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Pregabalin (Pregabalin)

Trade Name : Pregabalin

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 25 mg/1

PREGABALIN

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pregabalin (Pregabalin) which is also known as Pregabalin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Pregabalin (Pregabalin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Pregabalin capsules are indicated for:
  • Pediatric use information is approved for Pfizeru2019s LYRICAn- Array
  • Pregabalin is indicated for:
  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ()
  • Postherpetic neuralgia (PHN) ()
  • Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older ()
  • Fibromyalgia ()
  • Neuropathic pain associated with spinal cord injury ()
  • No data
  • Capsules: 25 mg, 50 mg
  • [see u00a0and ]
  • Capsules: 25 mg, 50 mg, (3)
  • Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy .
  • Known hypersensitivity to pregabalin or any of its components. ()
  • No data
  • Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in these cases. ()
  • Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue pregabalin immediately in these patients. ()
  • Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Withdraw pregabalin gradually over a minimum of 1 week. ()
  • Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. ()
  • Pregabalin may cause peripheral edema. Exercise caution when coadministering pregabalin and thiazolidinedione antidiabetic agents. ()
  • Pregabalin may cause dizziness and somnolence and impair patientsu2019 ability to drive or operate machinery. ()
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). ()
  • Since pregabalin 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. and studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
  • Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs .
  • Pharmacodynamics
  • Multiple oral doses of pregabalin were coadministered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when pregabalin was coadministered with these drugs. No clinically important effects on respiration were seen.
  • Pediatric use information is approved for Pfizeru2019s
  • LYRICA
  • (pregabalin) Capsules and Oral Solution products. However, due to Pfizeru2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Pregnancy: May cause fetal harm. Advise of potential risk to the fetus. ()
  • Lactation: Breastfeeding is not recommended. ()
  • No data
  • Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
  • There is limited experience with overdose of pregabalin. The highest reported accidental overdose of pregabalin during the clinical development program was 8000 mg, and there were no notable clinical consequences.
  • Treatment or Management of Overdose
  • There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with pregabalin.
  • Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
  • Pregabalin, USP is described chemically as ()-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is CHNO and the molecular weight is 159.23. The chemical structure of pregabalin, USP is:
  • Pregabalin, USP is a white to off-white, crystalline solid with a pK of 4.2 and a pK of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35.
  • Pregabalin capsules are administered orally and are supplied as imprinted, hard gelatin capsules containing 25 mg and 50 mg of pregabalin and the following inactive ingredients: gelatin, iron oxide black, mannitol, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, talc, and titanium dioxide. Additionally, the 50 mg capsules contain D&C yellow #10 and FD&C yellow #6.
  • No data
  • No data
  • No data
  • Pregabalin capsules are available as follows:
  • 25 mg u2013 Hard gelatin capsules with a white opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with u201cTEVAu201d and u201c7622u201d on the body and cap, in bottles of 90 (NDC 0093-7622-98).
  • 50 mg u2013 Hard gelatin capsules with a buff opaque body and cap, filled with a white to off-white powder with small agglomerates, imprinted with u201cTEVAu201d and u201c7623u201d on the body and cap, in bottles of 90 (NDC 0093-7623-98).
  • Storage and Handling
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Angioedema
  • Advise patients that pregabalin capsules may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue pregabalin capsules and immediately seek medical care if they experience these symptoms .
  • Hypersensitivity
  • Advise patients that pregabalin capsules have been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue pregabalin capsules and immediately seek medical care if they experience these symptoms .
  • Adverse Reactions with Abrupt or Rapid Discontinuation
  • Advise patients to take pregabalin capsules as prescribed. Abrupt or rapid discontinuation may result in increased seizure frequency in patients with seizure disorders, and insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea .
  • Suicidal Thinking and Behavior
  • Patients, their caregivers, and families should be counseled that AEDs, including pregabalin capsules, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers .
  • Dizziness and Somnolence
  • Counsel patients that pregabalin capsules may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on pregabalin capsules to gauge whether or not it affects their mental, visual, and/or motor performance adversely .
  • Weight Gain and Edema
  • Counsel patients that pregabalin capsules may cause edema and weight gain. Advise patients that concomitant treatment with pregabalin capsules and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure .
  • Ophthalmological Effects
  • Counsel patients that pregabalin capsules may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician .
  • Creatine Kinase Elevations
  • Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever .
  • CNS Depressants
  • Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as somnolence .
  • Alcohol
  • Tell patients to avoid consuming alcohol while taking pregabalin capsules, as pregabalin capsules may potentiate the impairment of motor skills and sedating effects of alcohol.
  • Missed Dose
  • Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time.
  • Pregnancy
  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin capsules during pregnancy .
  • Lactation
  • Advise nursing mothers that breastfeeding is not recommended during treatment with pregabalin capsules .
  • Male Fertility
  • Inform men being treated with pregabalin capsules who plan to father a child of the potential risk of male-mediated teratogenicity. In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical significance of this finding is uncertain .
  • Dermatopathy
  • Instruct diabetic patients to pay particular attention to skin integrity while being treated with pregabalin capsules and to inform their healthcare provider about any sores or skin problems. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with pregabalin capsules were observed in clinical trials n
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Iss. 7/2019
  • Pregabalin (pree gab' a lin)
  • Capsulesu00a0 CV
  • Read this Medication Guide before you start taking pregabalin capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about pregabalin capsules, ask your healthcare provider or pharmacist.
  • What is the most important information I should know about pregabalin capsules?
  • Pregabalin capsules may cause serious side effects including:
  • These serious side effects are described below:
  • If you have suicidal thoughts or actions, do not stop pregabalin capsules without first talking to a healthcare provider.
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • What are pregabalin capsules?
  • Pregabalin capsules are a prescription medicine used in adults, 18 years of age and older to treat:
  • It is not known if pregabalin capsules are safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury.
  • Pregabalin capsules are a prescription medicine used in people 17 years of age and older to treat:
  • For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if pregabalin capsules are safe and effective in children under 1 month of age.
  • Who should not take pregabalin capsules?
  • Do not take pregabalin capsules if you are allergic to pregabalin or any of the ingredients in pregabalin capsules.
  • See for the signs of an allergic reaction. See the end of this Medication Guide for a complete list of ingredients in pregabalin capsules.
  • What should I tell my healthcare provider before taking pregabalin capsules?
  • Before taking pregabalin capsules, tell your healthcare provider about all your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
  • How should I take pregabalin capsules?
  • What should I avoid while taking pregabalin capsules?
  • What are the possible side effects of pregabalin capsules?
  • Pregabalin capsules may cause serious side effects, including:
  • The most common side effects of pregabalin capsules in adults are:
  • Pregabalin capsules caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking pregabalin capsules and tell your healthcare provider about any sores or skin problems.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of pregabalin capsules. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store pregabalin capsules?
  • Keep pregabalin capsules and all medicines out of the reach of children.u00a0
  • General information about the safe and effective use of pregabalin capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pregabalin capsules for a condition for which they were not prescribed. Do not give pregabalin capsules to other people, even if they have the same symptoms you have. They may harm them. You can ask your healthcare provider or pharmacist for information about pregabalin capsules that is written for health professionals.
  • What are the ingredients in pregabalin capsules?
  • Active ingredient:
  • Inactive ingredients: gelatin, iron oxide black, mannitol, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, talc, and titanium dioxide. Additionally, the 50 mg capsules contain D&C yellow #10 and FD&C yellow #6.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.n
  • Pediatric use information is approved for Pfizeru2019s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizeru2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Manufactured In Israel By: Jerusalem, 9777402, Israel
  • Manufactured For: North Wales, PA 19454
  • For more information call Teva Pharmaceuticals USA, Inc., at 1-888-838-2872.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Iss: 5/2019
  • NDC 0093-7622-98
  • Pregabalinu00a0Capsules
  • 25 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • 90 CAPSULES
  • TEVA
  • DC 0093-7623-98
  • Pregabalin Capsules
  • 50 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • 90 CAPSULES
  • TEVA

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