Tag: Restless Legs Syndrome

Gabapentin 100mg, Ascend Laboratories, 216 Pill – white capsule/oblong, 14mm

Pill with imprint 216 is White, Capsule/Oblong and has been identified as Gabapentin 100 mg. It is supplied by Ascend Laboratories, LLC.

Gabapentin is used in the treatment of Back Pain; Postherpetic Neuralgia; Epilepsy; Chronic Pain; Seizures and belongs to the drug class gamma-aminobutyric acid analogs. Risk cannot be ruled out during pregnancy. Gabapentin 100 mg is not a controlled substance under the Controlled Substances Act (CSA).

Gabapentin

Imprint
216
Strength
100 mg
Color
White
Size
14.00 mm
Shape
Capsule/Oblong
Availability
Prescription only
Drug Class
Gamma-aminobutyric acid analogs
Pregnancy Category
C – Risk cannot be ruled out
CSA Schedule
Not a controlled drug
Labeler / Supplier
Ascend Laboratories, LLC
Inactive Ingredients
corn starch, lactose anhydrous, magnesium silicate, gelatin, sodium lauryl sulfate, titanium dioxide

Note: Inactive ingredients may vary.

Labelers / Repackagers

NDC Code Labeler / Repackager
67877-0222 Ascend Laboratories LLC
16714-0503 NorthStar Rx LLC

What Is Gabapentin and What I should Know Before I Buy Gabapentin Online ?

Gabapentin is a prescription medication primarily used to treat epilepsy, neuropathic pain, and restless legs syndrome (RLS). It belongs to a class of drugs known as anticonvulsants. Here’s a more detailed look at its uses and mechanisms:

  1. Uses:
    • Seizure Management: Gabapentin is used as an adjunctive therapy to reduce the frequency of partial-onset seizures in adults and children aged three and older.
    • Neuropathic Pain: It is commonly prescribed for the management of neuropathic pain, such as postherpetic neuralgia (pain following shingles).
    • Restless Legs Syndrome (RLS): Gabapentin enacarbil, a prodrug of gabapentin (brand name Horizant), is used to treat moderate-to-severe RLS.
    • Off-Label Uses: Gabapentin may also be used off-label for conditions like fibromyalgia, persistent hiccups, migraine prevention, and hot flashes.
  2. Mechanism of Action:
    • While the exact mechanism is not fully understood, gabapentin is thought to work by modulating the activity of certain neurotransmitters in the brain and affecting the way the nervous system transmits pain signals.

What You Should Know Before Buying Gabapentin Online

  1. Prescription Requirement:
    • Gabapentin is a prescription medication, meaning it legally requires a doctor’s prescription. Always ensure you have a valid prescription before purchasing it online.
  2. Source Legitimacy:
    • Only buy gabapentin from reputable online pharmacies. Verify that the pharmacy is licensed and requires a prescription for purchase. Look for certifications like the Verified Internet Pharmacy Practice Sites (VIPPS) seal in the U.S.
  3. Potential Risks:
    • Side Effects: Common side effects include dizziness, drowsiness, tiredness, fever, and nystagmus (rapid, uncontrollable eye movements). Gabapentin can also cause behavioral changes in children, blurred vision, dry mouth, peripheral edema, tremor, and gastrointestinal disturbances.
    • Mental Health Risks: Gabapentin may increase the risk of depression and suicidal thoughts, particularly in young adults under 24 years old.
    • Withdrawal Symptoms: Abruptly stopping gabapentin can lead to withdrawal symptoms such as anxiety, insomnia, nausea, pain, and sweating. It should be tapered off slowly under a doctor’s guidance.
    • Drug Interactions: Gabapentin can interact with other medications, including antacids, hydrocodone, morphine, and other drugs that cause sedation or dizziness. It may also cause false-positive results on some urinary protein tests.
  4. Dosage Adjustments:
    • The dosage of gabapentin needs to be adjusted for individuals with kidney disease. Always follow your doctor’s instructions regarding dosage.
  5. Quality and Authenticity:
    • Be cautious of counterfeit medications. Authentic gabapentin should come from a reliable source, and the packaging should be intact with proper labeling.
  6. Misuse and Abuse Potential:
    • Gabapentin has been associated with misuse and abuse, particularly in individuals with a history of drug abuse. Be mindful of this potential and use the medication only as prescribed.
  7. Cost and Insurance:
    • Check if the online pharmacy accepts your insurance or offers competitive pricing. Compare prices from different legitimate sources to ensure you are getting a fair deal.

Ascend Laboratories

Ascend Laboratories is a pharmaceutical company that specializes in the development, manufacturing, and distribution of generic pharmaceuticals. Ascend Laboratories, as a subsidiary of Alkem Laboratories, plays a significant role in the generic pharmaceutical industry. With a strong focus on quality, regulatory compliance, and affordability, Ascend Laboratories continues to expand its presence in the U.S. market. The company’s commitment to sustainable practices and community engagement further underscores its dedication to improving healthcare access and quality of life for patients.

 

Here is an overview of Ascend Laboratories:

Company Overview

  1. Headquarters:
    • Location: Montvale, New Jersey, USA.
  2. Parent Company:
    • Alkem Laboratories: Ascend Laboratories is a wholly-owned subsidiary of Alkem Laboratories, a leading Indian pharmaceutical company that is known for its wide range of generic medicines and active pharmaceutical ingredients (APIs).

Operations and Facilities

  1. Manufacturing:
    • Ascend Laboratories benefits from the extensive manufacturing network of Alkem Laboratories, which includes facilities in India and the United States. These facilities are designed to meet stringent regulatory standards set by agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global health authorities.
  2. Product Development:
    • The company focuses on developing high-quality generic medications across various therapeutic areas. The product development process involves rigorous research, formulation, and testing to ensure that the generics are bioequivalent to their branded counterparts.

Product Portfolio

  1. Generics:
    • Ascend Laboratories offers a broad range of generic pharmaceuticals covering multiple therapeutic categories, including cardiovascular, central nervous system, anti-infective, gastrointestinal, and pain management drugs.
    • The company’s products are known for their affordability and quality, making essential medications accessible to a wider patient population.
  2. OTC Products:
    • In addition to prescription medications, Ascend Laboratories also offers over-the-counter (OTC) products that address common health concerns.

Key Areas of Operation

  1. Regulatory Compliance:
    • Quality Assurance: Ascend Laboratories adheres to rigorous quality control measures and regulatory requirements to ensure the safety, efficacy, and quality of its products.
    • GMP Compliance: The company’s manufacturing processes comply with Good Manufacturing Practices (GMP), ensuring that all products meet high standards of quality.
  2. Market Strategy:
    • Product Launches: The company focuses on the timely introduction of generic medications to the market, providing affordable options as patents for branded drugs expire.
    • Competitive Pricing: Ascend’s pricing strategy ensures that its products remain affordable without compromising on quality.
  3. Distribution Networks:
    • Ascend Laboratories has established robust distribution networks that ensure the widespread availability of its products across the United States.

Strategic Growth

  1. Acquisitions and Partnerships:
    • Ascend Laboratories leverages the global presence and expertise of Alkem Laboratories to expand its market reach through strategic acquisitions and partnerships.
    • The company continuously seeks opportunities to enhance its product portfolio and enter new markets.
  2. Innovation:
    • The company is committed to innovation in generic pharmaceuticals, focusing on developing complex generics and novel drug delivery systems to address unmet medical needs.

Corporate Responsibility

  1. Sustainability:
    • Ascend Laboratories is committed to sustainable business practices, including minimizing environmental impact through efficient resource use and waste management.
  2. Community Engagement:
    • The company engages in corporate social responsibility (CSR) initiatives aimed at improving healthcare access, supporting education, and contributing to the well-being of the communities it serves.

 

I Want to Buy Gabapentin, What Should I know Before I see A doctor ?

If you’re considering gabapentin, it’s important to consult with a doctor beforehand. Here are some key points to consider before your appointment:

  1. Medical History: Be prepared to discuss your medical history with your doctor, including any past or current conditions, medications you’re taking, and any allergies you may have.
  2. Reason for Use: Be ready to explain why you believe gabapentin may be necessary for your health. Whether it’s for epilepsy, neuropathic pain, or another condition, your doctor will need to understand your symptoms and medical needs.
  3. Potential Side Effects: Familiarize yourself with the potential side effects of gabapentin. These can include dizziness, drowsiness, and coordination problems. Understanding the possible risks can help you make an informed decision.
  4. Interactions: Gabapentin can interact with other medications, including over-the-counter drugs and supplements. Make sure to inform your doctor of all medications you’re taking to avoid any potential interactions.
  5. Dosage and Administration: Your doctor will determine the appropriate dosage of gabapentin based on your condition and medical history. Be prepared to discuss dosing instructions and how to take the medication correctly.
  6. Monitoring: Your doctor may recommend regular check-ups to monitor your progress and adjust your treatment plan if necessary. It’s important to follow up with your doctor as directed to ensure the medication is working effectively and safely.
  7. Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your doctor. Gabapentin may not be suitable during pregnancy or while breastfeeding, and your doctor can advise you on the best course of action.
  8. Alternative Treatments: Explore alternative treatments or therapies that may be available for your condition. Your doctor can help you weigh the benefits and risks of gabapentin compared to other options.

By discussing these points with your doctor, you can ensure that gabapentin is the right choice for you and that you understand how to use it safely and effectively.

 

 

Gabapentin is used for Restless legs syndrome

What is restless legs syndrome?

Restless legs syndrome (RLS), also called Willis-Ekbom Disease, causes unpleasant or uncomfortable sensations in the legs and an irresistible urge to move them.  Symptoms commonly occur in the late afternoon or evening hours, and are often most severe at night when a person is resting, such as sitting or lying in bed.

They also may occur when someone is inactive and sitting for extended periods (for example, when taking a trip by plane or watching a movie).  Since symptoms can increase in severity during the night, it could become difficult to fall asleep or return to sleep after waking up.  Moving the legs or walking typically relieves the discomfort but the sensations often recur once the movement stops.

RLS is classified as a sleep disorder since the symptoms are triggered by resting and attempting to sleep, and as a movement disorder, since people are forced to move their legs in order to relieve symptoms.  It is, however, best characterized as a neurological sensory disorder with symptoms that are produced from within the brain itself.

RLS is one of several disorders that can cause exhaustion and daytime sleepiness, which can strongly affect mood, concentration, job and school performance, and personal relationships.  Many people with RLS report they are often unable to concentrate, have impaired memory, or fail to accomplish daily tasks.  Untreated moderate to severe RLS can lead to about a 20 percent decrease in work productivity and can contribute to depression and anxiety.  It also can make traveling difficult.

It is estimated that up to 7-10 percent of the U.S. population may have RLS.  RLS occurs in both men and women, although women are more likely to have it than men.   It may begin at any age.  Many individuals who are severely affected are middle-aged or older, and the symptoms typically become more frequent and last longer with age.

More than 80 percent of people with RLS also experience periodic limb movement of sleep (PLMS).  PLMS is characterized by involuntary leg (and sometimes arm) twitching or jerking movements during sleep that typically occur every 15 to 40 seconds, sometimes throughout the night.  Although many individuals with RLS also develop PLMS, most people with PLMS do not experience RLS.

Fortunately, most cases of RLS can be treated with non-drug therapies and if necessary, medications.

Gabapentin in the management of restless legs syndrome (RLS) has been evaluated in small controlled trials, demonstrating benefits compared with placebo. Gabapentin enacarbil is FDA-approved for the treatment of RLS .

The American Academy of Sleep Medicine (AASM) guidelines regarding RLS management consider gabapentin effective based on low-level evidence and note that patients with pain symptoms appeared to benefit most.

The benefit-risk ratio is unclear. The European Federation of Neurological Societies/European Neurological Society/European Sleep Research Society (EFNS/ENS/ESRS) Task Force guidelines consider gabapentin effective for short-term management and possibly effective for long-term management of RLS.

Additional study is needed to establish optimal dosing. Based on the International Restless Legs Syndrome Study Group, European Restless Legs Syndrome Study Group, and RLS Foundation (IRLSSG/EURLSSG/RLS-F) guidelines for the prevention and treatment of dopaminergic augmentation in restless legs syndrome, α2δ ligands (eg, gabapentin) are effective and should be considered for the initial treatment of patients with RLS due to their minimal risk of augmentation.

Additionally, patients who experience augmentation on dopaminergic agents may benefit from a switch to α2δ ligands (eg, gabapentin). However, the guidelines note that long-term studies are needed.

How is restless legs syndrome treated?

RLS can be treated, with care directed toward relieving symptoms.  Moving the affected limb(s) may provide temporary relief.  Sometimes RLS symptoms can be controlled by finding and treating an associated medical condition, such as peripheral neuropathy, diabetes, or iron deficiency anemia.

Iron supplementation or medications are usually helpful but no single medication effectively manages RLS for all individuals.  Trials of different drugs may be necessary.  In addition, medications taken regularly may lose their effect over time or even make the condition worse, making it necessary to change medications.

Treatment options for RLS include:

Lifestyle changes.  Certain lifestyle changes and activities may provide some relief in persons with mild to moderate symptoms of RLS.  These steps include avoiding or decreasing the use of alcohol and tobacco, changing or maintaining a regular sleep pattern, a program of moderate exercise, and massaging the legs, taking a warm bath, or using a heating pad or ice pack.  There are new medical devices that have been cleared by the U.S. Food & Drug Administration (FDA), including a foot wrap that puts pressure underneath the foot and another that is a pad that delivers vibration to the back of the legs.  Aerobic and leg-stretching exercises of moderate intensity also may provide some relief from mild symptoms.

Iron.  For individuals with low or low-normal blood tests called ferritin and transferrin saturation, a trial of iron supplements is recommended as the first treatment.  Iron supplements are available over-the-counter.  A common side effect is upset stomach, which may improve with use of a different type of iron supplement.  Because iron is not well-absorbed into the body by the gut, it may cause constipation that can be treated with a stool softeners such as polyethylene glycol.  In some people, iron supplementation does not improve a person’s iron levels.  Others may require iron given through an IV line in order to boost the iron levels and relieve symptoms.

Anti-seizure drugs.  Anti-seizure drugs are becoming the first-line prescription drugs for those with RLS.  The FDA has approved gabapentin enacarbil for the treatment of moderate to severe RLS, This drug appears to be as effective as dopaminergic treatment (discussed below) and, at least to date, there have been no reports of problems with a progressive worsening of symptoms due to medication (called augmentation).  Other medications may be prescribed “off-label” to relieve some of the symptoms of the disorder.

Other anti-seizure drugs such as the standard form of gabapentin and pregabalin can decrease such sensory disturbances as creeping and crawling as well as nerve pain.  Dizziness, fatigue, and sleepiness are among the possible side effects.  Recent studies have shown that pregabalin is as effective for RLS treatment as the dopaminergic drug pramipexole, suggesting this class of drug offers equivalent benefits.

Dopaminergic agents.  These drugs, which increase dopamine effect, are largely used to treat Parkinson’s disease.  They have been shown to reduce symptoms of RLS when they are taken at nighttime.  The FDA has approved ropinirole, pramipexole, and rotigotine to treat moderate to severe RLS.  These drugs are generally well tolerated but can cause nausea, dizziness, or other short-term side effects.  Levodopa plus carbidopa may be effective when used intermittently, but not daily.

Although dopamine-related medications are effective in managing RLS symptoms, long-term use can lead to worsening of the symptoms in many individuals.  With chronic use, a person may begin to experience symptoms earlier in the evening or even earlier until the symptoms are present around the clock.  Over time, the initial evening or bedtime dose can become less effective, the symptoms at night become more intense, and symptoms could begin to affect the arms or trunk.  Fortunately, this apparent progression can be reversed by removing the person from all dopamine-related medications.

Another important adverse effect of dopamine medications that occurs in some people is the development of impulsive or obsessive behaviors such as obsessive gambling or shopping.  Should they occur, these behaviors can be improved or reversed by stopping the medication.

Opioids.  Drugs such as methadone, codeine, hydrocodone, or oxycodone are sometimes prescribed to treat individuals with more severe symptoms of RLS who did not respond well to other medications.  Side effects include constipation, dizziness, nausea, exacerbation of sleep apnea, and the risk of addiction; however, very low doses are often effective in controlling symptoms of RLS.

Benzodiazepines.  These drugs can help individuals obtain a more restful sleep.  However, even if taken only at bedtime they can sometimes cause daytime sleepiness, reduce energy, and affect concentration.  Benzodiazepines such as clonazepam and lorazepam are generally prescribed to treat anxiety, muscle spasms, and insomnia.  Because these drugs also may induce or aggravate sleep apnea in some cases, they should not be used in people with this condition.  These are last-line drugs due to their side effects.