Mapa del Site
 
N-METILGLUCAMINA, ANTIMONIATO, MEGLUMINA, GLUCAMINA, METILGLUCAMINA, ANTIMONIATO DE MEGLUMINA, ANTIMONIATO DE GLUCAMINA, ANTIMONIATO DE METILGLUCAMINA, ANTIMONIATO DE N-METILGLUCAMINA, ANTIMONIATO AMPOLLAS, ANTIMONIATO AMPOLLETAS, ANTIMONIATO MEDICINA, ANTIMONIATO MEDICAMENTO, ANTIMONIATO PRODUCTOR, ANTIMONIATO FABRICANTE, ANTIMONIATO EXPORTADOR, ANTIMONIATO INYECTABLE, ANTIMONIATO LEISHMANIA, ANTIMONIATO LEISHMANIASIS, MEGLUMINA AMPOLLAS, MEGLUMINA AMPOLLETAS, MEGLUMINA MEDICINA, MEGLUMINA, MEDICAMENTO, MEGLUMINA PRODUCTOR, MEGLUMINA FABRICANTE, MEGLUMINA EXPORTADOR, MEGLUMINA INYECTABLE, MEGLUMINA LEISHMANIA, MEGLUMINA LEISHMANIASIS, GLUCAMINA AMPOLLAS, GLUCAMINA AMPOLLETAS, GLUCAMINA MEDICINA, GLUCAMINA MEDICAMENTO, GLUCAMINA PRODUCTOR, GLUCAMINA FABRICANTE, GLUCAMINA EXPORTADOR, GLUCAMINA INYECTABLE, GLUCAMINA LEISHMANIA, GLUCAMINA LEISHMANIASIS, METILGLUCAMINA AMPOLLAS, METILGLUCAMINA AMPOLLETAS, METILGLUCAMINA MEDICINA, METILGLUCAMINA MEDICAMENTO, METILGLUCAMINA PRODUCTOR, METILGLUCAMINA FABRICANTE, METILGLUCAMINAEXPORTADOR, METILGLUCAMINA INYECTABLE, METILGLUCAMINA LEISHMANIA, METILGLUCAMINA LEISHMANIASIS, MEDICINA LEISHMANIA, MEDICINA LEISHMANIASIS, MEDICINA UTA, MEDICINA KALA AZAR, MEDICINA ESPUNDIA, MEDICAMENTO LEISHMANIA, MEDICAMENTO LEISHMANIASIS, MEDICAMENTO UTA, MEDICAMENTO KALA AZAR, MEDICAMENTO ESPUNDIA, DROGA KALA AZAR, DROGA LEISHMANIA, DROGA LEISHMANIASIS, FIEBRE DUNDUN , LEPRA BLANCA, LEISHMANIA PROMATIGOT, LEISHMANIA AMASTIGOTE, VENTA N-METILGLUCAMINA, VENTA MEDICAMENTO KALA AZAR, VENTA MEDICAMENTO ESPUNDIA, VENTA MEDICAMENTO LEISHMANIA, PRODUCTORES N-METILGLUCAMINA, PRODUCTORES, PRODUCTORES ANTIMONIATO, PRODUCTORES MEGLUMINA, PRODUCTORES GLUCAMINA, PRODUCTORES METILGLUCAMINA, PRODUCTORES ANTIMONIATO DE MEGLUMINA, PRODUCTORES ANTIMONIATO DE GLUCAMINA, PRODUCTORES ANTIMONIATO DE METILGLUCAMINA, PRODUCTORES ANTIMONIATO DE N-METILGLUCAMINA, PRODUCTORES ANTIMONIATO AMPOLLAS, PRODUCTORES ANTIMONIATO AMPOLLETAS, PRODUCTORES ANTIMONIATO MEDICINA, PRODUCTORES ANTIMONIATO MEDICAMENTO, PRODUCTORES ANTIMONIATO, ANTILEISHMANIASICO, VENTA ANTILEISHMANIASICO, VENTA MEDICINA ANTIMONIATO, SALES ANTILEISHMANIASICOS, TREATMENT LEISHMANIA


COMPOSITION :

Each vial contains :

Meglumine Antimoniate ......................... 1,5 g
(Antimony Equivalence ......................... 425 mg)

Excipients c.s.p. ................................... 5,0 mL

PHARMACEUTICAL PRESENTATION :

Injectable solution.

INDICATIONS :
GLUCANTRIX® is an antiparasitic drug recommended for the treatment of visceral and cutaneous Leishmaniasis.

CONTRAINDICATIONS :
Hypersensitivity to Meglumine Antimoniate, sodium stibogluconate, and other antimony compounds. Pulmonary tuberculosis, liver failure, severe kidney failure, and heart disease.

PHARMACOLOGY :
Meglumine Antimoniate is a pentavalent antimony used for the treatment of Leishmaniasis. One hundred mg. of Meglumine Antimoniate contains 28 mg. of antimony. The mechanism of action of pentavalent antimony is not precisely known, but it is believed that many leishmania enzymes are selectively inhibited; thus, hindering phosphofructokinase and, subsequently, blocking the production of adenosine triphosphate. The liposomal preparation of Meglumine Antimoniate is under investigation to improve its selectivity and effectiveness. Animal tests showed that the liposome-encapsulated muramyl dipeptide analog enhances the antileishmanial activity of Meglumine Antimoniate.

Pentavalent antimonies have higher plasma concentrations than trivalent; therefore, most of the dose is excreted in the urine within 24 hours. They are distributed in a volume of about 0,22 L/kg and eliminated in two phases. The elimination phase may reflect the conversion of pentavalent antimony to trivalent, also responsible for the accumulation and slow release of the drug in multiple dosing.

DRUG INTERACTIONS :

None have been reported in reference materials.


PRECAUTIONS :

Assess the levels of iron and other related substances in the blood prior to starting treatment. Enrich meals with protein during treatment. Reduce dose in the event of impaired heart, liver or kidney function. Caution should be exercised when applying in patients with pneumonia and/or tuberculosis; and in children under 18 months of age. It may even show abnormalities in EKG tests; therefore, it is essential to perform electrocardiograms regularly during prolonged use of Meglumine Antimoniate.

INCOMPATIBILITIES :

None have been reported in reference materials.

SIDE EFFECTS :

At blood level : Leucopene has been reported during treatment with Meglumine Antimoniate; being more severe at high doses, even with a white cell count of less than 4x109 / L.

Occasionally, cases of agranulocytosis and fatal sepsis have been reported. Thus, regular monitoring of white cell count is recommended during therapy with Meglumine Antimoniate.

At cardiovascular level : Polymorphic ventricular tachycardia was observed in a 73-year-old male patient after receiving an intramuscular dose of 75 mg / kg of Meglumine Antimoniate for the treatment of Leishmaniasis. Initially, the patient reported chest pain, dyspnea, and palpitations. After a loading dose of 150 mg of Meglumine Antimoniate, an EKG was performed and the patient was diagnosed with atrial fibrillation and QTc interval prolongation; Methyl Digoxin 0.4 mg (single dose) and Amiodarone 300 mg were administered intravenously over a period of 8 hours.

As mentioned above, Meglumine Antimoniate is contraindicated in patients with heart disease (AMA, 1991).

WARNINGS :

Treatment should not be discontinued abruptly without the authorization of the specialist. This product contains sulfites that may cause hypersensitivity reactions, especially in patients with asthma.

TREATMENT IN CASE OF OVERDOSE :

One of the treatments in case of overdose is the use of Dimecaptopropanol (Dimercaprol). Symptoms appear as an exacerbation of side effects, and damage to the liver and kidney. Therefore, it is recommended to seek medical attention immediately.

DOSE AND ROUTE OF ADMINISTRATION :

Doctor's intructions should be strictlly followed always. This medication has been prescribed solely for the use of the patient for a given situation. It cannot be used to treat another case, and should not be recommended to others. Furthermore, this drug should be administered at the time and frequency indicated by the physician.

SYNONYMS :

N-Methyl Glucamine Antimoniate, Meglumine Antimoniate, Meglumine Antimonate, N-Methylglucamine Antimoniate, Glucamine Antimonate, Protostib.

ADULT DOSE :


Normal intralesional dose :
Limited studies show advantages of intralesional injections (local infiltration) of Meglumine Antimoniate in cutaneous Leishmaniasis. A 76% recovery rate was observed eight days after the intralesional administration of two vials of 5 mL of Meglumine Antimoniate. Perilesional infiltration of 1-3 mL of Meglumine Antimoniate (85 mg Antimony / mL) once a week was effective in the treatment of cutaneous Leishmaniasis. Further studies are needed to evaluate the effectiveness of intramuscular pentavalent antimony therapy.


Normal parenteral dose :

Meglumine Antimoniate may be administered intramuscularly. The recommended dose of Meglumine Antimoniate for the treatment of visceral, mucocutaneous or cutaneous Leishmaniasis is 20 mg Antimony / kg / day for 20-28 days. This dose can be repeated and continued; long-term treatment is required in some forms of visceral Leishmaniasis.

Dosage in kidney failure : Most of the Meglumine Antimoniate dose is excreted in the urine, suggesting the need for dose adjustment in kidney failure cases. However, a specific clinical trial is not available.

PEDIATRIC DOSE :

Normal parenteral dose : Meglumine Antimoniate may be given intravenously. The dose is expressed in Pentavalent Antimony. The recommended pediatric dose of Meglumine Antimoniate for the treatment of visceral, mucocutaneous or cutaneous Leishmaniasis is 20 mg Antimony / kg / day for 20-28 days. This dose can be repeated and continued; long-term therapy may be required in some cases of visceral Leishmaniasis. The application of Meglumine Antimoniate at a dose of 15 mg / kg / day plus Allopurinol 15 mg / kg, divided into three doses per day, was effective in the treatment of infantile visceral Leishmaniasis.

COMBINATION THERAPY :
Researchers describe the effectiveness of combining Interferon Gamma and Meglumine Antimoniate in cutaneous Leishmaniasis cases that do not display sensitivity after two administrations of Meglumine Antimoniate. Other agents that may play an alternative role to Meglumine Antimoniate include Allopurinol, Rifampicin, Nifurtimox and Levamisole. Meglumine Antimoniate, used in combination with Paromomycin, was effective in the short-term treatment of epidemic visceral Leishmaniasis.


STORAGE CONDITIONS :

Store at a temperature between 10 and 20 ° C. This product should not be refrigerated.

PRESENTATION :

3 Vials per box (5 ml each)
5 Vials per box (5 ml each)
25 Vials per box (5 ml each)
50 Vials per box (5 ml each)


MASTER FARMA S.A.

Address :
Calle Mariano Odicio 490,
Miraflores,
Lima 18 – Perú

Phone :
+51 (1) 446 1250
+51 (1) 242 5577

Fax :
+51 (1) 445 7701


Propiedad de MASTER FARMA S.A. ®-2006