DRUGS & SUPPLEMENTS
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G-Neuro (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
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.|
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.
Allergic sensitization has been reported following both oral and parenteral administration of G-Neuro (Folic Acid) acid.
One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.
G-Neuro (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)
KEEP OUT OF REACH OF CHILDREN.
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
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
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.
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.
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.
Dosing regimen of G-Neuro is individual, depending on the indications and treatment regimens.
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.
Hypersensitivity to G-Neuro (Gabapentin).
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.
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.
Simultaneous administration of G-Neuro (Gabapentin) with:
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.
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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The information was verified by Dr. Rachana Salvi, MD Pharmacology