Colcigel
Colchicinum 4x
Gensco Laboratories, Llc
Human Prescription Drug
NDC 35781-0400Colcigel also known as Colchicinum 4x is a human prescription drug labeled by 'Gensco Laboratories, Llc'. National Drug Code (NDC) number for Colcigel is 35781-0400. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Colcigel drug includes Colchicine - 4 [hp_X]/15mL . The currest status of Colcigel drug is Active.
Drug Information:
| Drug NDC: | 35781-0400 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Colcigel |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Colchicinum 4x |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gensco Laboratories, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | COLCHICINE - 4 [hp_X]/15mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TRANSDERMAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 May, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Gensco Laboratories, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000182141
N0000000239
N0000193949
M0000713
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | SML2Y3J35T
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cytochrome P450 3A4 Inhibitors [MoA]
P-Glycoprotein Interactions [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Alkaloid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Alkaloids [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Alkaloid [EPC]
Alkaloids [CS]
Cytochrome P450 3A4 Inhibitors [MoA]
P-Glycoprotein Interactions [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 35781-0400-2 | 1 BOTTLE, DISPENSING in 1 CARTON (35781-0400-2) / 15 mL in 1 BOTTLE, DISPENSING | 01 May, 2015 | N/A | No |
| 35781-0400-4 | 2 BOTTLE, DISPENSING in 1 PACKAGE (35781-0400-4) / 30 mL in 1 BOTTLE, DISPENSING | 01 May, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Colcigel colchicinum 4x alcohol water isopropyl myristate lecithin, soybean urea docusate sodium colchicine colchicine
Drug Interactions:
7 drug interactions colcigel® (colchicinum 4x) is a substrate of the efflux transporter p-glycoprotein (p-gp). of the cytochrome p450 enzymes tested, cyp3a4 was mainly involved in the metabolism of colchicinum. if oral colchicine is administered with drugs that inhibit p-gp, most of which also inhibit cyp3a4, increased concentrations of colchicinum are likely. fatal drug interactions have been reported. topical application of colcigel® has demonstrated insignificant systemic absorption in animal testing and confirmed in limited human pharmacokinetic evaluations and, therefore, poses a limited risk of clinically significant drug interactions. physicians should, however, ensure that patients are suitable candidates for treatment with colcigel® and remain alert for signs and symptoms of toxicities related to increased colchicinum exposure as a result of a drug interaction. signs and symptoms of colcigel® toxicity should be evaluated promptly and, if toxicity is suspected, colc
Read more...igel® should be discontinued immediately.
Indications and Usage:
1 indications and usage colcigel® (colchicinum 4x) transdermal gel is an alkaloid indicated for: treatment and prophylaxis of gout flares in adults.( 1.1 ) colcigel® (colchicinum 4x) is not an analgesic medication and should not be used to treat pain from other causes. 1.1 gout flares colcigel® transdermal gel is indicated for prophylaxis and the treatment of acute gout flares. treatment of gout flares: colcigel® gel is indicated for treatment of acute gout flares when used at the first sign of a flare. prophylaxis of gout flares: colcigel® is indicated for prophylaxis of gout flares.
Warnings:
5 warnings for external use only ⢠avoid contact with eyes and mouth ⢠keep out of reach of children store at 25º c (77º f); exclusions permitted to 15º to 30ºc (59º to 86º f). see usp controlled room temperature
Dosage and Administration:
2 dosage and administration apply 1 â 4 pumps up to four times per day. 1 application = 1 pump (0.25ml) covers an area 4â in diameter. children under 16 years of age do not use unless directed by a physician. discard 6 months after first use
Dosage Forms and Strength:
3 dosage forms and strengths colcigel® is colchicinum 4x in a transdermal gel base. the gel is viscous and opaque in appearance. colcigel® is available in 15 ml sealed dispensing containers that produce 0.25 ml of gel per each manual depression of the plunger top (pump). colcigel® is colchicinum 4x in a transdermal gel base. the gel is viscous and opaque in appearance. colcigel® is available in 15 ml sealed dispensing containers that produce 0.25 ml of gel per each manual depression of the plunger top (pump).
Contraindications:
4 contraindications traumatized skin, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. patients with severe renal or severe hepatic impairment should not be given colcigel® in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors, except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with oral colchicine taken in therapeutic doses.
Adverse Reactions:
6 adverse reactions prophylaxis and treatment of gout flares: the most commonly reported adverse reaction in clinical trials for the prophylaxis and treatment of gout was mild skin irritation at the site of application.
Drug Interactions:
7 drug interactions colcigel® (colchicinum 4x) is a substrate of the efflux transporter p-glycoprotein (p-gp). of the cytochrome p450 enzymes tested, cyp3a4 was mainly involved in the metabolism of colchicinum. if oral colchicine is administered with drugs that inhibit p-gp, most of which also inhibit cyp3a4, increased concentrations of colchicinum are likely. fatal drug interactions have been reported. topical application of colcigel® has demonstrated insignificant systemic absorption in animal testing and confirmed in limited human pharmacokinetic evaluations and, therefore, poses a limited risk of clinically significant drug interactions. physicians should, however, ensure that patients are suitable candidates for treatment with colcigel® and remain alert for signs and symptoms of toxicities related to increased colchicinum exposure as a result of a drug interaction. signs and symptoms of colcigel® toxicity should be evaluated promptly and, if toxicity is suspected, colc
Read more...igel® should be discontinued immediately.
Clinical Pharmacology:
12 clinical pharmacology the mechanism by which colchicinum exerts its beneficial effect in patients has not been fully elucidated; however, evidence suggests that colchicinum may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1alpha. additionally, colchicine disrupts cytoskeletal functions through inhibition of alpha-tubulin polymerization into microtubules and consequently prevents the activation, degranulation, and migration of neutrophils thought to mediate some gout symptoms.
Nonclinical Toxicology:
13 nonclinical toxicology carcinogenesis carcinogenicity studies of colchicinum have not been conducted. due to the potential for colchicinum to produce aneuploid cells (cells with an unequal number of chromosomes), there is theoretically an increased risk of malignancy.. mutagenesis colchicine was negative for mutagenicity in the bacterial reverse mutation assay. in a chromosomal aberration assay in cultured human white blood cells, colchicine treatment resulted in the formation of micronuclei. since published studies demonstrated that colchicine induces aneuploidy from the process of mitotic nondisjunction without structural dna changes, colchicine is not considered clastogenic, although micronuclei are formed. impairment of fertility no studies of colchicinum effects on fertility were conducted with colcigel®. however, published nonclinical studies demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. reproductive studies also repor
Read more...ted abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females when exposed to colchicine. colchicine administered to pregnant animals resulted in fetal death and teratogenicity. these effects were dose dependent, with the timing of exposure critical for the effects on embryofetal development. the nonclinical doses evaluated were generally higher than an equivalent human oral therapeutic dose, but safety margins for reproductive and developmental toxicity could not be determined. case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare. a case report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicinum use and female infertility. the use of colchicinum needs to be weighed against the potential risks.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis carcinogenicity studies of colchicinum have not been conducted. due to the potential for colchicinum to produce aneuploid cells (cells with an unequal number of chromosomes), there is theoretically an increased risk of malignancy..
Mutagenesis colchicine was negative for mutagenicity in the bacterial reverse mutation assay. in a chromosomal aberration assay in cultured human white blood cells, colchicine treatment resulted in the formation of micronuclei. since published studies demonstrated that colchicine induces aneuploidy from the process of mitotic nondisjunction without structural dna changes, colchicine is not considered clastogenic, although micronuclei are formed.
Impairment of fertility no studies of colchicinum effects on fertility were conducted with colcigel®. however, published nonclinical studies demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. reproductive studies also reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females when exposed to colchicine. colchicine administered to pregnant animals resulted in fetal death and teratogenicity. these effects were dose dependent, with the timing of exposure critical for the effects on embryofetal development. the nonclinical doses evaluated were generally higher than an equivalent human oral therapeutic dose, but safety margins for reproductive and developmental toxicity could not be determined. case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare. a ca
Read more...se report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicinum use and female infertility. the use of colchicinum needs to be weighed against the potential risks.
How Supplied:
14 how supplied/storage and handling 14.1 how supplied colcigel® is colchicinum 4x in a transdermal gel base. the gel is viscous and opaque in appearance. colcigel® is available in 2x15ml sealed dispensing containers that produce 0.25 ml of gel per each manual depression of the plunger top (pump). 2x15ml (1.01 fl oz) bottles ndc 35781-0400-4 14.2 storage store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature] dispense in original container. us patent pending manufactured for: gensco pharma, llc 8550 nw 33rd street, suite 200. miami, fl 33122 (855) 743-6726 www.genscopharma.com
Package Label Principal Display Panel:
Box label