METHAZEL- methazel capsule 
Sterling-Knight Pharmaceuticals, LLC

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.

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Methazel
Capsules

Rx Only 

DESCRIPTION

Methazel is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels as well as other supplementation.


Methazel should be administered under the supervision o f a licensed medical practitioner.
Each capsule contains the following ingredients: 
Each capsule contains:
Folic Acid...............................................................1mg
Pyriodoxal 5 Phosphate...............,............................50mg
Methylcobalamin.....................................................2.5mg
CoQ10...................................................................25mg
Alpha Lipoic Acid ....................................................50mg
N-Acetylcysteine.....................................................50mg

Each capsule contains the following inactive ingredients: Soybean Oil, Gelatin (Bovine), Bees wax, Yellow, Glycerin, Deionized Water, Lecithin, Titanium Dioxide, FD&C Blue #1, FD&C Red #40.

* This product is a prescription vitamin that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

FOLATE REGULATION
The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate.

Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0 .1 mg doses, and must be administered under the supervision o f a licensed medical practitioner. 

INDICATIONS & USAGE

Methazel is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Methazel should be administered under the supervision o f a licensed medical practitioner.

PATIENT MEDICATION INFORMATION

Methazel is a prescription dietary supplement to be used only under licensed medical supervision.

DRUG INTERACTIONS

Drugs which may interact with folate include:

Drugs which may interact with vitamin B : 12

Drug s which interact with vitamin B6:

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS

Caution is recommended in patients with a history of bipolar illness.

PRECAUTIONS

General

Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. The 2 mgs of B12 (cyanocobalamin), the amount contained in Methazel, has been shown to provide an adequate amount of B12 to address this precaution. Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75 yrs) to have the potential to reduce natural killer cells’ cytotoxicity, which may result in an impaired immune response.

B12 should not be used in those with Leber’s optic atrophy. Decreased levels of B have been associated with reduced ability to detoxify the cyanide in exposed individuals and B may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder. Hydroxocobalamin can aid in the detoxification of cyanide. This form of B12, although not in this product, is an acceptable form for >B12 supplementation in those with this disorder.

Caution should be exercised when Methazel is administered to patients with diabetic nephropathy. One published study showed that among patients with diabetic nephropathy given high dose folic acid, vitamin B12, and vitamin B (pyridoxine) versus a placebo, there was a greater decrease in glomerular filtration rate (GRF).

Pregnant women and nursing mothers may be recommended to use 12 microgram doses of B12 from nutritional supplements, although higher doses should only be taken on the recommendations of a prescribing medical professional. Administration of doses of vitamin B12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.

Folate, when administered as a sing le agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations).

Folate therapy alone is inadequate for treatment o f a vitamin B12 deficiency.

PREGNANCY

Methazel is not intended for use as a prenatal/postnatal multivitamin for lactating and no n- lactating mother. T his pro duct contains B vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnlence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemiavera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

DOSAGE & ADMINISTRATION

One capsule daily or as directed by a licensed medical practitioner. Methazel capsules are supplied as purple capsules printed with 350 dispensed in HDPE plastic bottles of 30ct.

NDC 69336-350-30

STORAGE AND HANDLING

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

PACKAGE LABEL

KEEP THIS OUT OF T HE REACH OF CHILDREN.

Rx Only

Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663

MADE IN USA Rev. 10/2015

MethazelImg

METHAZEL 
methazel capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-350
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
PYRIDOXAL 5-PHOSPHATE (UNII: F06SGE49M6) (PYRIDOXAL 5-PHOSPHATE - UNII:F06SGE49M6) PYRIDOXAL 5-PHOSPHATE 50 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 2.5 mg
COENZYME Q10, (2Z)- (UNII: U705VLF0VW) (COENZYME Q10, (2Z)- - UNII:U705VLF0VW) COENZYME Q10, (2Z)- 25 mg
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) ALPHA LIPOIC ACID 50 mg
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 50 mg
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL (UNII: 241ATL177A)  
GELATIN (UNII: 2G86QN327L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color purple Score no score
Shape capsule Size 22mm
Flavor Imprint Code 350
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69336-350-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/12/2015
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)

Revised: 10/2015
Document Id: 9b74d855-bc07-4fa4-b48d-aafdff54343d
Set id: 88ecef82-6c3c-419b-9138-921fea04913a
Version: 1
Effective Time: 20151012
 
Sterling-Knight Pharmaceuticals, LLC