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Excipients: sodium lauryl sulfate - 1.2 mg, calcium carbonate - 136.17 mg, potato starch - 15.13 mg, colloidal silicon dioxide - 11.8 mg, talc - 5.9 mg, magnesium stearate - 1.8 mg.

Composition of the capsule cap:
Composition of the capsule body: titanium dioxide - 2%, gelatin - up to 100%.

10 pieces. - contour cellular packaging (aluminum/PVC) (1) - packs made of box cardboard.
10 pieces. - contour cellular packaging (aluminum/PVC) (2) - packs of boxed cardboard.
10 pieces. - contour cellular packaging (aluminum/PVC) (3) - packs made of box cardboard.
10 pieces. - contour cellular packaging (aluminum/PVC) (4) - packs made of box cardboard.
10 pieces. - contour cellular packaging (aluminum/PVC) (5) - packs made of box cardboard.
10 pieces. - contour cellular packaging (aluminum/PVC) (6) - packs made of box cardboard.
30 pcs. - bottles (1) - packs of cardboard boxes.
60 pcs. - bottles (1) - packs of cardboard boxes.

pharmachologic effect

Anticonvulsant with analgesic and anxiolytic effects. Pregabalin is a GABA analogue.

It is assumed that the analgesic and anticonvulsant effect is due to the binding of pregabalin to an additional subunit (α 2 -delta protein) of voltage-gated calcium channels in the central nervous system, which leads to irreversible replacement.

Pregabalin reduces the clinical manifestations of generalized anxiety disorder.

Pharmacokinetics

After oral administration on an empty stomach, pregabalin is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is achieved after 1 hour with both single and repeated doses. The oral bioavailability of pregabalin is ≥ 90% and is independent of dose. With repeated use, a steady state is achieved within 24-48 hours. When used after a meal, Cmax is reduced by approximately 25-30%, and the time to reach Cmax increases to approximately 2.5 hours. However, food intake does not have a clinically significant effect on the overall absorption of pregabalin .

The apparent Vd of pregabalin after oral administration is approximately 0.56 L/kg. Pregabalin is not protein bound.

Pregabalin is practically not metabolized. After taking labeled pregabalin, approximately 98% of the radioactive tracer was detected in the urine unchanged. The proportion of N-methylated pregabalin derivative, which is the main metabolite found in urine, was 0.9% of the dose. There was no evidence of racemization of the S-enantiomer of pregabalin into the R-enantiomer.

Pregabalin is excreted mainly unchanged by the kidneys. The average T1/2 is 6.3 hours. Plasma clearance of pregabalin and renal clearance are directly proportional to QC.

The pharmacokinetic parameters of pregabalin at steady state in healthy volunteers, in patients with epilepsy receiving antiepileptic therapy, and in patients receiving it for chronic pain syndromes were similar.

If renal function is impaired, it should be taken into account that the clearance of pregabalin is directly proportional to CC. Pregabalin is effectively removed from plasma by hemodialysis (after a 4-hour hemodialysis session, plasma pregabalin concentrations are reduced by approximately 50%).

The pharmacokinetics of pregabalin in patients with impaired liver function have not been specifically studied. Pregabalin is practically not metabolized and is excreted mainly unchanged in the urine, so impaired liver function should not significantly alter plasma concentrations of the drug.

When prescribing the drug to elderly patients over 65 years of age, it should be taken into account that the clearance of pregabalin tends to decrease with age, which reflects an age-related decrease in CC. Elderly people with impaired renal function may need to reduce the dose of the drug.

Indications

Treatment of neuropathic pain in adults.

Treatment of fibromyalgia in adults.

Epilepsy: As adjunctive therapy in adults with partial seizures with or without secondary generalization.

Treatment of generalized anxiety disorder in adults.

Contraindications

Children and adolescents up to 17 years of age inclusive, hypersensitivity to pregabalin.

Dosage

Taken orally, regardless of food intake, in a daily dose of 150 to 600 mg in 2 or 3 divided doses.

Patients with impaired renal function the dose is selected individually taking into account QC.

U patients with liver dysfunction no dose adjustment is required.

Elderly patients over 65 years of age A dose reduction of pregabalin may be required due to decreased renal function.

If you miss a dose of pregabalin, take the next dose as soon as possible, but do not take the missed dose if it is almost time for the next one.

Side effects

From the mental side: often - euphoria, confusion, decreased libido, irritability, insomnia, disorientation; uncommon - depersonalization, anorgasmia, anxiety, depression, agitation, mood lability, depressed mood, difficulty finding words, hallucinations, unusual dreams, increased libido, panic attacks, apathy, increased insomnia; rarely - disinhibition, high spirits.

From the nervous system: very often - dizziness, drowsiness; often - ataxia, impaired attention, impaired coordination, memory impairment, tremor, dysarthria, paresthesia, imbalance, amnesia, sedation, lethargy; uncommon - cognitive disorders, hypoesthesia, nystagmus, speech impairment, myoclonic convulsions, weakened reflexes, dyskinesia, psychomotor agitation, postural dizziness, hyperesthesia, loss of taste, burning sensation on the mucous membranes and skin, intention tremor, stupor, fainting; rarely - hypokinesia, parosmia, dysgraphia; frequency unknown - headache.

From the senses: often - dizziness, blurred vision, diplopia; uncommon - hyperacusis, narrowing of visual fields, decreased visual acuity, eye pain, asthenopia, dry eyes, swelling of the eyes, increased lacrimation; rarely - flashing sparks before the eyes, eye irritation, mydriasis, oscillopsia (subjective sensation of vibration of the objects in question), impaired perception of depth of vision, loss of peripheral vision, strabismus, increased brightness of visual perception; frequency unknown - keratitis.

From the side of metabolism: often - increased appetite, weight gain; uncommon - anorexia, hypoglycemia; rarely - weight loss.

From the cardiovascular system: infrequently - tachycardia, AV block of the first degree, hot flashes, decreased blood pressure, cold extremities, increased blood pressure; rarely - sinus tachycardia, sinus arrhythmia, sinus bradycardia; frequency unknown - chronic failure, prolongation of the QT interval.

From the respiratory system: uncommon - shortness of breath, cough, dry nasal mucosa, nasopharyngitis; rarely - nasal congestion, nosebleeds, rhinitis, snoring, tightness in the throat; infrequently - pulmonary edema.

From the digestive system: often - dry mouth, constipation, vomiting, flatulence, bloating; uncommon - increased salivation, gastroesophageal reflux, hypoesthesia of the oral mucosa; rarely - ascites, dysphagia, pancreatitis; frequency unknown - swelling of the tongue, nausea, diarrhea.

From the musculoskeletal system: uncommon - muscle twitching, joint swelling, muscle spasms, myalgia, arthralgia, pain in the limbs, muscle stiffness; rarely - spasm of the neck muscles, neck pain, rhabdomyolysis.

From the urinary system: infrequently - dysuria, urinary incontinence; rarely - oliguria, renal failure.

From the reproductive system: often - erectile dysfunction; infrequently - delayed ejaculation, sexual dysfunction; rarely - amenorrhea, pain in the mammary glands, discharge from the mammary glands, dysmenorrhea, enlargement of the mammary glands.

From the hematopoietic system: rarely - neutropenia.

Dermatological reactions: infrequently - skin hyperemia, sweating, papular rash; rarely - cold sweat; frequency unknown - itchy skin, Stevens-Johnson syndrome.

Allergic reactions: rarely - urticaria; frequency unknown - angioedema, hypersensitivity.

From the laboratory parameters: infrequently - increased activity of ALT, AST, CPK, decreased platelet count; rarely - an increase in the level of creatinine in the blood, a decrease in the level of potassium in the blood, a decrease in the number of leukocytes in the blood.

Others: often - fatigue, peripheral edema, feeling of intoxication, gait disturbance; infrequently - asthenia, falls, thirst, chest tightness, generalized edema, chills, pain; rarely - hyperthermia.

Drug interactions

Cases of respiratory failure and coma have been reported when pregabalin was used concomitantly with other CNS depressants.

Pregabalin has also been reported to have a negative effect on the gastrointestinal tract (including the development of intestinal obstruction, paralytic ileus, constipation) when used concomitantly with drugs that cause constipation (such as non-narcotic drugs).

Repeated oral administration of pregabalin with oxycodone, lorazepam, or ethanol did not have a clinically significant effect on breathing. Pregabalin appears to enhance cognitive and motor impairment caused by oxycodone. Pregabalin may enhance the effects of ethanol and lorazepam.

special instructions

Use with caution in case of renal failure or heart failure. Due to isolated isolated cases of uncontrolled use of pregabalin, it should be used with caution in patients with a history of drug dependence (strict medical supervision is required during treatment in such cases).

In patients with diabetes mellitus, in case of weight gain during treatment with pregabalin, dosage adjustment of hypoglycemic drugs may be required.

Pregabalin should be discontinued if symptoms of angioedema (such as facial swelling, perioral edema or upper respiratory tract swelling) develop.

Pregabalin, like other anticonvulsants, may increase the risk of suicidal thoughts or behavior. Therefore, during the treatment period, patients require careful medical monitoring for the emergence or worsening of depression, the emergence of suicidal thoughts or behavior.

Pregabalin treatment has been associated with dizziness and drowsiness, which increase the risk of accidental injury (falls) in older adults. Cases of loss of consciousness, confusion and cognitive impairment have also been reported during post-marketing use. Therefore, until patients appreciate the possible effects of pregabalin, they should exercise caution.

Data on the possibility of discontinuing other anticonvulsants when seizures are suppressed with pregabalin and the advisability of pregabalin monotherapy are insufficient. There are reports of the development of seizures, incl. status epilepticus and minor seizures, during the use of pregabalin or immediately after the end of therapy.

There have also been cases of renal failure; in some cases, renal function was restored after discontinuation of pregabalin.

The following adverse events have been observed following discontinuation of pregabalin after long-term or short-term therapy: insomnia, headache, nausea, diarrhea, flu-like syndrome, depression, sweating, dizziness, convulsions and anxiety. There is no information on the frequency and severity of manifestations of pregabalin withdrawal syndrome depending on the duration of therapy with the latter and its dose.

During post-marketing use of pregabalin, the development of chronic heart failure during pregabalin therapy has been reported, primarily in elderly patients with impaired cardiac function and receiving the drug for neuropathy. Therefore, pregabalin should be used with caution in this category of patients. After discontinuation of pregabalin, the manifestations of such reactions may disappear.

The incidence of central nervous system adverse reactions, especially drowsiness, increases with the treatment of central neuropathic pain due to spinal cord lesions, which, however, may be due to the additive effects of pregabalin and other concomitantly administered drugs (eg, antispastic agents). This circumstance should be taken into account when prescribing pregabalin for this indication.

There are reports of cases of dependence developing with the use of pregabalin. Patients with a history of drug dependence require close medical monitoring for symptoms of pregabalin dependence.

Cases of encephalopathy have been reported, especially in patients with concomitant diseases that may lead to the development of encephalopathy.

Impact on the ability to drive vehicles and operate machinery

Pregabalin may cause dizziness and drowsiness and, accordingly, affect the ability to drive vehicles and use complex equipment. Patients should not drive vehicles, use complex machinery, or engage in other potentially hazardous activities until their individual response to pregabalin has been established.

Pregnancy and lactation

There have been no adequate, strictly controlled studies of the safety of pregabalin during pregnancy. When using pregabalin, women of reproductive age should use adequate methods of contraception.

It is unknown whether pregabalin is excreted into breast milk in humans. If it is necessary to use pregabalin during lactation, the issue of stopping breastfeeding should be decided.

IN experimental studies In animals, pregabalin had a toxic effect on reproductive function. It has been established that pregabalin is excreted in breast milk in rats.

Pregabalin is an antiepileptic drug.

Release form and composition

Dosage form of Pregabalin – capsules:

• 25 mg each: gelatin, hard, size No. 4, with a body from white with a yellowish tint to white or almost white and a lid from dark green to green, inside filled with white or almost white compacted powder mass or powder;
• 75 mg each: gelatin, hard, size No. 4, with a body from white with a yellowish tint to white or almost white and a blue cap, inside filled with white or almost white compacted powder mass or powder;
• 100 mg each: gelatin, hard, size No. 4, with a body and cap from white with a yellowish tint to white or almost white, inside filled with white or almost white compacted powder mass or powder;
• 150 mg each: gelatin, hard, size No. 2, with a body and cap from white with a yellowish tint to white or almost white, filled inside with white or almost white compacted powder mass or powder;
• 300 mg each: gelatin, hard, size No. 0, with a body and cap from white with a yellowish tint to white or almost white, filled inside with white or almost white compacted powder mass or powder.

Capsules are produced in blister packs of 10 pieces, in jars or bottles of 30 or 60 pieces; 1, 2, 3, 4, 5 or 6 packages, 1 jar or 1 bottle are placed in a cardboard box.

Composition of Pregabalin (capsules 25/75/100/150/300 mg, respectively):

• active substance: pregabalin – 25/75/100/150/300 mg;
• auxiliary components: magnesium stearate – 0.5/0.5/0.5/0.9/1.8 mg; talc – 1.6/1.6/1.6/2.95/5.9 mg; colloidal silicon dioxide – 3.3/3.3/3.3/5.9/11.8 mg; potato starch – 9.95/4.93/2.42/7.565/15.13 mg; calcium carbonate – 89.55/44.37/21.78/68.085/136.17 mg; sodium lauryl sulfate – 0.1/0.3/0.4/0.6/1.2 mg;
• cap: gelatin – up to 100%; titanium dioxide – 1% (capsules of 25 or 75 mg) or 2% (capsules of 100, 150 or 300 mg); 25 mg capsules – yellow oxide jelly dye – 1.7143%, indigo carmine – 0.3%; 75 mg capsules – indigo carmine – 0.1333%;
• body: gelatin – up to 100%, titanium dioxide – 2%.

Indications for use

• fibromyalgia;
• generalized anxiety disorder;
• neuropathic pain;
• epilepsy in patients with partial seizures, with or without secondary generalization (as an additional treatment).

Contraindications

• age under 17 years;
• breastfeeding period;
• individual intolerance to the components in Pregabalin.

Conditions/diseases for which the drug is prescribed with caution:

• renal and heart failure;
• history of drug dependence;
• elderly age;
• pregnancy.

Pregabalin: instructions for use (method and dosage)

Pregabalin capsules are taken orally, regardless of food.

Usually prescribed from 0.15 to 0.6 g of the drug per day, divided into 2 or 3 doses.

• neuropathic pain: initial dose – 0.15 g per day; after 3–7 days, the dose can be increased by 2 times, depending on the effect achieved; in the future, if necessary, after 7 days it can be increased to a maximum daily value of 0.6 g;
• epilepsy: initial dose – 0.15 g per day; after 7 days, the dose can be increased by 2 times depending on the effect achieved; in the future, if necessary, after another 7 days it can be increased to a maximum daily value of 0.6 g;
• fibromyalgia: initial dose – 0.075 g 2 times a day; after 7 days, the dose can be increased by 2 times - depending on the effect achieved; in the absence of a therapeutic effect, it can be increased to 0.225 g 2 times a day, and after 7 days, if necessary, it can be increased to a maximum daily dose of 0.6 g; It is important to take into account that the maximum dose does not provide additional benefits and is less well tolerated;
• generalized anxiety disorder: initial dose – 0.15 g per day; after 7 days, the dose can be increased by 2 times - depending on the effect achieved; in the absence of a therapeutic effect, after 7 days it can be increased to 0.45 g per day, and after another 7 days, if necessary, it can be increased to a maximum daily dose of 0.6 g.

It is important to regularly evaluate the need for continued treatment.

If renal function is impaired, the dose of Pregabalin is set individually depending on CC (creatinine clearance) according to the formula:

CC (ml per 1 min) = x weight (kg) / 72 x serum creatinine (mg per 1 dl) (x 0.85 for women)

The daily dose for patients on hemodialysis is selected taking into account renal function. After a hemodialysis session lasting 4 hours, the concentrations of pregabalin in the blood plasma are reduced by approximately 2 times. Immediately after each hemodialysis session lasting 4 hours, an additional dose of Pregabalin is prescribed - from 0.025 to 0.1 g once.

Side effects

• infections and infestations: often – nasopharyngitis;
• blood and lymphatic system: uncommon – neutropenia;
• metabolism and nutrition: often – increased appetite; uncommon – hypoglycemia, anorexia;
• psyche: often - apathy, panic attack, decreased libido, disorientation, depression, irritability, insomnia, confusion, state of euphoria; uncommon – increased insomnia, anorgasmia, increased libido, difficulty finding words, depersonalization, disturbing dreams, aggressiveness, mood swings, anxious arousal, restlessness, hallucinations; rarely – disinhibition;
• neurological disorders: very often – headache, drowsiness, dizziness; often - ageusia, lethargy, imbalance, sedation, hypoesthesia, paresthesia, impaired attention, memory impairment, amnesia, dysarthria, tremor, loss of coordination, ataxia; uncommon – cognitive impairment, loss of consciousness, hyperesthesia, burning sensation on the skin and mucous membranes, decreased reflexes, speech impairment, nystagmus, intention tremor, orthostatic dizziness, dyskinesia, psychomotor agitation, myoclonus, fainting; rarely – convulsions, dysgraphia, hypokinesia, parosmia, pathological numbness;
• organ of vision: often – diplopia, blurred vision; uncommon – irritation of the mucous membrane of the eyes, increased lacrimation, dry eye syndrome, photopsia, asthenopia, eye pain, visual field defect, swelling of the eye, blurred vision, loss of peripheral vision; rarely – loss of vision, keratitis, increased brightness of visual perception, strabismus, mydriasis, change in the depth of visual perception, oscillopsia;
• organ of hearing and vestibular apparatus: often – vertigo; infrequently – hyperacusis;
• cardiovascular system: uncommon – chronic heart failure, sinus bradycardia, first degree atrioventricular block, tachycardia; rarely - prolongation of the QT interval, sinus arrhythmia, tachycardia;
• vessels: infrequently - cold extremities, hot flashes, skin flushing, hypertension, hypotension;
• respiratory system: often – dry nasal mucosa; infrequently - snoring, rhinitis, nasal congestion, cough, nosebleeds, shortness of breath; rarely - pulmonary edema, tightness in the throat;
• digestive system: often - diarrhea, nausea, dry mouth, bloating, flatulence, constipation, vomiting; uncommon – decreased sensitivity of the oral mucosa, hypersecretion of the salivary glands, gastroesophageal reflux; rarely - swelling of the tongue, dysphagia, pancreatitis, ascites;
• skin and subcutaneous tissues: uncommon – itching, facial swelling, increased sweating, urticaria, papular rash; rarely - cold sweat, Stevens-Johnson syndrome;
• musculoskeletal system: often – muscle spasm of the cervical spine, pain in the limbs, back, arthralgia, muscle cramps; uncommon – muscle stiffness, neck pain, muscle cramps, myalgia, joint swelling; rarely - rhabdomyolysis;
• urinary system: infrequently – dysuria, urinary incontinence; often – urinary retention, oliguria, renal failure;
• reproductive system: often – erectile dysfunction, pain in the mammary glands; uncommon – breast enlargement, mammary discharge, amenorrhea, dysmenorrhea, delayed ejaculation, sexual dysfunction; rarely - gynecomastia;
• general disorders and disorders at the injection site: often - fatigue, poor health, feeling of intoxication, falling, gait disturbance, peripheral edema; uncommon – malaise, general weakness, chills, thirst, fever, pain, chest tightness, generalized edema;
• laboratory and instrumental data: often - increased creatinine concentration in the blood, increased body weight; infrequently - loss of body weight, decrease in potassium content in the blood, decrease in platelet count, increase in blood glucose concentration, increase in the activity of aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase; rarely – a decrease in the number of leukocytes in the blood;
• immune system: uncommon – hypersensitivity reactions; rarely - allergic reactions, angioedema.

Overdose

Main symptoms: anxiety, agitation, depression, confusion, drowsiness, affective disorders; in rare cases - coma.

Therapy: gastric lavage, supportive treatment and hemodialysis (if necessary).

special instructions

If patients with diabetes mellitus experience weight gain while taking Pregabalin, dose adjustment of hypoglycemic agents may be required.

With the development of facial edema, perioral edema or swelling of the tissues of the upper respiratory tract (symptoms of angioedema), discontinuation of the drug is necessary.

Taking Pregabalin may increase the risk of suicidal behavior or thoughts. In this regard, during the period of therapy, careful monitoring of the patient is necessary for the development or worsening of depression, the emergence of suicidal behavior or thoughts.

When combined with pregabalin and opioids, it is recommended to take measures to prevent the development of constipation, especially in women and elderly patients.

While using the drug or immediately after stopping it, seizures may develop, including status epilepticus and petit mal seizures.

In clinical studies, blurred vision was observed in patients chronically receiving Pregabalin. This side effect ceased as therapy continued. Changes in the fundus of the eye, decreased acuity, and changes in visual fields were also found in patients undergoing an ophthalmological examination. Despite the fact that the clinical significance of these disorders has not been established, the doctor should be informed of changes in vision during treatment with the drug. If symptoms of visual impairment persist, medical observation is continued. Patients who are already seen regularly by an ophthalmologist should have more frequent eye exams. In cases where blurred vision, loss of vision, or other visual disturbances occur in response to pregabalin, discontinuation of pregabalin may resolve these symptoms.

During the period of taking the capsules, renal failure may develop; after discontinuation of therapy, in some cases, organ function was restored.

After discontinuation of Pregabalin, the following effects may develop: anxiety, convulsions, dizziness, sweating, depression, flu-like syndrome, diarrhea, nausea, headache, insomnia. There may be a relationship between the frequency of development and severity of withdrawal symptoms with the dose taken.

There are no data on the activity of pregabalin in relation to the receptors responsible for the development of drug abuse in patients. Post-registration studies have revealed cases of drug abuse and violation of the recommended dosage regimen. A careful assessment of the patient's medical history for possible drug abuse and medical monitoring are recommended.

In some patients, the development of chronic heart failure was detected during post-registration use of Pregabalin. There was no association between peripheral edema and cardiovascular complications such as increased blood pressure or chronic heart failure in patients without clinically significant signs of heart or vascular disease. These reactions were mainly found in elderly patients with impaired cardiac function who were receiving the drug for neuropathy. After discontinuation of therapy, such reactions may disappear.

The incidence of side effects from the central nervous system, especially drowsiness, increases when treating central neuropathic pain caused by spinal cord damage. It is assumed that this may be a consequence of the summation of the effects of pregabalin and other drugs taken in parallel. It is important to take these data into account when prescribing the drug for the indicated indication.

Use during pregnancy and lactation

Pregabalin is contraindicated during lactation. During pregnancy, its use is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Use in childhood

As indicated in the instructions, Pregabalin is contraindicated in children and adolescents under the age of 17 years, since the safety and effectiveness of its use in patients of this age group have not been established.

For impaired renal function

Pregabalin is prescribed with caution in patients with renal failure.

Use in old age

Elderly patients with impaired renal function may require a reduction in the dose of Pregabalin.

Drug interactions

When pregabalin is used in combination with other drugs that depress the central nervous system, breathing problems and coma may occur; with ethanol or lorazepam – enhancing their effects; with oxycodone – increased impairment of cognitive and motor functions; with drugs that cause constipation (opioids) - a negative effect on the activity of the gastrointestinal tract, including paralytic ileus, intestinal obstruction and constipation.

Analogs

Analogues of Pregabalin are Replica, Prigabilon, Pregabalin-SZ, Pregabalin-Richter, Prabegin, Lyrica, Algerica.

Terms and conditions of storage

Store in a place protected from light and moisture, at temperatures up to 25 °C. Keep away from children.

Shelf life – 3 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Price for Pregabalin in pharmacies

The price of Pregabalin is unknown, since the drug is not available in pharmacies. Group analogues are available: Algerica capsules 300 mg (14 pieces per package) – 750 rubles, 75 mg capsules (14 pieces per package) – 437 rubles; Lyrica capsules 150 mg (14 or 56 pieces per package) - 630 or 2510 rubles, respectively, 25 mg (14 pieces per package) - 210 rubles, 300 mg (14 pieces per package) - 1051 rubles, according to 75 mg (14 pcs.) – 615 rubles.

Pregabalin is an anticonvulsant drug that is used as adjunctive therapy for partial seizures with secondary generalization and neuropathic pain. This drug also helps in the treatment of generalized anxiety disorders. The drug was developed as a more powerful replacement for Gebapentin.

Pregabalin is used in the treatment of:

• diabetic peripheral neuropathy;
• epilepsy;
• postherpetic neuralgia;
• fibromyalgia.

The drug also gives a good effect in the treatment of chronic pain that accompanies damage to the musculoskeletal system, as well. In America Pregabalin classified as a schedule V drug.

In a similar article we already looked at the list.

Instructions for use

Before starting to take the drug, you should consult with doctor, and also carefully study the instructions for use of the drug.

According to the instructions, the medicine should be used for the following purposes:

• treatment of epileptic seizures;
• neuropathic pain treatment nature, which is a consequence of neuronal excitation (but not a reaction to mechanical stimuli or damage);
• for the treatment of chronic pain of the musculoskeletal system;
• effective in treatment anxiety disorders and obsessive-compulsive disorders, the main feature of which is an inexplicable feeling of anxiety that has no connection with life situations.

Contraindications

Like any other drug, Pregabalin has a number of contraindications:

• you should not use the drug people with intolerance to any of the components of the drug;
• medicine is strictly prohibited o taken by people with Sami lactase deficiency and those who suffer from lactose intolerance;
• the drug is possible use from the age of seventeen;
• for people with disabilities the absorption of galactose or glucose may cause the drug to be dangerous;
• people with kidney failure and those suffering from liver diseases can use the medicine only after a doctor’s prescription and be extremely attentive to the instructions.

Dosage of the drug

The dosage is prescribed by the doctor depending on the severity of the disease, as well as concomitant illness:

• For neuropathic pain The initial dose of the drug is 150 mg per day. After 3-7 days, depending on the result achieved, the daily dose is increased to 300 mg, and after another week (if necessary), to 600 mg per day.
• Daily dose of the drug for fibromyalgia is 300-600 mg.
• Patients over 60 years old It is worth reducing the dose, since kidney function decreases with age.
• For epilepsy, the drug is taken 2-3 times a day, regardless of meal time. The initial dose is 150 mg per day. After 3-7 days it increases to 300 mg per day. After another week, up to 600 mg per day.

If you miss the time to take the drug, you should take the next dose of the drug as quickly as possible, and the sooner this happens, the better. It is worth noting that increasing the dose of Pregabalin without consulting a doctor is unacceptable. Starting from the next day, the standard regimen of using the drug should be restored.

Overdose

In case of drug overdose the following are observed:

• disorders affective nature;
• depressive condition. Read about it here.
• feeling constant drowsiness and fatigue;
• dizziness;
• increased anxiety.

No more serious symptoms of side effects were recorded.

Side effects

Side effects from the use of the drug are extremely rare and appear mild.

These include:

special instructions

The instructions for Pregabalin contain a number of special instructions that you should read before starting use:

• People suffering from diabetes you need to adjust the daily dosage of the drug, as there is a risk of weight gain
• Since the drug sometimes causes excessive drowsiness and dizziness, you should not leave elderly people unattended, as loss of consciousness is possible.
• When swelling of the respiratory tract occurs pathways or person should immediately stop taking the drug, as these symptoms may indicate intolerance to the drug.
• If your vision has deteriorated, you should contact see your doctor to review your daily dosage of the drug
• Pregabalin and alcohol are incompatible, Therefore, drinking any alcoholic beverages during treatment is strictly prohibited, as this can lead to serious consequences.

Interaction with other drugs

The drug can be taken in parallel with almost all types of medications. Side effects observed with simultaneous use of Pregabalin and drugs that have a depressant effect on the central nervous system.

Treatment with Pregabalin during pregnancy and lactation

During pregnancy, the use of Pregabalin is allowed only after a doctor's prescription. During breastfeeding, the use of the medicine is strictly prohibited.

Price

The drug is available in capsule form. average price 75mg capsules is approximately 500 rubles.

Price 150 mg capsules from 2 to 3 thousand rubles .

Latin name: Pregabalin Richter
ATX code: N03A X16
Active substance: pregabalin
Manufacturer: Gedeon Richter (Hungary)
Dispensing from the pharmacy: on prescription
Storage conditions: at temperatures below 25°C
Best before date: 3 years.

Pregabalin Richter is an anticonvulsant drug in capsules. Used in adult patients for:

• Therapy for neuropathic pain syndrome
• As a means of combined treatment of patients suffering from epilepsy with concomitant seizures (may or may not have secondary generalization)
• Generalized form of anxiety disorder
• Fibromyalgia.

Composition and release forms

The drug Pregabalin-Richter is produced in the form of capsules with different contents of the active ingredient.

• Active: 25 mg/50 mg/75 mg/100 mg/150 mg/200 mg/300 mg pregabalin
• Auxiliary ingredients: lactose in the form of monohydrate, corn starch (pregelled and regular), talc.

Composition of capsule body and lid components:

• Drugs 25 mg, 50 mg, 75 mg: cap – gelatin, E 171, E 172 (yellow, red, black), body – gelatin, E 171, E 104, E 110
• LS 100 mg: cap – gelatin, E 171, E 172 (yellow, red, black), body – gelatin, E 171, E104, E 110
• LS 150 mg: gelatin, E 171, E 172 (yellow, red and black)
• LS 200 mg: cap – gelatin, E 172 (red, black), body – E 171, E 104, E 110
• Drug 300 mg: gelatin, E 172 (red and black).

Medicines in the form of gelatin capsules. Filling: crystalline white or almost white powder. The color and size of the pills are different:

• Caps. 25 mg (size no. 4): yellow
• Caps. 50 mg (size #3): pale brown cap, yellow body
• Caps. 75 mg (size no. 4): pale brown
• Caps. 100 mg (size no. 3): brown cap, yellow body
• Caps. 150 mg (size No. 2): brown
• Caps. 200 mg (size no. 1): dark brown cap, yellow body
• Caps. 300 mg (size no. 0): dark brown.

The drug is packaged in blisters of 14 pieces. In a cardboard package - 1 or 4 plates, description and instructions.

Medicinal properties

The anticonvulsant effect of Pregabalin Richter is ensured by the properties of its main component - pregabalin, a synthetic substitute for γ-aminobutyric acid.

It is known that in the body the component binds to certain subunits of calcium channels in the central nervous system, irreversibly replacing gabapentin. It is believed that analgesic and anticonvulsant effects are achieved through this mechanism.

After oral administration, the substance is absorbed at a high rate. The effect appears especially quickly if the medicine was taken on an empty stomach. Bioavailability is about 90%, regardless of the dosage. Maximum concentrations are achieved after repeated administration - after 1-2 days.

Pregabalin is almost not metabolized. As experiments with the labeled substance showed, it was found unchanged in the patient’s urine.

The substance is excreted from the body by the kidneys. The average half-life is almost 6.5 hours.

Directions for use and dosage

Pregabalin Richter capsules can be taken according to the instructions for use, regardless of meals. Dosage and duration of administration are determined individually. Manufacturers' recommended daily allowance (DV) is 150-600 mg, divided into 2-3 doses.

• Elimination of neuropathic pain: at the beginning of the course – 150 mg per day. After 3-7 days of administration, based on the results of tolerability and therapeutic effect, SN can be increased to 300 mg, and if necessary, after a week, increase to a daily maximum of 600 mg.
• Treatment of epilepsy: at the beginning - 150 mg per day, after 1 week it can be increased to 300 mg, if necessary, the dose is increased to the maximum (600 mg).
• For fibromyalgia: 75 mg x 2 times a day. If indicated, the dosage is increased in the same way.
• For generalized anxiety disorder: at the beginning – 150 mg per day. SN is increased once a week according to the same scheme as in the treatment of fibromyalgia.

Discontinuation of Pregabalin Richter is carried out with a gradual reduction in the dose over several weeks (at least one) so as not to provoke a shock reaction in the body.

During pregnancy and breastfeeding

There is not yet enough information about the specific effects of Pregabalin-Richter on the course of pregnancy. Preliminary animal studies have shown that the active substance has reproductive toxicity. For this reason, the drug can be prescribed only in serious cases, when the benefit to the woman outweighs the risk of complications for the unborn child.

There is no data yet whether pregabalin passes into human milk. But preliminary experiments on laboratory rats recorded its presence in the animals’ milk. Therefore, in order not to expose the child to unnecessary risk, breastfeeding women are advised to stop lactation during therapy.

Contraindications and precautions

Price: 75 mg (14 pcs.) – 476 rubles, (56 pcs.) – 1573 rubles. 150 mg (14 pcs.) – 495 rub., (56 pcs.) – 1917 rub. 300 mg (14 pcs.) – 784 rub., (56 pcs.) – 2978 rub.

Pregabalin-Richter is prohibited for use when:

• Individual hypersensitivity to the contained components
• Congenital galactose intolerance, lactase deficiency, GG malabsorption syndrome
• Rare hereditary pathologies
• Age up to 17 years.

Relative contraindications

• Heart and/or renal failure
• History of drug dependence.

Cross-drug interactions

Since the active substance is excreted from the body in unchanged form, is practically not metabolized and does not suppress the metabolic processes of other active components of the drug, then most likely it does not react with other medications.

When combined in one treatment regimen with Phenytoin, Carbamazepine, Porazepaomo, ethanol, and oral contraceptives, no clinically significant pharmacokinetic reactions are observed.

When Pregabalin Richter was combined with drugs that suppress the central nervous system, patients experienced depression of respiratory activity followed by coma.

There is information about the negative impact of the drug on the functions of the gastrointestinal tract, which manifested itself as intestinal obstruction, constipation, ileus, etc.) when combined with medications that cause difficulty in bowel movement (for example, non-narcotic painkillers).

There are suggestions that pregabalin, when combined with Oxycodone, may enhance its inhibitory effect on motor and cognitive functions.

During therapy with Pregabalin Richter, you should refrain from drinking alcohol and ethanol-containing medications, as the medicine can enhance the inhibitory effect of alcohol on the central nervous system.

Side effects and overdose

Undesirable effects accompanying Pregabalin therapy most often manifest themselves in the form of daytime drowsiness and dizziness of varying degrees of intensity. Side effects of the drug, the appearance of which requires discontinuation of therapy - ataxia, confusion, absent-mindedness, attention disorder, deterioration in visual clarity, uncoordinated movements, peripheral edema, asthenic state.

In addition to these, during treatment the patient may experience other negative reactions from various internal organs:

• Circulatory system: neutropenia
• Immune system: Quincke's edema, individual manifestations of allergies
• Metabolism: increased appetite, hypoglycemia, anorexia
• NS: euphoria, confusion, increased irritability, libido disorder, loss of orientation, hallucinations, irritability, aggressiveness, depressed state, mood lability, panic attacks, self-perception disorder, speech disorder, strange dreams, increased libido, convulsions, extrapyramidal effects, mania , paranoia, insomnia.
• Visual organs: decreased vision clarity, double vision, tunnel vision, swelling or dry eyes, photophobia, increased lacrimation, blindness, keratitis, visual spatial perception disorder, blepharitis, hemorrhage in the eye, corneal ulceration, optic neuropathy, miosis, ptosis, conjunctivitis , strabismus.
• Hearing organs: vertigo, distorted perception of sounds
• CVS: tachycardia, stage 1 block, sinus tachy- or bradycardia, CHF, prolongation of the QT interval, arterial hypo- or hypertension, hot flashes, coldness in the extremities, rarely – facial flushing
• Respiratory system: apnea, dry mouth, nosebleeds, cough, runny nose, snoring, discomfort in the throat, pulmonary edema/fibrosis, hiccups, laryngospasm, atelectasis
• From the digestive system: nausea, vomiting, constipation/diarrhea, flatulence, dry mouth, heartburn, drooling, ascites, swelling of the tongue, bleeding in the gastrointestinal tract, stomatitis, ulceration of the esophagus
• Skin and subcutaneous tissue: rash, itching, urticaria, increased sweating, cold sweat, bedsores, hair loss, Stevens-Johnson syndrome, eczema, excessive hair growth, exfoliative dermatitis, nail damage, purpura, dermal atrophy, tissue necrosis
• Locomotor system: muscle spasms, joint spasms, back/limb/neck pain, joint swelling, muscle tics, muscle rigidity, myalgia
• Genitourinary system: incontinence, renal dysfunction, difficulty urinating, hematuria, nephritis, stone formation, albuminuria, oliguria
• Reproductive system: erectile dysfunction, ejaculation disorder, breast pain, breast enlargement, nipple discharge, dysmenorrhea, gynecomastia, menorrhagia, impotence
• Other: swelling of the limbs, gait disorder, feeling of intoxication, rapid fatigue, facial swelling, chest pressure, fever, sensitivity to light, thirst, asthenia
• Laboratory tests: most often - weight gain, in some cases - an increase in the activity of liver enzymes, a decrease in the number of platelets, rarely - an increase in glycemia, a decrease in the number of potassium, leukocytes, etc.

Withdrawal syndrome after incorrect cessation of therapy manifested itself in the form of sleep disturbances, headaches, increased anxiety, flu-like state, convulsions, depression, severe sweating, dizziness, and nausea. If these or other negative phenomena develop, you should definitely contact your doctor.

The use of high dosages may provoke increased adverse reactions. Most often, the consequences of overloading the body with pregabalin are: affectation, severe drowsiness, confusion, depressive states, agitation, and increased anxiety. In rare cases, a coma may occur.

Therapy: measures to cleanse the body of drug residues (gastric lavage, etc.), if necessary, maintenance therapy, hemodialysis.

Analogs

Synonyms: Algerica, Briviac, Vimpat, Gabagamma, Gabapentin, Zonegran, Catena, Keppra, Convalis, Lamictal, Lamolep, Lamotrigine Canon, Levetinol, Levetiracetam, Lyrica, Neurontin, Pagluferal, Pregabalin, Sezar, Tebantin, Topalepsin, Topamax, Topiramate, Topsaver , Toreal, Faikompa, Epiterra, Epitropil.

Torrent Pharmaceuticals (India)

Price:

tab. 25 mg (30 pcs.) – 216 rub., (50 pcs.) – 342 rub.,

50 mg (30 pcs.) – 355 rub., (50 pcs.) – 510 rub.,

100 mg (30 pcs.) – 533 rub., (50 pcs.) – 802 rub.

Antiepileptic drugs based on lamotrigine. The medicine is used in adults and children over 12 years of age for the treatment of various types of convulsive seizures, typical and atypical absence seizures.

The drug is produced in tablets with different dosages. The dosage regimen and duration of therapy are determined individually.

Pros:

• Prevents seizures
• Helps eliminate generalized seizures.

Minuses:

• Not always available in pharmacies
• Muscle contractions.