NDC 13845-1203 Seromycin

Cycloserine

NDC Product Code 13845-1203

NDC CODE: 13845-1203

Proprietary Name: Seromycin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cycloserine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used with other medications to treat tuberculosis (TB). In some cases, it may also be used to treat urinary tract infections (UTIs). It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Product Characteristics

Color(s):
RED (C48326 - OPAQUE RED 353)
GRAY (C48324 - OPAQUE GREY 284)
Shape: CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
PGCFO4
Score: 1

NDC Code Structure

  • 13845 - Parsolex Gmp Center, Inc.

NDC 13845-1203-2

Package Description: 3 BLISTER PACK in 1 CARTON > 10 CAPSULE in 1 BLISTER PACK

NDC Product Information

Seromycin with NDC 13845-1203 is a a human prescription drug product labeled by Parsolex Gmp Center, Inc.. The generic name of Seromycin is cycloserine. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Parsolex Gmp Center, Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Seromycin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CYCLOSERINE 250 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • GELATIN (UNII: 2G86QN327L)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SODIUM PROPIONATE (UNII: DK6Y9P42IN)
  • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • TALC (UNII: 7SEV7J4R1U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Parsolex Gmp Center, Inc.
Labeler Code: 13845
FDA Application Number: ANDA060593 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-01-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Seromycin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Seromycin®CycloSERINE CAPSULES, USPDESCRIPTIONSeromycin® (CycloSERINE Capsules, USP) D-Cycloserine, (R)-4-amino-3-isoxazol-idinone, 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 C3H6N2O2. 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, titanium dioxide, sodium lauryl sulfate, benzyl alcohol, sodium propionate, edetate calcium disodium, butylparaben, methylparaben, propylparaben, and carboxymethylcellulose.

Clinical Pharmacology

CLINICAL PHARMACOLOGYAfter oral administration, Seromycin® 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 mother’s milk approach those found in the serum. Detectable amounts are found in ascitic fluid, bile, sputum, amniotic fluid, and lung and lymph tissues. Approximately 65% of a single dose of Seromycin® 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

Mechanism of Action: The antibacterial activity of Seromycin® results from inhibition of cell-wall synthesis in susceptible strains of gram-positive and gram-negative bacteria.

Other

Antibacterial Activity: Seromycin® 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.

Indications & Usage

INDICATIONS AND USAGESeromycin® 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, Seromycin® should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent.Seromycin® may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram- positive and gram-negative bacteria. Use of Seromycin® 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.

Contraindications

CONTRAINDICATIONSAdministration is contraindicated in patients with any of the following:• Hypersensitivity to Seromycin®• Epilepsy• Depression, severe anxiety, or psychosis• Severe renal insufficiency• Excessive concurrent use of alcohol

Warnings

WARNINGSAdministration of Seromycin® 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 Seromycin® is closely related to excessive blood levels (above 30 µg/mL), as determined by highdosage 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.

Precautions

PRECAUTIONSGeneral: Before treatment with Seromycin® is initiated, cultures should be taken and the organism’s susceptibility to the drug should be established. In tuberculous infections, the organism’s susceptibility to the other antituberculosis agents in the regimen should also be demonstrated.Anticonvulsant drugs or sedatives may be effective in controlling symptoms of CNS toxicity, such as convulsions, anxiety, and tremor. Patients receiving more than 500 mg of Seromycin® daily should be closely observed for such symptoms. The value of pyridoxine in preventing CNS toxicity from Seromycin® has not been proved.Administration of Seromycin® and other antituberculosis drugs has been associated in a few instances with vitamin B12 and/or folic-acid deficiency, megaloblastic anemia, and sideroblastic anemia. If evidence of anemia develops during treatment, appropriate studies and therapy should be instituted.

Laboratory Tests

Laboratory Tests: Blood levels should be determined at least weekly for patients with reduced renal function, for individuals receiving a daily dosage of more than 500 mg, and for those showing signs and symptoms suggestive of toxicity. The dosage should be adjusted to keep the blood level below 30 µg/mL.

Drug Interactions

Drug Interactions: Concurrent administration of ethionamide has been reported to potentiate neurotoxic side effects.Alcohol and Seromycin® are incompatible, especially during a regimen calling for large doses of the latter. Alcohol increases the possibility and risk of epileptic episodes.Concurrent administration of isoniazid may result in increased incidence of CNS effects, such as dizziness or drowsiness. Dosage adjustments may be necessary and patients should be monitored closely for signs of CNS toxicity.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenicity, and Impairment of Fertility: Studieshave not been performed to determine potential for carcinogenicity. The Ames test and unscheduled DNA repair test were negative. A study in 2 generations of rats showed no impairment of fertility relative to controls for the first mating but somewhat lower fertility in the second mating.

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies with the use of Seromycin® in pregnant women. A study in 2 generations of rats given doses up to 100 mg/kg/day (approximately equivalent to the maximum recommended human dose on a body surface area basis) demonstrated no teratogenic effect in offspring. Seromycin® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from Seromycin®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Usage in Pediatric Patients: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Geriatric Use: Clinical studies of Seromycin® did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. The toxicity of Seromycin® is closely related to excessive blood levels (above 30 µg/mL) as determined by high dosage or inadequate renal clearance (see WARNINGS). Blood levels should be determined at least weekly for patients with reduced renal function, for individuals receiving a daily dosage of more than 500 mg, and for those showing signs and symptoms suggestive of toxicity. The dosage should be adjusted to keep the blood level below 30 µg/mL (see PRECAUTIONS, Laboratory Tests).

Adverse Reactions

ADVERSE REACTIONSMost adverse reactions occurring during therapy with Seromycin® involve the nervous system or are manifestations of drug hypersensitivity. The following side effects have been observed in patients receiving Seromycin®: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• ComaCardiovascular: Sudden development of congestive heart failure in patients receiving 1 to 1.5 g of Seromycin® daily has been reportedAllergy (apparently not related to dosage)Skin rashMiscellaneous: Elevated serum transaminase, especially in patients with preexisting liver disease

Overdosage

OVERDOSAGESigns and Symptoms: Acute toxicity from Seromycin® can occur if more than 1 g is ingested by an adult. Chronic toxicity from Seromycin® 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 Seromycin® can be both treated and prevented with the administration of 200 to 300 mg of pyridoxine daily.Hemodialysis has been shown to remove Seromycin® from the bloodstream. This procedure should be reserved for patients with life threatening toxicity that is unresponsive to less invasive therapy.

Dosage & Administration

DOSAGE AND ADMINISTRATIONSeromycin® 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.

How Supplied

HOW SUPPLIEDSeromycin® is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with “PGC” and “F04” in edible black ink on both the cap and the body.Aluminum blisters (a pack of 3 cards each with 10 capsules). NDC 13845-1200-2.Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

References

REFERENCES1. Kubica GP, Dye WE: Laboratory methods for clinical and public health—mycobacteriology. US Department of Health, Education and Welfare, Public Health Service, 1967, pp 47–55, 66–70.2. Jones LR: Colorimetric determination of cycloserine, a new antibiotic. Anal Chem 1956; 28:39.

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