Neurontin - instructions for use, dose, side effects, contraindications

Dosage 600 mg: white, elliptical-shaped tablets, film-coated, engraved "NT" and "16", risk between engraving on one side and risk on the other side.

Dosage 800 mg: White, elliptical-shaped tablets, film-coated, with gwork "NT" and "26", risk between engraving on one side and risk on the other side.

Pharmacotherapeutic group:Antiepileptic remedy

ATX: & nbsp

N.03.A.X.12 Gabapentin

Pharmacodynamics:

Mechanism of action

Gabapentin easily penetrates the brain tissue and prevents the development of seizures in various animal models of epilepsy. Gabapentin does not have an affinity for receptors GABA_A (gamma-aminobutyric acid) and GABA_AT and does not affect the metabolism of GABA. Gabapentin does not bind to the receptors of other neurotransmitters present in the brain and does not affect the sodium channels.

Gabapentin has a high affinity and binds to the α-2-δ (alpha-2-delta) subunit of the potential-dependent calcium channels,that the connection of gabapentin with the α-2-δ subunit is involved in the mechanism of anticonvulsant effect in animals. In screening a large group of target molecules for this drug, it has been shown that the only target for it is the α2δ subunit.

The results obtained in several preclinical models show that the pharmacological activity of gabapentin can be realized by binding to the α2δ subunit by inhibiting the release of excitatory neurotransmitters in certain regions of the central nervous system. Such activity may underlie the anticonvulsant effect of gabapentin. The importance of these mechanisms of action of gabapentin for its anticonvulsant effects in humans still need to be established.

The effectiveness of gabapentin is also shown in several preclinical studies in animal models of pain syndrome. It is suggested that the specific binding of gabapentin to the α2δ subunit leads to several different effects that may be responsible for the analgesic effect in animal models. An analgesic effect of gabapentin can occur at the level of the spinal cord,and also at the level of higher think tanks through interactions with downstream ways that suppress the transmission of painful impulses. The significance of these properties of gabapentin, revealed in preclinical studies, is unknown.

Clinical efficacy and safety

In the clinical study of adjuvant therapy of partial seizures in children aged 3 to 12 years, there were quantitative but statistically unreliable differences in the incidence of seizures by more than 50% in the gabapentin group compared with the placebo group. Additional analysis of the frequency of response to therapy depending on age (when considering age as a continuous variable or in the allocation of two age subgroups: 3-5 years and 6 to 12 years) did not reveal a statistically significant effect of age on the effectiveness of therapy.

The results of this additional analysis are presented in the table below.

Response (≥ 50% reduction in seizure frequency) depending on treatment and age, population MITT*
Age group	Placebo	Gabapentin	P-value
<6 years	4/21	4/17	0,7362
	(19,0%)	(23,5%)
6-12 years old	17/99	20/96	0,5144
	(17,2%)	(20,8%)

* Modified population "intentionally treated" (MITT) was defined as the aggregate of all patients randomized to the study group and who had the diabetic seizure diaries to be evaluated over a 28-day period within the baseline and double-blind phases of the study.

Pharmacokinetics:

Suction

After oral administration, the maximum concentration of gabapentin in plasma is reached within 2 to 3 hours. The bioavailability of gabapentin tends to decrease with increasing dose of the drug. Absolute bioavailability when taking 300 mg capsules is approximately 60%. Food, including high-fat, does not have a clinically significant effect on the pharmacokinetics of gabapentin.

The pharmacokinetics of gabapentin does not change with repeated administration of the drug. Although the clinical concentration of gabapentin in the plasma usually ranged from 2-20 μg / ml, it did not predict the efficacy or safety of the drug. Parameters of pharmacokinetics are presented in the table.

Table. Aggregate averages (CV,%) parameters of pharmacokinetics of gabapentin in the equilibrium state with repeated administration with a dosing interval of eight hours

Parameter pharmacokinetics	300 mg (N = 7)		400 mg (N= 14)		800 mg (N = 14)
	Average	% CV	Average	% CV	Average	% CV
FROM_m_Oh (μg / ml)	4,02	(24)	5,74	(38)	8,71	(29)
T_m_Oh (h)	2,7	(18)	2,1	(54)	1,6	(76)
T_1/2(h)	5,2	(12)	10,8	(89)	10,6	(41)
AUC (0-8) (μg * h / ml)	24,8	(24)	34,5	(34)	51,4	(27)
Ae% (%)	Data no	Data no	47,2	(25)	34,4	(37)
FROM_m_Oh ^- the maximum concentration in the plasma in the equilibrium state, t_max - time to reach FROM_m_Oh T_1/2- half-life. AUC(0-8) - area under the curve "concentration-time" in the equilibrium state in the period from 0 to 8 hours after taking the drug. Ae% - the proportion of the drug, eliminated with urine unchanged for a period of 0 to 8 hours after taking the drug, as a percentage of the dose.

Distribution

Gabapentin does not bind to plasma proteins, and its volume of distribution is 57.7 liters. In patients with epilepsy, the concentration of gabapentin in the cerebrospinal fluid (CSF) is approximately 20% of the minimum equilibrium plasma concentration. Gabapentin penetrates the breast milk of women breastfeeding.

Biotransformation

There are no data on the metabolism of gabapentin in the human body. Gabapentin does not cause induction of nonspecific liver oxidases responsible for the metabolism of drugs. Excretion

Gabapentin is excreted unchanged only by renal excretion.The half-life of gabapentin does not depend on the dose taken and is on average 5 to 7 hours.

In elderly patients and patients with impaired renal function, clearance of gabapentin from plasma decreases. The elimination constant, plasma clearance and renal clearance of gabapentin are directly proportional to the creatinine clearance.

Gabapentin is removed from the plasma during hemodialysis. Patients with impaired renal function or who are on hemodialysis are recommended to adjust the dose of the drug (see section "Method of administration and dose").

The pharmacokinetics of gabapentin in children was studied in 50 healthy volunteers aged 1 month to 12 years. In general, the concentration of gabapentin in the plasma of children older than 5 years is similar to that of adults when the drug is administered in an equivalent dose based on the calculation of mg / kg of body weight.

In the study of pharmacokinetics in 24 healthy children aged 1 to 48 months, exposure parameters of the drug (AUC) were about 30% lower, C_mOh - lower, and the clearance is higher when calculated per unit body weight in comparison with the available published data on the kinetics of the drug in children over the age of 5 years.

Linearity / non-linearity of pharmacokinetics parameters

The bioavailability of gabapentin decreases with increasing dose, which leads to a nonlinearity of the pharmacokinetics parameters, which include the bioavailability index (F), for example Ae2, CL/F, Vd/F. Pharmacokinetics of elimination (parameter parameters, not including F, such as CLr and T_1/2) is better described by a linear model. Equilibrium concentrations of gabapentin in plasma are predictable based on kinetics data for a single dose.

Indications:

Epilepsy

Monotherapy of partial seizures with secondary generalization and without it in adults and children aged 12 years and older. The efficacy and safety of monotherapy in children under the age of 12 years are not established.

As an additional tool in the treatment of partial seizures with secondary generalization and without it in adults and children aged 3 years and older. The safety and efficacy of additional therapy with gabapentin in children less than 3 years of age have not been established.

Neuropathic pain

Treatment of neuropathic pain in adults aged 18 years and older. Efficacy and safety in patients under the age of 18 years are not established.

Contraindications:

Hypersensitivity to gabapentin or auxiliary components of the drug.

Epilepsy

Use as a monotherapy of partial seizures with secondary generalization and without it in children under 12 years of age.

Use as an additional agent in the treatment of partial seizures with secondary generalization and without it in children under 3 years.

Neuropathic pain

For the treatment of neuropathic pain in children and adolescents under the age of 18.

Carefully:

Renal failure (see section "Method of administration and dose").

Pregnancy and lactation:

Pregnancy

There are no data on the use of the drug in pregnant women.

The general risk associated with epilepsy and antiepileptic drugs

The risk of the birth of children with congenital anomalies in mothers who are treated with anticonvulsants is increased by 2-3 times. The cleft of the upper lip and palate, the developmental defects of the cardiovascular system and neural tube defects are most often observed. In this case, taking several anticonvulsants can be associated with a greater risk of malformations than in the case of monotherapy. Therefore, if possible, one of the anticonvulsants should be used.

Women of childbearing age, as well as all women who may have pregnancy, should consult a qualified specialist. If a woman is planning a pregnancy, one should once again assess the need for continuing anticonvulsant therapy. In this case, anticonvulsants should not be abruptly abolished, as this can lead to the resumption of seizures with severe consequences for the mother and child.

In rare cases, children whose mothers have epilepsy have experienced a developmental delay. It is not possible to determine whether developmental delay is related to genetic or social factors, maternal illness or anticonvulsant therapy.

The risk caused by gabapentin

In animal experiments, the toxicity of the drug against the fetus was demonstrated. As for the possible risk, people do not have data. therefore gabapentin should be used during pregnancy only if the intended benefit to the mother justifies the possible risk to the fetus.

It is impossible to make an unambiguous conclusion about the connection of gabapentin with an increased risk of congenital anomalies when used during pregnancydue to the presence of epilepsy itself and the simultaneous use of other antiepileptic drugs in each reported case.

Breast-feeding

Gabapentin is excreted in breast milk, its influence on the infant is unknown, therefore, during breastfeeding, Neurontin® should be given only if the benefit to the mother clearly outweighs the risk to the baby.

Fertility

In studies on animals, gabapentin has not been shown to influence fertility.

Dosing and Administration:

Dosing

For all indications, the dose titration scheme for initiating therapy is presented in Table 1. This scheme is presented for adult patients and adolescents aged 12 years and older. The scheme of titration for children under the age of 12 years is presented below under a separate subtitle.

Table No. 1 Diagram of dose titration at the beginning of therapy

Day # 1	Day # 2	Day # 3
300 mg once a day	300 mg twice a day	300 mg 3 times a day

Termination of gabapentin therapy

According to modern clinical practice, if it is necessary to cancel gabapentin therapy, this should be done gradually for at least one week, regardless of the indications.

Epilepsy

Epilepsy usually requires long-term treatment.The dose of the drug is determined by the attending physician depending on the individual tolerability and effectiveness of the drug.

Adults and children over the age of 12 years: in clinical studies, the effective dose was from 900 to 3600 mg / day. Therapy can be started according to the scheme described above in Table 1 or at a dose of 300 mg 3 times a day on the first day. In the future, depending on the patient's response to therapy and the tolerability of the drug, the dose can be increased by 300 mg / day every 2-3 days, maximally to 3600 mg / day. In some patients, it may be advisable to increase the dose more slowly. The minimum time for which you can increase the dose to 1800 mg / day is 1 week, 2400 mg / day - 2 weeks, and to achieve a maximum daily dose of 3600 mg / day, it is necessary at least 3 weeks. In long open clinical trials, the drug was well tolerated at doses up to 4800 mg / day. The total daily dose should be divided into three doses. The maximum interval between doses with a three-time intake of the drug should not exceed 12 hours in order to avoid the resumption of seizures.

Children aged 3-12 years: the initial dose of the drug varies from 10 to 15 mg / kg / day, which is given in equal doses 3 times a day and raised to an effective dose for approximately 3 days.Effective dose of gabapentin in children aged 5 years and older is 25-35 mg / kg / day in equal doses in 3 divided doses. The effective dose of gabapentin in children aged 3 to 5 years is 40 mg / kg / day in equal doses in 3 divided doses. A good tolerability of the drug in doses up to 50 mg / kg / day with long-term use was noted. The maximum interval between taking doses of the drug should not exceed 12 hours in order to avoid the resumption of seizures.

There is no need to monitor the concentration of gabapentin in plasma. It can be used in combination with other anticonvulsants without taking into account changes in plasma concentration or concentration of other anticonvulsants in serum.

Neuropathic pain

Adults

Therapy can be started according to the scheme described in Table 1 above. Alternative dosing method - the initial dose is 900 mg / day in three doses in equal doses. In the future, depending on the patient's response to therapy and the tolerability of the drug, the dose can be increased by 300 mg / day every 2-3 days, maximally to 3600 mg / day. In some patients, it may be advisable to increase the dose more slowly.The minimum time for which you can increase the dose to 1800 mg / day is 1 week, 2400 mg / day - 2 weeks, and to achieve a maximum daily dose of 3600 mg / day, it is necessary at least 3 weeks.

In the treatment of peripheral neuropathic pain, under conditions such as painful form of diabetic neuropathy and postherpetic neuralgia, the efficacy and safety of the drug for a period longer than 5 months in clinical studies have not been studied. In case the patient needs to continue the therapy of peripheral neuropathic pain for more than 5 months, the attending physician should assess the clinical status of the patient and determine the need for additional therapy.

Recommendations for all indications

In severely ill patients, for example, in case of reduced body weight, after organ transplantation, etc., the dose should be increased more slowly, either by using smaller doses, or by taking longer intervals before increasing the dose.

Application in elderly patients (over the age of 65 years)

Due to the age-related decline in kidney function, elderly patients may need a dose adjustment (for more details see Table 2).Drowsiness, peripheral edema and asthenia in elderly patients can occur more often.

Use in patients with renal insufficiency

Patients with impaired renal function and / or patients on hemodialysis are recommended to reduce the dose of gabapentin according to table 2:

Table number 2. Dosage of gabapentin in adult patients depending on the function of the kidneys

Creatinine clearance (ml / min)	Daily dose (mg / day)^A
≥80	900-3600
50-79	600-1800
30-49	300-900
15-29	150^B-600
<15^AT	150^B-300

^A The daily dose should be given in three divided doses; reduced doses are indicated in patients with impaired renal function (creatinine clearance <79 mL / min)

^B Assign 300 mg every other day.

^AT In patients with creatinine clearance <15 ml / min, the daily dose should be reduced in proportion to the creatinine clearance (for example, a patient with a creatinine clearance of 7.5 ml / min should receive half the dose received by a patient with a creatinine clearance of 15 ml / min).

Use in patients on hemodialysis

Patients with anuria, who are on hemodialysis, who had not previously taken gabapentin, the drug is recommended to be prescribed in a saturating dose of 300-400 mg, and then apply it to 200-300 mg after every 4 hours of hemodialysis. In days when dialysis is not performed, treatment should not be carried out.

For patients with reduced renal function undergoing dialysis, the maintenance dose of gabapentin should be selected according to the recommendations in Table 2. In addition to maintenance therapy, 200-300 mg of gabapentin is recommended after every 4-hour dialysis procedure.

Method of administration

Neuronthin® is administered internally.

GABAPENTIN can be taken regardless of food intake, squeezed with enough liquid (for example, a glass of water). It is allowed to divide the pills in half.

Side effects:

Undesirable reactions observed in clinical studies in patients with epilepsy (with gabapentin as monotherapy or in combination with other anticonvulsant drugs) or neuropathic pains are presented below and are distributed according to organ systems and frequency.

The frequency category was defined as follows: very often (≥1 / 10); often (from ≥1 / 100 to <1/10); infrequently (from ≥1 / 1000 to <1/100); rarely (from ≥1 / 10000 to <1/1000); very rarely (<1/10000). If the frequency category was different in different studies, an undesirable reaction was assigned a higher category.

Unwanted reactions, reported during the use of the drug after registration, are assigned a category of frequency "unknown" (the frequency can not be calculated on the basis of available data).

In each section by frequency, adverse reactions are presented in order of decreasing severity.

Infectious and parasitic diseases: very often - viral infections; often - pneumonia, respiratory tract infection, urinary tract infection, other infections, otitis media.

Violations of the blood and lymphatic system: often - Lakopenia; unknown - Thrombocytopenia.

Immune system disorders: infrequently - allergic reactions, including hives; unknown - hypersensitivity, including systemic reactions such as fever, rashes, hepatitis, lymphadenopathy, eosinophilia and others.

Disorders from the metabolism and nutrition: often anorexia, increased appetite.

Mental disorders: often - hostility, confusion, depression, anxiety, nervousness; infrequent mental state; unknown - hallucinations.

Disturbances from the nervous system: very often - drowsiness, dizziness, ataxia; often convulsions, hyperkinesia, dysarthria, amnesia, tremor, insomnia, headache, impaired sensitivity (eg, paresthesia, hypoesthesia), impaired coordination, nystagmus, strengthening, weakening or lack of reflexes; infrequently - hypokinesia; rarely - loss of consciousness; unknown - other movement disorders (eg, choreoathetosis, dyskinesia and dystonia).

Disturbances on the part of the organ of sight: often - impaired vision (such as amblyopia, diplopia).

Hearing disorders and labyrinthine disorders: often - vergigo, unknown - noise in ears.

Heart Disease: infrequently - a feeling of palpitations.

Vascular disorders: often - symptoms of vasodilation or hypertension.

Disturbances from the respiratory system, chest and mediastinal organs: often - shortness of breath, bronchitis, pharyngitis, cough, rhinitis.

Disorders from the gastrointestinal tract: often - constipation, diarrhea, dryness of the oral mucosa or pharynx, dyspepsia, flatulence, nausea, vomiting, abdominal pain, dental diseases, gingivitis; unknown - pancreatitis.

Disturbances from the liver and bile ducts: unknown - hepatitis, jaundice.

Disturbances from the skin and subcutaneous tissue: often - swelling of the face, purpura (most often it was described as bruising that arose due to physical trauma), skin rash, acne, itching of the skin; unknown - Stevens-Johnson syndrome, angioedema, anaphylaxis, erythema multiforme, alopecia, drug-induced skin rash, including eosinophilia and systemic reactions (see section "Special instructions").

Disturbances from musculoskeletal and connective tissue: often - myalgia, arthralgia, back pain, muscle twitching; unknown - rhabdomyolysis, myoclonus.

Disorders from the kidneys and urinary tract: unknown - incontinence, acute renal failure.

Violations of the genitals and mammary gland: often - impotence; unknown - an increase in the volume of mammary glands, gynecomastia, sexual dysfunction (including changes in libido, ejaculation and anorgasmia).

General disorders and disorders at the site of administration: very often fatigue, fever; often - peripheral edema, gait disturbance, asthenia,pain of different localization, general malaise, flu-like syndrome; infrequently, generalized edema; unknown - withdrawal syndrome (most often the following undesirable reactions: anxiety, insomnia, nausea, pain of different locations and increased sweating), chest pain. Cases of sudden unexplained death have been reported, whose association with treatment with gabapentin has not been established.

Laboratory and instrumental data: often - reducing the concentration of white blood cells, weight gain; infrequently - increased activity of alanine aminotransferase, aspartate aminotransferase and bilirubin concentration in blood plasma, hyperglycemia; rarely - hypoglycemia (mainly in patients with diabetes mellitus); unknown - hyponatremia, increased activity of creatine phosphokinase.

Trauma, intoxication and complications of manipulation: often - injuries, fractures, abrasions associated with falls.

There are reports of the development of acute pancreatitis with gabapentin therapy. The causal relationship with gabapentin remains unclear (see section "Special instructions").

There are reports of cases of myopathy with an increase in creatine kinase activity in patients with terminal stage of renal failure who are on hemodialysis.Cases of respiratory tract infection, otitis media, bronchitis and seizures were noted only in clinical studies. In addition, clinical studies reported cases of aggressive behavior and hyperkinesis in children.

Overdose:

With a single administration of 49 g of gabapentin, the following symptoms: dizziness, double vision, speech impairment, drowsiness, loss of consciousness, a state of inhibition and mild diarrhea, which completely disappeared during symptomatic therapy. It should be borne in mind that after taking high doses of gabapentin, its absorption in the intestine decreases.

With an overdose of gabapentin, the development of coma is possible, especially with the simultaneous use of other drugs that suppress the central nervous system.

Although gabapentin can be inferred when hemodialysis, the experience shows that usually such a need does not arise.

Patients with severe renal insufficiency can be shown hemodialysis.

In experiments on mice and rats, which received the drug at doses up to 8000 mg / kg, it was not possible to establish a lethal dose of gabapentin when administered orally.Signs of acute toxicity in animals included ataxia, difficulty breathing, ptosis, hypoactivity or agitation.

Interaction:

There are reports of spontaneous cases, and according to information from literature sources, respiratory depression and / or sedation symptoms associated with gabapentin and opioid analgesics are possible. In some of these cases, the authors linked these symptoms with simultaneous use of gabapentin and opioids, especially in elderly patients.

In a study involving healthy volunteers (N= 12) with 600 mg of gabapentin 2 hours after administration of morphine in the form of capsules with prolonged release of 60 mg, an increase in the mean value AUC Gabapentin by 44% compared with monotherapy with gabapentin. In this regard, patients who require simultaneous therapy with opioid analgesics should be carefully monitored for signs of central nervous system depression such as drowsiness, sedation and respiratory depression, and the dose of gabapentin and opioid analgesics should be reduced accordingly.

Interactions between gabapentin and phenobarbital, phenytoin, valproic acid and carbamazepine have not been observed.

The pharmacokinetics of gabapentin in the equilibrium state is the same in healthy people and patients receiving other anticonvulsants.

The simultaneous use of gabapentin with oral contraceptives containing norethisterone and / or ethinyl estradiol, is not accompanied by changes in the pharmacokinetics of both components.

The simultaneous use of gabapentin with antacids containing aluminum and magnesium is accompanied by a decrease in bioavailability of gabapentin by approximately 24% (see section "Special instructions").

Probenecid does not affect renal excretion of gabapentin.

A slight decrease (14%) of renal excretion of gabapentin with simultaneous administration of cimetidine is probably of no clinical significance.

With the simultaneous use of naproxen (250 mg) and gabapentin (125 mg), there was an increase in absorption of gabapentin from 12% to 15%. Gabapentin does not affect the pharmacokinetic parameters of naproxen. These doses of drugs are less than the minimum therapeutic dose.Simultaneous use of these drugs in large doses has not been studied.

Special instructions:

Suicidal Ideas and Behavior

There are reports of the occurrence of suicidal thoughts or behavior in patients receiving antiepileptic drugs for various indications. A meta-analysis of randomized placebo-controlled trials of antiepileptic drugs also showed a slight increase in the risk of suicidal thoughts and behavior. The mechanism for increasing this risk is unknown and the available data do not exclude the possibility of such an increased risk for gabapentin.

Therefore, patients receiving these drugs should be carefully monitored for signs of suicidal thoughts or behavior. Such patients should consider the need for appropriate treatment. In case of signs of suicidal thoughts or behavior, patients or their caregivers should consult a doctor.

Acute pancreatitis

In the case of acute pancreatitis with gabapentin, the possibility of drug withdrawal should be assessed.

Convulsions (withdrawal syndrome)

Although the syndrome of "cancellation", accompanied by the development of seizures in the treatment of gabapentin is not checked, abrupt cessation of therapy anticonvulsants in epileptic patients may provoke the development of status epilepticus (see. Section "Dosage and administration").

As with the use of other antiepileptic drugs, with the use of gabapentin, there may be an increase in the frequency of seizures or the appearance of a different type of seizure.

Just as is the case with other antiepileptic drugs, attempts to cancel all related antiepileptics to start gabapentin monotherapy in refractory to treatment in patients receiving multiple antiepileptic drugs generally do not end successfully.

It is believed that gabapentin It is ineffective in primary generalized seizures, for example, absences, and can even intensify such seizures in some patients. In this regard, apply gabapentin patients with mixed seizures, including absences, should be treated with caution.

Opioid analgesics

Patients who require simultaneous therapy with opioid analgesics,should be carefully monitored for signs of central nervous system depression, such as drowsiness, sedation, and respiratory depression. In patients who simultaneously receive gabapentin and morphine an increase in the concentration of gabapentin may be observed. The dose of gabapentin and opioid analgesics should be reduced accordingly (see section "Interaction with other drugs").

Elderly patients

Systematic studies of patients aged 65 years and older receiving gabapentin, were not conducted. In a double-blind study of the use of gabapentin in neuropathic pain, a higher incidence of somnolence, peripheral edema, and asthenia was observed in patients aged 65 years and older compared with patients <65 years of age. With the exception of these results, a clinical examination of this group of patients showed that the profile of undesirable reactions did not differ from the others.

Children

The effect of prolonged therapy (more than 36 weeks) with gabapentin on learning ability, intelligence and development of children and adolescents is not sufficiently studied.It is necessary to estimate the ratio of possible risk and benefit in the appointment of long-term therapy.

Abuse and dependence

In the database of post-registration observations there are reports of cases of drug abuse and dependence. As with the administration of any drug that affects the central nervous system, doctors should carefully study the patient's history of drug abuse and monitor them to identify possible signs of abuse of gabapentin (eg, the desire to unreasonably receive the drug, the development of resistance to gabapentin, an unreasonable increase in dose preparation).

DRESS-syndrome (drug reaction with eosinophilia and systemic symptoms)

Against the background of taking antiepileptic drugs, including gabapentin, there have been reports of cases of development of severe life-threatening hypersensitivity reactions, such as drug rash with concomitant eosinophilia and systemic symptoms. It must be remembered that early signs of hypersensitivity reactions, such as fever, lymphadenopathy, can develop even in the absence of skin rash.In the case of such symptoms, an immediate examination of the patient is necessary. If no other cause is found other than gabapentin, the drug should be discontinued.

Anaphylaxis

The use of gabapentin can lead to the development of anaphylaxis. The following symptoms and signs were noted in cases of anaphylaxis development on the background of gabapentin - difficulty breathing, swelling of the lips, throat and tongue, there was also a marked decrease in arterial pressure requiring urgent medical intervention. Patients should be warned that with the development of signs or symptoms of anaphylaxis, stop taking the medication and seek medical help.

Laboratory Tests

With the joint use of gabapentin and other anticonvulsants, false-positive results were detected in determining the protein in the urine using test strips Ames N-Multistix SG®. To determine the protein in the urine it is recommended to use a more specific method of precipitation with sulfosalicylic acid.

Effect on the central nervous system

During the treatment with gabapentin, there were cases of dizziness and drowsiness, which may increase the chance of accidental injury (in the fall).In the post-registration period, there were also reported cases of confusion, loss of consciousness and mental disorders. Therefore, patients should be cautioned until they know the possible effects of this medication.

With simultaneous use with opioid analgesics, there may be an increase in the concentration of gabapentin in blood plasma. In this connection, the patient needs careful observation for signs of central nervous system (CNS) depression, such as drowsiness, sedation and respiratory depression. Doses of gabapentin or opioid analgesics should be reduced accordingly (see section "Interaction with other drugs").

Joint use with antacids

It is recommended to take gabapentin approximately 2 hours after taking the antacid.

Effect on the ability to drive transp. cf. and fur:

During the administration of the drug, it is not recommended for patients to drive vehicles or use potentially dangerous equipment until the negative effect of the drug on the performance of these functions is confirmed.

Gabapentin affects the central nervous system and can cause dizziness, drowsiness, confusion, loss of consciousness or other symptoms from the side of the central nervous system. Even with mild or moderate severity, these undesirable reactions can be dangerous for patients driving vehicles or other mechanisms. This probability is especially high at the beginning of treatment or after increasing the dose of Neurontin®.

Form release / dosage:

Film coated tablets, 600 mg and 800 mg.

Packaging:

For 10 tablets in blisters (contour cell packaging) made of PVC / PE / PVDC / aluminum foil with vinyl coating or 10 tablets in PVC / PVDC / aluminum blister.

For 2, 5 or 10 blisters with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N013567 / 02

Date of registration:06.10.2008 / 19.07.2013

Expiration Date:Unlimited

The owner of the registration certificate:Pfizer Manufakchuring Deutschland GmbH Pfizer Manufakchuring Deutschland GmbH Germany

Manufacturer: & nbsp

PFIZER MANUFACTURING DEUTSCHLAND, GmbH Germany

Representation: & nbspPfizer LtdPfizer LtdUSA

Information update date: & nbsp27.06.2018

Illustrated instructions

Instructions

Neuronthin® (Neurontin®)