Seromycin Prescribing Information
Seromycin is the brand name for cycloserine, an antibiotic medication that is primarily used to treat tuberculosis (TB) infections. It is classified as a second-line drug for TB, which means it is typically used when first-line drugs, such as isoniazid and rifampin, are not effective or when the TB bacteria are resistant to these first-line drugs.
Cycloserine works by inhibiting the growth of the TB bacteria by interfering with their ability to synthesize certain cell wall components. It is often used in combination with other TB medications to create a comprehensive treatment regimen.
Uses of Seromycin
Seromycin, which contains the active ingredient cycloserine, is primarily used for the treatment of tuberculosis (TB) infections. Here are its main uses:
- Treatment of Tuberculosis (TB): Antibiotic is considered a second-line drug for the treatment of TB. It is typically used in cases where first-line medications like isoniazid, rifampin, and others are not effective or when the TB bacteria are resistant to these first-line drugs.
- Drug-Resistant TB: Cycloserine, in combination with other second-line TB medications, is often used in the treatment of drug-resistant strains of TB, including multi-drug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). These are strains of TB that do not respond to the standard first-line drugs.
- Tuberculosis in Special Populations: Seromycin may also be used in certain cases involving special populations, such as children or pregnant women, when alternative medications are not suitable or effective.
The dosage of Seromycin can vary depending on several factors, including the individual patient's condition, the severity of the tuberculosis (TB) infection, and whether it is being used as part of a combination therapy. Generally, medicament is taken orally in the form of capsules.
Here are some general guidelines for the dosing in the treatment of TB:
- Initial Phase: During the initial phase of TB treatment, Seromycin is often given as part of a combination therapy with other TB medications. The usual starting dose for adults is 250 to 500 milligrams (mg) taken two times a day.
- Maintenance Phase: After the initial phase, when the TB infection is under control, the dosage of Seromycin may be adjusted. A lower maintenance dose of 250 to 500 mg taken once daily.
- Pediatric Dosage: For children, the dosage is typically based on body weight.
- Renal Impairment: If a patient has kidney problems, the dosage of Cycloserine may need to be adjusted to account for reduced kidney function.
Side Effects of Seromycin
Seromycin can cause various side effects, and it's important to be aware of them when taking this medication. Not everyone will experience these side effects, and some people may experience them to a greater or lesser degree. Common side effects may include:
Central Nervous System (CNS) Effects: Seromycin can affect the central nervous system, leading to side effects such as:
- Sleep disturbances (insomnia)
Psychiatric Effects: Some individuals may experience more severe psychological side effects, including:
- Mood changes (depression, anxiety, or even psychosis)
- Suicidal thoughts
Gastrointestinal Disturbances: Common GI side effects include:
- Abdominal pain
Hypersensitivity Reactions: In rare cases, hypersensitivity reactions to Seromycin may occur, leading to symptoms like skin rash, itching, and fever. Severe allergic reactions are possible but uncommon.
Neurological Effects: Serious neurological side effects can occur with Seromycin, especially at higher doses. These may include:
- Seizures (fits)
- Numbness or tingling in the hands or feet
Vitamin B6 Deficiency: Seromycin interferes with the metabolism of vitamin B6 (pyridoxine). Vitamin B6 deficiency can lead to neurological symptoms.
Due to the potential for neurological side effects, people taking Seromycin should avoid alcohol, which can exacerbate these issues. Drug should also be used with caution in individuals with a history of seizures or certain psychiatric conditions.
Interaction with other drugs
Seromycin can interact with other drugs, potentially affecting their effectiveness or increasing the risk of side effects. Here are some notable interactions to be aware of:
- Alcohol: Combining alcohol with Seromycin can increase the risk of central nervous system (CNS) side effects, such as dizziness and confusion. It's advisable to avoid alcohol while taking this medication.
- Anticonvulsant Medications: Antibiotic may lower the seizure threshold and increase the risk of seizures when used concurrently with anticonvulsant medications (drugs used to treat seizures). Close monitoring is essential if these medications must be used together.
- Isoniazid: Isoniazid is a common first-line drug used to treat tuberculosis (TB). When Seromycin is combined with isoniazid, there may be an increased risk of CNS side effects, such as confusion and psychosis.
- Other Psychiatric Medications: Cycloserine may interact with other medications used to treat psychiatric conditions, potentially leading to an increased risk of mood changes, depression, or anxiety.
- Medications that Lower Seizure Threshold: Drugs that lower the seizure threshold, such as some antidepressants and certain antipsychotic medications, may interact with Seromycin and increase the risk of seizures.
- Medications Metabolized by the Liver: Medicine is metabolized by the liver, so it can potentially interact with other drugs that are metabolized by the same liver enzymes. This can affect the levels and effectiveness of both drugs.
What to avoid while on Seromycin
When taking Seromycin, there are certain things you should avoid or be cautious about to ensure the effectiveness of the medication and minimize the risk of side effects. Here are some important things to avoid or be mindful of while on Cycloserine:
- Alcohol: It's advisable to avoid alcohol while taking Seromycin. Alcohol can interact with the medication and increase the risk of central nervous system (CNS) side effects, including dizziness and confusion. Additionally, alcohol can impair judgment and coordination, which may be worsened by Seromycin.
- Other CNS-Acting Medications: Be cautious when using other medications that can affect the central nervous system, such as sedatives, tranquilizers, and sleep aids. Combining these drugs with Seromycin may intensify CNS side effects, such as dizziness and mood changes.
- Avoid Skipping Doses: Skipping doses or stopping treatment prematurely can lead to treatment failure and the development of drug-resistant tuberculosis (TB).
- Driving and Operating Heavy Machinery: Due to the potential for dizziness and other CNS side effects, it's advisable to exercise caution when driving or operating heavy machinery until you are certain about how Seromycin affects you. If you experience dizziness or confusion, it may be best to avoid activities that require full concentration and coordination.
- Overexertion: While on Cycloserine, it's a good idea to avoid excessive physical exertion, especially if you experience dizziness or other side effects that can affect your balance and coordination.
Contraindications of Seromycin
Seromycin has several contraindications, which are conditions or situations in which the use of the medication is not recommended due to potential risks to the patient's health. Here are some contraindications:
- Known Hypersensitivity: Medicine should not be used in individuals with a known hypersensitivity or allergy to cycloserine or any of its components.
- Seizure Disorders: Antibiotic can lower the seizure threshold, increasing the risk of seizures. Therefore, it is contraindicated in individuals with a history of epilepsy or other seizure disorders. Caution should also be exercised when prescribing Seromycin to individuals with a history of seizures or other factors that may predispose them to seizures.
- Psychiatric Disorders: Seromycin can lead to mood changes, depression, anxiety, and other psychiatric side effects. It should be used with caution in individuals with a history of psychiatric disorders, including depression and psychosis.
- Chronic Alcohol Abuse: Individuals with a history of chronic alcohol abuse or dependence may be at an increased risk of developing neurological side effects when taking this drug. Avoiding alcohol while on Seromycin is advised.
- Severe Renal Impairment: Patients with severe renal impairment (kidney dysfunction) may require dosage adjustments or alternative treatments. The use of Seromycin in these cases should be carefully monitored.
- Neurological Conditions: Seromycin may exacerbate certain pre-existing neurological conditions or conditions that affect the central nervous system (CNS). It should be used with caution in individuals with such conditions.
- History of Drug-Resistant TB to Cycloserine: If a patient has a documented history of TB that is resistant to cycloserine, it should not be used again, as it is unlikely to be effective.
Pregnancy and Seromycin
Pregnancy and the use of Seromycin should be carefully considered, and the decision to prescribe this medication to pregnant individuals should be made on a case-by-case basis, taking into account the potential risks and benefits. Here's what you need to know about pregnancy and Seromycin:
- Risk to the Fetus: Cycloserine has the potential to cross the placenta and reach the developing fetus. While there is limited human data on the safety of Seromycin during pregnancy, animal studies have shown adverse effects on fetal development. This raises concerns about the potential risk to the fetus when Seromycin is used during pregnancy.
- Tuberculosis (TB) and Pregnancy: TB itself can pose risks to both the pregnant individual and the fetus. Therefore, the decision to use Seromycin during pregnancy must consider the severity of the TB infection and whether alternative treatments are available and effective.
- Balancing Risks and Benefits: If TB is not adequately treated during pregnancy, it can lead to serious complications for both the pregnant individual and the fetus.
- Monitoring and Precautions: If Seromycin is prescribed during pregnancy, close monitoring of the pregnant individual and the fetus is essential. This may include regular check-ups, monitoring for side effects, and fetal monitoring through ultrasound.
- Breastfeeding: Cycloserine is known to pass into breast milk, and its use during breastfeeding is generally discouraged. If it is necessary to use Seromycin while breastfeeding, careful monitoring of the infant for potential adverse effects is advised. In some cases, breastfeeding may need to be discontinued
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