Pregabalin 75 mg and Nortriptyline 10 mg Tablets

Description

Pregabalin 75 mg and Nortriptyline 10 mg Tablets are a clinically proven fixed-dose combination that is being used to treat neuropathic pain, which is one of the most difficult and poorly managed types of pain. This is a dual mechanism drug combination that combines two pharmaceutical agents that target two different pain mechanisms: Pregabalin, which is a voltage-gated calcium channel modulator reducing the abnormal pain signalling both at spinal and supraspinal levels, and Nortriptyline, which is a Tricyclic Antidepressant (TCA) that increases the effect of descending pain inhibition by norepinephrine reuptake inhibition. Thus, this combination targets neuropathic pain using two different mechanisms and provides better pain relief, sleep and functional recovery than any individual agent used alone.

This product is manufactured under GMP conditions and packed in a 10×10 Alu-Alu quality-protecting blister. The product is being supplied through PCD Pharma Franchise of Pharvax Biosciences, which is a high-prescription neuro and pain management combination for use by neurologists, diabetologists, orthopaedic surgeons and general physicians in managing patients with diabetic neuropathy, post-herpetic neuralgia and chronic neuropathic pain in India.

Uses and Indications

Pregabalin 75 mg + Nortriptyline 10 mg Tablets are indicated in neurologists, diabetologists, orthopaedic surgeons, and general practitioners for treating:

• Diabetic Peripheral Neuropathy (DPN) – burning, stabbing, tingling, and numbness in the feet and hands due to longstanding nerve damage in diabetes; most common indication for this combination in India
• Post-herpetic Neuralgia (PHN) – neuropathic pain syndrome occurring following herpes zoster infection, usually severe and resistant to conventional analgesics
• Fibromyalgia – widespread chronic musculoskeletal pain along with disturbance in sleep and fatigue; Pregabalin is FDA-approved for Fibromyalgia
• Neuropathic pain following Spinal Cord Injury – central neuropathic pain after traumatic or pathological damage to spinal cord
• Radiculopathy and nerve root compression pain – electric shock-like shooting pain originating from the spine and radiating to limbs; Cervical and Lumbar radiculopathy
• Generalised Anxiety Disorder (GAD) – Pregabalin is FDA-approved for GAD; Nortriptyline works by virtue of its antidepressant effect
• Complex Regional Pain Syndrome (CRPS) – complex types of neuropathic pain syndromes with central sensitisation that need multi-mechanism analgesics
• Sleep disturbance due to neuropathic pain – Nortriptyline 10 mg improves sleep architecture in patients with neuropathic pain; important advantage of Nortriptyline not achievable with Pregabalin

How Pregabalin 75 mg and Nortriptyline 10 mg Tablets Work

This combination provides dual-pathway neuropathic pain control — one of the most clinically rational and well-studied antineuropathic combinations in current practice.

Pregabalin 75 mg is a derivative of GABA that specifically binds to the α₂δ subunit of the voltage-gated calcium channels in the sensitised primary afferent neurons located in the dorsal horn of the spinal cord and brain. Binding to this particular subunit by pregabalin decreases the entry of calcium ions into the presynaptic terminals of the sensitised pain neurons, resulting in a decrease in the secretion of excitatory neurotransmitters, including glutamate, substance P, and calcitonin gene-related peptide (CGRP) at the synapse. It decreases the hyperexcitability and central sensitisation, which are characteristics of neuropathic pain; hence, resulting in pain relief, reduction in allodynia and hyperalgesia. Pregabalin has anxiolytic effects using the same mechanism in the limbic system.

 

Nortriptyline 10 mg belongs to the class of secondary amine TCAs. This drug acts by blocking the presynaptic transporters for norepinephrine (NET) and serotonin (SERT). With regard to pain control, the important function of Nortriptyline is the facilitation of the descending inhibitory noradrenergic pain pathway – an endogenous pain inhibition mechanism of the spinal cord starting from the brainstem and inhibiting pain signal transduction in the dorsal horn through release of norepinephrine. Blocking norepinephrine reuptake in these descending pathways leads to enhanced synthesis of norepinephrine and enhanced inhibitory pain modulation irrespective of Pregabalin presynaptic calcium channels.

Dosage and Administration

Pregabalin 75 mg + Nortriptyline 10 mg Tablets are for oral use only. Take once or twice daily as prescribed by a neurologist or physician, preferably at bedtime — the Nortriptyline component’s sedative effect is beneficial when taken before sleep, improving nocturnal pain relief and sleep quality simultaneously. May be taken with or without food. The dose, frequency, and duration of therapy are strictly determined by the prescribing physician based on the type and severity of neuropathic pain, the patient’s age, renal function, and response to treatment. Do not abruptly discontinue — both Pregabalin and Nortriptyline should be tapered under medical supervision.

Side Effects

The combination is generally well tolerated at the 75 mg + 10 mg dose. Reported side effects from both components include:

• Dizziness / Lightheadedness – The most frequent side effect of Pregabalin, especially at onset; it usually resolves on dose stabilisation
• Somnolence – Synergic sedative effect of Pregabalin and Nortriptyline; useful at night, but use caution during daytime activities
• Dry mouth – Anticholinergic effect of Nortriptyline; generally mild effect at 10 mg dosage
• Weight gain – Effect of Pregabalin; more pronounced with higher dosages of the drug and duration of treatment
• Peripheral oedema (swelling of ankles) – Side effect of Pregabalin; should be monitored in patients with cardiac or kidney problems
• Blurred vision – Anticholinergic effect of Nortriptyline at high dosages; uncommon with 10 mg
• Constipation – Anticholinergic effect of Nortriptyline
• Mild cognitive effects – Difficulty concentrating or memory confusion; mostly caused by Pregabalin at high dosages
• Orthostatic hypotension – Side effect of Nortriptyline; be cautious in elderly patients; possibility of falling down
• Occasionally, QTc prolongation at high dosages of Nortriptyline – Rarely applicable for 10 mg dosage, but relevant for cardiac patients

Patients experiencing persistent or severe side effects should consult their physician promptly.

Precautions and Warnings for Pregabalin 75 mg and Nortriptyline 10 mg Tablets

• Use strictly under the supervision of a qualified neurologist, diabetologist, or physician — prescription-only (Schedule H) medicine
• Do not drive or operate heavy machinery until the effect of this combination on alertness and coordination is established — significant dizziness and somnolence risk, particularly at treatment initiation
• Never abruptly discontinue Pregabalin — rebound seizures, anxiety, and withdrawal symptoms may occur; taper dose under physician guidance
• Monitor for signs and symptoms of congestive heart failure — Pregabalin-related peripheral oedema may worsen pre-existing cardiac conditions
• Check renal function before initiating therapy — Pregabalin is renally excreted; dose adjustment is required in patients with eGFR < 60 mL/min/1.73m²
• Inform the prescribing physician of all concurrent medications — Nortriptyline is a CYP2D6 substrate with significant interactions with MAO inhibitors (absolutely contraindicated), serotonergic drugs, and other CNS depressants
• Concomitant MAO inhibitor use is absolutely contraindicated — risk of severe serotonin syndrome and hypertensive crisis; a 14-day washout period is mandatory before switching
• Avoid alcohol during therapy — potentiates CNS depression from both Pregabalin and Nortriptyline
• Monitor body weight periodically — Pregabalin promotes weight gain
• Caution in elderly patients — increased risk of dizziness, falls, orthostatic hypotension, and anticholinergic effects
• Pregnant and breastfeeding women should not use without explicit specialist guidance — both agents carry pregnancy risks
• Keep out of reach of children

Contraindications

Pregabalin 75 mg + Nortriptyline 10 mg Tablets are contraindicated in:

• Known hypersensitivity to Pregabalin, Nortriptyline, other TCAs, or any component of the formulation
• Concurrent or recent (within 14 days) use of MAO inhibitors — risk of fatal serotonin syndrome
• Patients with uncontrolled narrow-angle glaucoma
• Significant renal impairment without dose adjustment (for Pregabalin)
• Severe hepatic impairment
• Acute recovery phase following myocardial infarction
• Pregnancy and breastfeeding

PCD Pharma Franchise for Pregabalin 75 mg + Nortriptyline 10 mg Tablets – Pharvax Biosciences

Pharvax Biosciences is an all-in-one pharmaceutical organisation providing 250+ products in various therapeutic segments such as Medivaxia (Neuro & Pain), Gynae, General Medicine and Paediatrics. We are inviting pharmaceutical professionals, medical representatives and distributors from across India to join us in partnering for PCD Pharma Franchise and Monopoly Distribution of Pregabalin + Nortriptyline Tablets and the full range of Pharvax Neuro & Pain Products.

Neuropathic pain is said to occur in 6–8% of Indians, where diabetic peripheral neuropathy, post-herpetic neuralgia and radiculopathy form the most common types of neuropathies. Pregabalin + Nortriptyline is increasingly becoming a preferred treatment choice amongst neurologists and diabetologists and is one of the most lucrative antineuropathic combinations for PCD franchisees.

Disclaimer: Pregabalin 75 mg + Nortriptyline 10 mg Tablets (JUVITILL-P) is a Schedule H prescription-only medicine. Use strictly under the supervision of a registered medical practitioner or neurologist. This document is for informational and PCD Pharma Franchise marketing purposes only and does not constitute medical advice.