Dermanic
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Questions & Answers
Side Effects & Adverse Reactions
This product contains iron.
Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Extreme caution should be used when prescribing this product to patients with a history of liver disease, jaundice, diabetes and/or kidney disease. These patients, as well as patients with a history of heavy use of alcohol, gallbladder disease, gout, and/or stomach ulcers, should be monitored closely. Abnormal liver functions tests have been reported in persons taking high doses of niacin. Patients with coronary artery disease or unstable angina should not take niacin without their licensed medical practitioner's supervision, as large doses can increase the risk of heart rhythm problems. Caution is also advised in patients with low blood pressure as niacin may cause a dangerous drop in blood pressure. Niacin can be toxic to the liver at high doses. Do not exceed 3 grams per day of nicotinamide.1 Do not use other niacin-containing products while taking this product unless under the supervision of a licensed healthcare practitioner. This product is not formulated or intended to be used to treat hyperlipidemias. This product contains four different forms of niacin as Quadracin™, with the majority of the niacin being supplied in slowly metabolized forms, such as nicotinamide and inositol nicotinate. Nicotinamide does not have the same lipid modifying effects as nicotinic acid.
Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.
Patients undergoing cancer treatment should consult their licensed medical practitioner for advice. Before having surgery, tell your licensed medical practitioner that you are taking this product.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
DermaNIC™ is indicated for the distinct nutritional requirements of individuals undergoing acne therapy who require advanced niacin and/or zinc supplementation. DermaNIC™ is not a drug, but may be used as monotherapy5 ("rescue" therapy) or adjunctive therapy as determined by your licensed medical practitioner. The adjunctive use of DermaNIC™ enables medical practitioners to combine therapeutic modalities (dietary management and drug therapy). The multifactorial etiologies of acne (i.e., hyperkeratinization, increased sebum, P. acnes, and inflammation) as well as the prevention of bacterial resistance all facilitate the need for new developments in combination acne therapy. Combining agents that target the different etiological factors of acne can help increase efficacy and response time.
- 5
- In patients with suboptimal folate levels - and as determined by your licensed medical practitioner, DermaNIC™ may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of hyperhomocysteinemia such as may be found with isotretinoin acne therapy. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias8 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin,24-26 pregnancy,17 infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.9
History
There is currently no drug history available for this drug.
Other Information
DermaNIC™ is an orally administered, folate-containing prescription (Rx) dietary supplement for the clinical dietary management of suboptimal niacin and zinc levels associated with acne and/or acne therapy. DermaNIC™ may be administered as adjunctive niacin-folate therapy to provide a protective effect in reducing the risk of hyperhomocysteinemia and/or pellegra in patients undergoing acne therapy or may be administered as monotherapy for patients who are in need of advanced niacin and zinc supplementation as determined by a licensed medical practitioner.2,3,20,22,23 DermaNIC™ is not a drug, but may be prescribed along with acne medications for concomitant care.3 The ultimate goal of acne treatment is to address as many of the pathogenic factors of acne as possible while minimizing side effects.
DermaNIC™ is formulated with niacin and zinc, which support healthful methylation biochemistry and have anti-inflammatory effects via preservation of intracellular coenzyme homeostasis.21 Furthermore, natural ingredients have been added to DermaNIC™ that combine anti-inflammatory and antimicrobial properties along with inhibiting effects on sebum production.22,24-26 Lastly, antibiotic use, which is common in acne patients, can lower the levels of B vitamins that are essential for methylation biochemistry.18 Specifically, studies have shown that acne patients on isotretinoin therapy have decreased folate levels and increased levels of homocysteine.19
| Supplement Facts | ||||
|---|---|---|---|---|
| Serving Size: 1 Multiphasic Tablet | Servings Per Container: 60 | |||
| Amount Per Tablet | % DV† | |||
|
||||
| Niacin (moiety) from Quadracin™‡ | 760 mg | 3800% | ||
| moiety comprised of - | 498 mg from nicotinamide (niacinamide) 260 mg from inositol nicotinate 1.5 mg from nicotinic acid 0.5 mg from chromium polynicotinate |
|||
| Folic Acid, USP as CitraFolic®§ [from controlled-release citrated-pteroylmonoglutamic acid] | 500 mcg | 125% | ||
| Cobalamin (hydroxocobalamin) | 15 mcg | 250% | ||
| Iron (elemental) as AminoFerr®¶ [from ferrous glycine cysteinate] | 1.5 mg | 8% | ||
| Zinc as Zinc-NACx®# [from zinc n-acetyl-l-cysteine] | 20 mg | 133% | ||
| Chromium [from chromium polynicotinate] | ~70 mcg | 58% | ||
| Inositol [from inositol nicotinate] | ~68 mg | Þ | ||
| N-acetyl-l-cysteine [from zinc n-acetyl-l-cysteine] | 49.5 mg | Þ | ||
Coating (FD&C Yellow No. 6 Lake, FD&C Blue No. 2 Lake, hydroxypropyl methylcellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, piperine1, pregelatinized starch, silicified microcrystalline cellulose, silicon dioxide, stearic acid.…. [and other ancillary ingredients2 as needed to ensure product stability]…
This product contains FD&C Yellow #6 Lake.
- 1
- Bioavailability enhancer piperine as BioPerine® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. Protected and manufactured under US Patent Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585.
- 2
- Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality.
Sources
Dermanic Manufacturers
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Allegis Pharmaceuticals, Llc
![Dermanic (Niacinamide, Inositol Niacinate, Niacin, Chromium Nicotinate, Folic Acid, Hydroxocobalamin, Ferrous Cysteine Glycinate, And Acetylcysteine Zinc) Tablet [Allegis Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dermanic | Allegis Pharmaceuticals, Llc
Take 1 (one) tablet once or twice daily or as prescribed by a licensed medical practitioner6. DermaNIC™ should be taken with food. Do not take at the same time as a tetracycline antibiotic.
6 Tablet may be split in half in order to titrate the dosage level. To titrate the medication is to start by taking a low dose of medicine then to gradually increase the dosage to the required level. Titration helps in reducing the side effects of medicine as it allows the body to first adapt to the medication.
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