Lyrics - drug with anticonvulsant action.
Release form and composition
Lyrics produced in the form of capsules:
- 25 mg each: solid gelatin, No. 4, with a body and a white lid, on the case black dosage and code “PGN 25, on the lid -“ Pfizer ”(14 pieces in blisters, 1 blister in a cardboard box);
- At 50 mg: solid gelatin, No. 3, with a white casing with a black stripe and a white lid, on the casing black dosage and the code “PGN 50, on the lid — Pfizer (10 pcs in blisters, 10 blisters in carton pack; 14 pieces in blisters, 1 or 4 blisters in a carton pack; 21 pieces in blisters, 4 blisters in a carton pack;
- On 75 mg: solid gelatin, No. 4, from white color by the case and a lid from dark red-brown to red-brown color; on the case in black ink indicates the dosage and the code "PGN 75", on the lid - "Pfizer" (14 pieces in blisters, 1 or 4 blisters in a cardboard box);
- On 100 mg: solid gelatin, No. 3, with the case and a lid from dark red-brown to red-brown color, on the case a black dosage and a code "PGN 100", on a lid - "Pfizer" (10 pieces in blisters , 10 blisters in a carton box; 14 pieces in blisters, 1 or 4 blisters in a carton box, 21 pieces in blisters, 4 blisters in a carton box;
- On 150 mg: solid gelatin, No. 2, with the case and a lid of white color; on the case in black ink indicates the dosage and code "PGN 150", on the lid - "Pfizer" (14 pieces in blisters, 1 or 4 blisters in a cardboard box);
- 200 mg: solid gelatin, No. 1, with a body and a lid from red-brown to light red-brown, on the case black dosage and the code "PGN 200", on the lid - "Pfizer" (10 pcs. In blisters , 10 blisters in a carton box; 14 pieces in blisters, 1 or 4 blisters in a carton box, 21 pieces in blisters, 4 blisters in a carton box;
- 300 mg: solid gelatinous, No. 0, from white color with body and lid from dark red-brown to red-brown; on the case in black ink indicates the dosage and code "PGN 300", on the lid - "Pfizer" (14 pieces in blisters, 1 or 4 blisters in a cardboard box).
The composition of 1 capsule includes:
- Active substance: pregabalin - 25, 50, 75, 100, 150, 200 or 300 mg.
- Auxiliary components: corn starch - 20/40 / 8.375 / 11.17 / 16.75 / 22.33 / 33.5 mg; lactose monohydrate - 35/70 / 8.25 / 11 / 16.5 / 22/33 mg; talc - 20/40 / 8,375 / 11,17 / 16,75 / 22,33 / 33.5 mg.
The composition of the body and caps of capsules:
- The body and cap of the capsules are 25, 50, 150 mg: titanium dioxide - 2.4423%; gelatin - up to 100%;
- The body of the capsules 75 mg: titanium dioxide - 2,4423%; gelatin - up to 100%;
- 75 mg capsule cap: iron dye red oxide - 1.7361%; titanium dioxide - 0.409%; gelatin - up to 100%;
- The body and cap of the capsules 100 mg: iron dye red oxide - 1.7361%; titanium dioxide - 0.409%; gelatin - up to 100%;
- The body and cap of the capsules 200 mg: iron dye red oxide - 0.4398%; titanium dioxide - 0.4144%; gelatin - up to 100%;
- The case of capsules of 300 mg: titanium dioxide - 2.4423%; gelatin - up to 100%;
- 300 mg capsule cap: iron dye red oxide - 0.7361%; titanium dioxide - 0.409%; gelatin - up to 100%.
The composition of the ink capsules: shellac, concentrated ammonia, ethanol, isopropanol, potassium hydroxide, butanol, propylene glycol, purified water, iron dye, black oxide.
Indications for use
- Neuropathic pain in adults;
- Generalized anxiety disorder in adults;
- Epilepsy: as an additional therapy in adults with partial convulsive seizures (with or without secondary generalization);
- Fibromyalgia in adults.
- Rare hereditary diseases, including galactose intolerance, impaired glucose / galactose absorption, and lactase deficiency;
- Age up to 17 years inclusive (due to the lack of data on the effectiveness and safety of the use of Lyrics in this category of patients);
- Hypersensitivity to the drug.
Lyrics should be taken with caution in renal and heart failure, as well as in patients with drug dependence in history (during treatment with the drug for such patients, close medical supervision is necessary).
Pregnant women Lyrics can be assigned only in cases of excess of the health benefits of the mother over the possible risk to the fetus. Women of reproductive age should use reliable methods of contraception. Breastfeeding women who are lactating at the time of therapy should be interrupted.
Dosing and Administration
Lyrics are taken orally, regardless of the meal.
The daily dose may vary in the range of 150-600 mg in 2 or 3 doses.
The scheme of use of the drug is determined by the indications. For neuropathic pain, epilepsy, generalized anxiety disorders and fibromyalgia, the initial daily dose is 150 mg. After 3-7 days (depending on tolerance and effect achieved), it can be increased by 2 times (in the absence of positive dynamics, it is increased to 450 mg per day). If necessary, a week later, the daily dose is increased to a maximum of 600 mg per day.
Canceling therapy should be gradual, for at least 7 days.
Patients with functional disorders of the kidneys should select the dose individually, taking into account creatinine clearance. Dose adjustment is not required for patients with impaired liver function.
Elderly patients (over 65) may need to reduce the dose of pregabalin, which is associated with a decrease in renal function.
When skipping a dose of Lyrica, it should be taken as soon as possible, but the next dose should not be doubled.
The most common side effects are drowsiness and dizziness. As a rule, these phenomena are mild or moderate, but in some cases they are a causative drug withdrawal. Other reasons for which treatment was discontinued were: confusion, incoordination, ataxia, blurred vision, impaired attention, peripheral edema, and asthenia. These phenomena may be associated with the underlying disease, or be caused by concomitant therapy.
During drug treatment, the following side effects may develop:
- Hematopoietic system: rarely - neutropenia;
- Nervous system: very often - drowsiness, dizziness; often - dysarthria, ataxia, impaired attention and coordination, tremor, paresthesia, memory impairment, imbalance, sedative effect, amnesia, lethargy; infrequently - nystagmus, stupor, cognitive disorders, hypesthesia, speech disorder, myoclonic convulsions, postural dizziness, weakening of reflexes, burning sensation on the skin and mucous membranes, psychomotor agitation, dyskinesia, hyperesthesia, loss of taste sensations, intentional tremor, fainting; rarely - parosmia, hypokinesia, dysgraphia;
- The digestive system: often - bloating, flatulence, dry mouth, vomiting, constipation; infrequently - hypoesthesia of the oral mucosa, gastroesophageal reflux, increased salivation; rarely - dysphagia, ascites, pancreatitis;
- Respiratory system: infrequently - shortness of breath, dryness of the nasal mucosa, cough; rarely - bleeding from the nose, feeling of tightness in the throat, nasal congestion, snoring, rhinitis;
- Musculoskeletal system: infrequently - swelling of joints, muscle twitching, muscle spasms, stiffness in muscles, arthralgia, myalgia, back and limb pain; rarely - neck pain, spasm of the neck muscles, rhabdomyolysis;
- Urinary system: infrequently - urinary incontinence, dysuria; rarely - renal failure, oliguria;
- Reproductive system: often - erectile dysfunction; infrequently - sexual dysfunction, delayed ejaculation; rarely - dysmenorrhea, pain in the mammary glands, amenorrhea, discharge from the mammary glands, an increase in the mammary glands in volume;
- Cardiovascular system: infrequently - a cooling of the limbs, tachycardia, hot flashes, AV-blockade I degree, a decrease or increase in blood pressure; rarely - sinus arrhythmia, sinus tachycardia, sinus bradycardia;
- Organ of vision: often - diplopia, blurred vision; infrequently - eye pain, puffiness of the eyes, narrowing of the visual fields, increased tearing, reduced visual acuity, dry eyes, asthenopia; rarely - eye irritation, flickering of sparks before eyes, oscillopsia (subjective sensation of oscillation of the objects in question), mydriasis, loss of peripheral vision, impaired perception of depth of vision, increased brightness of visual perception, strabismus;
- Mind: often - irritability, euphoria, decreased libido, confusion, disorientation, insomnia; infrequently - mood lability, depersonalization, anxiety, apathy, anorgasmia, depression, panic attacks, agitation, difficulty in choosing words, depressed mood, hallucinations, increased libido, increased insomnia, unusual dreams; seldom - high spirits, disinhibition;
- Organs of the vestibular apparatus and hearing: often - dizziness; infrequently - hyperacusia;
- Dermatological reactions: infrequently - sweating, skin flushing, papulosis rash; rarely - urticaria, cold sweat;
- Infections and invasions: infrequently - nasopharyngitis;
- Metabolism: often - an increase in body weight, increased appetite; infrequently - hypoglycemia, anorexia; rarely, weight loss;
- Laboratory indicators: infrequently - an increase in the activity of alanine aminotransferase, aspartate aminotransferase, creatine phosphokinase, a decrease in the number of platelets; rarely, a decrease in the level of potassium in the blood, an increase in the content of creatinine and glucose in the blood, a decrease in the number of leukocytes in the blood;
- Other: often - peripheral edema, fatigue, gait disturbance, feeling of intoxication; infrequently - generalized edema, asthenia, thirst, falls, chest tightness, pain, chills; rarely - hyperthermia.
During post-marketing surveillance when Lyrics were applied, the development of the following disorders was noted:
- Nervous system: loss of consciousness, headache, convulsions, cognitive impairment;
- Cardiovascular system: prolongation of the QT interval, chronic heart failure;
- Urinary system: urinary retention;
- Reproductive system: gynecomastia;
- Respiratory system: pulmonary edema;
- The digestive system: rarely - nausea, swelling of the tongue, diarrhea;
- Organ of vision: loss of vision, keratitis;
- Allergic reactions: rarely - hypersensitivity, angioneurotic reactions (including swelling of the face);
- Dermatological reactions: rarely - Stevens-Johnson syndrome, pruritus;
- Other: increased fatigue.
During therapy in cases where diabetic patients increase body weight, it may be necessary to adjust the doses of hypoglycemic drugs.
With the development of symptoms of angioedema (perioral swelling, swelling of the face or swelling of the tissues of the upper respiratory tract) treatment should be interrupted.
Antiepileptic drugs (including pregabalin) can increase the risk of suicidal behavior or thoughts, so patients receiving Lyric should be under close medical supervision.
During therapy, dizziness and drowsiness may develop, which can cause accidental injuries (falls) in elderly patients. During the post-marketing use of Lyrics, there were also cases of loss of consciousness, impairment of cognitive functions and confusion.
When an undesirable phenomenon such as blurred vision occurs during treatment, or when other disorders of the organ of vision develop, the cancellation of Lyrics can lead to the disappearance of these symptoms.
There were also cases of renal failure, in some cases, after the cancellation of Lyrics, the kidney function was restored.
If Lyrics are canceled after prolonged or short-term treatment, the following undesirable effects may occur: headache, insomnia, nausea, diarrhea, depression, flu-like syndrome, dizziness, sweating, anxiety and convulsions.
The frequency of adverse events from the central nervous system, especially drowsiness, increases during the treatment of central neuropathic pain associated with damage to the spinal cord. It may also be due to the summation of Lyric effects with other concurrently taken means (for example, antispastic). This should be considered when prescribing a drug for this indication.
During treatment, cases of encephalopathy were observed, especially in patients with concomitant diseases that have an increased risk of encephalopathy.
Due to the fact that Lyrics may cause drowsiness and dizziness, it is not recommended for patients taking the drug to drive vehicles, or to perform other potentially dangerous types of work, or to use complex equipment until the extent of the drug’s influence on the performance of such tasks is found out.
Pregabalin is mainly excreted in the urine in unchanged form, undergoing minimal metabolism, and does not bind to plasma proteins, as a result of which it can hardly enter into pharmacokinetic interaction.
With the simultaneous use of pregabalin with other drugs that depress the central nervous system, cases of respiratory disorders and coma have been reported.
There were also reports of the negative effects of pregabalin on the activity of the gastrointestinal tract (including the development of paralytic ileus, intestinal obstruction, constipation) when used together with drugs that cause constipation (such as non-narcotic analgesics).
Repeated oral intake of pregabalin with oxycodone, ethanol or lorazepam did not have a clinically significant effect on respiration. Pregabalin may increase the motor and cognitive impairment caused by oxycodone. Pregabalin can enhance the effects of lorazepam and ethanol.
Terms and conditions of storage
Store in a dry place out of reach of children at a temperature up to 25 ° C.
Shelf life - 3 years.