Lyrolin is used with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. Lyrolin will not cure epilepsy and will only work to control seizures for as long as you continue to take it.
Lyrolin is also used for postherpetic neuralgia (pain that occurs after shingles) and pain caused by nerve damage from diabetes or a spinal cord injury. It is used to treat a condition called fibromyalgia (muscle pain and stiffness).
Lyrolin works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent.
Lyrolin is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Neuropathic Pain: Lyrolin is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.
Epilepsy: Lyrolin is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.
Generalized Anxiety Disorder: Lyrolin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
Fibromyalgia: Lyrolin is indicated for the management of fibromyalgia.
How should I use Lyrolin?
Use Lyrolin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Lyrolin solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lyrolin solution refilled.
Take Lyrolin solution by mouth with or without food.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
Taking Lyrolin solution at the same time each day will help you remember to take it.
Take Lyrolin solution on a regular schedule to get the most benefit from it.
If you miss a dose of Lyrolin solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lyrolin solution.
Uses of Lyrolin in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Fibromyalgia (immediate release only): Management of fibromyalgia
Neuropathic pain associated with diabetic peripheral neuropathy (immediate release and extended release): Management of neuropathic pain associated with diabetic peripheral neuropathy
Neuropathic pain associated with spinal cord injury (immediate release only): Management of neuropathic pain associated with spinal cord injury
Postherpetic neuralgia (immediate release and extended release): Management of postherpetic neuralgia
Seizures, focal (partial) onset (immediate release only): Adjunctive therapy in patients ≥1 month of age with focal onset (partial-onset) seizures
Off Label Uses
Cough, chronic refractory
Data from a limited number of patients in a controlled trial suggest that Lyrolin in combination with speech pathology therapy may be beneficial for the treatment of refractory chronic cough.
Based on the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) position statement on menopause, the Endocrine Society guideline on the treatment of symptoms of menopause, and the North American Menopause Society (NAMS) position statement on nonhormonal management of menopause-associated vasomotor symptoms, Lyrolin is an effective and recommended alternative for the management of vasomotor symptoms associated with menopause in patients with contraindications to hormonal therapy or who prefer not to use hormonal therapy.
Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.
Lyrolin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.
Lyrolin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05 M phosphate buffer) at pH 7.4 is -1.35.
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Epilepsy: Lyrolin treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week.
Generalised Anxiety Disorder: The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.
Lyrolin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week, the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.
Discontinuation of Lyrolin: In accordance with current clinical practice, if Lyrolin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Patients with Renal Impairment: Lyrolin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Lyrolin clearance is directly proportional to creatinine clearance, dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CrCl), as indicated in Table 1 determined using the following formula.
Lyrolin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Lyrolin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour haemodialysis treatment.
Patients with Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.
Children: The safety and efficacy of Lyrolin Sandoz in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No data are available.
Elderly (over 65 years of age): Elderly patients may require a dose reduction of Lyrolin due to a decreased renal function.
Administration: Lyrolin Sandoz may be taken with or without food.
Since Lyrolin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that Lyrolin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between Lyrolin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between Lyrolin and commonly used antiepileptic drugs.
Multiple oral doses of Lyrolin were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when Lyrolin was co-administered with these drugs. No clinically important effects on respiration were seen.
Drug Abuse And Dependence
Lyrolin is a Schedule V controlled substance.
Lyrolin is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of Lyrolin misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).
In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, Lyrolin (450 mg, single dose) received subjective ratings of “good drug effect,” “high” and “liking” to a degree that was similar to diazepam (30 mg, single dose). In controlled clinical studies in over 5500 patients, 4 % of Lyrolin-treated patients and 1 % of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1 to 12%.
In clinical studies, following abrupt or rapid discontinuation of Lyrolin, some patients reported symptoms including insomnia, nausea, headache or diarrhea, consistent with physical dependence. In the postmarketing experience, in addition to these reported symptoms there have also been reported cases of anxiety and hyperhidrosis.
The Lyrolin clinical programme involved over 8900 patients who were exposed to Lyrolin, of whom over 5600 were in double-blind placebo controlled trials. The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving Lyrolin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Lyrolin treatment groups were dizziness and somnolence.
In Table 2, all adverse reactions which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<l/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased.
Additional reactions reported from post-marketing experience are included as Frequency not known in italics in the table below.
After discontinuation of short-term and long-term treatment with Lyrolin withdrawal symptoms have been observed in some patients. The following reactions have been mentioned: Insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.
Concerning discontinuation of long-term treatment of Lyrolin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
If you are taking Lyrolin to prevent seizures, keep taking the medication even if you feel fine.
Do not stop using Lyrolin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using Lyrolin.
Do not change your dose of Lyrolin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.
Wear a medical alert tag or carry an ID card stating that you take Lyrolin. Any medical care provider who treats you should know that you take seizure medication.
DailyMed. "PREGABALIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Lyrolin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lyrolin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
1 consumer reported useful
Was the Lyrolin drug useful in terms of decreasing the symptom or the disease? According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Lyrolin drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
4 consumers reported time for results
To what extent do I have to use Lyrolin before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 1 month and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Lyrolin. To get the time effectiveness of using Lyrolin drug by other patients, please click here.
12 consumers reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology