LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, , , , , and mg. Jun 11, Lyrica (pregabalin) is an FDA-approved drug that is used to treat fibromyalgia and certain other conditions. You may have seen advertisements. Find patient medical information for Lyrica Oral on WebMD including its uses, side pharmacist before you start using pregabalin and each time you get a refill .
Lyrica 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin. Lyrica mg hard capsules Each hard capsule contains mg of pregabalin. Excipients with known effect Lyrica 25 mg hard capsules Each hard capsule also contains 35 mg lactose monohydrate.
Lyrica 50 mg hard capsules Each hard capsule also contains 70 mg lactose monohydrate. Lyrica 75 mg hard capsules Each hard capsule also contains 8. Lyrica mg hard capsules Each hard capsule also contains 11 mg lactose monohydrate. Lyrica mg hard capsules Each hard capsule also contains Lyrica mg hard capsules Each hard capsule also contains 22 mg lactose monohydrate.
Lyrica mg hard capsules Each hard capsule also contains 33 mg lactose monohydrate. For the full list of excipients, see section 6. Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Posology The dose range is to mg per day given in either two or three divided doses. Neuropathic pain Pregabalin treatment can be started at a dose of mg per day given as two or three divided doses.
Epilepsy Pregabalin treatment can be started with a dose of mg per day given as two or three divided doses. Generalised anxiety disorder The dose range is to mg per day given as two or three divided doses.
Discontinuation of pregabalin In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication see sections 4. Renal impairment Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
Hypersensitivity to the active substance or to any of the excipients listed in section 6. Diabetic patients In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products. Hypersensitivity reactions There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema.
Dizziness, somnolence, loss of consciousness, confusion and mental impairment Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury fall in the elderly population. Vision-related effects In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
Renal failure Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.
Withdrawal of concomitant anti-epileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Withdrawal symptoms After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed in some patients.
Congestive heart failure There have been postmarketing reports of congestive heart failure in some patients receiving pregabalin. Treatment of central neuropathic pain due to spinal cord injury In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. Reduced lower gastrointestinal tract function There are postmarketing reports of events related to reduced lower gastrointestinal tract function e.
Misuse, abuse potential or dependence Cases of misuse, abuse and dependence have been reported. Encephalopathy Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy. Lactose intolerance Lyrica contains lactose monohydrate. In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam. Interactions and the elderly No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Pregnancy There are no adequate data from the use of pregabalin in pregnant women.
Breast-feeding Pregabalin is excreted into human milk see section 5. Fertility There are no clinical data on the effects of pregabalin on female fertility. In rare occasions, cases of coma have been reported. Anti-epileptics, other anti-epileptics ATC code: N03AX16 The active substance, pregabalin, is a gamma-aminobutyric acid analogue [ S aminomethyl methylhexanoic acid]. Clinical efficacy and safety Neuropathic pain Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
A reduction in seizure frequency was observed by Week 1. Paediatric population The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established. Monotherapy newly diagnosed patients Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing. Generalised Anxiety Disorder Pregabalin has been studied in 6 controlled trials of week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double-blind relapse prevention phase of 6 months duration.
Absorption Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations occurring within 1 hour following both single and multiple dose administration.
Distribution In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys. Biotransformation Pregabalin undergoes negligible metabolism in humans. Elimination Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
Gender Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of pregabalin. Renal impairment Pregabalin clearance is directly proportional to creatinine clearance. Hepatic impairment No specific pharmacokinetic studies were carried out in patients with impaired liver function. Paediatric population Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy age groups: Elderly Pregabalin clearance tends to decrease with increasing age.
Lyrica 25 mg, 50 mg, mg hard capsules Capsules content: Lactose monohydrate Maize starch Talc Capsules shell: Shellac Black iron oxide E Propylene glycol Potassium hydroxide Lyrica 75 mg, mg, mg, mg, mg hard capsules Capsules content: Shellac Black iron oxide E Propylene glycol Potassium hydroxide. This medicinal product does not require any special storage conditions. HDPE bottle containing hard capsules. Not all pack sizes may be marketed. Date of first authorisation: Company contact details Pfizer Limited.
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Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased. Convulsions, parosmia, hypokinesia, dysgraphia. Ear and labyrinth disorders. QT prolongation, sinus tachycardia, sinus arrhythmia. Hypotension, hypertension, hot flushes, flushing, peripheral coldness. Respiratory, thoracic and mediastinal disorders. Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness.
Pulmonary oedema, throat tightness. Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral. Ascites, pancreatitis, swollen tongue, dysphagia. Skin and subcutaneous tissue disorders. Rash papular, urticaria, hyperhidrosis, pruritus. Stevens Johnson syndrome, cold sweat. Musculoskeletal and connective tissue disorders. Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm.
Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness. Renal and urinary disorders. Renal failure, oliguria, urinary retention. Reproductive system and breast disorders. Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain.
Some people have thoughts about suicide while taking Lyrica. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. If you have diabetes or heart problems, call your doctor if you have weight gain or swelling in your hands or feet while taking Lyrica.
Do not stop using this medicine suddenly, even if you feel fine. Stopping suddenly may cause withdrawal symptoms. Do not change your dose without your doctor's advice.
Tell your doctor if the medication does not seem to work as well in treating your condition. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms. Follow your doctor's instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby.
Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pregabalin on the baby. This medication can temporarily decrease sperm count and may affect fertility in men your ability to have children.
In animal studies, pregabalin also caused birth defects in the offspring of males treated with this medicine.
However, it is not known whether these effects would occur in humans. Ask your doctor about your risk. Do not give this medicine to a child without medical advice. Lyrica is not FDA approved for seizures in anyone younger than 4 years old.
Take Lyrica exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. The European Federation of Neurological Societies recommends pregabalin as a first line agent for the treatment of pain associated with diabetic neuropathy , post-herpetic neuralgia , and central neuropathic pain.
Pregabalin is not recommended for certain other types of neuropathic pain such as trigeminal neuralgia  and its use in cancer-associated neuropathic pain is controversial. Pregabalin is generally not regarded as efficacious in the treatment of acute pain. The World Federation of Biological Psychiatry recommends pregabalin as one of several first line agents for the treatment of generalized anxiety disorder, but recommends other agents such as SSRIs as first line treatment for obsessive—compulsive disorder and post-traumatic stress disorder.
The effects of pregabalin appear after 1 week of use and is similar in effectiveness to lorazepam , alprazolam , and venlafaxine , but pregabalin has demonstrated superiority by producing more consistent therapeutic effects for psychosomatic anxiety symptoms.
Evidence finds little benefit and significant risk in those with chronic low back pain. Pregabalin has been shown to produce therapeutic effects that are similar to other controlled substances.
In clinical studies, pregabalin showed a side effect profile similar to other central nervous system depressants. Adverse drug reactions associated with the use of pregabalin include: Following abrupt or rapid discontinuation of pregabalin, some people reported symptoms suggestive of physical dependence.
The FDA determined that the substance dependence profile of pregabalin, as measured by a patient physical withdrawal checklist, was quantitatively less than benzodiazepines. It is unclear if it is safe for use in pregnancy with some studies showing potential harm.
Several renal failure patients developed myoclonus while receiving pregabalin, apparently as a result of gradual accumulation of the drug. Acute overdosage may be manifested by somnolence , tachycardia and hypertonicity. Plasma, serum or blood concentrations of pregabalin may be measured to monitor therapy or to confirm a diagnosis of poisoning in hospitalized patients.
No interactions have been demonstrated in vivo. The manufacturer notes some potential pharmacological interactions with opioids , benzodiazepines , barbiturates , ethanol alcohol , and other drugs that depress the central nervous system.
Pregabalin may enhance the fluid-retaining effect of anti-diabetic agents Thiazolidinedione. It is a gabapentinoid and acts by inhibiting certain calcium channels. Pregabalin is absorbed from the intestines by an active transport process mediated via the large neutral amino acid transporter 1 LAT1, SLC7A5 , a transporter for amino acids such as L -leucine and L -phenylalanine.
Pregabalin crosses the blood—brain barrier and enters the central nervous system. Pregabalin undergoes little or no metabolism. Pregabalin is eliminated renally in the urine , mainly in its unchanged form. Chemical syntheses of pregabalin have been described. Pregabalin was synthesized in as an anticonvulsant.
Silverman hoped that the enzyme would increase production of the inhibitory neurotransmitter GABA and block convulsions. The drug was approved in the European Union in The US received FDA approval for use in treating epilepsy , diabetic neuropathic pain , and postherpetic neuralgia in December Pregabalin then appeared on the US market under the brand name Lyrica in fall of In the United States, the Food and Drug Administration FDA has approved pregabalin for adjunctive therapy for adults with partial onset seizures , management of postherpetic neuralgia and neuropathic pain associated with spinal cord injury and diabetic peripheral neuropathy , and the treatment of fibromyalgia.
Since , Pfizer has engaged in extensive direct-to-consumer advertising campaigns to promote its branded product Lyrica for fibromyalgia and diabetic nerve pain indications. Up until , Pfizer promoted Lyrica for other uses which had not been approved by medical regulators. The university holds a patent on it, exclusively licensed to Pfizer. As of October , pregabalin was marketed under many brand names in other countries: Pfizer's main patent for Lyrica, for seizure disorders, in the UK expired in In November the Supreme Court of the United Kingdom ruled that Pfizer 's second patent on the drug, for treatment of pain, was invalid because there was a lack of evidence for the conditions it covered — central and peripheral neuropathic pain.
From October GPs were forced to change patients from generic pregabalin to branded until the second patent ran out in July From Wikipedia, the free encyclopedia.
C Risk not ruled out. S4 Prescription only CA: Retrieved May 6, Indian Journal of Nephrology. The Journal of Clinical Pharmacology. Pharmacology and the Nursing Process. Retrieved 3 February European journal of neurology. British Journal of Anaesthesia.
See risks and benefits of LYRICA® (pregabalin) CV. Rx treatment for FM, diabetic nerve pain, pain after shingles, spinal cord injury nerve pain and partial onset. LYRICA (pregabalin) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat fibromyalgia, diabetic nerve pain, spinal cord. Find answers to frequently asked questions about LYRICA® (pregabalin) CV. See risks & benefits of LYRICA.