prescribed quality LYRICA PREGABALIN 300MG 28 Caps sold under the brand name Lyrica among others, is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures. When used before surgery, it reduces pain but results in greater sedation and visual disturbances. It is taken by mouth.
Common side effects of prescribed quality LYRICA PREGABALIN 300MG 28 Caps include headache, dizziness, sleepiness, confusion, trouble with memory, poor coordination, dry mouth, problem with vision, and weight gain. Serious side effects may include angioedema, drug misuse, and an increased suicide risk. When pregabalin is taken at high doses over a long period of time, addiction may occur, but if taken at usual doses the risk is low. Use during pregnancy or breastfeeding is of unclear safety. Pregabalin is a gabapentinoid and acts by inhibiting certain calcium channels.
prescribed quality LYRICA PREGABALIN 300MG 28 Caps was approved for medical use in the United States in 2004. It was developed as a successor to gabapentin. It is available as a generic medication in a number of countries, including the United States as of 2019. A generic version of the extended-release formulation is available in the United States as of April 2021. In 2019, it was the 81st most commonly prescribed medication in the United States, with more than 9 million prescriptions. In the US, pregabalin is a Schedule V controlled substance under the Controlled Substances Act of 1970. It is a Class C controlled substance in the UK.
where to get prescribed quality LYRICA PREGABALIN 300MG 28 Caps
prescribed quality LYRICA PREGABALIN 300MG 28 Caps is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia.
How to use prescribed quality LYRICA PREGABALIN 300MG 28 Caps
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using prescribed quality LYRICA PREGABALIN 300MG 28 Caps and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Takepresc ribed quality LYRICA PREGABALIN 300MG 28 Caps by mouth as directed by your doctor, usually 2 to 3 times a day with or without food. The dosage is based on your medical condition, kidney function, and response to treatment. Children’s dosage is also based on weight.
If you are using the liquid form of prescribed quality LYRICA PREGABALIN 300MG 28 Caps, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
To reduce your risk of side effects (such as dizziness and drowsiness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. This drug works best when the amount of medicine in your body is kept at a constant level. Therefore it is best to take prescribed quality LYRICA PREGABALIN 300MG 28 Caps at evenly spaced intervals throughout the day and night.
Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as difficulty sleeping, nausea, headache and diarrhea. To prevent these symptoms while you are stopping treatment with prescribed quality LYRICA PREGABALIN 300MG 28 Caps, your doctor may reduce your dose gradually. Report any new or worsening symptoms right away.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your condition persists or worsens
Dosage (Posology) of prescribed quality LYRICA PREGABALIN 300MG 28 Caps and method of administration
prescribed quality LYRICA PREGABALIN 300MG 28 Caps treatment can be started at 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 an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
prescribed quality LYRICA PREGABALIN 300MG 28 Caps 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.
prescribed quality LYRICA PREGABALIN 300MG 28 Caps 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 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.
prescribed quality LYRICA PREGABALIN 300MG 28 Caps is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As pregabalin clearance is directly proportional to creatinine clearance , dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
prescribed quality LYRICA PREGABALIN 300MG 28 Caps is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the pregabalin 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 (see Table 1).
Table 1. Pregabalin dose adjustment based on renal function
|Creatinine Clearance(CLcr) (mL/min)||Total prescribed quality LYRICA PREGABALIN 300MG 28 Caps|
daily dose *
|Starting dose(mg/day)||Maximum dose(mg/day)|
|> 60||150||600||BID or TID|
|>30 – <60||75||300||BID or TID|
|>15 – <30||25 – 50||150||Once Daily or BID|
|< 15||25||75||Once Daily|
|Supplementary dosage following haemodialysis (mg)|
TID = Three divided doses
BID = Two divided doses
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose
+ Supplementary dose is a single additional dose
No dose adjustment is required for patients with hepatic impairment.
Paediatric population<1 and 5.2 but no recommendation on a posology can be made.
Elderly patients may require a dose reduction of prescribed quality LYRICA PREGABALIN 300MG 28 Caps due to a decreased renal function.
Method of administration
Pregabalin Milpharm may be taken with or without food.
Pregabalin Milpharm is for oral use only.
Interaction of prescribed quality LYRICA PREGABALIN 300MG 28 Caps with other medicinal products and other forms of interaction
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
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. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin clearance.
Oral contraceptives, norethisterone and/or ethinyl oestradiol
Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
CNS influencing medical products
Pregabalin may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration. In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medicinal products. Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
Interactions and the elderly
No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Interaction studies have only been performed in adults.
Special warnings and precautions for the use of prescribed quality LYRICA PREGABALIN 300MG 28 Caps
In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.
There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema. prescribed quality LYRICA PREGABALIN 300MG 28 Caps should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Dizziness, somnolence, loss of consciousness, confusion and mental impairment
prescribed quality LYRICA PREGABALIN 300MG 28 Caps treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population. There have also been post-marketing reports of loss of consciousness, confusion and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
In controlled trials, a higher proportion of patients treated with prescribed quality LYRICA PREGABALIN 300MG 28 Caps reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing. In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients.
In the post-marketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient.
Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Cases of renal failure have been reported and in some cases discontinuation of prescribed quality LYRICA PREGABALIN 300MG 28 Caps did show reversibility of this adverse reaction.
Withdrawal of concomitant antiepileptic medicinal products
There are insufficient data for the withdrawal of concomitant antiepileptic medicinal products, once seizure control with prescribed quality LYRICA PREGABALIN 300MG 28 Capsin the add-on situation has been reached, in order to reach monotherapy on pregabalin.
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.
Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Congestive heart failure
There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.
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. This may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity agents) needed for this condition. This should be considered when prescribing pregabalin in this condition.
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Reduced lower gastrointestinal tract function
There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics. When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered (especially in female patients and elderly).
Misuse, abuse potential or dependence
Cases of misuse, abuse and dependence have been reported. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have been reported).
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
There are no adequate data from the use of prescribed quality LYRICA PREGABALIN 300MG 28 Caps in pregnant women.
Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Pregabalin Milpharm should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Pregabalin is excreted into human milk. The effect of pregabalin on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
There are no clinical data on the effects of pregabalin on female fertility.
In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no effects on sperm motility.
A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male rats have shown adverse reproductive and developmental effects. The clinical relevance of these findings is unknown.
In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses. In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia. An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long term exposure to pregabalin at exposures > 5 times the mean human exposure at the maximum recommended clinical dose.
Pregabalin was not teratogenic in mice, rats or rabbits. Foetal toxicity in rats and rabbits occurred only at exposures sufficiently above human exposure. In prenatal/postnatal toxicity studies, pregabalin induced offspring developmental toxicity in rats at exposures >2 times the maximum recommended human exposure.
Adverse effects on fertility in male and female rats were only observed at exposures sufficiently in excess of therapeutic exposure. Adverse effects on male reproductive organs and sperm parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were associated with spontaneous degenerative processes in male reproductive organs in the rat. Therefore the effects were considered of little or no clinical relevance.
prescribed quality LYRICA PREGABALIN 300MG 28 Caps is not genotoxic based on results of a battery of in vitro and in vivo tests.
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No tumours were observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended clinical dose of 600 mg/day. In mice, no increased incidence of tumours was found at exposures similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures. The non-genotoxic mechanism of pregabalin-induced tumour formation in mice involves platelet changes and associated endothelial cell proliferation. These platelet changes were not present in rats or in humans based on short term and limited long term clinical data. There is no evidence to suggest an associated risk to humans.
In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats. However, juvenile rats are more sensitive. At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression). Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure. Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at >2 times the human therapeutic exposure. Nine weeks after exposure, this effect was no longer observable.