Information

  • Preganur-M 75/750 | 75/1500
  • Dosage Form: Capsule
  • Pack Type: Strip
  • Pack Size: 1X10's Capsules
  • Division: Unimax

PREGANUR-M

Pregabalin & Methylcobalamin

Preganur-M 75/750: Each hard gelatin capsule contains Pregabalin 75 mg and Methylcobalamin 750 mcg

Preganur-M 75/1500:Each hard gelatin capsule contains Pregabalin 75 mg and Methylcobalamin 1500 mcg

Clinical Pharmacology:

Pregabalin:

Pregabalin achieves antihyperalgesic activity by binding to the α2δ subunit of the voltage-dependent calcium channels.

Methylcobalamin:

 

It works by functioning in the production of a compound called myelin, which covers and protect nerve fibers. Methylcobalamin rejuvenates the damaged neuron.

It is indicated for the treatment of

Peripheral neuropathic pain,

Diabetic neuropathy,

Post Herpetic Neuralgia

The dose range for pregabalin is 150 to 600 mg per day given in two or three divided doses. 

The usual dose of methylcobalamin is 1.5 mg daily in three divided doses. The dose may be adjusted depending on the patient’s age and severity of symptoms.

Discontinuation of Pregabalin: If this medicine has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORM OF INTERACTION:

 

  • Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.

  • Pregabalin may potentiate the effects of ethanol and lorazepam.

  • There are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system depressant medicinal products.

  • Antibiotics may alter the intestinal microflora and may decrease the absorption of methylcobalamin.

  • Cholestyramine, colchicines or colestipol may decrease the enterohepatic re-absorption of methylcobalamin.

  • Metformin, para-aminosalicylic acid and potassium chloride may decrease the absorption of methylcobalamin.

  • Nitrous oxide can produce a functional methylcobalamin deficiency

  • Chloramphenicol should not be used with mecobalamin.

 

  • Most common side effects seen with pregabalin are: dizziness, somnolence, headache, ataxia, asthenia, dry mouth, constipation, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention).

  • Methylcobalamin has no known toxicity at the dosage for clinical effects and it appears to be well tolerated, with a safety and tolerability profile similar to that of the placebo. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methylcobalamin

 

  • Some diabetic patients who gain weight on Pregabalin treatment may need to adjust hypoglycemic medications.

  • Hypersensitivity reactions, including cases of angioedema have been reported after the use of Pregabalin. Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.

  • 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.

  • There are insufficient data for the withdrawal of concomitant antiepileptic medical products, once seizure control with Pregabalin in the add-on situation has been reached, in order to reach monotherapy on Pregabalin.

  • 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).

PREGNANCY AND BREAST-FEEDING:

There are no adequate data from the use of Pregabalin in pregnant women. Pregabalin should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).

 

Pregabalin is excreted into human milk. A decision must be made whether to discontinue breast-feeding or to discontinue Pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.