Nigalax Suppositories

Bisacodyl:

• Active ingredient(in each tablet)
• Use
• Warnings
• Stop using this product and consult a doctor if you
• Keep out of reach of children
• Directions
• Other information
• Inactive ingredients
• Questions?
• Nigalax Suppositories (Bisacodyl) reviews

Active Ingredient

Nigalax Suppositories (Bisacodyl) 5 mg...Stimulant Laxative

Use

For relief of occasional constipation.

Warnings

May cause abdominal discomfort, faintness and cramps.

If pregnant or breast-feeding, ask a health professional before use.

Ask a doctor before using any laxative if you have

• abdominal pain, nausea or vomiting
• a sudden change in bowel habits lasting more than 2 weeks
  

• already used a laxative for more than 1 week
  

Do not take within 1 hour after taking an antacid, milk or milk products.

Stop using this product and consult a doctor if you

• have rectal bleeding
• have no bowel movement after use

These symptoms may indicate a serious condition.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Single Daily Dosage

Other Information

• this product generally produces bowel movement in 6-12 hours
• each tablet is imprinted with "TCL 0003" for identification
  

• store at temperatures not above 86F (30C)
• do not use if foil imprinted with "Bisacodyl 5mg Laxative Tablet" is broken or missing
• consult Physicians' Desk Reference for complete professional labeling
  

Inactive Ingredients

acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, collodial silicon dioxide, corn starch, DandC yellow 10 lake, FDandC yellow 6 lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sucrose, talc, titanium dioxide

Questions?

1-866-255-6960 or www.fleetlabs.com

Docusate Sodium:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Warning
• Precautions
• Adverse reactions
• Drug interactions
• Overdosage
• Dosage and administration
• How supplied
• Storage
• Nigalax Suppositories (Docusate Sodium) reviews

DESCRIPTION

Nigalax Suppositories (Docusate Sodium) is a dark grey, oval, film-coated tablet, debossed "TL012". Each dark grey film-coated tablet for oral administration contains:

Inactive Ingredients:

Microcrystalline Cellulose, Di Calcium Phosphate, TriPotassium Citrate, Sodium Carboxymethyl Cellulose, Acacia, Povidone K30, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Citric Acid, Dextrin, Dextrose, Lecithin, and Sodium Citrate.

CLINICAL PHARMACOLOGY

Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B₁₂ is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

INDICATIONS AND USAGE

Nigalax Suppositories (Docusate Sodium) is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Hemolytic anemia, 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.

Warning

PRECAUTIONS

General

Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Nigalax Suppositories tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

Folic Acid

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

OVERDOSAGE

Symptoms: Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

NOTICE:Contact with moisture can discolor or erode the tablet. Do not chew tablet.

HOW SUPPLIED

Nigalax Suppositories (Docusate Sodium) is packaged in bottles of 90 tablets.

Product Code: 13811-012-90

STORAGE

Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F).

Dispense in a tight container with a child-resistant closure.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF THE REACH OF CHILDREN.

Rx Only

All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:

TRIGEN Laboratories, Inc., Sayreville, NJ 08872

www.trigenlab.com

Rev. 07/13