Gabagamma, capsules 300 mg 50 pcs

• complex therapy of partial seizures with or without secondary generalization in adults and children from 12 years old;
• pain syndrome in diabetic neuropathy;
• postherpetic neuralgia in adults.
  

Active ingredient

Composition

Active substance:

Gabapentin 300 mg;

Ancillary substances:

Lactose;

Corn starch;

Talc;

Gelatin;

Titanium dioxide;

Iron oxide yellow;

Iron oxide red

How to take, the dosage

Orally, with or without food.

If it is necessary to reduce the dose, stop the drug, or replace it with an alternative remedy, this should be done gradually over at least one week.

Neuropathic pain in adults

The starting dose is 900 mg/day in 3 doses in equal doses; if necessary, the dose is gradually increased to a maximum of 3600 mg/day. The treatment may begin immediately with a dose of 900 mg/day (300 mg three times a day), or during the first three days the dose may be increased gradually to 900 mg/day in the following scheme: on day 1 – 300 mg of the drug once a day, on day 2 – 300 mg twice a day, on day 3 – 300 mg three times a day. It is also possible to use a dosage of 400 mg for patients who are either overweight or taller than average, similarly to titration of the 300 mg dosage.

Partial seizures in adults and children from 12 years of age

The effective dose is 900 to 3,600 mg/day. Therapy may be started with a dose of 300 mg 3 times daily on the first day or increased gradually to 900 mg according to the scheme described above (see “Neuropathic pain in adults”). Subsequently, the dose may be increased to 3600 mg/day(divided into 3 equal doses). The maximum interval between doses at 3 doses should not exceed 12 hours in order to avoid recurrence of seizures.

It is not necessary to monitor the plasma concentration of gabapentin. It may be used in combination with other anticonvulsants without regard to changes in its plasma concentrations or serum concentrations of other antiepileptic drugs.

Interaction

Morphine: when gabapentin and morphine were coadministered, when morphine was taken 2 hours before gabapentin, there was a 44% increase in the mean AUC of gabapentin compared to gabapentin monotherapy, which was associated with an increase in pain threshold (cold pressor test). The clinical significance of this change has not been established, and the pharmacokinetic characteristics of morphine were not altered. Side effects of morphine co-administration with gabapentin did not differ from those of morphine co-administration with placebo.

There were no interactions between gabapentin and phenobarbital, phenytoin, valproic acid and carbamazepine. Equilibrium pharmacokinetics of gabapentin are similar in healthy subjects and patients receiving other anticonvulsants.

The concomitant use of gabapentin with oral contraceptives containing norethindrone and/or ethinylestradiol was not accompanied by changes in the pharmacokinetics of both components.

The concomitant use of gabapentin with antacids containing aluminum and magnesium is accompanied by a decrease in the bioavailability of gabapentin by approximately 20%. It is recommended to take gabapentin about 2 hours after taking an antacid.

Probenecid does not affect renal excretion of gabapentin.

A slight decrease in renal excretion of gabapentin with concomitant administration of cimetidine is probably not clinically relevant.

Special Instructions

While withdrawal syndrome with seizures has not been reported with gabapentin treatment, abrupt discontinuation of therapy with antiepileptic drugs in patients with partial seizures may induce seizures (see “Administration and Doses”).

Gabapentin is not considered an effective treatment for absences epilepsy.

In patients who require concomitant therapy with morphine, an increased dose of gabapentin may be required. Patients should be closely monitored for signs of CNS depression such as drowsiness. In this case, the dose of gabapentin or morphine should be adequately reduced (see “Interaction with other medicinal products”).

Laboratory studies. When gabapentin is added to other anticonvulsants, false-positive results have been reported for urine protein determination using Ames N-Multistix SG® Test Strips. The more specific sulfosalicylic acid precipitation method is recommended for determining protein in urine.

The effect on the ability to drive and use machinery. Patients should avoid driving and performing work requiring rapid psychomotor reactions.

Contraindications

Side effects

Cardiovascular system: symptoms of vasodilation or increased blood pressure, palpitations.

Gastrointestinal system: flatulence, anorexia, gingivitis, abdominal pain, constipation, dental disease, diarrhea, dyspepsia, increased appetite, dry mouth or throat, nausea, vomiting, dental disease, increased activity of liver transaminases, hepatitis, jaundice, pancreatitis.

The blood system, lymphatic system: purpura (most commonly described as bruising from physical trauma), leukopenia, thrombocytopenia.

Muscular system: arthralgia, back pain, increased bone fragility, myalgia.

Nervous system: Dizziness; headache, hyperkinesias, muscle dyskinesia and dystonia, choreoathetosis, increased, weakened or absent reflexes; dysarthria, ataxia, nystagmus, paresthesias, seizures, confusion, increased fatigue, asthenia, amnesia, depression, thought disorder, hostility, emotional lability, insomnia, anxiety, somnolence, hallucinations.

Respiratory system: pneumonia, bronchitis, shortness of breath, respiratory infections, cough, pharyngitis, rhinitis.

Skin and subcutaneous tissues: acne, skin itching, skin rash, peripheral edema, erythema multiforme (including Stephen-Johnson syndrome).

Miniminary system: urinary tract infection, impotence, urinary incontinence, acute renal failure.

Sensory organs: visual impairment, amblyopia, diplopia, tinnitus, otitis media.

Others: fever, viral infection, weight gain, labile plasma glucose levels in diabetic patients, and pain of different localization.

Overdose

Symptoms: dizziness, diplopia, speech disorders, drowsiness, lethargy, diarrhea and increased severity of other side effects.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy. Hemodialysis may be indicated in patients with severe renal failure.

Similarities