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Zolate

Generic Name: folic acid, cholecalciferol
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Zolate Description

Zolate is an orally-administered (capsule) prescription folate product specifically formulated for the dietary management of patients with unique nutritional needs due to medical conditions and disease states requiring increased folate levels and specific Vitamin D supplementation levels.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated.

Warnings and Precautions

Caution is recommended in patients with a history of bipolar illness, as mood elevation is possible in this population.

Patients taking anticonvulsant medications should also exercise caution before taking this product, as folate may (i) interfere with anticonvulsant medication, and/or (ii) lower seizure threshold. Conversely, anticonvulsant medications may interfere with folate metabolism, although the exact mechanism of action is not clear or well understood.

Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.

Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.

Adverse Reactions

Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine. Call your medical practitioner about side effects.

PHARMACOLGY

Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development. During the first four weeks of pregnancy—when many women do not even realize that they have conceived—adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status.
Folate is involved in transformylation and methylation metabolism as well as (indirectly) succinylation metabolism (through the “methyl trap” hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate. Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intakes may affect the magnitude of risk reduction or participate in a co-protective effect with folate.

Indications and Usage for Zolate

Zolate is indicated for the distinct nutritional requirements of patients in need of folate and Vitamin D supplementation as determined by a licensed medical practitioner.

Zolate should be administered under the supervision of a licensed medical practitioner.

Zolate Dosage and Administration

One (1) capsule daily or as directed by a licensed medical practitioner.

How is Zolate Supplied

Zolate are clear gelatin capsules, and are supplied in bottles of 30 capsules.

STORAGE

Store at Controlled Room Temperature 15°-30° C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

Zolate 
folic acid, cholecalciferol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70033-113
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg  in 1 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL .094 mg  in 1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color white Score no score
Shape capsule Size 15mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:70033-113-30 30 mg in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/25/2016
Labeler - Axiom Pharma (079919011)
Establishment
Name Address ID/FEI Operations
Carecam International, Inc. 958024937 manufacture(70033-113), analysis(70033-113), label(70033-113), pack(70033-113)
Revised: 07/2016
 
Axiom Pharma
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