MAXARON

CENTRIX PHARMACEUTICAL, INC,

MAXARON™ FORTE Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• MAXARON DESCRIPTION
• CLINICAL PHARMACOLOGY
• MAXARON INDICATIONS AND USAGE
• MAXARON CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Pediatric Use
  • Information or Patients
• MAXARON ADVERSE REACTIONS
• MAXARON DOSAGE AND ADMINISTRATION
  • Adults
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

MAXARON DESCRIPTION

Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, FD&C Red #40 Lake, FD&C Yellow # 6 Lake (as a color additive), Gelatin, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinylpyrrolidone, Stearic Acid and Titanium Dioxide.

CLINICAL PHARMACOLOGY

IRON is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropolesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.

FOLIC ACID is required for nucleoprotein synthesis and the maintenance of normal erythropolesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase.

VITAMIN B12 is required for the maintenance of normal erythropolesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B12 from the gastrointestinal tract.

MAXARON INDICATIONS AND USAGE

MAXARON™ FORTE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

MAXARON CONTRAINDICATIONS

MAXARON™ FORTE is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

PRECAUTIONS

General

The type of anemia and the underlying cause or causes should be determined before starting therapy with MAXARON™ FORTE. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hemotologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

Information or Patients

As with all oral iron preparations, MAXARON™ FORTE should be stored out of the reach of children to guard against accidental iron poisoning. Patients should not exceed the recommended dosage unless directed by the physician. Patients should be informed that iron therapy can cause black or dark stools.

MAXARON ADVERSE REACTIONS

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

The clinical cause of acute iron overdosage can be variable. Initial symptoms may include: abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

The oral LD₅₀ of polysaccharide-iron complex was estimated to be greater than 5000 mg. iron/kg in rats. Chronic toxicity studies in rats and dogs administered polysaccharide-iron complex showed that a daily dosage of 250 mg iron/kg for three months had no adverse effects.

Warning: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

MAXARON DOSAGE AND ADMINISTRATION

Adults

One capsule daily or as directed by a physician.

HOW SUPPLIED

MAXARON™ FORTE capsules are orange colored with imprint CENTRIX 135. NDC 11528-135-01.

Protect from light and moisture.
Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Mfg. by: Contract Pharmacal Corp.
Hauppauge, NY 11788

Dist. by: Centrix Pharmaceutical, Inc.
Birmingham, AL 35242 USA

Rx Only

Iss. 12/07

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

NDC 11528-135-01

MAXARON™FORTE
capsules

Iron (Ferrous Bisglycinate) 80mg, Iron (Polysaccharide Iron) 70mg,
Vitamin C (Calcium Ascorbate and Threonate) 60mg,
Vitamin B-12 (Cynaocobalamin) 25mcg, Folic Acid 1mg

Do not use if any tamper evident seal
is broken or missing.

Rx Only
100 Capsules

CP

CENTRIX^®
PHARMACEUTICAL, INC.