The uses of Pregasafe medication

Pregasafe is used in cases of pain caused by neurological factors and supports the treatment of epilepsy. Additionally, the medication is used for other purposes under the doctor's prescription.

1. Uses of Pregasafe medication

Pregasafe medication contains the active ingredient Pregabalin, formulated in hard capsule form with the following dosages:

  • Pregasafe 50 mg contains 50 mg of Pregabalin;
  • Pregasafe 75 mg contains 75 mg of Pregabalin.

The medication works by inhibiting nerve transmission, with Pregabalin binding to the α2-δ subunit of the calcium channel protein in the central nervous system, replacing [3H]-gabapentin.
Pregabalin is rapidly absorbed when taken on an empty stomach, with peak plasma concentration reached after 1 hour for both single and multiple doses. The oral bioavailability of Pregabalin is about 90% and depends on the dose. Absorption of Pregabalin is reduced when taken with food. However, in practice, taking Pregabalin with food does not have a significant clinical effect on its absorption, so the medication can be taken with or without food.

2. Indications and contraindications of Pregasafe

Pregasafe is indicated for use in the following conditions:

  • Treatment of neuropathic pain: Pregabalin is indicated for treating neuropathic pain in adults, such as sciatica, brachial plexus pain, intercostal neuralgia, etc.;
  • Treatment of partial epilepsy: Pregabalin is indicated as an adjunctive therapy for partial epilepsy in adults, and can be used in cases of secondary generalized epilepsy;
  • Treatment of generalized anxiety disorder: Pregabalin is indicated for the treatment of generalized anxiety disorder in adults.

Pregasafe should not be used in individuals who are allergic to any of its components. It is not recommended for use in children under 18 years old, as safety in this age group has not been established. Use with caution in individuals with kidney impairment.

3. Dosage and administration of Pregasafe

Pregasafe should be taken orally, with or without food.
The usual dose of Pregasafe is 150 mg to 600 mg per day, divided into 2 to 3 doses.
For neuropathic pain:

  • Treatment may begin with a dose of 150 mg per day, divided into 2 to 3 doses;
  • Depending on individual response and tolerance, the dose may be increased to about 300 mg per day after approximately 7 days, and if necessary, increased to a maximum of 600 mg per day after 7 days of treatment with 300 mg;
  • However, in many cases, a dose of 600 mg does not significantly improve therapeutic efficacy and may increase side effects, so the dose should generally not exceed 600 mg.

For epilepsy:

  • Treatment may begin with a dose of 150 mg per day, divided into 2 to 3 doses;
  • The dose may be increased to 300 mg per day after 1 week, and if necessary, increased to 600 mg per day after 1 week of treatment with 300 mg.

For generalized anxiety disorder:

  • The starting dose may be approximately 150 mg per day;
  • Depending on individual response and tolerance, the dose may be increased to 300 mg per day after 1 week of treatment;
  • After another week of treatment, the dose may be increased to 450 mg per day;
  • The maximum dose of 600 mg per day may be reached after another week of treatment, but only when necessary.

In patients with kidney impairment:
Dosage adjustments are required for patients with impaired kidney function. Dosage is based on the creatinine clearance (CLcr) rate:

  • CLcr ≥ 60: Starting dose of 150 mg, maximum dose of 600 mg, divided into 2 or 3 doses;
  • CLcr ≥ 30 and < 60: Starting dose of 75 mg, maximum dose of 300 mg, divided into 2 or 3 doses;
  • CLcr ≥ 15 and < 30: Starting dose of 25-50 mg, maximum dose of 150 mg, taken in 2 doses or a single dose;
  • CLcr < 15: Starting dose of 25 mg, maximum dose of 75 mg, single dose;
  • Post-hemodialysis: Starting dose of 25 mg, maximum dose of 100 mg, single dose.

For elderly patients:
Elderly individuals may need a dose reduction due to decreased renal function.
Discontinuation of Pregasafe:
If discontinuing Pregasafe, the dose should be gradually reduced over at least 1 week.

4. Side effects of Pregasafe

Common side effects may include:

  • Very common: Dizziness, drowsiness;
  • Common: Increased appetite, euphoria, irritability, agitation, reduced libido, loss of direction, insomnia, lack of coordination, tremors, feeling unwell, memory impairment, inability to concentrate, tingling, lack of balance, sleepiness, blurred vision, double vision, nausea, vomiting, dry mouth, constipation, bloating, erectile dysfunction, fatigue, peripheral edema, weight gain;
  • Uncommon: Nasopharyngitis, shortness of breath, dry nose, anorexia, hypoglycemia, skin rashes, sweating, falls, thirst, chest pain, weakness, chills, hallucinations, feelings of being attacked, apathy, anxiety, depression, restlessness, mood swings, difficulty expressing information, nightmares, increased libido, anorgasmia, confusion, fainting, muscle twitches, increased psychomotor activity, loss of taste, movement disorders, dizziness upon position changes, tremors, nystagmus, cognitive disorders, reduced reflexes, sensory loss, memory loss, burning sensation, vision disorders, reduced visual acuity, eye pain, eye strain, dry eyes, increased hearing;
  • Rare: Neutropenia, loss of conditioned reflexes, happy mood, reduced muscle activity, olfactory disorders, difficulty writing, double vision, changes in image depth, dizziness, eye irritation, pupil dilation, strabismus, light sensitivity, hypotension or hypertension, tachycardia, arrhythmias, bradycardia, abdominal bloating, abdominal pain, gastroesophageal reflux, excessive salivation, loss of taste, pancreatitis, difficulty swallowing, nosebleeds, urticaria, cold sweats, renal failure, oliguria, amenorrhea, galactorrhea, breast pain, breast hypertrophy, hypokalemia, thrombocytopenia, peripheral edema, fever, withdrawal syndrome.

If you experience any of these side effects, stop using the medication and inform your doctor or seek immediate medical assistance.

5. Precautions when using Pregasafe

  • Pregasafe should only be used according to a doctor's prescription, so inform your doctor about any allergies or coexisting conditions before using the medication.
  • Patients with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication due to the presence of lactose in the excipients.
  • Some diabetic patients may experience weight gain when using Pregabalin, so adjustments to antidiabetic medications may be necessary.
  • Treatment with Pregabalin may cause dizziness and drowsiness, which may increase the risk of accidents in elderly patients, so caution is advised.
  • Pregasafe can cause drowsiness and dizziness, so avoid operating machinery or driving due to the risk of accidents.
  • Although there is no clear evidence linking high or prolonged doses to withdrawal syndrome, it is advisable to gradually reduce the dose over a period of 1 week if discontinuing the medication.
  • Pregasafe is not recommended during pregnancy or breastfeeding, and should only be used if absolutely necessary.
  • Like other anticonvulsants, Pregasafe may be associated with suicidal thoughts and behaviors, so close monitoring is needed, especially in patients with a history of depression.
  • Pregasafe is primarily excreted unchanged through the kidneys, so it has minimal interaction with other medications.
  • Store the medication in a cool, dry place, away from children.

In summary, Pregasafe is a prescription medication, and you should not stop or take it without a doctor's prescription.

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