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Generic name:  Pregabalin and Methylcobalamin 

Pharmacotherapeutic group:

Pregabalin: Neuropathic pain agent/Alpha-2 delta ligand

Methylcobalamin: Anti-anaemic agent/Vitamin/Nerve Supplement

Composition: Pregabalin 75 mg and Methylcobalamin 750 mcg Capsule. 

  • What is Pregalin-M? 

Pregabalin-M contains Pregabalin 75 mg and Methylcobalamin 750 mcg Capsule form. 

  • What is it used for?

Pregalin-M is indicated for 

  • Diabetic Peripheral  Neuropathy
  • Post-herpetic Neuralgia
  • Fibromyalgia
  • Sciatica
  • Reflex sympathetic dystrophy syndrome
  • Adjunctive therapy for seizures

  •  How it works? 

Combination of Pregabalin and methylcobalamin not only decrease the release of neurotransmitters but also helps in regeneration of the myelin sheath. Pregabalin possesses analgesic activity which reduces the pain associated with neuropathy. Thus, the combination of pregabalin and methylcobalamin is useful for arresting the process of diabetic neuropathy and also helps in relieving the pain associated with neuropathy.

  • How to take Pregalin-M? 

Take this medicine in the dose and duration as advised by your doctor. Pregalin-M 750 mcg/75 mg Capsule may be taken with or without food, but it is better to take it at a fixed time.

  • What if you miss the dose? 

If you miss a dose of Pregalin-M 750 mcg/75 mg Capsule, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

  • What to do in case of over dose? 

Contact your health care professional or go to the nearest hospital emergency unit                   immediately.

  • What do you need to know before you take Pregalin-M? 

Do not take it

  • Don’t use this medicine if you have hypersensitivity to pregabalin or methylcobalamin.
  • Do not drink alcohol while taking methylcobalamin+pregabalin as drinking alcohol can increase the severity of drowsiness or sleepiness.
  1. Warning and Precautions
  • Consult with your doctor if you are pregnant or breast feeding woman before taking this medicine to understand the risk and benefit ratio.
  • Talk to your doctor about past medical history like kidney problem or liver problem before taking this medicine.
  • Don’t double the dose for the missed one.
  • Complete the prescribed dose and duration of medicine.
  • Some diabetic patients who gain weight on Pregabalin treatment may need to adjust hypoglycemic medications.
  • Visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient. Discontinuation of Pregabalin may result in resolution or improvement of these visual symptoms.
  • Convulsions, including status epilepticus and grand mal convulsions, may occur during Pregabalin use or shortly after discontinuing pregabalin.
  • Congestive heart failure in some patients receiving Pregabalin has been reported, mostly in elderly cardiovascular compromised patients during treatment for a neuropathic indication. Discontinuation of Pregabalin may resolve the reaction.
  • Patients with a history of substance abuse should be monitored for symptoms of Pregabalin abuse.
  • Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.
  • Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury in elderly population. Cases of loss of consciousness, confusion and mental impairment have also been reported. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
  • After discontinuation of short-term and long-term treatment with Pregabalin withdrawal symptoms have been observed in some patients, (e.g. insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating and dizziness). The patient should be informed about this at the start of the treatment. Concerning discontinuation of long-term treatment of Pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose related.
  • In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, central nervous system adverse events and especially somnolence was increased. This may be attributed to an additive effect due to concomitant medication (e.g. anti-spasticity agents) needed for this condition.
  • Cases of renal failure have been reported. Some cases were reversible upon discontinuation of treatment.
  • Patients should be monitored for signs of suicidal ideation and behaviors. Appropriate treatment should be considered.
  • When Pregabalin and opioids are co-administered, measures to prevent constipation may be considered (especially in female patients and elderly).
  1. Pregnancy and breast- feeding

Pregnancy

Pregalin-M 750 mcg/75 mg Capsule may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

Breast – feeding 

Pregalin-M 750 mcg/75 mg Capsule is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breast milk and harm the baby.

  • Driving and using machines

Pregalin-M 750 mcg/75 mg Capsule may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.

 

  • What are the possible side effects?

Common side effects include dizziness, drowsiness, dry mouth, constipation, tiredness, uncoordinated body movements. If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist. Call your doctor right away if you have serious side effects like serious allergic reactions.

INDICATIONS BRIEFING 

  • Diabetic Peripheral Neuropathy:

In Diabetic Peripheral Neuropathy (DPN),damage occur to nerves due to uncontrolled  Diabetes Mellitus(DM).Since in DM, blood glucose levels are very high and nerves are extremely susceptible to damage. Diabetic Neuropathy (DN) affects peripheral nerves in (limbs) & those that control autonomic functions of body like (digestion, heart rate, etc).

  • Post-herpetic Neuralgia:

Post-herpetic neuralgia is a painful condition that affects the nerve fibers and skin. It is a complication of shingles and shingles is a complication of chicken pox. If the pain caused by shingles continues after the bout of shingles is over, it is known as post herpetic neuralgia.

  • Fibromyalgia:

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Is a long term conditions that causes pain all over the body.

 

  • Sciatica

Sciatica is a term used to describe nerve pain in the leg that is caused by irritation and/or compression of the sciatic nerve. Sciatica originates in the lower back, radiates deep into the buttock, and travels down the leg.

  • Reflex sympathetic dystrophy syndrome

Is a form of chronic pain that usually affects an arm or a leg. It typically develops after an injury, a surgery, a stroke or a heart attack. But the severity of pain is typically worse than the original injury itself.

  • Adjunctive therapy for seizures

Seizure is a single event of abnormal electrical discharge in the brain resulting in an abrupt and temporary altered state of cerebral function.