Kovalis - instructions for use, reviews, analogs and forms of release (capsules or tablets 300 mg) of a drug for the treatment of epilepsy, including seizures and neuropathic pain in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Convalis. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Kovalys in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Constalis in the presence of existing structural analogues.Use for the treatment of epilepsy, epileptic seizures and neuropathic pain in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Convalis - similar in structure to the neurotransmitter GABA, however its mechanism of action differs from that of some other drugs interacting with GABA receptors, including valproic acid, barbiturates, benzodiazepines, inhibitors of GABA transaminase, GABA capture inhibitors, GABA agonists and prodrugs of GABA: it does not has GABA-ergic properties and does not affect the capture and metabolism of GABA.

Preliminary studies indicate that Gabapentin (the active ingredient of the drug Convalis) binds to the alpha2-gamma subunit of potential-dependent calcium channels and suppresses the flow of calcium ions, which plays an important role in the occurrence of neuropathic pain. Other mechanisms involved in the action of gabapentin in neuropathic pain are: reduction of glutamate-dependent neuronal death, an increase in GABA synthesis, inhibition of the release of neurotransmitters of the monoamine group. Gabapentin does not bind to other receptors at clinically significant concentrations, including the GABAA, GABAB, benzodiazepine, glutamate, glycine, or N-methyl-d-acanthate receptors.Unlike phenytoin and carbamazepine, gabapentin does not interact with sodium channels.

Composition

Gabapentin + auxiliary substances.

Pharmacokinetics

After ingestion of Cmax gabapentin in plasma is achieved after 2-3 hours. Absolute bioavailability of gabapentin in capsules is about 60%. Bioavailability is not proportional to the dose; When the dose is increased, it decreases. Food, incl. with a high fat content, does not affect the pharmacokinetics. Pharmacokinetics does not change with repeated application. Gabapentin practically does not bind to plasma proteins (less than 3%). It is excreted exclusively by the kidneys in unchanged form, it is not metabolized. The drug does not induce oxidative liver enzymes with a mixed function involved in the metabolism of drugs.

Indications

• epilepsy: in adults and children over 12 years - as a monotherapy or as part of combination therapy for the treatment of partial epileptic seizures, incl. proceeding with secondary generalization;
• for the treatment of neuropathic pain in adults.

Forms of release

Capsules 300 mg (sometimes mistakenly called pills).

Instructions for use and dosing regimen

The drug is taken orally, regardless of food intake, without chewing and washing down with the necessary amount of liquid.

Monotherapy and the use of Kovalis as an adjunct for the treatment of partial epileptic seizures in children over 12 years of age and adults

Treatment begins with a dose of 300 mg once a day and gradually increases to 900 mg per day (the first day - 300 mg once a day, the second - 300 mg twice a day, the third - 300 mg 3 times a day). In the future, the dose may be increased. Usually the dose of Convalys is 900-1200 mg per day. The maximum dose is 3600 mg per day, divided into three equal doses in 8 hours. The maximum interval between taking the doses of the drug should not exceed 12 hours in order to avoid the resumption of seizures.

Neuropathic pain in adults

Treatment starts with a dose of 300 mg on the first day, then: 600 mg (300 mg 2 times) on the second day, 900 mg (300 mg 3 times) on the third day. With intense pain, Kovalis can be used from the first day to 300 mg 3 times a day. Depending on the effect, the dose can be gradually increased, but not more than 3600 mg per day.

In patients with impaired renal function (with KK 50-79 ml / min) the daily dose of the drug is 600-1800 mg per day, with KK 30-49 ml / min - 300-900 mg per day, with KK 15-29 ml / min - 300-600 mg per day, with QC less than 15 ml / min - 300 mg every other day or every day.

In patients on hemodialysis, the initial dose of Convalis is 300 mg. The additional postgemodialysis dose is 300 mg after each 4-hour hemodialysis session. In days when dialysis is not carried out, Kovalis is not used.

Side effect

In the treatment of neuropathic pain:

• constipation, diarrhea;
• dry mouth;
• dyspepsia;
• flatulence;
• nausea, vomiting;
• abdominal pain;
• violation of gait;
• amnesia;
• ataxia;
• confusion of consciousness;
• dizziness;
• hypoesthesia;
• drowsiness;
• violation of thinking;
• tremor;
• dyspnea;
• pharyngitis;
• skin rash;
• amblyopia;
• asthenic syndrome;
• influenza-like syndrome;
• headache;
• infectious diseases;
• pain of different localization;
• peripheral edema;
• increase in body weight.

When treating partial seizures:

• symptoms of vasodilation;
• increase or decrease in blood pressure;
• flatulence;
• anorexia;
• gingivitis;
• abdominal pain;
• constipation, diarrhea;
• Disease of teeth;
• dyspepsia;
• increased appetite;
• dry mouth or throat;
• nausea, vomiting;
• purpura (most often it was described as bruising that occurs with physical trauma);
• leukopenia;
• arthralgia;
• backache;
• increased brittleness of bones;
• myalgia;
• dizziness;
• hyperkinesis;
• strengthening, weakening or absence of tendon reflexes;
• paresthesia;
• anxiety;
• hostility;
• amnesia;
• ataxia;
• confusion of consciousness;
• violation of coordination of movements;
• depression;
• dysarthria;
• emotional lability;
• insomnia;
• nystagmus;
• drowsiness;
• violation of thinking;
• tremor;
• fibrillation of muscles;
• pneumonia;
• cough;
• pharyngitis;
• rhinitis;
• acne;
• itching of the skin;
• skin rash;
• urinary tract infection;
• impotence;
• impaired vision;
• amblyopia, diplopia;
• asthenic syndrome;
• swelling of the face;
• fatigue;
• fever;
• headache;
• viral infection;
• peripheral edema;
• increase in body weight.

Post-registration application experience

Possible cases of sudden unexplained death are not associated with treatment with gabapentin. In the course of treatment with gabapentin the following undesirable phenomena can be observed:

• various allergic reactions;
• acute renal insufficiency;
• impaired liver function, pancreas;
• increased volume of mammary glands;
• gynecomastia;
• hallucinations;
• motor disorders (myoclonus, dyskinesia, dystonia);
• palpitation;
• thrombocytopenia;
• noise in ears;
• disorders of urination.

After abrupt abolition of gabapentin therapy, the most common side effects were anxiety, insomnia, nausea, pain of varying localization and sweating.

If any of the side effects indicated in the manual are aggravated or other side effects not indicated in the instructions are noted, you should inform the doctor about it.

Contraindications

• acute pancreatitis;
• children's age till 12 years;
• deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;
• hypersensitivity to the drug and / or its components.

Application in pregnancy and lactation

There is insufficient data on the use of Convalis in pregnant women. Do not use the drug during pregnancy, if the potential benefit to the mother does not exceed the possible risk to the fetus.

The drug penetrates into breast milk, the effect on children during breastfeeding is unknown, so during breastfeeding, the drug should be used only if the potential benefit to the mother from taking the drug clearly exceeds the potential risk for the baby.

Use in children

The use of the drug is contraindicated in children under 12 years of age.

special instructions

When analyzing urine for total protein using the Ames N-Multistix SG test system, a false positive result is possible. You must confirm the result with another method of analysis.

Patients with diabetes sometimes need a change in the dose of hypoglycemic drugs.

When there are signs of acute pancreatitis, drug treatment should be stopped.

Abolish the drug or replace it with an alternative drug should be gradually, at least within a week. A sharp cessation of therapy with anticonvulsants in patients with partial seizures can provoke the development of seizures.

There is an increased risk of suicide and suicidal thoughts. With the purpose of early detection of behavioral disorders, which may be harbingers of suicidal thoughts and actions, it is recommended to monitor the mental state of patients.

Caution should be given to Kovalis with renal insufficiency.

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, it is necessary to refrain from driving and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Drug Interactions

When simultaneous administration of gabapentin and morphine when morphine was taken 2 hours prior to gabapentin, the increase observed average AUC of gabapentin by 44% compared to a monotherapy gabapentin, which was associated with an increase in pain threshold (Kholodova pressor test). The clinical significance of this change has not been established, the pharmacokinetic characteristics of morphine remain unchanged. The side effects of morphine when taken together with gabapentin did not differ from those when taking morphine together with placebo.

Interactions between Convalys 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.

Simultaneous application of the Convalis with oral contraceptives containing norethisterone and / or ethinylestradiol,was not accompanied by changes in the pharmacokinetics of both components.

Antacid preparations containing aluminum or magnesium reduce the bioavailability of gabapentin by about 20%. In this regard, the drug should be taken no earlier than 2 hours after taking antacids.

Cimetidine slightly reduces renal excretion of gabapentin.

Ethanol (alcohol) and drugs acting on the central nervous system can increase the side effects of the Convalys from the side of the central nervous system.

With the simultaneous administration of Naproxen with gabapentin, the absorption of the latter increases, while gabapentin does not affect the pharmacokinetic parameters of naproxen.

The simultaneous use of gabapentin with hydrocodone leads to a decrease in the pharmacokinetic parameters (Cmax and AUC) of hydrocodone and an increase in gabapentin AUC.

Analogues of the drug Convalis

Structural analogs for the active substance:

• Gabagamma;
• Gabapentin;
• Gapentec;
• Caten;
• Neuronthin;
• Tebantin;
• Egipentin;
• Eplorontin.

Analogues for the pharmacological group (antiepileptic drugs):

• Actinerval;
• Algerian;
• Acetazolamide;
• Benzobarbital;
• Benzon;
• Valopixime;
• Valparin;
• Valproate sodium;
• Valproic acid;
• Habitryl;
• Gapentec;
• Depakin;
• Depakin chrono;
• Depamid;
• Diazepam;
• Diakarb;
• Diphenine;
• Zagreton;
• Zenicetam;
• Zonegran;
• Inovevelon;
• Carbaleptin retard;
• Carbamazepine;
• Carbapine;
• Keppra;
• Clonazepam;
• Comwiron;
• Convulex;
• Convulsant;
• Convulsofin;
• Lameptil;
• Lamitor;
• Lamotrigine;
• Levetinol;
• Levetiracetam;
• Lyrics;
• Mazepine;
• Maliazine;
• Mysolin;
• Neuronthin;
• Paglyuferal;
• Prabiegin;
• Pregabalin;
• Prigabilon;
• Relium;
• Replica;
• Ropimat;
• Sibazon;
• Storilate;
• Tebantin;
• Tegretol;
• Topalepsin;
• Topamax;
• Topiramate;
• Topiromax;
• Thoreal;
• Trileptal;
• Phenobarbital;
• Fimazepsin;
• Finlepsin;
• Finlepsin retard;
• Chloracon;
• Exalieff;
• Eltator;
• Enkorat;
• Epial;
• Epimax;
• Epitera;
• Epiterra Long;
• Epitropyl;
• Eplorontin.

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