Is it safe to administer pregabalin and methylcobalamin to older adults with hemiplegia?

From the FDA Drug Label

1. 5 Geriatric Use In controlled clinical studies of pregabalin in neuropathic pain associated with diabetic peripheral neuropathy, 246 patients were 65 to 74 years of age, and 73 patients were 75 years of age or older In controlled clinical studies of pregabalin in neuropathic pain associated with postherpetic neuralgia, 282 patients were 65 to 74 years of age, and 379 patients were 75 years of age or older. In controlled clinical studies of pregabalin in epilepsy, there were only 10 patients 65 to 74 years of age, and 2 patients who were 75 years of age or older No overall differences in safety and efficacy were observed between these patients and younger patients.

The FDA drug label does not provide information on the safety of administering pregabalin and methylcobalamin to older adults with hemiplegia. There is no mention of methylcobalamin or hemiplegia in the provided drug label 1.

From the Research

Safety of Pregabalin and Methylcobalamin in Older Adults with Hemiplegia

• The safety of administering pregabalin and methylcobalamin to older adults with hemiplegia can be inferred from several studies 2, 3, 4, 5, 6.
• A study published in the International Journal of General Medicine found that a fixed-dose combination of sustained-release pregabalin and methylcobalamin was well-tolerated in Indian patients with neuropathic pain, with common adverse effects including giddiness, sedation, dizziness, drowsiness, and nausea 2.
• Another study published in The International Journal of Neuroscience reported that a combination of pregabalin and transcutaneous electrical nerve stimulation was effective in relieving neuropathic pain in a stroke patient with hemiplegia, with no significant adverse effects reported 3.
• A review of pregabalin's pharmacology and its relevance to clinical practice found that pregabalin has a predictable and linear pharmacokinetic profile, with a low risk of pharmacokinetic drug-drug interactions 4.
• A Cochrane review of pregabalin for neuropathic pain in adults found that pregabalin was effective in reducing pain intensity and improving sleep quality, but was associated with an increased risk of somnolence and dizziness 5.
• A pilot study published in the Annals of Indian Academy of Neurology found that a combination of methylcobalamin, alpha-lipoic acid, and pregabalin was effective in improving pain and nerve conduction velocity in patients with type 2 diabetes-associated peripheral neuropathy, with no significant adverse effects reported 6.

Adverse Effects

• Common adverse effects associated with pregabalin include somnolence, dizziness, and nausea 2, 5.
• Methylcobalamin is generally well-tolerated, with few adverse effects reported 6.
• The combination of pregabalin and methylcobalamin may increase the risk of adverse effects, particularly somnolence and dizziness 2, 5.

Dosage and Administration

• The recommended dosage of pregabalin varies depending on the condition being treated, but typical doses range from 150-600 mg per day 4, 5.
• Methylcobalamin is typically administered at a dose of 750-1500 μg per day 2, 6.
• The combination of pregabalin and methylcobalamin should be administered with caution, particularly in older adults with hemiplegia, due to the potential for increased adverse effects 2, 5, 6.