Information about Lyrica medicine, how to use, dosage and side effects:
Lyrica is indicated for the treatment of central and peripheral neuropathic pain in adults.
Lyrica is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.
Generalized anxiety disorder
Lyrica is indicated for the treatment of generalized anxiety disorder (GAD) in adults.
Dosage and administration
The dose is in the range of 150 to 600 mg daily, divided into two or three doses.
Treatment with Lyrica may commence with a dose of 150 mg daily, divided into two or three doses. Depending on the response and tolerability of the medicine in the individual patient, the dose after a period of 3 to 7 days can be increased to 300 mg daily and, if necessary, after an additional 7 days to a maximum dose of 600 mg per day.
Treatment with Lyrica may commence with a dose of 150 mg daily, divided into two or three doses. Depending on the response and tolerability of the medicine in the individual patient, the dose may be after one week increased to 300 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.
Generalized anxiety disorder
The dose is in the range of 150 to 600 mg daily, divided into two or three doses. It should be regularly evaluate the need for treatment. Treatment with Lyrica may commence with a dose of 150 mg per day. Depending on the response and tolerance of the medicine in the individual patient, the dose may be after one week increased to 300 mg per day. After the following week the dosage may be increased to 450 mg per day. The maximum dose of 600 mg per day can be achieved after an additional one week.
Discontinuation treatment with Lyrica
In accordance with current clinical practice, if Lyrica treatment must be discontinued, it is recommended to gradually phased out for at least one week, regardless of the indication.
Special populations (Patients with renal impairment)
Lyrica is removes from the systemic circulation primarily with excretion of unchanged medicine via kidney. Since the clearance of Lyrica is exactly proportional to the clearance of creatinine, in an individual patient with renal impairment the dose must be adjusted in accordance with the a creatinine clearance (CLcr), as indicated in table 1, using the following formula: CLcr(ml/min)=] x 0,85 Lyrica is effectively removed from the plasma by hemodialysis 50 % of the medicine over 4 hours). In the patients undergoing hemodialysis, the daily dose of Lyrica should be adjusted based on renal function. In addition to daily dose should be administered an additional dose of Lyrica immediately after each four-hour procedure hemodialysis treatment (see Table 1). Table 1: Adjustment of the dose of Lyrica depending of the renal function
|Clearance creatinine (CLcr) (ml / min)||The total daily dose of Lyrica||Frequency of dosing|
|Initial dose||The maximum dose|
|>60||150||600||Divided in 2 or 3 doses|
|≥30 < 60||75||300||Divided in 2 or 3 doses|
|≥15 < 30||25-50||150||Once a day or divided in 2 doses|
|< 15||25||75||Once a day|
|Supplemental doses after hemodialysis (mg)|
It is not necessary to adjust the dose in patients with hepatic impairment.
The safety and efficacy of the medicine Lyrica in children younger than 12 years and adolescents (12-17 years) were no established. No information available.
Use in the elderly (over 65 years)
In older patients it may be necessary to reduce the dose of Lyrica for impaired renal function (see Patients with renal impairment).
Method of application
Lyrica can be taken with or without food. Lyrica is intended for oral administration.
Warning and precautions
Do not use Lyrica If you are allergic to Lyrica or any other medicine.
Patients with diabetes
In accordance with current clinical practice, some patients with diabetes who gain weight during treatment with Lyrica may be necessary to adjust the anti-diabetic therapy.
It have been reported hypersensitivity reactions, including cases of angioedema. Application of Lyrica should be stopped immediately in case of symptoms of angioedema, such as swelling of the face, the area around the mouth or upper respiratory tract.
Dizziness, somnolence, loss of consciousness, confusion and weakening of mental ability
Treatment of Lyrica is associated with the occurrence of somnolence, dizziness, which can increase the number of unintentional injuries (falls) in the elderly population. It have been reported and loss of consciousness, confusion and weakening of mental ability. Therefore, patients should be advised to be careful until they are familiar with the potential effects of the medicine.
Effects associated with vision
In controlled clinical trials, blurred vision was reported in a higher proportion of patients treated with Lyrica than patients receiving the placebo. These side effects in most cases was withdrawn from continued therapy. In clinical trials in which was conducted ophthalmic search, reduction of visual acuity and visual field changes, there was a higher incidence in patients who used Lyrica than in the placebo group; the incidence of changes in the eye fundus was higher in patients who received placebo. Side effects associated with vision have been reported in the aftermath of marketing experience, including loss of vision, blurred vision or other changes in visual acuity, and many of which were transient. Termination of application of Lyrica may result in withdrawal symptoms, or improvements of that symptoms.
There are reported cases of renal failure, and in some cases after discontinuation of the treatment side effects of Lyrica was withdrew.
Reversal simultaneously applied AEDs (anti epileptic medicines)
There is not enough data to abolish simultaneously applied AEDs, after adding Lyrica is achieved control of epileptic seizure in order to monotherapy with Lyrica.
After termination of the short and long term Lyrica treatment in some patients observed withdrawal symptoms. There have been reported following side effects: insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, anxiety, depression, pain, convulsion, hyperhidrosis and dizziness. Patients should inform about this side effects on the beginning of treatment. During or shortly after discontinuation of Lyrica may occur convulsions, including status epilepticus, and grand mal seizures. If the long-term treatment of Lyrica is interrupted, there is no data on the incidence and severity of the withdrawal symptoms in relation to the duration of use and dose of Lyrica.
Congestive heart failure
In some patients who was receiving Lyrica it is reported congestive heart failure. Such reactions are generally observed in elderly cardiovascular patients during the treatment with Lyrica in neuropathic indications. Lyrica at these patients should be used with caution. With discontinuation of Lyrica treatment this side effect can withdraw.
Treatment of central neuropathic pain caused by spinal cord injury
In the treatment of central neuropathic pain caused by spinal cord injury was observed increased overall incidence of adverse events and side effects of central nervous system, particularly somnolence. It could be attributed to the additive effect of the medicines administered at the same time required to treat the condition (eg, spasmolytic).
Suicidal ideation and behavior
Suicidal ideation and behavior have been reported in patients treated with antiepileptic medicines in different indications. Meta analysis of randomized placebo controlled trials of anti-epileptic medicine showed the slightly increased risk of suicidal thoughts and behavior. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Lyrica. Therefore patients should be monitored in order to detect possible signs of suicidal thoughts and behavior and consider the application of appropriate therapy. Patients (and their caregivers) should be advised to seek medical attention if they experience signs of suicidal thoughts or behavior.
Impairment of the function of the lower part of the gastrointestinal tract
There have been reported events associated with impaired function of the lower parts of the gastrointestinal tract (e.g. bowel obstruction, paralytic ileus, constipation) when Lyrica was applied simultaneously with the medicines, which can cause constipation, such as opioid analgesics (morphine, oxycodone, meperidine, fentanyl, alfentanyl, hydromorphone etc). When Lyrica administered in combination with opioids, doctor may consider measures to prevention of constipation (especially in women and older patients).
There are reported cases of abuse of the medicine. Caution should be exercised in the administration of the medicine in patients with a history of medicine abuse, and such patients should be monitored in order to detect symptoms of abuse of Lyrica.
There are reported cases of encephalopathy, mainly in patients with existing conditions which can cause encephalopathy.
Use with other medicines (Interaction)
Since Lyrica is mainly excreted unchanged in the urine, that it is negligible metabolized in the body (< 2 % of the dose is found in the urine as metabolite), it does not inhibits the in vitro metabolism of medicines and does not bind to plasma proteins, and it is not likely to induce or go to pharmacokinetic interactions.
In vivo tests and population pharmacokinetic analysis
Accordingly, in the tests in vivo were not observed clinically significant pharmacokinetic interactions with Lyrica and from phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis showed that oral antidiabetics(such as metformin), diuretics, insulin, phenobarbital, topiramate, tiagabine do not have a clinically meaningful effect on clearance of Lyrica.
Oral contraceptives, norethisterone and/or ethinylestradiol
Co-administration of Lyrica with the oral contraceptives norethisterone and/or ethinylestradiol do not affect the pharmacokinetics of any of these medicines in a state of dynamic equilibrium.
Ethanol, lorazepam, oxycodone
Lyrica may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, application of multiple oral doses of Lyrica simultaneously with oxycodone, lorazepam, or ethanol did not cause clinically important effects on respiration. In patients who are taking Lyrica and other CNS depressants have been reported respiratory failure and coma. It appears that Lyrica further contributes oxycodone caused damage to cognitive and gross motor functions.
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females
Since there is a potential risk for humans is unknown, women of childbearing potential must use effective contraception.
There are no adequate data from the use of Lyrica in pregnant women. Animal studies have shown reproductive toxicity. It is not known the potential risk for the people. Lyrica should not be used during pregnancy unless it is necessary (if the benefit of treatment for mother clearly exceeds the potential risk to the fetus).
It is not known whether the Lyrica (Lyrica( is excreted in human milk, but it is present in the milk of female rats. Therefore, the breast-feeding during treatment with Lyrica is not recommended.
There are no clinical data on the effects of Lyrica on female fertility. In a clinical trial in which assessed the effect of Lyrica on sperm motility, healthy male subjects were exposed to Lyrica 600 mg per day. After 3 months of treatment it was no any effect on sperm motility. Fertility study in rats has shown adverse effects on reproduction. Research of the fertility in male rats have shown adverse effects on reproduction. The clinical significance of these findings is unknown.
Driving and using machines
Lyrica may have a small or moderate influence on the ability to drive and use machines. Lyrica may cause dizziness and somnolence and therefore affect the ability to drive or use machines. Patients are advised not to drive, do not operate complex machinery and undertake other potentially hazardous activities until it is determined whether this medication affects their ability to do so.
The clinical program involved testing of Lyrica over 8900 patients who were Lyrica exposed, one of which is more than 5600 were enrolled in a double- blind, placebo controlled trials. The most commonly reported adverse events were dizziness and somnolence. Side effects were usually mild to moderate intensity. In all contolled clinical trials, the proportion of the patients who discontinued treatment due to side effects was 12 % among patients who received Lyrica and 5 % among patients who received placebo. The most common side effects due which the treatment was interrupted were dizziness and somnolence. The following list shows all of the side effects that have appeared with a greater incidence than placebo in more than one patient are listed by system organ class and frequency of occurrence (often (≥ 1/10), common ( ≥ 1 /100 ≤ 1/10), uncommon ( ≥ 1/1000 of i ≤ 1/100 of ), rare ( ≥ 1 /10, 000 and ≤ 1/1000 of ) very rare ( ≤ 1/10 000), the unknown (can not be estimated from available data). Within each group, the frequency of adverse reactions are presented in order of decreasing seriousness.
Infections and infestations
Blood and lymphatic system
Immune system disorders
Unknown frequency: hypersensitivity, angioedema, allergic reaction
Metabolism and nutrition disorders
Less frequently: anorexia, hypoglycemia
Often: euphoric mood, confusion, irritability, decreased libido, disorientation, insomnia Uncommon: hallucinations, panic attacks, anxiety, agitation, depression, depressed mood, depersonalization, difficulty in finding words, unusual dreams, increased libido, anorgasmia, apathy Rarely: disinhibition, elevated mood Unknown frequency: aggression
Nervous system disorders
Very often: dizziness, somnolence Often: ataxia, coordination disorder, tremor, dysarthria, memory disorder, attention deficit disorder, paresthesia, sedation, balance disorder, lethargy, headache Uncommon: syncope, stupor, myoclonus, psychomotor hyperactivity, dyskinesia, postural dizziness, intentionally tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexion, hypoesthesia, amnesia, hyperaesthesia, burning sensation. Rarely: hypokinesia, dysgraphia Unknown frequency: loss of consciousness, loss of mental abilities, convulsions, general weakness
Often: blurred vision, diplopia (double vision) Uncommon: swelling of the eye, visual field constriction, blur vision, eye pain, dry eye, excessive tearing Rarely: loss of peripheral vision, change the perception of depth, eye irritation, mydriasis, strabismus, a sense of brightness. Unknown frequency: loss of vision
Ear and labyrinth disorders
Often: dizziness Uncommon: hyperacusis
Uncommon: tachycardia, atrioventricular block first degree Rarely: sinus tachycardia, sinus bradycardia, sinus arrhythmia Non- prevalence: congestive heart failure, prolongation of the QT-interval
Less frequently: flushing, hypotension, hypertension Rarely: cold of peripheral parts of the body
Respiratory, thoracic and mediastinal disorders
Uncommon: dyspnea, dry nose Rarely: epistaxis, tightness in the throat, cough, nasal congestion, rhinitis, snoring Unknown frequency: pulmonary edema
Often: vomiting, dry mouth, constipation, flatulence Uncommon: abdominal distension, gastroesophageal reflux disease, salivary hypersecretion, oral hypoesthesia. Rarely: ascites, pancreatitis, dysphagia Unknown frequency: swollen tongue, diarrhea, nausea
Skin and subcutaneous tissue disorders
Less often: papular rash, hyperhidrosis Rarely: urticaria, cold sweat Unknown frequency: Stevens – Johnson syndrome, itching
Disorders of the musculoskeletal system and connective tissue
Uncommon: muscle twitching, joint swelling, muscle cramps, myalgia, arthralgia, back pain, pain in the limbs, muscle stiffness Rarely: rhabdomyolysis, cervical spasm, neck pain
Renal and urinary system disorders
Uncommon: urinary incontinence, dysuria Rarely: renal failure, oliguria Unknown frequency: urinary retention
Reproductive system and breast disorders
Often: erectile dysfunction Less often: delayed ejaculation, sexual dysfunction Rarely: amenorrhea, breast discharge, breast pain, dysmenorrhea, breast augmentation Unknown frequency: gynecomastia
General disorders and administration site disorders
Often: an unusual move, feeling drunkenness, fatigue, peripheral edema, edema Uncommon: chest tightness, asthenia, thirst, pain, unusual feeling, chills Rarely: generalized edema, pyrexia Unknown frequency: facial edema
Often: an increase in body weight Less often: an increase creatine kinase in the blood, increase in alanine aminotransferase, increase of aspartate aminotransferase. Rarely: increasing blood glucose levels, decreased levels of potassium in the blood, the reduction of the number of white blood cells, blood creatinine increase, decrease weight. After termination of the short and long term Lyrica treatment in some patients observed withdrawal symptoms. There are recorded the following reactions: insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, seizures, nervousness, depression, pain, hyperhidrosis and dizziness.
In overdoses up to 15 g there are not reported unexpected adverse effects. After placing the Lyrica on the market most commonly reported side effects of an overdose of Lyrica include somnolence, confusion, agitation and restlessness. Treatment of Lyrica overdose should include general supportive measures, if necessary, may include hemodialysis. You should never take more tablets than you prescribed by your doctor. If you have taken too many tablets at once, contact your doctor immediately. Show the doctor the remaining tablets in the package.
If you forget to take the medicine
If you forget to take medication, do not use double dose later. Simply continue to use the medicine according to the usual schedule. If you missed medication applied, please do so as soon as possible, and then proceed with its application to the usual schedule and suitably. For more information about medicine Lyrica visit Wikipedia: http://en.wikipedia.org/wiki/Pregabalin