NICOTINAMIDE ZCF
-
niacinamide,
zinc oxide,
cupric oxide and
folic acid tablet
River's Edge Pharmaceuticals, LLC
----------
Nicotinamide ZCFDosage & Administration:
Usual adult dose is one tablet taken once or twice a day or as prescribed
by a physician.
Description:
Nicotinamide ZCF Tablets for oral administration are white-colored
tablets, embossed with “TL” on one side and “032” on the other.
How Supplied:
Nicotinamide ZCF is supplied in bottles of 60’s, NDC 68032-344-60.
Each oral tablet provides:
Nicotinamide, USP 750 mg
Zinc Oxide, USP 25 mg
Cupric Oxide 1.5 mg
Folic Acid, USP 500 mcg
Inactive Ingredients:
Copovidone, Dicalcium Phosphate, Ethylcellulose, Hypromellose,
Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose,
Mineral Oil, Pharmaceutical Glaze, Silica, Sodium Lauryl Sulfate, Titanium
Dioxide and Triacetin.
The biphasic delivery of Nicotinamide ZCF minimizes the potential for
competitive antagonism in absorption of its ingredients. The biphasic
delivery system facilitates the immediate release of 750 mg Nicotinamide,
1.5 mg Cupric Oxide, and 500 mcg Folic Acid, as well as, the sustained
release of 25 mg Zinc Oxide. The biphasic delivery system also minimizes
the potential for drug interaction induced deficiency states and impaired
absorptions of other therapeutic agents.
Clinical Pharmacology:
Nicotinamide is a water-soluble component of the vitamin B complex
group. In vivo, Nicotinamide is incorporated into nicotinamide adenine
dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate
(NADP). NAD and NADP function as coenzymes in a wide variety of
enzymatic oxidation-reduction reactions essential for tissue
respiration, lipid metabolism, and glycogenolysis. Nicotinamide has
demonstrated anti-inflammatory actions which may be of benefit
in patients with inflammatory acne vulgaris, including but not
limited to, suppression of antigen induced-lymphocytic
transformation and inhibition of 3'-5' cyclic AMP
phosphodiesterase. Nicotinamide has demonstrated the ability to
block the inflammatory actions of iodides known to precipitate or
exacerbate inflammatory acne.
Nicotinamide lacks the vasodilator, gastrointestinal, hepatic, and
hypolipemic actions of nicotinic acid or niacin. As such
nicotinamide has not been shown to produce the flushing, itching
and burning sensations of the skin as is commonly seen when
large doses of nicotinic acid or niacin are administered orally. (See
Adverse Reactions section.)
Zinc has been shown to inhibit the inflammatory
polymorphonuclear leukocyte chemotaxis in acne patients. Zinc
has also demonstrated an inhibitory effect on the lipase of the
three Propionibacterium species found in human pilosebaceous
follicles.
Patients with inflammatory acne have been shown to have
significantly lower serum zinc levels than matched healthy
controls.
Copper is an essential trace mineral in human nutrition. Although
rare, copper deficiency has been induced by supplemental zinc
therapy. Chronic zinc supplementation has been shown to reduce
the intestinal absorption and utilization of copper, which can
induce signs of copper deficiency in some patients. Symptoms of
copper deficiency include anemia and decreased activity of
cytochrome c oxidase. Heartbeat irregularities have also been
reported in some studies. The biphasic delivery system is designed
to address this issue by delivering supplemental copper with zinc
in a manner that minimizes the potential for competitive
antagonism in absorption. Folic acid serves as an essential
cofactor for the biosynthesis of thymidine and purine nucleotides
required for normal cellular DNA synthesis. Deficiencies of folic
acid have been demonstrated to occur in some cutaneous
inflammatory disorders.
Indications & Usage:
Nicotinamide ZCF is indicated for non-pregnant patients with
acne vulgaris, acne rosacea or other inflammatory skin disorders
who are deficient in, or at risk of deficiency in, one or more of the
components of Nicotinamide ZCF.
Contraindications:
Nicotinamide ZCF is contraindicated in patients with
hypersensitivity to any of its components.
Supplemental copper is contraindicated in those with Wilson's
disease (hepatolenticular degeneration) a disease of abnormal
copper accumulation.
Warnings:
Folic Acid alone is improper therapy in the treatment of pernicious
anemia and other megaloblastic anemias where Vitamin B12 is
deficient.
Precautions:
General: Patients with a history of jaundice, liver disease, or
diabetes mellitus should exercise caution in the use of high doses
of nicotinamide.
Folic Acid in doses above 0.1 mg daily may obscure pernicious
anemia, in that hematologic remission may occur while
neurological manifestations remain progressive.
Extreme caution should be exercised in the use of supplements
containing copper in patients with chronic liver failure and chronic
renal failure.
Drug Interactions:
Nicotinamide: The clearance of primidone and carbamazepine
may be reduced with the concomitant use of nicotinamide.
Zinc Oxide: The absorption of quinolones or tetracycline may be
decreased with the concomitant use of zinc.
Cupric Oxide: Concomitant use of penicillamine and copper can
cause decreased absorption of both substances.
Pregnancy:
Large doses of nicotinamide, zinc, or copper should
be avoided in pregnancy.
Nursing Mothers:
Caution should be exercised when using
Nicotinamide ZCF in nursing mothers.
Pediatrics:
Safety and effectiveness of Nicotinamide ZCF in
pediatric patients have not been established.
Geriatrics:
Clinical studies of Nicotinamide ZCF have not been
performed to determine whether elderly subjects respond
differently than younger subjects. In general dose selection for an
elderly patient should be cautious, usually starting at the low end
of the dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy.
Adverse Reactions:
Allergic sensitization has been reported rarely following oral and
parenteral administration of Folic Acid.
Nicotinamide ZCF is expected to be well tolerated at
recommended doses. At doses greater than the recommended
dose gastrointestinal distress such as nausea or vomiting have
been associated with the administration of nicotinamide or zinc.
Nicotinamide: Dizziness, headache, hyperglycemia, nausea,
vomiting, diarrhea, elevations in liver function tests,
hepatotoxicity, blurred vision, flushing, rash.
Store between 15°-30°C (59°-86°F).
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 07/08 344-11
Package Label:
Each tablet contains: Nicotinamide USP, Zinc
Oxide USP, Copper (Cupric Oxide), Folic Acid
USP, Copovidone, Dicalcium Phosphate,
Ethylcellulose, Hypromellose, Magnesium
Silicate, Magnesium Stearate, Microcrystalline
Cellulose, Mineral Oil, Pharmaceutical Glaze,
Silica, Sodium Lauryl Sulfate, Titanium Dioxide
and Triacetin.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Indications and Usage: Indicated for
non-pregnant patients with acne vulgaris, acne
rosacea or other inflammatory skin disorders who
are deficient in, or at risk of deficiency in, one or
more of the components of Nicotinamide ZCF.
Dosage: Adults—One tablet once or twice a day
or as directed by a physician.
Storage: Store between 15°-30°C (59°-86°F).
Keep tightly closed.
Description: White tablet with “TL” on one side,
“032” on the other. NDC# 68032-344-60.
PLEASE REFER TO PACKAGE INSERT FOR
WARNINGS AND PRECAUTIONS.
Keep out of the reach of children.
| NICOTINAMIDE ZCF
nicotinamide zcf, nicotinamide 750mg, zinc oxide 25mg, cupric oxide 1.5mg, folic acid 500mcg tablet |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 07/01/2008 | 09/14/2009 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |