Samitol

Each film-coated tablets contains: Secnidazole 500 mg.
Excipients/Inactive Ingredients: Microcrystalline cellulose PH101 and PH102, colloidal anhydrous silica, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol 400 and purified water.

Pharmacotherapeutic group: Antiprotozoal. ATC code: P01AB07.
Pharmacology: Pharmacodynamics: Secnidazole is a semisynthetic derivative of the series of nitro-imidazoles. It has antiprotozoal and antiparasitic properties and acts as an amoebicide essentially in tissue. Acts as parasiticide against Entamoeba histolytica and has activity on Giardia lamblia and Trichomonas vaginalis.
Pharmacokinetics: Absorption: Secnidazole is absorbed quickly after oral administration and peak concentrations were achieved within 1.5-3 hours. Absolute bioavailability is near 100% when a single dose of 0.5-2g secnidazole is taken orally. In the range of the application dose, the dose is in direct ratio with peak plasma concentration (C_max) and plasma drug concentration area under the curve (AUC).
Distribution: Secnidazole is not widely distributed in vivo. Steady state volume (49.2 L) is very small and only 15% total plasma blood dosage is combined with plasma protein or globulin. Serum drug concentration is similar to that in gingival crevice secretion, thus this product can easily infiltrates into gingiva. Besides, it can also permeate placental membrane and found in breast milk.
Metabolism: Secnidazole is mainly metabolized in the liver.
Elimination: The plasma half-life of elimination of secnidazole is 25 hours. The removal is essentially urinary, is slow (16% of the ingested dose is excreted in 72 hours and 50% of the ingested dose is excreted in 120 hours).
Secnidazole crosses the placenta and passes into breast milk.

Secnidazole (Samitol) tablet is indicated in: Urogenital trichomoniasis, both in man and in woman.
Intestinal and hepatic amebiasis and giardiasis.
Infections caused by anaerobic bacteria depends on their possible use according to sensitivity of the causative agent.

Dosage: Urogenital trichomoniasis: 4 tablets of 500 mg in a day as a single dose or in two doses at an interval of 12 hours (total 2 g).
Amebiasis and acute intestinal giardiasis: 4 tablets of 500 mg in a day as a single dose or in two doses at an interval of 12 hours (total 2 g).
Chronic carriers of amoeba: 3 tablets of 500 mg per day in a several doses for 3 days.
Liver Amebiasis: 3 tablets of 500 mg per day in one or several doses for at least 5 days.
Children: According to medical criteria, 25-30 mg/kg/day. The duration of treatment is to same clinical situation, identical to adults.
In patients with renal or hepatic impairment, the recommended doses are the derivatives of 5-nitro-imidazole in general.
Thus, in case of moderate to severe renal impairment, the pharmacokinetics of Samitol is not significantly changed, so they are not usually necessary adjustments in dosage, particularly for short-term treatments.
If a patient with severe hepatic impairment, the physician must evaluate the situation and reduce the daily dose according to the severity of this.
In both cases, the physician's discretion, as usual, is decisive in these situations.
Mode of administration: Oral.

In case of overdose, general measures are recommended like observation in hospital, medical and symptomatic treatment. The clinical picture are exaggerated side effects described here, particularly neurological. If necessary, secnidazole can be eliminated by hemodialysis.

Hypersensitivity to the active substance and other imidazole derivatives or any of the excipients used in the formulation.
Is also contraindicated in the following situations: 1st trimester of pregnancy, Patients with organic neurological disorders, Patients with a history or current history of blood dyscrasias.

During treatment liquor should not be taken until at least 72 hours after its termination due to the possibility of the occurrence of reactions similar to those observed with the administration of disulfiram (redness, cramping abdominal pain, vomiting and tachycardia). If for reasons of use during disaster, Secnidazole have to be administered for more time than is usually recommended, it is recommended to carry out regular hematological tests, particularly leukocyte count, and patients should be monitored for any adverse reactions, neuropathies, central or peripheral (paresthesias, ataxia, dizziness, seizures convulsants). Secnidazole tablets should be administered with caution in patients with liver encephalopathy. Treatment should be stopped if detected incoordination, dizziness or mental confusion.
As in all vaginal infections, intercourse is not recommended during treatment with Secnidazole tablets.
Effects On Ability to Drive and Use Machines: Secnidazole is not expected to affect a patient's ability to drive or operate machinery.

Secnidazole should not be used in pregnant women and during lactation.

Described as follows the undesirables effects sorted by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), including events isolates.
Blood and lymphatic system disorder: Rare: Moderate leucopenia and reversible to stopping treatment.
Very rare: Agranulocytosis, neutropenia, thrombocytopenia.
Immune system disorders: Rare: Hypersensitivity reactions, occasionally severe, as of rash, pruritus, urticaria, angioneurotic edema, bronchospasm, edema of face, periorbital and throat, fever, erythema and anaphylactic reaction (see Contraindications).
Psychiatric disorders: Very rare: Psychotic syndromes, confusion and hallucinations.
Nervous system disorders: Rare: Headache, convulsions, dizziness, paresthesia, Peripheral sensory neuropathy and sensory-motor, polyneuritis.
Very rare: Cases of encephalopathy (e.g. confusional state) and subacute cerebellar syndrome (e.g. ataxia, disartria, motor incoordination, nystagmus and tremor), reversible upon discontinuation of treatment.
Cardiac disorders: Rare: Palpitations.
Gastrointestinal disorders: Common: Epigastric and/or abdominal pain, nausea, vomiting, diarrhea, constipation.
Uncommon: Glossitis, stomatitis, changes in taste (metallic taste), anorexia.
Hepatobiliary disorders: Very rare: Hepatitis.

Secnidazole tablets should not be associated with disulfiram because there is the risk of onset of acute confusional and psychotic states.
Intake of alcohol is discouraged along with Secnidazole, because it can cause abdominal cramps, facial flushing, vomiting, and tachycardia.
It potentiates the anticoagulant effect of warfarin, so concurrent administration should be done under strict medical supervision. The prothrombin time must be carefully monitored and dosage adjustments should be made whenever necessary.
Lithium: Lithium plasma levels may be increased.
Cyclosporine: Risk of increased serum levels of cyclosporine. Cyclosporine level and serum creatinine should be tightly controlled where simultaneous administration is necessary.
5-Fluorouracil: Decreased clearance of 5-fluorouracil, which yields an increasing the toxicity of 5-fluorouracil.
The drug is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).
In combination with amoxicillin, activity of Helicobacter pylori is increased (Amoxicillin suppresses development of resistance).

Store at temperatures not exceeding 30°C.

Antiamoebics / Other Antiprotozoal Agents

P01AB07 - secnidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.

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