinking until the tablet has fully dissolved to maximize absorption and efficacy.
• Dosage guidance: ABSTRAL 200mcg should be taken exactly as prescribed by your healthcare provider, typically for breakthrough cancer pain episodes only.
• Opioid tolerance: This medication is strictly for patients who are opioid tolerant. Do not use if you are opioid naive.
• Frequency: Use the medication only when breakthrough pain occurs; do not exceed the prescribed number of doses per day.
• Initial dosing: If switching from a lower dose or another opioid, the doctor will guide a safe dose adjustment.
• Missed dose: If you miss a dose, do not double the next one. Use ABSTRAL only when breakthrough pain happens.
• Disposal: Dispose of unused tablets properly to prevent accidental ingestion or misuse.
• Avoid alcohol and other CNS depressants: These can increase sedation and respiratory depression risk.

Following these instructions carefully helps reduce risks of overdose and ensures fast, effective relief from breakthrough pain.

Mode of Action ABSTRAL 200mcg

ABSTRAL 200mcg contains fentanyl citrate, a potent synthetic opioid, which acts primarily on the central nervous system to provide analgesia. Its mode of action includes:

• Mu-opioid receptor agonism: Fentanyl binds selectively to mu-opioid receptors located in the brain and spinal cord, inhibiting pain transmission pathways.
• Inhibition of neurotransmitter release: Activation of these receptors suppresses the release of neurotransmitters such as substance P and glutamate, which are involved in transmitting pain signals.
• Rapid absorption: Sublingual administration bypasses first-pass metabolism, allowing fentanyl to rapidly enter systemic circulation, producing analgesic effects within minutes.
• Potency: Fentanyl is roughly 50–100 times stronger than morphine, allowing it to effectively manage severe breakthrough pain episodes.
• Duration: The analgesic effect typically lasts for 1 to 2 hours, corresponding to the transient nature of breakthrough pain.
• CNS effects: Besides analgesia, fentanyl can cause sedation and euphoria by its central nervous system activity.

This targeted and rapid mechanism of action makes ABSTRAL 200mcg an effective agent for managing acute pain flares in opioid-tolerant cancer patients.

ABSTRAL 200mcg Interactions ABSTRAL 200mcg

ABSTRAL (fentanyl citrate) has several clinically significant drug interactions that must be carefully managed to avoid adverse outcomes. Important interactions include:

• Central nervous system (CNS) depressants: Combining ABSTRAL with benzodiazepines, alcohol, sedatives, hypnotics, or other opioids can lead to enhanced sedation, respiratory depression, coma, or death.
• Monoamine oxidase inhibitors (MAOIs): Concurrent use or use within 14 days of MAOIs is contraindicated due to increased risk of serotonin syndrome or opioid toxicity.
• CYP3A4 inhibitors: Medications such as ketoconazole, clarithromycin, ritonavir can increase fentanyl blood levels, raising risk of toxicity and overdose.
• CYP3A4 inducers: Drugs like carbamazepine, phenytoin, rifampin can reduce fentanyl plasma concentrations, potentially decreasing analgesic efficacy.
• Serotonergic agents: SSRIs, SNRIs, triptans, and others may increase risk of serotonin syndrome when used with fentanyl.
• Anticholinergic drugs: Co-administration may increase the risk of severe constipation, urinary retention, or paralytic ileus.
• Muscle relaxants and anesthetics: Increased CNS and respiratory depression risk when combined with fentanyl.

Patients should inform healthcare providers of all medications they are taking to avoid dangerous interactions and adjust therapy as needed.

Dosage of ABSTRAL 200mcg

The dosage of ABSTRAL 200mcg must be individualized and carefully titrated by a healthcare professional, typically a pain specialist. Key dosing considerations include:

• Opioid tolerance requirement: Only patients who have been taking around-the-clock opioid therapy and are opioid tolerant should use ABSTRAL.
• Initial dose: Usually, the lowest effective dose is selected based on the patient’s opioid history and breakthrough pain severity. For some, 200mcg may be the starting dose, while others may require titration from a lower dose.
• Titration: Dose adjustments are made cautiously based on patient response and side effects. Dosage increments or decrements depend on effectiveness and tolerability.
• Frequency: ABSTRAL is used only as needed to treat breakthrough pain episodes and not as a scheduled medication.
• Maximum daily dose: Determined individually, and exceeding prescribed doses can cause serious toxicity.
• Special populations: Elderly, hepatic or renal impairment patients require close monitoring and possible dose modifications.
• Switching opioids: When transitioning from other opioids, careful calculation and monitoring are necessary to prevent overdose or inadequate pain relief.

Strict adherence to prescribed dosing and regular medical follow-up are vital to ensure safe and effective pain management with ABSTRAL.

Possible side effects of ABSTRAL 200mcg

Like all opioids, ABSTRAL 200mcg may cause a range of side effects. Understanding these helps patients and caregivers identify issues early and seek medical attention if necessary.

• Common side effects: Drowsiness, dizziness, nausea, vomiting, constipation, dry mouth, headache, sweating, weakness, and fatigue.
• Respiratory depression: A potentially fatal slowing or cessation of breathing, especially if overdosed or used by opioid non-tolerant individuals.
• Hypotension: Low blood pressure, which can cause dizziness or fainting.
• Central nervous system effects: Confusion, hallucinations, sedation, mood changes, or euphoria.
• Allergic reactions: Rash, itching, swelling, and in rare cases, anaphylaxis.
• Withdrawal symptoms: Occur if the drug is stopped abruptly after prolonged use; symptoms may include agitation, sweating, muscle aches, and anxiety.
• Serotonin syndrome: Rare but serious when combined with serotonergic drugs; symptoms include agitation, hallucinations, rapid heartbeat, and fever.

Any serious or unusual side effects should prompt immediate medical consultation.

ABSTRAL 200mcg Contraindications ABSTRAL 200mcg

ABSTRAL is contraindicated in the following cases:

• Patients who are not opioid tolerant due to high risk of respiratory depression and fatal overdose.
• Known hypersensitivity to fentanyl or any component of the formulation.
• Severe respiratory depression or acute asthma attack.
• Paralytic ileus or severe gastrointestinal obstruction.
• Concurrent use or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs).
• Severe central nervous system depression or coma.
• Patients with increased intracranial pressure or head injury without close monitoring.

Strict patient selection and careful medical supervision are essential to minimize risks.

Storage of ABSTRAL 200mcg

Proper storage of ABSTRAL 200mcg maintains its potency and safety:

• Store tablets in their original blister packs until use to protect them from moisture and light.
• Keep at room temperature, ideally between 15°C and 30°C (59°F to 86°F).
• Avoid exposure to excessive heat, cold, or humidity.
• Keep out of reach