What is Mylan-Pregabalin?
Mylan-Pregabalin (Mylan-Pregabalin) is an anti-epileptic drug, also called an anticonvulsant. Mylan-Pregabalin works by slowing down nerve impulses in the brain and affects chemicals that send pain signals across the nervous system.
Mylan-Pregabalin is a prescription medicine used to treat pain caused by damaged nerves in people with diabetes (diabetic neuropathy). Mylan-Pregabalin is also used to treat pain caused by damaged nerves (neuropathic pain) that follows healing of shingles (herpes zoster). This condition is called post-herpetic neuralgia.
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It is not known if Mylan-Pregabalin is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures.
Mylan-Pregabalin is supplied as extended-release tablets in the following strengths: 82.5 mg, 165 mg, and 330 mg.
Mylan-Pregabalin indications
Neuropathic Pain: Mylan-Pregabalin is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.
Epilepsy: Mylan-Pregabalin is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.
Generalized Anxiety Disorder: Mylan-Pregabalin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
Fibromyalgia: Mylan-Pregabalin is indicated for the management of fibromyalgia.
How should I use Mylan-Pregabalin?
Use Mylan-Pregabalin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Mylan-Pregabalin solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mylan-Pregabalin solution refilled.
- Take Mylan-Pregabalin 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 Mylan-Pregabalin solution at the same time each day will help you remember to take it.
- Take Mylan-Pregabalin solution on a regular schedule to get the most benefit from it.
- If you miss a dose of Mylan-Pregabalin 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 Mylan-Pregabalin solution.
Uses of Mylan-Pregabalin in details
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 Mylan-Pregabalin 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, Mylan-Pregabalin 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.
Mylan-Pregabalin description
Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.
Mylan-Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.
Mylan-Pregabalin 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.
Mylan-Pregabalin dosage
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Epilepsy: Mylan-Pregabalin 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.
Mylan-Pregabalin 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 Mylan-Pregabalin: In accordance with current clinical practice, if Mylan-Pregabalin 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: Mylan-Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Mylan-Pregabalin 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.
Mylan-Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Mylan-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.
Patients with Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.
Children: The safety and efficacy of Mylan-Pregabalin 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 Mylan-Pregabalin due to a decreased renal function.
Administration: Mylan-Pregabalin Sandoz may be taken with or without food.
Mylan-Pregabalin Sandoz is for oral use only.
Mylan-Pregabalin interactions
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What other drugs will affect Mylan-Pregabalin?
Since Mylan-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.
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between Mylan-Pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis indicated that the oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on Mylan-Pregabalin clearance.
Co-administration of Mylan-Pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance. Mylan-Pregabalin may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, multiple oral doses of Mylan-Pregabalin co-administered with oxycodone, lorazepam or ethanol did not result in clinically important effects on respiration. In the post-marketing experience, there are reports of respiratory failure and coma in patients taking Mylan-Pregabalin and other CNS depressant medications. Mylan-Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
No specific pharmacodynamic interaction studies were conducted in elderly volunteers.
Mylan-Pregabalin side effects
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What are the possible side effects of Mylan-Pregabalin?
The Mylan-Pregabalin clinical program involved over 8900 patients who were exposed to Mylan-Pregabalin, 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 Mylan-Pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Mylan-Pregabalin 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, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), 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 in italics in Table 2.
After discontinuation of short-term and long-term treatment with Mylan-Pregabalin 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 Mylan-Pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Mylan-Pregabalin contraindications
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What is the most important information I should know about Mylan-Pregabalin?
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 Mylan-Pregabalin to prevent seizures, keep taking the medication even if you feel fine.
Do not stop using Mylan-Pregabalin 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 Mylan-Pregabalin.
Do not change your dose of Mylan-Pregabalin 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 Mylan-Pregabalin. Any medical care provider who treats you should know that you take seizure medication.
Active ingredient matches for Mylan-Pregabalin:
Pregabalin in Canada.
| Unit description / dosage (Manufacturer) | Price, USD |
| Mylan-pregabalin capsule 75 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| Mylan-pregabalin capsule 150 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| Mylan-pregabalin capsule 25 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| Mylan-pregabalin capsule 300 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| Mylan-pregabalin capsule 225 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| Mylan-pregabalin capsule 50 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
List of Mylan-Pregabalin substitutes (brand and generic names): | |
| MYGALIN (India) | |
| Mygalin 75mg CAP / 10 (Gentech HC) | $ 1.02 |
| Mystika (Argentina) | |
| NEOGABA (Turkey) | |
| 300 mg x 100's (Polaris (Symbiosis Pharmaceuticals Pvt Ltd)) | $ 12.05 |
| Neogaba 300 mg Tablet (Polaris (Symbiosis Pharmaceuticals Pvt Ltd)) | $ 0.12 |
| Neogaba 300mg TAB / 100 (Polaris (Symbiosis Pharmaceuticals Pvt Ltd)) | $ 12.05 |
| NEOGABA tab 300 mg x 10's (Polaris (Symbiosis Pharmaceuticals Pvt Ltd)) | $ 1.20 |
| Neogaba 300mg TAB / 100 (Polaris (Symbiosis Pharmaceuticals Pvt Ltd)) | $ 12.05 |
| Nergab (Pakistan) | |
| Nervax (Oman) | |
| Nervica (Tunisia) | |
| Nervmax (India) | |
| Nervmax Pregabalin 75 mg, Methylcobalamin 750 mcg. CAP / 10 (Alkem (Bergen)) | $ 1.19 |
| NERVMAX CAPSULE 1 strip / 10 capsules each (Alkem (Bergen)) | $ 1.55 |
| NERVMAX SR 150MG TABLET 1 strip / 10 tablets each (Alkem (Bergen)) | $ 1.58 |
| NERVMAX SR 75MG TABLET 1 strip / 10 tablets each (Alkem (Bergen)) | $ 1.58 |
| NERVMAX cap 10's (Alkem (Bergen)) | $ 1.19 |
| Nervmax Capsule (Alkem (Bergen)) | $ 0.17 |
| Nervmax SR 75 Tablet (Alkem (Bergen)) | $ 0.17 |
| Nervomac-P (India) | |
| Nervomac-P Pregabalin 75 mg, Mecobalamin750 mcg. TAB / 10 (Medihealth) | |
| NERVOMAC-P tab 10's (Medihealth) | |
| Neugaba (India) | |
| Neugaba 75MG CAP / 10 (Sun Pharmaceutical Industries Ltd.) | $ 1.06 |
| 75 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 0.99 |
| Neugaba 150 mg Capsule (Sun Pharmaceutical Industries Ltd.) | $ 0.18 |
| Neugaba 75 mg Capsule (Sun Pharmaceutical Industries Ltd.) | $ 0.11 |
| Neugaba 150mg CAP / 10 (Sun Pharmaceutical Industries Ltd.) | $ 1.78 |
| NEUGABA 150 MG CAPSULE 1 strip / 10 capsules each (Sun Pharmaceutical Industries Ltd.) | $ 2.41 |
| NEUGABA 75 MG CAPSULE 1 strip / 10 capsules each (Sun Pharmaceutical Industries Ltd.) | $ 1.45 |
| NEUGABA ER 150 MG TABLET 1 strip / 10 tablets each (Sun Pharmaceutical Industries Ltd.) | $ 1.87 |
| NEUGABA ER 75 MG TABLET 1 strip / 10 tablets each (Sun Pharmaceutical Industries Ltd.) | $ 1.47 |
| NEUGABA cap 75 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 1.12 |
| NEUGABA cap 150 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 1.78 |
| Neugaba 150mg Capsule (Sun Pharmaceutical Industries Ltd.) | $ 0.26 |
| Neugaba 75mg Capsule (Sun Pharmaceutical Industries Ltd.) | $ 0.15 |
| Neugaba 75mg Tablet ER (Sun Pharmaceutical Industries Ltd.) | $ 0.16 |
| Neugaba ER | |
| Neugaba ER 150 mg Tablet (Sun Pharmaceutical Industries Ltd.) | $ 0.19 |
| Neugaba ER 75 mg Tablet (Sun Pharmaceutical Industries Ltd.) | $ 0.11 |
| NEUGABA-ER (India) | |
| NEUGABA-ER tab 75 mg x 10's (Sun) | $ 1.05 |
| NEUGABA-ER tab 150 mg x 10's (Sun) | $ 1.87 |
| Neugaba-M (India) | |
| Neugaba-M Pregabalin 75 mg, Mecobalamin/ FC-tab 0.75 mg. CAP / 10 (Sun) | $ 1.14 |
| NEUGABA-M cap 10's (Sun) | $ 1.14 |
| NEUGABID | |
| NEUGABID SR 75MG TABLET 1 strip / 10 tablets each (Emenox Healthcare) | $ 1.14 |
| Neugabid 75mg Tablet SR (Emenox Healthcare) | $ 0.11 |
| NEUGABID-SR (India) | |
| NEUGABID-SR tab 75 mg x 10's (Emenox) | $ 1.14 |
See 1510 substitutes for Mylan-Pregabalin | |
References
- 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).
- PubChem. "Pregabalin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Pregabalin". http://www.drugbank.ca/drugs/DB00230 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Mylan-Pregabalin 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 Mylan-Pregabalin. 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.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
