Secnidox (Secnidazole)
TRADE NAME
Secnidox
INTERNATIONAL NON-PATENTED NAME
Secnidazole
CHEMICAL
FORMULA
1-(2-methyl-5-nitroimidazole-1-yl)propane
PHARMACEUTICAL FORM
Film coated tablets.
Description: blue
colored caplet shaped film coated tablets with ”SECN” embossing on one side,
break line on the other side.
COMPOSITION
1 tablet film coated contains
Active ingredient:
secnidazole 1.0 g.
Inactive ingredients:
maize starch, calcium hydrogen phosphate, microcrystalline cellulose, sodium
starch glycolate, povidone (K30), magnesium stearate, purified talc.
Coated tablet:
hypromellosa (Е15), titanium dioxide, indigo carmine lake, purified talc,
propylene glycol.
ATC CODE P01AB
PHARMACOTHERAPEUTIC GROUP
Antimicrobial and antiprotozoal preparation.
Derivative of nitroemodozole.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Secnidox
- is an antiprotozoal
preparation of nitroemodozole group with
antibacterial action. Secnidox is characterized by bactericidal
(against gram positive and gram negative anaerobic bacteria) and amebiasis
(in-and extraenteric) effect. Secnidox is especially active in
regards of Trichomonas vaginalis, Entamoeba histolytica, Giardia
lamblia. Getting inside of a cell of the
microorganism, secnidazole is activated as a result of restoration of
5-nitrogroup and due to this interacts with cellular DNA. The infringement
happens of its helicoid structure and destruction of strings, inhibition of
nucleotide synthesis and destruction of a cell.
PHARMACOKINETICS
After the oral administration, Secnidox
is quickly and completely absorbed from the gastroenteric tract.
Bioavailability makes about 80%. Secnidazole passes through hematoencephalic
barrier, gets into the chest milk. Time of secnidazole semiejection is equal
approximately to 25 h, that allows to simplify the scheme of the preparation
administration, making it more convenient for patients.
INDICATIONS TO APPLICATIO
- mycotic urethritis and vaginitis (caused by
Trichomonas vaginalis);
- Bacterial vaginosis;
- amebiasis of intestine (caused by Еntamoeba histolytica);
- amebiasis of liver (caused by Еntamoeba histolytica);
- lambliasis (caused by Giardia lamblia).
CONTRA-INDICATIONS
- hypersensitivity to secnidazole and to other
derivatives of imidazole;
- organic CNS diseases;
- pregnancy and the period of lactation.
PARTICULAR INDICATIONS
Secnidox
should not be prescribed patients with blood dyscrasia in the anamnesis. At
treatment by the preparation can occur the reversible hypogranulocytosis.
The quantity of leukocytes is restored after the termination of treatment.
At administration of the preparation it is necessary to avoid the use of
alcohol.
Influence on ability of driving vehicles and
work with mechanisms
Secnidox
does not influence the ability of driving the car and performance of works
demanding high speed of psychomotor reactions.
SIDE EFFECTS
Secnidox is
easily tolerable, but side-effects may occur:
From digestive system:
infringements of digestion, nausea, pains in the field of stomach, "metal"
smack in a mouth, glossitis, stomatitis.
Less widespread:
From system hematosis:
moderate reversible leukopenia.
Allergic reactions:
hives.
POSOLOGY AND METHOD OF ADMINISTRATION
Secnidox is
administered orally directly before the meal, drinking after a small amount
of water.
Doses for adults:
Mycotic urethritis and vaginitis, bacterial
vaginosis: 2 tablets at once.
Amebeasis of intestine:
- Acute symptomatic amebeasis: 2 tablets at
once.
- Asymptomatic amebeasis, including focal and cystitis forms: 2 tablets at
once daily during 3 days.
Amebeasis of liver:
daily 1,5 tablets (1,5g) once or in separate doses during 5 days.
Doses for children:
Amebeasis of intestine:
- Acute symptomatic amebeasis: 30 mg/kg of
body weight once.
- Asymptomatic amebiasis, including focal and cystitis forms: once a day or
separate administration of the preparation in a dose of 30 mg/kg of body
weight during 3 days.
Amebeasis of liver:
once a day or separate administration of the preparation in a dose of 30
mg/kg of body weight during 5 days.
Lambliasis: 30
mg/kg of body weight once.
OVERDOSE
Symptoms: probable aggravation of
side-effects.
Treatment:
there's no a specific antidote. If necessary symptomatic therapy is applied.
INTERACTION WITH OTHER MEDICAMENTS
Secnidox at
simultaneous application strengthens the action of indirect
anticoagulants (derivatives of coumarin or indandione).
Simultaneous administration of Secnidox with disulfiram can
cause paranoiac reactions and psychoses. In combination with alcohol
causes the symptoms of disulfiramlike reaction (spasms in stomach, nausea,
vomiting, headache, rush of blood to the face).
Secnidox at
simultaneous application with preparations of lithium increases its
concentration in blood plasma.
The preparation is not recommended to be combined with nondepolarizing
muscle relaxant (vecuronium bromide).
In combination with amoxicillin increases the activity concerning
Helicobacter pylori (amoxicillin suppresses development of resistance).
PACKAGING
2 film coated tablets in blister.
1 blister in carton box with enclosed leaflet.
STORAGE CONDITIONS
Store in a dry place at temperature not exceeding 25°С.
Keep out of the reach of children.
SHELF LIFE
3 years from the
manufacture date.
Do not use if the labeled working life is expired.
SALES TERMS
Sold under prescription
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