Pregabalin – action, indications, contraindications, dosage, side effects

Proven content

Pregabalin is a derivative of gamma-aminobutyric acid, abbreviated as GABA. It is used, among others, in the treatment of anxiety disorders in adults. It also supports the treatment of pain of peripheral or central origin. Pregabalin is an active ingredient, incl. Pregabalin Apotex.

Pregabalin – what is it?

Pregabalin is a structural analog of the neurotransmitter GABA. It has an analgesic, anticonvulsant, anxiolytic and sleep-modulating effect. It is indicated for the treatment of epilepsy and neuropathic pain. Pregabalin has a pharmacological effect similar to that of gabapentin.

Pregabalin is indicated for the treatment of:

1. in peripheral and central neuropathic pain in adults,
2. Associated partial seizures in adults with or without secondary generalization
3.  Generalized Anxiety Disorder (GAD) in adults.

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Pregabalin – dosage

Pregabalin dosing depends on the disease under which the preparation is used. The dose ranges from 150 mg to 600 mg a day given in two or three divided doses.

Pregabalin dosing for neuropathic pain

Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses. Depending on individual response and tolerability of the treatment, the dose may be increased to 3 mg daily after 7 – 300 days, and then, as needed, up to a maximum of 7 mg daily after another 600 days.

Pregabalin dosing for epilepsy

Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses. Depending on individual response and tolerability of the treatment, the dose may be increased to 1 mg daily after 300 week of treatment. A maximum dose of 600 mg per day may be reached after another week.

Pregabalin dosing for generalized anxiety disorder

The dose ranges from 150 mg to 600 mg per day given in two or three divided doses. The need for continued treatment should be reassessed on a regular basis. Pregabalin treatment can be started at a dose of 150 mg per day. Depending on individual response and tolerability, this dose may be increased to 1 mg daily after 300 week of treatment. After another week, the dose may be increased to 450 mg daily. After one more week, a maximum dose of 600 mg per day can be entered.

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Pregabalin – precautions

For certain medical conditions and diseases, you should take special care when taking pregabalin. These include the following diseases and conditions.

Diabetes mellitus in people with diabetes whose body weight increases during treatment with pregabalin, the doses of hypoglycaemic medicinal products may need to be adjusted.

Hypersensitivity reactions: Hypersensitivity reactions, including cases of angioedema, have been reported in post-marketing experience. Pregabalin should be discontinued immediately following symptoms of angioedema, such as facial swelling, swelling of the mouth, or upper respiratory tract edema.

Dizziness, somnolence, loss of consciousness, confusion and mental disorders: Pregabalin treatment has been associated with dizziness and somnolence, which may increase the risk of accidental injury (fall) in the elderly. Loss of consciousness, confusion, and psychiatric disorders have also been reported with the use of pregabalin. Therefore, patients taking pregabalin should be advised to exercise caution until the effect of the medicinal product on them is established.

Renal failure: Renal failure has been reported, but in some cases this side effect resolved after stopping pregabalin.

Vision problems: There have also been reports of ocular side effects, including loss of vision, blurred vision, or other changes in visual acuity, many of which are transient, in post-marketing experience. Stopping your treatment with pregabalin may help to improve or reduce these symptoms.

Respiratory depression: Cases of severe respiratory depression have been reported in association with the use of pregabalin. People with impaired respiratory function, respiratory or neurological disease, kidney problems, and those taking concomitant CNS depressants, and the elderly may be at greater risk of developing this serious side effect. These people may need to adjust the pregabalin dose.

Lower GI tract weakness: Cases of undesirable effects related to the weakening of the lower GI tract (e.g. bowel obstruction, paralytic ileus, constipation) have been reported when pregabalin is used with products that may cause constipation, such as opioid analgesics. If pregabalin is to be used concomitantly with opioids, anti-constipation measures should be considered (especially in women and the elderly).

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Pregabalin – withdrawal

Do not stop taking the medicine that contains pregabalin on your own. Following discontinuation, some people have seen withdrawal effects when discontinuing short and long term treatment with pregabalin.

The following symptoms may occur after discontinuation of pregabalin: insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, nervousness, depression, pain, seizures, sweating, and dizziness, suggesting physical dependence. Convulsions, including status epilepticus and grand mal seizures, can occur with pregabalin or shortly after treatment is stopped. Regarding discontinuation of long-term treatment with pregabalin, data indicate that the incidence and severity of withdrawal symptoms may be dose-dependent.

See: Depression in a senior. Characteristic symptoms of depression in the elderly

Pregabalin – side effects

Pregabalin can cause a number of side effects. However, this does not change the fact that not everyone who takes pregabalin may develop them. Side effects may occur very often, frequently, uncommonly, rarely and very rarely.

Very common side effects – may affect more than 1 in 10 people:

1. dizziness,
2. somnolence,
3. headaches. 

Common side effects – may affect up to 1 in 10 people:

1. increase in appetite,
2. elevated mood, confusion, disorientation, decreased sexual interest, irritability,
3. difficulty paying attention, clumsiness, memory impairment, memory loss, tremors
4. difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
5. blurred vision, double vision
6. dizziness, imbalance, fall
7. dry mouth, constipation, vomiting, gas, diarrhea, nausea, abdominal distension
8. difficulties in getting an erection,
9. swelling of the body, including the limbs,
10. feeling drunk, abnormal gait,
11. weight gain
12. muscle cramps, joint pain, back pain, pain in extremity,
13. sore throat.

Uncommon side effects – may affect up to 1 in 100 people:

1. loss of appetite, weight loss, low blood sugar, high blood sugar,
2. changes in self-perception, restlessness, depression, agitation, mood changes, difficulty finding the right words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental disorders, thinking difficulties, increased sexual interest, sexual problems , including the inability to achieve orgasm, delayed ejaculation,
3. changes in vision, unusual eye movement, visual disturbances including tunnel vision, flashes, jerky movements, weakened reflexes, increased activity, dizziness when standing, skin sensitivity, loss of taste, burning sensation, trembling with movements, disturbance of consciousness , loss of consciousness, fainting, increased sensitivity to noise, malaise,
4. dry eyes, eye swelling, eye pain, weak eye movement, watery eyes, eye irritation,
5. heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart beat, heart failure
6. flushing, flushing, difficulty breathing, dry nose, nasal congestion,
7. increased salivation, heartburn, numbness around the mouth, sweating, rash, chills, fever
8. muscle twitching, joint swelling, muscle stiffness, aches and pains including muscle pain, neck pain, breast pain
9. difficulty urinating or painful pressure on the bladder, urinary incontinence
10. weakness, thirst, tightness in the chest
11. hypersensitivity, swelling of the face, itching, hives, runny nose, nosebleed, cough, snoring,
12. painful menstruation,
13. freezing of hands and feet. 

Pregabalin – pregnancy and breastfeeding

Pregabalin should not be used during pregnancy or while breast-feeding, unless your doctor tells you otherwise. Women of childbearing potential should use an effective method of contraception while taking pregabalin. If a woman is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby, she should consult a physician or pharmacist before taking this preparation.

See: Characteristics of pain in peripheral neuropathy

Pregabalina – driving and operating machinery

Pregabalin may cause dizziness, somnolence and decreased concentration. You should not drive a car, operate complex machinery or engage in other potentially hazardous activities until you determine the effect of the preparation on your ability to perform the above activities.

Pregabalin – drug interactions

You should absolutely not consume alcohol while taking pregabalin preparations, as pregabalin may increase its effect. Additionally, it may increase the effect of lorazepam.

However, in studies with pregabalin, no interactions were found with phenytoin, carbamazepine, gabapentin, oral antidiabetics, insulin, phenobarbital, topiramate, and tiagabine. If you are using oral contraceptives, the absorption of pregabalin is not affected, and vice versa, pregabalin does not impair the absorption of contraceptives.