Cycloserine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Cycloserine is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of active pulmonary and extrapulmonary tuberculosis and in the treatment of acute urinary tract infections caused by susceptible strains of gram–positive and gram–negative bacteria. Common adverse reactions include confusion, dizziness, headache and somnolence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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, especially Enterobacter spp. and Escherichia coli.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cycloserine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cycloserine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Cycloserine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cycloserine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cycloserine in pediatric patients.
Contraindications
There is limited information regarding Cycloserine Contraindications in the drug label.
Warnings
There is limited information regarding Cycloserine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cycloserine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Cycloserine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Cycloserine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cycloserine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cycloserine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cycloserine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cycloserine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Cycloserine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Cycloserine in geriatric settings.
Gender
There is no FDA guidance on the use of Cycloserine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cycloserine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cycloserine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cycloserine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cycloserine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cycloserine in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Monitoring
There is limited information regarding Cycloserine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Cycloserine and IV administrations.
Overdosage
There is limited information regarding Cycloserine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cycloserine Pharmacology in the drug label.
Mechanism of Action
Cycloserine inhibits cell–wall synthesis in susceptible strains of gram–positive and gram–negative bacteria and in Mycobacterium tuberculosis.
Structure
The molecular weight of cycloserine is 102.09, and it has an empirical formula of C3H6N2O2.
Pharmacodynamics
There is limited information regarding Cycloserine Pharmacodynamics in the drug label.
Pharmacokinetics
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.
Nonclinical Toxicology
There is limited information regarding Cycloserine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cycloserine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cycloserine How Supplied in the drug label.
Storage
There is limited information regarding Cycloserine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cycloserine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cycloserine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cycloserine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cycloserine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3] ; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [4]
Overview
Cycloserine is an oral broad spectrum antibiotic effective against tuberculosis, by inhibiting cell wall synthesis of TB bacilli at early stage of peptidoglycan synthesis. For the treatment against tuberculosis, it is classified as a second line drug.
It is also being trialed for treatment of phobias as well as an adjuvant to conventional treatments for depression, obsessive-compulsive disorder and schizophrenia.
Category
Antimycobacterial
US Brand Names
SEROMYCIN®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Overdosage | Dosage and Administration | How Supplied | Labels and Packages
Mechanism of Action
Cycloserine interferes with cell wall synthesis by competing with D-alanine for incorporation into the bacterial cell wall.