Universal reference book for medicines
Product name: CYCLO PLUS (CYCLO PLUS)

Active substance: cycloserine, pyridoxine

Type: Anti-TB drug

Manufacturer: SPINCOMED (India) manufactured by AUROCHEM LABORATORIS (India)
Composition, form of production and packaging
The tablets covered with a cover
1 tab.

cycloserine 250 mg

pyridoxine hydrochloride 25 mg

10 pieces.
- packings cellular planimetric (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Combined drug.

Cycloserin is a broad-spectrum bactericidal antibiotic;
inhibits the synthesis of the cell wall of sensitive strains of gram-positive and gram-negative bacteria and mycobacteria tuberculosis.
Pyridoxine reduces the severity of adverse reactions of cycloserine from the side of the central nervous system.

PHARMACOKINETICS

After ingestion, cycloserine is rapidly absorbed into the systemic circulation from the gastrointestinal tract, the time to reach Cmax is 3-6 hours (on average about 5 hours), Cmax is 30-40 μg / ml, after which the concentration decreases exponentially and after 48 h, cycloserine is determined in the blood plasma in minimal amounts (the concentration of cycloserine is about 1.0 μg / ml).
Cycloserine penetrates the blood-brain barrier, while the concentration in the cerebrospinal fluid is comparable to that in plasma. It is found in sputum, in pleural, amniotic and ascitic fluid, in fetal blood, breast milk, lung tissues and in lymphoid tissue. About 35% of cycloserine is metabolized; metabolites have not been found to date. T 1/2 - 8-12 hours; with normal kidney function - an average of 10 hours, with chronic kidney failure can cumulate (after 2-3 days). About 60% is excreted by the kidneys; in small quantities is excreted by the intestine.
Pyridoxine does not affect the pharmacokinetic parameters of cycloserine.

INDICATIONS

In combination with other anti-tuberculosis drugs:

active pulmonary tuberculosis;

- extrapulmonary tuberculosis (including kidney damage);

- in case of sensitivity of microorganisms to the drug and after an unsuccessful adequate treatment with basic anti-tuberculosis drugs (rifampicin, isoniazid, streptomycin, ethambutol);

- Combination of tuberculosis with acute infections of the urinary tract caused by sensitive strains of Gram-positive and Gram-negative bacteria, especially Klebsiella spp., Enterobacter spp., Escherichia coli with ineffective essential drugs;

- atypical mycobacterial infections (including those caused by Mycobacterium avium).

DOSING MODE

Inside, immediately before meals (with irritation of the mucous membrane of the gastrointestinal tract - after eating).
Calculation of the dose is given in terms of cycloserine.
Adults: at the rate of 12.5 mg / kg 2-3 times a day, the initial dose for adults is 250 mg in 2 divided doses with a 12-hour interval during the first 1 week.
The average daily dose is 250-1000 mg.
Patients older than 60 years , as well as patients with a body weight of less than 50 kg - 250 mg 2 times / day.

Children: the initial dose of 10 mg / kg 1-2 times / day.
The daily dose is not more than 750 mg.
SIDE EFFECT

Convulsions, drowsiness, headache, tremor, dysarthria, dizziness, confusion and disorientation accompanied by loss of memory;
psychoses (including suicidal attempts); irritability, aggressiveness, peripheral paresis, hyperreflexia, paresthesia, large and small seizures of clonic convulsions, coma, allergic reactions (skin rash, itching), cyanocobalamin and folate deficiency, sideroblastic and megaloblastic anemia, increased activity of "hepatic" aminotransferases (alanine aminotransferase and aspartate aminotransferase ), nausea, heartburn, diarrhea, especially in elderly patients with pre-existing liver disease; exacerbation of chronic heart failure was noted when applied at a dose of 1000-1500 mg / day (see the section "Contraindications").
CONTRAINDICATIONS

- epilepsy (including in the anamnesis);

- Depression;

- expressed state of excitement or psychosis;

- severe chronic renal failure (CC less than 25 ml / min);

acute and chronic heart failure;

- chronic alcoholism;

- hypersensitivity to cycloserine and pyridoxine or other components of the drug.

With caution: child age, chronic renal failure with QC greater than 25 ml / min.

PREGNANCY AND LACTATION

The use of Cyclo Plus in pregnancy is possible only in exceptional cases, when the intended use for the mother exceeds the potential risk to the fetus.

If you need to use the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe chronic renal failure (CC less than 25 ml / min).

With caution: chronic renal failure with QC greater than 25 ml / min.
In the treatment of patients with reduced renal function, taking a daily dose of cycloserine more than 500 mg, weekly monitoring of urinalysis is necessary.
APPLICATION FOR CHILDREN

Use with caution in
childhood.
APPLICATION IN ELDERLY PATIENTS

The application is possible according to a special dosing regimen.

SPECIAL INSTRUCTIONS

In case of development against the background of treatment of allergic dermatitis or symptoms of CNS damage (cramps, psychosis, drowsiness, confusion, hyperreflexia, headache, dizziness, tremor, peripheral paresis, dysarthria), the drug should be discontinued.
During the treatment period, the electroencephalogram, hematological parameters, kidney and liver function should be monitored. In the treatment of patients with reduced renal function, taking a daily dose of cycloserine more than 500 mg, weekly monitoring of urinalysis is necessary. Anticonvulsants or sedatives can be effective in preventing symptoms of CNS damage (including seizures, agitation, tremors). Patients who receive more than 500 mg of cycloserine per day should be under the direct supervision of a doctor because of the possible development of such symptoms. For the prevention of neurotoxic effects, prescribe benzodiazepine series drugs (diazepam), nootropic drugs (piracetam, glutamic acid).
In some cases, the use of cycloserine and other anti-tuberculosis drugs can lead to the development of insufficiency of cyanocobalamin and folic acid, megaloblastic anemia.

Impact on the ability to drive vehicles and manage mechanisms

Influence of the drug on the ability to drive and work with mechanisms is not established, however, taking into account the profile of side effects of cycloserine, during treatment it is recommended to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms caused by cycloserine (when applied more than 1 g in patients with impaired renal function): headache, dizziness, confusion, irritability, paresthesia, dysarthria, psychosis, peripheral paresis, convulsions and coma.

Treatment: symptomatic.
To reduce the absorption of the drug, it is more preferable to use activated charcoal rather than induction of vomiting and gastric lavage.Cycloserine is excreted by hemodialysis.
DRUG INTERACTION

Ethanol increases the risk of epileptic seizures when cycloserine is used, especially in individuals with chronic alcoholism (see "Contraindications").

Ethionamide increases the risk of side effects of cycloserine from the side of the central nervous system, especially seizures.

Isoniazid increases the incidence of dizziness, drowsiness with cycloserine (a dose adjustment of both drugs may be required).

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

In dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life - 2 years.
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