Neurontin®
Adverse effects observed in clinical studies in patients with epilepsy (when using gabapentin as monotherapy or in combination with other anticonvulsants) or neuropathic pain are presented below and categorized by organ system and frequency.
The frequency category was defined as follows: very often (≥1/10); often (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000). If the frequency category was different between studies, the side effect was assigned a higher category.
Side effects reported during the use of the drug after registration were assigned a frequency category of “unknown” (frequency cannot be calculated based on available data).
In each frequency section, side effects are presented in order of decreasing severity.
Infectious and parasitic diseases:
very often -
viral infections;
often -
pneumonia, respiratory tract infection, urinary tract infection, other types of infection, otitis media.
Blood and lymphatic system disorders : common
leukopenia;
unknown -
thrombocytopenia.
Immune
system disorders: uncommon
- allergic reactions, including urticaria;
unknown -
hypersensitivity, including systemic reactions such as fever, rash, hepatitis, lymphadenopathy, eosinophilia and others.
Metabolic and nutritional disorders:
often
- anorexia, increased appetite.
Mental disorders:
often
- hostility, confusion, depression, anxiety, nervousness, impaired thinking, emotional lability;
infrequently
- deterioration of mental state;
unknown -
hallucinations.
Nervous system disorders:
very often -
drowsiness, dizziness, ataxia;
often -
convulsions, hyperkinesia, dysarthria, amnesia, tremor, insomnia, headache, sensory disturbances (for example, paresthesia, hypesthesia), loss of coordination, nystagmus, strengthening, weakening or absence of reflexes;
infrequently -
hypokinesia;
rarely -
loss of consciousness;
unknown -
other movement disorders (for example, choreoathetosis, dyskinesia and dystonia).
Visual disorders:
often -
visual impairment (such as amblyopia, diplopia).
Hearing and labyrinthine disorders:
often -
vertigo;
unknown -
tinnitus.
Cardiac disorders:
uncommon -
palpitations.
Vascular disorders:
often -
symptoms of vasodilation, arterial hypertension.
Respiratory system disorders
,
organs of the chest and mediastinum: often
- shortness of breath, bronchitis, pharyngitis, cough, rhinitis.
Gastrointestinal disorders:
often -
constipation, diarrhea, dry mucous membrane of the mouth or pharynx, dyspepsia, flatulence, nausea, vomiting, abdominal pain, dental disease, gingivitis;
unknown -
pancreatitis.
Liver and biliary tract disorders:
unknown -
hepatitis, jaundice.
Disorders of the skin and subcutaneous tissues:
often
- swelling of the face, purpura (most often described as bruising resulting from physical trauma), skin rash, acne, skin itching;
unknown
- Stevens-Johnson syndrome, angioedema, anaphylaxis, erythema multiforme, alopecia, drug skin rash, including eosinophilia and systemic reactions (see section "Special Instructions").
Musculoskeletal and connective tissue disorders:
often -
myalgia, arthralgia, back pain, muscle twitching;
unknown
rhabdomyolysis, myoclonus.
Renal and urinary tract disorders:
unknown -
urinary incontinence, acute renal failure.
Disorders of the genital organs and mammary gland:
often -
impotence;
unknown -
increase in the volume of the mammary glands, gynecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia).
General disorders and disorders at the injection site:
very often -
fatigue, fever;
often
peripheral edema, gait disturbance, asthenia, pain of various localizations, general malaise, flu-like syndrome;
infrequently -
generalized edema, falls;
unknown
- withdrawal syndrome (the most frequently reported side effects were anxiety, insomnia, nausea, pain of various localizations and increased sweating), chest pain. There have been cases of sudden unexplained death, the connection of which with gabapentin treatment has not been established.
Laboratory and instrumental data:
often
- decreased leukocyte concentration, increased body weight;
infrequently -
increased activity of alanine aminotransferase, aspartate aminotransferase and bilirubin concentration in the blood plasma, hyperglycemia;
rarely
- hypoglycemia (mainly in patients with diabetes mellitus);
unknown -
hyponatremia, increased creatine phosphokinase activity.
Injuries, intoxications and complications of manipulations:
often
- injuries, fractures, abrasions associated with falls.
There are reports of the development of acute pancreatitis during gabapentin therapy. The causal relationship with gabapentin remains unclear (see section "Special instructions").
There are reports of cases of myopathy with increased creatine kinase activity in patients with end-stage renal failure undergoing hemodialysis.
Cases of respiratory tract infection, otitis media, bronchitis and seizures were reported only in clinical studies. In addition, clinical studies have reported cases of aggressive behavior and hyperkinesis in children.
NEURONTIN
special instructions
Suicidal ideation and behavior
Antiepileptic drugs, including gabapentin, may increase the risk of suicidal ideation or behavior. A meta-analysis of randomized placebo-controlled trials of antiepileptic drugs demonstrated a small increase in the risk of suicidal ideation and behavior. The mechanism for increasing the risk of developing suicidal ideation is unknown, but for gabapentin it cannot be excluded. Therefore, patients receiving these drugs should be closely monitored for new or worsening depression, the emergence of suicidal thoughts or behavior, and any changes in behavior. Patients or their caregivers should seek medical attention if signs of suicidal thoughts or behavior occur.
Acute pancreatitis
If acute pancreatitis develops while taking gabapentin, the possibility of discontinuing the drug should be assessed.
Convulsions ("oo" syndrome).
As with other antiepileptic drugs, gabapentin may cause an increase in the frequency of seizures or the appearance of a different type of seizure.
As with other anticonvulsants, attempts to discontinue all concomitant antiepileptic drugs in order to initiate gabapentin monotherapy in cases of treatment refractory in patients taking multiple anticonvulsants are generally unsuccessful.
Gabapentin is not thought to be effective for primary generalized seizures, such as absence seizures, and may even worsen such seizures in some patients. In this regard, gabapentin should be used with caution in patients with mixed seizures, including absence seizures.
Elderly patients
Systematic studies have not been conducted in patients aged 65 years and older taking gabapentin. In a double-blind study of gabapentin for neuropathic pain, patients aged 65 years and older had a higher incidence of somnolence, peripheral edema, and asthenia compared with patients aged <65 years. Apart from these results, clinical examination of this group of patients showed that their side effect profile did not differ from the rest.
Children
The effect of long-term therapy (more than 36 weeks) with gabapentin on the learning ability, intelligence and development of the child has not been sufficiently studied. The ratio of possible risks and benefits should be assessed when prescribing long-term therapy. Abuse and addiction. The post-marketing surveillance database contains reports of cases of drug abuse and dependence. As with any drug that affects the central nervous system, clinicians should carefully review patients' drug abuse history and monitor patients for possible signs of gabapentin abuse (eg, drug seeking, development of resistance to gabapentin therapy, inappropriate dosage increases). ).
DRESS syndrome
Severe life-threatening hypersensitivity reactions, such as drug rash with associated eosinophilia and systemic symptoms, have been reported while taking antiepileptic drugs, including gabapentin. It is necessary to remember this. that early signs of a hypersensitivity reaction, such as fever, lymphadenopathy, can develop even in the absence of skin rash. If such symptoms occur, immediate examination of the patient is necessary. If no other reason is found other than the use of gabapentin, the use of the drug should be discontinued.
Anaphylaxis
Taking gabapentin can lead to the development of anaphylaxis. The following symptoms and signs were noted in cases of anaphylaxis while taking gabapentin: difficulty breathing, swelling of the lips, throat and tongue, and a marked decrease in blood pressure was also noted, requiring urgent medical intervention. Patients should be warned that if signs or symptoms of anaphylaxis develop, they should stop taking the drug and seek medical attention.
Laboratory tests
When gabapentin and other anticonvulsants were co-administered, false-positive results have been reported when measuring urinary protein using Ames N-Multistix SG test strips. To determine protein in urine, it is recommended to use the more specific precipitation method of sulfosalicylic acid.
Effect on the central nervous system
During treatment with gabapentin, cases of dizziness and drowsiness have been observed, which may increase the likelihood of accidental injury (from a fall). Cases of confusion, loss of consciousness and mental impairment have also been reported during the post-marketing period. Therefore, patients should be advised to use caution until they are aware of the possible effects of this drug.
When used simultaneously with opioid analgesics, an increase in the concentration of gabapentin in the blood plasma may be observed. In this regard, the patient needs to be closely monitored for the development of signs of CNS depression, such as drowsiness, sedation, and respiratory depression. Doses of gabapentin or opioid analgesics should be reduced accordingly (see section "Interactions with other drugs").
Combined use with antacids
It is recommended to take gabapentin approximately 2 hours after taking the antacid.
Neurontin capsules 300 mg 50 pcs.
Infectious and parasitic diseases: very often - viral infections; often - pneumonia, respiratory tract infection, urinary tract infection, other types of infection, otitis media. Disorders of the blood and lymphatic system: often - leukopenia; unknown - thrombocytopenia. Immune system disorders: uncommon - allergic reactions, including urticaria; unknown - hypersensitivity, including systemic reactions such as fever, rash, hepatitis, lymphadenopathy, eosinophilia and others. Metabolic and nutritional disorders: often - anorexia, increased appetite. Mental disorders: often - hostility, confusion, depression, anxiety, nervousness, impaired thinking, emotional lability; infrequently - deterioration of mental state; unknown - hallucinations. Nervous system disorders: very often - drowsiness, dizziness, ataxia; often - convulsions, hyperkinesia, dysarthria, amnesia, tremor, insomnia, headache, sensory disturbances (for example, paresthesia, hypesthesia), loss of coordination, nystagmus, strengthening, weakening or absence of reflexes; infrequently – hypokinesia; rarely - loss of consciousness, unknown - other movement disorders (for example, choreoathetosis, dyskinesia and dystonia). Visual disorders: often - visual impairment (such as amblyopia, diplopia). Hearing and labyrinthine disorders: often - vertigo, unknown - tinnitus. Cardiac disorders: uncommon - palpitations. Vascular disorders: often - symptoms of vasodilation, arterial hypertension. Disorders of the respiratory system, chest and mediastinal organs: often - shortness of breath, bronchitis, pharyngitis, cough, rhinitis. Gastrointestinal disorders: often - constipation, diarrhea, dry mucous membrane of the mouth or pharynx, dyspepsia, flatulence, nausea, vomiting, abdominal pain, dental disease, gingivitis; unknown - pancreatitis. Liver and biliary tract disorders: unknown - hepatitis, jaundice. Disorders of the skin and subcutaneous tissues: often - swelling of the face, purpura (most often described as bruising resulting from physical trauma), skin rash, acne, skin itching; unknown - Stevens-Johnson syndrome, angioedema, anaphylaxis, erythema multiforme, alopecia, drug skin rash, including eosinophilia and systemic reactions. Musculoskeletal and connective tissue disorders: often - myalgia, arthralgia, back pain, muscle twitching; unknown - rhabdomyolysis, myoclonus. Renal and urinary tract disorders: unknown - urinary incontinence, acute renal failure. Disorders of the genital organs and mammary gland: often - impotence, unknown - increase in the volume of the mammary glands, gynecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia). General disorders and disorders at the injection site: very often - fatigue, fever; often - peripheral edema, gait disturbance, asthenia, pain of various localizations, general malaise, flu-like syndrome; infrequently - generalized edema, falls; unknown - withdrawal syndrome (the most frequently reported side effects were anxiety, insomnia, nausea, pain of various localizations and increased sweating), chest pain. There have been cases of sudden unexplained death, the connection of which with gabapentin treatment has not been established. Laboratory and instrumental data: often - decreased leukocyte concentration, increased body weight; infrequently - increased activity of alanine aminotransferase, aspartate aminotransferase and bilirubin concentration in the blood plasma, hyperglycemia; rarely - hypoglycemia (mainly in patients with diabetes mellitus); unknown - hyponatremia, increased creatine phosphokinase activity. Injuries, intoxications and complications of manipulations: often - injuries, fractures, abrasions associated with falls. There are reports of the development of acute pancreatitis during gabapentin therapy. The causal relationship with gabapentin remains unclear. There are reports of cases of myopathy with increased creatine kinase activity in patients with end-stage renal failure undergoing hemodialysis. Cases of respiratory tract infection, otitis media, bronchitis and seizures were reported only in clinical studies. In addition, clinical studies have reported cases of aggressive behavior and hyperkinesis in children.
