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Pregalin 75/150
Generic Name:Pregabalin
Therapeutic Category:Neuropathic-Pain Agent
Pharmacological Class:Alpha-2 delta ligand
Composition: Pregalin 75
Each capsule contains Pregabalin 75 mg
Pregalin 150
Each capsule contains Pregabalin 75 mg
Pregnancy Category:C
Presentation:Pregalin-75
Available in the pack size as 10 tablets X 10 blisters
Pregalin-150
Available in the pack size as 10 tablets X 3 blisters

What is Pregalin and what is it used for?

Pregalin contains Pregabalin 75 mg and Pregabalin 150 mg in capsule form. It is used to treat epilepsy, neuropathic pain and Generalized Anxiety Disorder (GAD) in adults.

How does it work?

Pregabalin works in different ways:

  • in epilepsy it stops seizures by reducing the abnormal electrical activity in the brain
  • with nerve pain it blocks pain by interfering with pain messages travelling through the brain and down the spine
  • in anxiety it stops your brain from releasing the chemicals that make you feel anxious

 

How to take Pregalin?

Always take this medicine exactly as your healthcare professional has told you. Your doctor will determine what dose is appropriate for you. Pregalin is for oral use only.

If you are an elderly patient (over 65 years of age), you should take Pregalin normally except if you have problems with your kidneys.

What if you miss a dose?

It is important to take your Pregalin capsules regularly at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. In that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose.

What to do in case of overdose?

Contact your healthcare professional or go to the nearest hospital emergency unit immediately. Take your box of Pregalin capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregalin than you should. Fits have also been reported.

 

What do you need to know before you take Pregalin?

Do not take Pregalin

If you are allergic to pregabalin or any of the other ingredients of this medicine

 

Warnings and Precautions

  • Talk to your healthcare professional before taking Pregalin.
  • If you experience any reactions such as swelling of the face, lips, tongue, and throat, as well as diffuse skin rash, you should contact your physician immediately.
  • Pregalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have.
  • Pregalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision.
  • There have been reports of heart failure in some patients when taking Pregalin; these patients were mostly elderly with cardiovascular conditions. Before taking this medicine you should tell your doctor if you have a history of heart disease.
  • If while taking Pregalin you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
  • A small number of people being treated with anti-epileptics such as Pregalin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
  • When Pregalin is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralyzed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem.
  • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed.
  • There have been reports of convulsions when taking Pregalin or shortly after stopping Pregalin. If you experience a convulsion, contact your doctor immediately.

 

Children and adolescents

The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.

 

Pregnancy and breast-feeding

Pregalin should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your healthcare professional.

 

Driving and using machines

Pregalin may produce dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Pregabalin and Alcohol

Alcohol can increase the nervous system side effects of pregabalin such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with pregabalin.

 

What are the possible side effects?

Very common side effects are dizziness, drowsiness, headache.

Common side effects include:

  • Increased appetite.
  • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
  • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
  • Blurred vision, double vision.
  • Vertigo, problems with balance, fall.
  • Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.
  • Difficulties with erection.
  • Swelling of the body including extremities.
  • Feeling drunk, abnormal style of walking.
  • Weight gain.
  • Muscle cramp, joint pain, back pain, pain in limb.

Mechanism of action:

Pregalin binds to ALPHA2-DELTA (α2-delta) subunit on voltage gated calcium channels in hyper-excited neurons. This inhibits influx of calcium and reduces release of glutamate, norepinephrine, substance P and other neurotransmitters. Such decrease in neurotransmitter release from synapses in several neuronal tissues in the spinal cord and brain is likely to attenuate neuronal hyper-excitability and abnormal synchronization.

This may thus explain its anticonvulsant, analgesic, and anxiolytic activity.

 

Pharmacokinetic properties:

Absorption: After oral dosing administered in the fasted state, pregabalin absorption is rapid, and extensive. Pregabalin oral bioavailability is reported to be ≥90% regardless of the dose. Cmax is attained within 1.5 hours after single or multiple doses, and steady state is attained within 24-48 hours with repeated administration.

The effect of food does not appear to impact the total absorption of pregabalin in a way that is clinically relevant. As a result, pregabalin can be administered with or without food.

Protein binding: Pregabalin is not plasma protein bound.

Volume of distribution: After oral administration of pregabalin, the reported apparent volume of distribution is roughly 0.5 L/kg.

Metabolism: Less than 2% of pregabalin is metabolized and it is excreted virtually unchanged in the urine.

Route of elimination: Pregabalin is almost exclusively eliminated in the urine.

Half-life: The elimination half-life of pregabalin is 6.3 hours.

Clearance: In young healthy subjects the mean renal clearance is estimated to be 67.0 to 80.9 mL mL/min.

 

Drug Interaction

Pregalin and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregalin may potentiate these effects, and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregalin is taken together with medicines containing: Oxycodone – (used as a pain-killer), Lorazepam – (used for treating anxiety). Pregalin may be taken with oral contraceptives.

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