Konvalis

Konvalis – drug with antiepileptic and analgeziruyushchy action.

Form of release and structure

Konvalis release in the form of capsules: yellow, size No. 0; contents of capsules – crystal powder white with slightly yellowish shade or white color (on 10 pieces in blister strip packagings, on 3 or 5 packagings in a cardboard pack).

Is a part of 1 capsule:

• Active agent: габапентин – 300 mg;
• Auxiliary components: talc – 3 mg, monohydrate of lactose – 66 mg, prezhelatinizirovanny corn starch – 30 mg, magnesium stearate – 1 mg;
• Case of capsules: dye iron oxide yellow – 0,6286%, titanium dioxide – 2%, gelatin – to 100%.

Indications to use

• Epilepsy (as monotherapy or along with other medicines at adults and children of 12 years at treatment of partial epileptic attacks, including proceeding with secondary generalization);
• Neyropatichesky pains (treatment at adults).

Contraindications

• Lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption;
• Acute pancreatitis;
• Age up to 12 years;
• Hypersensitivity to drug components.

Patients with a renal failure Konvalis should take with caution.

Due to the lack of necessary data drug during pregnancy can be accepted only in cases if the advantage of therapy is higher than potential harm. During a lactation in need of performing treatment breastfeeding needs to be interrupted.

Route of administration and dosage

Konvalis accept inside, washing down with liquid in necessary quantity, regardless of meal. It is not necessary to chew capsules.

At treatment of partial epileptic attacks at adults and children of 12 years (as monotherapy or along with other medicines) the initial dose makes 300 mg (1 capsule) once a day. The daily dose is gradually increased to 900 mg, increasing frequency rate of administration of drug: the second day – 2 times a day, the third day – 3 times a day. If necessary perhaps further increase in a dose.

The average daily dose (in 3 equal receptions) makes 3-4 capsules, maximum – 12 capsules. To avoid resuming of spasms, the maximum break between reception of doses of drug should not be more than 12 hours.

At treatment of neyropatichesky pains at adults the initial dose makes 300 mg once a day. Then for two days frequency rate of reception is increased to 3 times a day. At megalgias drug in a daily dose of 900 mg (in 3 receptions) can be accepted from the first day. Depending on reaction to treatment perhaps gradual increase in a dose, but no more than 12 capsules a day.

At functional disturbances of kidneys the mode of dosing is defined by the level of clearance of creatinine (daily dose):

• 50-79 ml a minute: 2-6 capsules;
• 30-49 ml a minute: 1-3 capsules;
• 15-29 ml a minute: 1-2 capsules;
• To 15 ml a minute: 1 capsule (reception every other day is possible).

The initial dose at the patients who are on a hemodialysis makes 300 mg. In addition after each four-hour session of a hemodialysis appoint the same dose. In days when dialysis is not carried out, drug should not be accepted.

Side effects

At Konvalis's use at neyropatichesky pains development of the following side effects is possible:

• Respiratory system: pharyngitis, short wind;
• Central nervous system: tremor, gait disturbance, ataxy, amnesia, confusion of consciousness, hypesthesia, dizziness, disturbance of thinking, drowsiness;
• Alimentary system: abdominal pains, a lock, a meteorism, dryness in a mouth, diarrhea, dyspepsia, vomiting, nausea;
• Sense bodys: amblyopia;
• Integuments: skin rash;
• Others: peripheral hypostases, headache, asthenic and grippopodobny syndromes, pains of various localization, infectious diseases, increase in body weight.

At Konvalis's use for treatment of partial spasms disturbances from some systems of an organism can develop:

• Alimentary system: nausea, vomiting, anorexia, a meteorism, an ulitis, a lock, an abdominal pain, a disease of teeth, dyspepsia, diarrhea, dryness in a drink or in a mouth, increase in appetite;
• Cardiovascular system: vazodilatation symptoms, increase or lowering of arterial pressure;
• Central nervous system: emotional lability, hyperkinesias, dizziness, absence, easing or strengthening of tendon jerks, paresthesia, hostility, concern, amnesia, confusion of consciousness, ataxy, depression, incoordination of movements, dysarthtia, drowsiness, sleeplessness, nystagmus, disturbance of thinking, fibrillation of muscles, tremor;
• Respiratory system: pneumonia, pharyngitis, cough, rhinitis;
• Urinary system: infections of uric ways;
• Hemopoietic system: a leukopenia, a purpura (as a rule, it is described as the bruises arising at a physical injury);
• Reproductive system: impotence;
• Musculoskeletal system: a mialgiya, dorsodynias, an arthralgia, the increased fragility of bones;
• Sense bodys: amblyopia, vision disorders, diplopia;
• Integuments: skin rash, grazes, itch of skin, acne;
• Others: peripheral hypostases, asthenic syndrome, headache, face edema, fever, exhaustion, viral infection, increase in body weight.

When comparing portability of Konvalis in daily doses of 300 and 3600 mg the dozozavisimost of such phenomena as an ataxy, dizziness, drowsiness, a nystagmus and paresthesia was noted.

When carrying out post-registration researches cases of inexplicable sudden death which connection with treatment by Konvalis was not established were noted. In the course of therapy such side effects as can develop: thrombocytopenia, an acute renal failure, various allergic reactions, dysfunction of a pancreas and liver, a gynecomastia, increase in volume of mammary glands, heartbeat, hallucinations, motive frustration (in the form of a myoclonus, dyskinesia, dystonia), frustration of an urination, a sonitus.

After sharp drug withdrawal the following disturbances were most often noted: perspiration, concern, nausea, sleeplessness, pains of various localization.

In case of aggravation of any of the specified side effects or at development of other disturbances which are not specified in the instruction it is necessary to consult at the doctor.

Special instructions

At a diabetes mellitus there can be a need for dose adjustment of hypoglycemic medicines.

During Konvalis's use in the analysis of urine on crude protein with use of the Ames N-Multistix SG test system obtaining false positive result is possible. The received result needs to be confirmed by means of other method.

At development of symptoms of acute pancreatitis therapy should be interrupted.

During Konvalis's reception the increased risk of development of suicide thoughts and suicides is possible. Control of a mental condition of patients is necessary for early detection of behavior disorders which can be harbingers of suicide acts and thoughts.

It is necessary to cancel treatment or to replace Konvalis with alternative drug gradually, at least for 7 days. Sharp drug withdrawal at patients with partial spasms can lead to development of spasms.

During therapy it is necessary to abstain from driving and performance of potentially dangerous types of the works demanding bystry psychomotor reactions and the increased concentration of attention.

Medicinal interaction

At joint appointment of Konvalis with some medicines there can be following effects (AUC – total concentration of substance in a blood plasma; _Cmax – the maximum concentration of substance in blood):

• Antiacid drugs with the content of aluminum or magnesium: decrease in bioavailability of a gabapentin (it is necessary to observe an interval not less than 2 hours between administrations of drugs);
• Morphine (at reception of morphine in 2 hours prior to Konvalis's reception): increase in average AUC value of a gabapentin by 44% (in comparison with monotherapy gabapentiny);
• Cimetidinum: insignificant decrease in renal excretion of a gabapentin;
• The ethanol and drugs operating on the central nervous system: strengthening of side effects of a gabapentin from the central nervous system;
• Naproxenum: increase in absorption of a gabapentin;
• Hydrocodon: increase in AUC of a gabapentin and reduction of AUC and _Cmax of a hydrocodon.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.