SECDAZA

 

TRADE NAME

Secdaza

 

INTERNATIONAL NONPROPRIETARY NAME

Secnidazole

 

CHEMICAL NAME

α,2-dimethyl-5-nitro-1Н-imidazole-1-ethanol

 

PHARMACEUTICAL FORM

Film coated tablets.

Description: blue coloured, oval shaped, biconvex film coated tablets.

 

COMPOSITION

Film coated tablet contains:

Active ingredient: secnidazole 0.5 g.

Excipients: maize starch, magnesium stearate, calcium hydrogen phosphate dihydrate, cellulose microcrystalline, povidone K30, sodium starch glycolate, talc.

Film coating composition: opadry^® II Blue 85F20400 (polyvinyl alcohol, macrogol, titanium dioxide, talc, indigo carmine aluminium lake).

 

ATC CODE          P01AB

 

PHARMACOTHERAPEUTIC GROUP

Antimicrobial and antiprotozoal agent. Nitroimidazole derivative.

 

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

Secdaza is a nitroimidazole antiprotozoal agent with antibacterial action; it is characterized with bactericidal (against gram-positive and gram-negative anaerobe bacteria) and amebicide (intraluminal and extraluminal) effect. Secdaza is particularly active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia. By entering the bacterial cell secnidazole activates on consequence of the recovery of 5-nitro group; as a result it interacts with a cellular DNA. Thus, its spiral structure damage and fibre distruction, nucleotide synthesis inhibition and cell death take place.

PHARMACOKINETICS

After oral intake Secdaza is rapidly and fully absorbed from the gastrointestinal tract. The bioavailability is about 80%. Secnidazole passes through the blood-brain barrier and enters breast milk. The elimination half-life of secnidazole is approximately 25 hours that allows simplifying the drug dosage regimen by making it more convenient for patients.

 

THERAPEUTIC INDICATIONS

- trichomonas urethritis and vaginitis (caused by Trichomonas vaginalis);

- bacterial vaginosis;

- intestinal amebiasis (caused by Еntamoeba histolytica);

- hepatic amebiasis (caused by Еntamoeba histolytica);

- lambliasis (caused by Giardia lamblia).

 

DOSAGE AND ADMINISTRATION

Secdaza is administered orally immediately before meal, washing down with large amount of water.

Doses for adults:

Trichomonas urethritis and vaginitis, bacterial vaginosis: 2.0 g given as a single dose.

Intestinal amebiasis:

- acute symptomatic amebiasis: 2.0 g given as a single dose.

- asymptomatic amebiasis, including focal and cystic forms: daily as 2.0 g given as a single dose during 3 days.

Hepatic amebiasis: daily as 1.5 g given as single or separate doses during 5 days.

Doses for children:

Intestinal amebiasis:

- acute symptomatic amebiasis: 30 mg/kg body weight as a single dose.

- asymptomatic amebiasis, including focal and cystic forms: daily administration of a single dose or divided administration in dose of 30 mg/kg body weight during 3 days.

Hepatic amebiasis: daily single or divided drug administration in dose of 30 mg/kg body weight during 5 days.

Lambliasis: 30 mg/kg body weight as a single dose.

 

CONTRAINDICATIONS

- hypersensitivity to secnidazole or to other imidazole derivatives;

- organic CNS diseases;

- pregnancy and lactation period.

 

ADVERSE EFFECTS

Secdaza is well tolerated, but it is possible the appearance of side effects:

Digestive system: indigestion, nausea, stomach pain, metallic aftertaste, glossitis, stomatitis.

Less common:

Hematopoietic system: moderate reversible leukopenia.

Allergic reactions: nettle-rash.

 

PARTICULAR INDICATIONS

Secdaza shouldn’t be prescribed to the patients with blood dyscrasia in their anamnesis. A reversible neutropenia can appear during the treatment with the drug. White blood count is restored after the therapy termination.

Avoid the alcohol use while the drug administration.

 

INFLUENCE ON ABILITY TO DRIVE AND TO OPERATE MECHANISMS

Secdaza doesn’t affect the ability to drive and perform the kinds of work demanding the high rate of psychomotor activities.

 

USE DURING PREGNANCY AND LACTATION

The drug is contraindicated during pregnancy and lactation period.

 

PAEDIATRIC USE

The drug is used in paediatric practice.

 

DRUG INTERACTIONS

In coadministration Secdaza enhances the action of indirect anticoagulants (coumarin or indandione derivatives).

The cotreatment with disulfiram can cause paranoiac reactions and psychoses. The combination with alcohol evokes the symptoms of disulfiram-like reaction (abdominal cramping, nausea, vomiting, headache, blush).

In coadministration with lithium agents Secdaza increases its blood plasma concentration.

The drug is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

The activity against Helicobacter pylori is increased in combination with amoxicillin (amoxicillin inhibits the resistance development).

 

OVERDOSAGE

Symptoms: possible enhancement of side effects.

Treatment: there is no any specific antidote. In case of necessity perform the symptomatic therapy.

 

PACKAGING

Film coated tablets.

4 tablets in a blister.

1 blister with the enclosed leaflet in a carton box.

 

STORAGE CONDITIONS

Store in a protected from moisture place at temperature not exceeding 25°С.

Keep out of reach of children!

 

SHELF LIFE

3 years from the date of manufacture.

Do not apply after the expiry date.

 

SALES TERMS

Sold under prescription.

 

MANUFACTURER

The holder of trade mark and Marketing Authorization is

"DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ", TURKEY.

Manufactured by

"World Medicine İlaç San. ve Tic. A.Ş.", Turkey

(Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No:50 K.1B Zemin 4-5-6, İstanbul).