Leuco

Cada supositorio vaginal contiene tioconazol 100 mg y Leuco 150 mg. También contiene witepsol como excipiente.

Trichomoniasis

Leuco is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.

Giardiasis

Leuco is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age.

Amebiasis

Leuco is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage.

Bacterial Vaginosis

Leuco is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Leuco Tablets and other antibacterial drugs, Leuco Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Leuco (Leuco) is an antibiotic that fights bacteria in the body.

Leuco is used to treat certain infections caused by bacteria, such as infection of the intestines or vagina. It is also used to treat certain sexually transmitted infections.

Leuco may also be used for purposes other than those listed in this medication guide.

Usual Adult Dose for Trichomoniasis

2 g orally once with food

The sexual partners should be treated with the same dose at the same time.

Usual Adult Dose for Giardiasis

2 g orally once with food

Usual Adult Dose for Amebiasis

Intestinal: 2 g orally once a day with food for 3 days

Amebic liver abscess: 2 g orally once a day with food for 3 to 5 days

Usual Adult Dose for Bacterial Vaginosis

Nonpregnant, adult women: 2 g orally once a day with food for 2 days or 1 g orally once a day with food for 5 days

Usual Pediatric Dose for Trichomoniasis

2 g orally once with food

The sexual partners should be treated with the same dose at the same time.

Usual Pediatric Dose for Giardiasis

3 years or older: 50 mg/kg (up to 2 g) orally once with food

Usual Pediatric Dose for Amebiasis

3 years or older:

Intestinal: 50 mg/kg (up to 2 g) orally once a day with food for 3 days

Amebic liver abscess: 50 mg/kg (up to 2 g) orally once a day with food for 3 to 5 days

Close monitoring is recommended when treatment durations exceed 3 days.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No data available for dosing adjustments for Leuco. However, caution should be used in dosing patients with severe hepatic dysfunction due to reduction of metabolic elimination of metronidazole in this patient population.

Dose Adjustments

No adjustment recommended

Precautions

Convulsive seizures and peripheral neuropathy have been reported. The drug should be discontinued if patient experiences abnormal neurological symptoms. Leuco should be administered cautiously to patients with diseases of the central nervous system.

Leuco may produce transient leukopenia and neutropenia, However no persistent hematological abnormalities attributable to Leuco have been observed clinically. If retreatment is necessary, total and differential leukocyte counts are recommended.

Alcoholic beverages should be avoided during and for 3 days after Leuco therapy.

Animal studies have revealed carcinogenicity with another agent in the nitroimidazole class (metronidazole). Therefore, unnecessary use of Leuco should be avoided.

Leuco is contraindicated during the first trimester of pregnancy.

Leuco is contraindicated in women who are breastfeeding. Interruption of breastfeeding is recommended for the duration of treatment and for 72 hours following the last dose.

To reduce the risk of development of drug resistant organisms, antibiotics should only be used to treat or prevent proven or suspected infections caused by bacteria. Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Patients should be advised to avoid missing doses and to complete the entire course of therapy.

Dialysis

Hemodialysis: On the day of hemodialysis, if Leuco is administered prior to hemodialysis, an additional dose equivalent to one-half of the original dose should be administered after the end of hemodialysis.

Peritoneal dialysis: Data not available

Other Comments

Bioavailability is not affected by food.

For patients unable to swallow tablets, Leuco tablets may be crushed in artificial cherry syrup and administered with food. The oral suspension may be prepared as follows:

1. Crush four 500 mg oral tablets to a powder with mortar and pestle.

2. Add about 10 mL cherry syrup to the powder and mix until smooth.

3. Transfer the suspension to a graduated amber container.

4. Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a total volume of 30 mL.

The oral suspension should be shaken well before each administration. The oral suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature.

Ver también:
¿Cuál es la información más importante que debo saber sobre Leuco??

Hipersensibilidad a Leuco, otros derivados de 5-nitroimidazol oa alguno de los excipientes de Leuco.

Al igual que con otros medicamentos de estructura similar, Leuco también está contraindicado en pacientes con o con antecedentes de discrasias sanguíneas, aunque no se han observado anomalías hematológicas persistentes en estudios clínicos o animales.

Uso en el embarazo: Leuco cruza la barrera placentaria. Dado que se desconocen los efectos de los compuestos de esta clase sobre el desarrollo fetal, el uso de Leuco durante el primer trimestre está contraindicado. No hay evidencia de que Leuco sea dañino durante las últimas etapas del embarazo, pero su uso durante los trimestres segundo y tercero requiere que los beneficios potenciales se comparen con los posibles peligros para la madre o el feto.

Uso en lactancia: Leuco se distribuye en la leche materna. Leuco puede estar presente en la leche materna durante> 72 horas después de la administración. Las mujeres no deben amamantar durante y durante al menos 3 días después de haber dejado de tomar Leuco.

Use Leuco según las indicaciones de su médico. Verifique la etiqueta en el medicamento para obtener instrucciones exactas de dosificación.

• Tome Leuco por vía oral con comida.
• Si tiene problemas para tragar las tabletas, consulte con su médico o farmacéutico.
• Si toma colestiramina, no la tome al mismo tiempo que toma Leuco. Hable con su médico acerca de cómo debe tomar colestiramina con Leuco.
• Si se requiere más de una dosis de Leuco, continúe usando Leuco para el tratamiento completo con el fin de aclarar su infección por completo, incluso si se siente mejor en unos días. No te pierdas ninguna dosis.
• Si olvida una dosis de Leuco, tómela lo antes posible. Si es casi la hora de su próxima dosis, omita la dosis omitida y vuelva a su horario regular de dosificación. No tome 2 dosis a la vez.

Hágale a su proveedor de atención médica cualquier pregunta que pueda tener sobre cómo usar Leuco.

Uso: Indicaciones etiquetadas

Amebiasis: Tratamiento de la amebiasis intestinal y absceso hepático amebiano causado por Entamoeba histolytica en adultos y pacientes pediátricos mayores de 3 años.

Limitaciones de uso: No está indicado para el tratamiento del paso asintomático del quiste.

Vaginosis bacteriana: Tratamiento de la vaginosis bacteriana (anteriormente denominada Haemophilus vaginitis Vaginitis Gardnerella, vaginitis inespecífica o vaginosis anaeróbica) en mujeres adultas.

Giardiasis: Tratamiento de la giardiasis causada por Giardia duodenalis (también denominado Giardia lamblia) en adultos y pacientes pediátricos mayores de 3 años.

Tricomoniasis: Tratamiento de la tricomoniasis causada por Trichomonas vaginalis; tratar a los socios de pacientes infectados simultáneamente para prevenir la reinfección.

Usos fuera de etiqueta

Erradicación de Helicobacter pylori

Basado en la Guía Clínica del Colegio Americano de Gastroenterología para el Tratamiento de Helicobacter pylori Infección, Leuco es un componente efectivo y recomendado de un régimen de múltiples fármacos para el tratamiento de esta afección.

Profilaxis contra enfermedades de transmisión sexual después de una agresión sexual

Según las pautas de tratamiento de enfermedades de transmisión sexual de los Centros para el Control y la Prevención de Enfermedades (CDC), Leuco, en combinación con ceftriaxona y azitromicina, es un régimen recomendado para la profilaxis contra enfermedades de transmisión sexual después de una agresión sexual en adolescentes y adultos.

Uretritis, nogonocócica (persistente y recurrente)

Según las pautas de tratamiento de enfermedades de transmisión sexual de los CDC, Leuco es efectivo y recomendado como tratamiento para la uretritis recurrente y persistente para hombres que tienen relaciones sexuales con mujeres y que viven en áreas donde T. vaginalis es frecuente. El cumplimiento del régimen inicial y la falta de reexposición a una pareja sexual no tratada deben excluirse antes de su uso. Las parejas sexuales deben ser derivadas para evaluación y tratamiento apropiado.

See also:
What other drugs will affect Leuco?

Although not specifically identified in studies with Leuco, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with Leuco.

Potential Effects Of Leuco On Other Drugs

Warfarin And Other

Oral Coumarin Anticoagulants

As with metronidazole, Leuco may enhance the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The dosage of oral anticoagulants may need to be adjusted during Leuco co-administration and up to 8 days after discontinuation.

Alcohols, Disulfiram

Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during Leuco therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients using metronidazole and disulfiram concurrently. Though no similar reactions have been reported with Leuco, Leuco should not be given to patients who have taken disulfiram within the last two weeks.

Lithium

Metronidazole has been reported to elevate serum lithium levels. It is not known if Leuco shares this property with metronidazole, but consideration should be given to measuring serum lithium and creatinine levels after several days of simultaneous lithium and Leuco treatment to detect potential lithium intoxication.

Phenytoin, Fosphenytoin

Concomitant administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin. Metronidazole did not significantly affect the pharmacokinetics of orally-administered phenytoin.

Cyclosporine, Tacrolimus

There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During Leuco co-administration with either of these drugs, the patient should be monitored for signs of calcineurin-inhibitor associated toxicities.

Fluorouracil

Metronidazole was shown to decrease the clearance of fluorouracil, resulting in an increase in side-effects without an increase in therapeutic benefits. If the concomitant use of Leuco and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities.

Potential Effects Of Other Drugs On Leuco

CYP3A4 Inducers And Inhibitors

Simultaneous administration of Leuco with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of Leuco, decreasing the plasma level of Leuco. Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of Leuco, increasing the plasma concentrations of Leuco.

Cholestyramine

Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and Leuco to minimize any potential effect on the oral bioavailability of Leuco.

Oxytetracycline

Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole.

Laboratory Test Interactions

Leuco, like metronidazole, may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD+↔ NADH). Potential interference is due to the similarity of absorbance peaks of NADH and Leuco.

Leuco, like metronidazole, may produce transient leukopenia and neutropenia; however, no persistent hematological abnormalities attributable to Leuco have been observed in clinical studies. Total and differential leukocyte counts are recommended if re-treatment is necessary.

See also:
What are the possible side effects of Leuco?

Applies to Leuco: oral tablet

As well as its needed effects, Leuco (the active ingredient contained in Leuco) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Leuco, check with your doctor immediately:

Rare

• Change in consciousness
• cough
• difficulty breathing
• loss of consciousness
• noisy breathing
• shortness of breath
• tightness in chest
• wheezing

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• burning, numbness, tingling, or painful sensations
• chest pain
• chills
• difficulty swallowing
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• hives
• increased transaminase levels
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• reddening of the skin, especially around ears
• seizures
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• swelling of eyes, face, or inside of nose
• swollen glands
• ulcers
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in arms, hands, legs, or feet

Minor Side Effects

Some Leuco side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Bitter taste
• metallic taste

• Acid or sour stomach
• belching
• cramps
• difficulty having a bowel movement (stool)
• dizziness
• general feeling of discomfort or illness
• headache
• heartburn
• indigestion
• loss of appetite
• pain or discomfort in chest, upper stomach, or throat
• vomiting
• weight loss

• Body aches or pain
• coating on tongue
• congestion
• depression
• dryness or soreness of throat
• hoarseness
• mood or mental changes
• runny nose
• tender, swollen glands in neck
• voice changes

• Abnormal liver
• darkened urine
• diarrhea
• difficulty in moving
• feeling of constant movement of self or surroundings
• giddiness
• lightheadedness
• muscle pain or stiffness
• pain, swelling, or redness in joints
• sensation of spinning
• shakiness and unsteady walk
• sleepiness
• sleeplessness
• swelling or inflammation of the mouth
• tongue discoloration
• trembling, or other problems with muscle control or coordination
• trouble sleeping
• unable to sleep
• white or brownish vaginal discharge
• white patches in the mouth or throat or on the tongue