Overview

GABOTT NT

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PRODUCT INTRODUCTION GABOTT NT

GABOTT NT is a fixed-dose combination of gabapentin, an anticonvulsant with proven neuropathic analgesic properties, and nortriptyline, a tricyclic antidepressant that also provides analgesic benefit in chronic neuropathic pain. The two drugs act by different mechanisms on pain pathways: gabapentin reduces neuronal hyperexcitability and abnormal pain signalling, while nortriptyline modulates monoaminergic neurotransmission and increases descending inhibitory control. Together they are intended to provide enhanced control of neuropathic pain symptoms such as burning, shooting pain, paraesthesia and sleep-disturbing pain in selected patients when prescribed by a clinician.

Indications and clinical use

GABOTT NT is indicated for the management of neuropathic pain conditions where combination therapy is appropriate and has been prescribed by a physician. Typical clinical situations include diabetic peripheral neuropathy, post-herpetic neuralgia, certain neuropathic pain syndromes and other chronic painful neuropathies when monotherapy is insufficient. Use only under medical supervision; the choice of combination therapy should follow clinical evaluation and consideration of comorbidities and concomitant medications.

Mechanism of action

Gabapentin binds to the α2δ subunit of voltage-gated calcium channels, reducing excitatory neurotransmitter release and decreasing neuronal hyperexcitability that underlies neuropathic pain. Nortriptyline inhibits the reuptake of norepinephrine and serotonin and has secondary anticholinergic and sodium channel effects; these actions enhance descending inhibitory pain pathways and alter central pain processing. Combined use targets complementary mechanisms to achieve better symptomatic relief for some patients.

Dosage and administration

Use GABOTT NT exactly as prescribed by the treating physician. Individual dose titration is usually required when initiating gabapentin because therapeutic gabapentin doses vary and should be adjusted to effect and tolerability; nortriptyline is usually started at a low dose and increased if needed, with monitoring for anticholinergic and cardiac effects. Do not exceed the dose recommended by your prescriber. Do not stop therapy abruptly without medical advice: gabapentin discontinuation should generally be tapered to reduce the risk of withdrawal symptoms (including increased pain or, rarely, seizures), and nortriptyline should be tapered to avoid adverse withdrawal effects. Follow specific instructions on timing (some patients are advised to take nortriptyline in the evening because of sedative effects).

Contraindications and precautions

Do not use GABOTT NT in patients with known hypersensitivity to gabapentin, nortriptyline, or any excipient. Exercise caution in patients with significant cardiac disease (arrhythmias, conduction abnormalities), urinary retention, angle-closure glaucoma, severe liver disease, or severe renal impairment (gabapentin is renally excreted and requires dose adjustment). Nortriptyline may worsen certain cardiac conduction defects and is relatively contraindicated in the acute recovery phase after myocardial infarction unless a cardiologist advises otherwise. Use caution in the elderly because of increased sensitivity to anticholinergic effects and fall risk. Assess suicide risk before and during treatment in patients with underlying psychiatric disorders; antidepressants and some antiepileptics have been associated with increased risk of suicidal thoughts in a small subset of patients.

Adverse effects and safety information

Common adverse effects related to gabapentin include dizziness, somnolence, peripheral oedema and unsteadiness. Common nortriptyline-related effects include dry mouth, constipation, blurred vision, urinary retention, orthostatic hypotension and sedation. Concomitant use may increase sedation and cognitive impairment; patients should avoid driving or operating machinery until they know how the combination affects them. Serious but less common risks include cardiac conduction abnormalities (nortriptyline), severe anticholinergic effects, significant respiratory depression when combined with other CNS depressants (alcohol, benzodiazepines, opioids), and rare allergic reactions. Report any severe rash, breathing difficulties, marked palpitations, fainting, severe dizziness, new or worsening depression or suicidal thoughts to a clinician immediately.

Drug interactions

GABOTT NT may interact with other central nervous system depressants (opioids, benzodiazepines, alcohol), increasing the risk of sedation and respiratory depression. Nortriptyline interacts with monoamine oxidase inhibitors (MAOIs) — coadministration is contraindicated — and may increase serotoninergic adverse effects if combined with SSRIs, SNRIs or other serotonergic drugs; monitor for serotonin syndrome. Nortriptyline is metabolised by cytochrome P450 enzymes (notably CYP2D6); inhibitors of these enzymes can raise nortriptyline levels and increase adverse effects. Concomitant antihypertensive medications and sympathomimetics can alter blood pressure response. Always provide your prescriber with a complete list of medicines, including OTC products, herbal supplements and alcohol use.

Use in pregnancy and lactation

Data are limited. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus and under specialist oversight. Both agents are excreted in breast milk to varying degrees; breastfeeding mothers should discuss risks and benefits with their physician before using the combination.

Special warnings

Adjust gabapentin dosing in renal impairment and consider monitoring nortriptyline plasma levels in situations where interactions or hepatic impairment could alter exposure. Monitor elderly patients closely for confusion, falls and anticholinergic effects. Counsel patients to avoid alcohol and to be cautious with other sedating medicines. If severe neuropsychiatric symptoms, signs of arrhythmia, severe anticholinergic reactions or signs of severe allergic reaction occur, stop treatment and seek medical attention.

Storage

Store GABOTT NT in a cool, dry place below 25–30°C away from direct sunlight and moisture. Keep the container tightly closed when not in use. Keep out of reach of children.

When to consult a healthcare professional

Seek immediate medical attention for signs of severe allergic reaction, new or worsening mood changes or suicidal thoughts, sudden fainting, chest pain, irregular heartbeat or other worrying cardiac symptoms, severe dizziness or severe difficulty breathing. Consult your prescriber before stopping or changing the dose.