Agemax-G

Folic Acid:

• Indications and usage
• Contraindications
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Storage
• Agemax-G (Folic Acid) reviews

INDICATIONS AND USAGE

Agemax-G (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.

PRECAUTIONS

Agemax-G (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 Agemax-G (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

Agemax-G (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.

Agemax-G (Folic Acid) and the BIFERA logo are registered trademarks and the Agemax-G (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
• Pharmacokinetics
• Why is Agemax-G prescribed?
• Dosage and administration
• Agemax-G (Gabapentin) side effects, adverse reactions
• Agemax-G contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Agemax-G drug interactions
• Agemax-G in case of emergency / overdose
• Agemax-G (Gabapentin) reviews

Pharmacological action

Agemax-G 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 Agemax-G (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 Agemax-G (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 Agemax-G (Gabapentin) and its derivatives. Agemax-G (Gabapentin) in clinically relevant concentrations is not associated with other conventional drugs and neurotransmitter receptors in the brain.

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

Pharmacokinetics

Agemax-G (Gabapentin) is absorbed from the gastrointestinal tract. After oral administration of Agemax-G (Gabapentin) C_max 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 Agemax-G (Gabapentin).

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

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

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

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

Why is Agemax-G 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.

Dosage and administration

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

Agemax-G (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.

Agemax-G contraindications

Hypersensitivity to Agemax-G (Gabapentin).

Using during pregnancy and breastfeeding

Adequate and well-controlled studies on the safety of Agemax-G during pregnancy and lactation in humans has not been conducted. If necessary use Agemax-G (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.

Agemax-G (Gabapentin) is excreted in breast milk. When this drug used in the lactation period, the character of the action of Agemax-G (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 Agemax-G (Gabapentin), to cancel or replace it with an alternative means it should be phased over a minimum of 1 week.

Agemax-G (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 Agemax-G (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.

Agemax-G drug interactions

Simultaneous administration of Agemax-G (Gabapentin) with: