G-Neuro

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G-Neuro uses

G-Neuro consists of Folic Acid, Gabapentin, Methylcobalamin, Vitamin B6 (Pyridoxine Hydrochloride).

Folic Acid:


INDICATIONS AND USAGE

G-Neuro (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS

G-Neuro (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of G-Neuro (Folic Acid) acid.

DOSAGE AND ADMINISTRATION

One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.

HOW SUPPLIED

G-Neuro (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)

KEEP OUT OF REACH OF CHILDREN.

STORAGE

Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container to protect from light and moisture.

To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch

Distributed by:

Meda Pharmaceuticals Inc.

Somerset New Jersey 08873-4120

© 2014 Meda Pharmaceuticals Inc.

U.S. Patent Nos. 7,585,527 and 8,080,520

Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.

G-Neuro (Folic Acid) and the BIFERA logo are registered trademarks and the G-Neuro (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.

MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.

IN-6885-02 Rev 6/2014

Gabapentin:


Pharmacological action

G-Neuro is an antiepileptic drug. Chemical structure is similar to GABA fulfilling the function of the inhibitory neurotransmitter in the CNS. It is believed that the mechanism of action of G-Neuro (Gabapentin) is different from other anticonvulsants acting through GABA synapses (including valproate, barbiturates, benzodiazepines, inhibitors of GABA-transaminase, inhibitors of GABA capture, GABA agonists and prodrugs of GABA). In in vitro studies showed that G-Neuro (Gabapentin) is characterized by the presence of a new peptide binding sites in the brain tissues of rats, including the hippocampus and cerebral cortex, which may be relevant to the anticonvulsant activity of G-Neuro (Gabapentin) and its derivatives. G-Neuro (Gabapentin) in clinically relevant concentrations is not associated with other conventional drugs and neurotransmitter receptors in the brain.

The final mechanism of action of G-Neuro (Gabapentin) is not defined.

Pharmacokinetics

G-Neuro (Gabapentin) is absorbed from the gastrointestinal tract. After oral administration of G-Neuro (Gabapentin) Cmax in plasma achieved within 2-3 hours. The absolute bioavailability of approximately 60%. Taking of this medication in conjunction with food (including a high-fat) does not affect the pharmacokinetics of G-Neuro (Gabapentin).

G-Neuro (Gabapentin) is not bound to plasma proteins and has Vd 57.7 l.

G-Neuro (Gabapentin) is excreted only by the kidneys. Signs of biotransformation of G-Neuro (Gabapentin) in the human body were not found.

G-Neuro (Gabapentin) is removed from plasma by hemodialysis.

The concentrations of G-Neuro (Gabapentin) in the plasma of children were similar to those of adults.

Why is G-Neuro prescribed?

Treatment of neuropathic pain in adults over the age of 18 years; monotherapy of partial seizures with secondary generalization and without its fot children and adults older than 12 years; as an adjunct in the treatment of partial seizures with secondary generalization and without its for adults and children aged 3 years and older.

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Dosage and administration

Dosing regimen of G-Neuro is individual, depending on the indications and treatment regimens.

G-Neuro (Gabapentin) side effects, adverse reactions

CNS and peripheral nervous system: amnesia, ataxia, confusion, impaired coordination, depression, dizziness, dysarthria, nervous hyperexcitability, nystagmus, drowsiness, impaired thinking, tremor, muscle cramps, amblyopia, diplopia, hyperkinesia, strengthening, weakening or absence of reflexes, paresthesia, anxiety, hostility, impaired gait.

Digestive system: change in staining of teeth, diarrhea, increased appetite, dry mouth, nausea, vomiting, flatulence, anorexia, gingivitis, abdominal pain, pancreatitis, changes in liver function tests.

Hemopoietic system: leucopenia, decrease the number of leukocytes, thrombocytopenic purpura.

Respiratory system: rhinitis, pharyngitis, cough, pneumonia.

Musculoskeletal system: myalgia, arthralgia, bone fractures.

Cardiovascular: hypertension, manifestations of vasodilation.

Urinary system: urinary tract infections, urinary incontinence.

Allergic reactions: erythema multiforme, Stevens-Johnson syndrome.

Dermatological reactions: maceration of the skin, acne, itching, rash.

Other: back pain, fatigue, peripheral edema, impotence, fatigue, malaise, swelling of the face, increase in body weight, accidental injury, asthenia, flu-like syndrome, fluctuations in blood glucose in children - a viral infection, otitis media.

G-Neuro contraindications

Hypersensitivity to G-Neuro (Gabapentin).

Using during pregnancy and breastfeeding

Adequate and well-controlled studies on the safety of G-Neuro during pregnancy and lactation in humans has not been conducted. If necessary use G-Neuro (Gabapentin) during pregnancy and lactation patients should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or infant.

G-Neuro (Gabapentin) is excreted in breast milk. When this drug used in the lactation period, the character of the action of G-Neuro (Gabapentin) on the infant is not defined.

Category effects on the fetus by FDA - C.

Special instructions

Abrupt discontinuation of therapy by anticonvulsant drugs in patients with partial seizures may provoke a convulsive status. If necessary to reduce the dose of G-Neuro (Gabapentin), to cancel or replace it with an alternative means it should be phased over a minimum of 1 week.

G-Neuro (Gabapentin) is not an effective drug for treatment of absence seizures.

For patients with impaired renal function and patients in hemodialysis it requires correction of dosing regimen. Elderly patients may require correction of the dosing regimen of G-Neuro (Gabapentin) due to the fact that such patients may decrease renal clearance.

The efficacy and safety of neuropathic pain treatment in patients under age 18 is not defined.

During the period of treatment it is necessary to avoid taking alcohol.

Prior to determining individual response to treatment the patient should refrain from potentially dangerous activities coupled with the need to focus and improve the speed of psychomotor reactions.

G-Neuro drug interactions

Simultaneous administration of G-Neuro (Gabapentin) with:

  • antacids reduces the absorption of G-Neuro (Gabapentin) from the gastrointestinal tract.
  • felbamate may increase its T1/2.
  • described a case of increasing the concentration of phenytoin in blood plasma.

    G-Neuro in case of emergency / overdose

    There was reported an acute overdose while taking 49 g of G-Neuro (Gabapentin). Symptoms: double vision, slurred speech, drowsiness, lethargy, diarrhea.

    Treatment: maintenance therapy, hemodialysis.

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    G-Neuro pharmaceutical active ingredients containing related brand and generic drugs:

    Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


    G-Neuro available forms, composition, doses:

    Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
    Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
    Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


    G-Neuro destination | category:

    Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
    Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


    G-Neuro Anatomical Therapeutic Chemical codes:

    A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


    G-Neuro pharmaceutical companies:

    Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
    Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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    References

    1. Dailymed."FOLIC ACID INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."GABAPENTIN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL S6758UPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: 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/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming G-Neuro?

    Depending on the reaction of the G-Neuro after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider G-Neuro not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

    Is G-Neuro addictive or habit forming?

    Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

    Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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    Review

    sdrugs.com conducted a study on G-Neuro, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of G-Neuro consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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    The information was verified by Dr. Rachana Salvi, MD Pharmacology

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