Gabagamma - Instructions For Use, Price, Reviews, Capsule Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Gabagamma

Gababamma: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Use in the elderly
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Gabagamma

ATX code: N03AX12

Active ingredient: gabapentin (gabapentin)

Producer: Artesan Pharma (Germany)

Description and photo update: 2019-19-08

Prices in pharmacies: from 287 rubles.

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Gababamma is an antiepileptic drug.

Release form and composition

Dosage form of Gabagamma - hard gelatin capsules:

• 100 mg: size # 3, white;
• 300 mg: size # 1, yellow;
• 400 mg: size # 0, orange.

Capsule contents: white powder.

Packing of capsules: 10 pcs. in a blister, in a cardboard box 2, 5 or 10 blisters.

Active ingredient: gabapentin, in 1 capsule - 100, 300 or 400 mg.

Additional substances: titanium dioxide, talc, corn starch, gelatin, lactose, dyes iron oxide red and yellow.

Pharmacological properties

Pharmacodynamics

The structure of gabapentin resembles the structure of the neurotransmitter gamma-aminobutyric acid (GABA), but its mechanism of action is different from the mechanism characteristic of other drugs that interact with GABA receptors (prodrugs of GABA, GABA agonists, inhibitors of GABA uptake, inhibitors of GABA transaminase, valproate, benzodiazepines, barbiturates). For him, GABAergic properties are uncharacteristic, and gabapentin also does not change the course of the processes of capture and metabolism of GABA. As a result of preliminary studies, it was found that this substance binds to α ₂is a δ-subunit of voltage-dependent calcium channels and reduces the flow of calcium ions, which plays an important role in the development of neuropathic pain syndrome. Other mechanisms of action of gabapentin in attacks of neuropathic pain include inhibition of the release of monoamine neurotransmitters, an increase in GABA synthesis, and a decrease in glutamate-dependent neuronal death. The active substance Gababamma, which is determined in the body in clinically significant concentrations, has no effect of binding to receptors of other neurotransmitters or other common drugs, including receptors for N-methyl-D-aspartate, glycine, glutamate, benzodiazepine receptors and GABA _A and GABA _B receptors …

The interaction of gabapentin with sodium channels in vitro has not been revealed, which distinguishes it from carbamazepine and phenytoin. In some in vitro tests, gabapentin partially attenuated the effects of the glutamate receptor agonist N-methyl-D-aspartate, but only at concentrations exceeding 100 μmol, which is not achieved under in vivo conditions. Also, gabapentin slightly reduces the release of monoamine neurotransmitters in vitro.

Pharmacokinetics

The bioavailability of gabapentin is not dose-dependent, since it decreases with an increase in the dose of gabapentin. After oral administration, the maximum concentration of the active substance in the plasma is recorded after 2–3 hours. The absolute bioavailability of the drug in capsule form is approximately 60%. When taken together with food, including those with a high fat content, the pharmacokinetics of gabapentin does not change.

The process of elimination of gabapentin from blood plasma is most accurately described using a linear model. Its half-life from plasma is independent of dose and is approximately 5-7 hours. With repeated administration, the pharmacokinetic parameters of the drug remain unchanged, therefore, the equilibrium concentrations of gabapentin in blood plasma can be predicted based on the results of a single dose of Gabagamma.

For gabapentin, binding to plasma proteins is practically uncharacteristic (less than 3%). Its volume of distribution is 57.7 liters. The substance is excreted exclusively in the urine unchanged and does not participate in metabolic processes. The drug is not an inducer of liver oxidative enzymes with mixed function, which are responsible for the metabolism of drugs. The clearance of gabapentin from plasma is reduced in patients with renal dysfunction and in the elderly. Renal clearance, plasma clearance, and excretion rate constant are directly proportional to creatinine clearance. Gabapentin is cleared from plasma during hemodialysis. In patients with renal insufficiency and in patients regularly undergoing hemodialysis, a dose adjustment of Gababamma is recommended.

Indications for use

• partial convulsions, including those with secondary generalization, in adults and adolescents from 12 years old (as part of complex therapy);
• postherpetic neuralgia and pain syndrome in diabetic neuropathy in adults.

Contraindications

• hereditary galactose deficiency, glucose-galactose malabsorption, lactase deficiency;
• acute pancreatitis;
• pregnancy and the period of breastfeeding (except in cases of urgent need);
• hypersensitivity to any of the components of Gabagamma.

According to the instructions, Gabagammu should be used with caution in psychotic diseases and kidney failure.

Instructions for the use of Gabagamma: method and dosage

Gabagamma is a drug for oral administration. Food intake does not affect its effectiveness. The capsules should be swallowed whole.

Neuropathic pain in adults

The initial daily dose of Gabagamma is 900 mg. If necessary, the dose is gradually increased. The maximum daily dose is 3600 mg.

It is allowed to start treatment immediately with a daily dose of 900 mg - 300 mg 3 times a day, or you can adhere to the following scheme: the first day - 300 mg once, the second day - 300 mg twice a day, the third day - 300 mg three times a day …

Partial seizures in adults and children from 12 years of age

The average effective daily dose of Gabagamma can range from 900 to 3600 mg.

At the beginning of treatment, you can prescribe a daily dose of 900 mg - 300 mg 3 times a day, or gradually increase the dose according to the scheme described above. Further, if necessary, the dose is continued to increase. The maximum allowable dose is 3600 mg in 3 divided doses.

To avoid the resumption of seizures, the interval between doses should not exceed 12 hours.

Separate categories of patients

For patients with renal insufficiency, the daily dose of Gabagamma is reduced depending on the creatinine clearance (CC, ml / minute):

• > 80 - 900–3600 mg;
• 50–79 - 600–1800 mg;
• 30-49 - 300-900 mg;
• 15-29 - 150 * -600 mg;
• <15 - 150 * - 300 mg.

The daily dose is divided into 3 doses.

* Assign 300 mg every other day.

For patients on hemodialysis who have not previously received gabapentin, Gabagamma is prescribed in a saturating dose of 300-400 mg, during hemodialysis - 200-300 mg every 4 hours.

Patients who have undergone organ transplantation, people with low weight, weakened, as well as patients in a serious general condition, the dosage should be increased gradually using capsules at a dose of 100 mg.

Side effects

Classification of side effects depending on the frequency of their occurrence: very often - more than 10% of cases, often - 1-10%, infrequently - 0.1-1%, rarely - 0.01-0.1%, very rarely - less than 0, 01%, including individual cases, the frequency is unknown - based on the available data, it is not possible to determine the frequency of adverse reactions.

Possible side effects of Gabagamma:

• infections and parasitic diseases: very often - viral diseases; often - respiratory diseases, otitis media, pneumonia, viral infections, urinary tract infections;
• from the nervous system: very often - ataxia, dizziness, drowsiness; often - dysarthria, insomnia, hyperkinesis, headache, amnesia, tremors, convulsions, impaired coordination of movements, decreased, increased or absent reflexes, nystagmus, decreased or impaired sensitivity (for example, paresthesia); infrequently - hypokinesia; frequency unknown - other disorders of motor functions (including dyskinesia, choreoathetosis, dystonia);
• on the part of the psyche: often - thinking disorders, confusion of consciousness and emotional lability, increased nervous irritability, depression, hostility, anxiety; frequency unknown - hallucinations;
• from the immune system: infrequently - hypersensitivity syndrome, allergic reactions (including urticarial rash);
• from the respiratory system: often - rhinitis, pharyngitis, shortness of breath, cough, bronchitis;
• from the blood system: often - leukopenia; frequency unknown - thrombocytopenia;
• from the side of blood vessels and heart: often - hypertension, vasodilation; infrequently - palpitations;
• from the gastrointestinal tract: often - problems with teeth, dry mouth and throat, gingivitis, flatulence, abdominal pain, nausea, vomiting, constipation, diarrhea; frequency unknown - pancreatitis;
• from the kidneys and urinary tract: the frequency is unknown - urinary incontinence, acute renal failure;
• on the part of the organ of vision: often - visual impairment (double vision, decreased visual acuity);
• on the part of the organ of hearing, labyrinth disorders: often - vertigo; frequency unknown - ringing in the ears;
• from the connective tissue and musculoskeletal: often - convulsive twitching, back and joint pain, muscle pain; frequency unknown - myoclonus, rhabdomyolysis;
• from the liver and biliary tract: frequency unknown - jaundice, hepatitis;
• from the side of metabolism and nutrition: often - increased appetite, anorexia;
• from the genitals and breast: often - impotence; frequency unknown - gynecomastia, breast hypertrophy;
• on the part of the skin and subcutaneous tissues: often - itching, skin rash, facial swelling, acne, hemorrhagic rash (often described as bruising as a result of physical injury); frequency unknown - erythema multiforme, angioedema, alopecia, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS syndrome);
• general disorders: very often - fatigue, fever; often - flu-like syndrome, asthenia, malaise, pain, gait disturbances, peripheral edema; infrequently - generalized edema; frequency unknown - withdrawal syndrome (anxiety, sweating, chest pain, nausea, insomnia);
• laboratory and instrumental studies: often - an increase in body weight, a lowered content of leukocytes in the blood; infrequently - an increase in the concentration of bilirubin and liver enzymes; the frequency is unknown - an increase in the activity of creatine phosphokinase, in patients with diabetes mellitus - fluctuations in the concentration of glucose in the blood;
• others: often - accidental injuries, fractures, abrasions.

There have been reports of the development of myopathy with an increase in creatine kinase activity in patients on hemodialysis with end-stage renal failure.

Cases of acute pancreatitis and sudden death are known, but causal relationships with the use of gabapentin have not been established.

Otitis media, respiratory tract infections, bronchitis, seizures, aggressive behavior and hyperkinesis have been identified in clinical studies in children.

Overdose

Symptoms of an overdose of Gabagamma are an increase in the severity of adverse reactions, dizziness, drowsiness, speech impairment, diplopia and lethargy. In this case, gastric lavage is indicated with further intake of activated carbon and the appointment of symptomatic therapy. In patients with severe renal failure, hemodialysis gives good results.

special instructions

If it is necessary to reduce the dose of Gababamma, cancel it or replace it with an alternative therapy, the dose should be gradually reduced - at least for 1 week.

Some patients receiving gabapentin may experience an increased frequency of seizures or new types of seizures. The use of gabapentin as a monodrug in patients resistant to anticonvulsants is ineffective.

In rare cases, gabapentin can cause severe, life-threatening systemic hypersensitivity reactions. These include DRESS syndrome (drug rash with eosinophilia). Early manifestations of hypersensitivity include fever and / or lymphadenopathy (swollen lymph nodes) and may not have a rash. If such symptoms appear, you should immediately stop taking Gabagamma and consult a doctor.

Among patients who have been prescribed antiepileptic drugs for several indications, there have been cases of suicidal thoughts and behavior, in connection with which carers should be closely monitored, and if suspicious signs appear, consult a doctor. In this case, concomitant therapy is indicated.

Gababamma is ineffective for primary generalized seizures such as absence seizures, and may worsen the course in some patients.

Gababamma should be used with caution in the treatment of patients with mixed convulsive seizures, including those with absence epilepsy.

The drug acts on the central nervous system and can cause disturbances such as drowsiness and dizziness. Most often, they are noted at the beginning of treatment and during the dose increase period. Even in a mild degree, these phenomena can be potentially dangerous when driving a car and working with complex machinery.

Application during pregnancy and lactation

Mothers taking antiepileptic drugs have a 2-3 times higher risk of having children with congenital malformations. Most often, there are reports of cases of the birth of children with neural tube defects, malformations of the cardiovascular system and a cleft lip. Prescribing several antiepileptic drugs as part of complex therapy increases the risk of birth defects to a greater extent than monotherapy. Therefore, during pregnancy, the latter is preferred whenever possible. For women of reproductive age who require anticonvulsant treatment, consultation with a doctor is recommended.

The need for continued therapy with anticonvulsants should be reassessed if a woman is planning a pregnancy. Abrupt withdrawal of antiepileptic drugs is not recommended, as this can provoke a resumption of seizures and lead to serious consequences for the health of the mother and child. Developmental delays in children born to patients with epilepsy are rare. It is almost impossible to determine exactly what causes the developmental delay (use of antiepileptic drugs, maternal epilepsy, or genetic and social factors).

There is no information on the use of gabapentin in pregnant women. The results of experiments on animals confirm the presence of reproductive toxicity. The potential risk of taking the drug during pregnancy in humans has not been determined, therefore Gababamma is contraindicated for use in pregnant women, unless the intended benefits of treatment for the mother outweigh the possible risks to the fetus.

Accurate conclusions about the existence of an increased risk of congenital malformations in cases where the expectant mother took gabapentin cannot be drawn, since epilepsy itself and concomitant treatment with anticonvulsants were present in every report on the use of this drug during pregnancy.

Gabapentin passes into mother's milk. Since its effect on infants during lactation is unknown, precautions must be taken when prescribing Gababamma to a nursing mother. Gabapentin is recommended for use during breastfeeding only if the intended benefits of therapy to the mother outweigh the possible risks to the baby.

Pediatric use

Gababamma is used in children over 12 years old. Information on the effect of gabapentin on the intelligence, learning and development of children and adolescents undergoing prolonged (more than 36 weeks) drug treatment is insufficient. Therefore, when assessing the benefits of long-term therapy, possible health risks must be taken into account.

Use in the elderly

Systematic studies of the use of gabapentin in patients aged 65 years and older have not been conducted. The results of a double-blind study confirmed that the percentage of elderly patients with neuropathic pain in whom the drug is accompanied by asthenia, peripheral edema and drowsiness is slightly higher than in the case of younger people. At the same time, clinical studies conducted in this age group do not prove that the profile of adverse reactions differs significantly from that observed in younger patients.

Drug interactions

No interaction reactions were observed between gabapentin and valproic acid, phenytoin, phenobarbital, carbamazepine, oral contraceptives containing norethindrone and / or ethinyl estradiol.

With the simultaneous use of morphine, depression of the central nervous system is possible, therefore, patients should be closely monitored. A dose reduction of one or the other drug may be required.

The equilibrium state of gabapentin pharmacokinetics is the same for healthy individuals and patients with epilepsy receiving other anticonvulsants.

Antacids containing magnesium and aluminum reduce the bioavailability of gabapentin by 24%, and therefore a minimum of 2-hour intervals should be maintained between taking these agents.

Probenecid does not alter the renal excretion of gabapentin.

Cimetidine slightly reduces the renal excretion of gabapentin, but this interaction has no clinical significance.

Analogs

Analogs of Gabagamma are: Konvalis, Gabapentin, Lepsitin, Gapentek, Egipentin, Tebantin, Katena.

Terms and conditions of storage

Store out of the reach of children, at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Gabagamma

Most often, reviews about Gabagamma are left by patients who have used this drug for herpetic neuralgia, diabetic neuropathy and trigeminal neuralgia as monotherapy. Gabapentin is considered one of the first-line drugs for the treatment of these diseases, and it is usually taken at a dose of 1200–3600 mg per day. Patients note a pronounced analgesic effect, which many achieved even when taking small daily doses of 1200 or even 900 mg. They all report improved sleep during drug treatment.

Basically Gababamma is well tolerated, and only occasionally some patients experience side reactions: nausea, abdominal pain, headache. The advantages of the drug are considered to be the absence of hepatic metabolism, which is important for patients with liver diseases, and clinically significant interactions with most drugs.

Price for Gabagammu in pharmacies

On average, the price for Gababamma with a dosage of 300 mg is 367-395 rubles (for a package containing 20 capsules) or 900-990 rubles (for a package containing 50 capsules). You can buy a drug with a dosage of 400 mg for about 416-500 rubles (for a package containing 20 capsules) or 1030-1165 rubles (for a package containing 50 capsules). The drug with a dosage of 100 mg is currently not on sale.

Gabagamma: prices in online pharmacies

Drug name Price Pharmacy

Gababamma 300 mg hard gelatin capsules 20 pcs. 287 r Buy

Gababamma capsules 300mg 20 pcs. 353 r Buy

Gababamma 400 mg capsules, gelatinous hard 20 pcs. 449 r Buy

Gababamma 300 mg hard gelatin capsules 50 pcs. 716 RUB Buy

Gababamma capsules 300mg 50 pcs. 843 RUB Buy

Gababamma 400 mg hard gelatin capsules 50 pcs. 986 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!