Lyrics

Lyrics – antiepileptic medicine.

Form of release and structure

The drug Lyrics is produced in the form of capsules: firm, gelatinous, with the text of "Pfizer" put with ink of black color on a lid, on the case – a dosage and a code; contents of capsules – almost white or white color powder:

• 25 mg: size No. 4, white; on the case - "PGN 25" (in blisters on 14 pieces, on 1 blister in a cardboard pack);
• 50 mg: the size No. 3, white with a black strip on the case; on the case - "PGN 50" (in blisters on 10 pieces, on 10 blisters in a cardboard pack; in blisters on 14 pieces, on 1 or 4 blisters in a cardboard pack; in blisters on 21 pieces, on 4 blisters in a cardboard pack);
• 75 mg: the size No. 4, with the white case and a lid from red-brown till dark red-brown color; on the case - "PGN 75" (in blisters on 14 pieces, on 1 or 4 blisters in a cardboard pack);
• 100 mg: the size No. 3, from red-brown till dark red-brown color; on the case - "PGN 100" (in blisters on 10 pieces, on 10 blisters in a cardboard pack; in blisters on 14 pieces, on 1 or 4 blisters in a cardboard pack; in blisters on 21 pieces, on 4 blisters in a cardboard pack);
• 150 mg: size No. 2, white; on the case - "PGN 150" (in blisters on 14 pieces, on 1 or 4 blisters in a cardboard pack);
• 200 mg: the size No. 1, from light - red-brown till red-brown color; on the case - "PGN 200" (in blisters on 10 pieces, on 10 blisters in a cardboard pack; in blisters on 14 pieces, on 1 or 4 blisters in a cardboard pack; in blisters on 21 pieces, on 4 blisters in a cardboard pack);
• 300 mg: the size No. 0, with the white case and a lid from dark red-brown till red-brown color; on the case - "PGN 300" (in blisters on 14 pieces, on 1 or 4 blisters in a cardboard pack).

Is a part of 1 capsule:

• Active ingredient: прегабалин – 25, 50, 75, 100, 150, 200 or 300 mg;
• Auxiliary components (respectively): monohydrate of lactose – 35/70/8,25/11/16,5/22/33 mg, corn starch – 20/40/8,375/11,17/16,75/22,33/33,5 mg, talc – 20/40/8,375/11,17/16,75/22,33/33,5 mg.

Enters into structure of the case and lids of capsules:

• 25, 50 and 150 mg (case and lid), 75 and 300 mg (case): titanium dioxide – 2,4423%, gelatin – to 100%;
• 75 mg (lid), 100 mg (case and lid): dye red iron oxide – 1,7361%, titanium dioxide – 0,409%, gelatin – to 100%;
• 200 mg (case and lid): dye red iron oxide – 0,4398%, titanium dioxide – 0,4144%, gelatin – to 100%;
• 300 mg (lid): dye red iron oxide – 0,7361%, titanium dioxide – 0,409%, gelatin – to 100%.

Composition of ink of capsules: shellac, strong solution of ammonia, ethanol, isopropanol, potassium hydroxide, butanol, propylene glycol, dye black iron oxide, the purified water.

Indications to use

• Generalized alarming frustration;
• Neyropatichesky pain;
• Fibromyalgia;
• Epilepsy (as additional therapy at partial convulsive attacks which are followed by secondary generalization or without it).

Contraindications

• Rare hereditary diseases, including intolerance of a galactose, disturbance of absorption of galactose/glucose and lactose intolerance;
• Age up to 17 years inclusive (data on safety and efficiency of use of drug for this age category of patients are absent);
• Hypersensitivity to drug components.

The lyric poet needs to take with caution against the background of renal and heart failure, and also to patients with existence of medicinal dependence in the anamnesis (during therapy behind them careful medical control is necessary).

The feeding women for the period of treatment need to interrupt breastfeeding. It is possible to appoint Lyrics during pregnancy only after advantage ratio assessment for health of mother with probable risk for a fruit.

Women at reproductive age need to apply adequate methods of contraception.

Route of administration and dosage

To accept capsules inside, does not accord meal on efficiency of drug of influence.

The daily dose can fluctuate within 150-600 mg, frequency rate of reception –2-3 times a day.

The mode of dosing depends on indications. The initial dose at treatment of epilepsy, neyropatichesky pain, fibromyalgia and generalized alarming frustration makes 150 mg a day. In 3-7 days (is defined by portability of drug and the reached effect) its increase twice (is possible at insufficient effect – to 450 mg a day). In case of need, but not earlier than in 7 days, the daily dose can be increased to maximum – 600 mg.

It is necessary to cancel Lyrics gradually, at least, within one week.

At functional disturbances of kidneys the dose for men and women is selected taking into account the clearance of creatinine (CC) individually:

• Men: KK (ml a minute) = (body weight in kg) x (140 – age advanced in years) / 72 x serumal creatinine (mg/dl);
• Women: KK (ml a minute) = 0,85 x KK value for men.

The patient who is on a hemodialysis the daily dose of Lyrics is selected taking into account function of kidneys (depending on clearance of creatinine there is a daily starting/maximum dose and frequency rate of reception):

• ≥60 ml a minute: 150/600 mg, 2-3 times a day;
• ≥30 and <60 мл в минуту: 75/300 мг, 2-3 раза в день;
• ≥15 and <30 мл в минуту: 25-50/150 мг, 1-2 раза в день;
• <15 мл в минуту: 25/75 мг, 1 раз в день.

After each four-hour session of a hemodialysis the additional dose is once appointed: starting – 25 mg, maximum – 100 mg.

Dose adjustment with functional disturbances of a liver is not required from patients.

Decrease in a dose of a pregabalin can be required by elderly patients of 65 years because of depression of function of kidneys.

In case of the admission of reception of a dose, it needs to be accepted as soon as possible, however it is not necessary to increase the following dose.

Side effects

Drowsiness and dizziness belongs to the most widespread side effects. Usually these phenomena are characterized by an easy or moderate current, however in some cases they can become causal cancellation of therapy. Other side effects because of which cancelled treatment were: lack of coordination and attention, peripheral hypostases, ataxy, confusion of consciousness, adynamy and illegibility of sight. These side effects can be a consequence of a basic disease or to be caused by the accompanying therapy.

During use of Lyrics the following disturbances can develop:

• Nervous system: very often – drowsiness, dizziness; often – an ataxy, a dysarthtia, a lethargy, a tremor, disturbances of attention, balance and coordination, paresthesia, sedative action, a memory impairment, amnesia; infrequently – disturbance of the speech, a nystagmus, a stupor, cognitive frustration, a hypesthesia, myoclonic spasms, weakening of reflexes, postural dizziness, a burning sensation on mucous membranes and skin, a syncope, an intentsionny tremor, psychomotor excitement, dyskinesia, loss of flavoring feelings, a hyperesthesia; seldom – a hypokinesia, a dysgraphia, a parosmiya;
• System of a hemopoiesis: seldom – a neutropenia;
• Respiratory system: infrequently – cough, short wind, a xeromycteria; seldom – feeling of constraint in a drink, bleeding from a nose, a nose congestion, rhinitis, snore;
• Alimentary system: often – dryness in a mouth, abdominal distention, a meteorism, a lock, vomiting; infrequently – a gastroesophageal reflux, easing of sensitivity of a mucous membrane of an oral cavity, the increased salivation; seldom – ascites, a dysphagy, pancreatitis;
• Reproductive system: often – erectile dysfunction; infrequently – an ejaculation delay, sexual dysfunction; seldom – a dysmenorrhea, allocations from mammary glands and increase them in volume, an amenorrhea, pain in chest glands;
• Musculoskeletal system: infrequently – an arthralgia, twitchings of muscles, a mialgiya, a swelling of joints, spasms and constraint in muscles, pain in a back and extremities; seldom – trachelisms, neck pain, рабдомиолиз;
• Cardiovascular system: infrequently – tachycardia, a cold snap of extremities, inflows, decrease or increase in arterial pressure, AV blockade of the I degree; seldom – a sinus arrhythmia, tachycardia and bradycardia;
• Urinary system: infrequently – a dysuria, an urine incontience; seldom – a renal failure, an oliguria;
• Organ of sight: often – a diplopia, a sight illegibility; infrequently – puffiness of eyes, eye pain, decrease in visual acuity, an asthenopia, narrowing of fields of vision, the raised dacryagogue, dryness in eyes; seldom – squint, irritation of eyes, flashing of sparks before eyes, an ostsillopsiya, loss of peripheral sight, a mydriasis, disturbances of perception of depth of sight, strengthening of brightness of visual perception;
• Bodies of a vestibular mechanism and hearing: often – dizziness; infrequently – a hyperacusia;
• Mentality: often – decrease a libido, irritability, euphoria, confusion of consciousness, a disorientation, sleeplessness; infrequently – concern, lability of mood, depersonalization, apathy, hallucinations, the panic attacks, an anorgazmiya, a depression, difficulties in selection of words, agitation, the suppressed mood, strengthening of a libido and sleeplessness, unusual dreams; seldom – disinhibition, high spirits;
• Invasions and infections: infrequently – a nasopharyngitis;
• Dermatological reactions: infrequently – perspiration, a dermahemia, papular rash; seldom – a small tortoiseshell, cold sweat;
• Metabolism: often – increase in appetite and body weight; infrequently – anorexia, a hypoglycemia; seldom – decrease in body weight;
• Laboratory indicators: infrequently – increase in activity of a kreatinfosfokinaza, aspartate aminotransferase, alaninaminotranspherase, reduction of quantity of thrombocytes; seldom – decrease in potassium level blood, increase in content in blood of creatinine and glucose, reduction in blood of quantity of leukocytes;
• Others: often – gait disturbance, peripheral hypostases, feeling of intoxication, fatigue; infrequently – a fever, generalized hypostases, pain, an adynamy, falling, thirst, feeling of constraint in a breast; seldom – a hyperthermia.

When carrying out post-marketing observations at use of Lyrics the following side effects were noted:

• Cardiovascular system: lengthening of an interval of QT, chronic heart failure;
• Respiratory system: fluid lungs;
• Nervous system: spasms, loss of consciousness, headache, cognitive disturbances;
• Alimentary system: seldom – a paraglossa, nausea, diarrhea;
• Reproductive system: gynecomastia;
• Urinary system: ischuria;
• Organ of sight: keratitis, sight loss;
• Allergic and dermatological reactions: seldom – a skin itch, hypersensitivity reactions, Stephens-Johnson's syndrome, angioneurotic reactions, including a face edema;
• Others: increased fatigue.

Special instructions

During use of Lyrics, in cases when against the background of a diabetes mellitus at patients increase in body weight is observed, correction of doses of the used hypoglycemic drugs can be required.

During treatment development of drowsiness and dizziness is possible that at patients of advanced age can become the reason of accidental falling and injuries. During post-market researches cases of a loss of consciousness, emergence of confusion of consciousness and disturbances of cognitive functions were also noted.

Antiepileptic medicines (including Lyrics) can increase risk of development of suicide behavior or thoughts therefore for the patients undergoing treatment careful medical observation is necessary.

At emergence of signs of a Quincke's disease (in the form of perioral hypostasis, a face edema or puffiness of tissues of upper airways) therapy needs to be interrupted.

The illegibility of sight and other disturbances from an organ of sight usually pass without additional therapy after drug withdrawal.

Also during treatment development of a renal failure was in some cases noted, sometimes after therapy cancellation function of kidneys was recovered.

After treatment (long or short-term) cancellation of Lyrics can lead to development of the following undesirable phenomena: dizziness, depression, perspiration, alarm, headache, nausea, spasms, sleeplessness, diarrhea, grippopodobny syndrome.

Frequency of emergence of disturbances from the central nervous system, in particular drowsiness, increases during therapy of the central neyropatichesky pains connected with damage of a spinal cord. Also it can be connected with summing of actions of Lyrics with at the same time accepted medicines (for example, anti-spastic) that needs to be considered when performing treatment of neyropatichesky pains.

During therapy encephalopathy, in particular at patients with the accompanying diseases which can lead to its emergence can develop.

Because during use of Lyrics drowsiness and dizziness can develop, to manage vehicles, and also to carry out other potentially dangerous types of works till the moment, extent of impact of drug on the patient will not be found out yet, it is not recommended.

Medicinal interaction

Because the Lyrics is removed in not changed view with urine, is exposed to insignificant metabolism at the person, does not contact proteins of plasma, and also does not inhibit metabolism of other drugs, probability that drug can enter pharmacokinetic interaction, rather low.

At simultaneous use of Lyrics with some medicines there can be following effects:

• Other medicines oppressing the central nervous system: development of a coma and disturbance of breath;
• The drugs causing a lock (for example, non-narcotic analgesics): disturbance of work of digestive tract, including emergence of paralytic Ilheus, a lock, intestinal impassability;
• Oxycodone: disturbance of motive and cognitive functions;
• Lorazepam, ethanol: strengthening of their effects.

Terms and storage conditions

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

Period of validity – 3 years.