Prenatol M: Package Insert / Prescribing Info

Prenatol M Description

Each caplet contains:
Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE
Vitamin C (as Ascorbic Acid) ………………….………… 120 mg
Vitamin D3 (as Cholecalciferol).……………..... 20 mcg (800 IU)
Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….....….…. 13.5 mg
Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg
Riboflavin ……………………….…………………….…. 3.4 mg
Niacin (as Niacinamide) ………………..……………….… 20 mg
Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg
Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE
(1200 mcg as L-5-Methylfolate)
Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg
Choline (as Choline Bitartrate) …….……………………… 55 mg
Calcium (as Calcium Carbonate) ……...…………………. 200 mg
Iron (as Ferrous Fumarate) ………..……………………… 27 mg
Iodine (as Potassium Iodine) …...……………………….150 mcg
Magnesium (as Magnesium Oxide) …...………………… 200 mg
Zinc (as Zinc Oxide) ………………...…………………….. 25 mg
Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg
Manganese (as Manganese Sulfate) ……………………… 2.6 mg
Chromium (as Chromium Polynicotinate) ……………….. 45 mcg
Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg

Other Ingredients:

Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid, Coating: Hydroxypropyl Methylcellulose [HPMC], PEG-8.

Indications and Usage for Prenatol M

Indications and Usage: Prenatol-M™ is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years.

Prenatol-M™ may be beneficial in improving the nutritional status of women prior to conception.

Contraindications

This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folate may obscure its signs and symptoms.

Warnings

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Drug Interactions

Prenatol-M™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel).

Adverse Reactions/Side Effects

Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate.

Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Prenatol-M™ after meals may control occasional gastrointestinal disturbances. Prenatol-M™ is best absorbed when taken at bedtime.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic, and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Related/similar drugs

Overdosage

Iron: signs and symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis,melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Prenatol-M™ should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the reach of children.

Treatment:

For specific therapy, exchange transfusion and chelating agents should be used. For general management, gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

Prenatol M Dosage and Administration

Prenatol-M™ caplet daily, between meals or as directed by a licensed healthcare practitioner. Do not administer to children under
the age of 12.

How is Prenatol M supplied

Prenatol-M™ are beige speckled, oblong, coated caplets, supplied in a bottle containing 30 caplets (NDC 59088-009-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Storage and Handling

Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Prenatol-M™

Manufactured in the USA by:

PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873