Algerika

Algerika – the drug having anticonvulsant effect.

Form of release and structure

Dosage form of release of Algeriki – the capsule: opaque, on a lid the press of black TEVA color, contains in capsules partially pressed and granulated powder of white or almost white color; on 25 mg – a lid and the case of light yellow color, a text on the case – "7622"; on 50 mg – a lid and the case of light yellow color with a radial black strip, a text on the case – "7623"; on 75 mg – a lid of pink color, the case of light yellow color with a text "7624"; on 150 mg – a lid and the case of light yellow color, a text on the case – "7626": on 300 mg – a lid of pink color, on the case of light yellow color a text "7621" (on 7 pieces in blisters, on 2 or 8 blisters in a cardboard pack).

Structure of 1 capsule:

• Active agent: прегабалин – 25, 50, 75, 150 or 300 mg;
• Additional components (25/50/75/150/300 mg): talc – 9/18/8/16/32 mg, Mannitolum – 43/86/10/20/40 mg, prezhelatinizirovanny corn starch – 7/14/7/14/28 mg.

Structure of a cover of capsules:

• 25 mg "7622/TEVA": size No. 3, 48 of mg; case: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%; lid: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%;
• 50 mg "7623/TEVA": size No. 2, 61 of mg; case: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%; lid: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%;
• 75 mg "7624/TEVA": size No. 3, 48 of mg; case: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%; lid: titanium dioxide – 2,1747%, dye iron oxide red – 0,6996%, gelatin – to 100%;
• 150 mg "7626/TEVA": size No. 2, 61 of mg; case: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%; lid: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%;
• 300 mg "7621/TEVA": size No. 0, 96 of mg; case: titanium dioxide – 2%, dye iron oxide yellow – 0,1%, gelatin – to 100%; lid: titanium dioxide – 2,1747%, dye iron oxide red – 0,6996%, gelatin – to 100%.

The ink used for drawing texts on capsules: pharmaceutical glaze (shellac solution in ethanol) – 59,42%, isopropanol – 0,55%, propylene glycol – 1,3%, butanol – 9,75%, ethanol – 1,08%, dye black iron oxide – 24,65%, water ammonia – 0,001%, the purified water – 3,249%.

Indications to use

Algerika is appointed for treatment at adult following diseases:

• Fibromyalgia;
• Neyropatichesky pain;
• Generalized alarming frustration;
• The epilepsy with partial convulsive attacks proceeding with secondary generalization or without it (as additional therapy).

Contraindications

Absolute:

• Age up to 18 years;
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Relative (Algerik is appointed with care in the presence of the following diseases / states):

• Diabetes mellitus;
• Functional disturbances of kidneys;
• Heart failure;
• Encephalopathy (anamnestic data);
• Medicinal dependence (anamnestic data);
• The combined use with ethanol, lorazepam, oxycodone;
• Age of 65 years.

Women of reproductive age during therapy need to use effective contraceptive methods.

Route of administration and dosage

Algerika is accepted inside, regardless of meal, washing down with water in enough. Capsules need to be swallowed entirely, without crushing and without chewing.

The daily dose varies within 150-600 mg, frequency rate of reception – 2-3 times a day. Duration of treatment is defined by the doctor individually depending on indications and specific features of the patient.

The initial daily dose at all indications makes 150 mg. In 3-7 days (is defined by reaction to therapy and individual portability) its increase is possible twice. In 7 days, in case of need, its increase to maximum – 600 mg is possible.

Cancellation of treatment is carried out gradually – for at least 7 days.

At functional disturbances of kidneys at selection of a dose consider the clearance of creatinine (CC) calculated by a formula:

• Men: KK (ml/min.) = (weight in kg) × (140 - age advanced in years)/72 × concentration of creatinine in plasma (mg/dl);
• Women: KK (ml/min.) = 0,85 × KK for men.

The patient who is on a hemodialysis the daily dose of Algeriki is selected taking into account function of kidneys, at the same time directly after holding each four-hour session of a hemodialysis it is necessary to accept an additional dose (KK / an initial daily dose / the maximum daily dose / frequency rate of use):

• From 60 ml/min.: 150 mg / 600 mg / 2-3 once a day;
• 30-60 ml/min.: 75 mg / 300 mg / 2-3 once a day;
• 15-29 ml/min.: 25-50 mg / 150 mg / 1-2 once a day;
• To 15 ml/min.: 25 mg / 75 mg / once a day.

The additional daily dose appointed once after dialysis: initial – 25 mg, daily – 100 mg.

Dose adjustment for the patients having functional disturbances of a liver is not required.

To patients of 65 years because of depression of function of kidneys Algerika can be appointed in the reduced doses.

At the admission of a single dose it needs to be accepted as soon as possible. It is not necessary to accept the doubled dose.

Side effects

At Algeriki's reception it can be observed development of the following disturbances (very often (≥10%); often (≥1% and <10%); infrequently (≥0,1% and <1%); seldom (≥0,01% and <0,1%); very seldom (<0,01%, considering isolated cases)):

• Nervous system: very often – drowsiness, dizziness; often – a syncope, sedative action, irritability, decrease a libido, euphoria, confusion of consciousness, sleeplessness, a disorientation, an ataxy, a lethargy, a tremor, a memory impairment, paresthesia, amnesia; infrequently – hallucinations, an anorgazmiya, depersonalization, strengthening of sleeplessness, concern, agitation, a depression, lability of mood, difficulty in selection of words, loss of flavoring feelings, the suppressed mood, increase in a libido, dreadful dreams, the panic attacks, cognitive frustration, apathy, a hypesthesia, a nystagmus, myoclonic spasms, weakening of reflexes, a hyperesthesia, dyskinesia, burning sensation on mucous membranes and skin, psychomotor initiation, postural dizziness, a stupor, an intentsionny tremor, disturbance of the speech, coordination, balance and attention; seldom – a parosmiya, high spirits, a disinhibition, a hypokinesia, a dysgraphia;
• Alimentary system: often – a meteorism, dryness of a mucous membrane of an oral cavity, vomiting, abdominal distention, a lock; infrequently – a hypesthesia of a mucous membrane of an oral cavity, a gastroesophageal reflux, the increased salivation; seldom – a dysphagy, ascites, pancreatitis;
• Cardiovascular system: infrequently – AV blockade of the I degree, a dermahemia, inflows, increase in arterial pressure, tachycardia; seldom – sinus tachycardia, arrhythmia and bradycardia;
• Hemopoietic system: seldom – a leukopenia, a neutropenia, thrombocytopenia;
• Infectious diseases: infrequently – a nasopharyngitis;
• Urinary system: infrequently – an urine incontience, a dysuria; seldom – an oliguria, a renal failure;
• Respiratory system: infrequently – an asthma, dryness of a mucous membrane of a nasal cavity; seldom – nasal bleeding, a nose congestion, rhinitis, feeling of constraint in a drink, snore;
• Reproductive system: often – erection dysfunction; infrequently – an ejaculation delay, sexual dysfunction; seldom – a dysmenorrhea, mammary gland pains, an amenorrhea, allocations from mammary glands, and also increase them in volume;
• Skeletal and muscular system: infrequently – hypostasis of joints, twitchings of muscles, muscular spasms, constraint of muscles, a mialgiya, an arthralgia, extremity and spin pain; seldom – pain in a neck, a trachelism, рабдомиолиз;
• Skin and hypodermic fabrics: infrequently – perspiration, papular rash; seldom – a small tortoiseshell, cold sweat;
• Acoustic organ and labyrinth disturbances: often – вертиго; seldom – a hyperacusia;
• Organ of sight: often – doubling, an illegibility of visual perception; infrequently – narrowing of fields of vision, a vision disorder, decrease in visual acuity, puffiness of eyes, eye pain, quickly coming exhaustion of eyes, the raised dacryagogue, dryness in eyes; seldom – a mydriasis, irritation of eyes, flashing of "sparks" before eyes, an ostsillopsiya, squint, disturbance of perception of depth of sight, strengthening of brightness of visual perception, loss of peripheral sight;
• Metabolism and food: often – increase in weight and appetite; infrequently – a hypoglycemia, anorexia, a hyperglycemia; seldom – reduction of weight;
• Tool and datas of laboratory: infrequently – increase in activity of a kreatinfosfokinaza, aspartate aminotransferase, alaninaminotranspherase; seldom – a hypopotassemia, a giperkreatininemiya;
• Others: often – feeling of intoxication, fatigue, gait disturbance, hypostases, including peripheral; infrequently – falling, an adynamy, thirst, generalized hypostases, feeling of constraint in breasts, a fever, pain; seldom – a hyperthermia.

The side reactions recorded when carrying out post-marketing observation:

• Nervous system: with an unknown frequency – a loss of consciousness, a headache, cognitive disturbances;
• Alimentary system: seldom – nausea, a paraglossa, diarrhea;
• Cardiovascular system: with an unknown frequency – lengthening of an interval of QT, chronic heart failure;
• Respiratory system: with an unknown frequency – a fluid lungs;
• Urinary system: with an unknown frequency – an ischuria;
• Skin and hypodermic fabrics: seldom – a skin itch, a face edema;
• Organ of sight: with an unknown frequency – sight loss;
• Allergic reactions: with an unknown frequency – a Quincke's disease, hypersensitivity reaction, allergic reaction, Stephens-Johnson's syndrome.

Special instructions

During therapy or right after Algeriki's cancellation development of the epileptic status and emergence of convulsive attacks as grand mal is possible.

Disturbances from an organ of sight (in the form of decrease in visual acuity, sight loss) take place, as a rule, independently, both at treatment cancellation, and at its continuation.

There are data on development reversible (after Algeriki's cancellation) a renal failure.

After completion of treatment development of a withdrawal is possible (frequency of emergence and degree of manifestation of symptoms depend on a dose and duration of a course).

At a diabetes mellitus in case of increase in weight against the background of performing therapy there can be a need of correction of doses of hypoglycemic medicines.

In cases if symptoms of a Quincke's disease appear, drug is immediately cancelled.

During administration of drug dizziness and drowsiness can develop that increases probability of development of accidental injuries (falling) in patients of advanced age. It is necessary to be careful until the patient does not estimate possible effects of drug.

At treatment of neyropatichesky pain elderly patients have messages on developing of chronic heart failure with diseases of cardiovascular system.

The risk of development of disturbances from the central nervous system (in particular, drowsiness) increases in cases when drug is used at treatment of a pain syndrome at spine injuries (it can be connected with interaction with other medicines, including spasmolysants).

At emergence of the suicide ideas or attempts it is necessary to see a doctor immediately.

The patient with anamnestic data on medicinal dependence on any drugs Algerika is appointed with care.

Side effects in the form of encephalopathy were observed, mainly, in the presence of the accompanying states contributing to development of a disease.

In need of the combined use with opioid analgetics it is necessary to take measures of prevention of intestinal impassability and locks, in particular at elderly patients.

During Algeriki's reception it is necessary to refrain from control of motor transport and potentially dangerous works which performance demands the increased concentration of attention and bystry psychomotor reactions (it is connected with a possibility of development of side reactions in the form of dizziness, drowsiness and vision disorders).

Medicinal interaction

Pharmacokinetic interaction of Algeriki with other substances / medicines is improbable.

Pregabalin strengthens the disturbances of the main caused by oxycodone motive and mnestichesky functions, and also effects of lorazepam and ethanol.

At the combined use with opioid analgetics of Algerik can provoke weakening of function of lower parts of digestive tract, including intestinal impassability and a lock.

Terms and storage conditions

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

Period of validity – 2 years.