Cycloserine
Parsolex Gmp Center, Inc.
Human Prescription Drug
NDC 13845-1202Cycloserine is a human prescription drug labeled by 'Parsolex Gmp Center, Inc.'. National Drug Code (NDC) number for Cycloserine is 13845-1202. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Cycloserine drug includes Cycloserine - 250 mg/1 . The currest status of Cycloserine drug is Active.
Drug Information:
| Drug NDC: | 13845-1202 |
| 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: | Cycloserine |
| 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: | Cycloserine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Parsolex Gmp Center, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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: | CYCLOSERINE - 250 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | ANDA |
| 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: | 12 Sep, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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. |
| Application Number: | ANDA060593 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | Parsolex Gmp Center, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197551
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 95IK5KI84Z
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 13845-1202-2 | 3 BLISTER PACK in 1 CARTON (13845-1202-2) / 10 CAPSULE in 1 BLISTER PACK | 12 Sep, 2013 | 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:
Cycloserine cycloserine cycloserine cycloserine cap: boq - op. red 353 body: awz - op. grey 284 pgc;f04 imprint on both cap and body
Indications and Usage:
Indications and usage cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negative bacteria. use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug
Warnings:
Warnings administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of cns toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo paresis, or dysarthria. the toxicity of cycloserine is closely related to excessive blood levels (above 30 μg/ml), as determined by high dosage or inadequate renal clearance. the ratio of toxic dose to effective dose in tuberculosis is small. the risk of convulsions is increased in chronic alcoholics. patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.
Dosage and Administration:
Dosage and administration cycloserine is effective orally and is currently administered only by this route. the usual dosage is 500 mg to 1 g daily in divided doses monitored by blood levels. 2 the initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals for the first 2 weeks. a daily dosage of 1 g should not be exceeded.
Contraindications:
Contraindications administration is contraindicated in patients with any of the following: ⢠hypersensitivity to cycloserine ⢠epilepsy ⢠depression, severe anxiety, or psychosis ⢠severe renal insufficiency ⢠excessive concurrent use of alcoho
Adverse Reactions:
Adverse reactions most adverse reactions occurring during therapy with cycloserine involve the nervous system or are manifestations of drug hypersensitivity. the following side effects have been observed in patients receiving cycloserine: nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) ⢠convulsions ⢠drowsiness and somnolence ⢠headache ⢠tremor ⢠dysarthria ⢠vertigo ⢠confusion and disorientation with loss of memory ⢠psychoses, possibly with suicidal tendencies ⢠character changes ⢠hyperirritability ⢠aggression ⢠paresis ⢠hyperreflexia ⢠paresthesia ⢠major & minor (localized) clonic seizures ⢠coma cardiovascular: sudden development of congestive heart failure in patients receiving 1 to 1.5 g of cycloserine daily has been reported. allergy (apparently not related to dosage) skin rash miscellaneous: elevated serum transaminase, especial
Read more...ly in patients with preexisting liver disease
Overdosage:
Overdosage signs and symptoms: acute toxicity from cycloserine can occur if more than 1 g is ingested by an adult. chronic toxicity from cycloserine is dose related and can occur if more than 500 mg is administered daily. the central nervous system is the most common organ system involved with toxicity. toxic effects may include headache, vertigo, confusion, drowsiness, hyperirritability, paresthesias, dysarthria, psychosis paresis, convulsions, and coma. treatment: in adults, many of the neurotoxic effects of cycloserine can be both treated and prevented with the administration of 200 to 300 mg of pyridoxine daily. hemodialysis has been shown to remove cycloserine from the bloodstream. this procedure should be reserved for patients with life threatening toxicity that is unresponsive to less invasive therapy.
Description:
Description d -cycloserine, (r)-4-amino-3-isoxazolidinone, is a broad-spectrum antibiotic that is produced by a strain of streptomyces orchidaceus and has also been synthesized. cycloserine is a white to off-white powder that is soluble in water and stable in alkaline solution. it is rapidly destroyed at a neutral or acid ph. cycloserine has a ph between 5.5 and 6.5 in a solution containing 100 mg/ml. the molecular weight of cycloserine is 102.09, and it has an empirical formula of c 3h6n2o 2 . the structural formula of cycloserine is as follows: each capsule contains cycloserine, 250 mg (2.45 mmol); d & c yellow no. 10, f d & c blue no. 1, f d & c red no. 3, f d & c yellow no. 6, gelatin, iron oxide, talc, and titanium dioxide. structural formula of cycloserine
Clinical Pharmacology:
Clinical pharmacology after oral administration, cycloserine is readily absorbed from the gastrointestinal tract, with peak blood levels occurring in 4 to 8 hours. blood levels of 25 to 30 μg/ml can generally be maintained with the usual dosage of 250 mg twice a day, although the relationship of plasma levels to dosage is not always consistent. concentrations in the cerebrospinal fluid, pleural fluid, fetal blood, and motherâs milk approach those found in the serum. detectable amounts are found in ascitic fluid, file, sputum, amniotic fluid, and lung and lymph tissues. approximately 65% of a single dose of cycloserine can be recovered in the urine within 72 hours after oral administration. the remaining 35% is apparently metabolized to unknown substances. the maximum excretion rate occurs 2 to 6 hours after administration, with 50% of the drug eliminated in 12 hours. mechanism of action: the antibacterial activity of cycloserine results from inhibition of cell-wall synthesis in
Read more... susceptible strains of gram-positive and gram-negative bacteria. antibacterial activity: cycloserine has been shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections [see indications and usage]: mycobacterium tuberculosis.
How Supplied:
How supplied cycloserine is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with âpgcâ and âf04â in edible black ink on both the cap and the body. aluminum blisters (a pack of 3 cards each with 10 capsules). ndc 13845-1202-2. store at controlled room temperature, 20° to 25°c (68° to 77°f) [see usp controlled room temperature].
Package Label Principal Display Panel:
Package label display picture of carton carton specifications cycloserine carton picture carton specifications