Neurontin is an anticonvulsant drug.
Release form and composition
Neurontin is available in two dosage forms:
- Capsules: opaque, hard gelatin, with the words “PD” on the body and “Neurontin” on the lid, the contents of the capsules are almost white or white powder, 100 mg each is size No. 3, the body and cover are white, the label on the lid is “100 mg "; 300 mg each - size No. 1, the case and cover are light yellow, marking on the cover is “300 mg”; 400 mg each - size No. 0, body and lid of cream-orange color, marking on the lid - “400 mg” (10 pieces in blisters, 2, 5 or 10 packs in a cardboard box);
- Tablets, film coated: elliptical, white, engraved with "NT" and "16" (600 mg each) or "26" (800 mg each), with a risk between engraving on one side and a risk on the other side ( 10 pieces in blisters, 2, 5 or 10 packs in a carton box).
The composition of 1 capsule includes:
- Active substance: gabapentin - 100, 300 or 400 mg;
- Auxiliary components (capsules of 100/300/400 mg, respectively): lactose monohydrate - 14.25 / 42.75 / 57 mg; corn starch - 10/30/40 mg; talc - 10/30/40 mg;
- Capsule shell (100/300/400 mg capsules, respectively): gelatin - 39.6 / 64.07 / 80.01 mg; titanium dioxide (E171) - 1.44 / 0.76 / 1.28 mg, sodium lauryl sulfate - less than 0.1 / 0.15 / 0.19 mg; the dye iron oxide yellow (E172) - 0 / 0.15 / 0.62 mg; the dye iron oxide red (E172) - 0/0 / 0.06 mg;
- Ink (for all types of capsules): shellac - 0.075 mg; titanium dioxide (E171) —0.027 mg; Indigo Carmine - 0.021 mg.
The composition of 1 tablet includes:
- Active substance: gabapentin - 600 or 800 mg;
- Auxiliary components (tablets 600/800 mg, respectively): Poloxamer 407 - 80 / 106.7 mg; copovidone - 64.8 / 86.4 mg; corn starch - 49.2 / 65.6 mg; magnesium stearate - 6/8 mg;
- Film coating: Opadry white YS-1-18111 - 24/32 mg (talc - 17.4 / 23.2 mg; hyprolosis - 6.6 / 8.8 mg); herbal wax (candela) - 0.6 / 0.8 mg.
Indications for use
- Neuropathic pain in adults (treatment);
- Partial seizures with and without secondary generalization in adults and children from 12 years of age (monotherapy);
- Partial convulsions with secondary generalization and without it in adults and children from 3 years (as an additional means).
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- Age up to 3 years (an additional agent in the treatment of partial seizures with and without secondary generalization), 12 years (monotherapy of partial seizures with and without secondary generalization) and 18 years (treatment of neuropathic pain);
- Hypersensitivity to the drug.
Neurontin should be used with caution in patients with renal insufficiency.
Nursing and pregnant women can prescribe the drug only after assessing the benefit / risk ratio for mother and child.
Dosing and Administration
Neurontin is taken orally, regardless of the meal. If necessary, reduce the dose, cancel therapy or replace the drug with an alternative, it should be done gradually over at least 7 days.
The initial daily dose for neuropathic pain in adults is 900 mg, the multiplicity of reception - 3 times a day (in equal parts). If necessary, gradually increase the dose to a maximum of 3600 mg per day. It should be borne in mind that when using Neurontin at a daily dose above 1800 mg, no additional efficacy is noted.
Therapy can be started immediately with a daily dose of 900 mg or with its gradual increase during the first 3 days. To do this, take the drug in a single dose of 300 mg, increasing the frequency of taking the drug: the first day - 1 time a day, the second day - 2 times a day, the third day - 3 times a day.
The effective dose for partial convulsions in adults and children from 12 years is 900-3600 mg. You can start therapy according to one of the schemes described above. In the future, a single dose can be increased to 1200 mg with a frequency of 3 times a day. A good tolerability of Neurontin in a daily dose of up to 4800 mg was noted. To avoid seizures, the maximum interval between doses of doses should not exceed 12 hours.
The initial dose in children 3-12 years is 10-15 mg / kg per day in 3 doses. Within 3 days it is gradually increased to effective. As a rule, the effective daily dose in children from 5 years is 25-35 mg / kg, children 3-5 years old - 40 mg / kg (in equal parts in 3 doses). With long-term use, good tolerability of Neurontin was noted in doses up to 50 mg / kg per day. To avoid seizures, the maximum interval between doses should not exceed 12 hours.
To control the concentration of gabapentin in the blood plasma is not necessary. Neurontin can be used simultaneously with other anticonvulsants without taking into account changes in its plasma concentration or concentration of other anticonvulsant drugs in serum.
In case of kidney failure, it is recommended to use lower doses of Neurontin (creatinine clearance / daily dose):
- From 80 ml per minute: 900-3600 mg;
- 50-79 ml per minute: 600-1800 mg;
- 30-49 ml per minute: 300-900 mg;
- 15-29 ml per minute: 150-600 mg (to receive a dose of 150 mg, 300 mg every other day is prescribed);
- Less than 15 ml per minute: 150-300 mg.
The daily dose must be taken in 3 doses.
Patients on hemodialysis who have not taken gabapentin before, are recommended to administer Neurontin in a saturating dose of 300-400 mg, after which it is used after every 4 hours of hemodialysis at 200-300 mg.
When treating neuropathic pain, the following disorders may develop (at least in 1% of patients):
- Nervous system: amnesia, gait disturbance, thinking and coordination, ataxia, drowsiness, confusion, dizziness, hypesthesia, tremor, headache;
- Respiratory system: pharyngitis, shortness of breath;
- The digestive system: nausea, vomiting, diarrhea, constipation, dry oral mucosa, dyspepsia, flatulence, abdominal pain;
- Sense organs: otitis media, amblyopia, conjunctivitis, vertigo;
- Skin: skin rash;
- Other: infection, accidental injury, peripheral edema, hyperglycemia, asthenia, flu-like syndrome, back pain, pain of different localization, weight gain.
During the treatment of partial seizures such side effects may develop (not less than in 1% of patients):
- Cardiovascular system: hypertension or symptoms of vasodilation;
- The digestive system: nausea and / or vomiting, constipation, dyspepsia, diarrhea, increased appetite, dry pharyngeal or oral mucosa, abdominal pain, anorexia, flatulence, dental disease, gingivitis;
- Hematopoietic organs: leukopenia, a decrease in the concentration of white blood cells, purpura (in most cases it is described as bruising that occurred with little physical impact);
- Musculoskeletal system: myalgia, fractures, arthralgia;
- Nervous system: amnesia, ataxia, incoordination, confusion, depression, dysarthria, emotional lability, insomnia, nystagmus, nervousness, drowsiness, impaired thinking, muscle twitching, tremor, dizziness, hyperkinesia, paresthesia, hostility, anxiety, headache, aggravation , lack or weakening of reflexes;
- Respiratory system: respiratory tract infections, bronchitis, cough, pharyngitis, pneumonia, rhinitis;
- Skin: abrasions, itching and rash, acne;
- Sense organs: amblyopia, blurred vision, diplopia, vertigo;
- Genitourinary system: impotence, urinary tract infection;
- Other: erectile dysfunction, peripheral edema, back pain, fever, fatigue, viral infections, weight gain, facial swelling, asthenia, general malaise.
Side effects are usually mild or mild. Disorders in elderly patients do not differ from those in younger patients.
When comparing the tolerability of Neurontin in daily doses of 300 and 3600 mg, dose dependence is observed for such phenomena as ataxia, dizziness, drowsiness, nystagmus and paresthesia.
During therapy in children 3-12 years old with a frequency of 2% and higher than with placebo, the following side effects were noted:
- Digestive system: nausea and / or vomiting;
- Nervous system: dizziness, drowsiness, hyperkinesia, emotional lability, hostility;
- Respiratory system: respiratory infections, bronchitis;
- Other: fatigue, fever, viral infections, weight gain.
Also in children of this age, rhinitis, pharyngitis, otitis media, headache, diarrhea, anorexia, seizures may occur during therapy.
The development of side effects such as drowsiness, ataxia, fatigue, dizziness, nausea and / or vomiting when using Neurontin as an adjuvant usually requires discontinuation of therapy. If the drug is used as monotherapy, the appearance of dizziness, drowsiness, nervousness, weight gain, nausea and / or vomiting also requires the abolition of Neurontin. Disorders that interrupt therapy in children include drowsiness, hostility, and hyperkinesia.
After registration of the drug, cases of unexplained sudden death were reported (the connection with treatment with gabapentin has not been established).
Other adverse events include allergic reactions (including urticaria, angioedema and generalized edema), drug rash (including eosinophilia and systemic reactions), alopecia, fluctuations in blood glucose concentration in patients with diabetes, chest pain, gynecomastia, hallucinations, elevated creatine phosphine concentration in blood plasma, jaundice, hepatitis, erythema multiforme exudative (including Stevens-Johnson syndrome), tinnitus, hypersensitivity (including systemic reactions), motor upset Properties (including choreoathetosis, dyskinesia and dystonia), thrombocytopenia, myoclonus, pancreatitis, urinary incontinence, palpitations, rhabdomyolysis, acute renal failure.
After the abrupt cancellation of Neurontin, the following side effects were most often noted: excessive sweating, nausea, insomnia, anxiety and pains of various localization.
Taking Neurontin increases the risk of suicidal thoughts and / or suicidal behavior. Therefore, patients receiving the drug should be carefully monitored for the development or strengthening of depression, the occurrence of suicidal thoughts or behavior, as well as for any changes in behavior.
With the development of acute pancreatitis in patients receiving Neurontin, it is necessary to evaluate the possibility of canceling therapy.
Abrupt cessation of treatment in patients with epilepsy can lead to the development of status epilepticus (despite the fact that the withdrawal syndrome with the occurrence of seizures when using Neurontin is not marked).
When combined with morphine, there may be an increase in plasma concentration of gabapentin. In this regard, the patient needs to be carefully monitored for the development of signs of depression of the central nervous system (in particular, drowsiness). The dose of morphine or gabapentin must be adequately reduced.
For the treatment of absence epilepsy, Neurontin is not considered an effective remedy.
During the use of antiepileptic drugs, severe, life-threatening hypersensitivity reactions may develop, such as a drug rash with concomitant systemic symptoms and eosinophilia. Early signs of a hypersensitivity reaction are lymphadenopathy, an increase in body temperature, and these symptoms can appear even in the absence of a skin rash. In the case of the development of such signs, you should immediately conduct an examination of the patient. If no other cause is found other than Neurontin, therapy should be interrupted.
During treatment, the frequency of seizures may increase or seizures of a different type may appear.
Neurontin is recommended to be taken approximately 2 hours after taking an antacid. Before prescribing long-term therapy (longer than 36 weeks), children should assess the ratio of the possible risk associated with the effect on learning ability, intelligence and development, and the benefits of taking the drug.
In combination therapy with other anticonvulsants, false-positive results were detected when determining urine protein using the Ames N-Multistix SG test strips. In this regard, for the determination of protein in the urine, more specific sulfosalicylic acid precipitation methods should be used.
While taking Neurontin, it is not recommended to drive vehicles or other potentially dangerous equipment until the confirmation of the absence of a negative effect of the drug on the performance of these functions.
The simultaneous use of Neurontin with antacids containing aluminum and magnesium is accompanied by a decrease in the bioavailability of gabapentin.
When combined with hydrocodone, a dose-dependent decrease in its C max (maximum concentration in blood) and AUC (total drug concentration in plasma) is observed in comparison with hydrocodone monotherapy.
Terms and conditions of storage
Keep out of reach of children at temperature up to 25 ° C.
- Capsules - 3 years;
- Tablets - 2 years.