NDC 13845-1200 Seromycin

Cycloserine

NDC Product Code 13845-1200

NDC CODE: 13845-1200

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):
10 MM
Imprint(s):
CHAOFO4
Score: 1

NDC Code Structure

  • 13845 - Parsolex Gmp Center, Inc.

NDC 13845-1200-3

Package Description: 40 CAPSULE in 1 BOTTLE > 250 mg in 1 CAPSULE (13845-1200-1)

NDC Product Information

Seromycin with NDC 13845-1200 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/250mg

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)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

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".

* Please review the disclaimer below.

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 Section

Seromycin (Cycloserine Capsules, USP), 3-isoxazolidinone, 4-amino –, (R)– 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.

Inactive Ingredient Section

Each capsule contains cycloserine, 250 mg (2.45 mmol); D and C Yellow No. 10, FD
and C Blue No. 1, FD and C Red No. 3, FD and C Yellow No. 6, gelatin, iron
oxide, talc, titanium dioxide, and other inactive ingredients.

Clinical Pharmacology Section

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 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 percent of a single dose of cycloserine can be
recovered in the urine within 72 hours after oral administration. The remaining
35 percent is apparently metabolized to unknown substances. The maximum
excretion rate occurs 2 to 6 hours after administration, with 50 percent of the
drug eliminated in 12 hours.

Microbiology Section

Cycloserine inhibits cell–wall synthesis in susceptible strains
of gram–positive and gram–negative bacteria and in Mycobacterium tuberculosis. Susceptibility
Tests
Cycloserine clinical laboratory standard powder is available for both direct
and indirect methods1 of determining the susceptibility
of strains of mycobacteria. Cycloserine MICs for susceptible strains are
25 μg/mL or lower.

Indications & Usage Section

Seromycin 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,
especially Enterobacter spp. and Escherichia coli. It is generally no more and is usually
less effective than other antimicrobial agents in the treatment of urinary tract
infections caused by bacteria other than mycobacteria. 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 Section

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 alcohol

Warnings Section

Administration 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 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.

Precautions Section

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 Section

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 Section

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,
Mutagenicity, and Impairment of Fertility
Studies have 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 Section

Pregnancy Category C
A study in 2 generations of rats given doses up to 100 mg/kg/day
demonstrated no teratogenic effect in offspring. It is not known whether cycloserine can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Seromycin should be given to a pregnant woman only
if clearly needed.

Nursing Mothers Section

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 Section

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions Section

Most 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)
ConvulsionsDrowsiness and somnolenceHeadacheTremorDysarthriaVertigoConfusion and disorientation with loss of memoryPsychoses, possibly with suicidal tendenciesCharacter changesHyperirritabilityAggressionParesisHyperreflexiaParesthesiaMajor and minor (localized) clonic seizuresComaCardiovascularSudden development of congestive heart failure in patients
receiving 1 to 1.5 g of Seromycin daily has been reported Allergy (apparently not related to
dosage) Skin rashMiscellaneousElevated serum transaminase, especially in patients with
preexisting liver disease

Overdosage Section

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. Patients with renal impairment
will accumulate cycloserine and may develop toxicity if the dosing regimen is
not modified. Patients with severe renal impairment should not receive the drug.
The central nervous system is the most common organ system involved with
toxicity. Toxic effects may include headache, vertigo, confusion, drowsiness,
hyperirritability, paresthesias, dysarthria, and psychosis. Following larger
ingestions, paresis, convulsions, and coma often occur. Ethyl alcohol may
increase the risk of seizures in patients receiving cycloserine. The oral median lethal dose in mice is 5290 mg/kg.Treatment
To obtain up–to–date information about the treatment of overdose, a good
resource is your certified Regional Poison Control Center. Telephone numbers of
certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage,
consider the possibility of multiple drug overdoses, interaction among drugs,
and unusual drug kinetics in your patient. Overdoses of cycloserine have been reported rarely. The following is provided
to serve as a guide should such an overdose be encountered. Protect the patient’s airway and support ventilation and perfusion.
Meticulously monitor and maintain, within acceptable limits, the patient’s vital
signs, blood gases, serum electrolytes, etc. Absorption of drugs from the
gastrointestinal tract may be decreased by giving activated charcoal, which, in
many cases, is more effective than emesis or lavage; consider charcoal instead
of or in addition to gastric emptying. Repeated doses of charcoal over time may
hasten elimination of some drugs that have been absorbed. Safeguard the
patient’s airway when employing gastric emptying or charcoal. 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. The use of 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.

Dosage & Administration Section

Seromycin 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 Section

Seromycin is available as a 250 mg capsule
with an opaque red cap and opaque gray body imprinted with “CHAO” and “F04” in
edible black ink on both the cap and the body.    Bottles of 40  NDC 13845-1200-3Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

References Section

1. Kubica GP, Dye WE: Laboratory methods for clinical and public health - mycobacteriology, US Department of Health, Education, and Welfare, Public Health Services, 1967, pp47-55, 66-70.2. Jones LR: Colorimetric determination of cycloserine, a new antibiotic. Anal Chem 1956; 28:39.The Chao Center for Industrial Pharmacy and Contact Manufacturing  West Lafayette, IN, 47906, USALiterature revised 14 JANUARY 2009LM000251.00  PRINTED IN USA

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