Project Description

Novitropan (tablets 0.25 g)

international nonproprietary name

Oxybutynin.

Ref

BP-0089

Pharmacotherapeutic group

Spasmolytic, miotropic agent.

Composition of the preparation

1 tablet contains 250 mg of metronidazoleа.

Pharmacological action

Pharmacodynamics

Metronidazole is related to the family of nitro-5-imidazole and is of vast gamma of action towards anaerobic bacteria — Peptostreptococcus, Clostridium spp., Bacteroides spp., Fusobacterium, Prevotella, Veilonella. It inhibits the propagation of protozoa — Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica.

Pharmacokinetics

In oral intake metronidazole is easily and practically completely absorbed. Meals do not influence the drug absorption. Half-excretion is 8—10 h., plasma protein binding is low and NMT 10—20%. Metronidazole is easily absorbed in tissues (liver, kidneys, bile, saliva, spinal-cord fluid, brain, bone tissue, vaginal and urethral secrets), breast milk, to placenta barrier. Metronidazole is liver metabolized via oxidation. It is renal excreted to 40—70% (about 20% unmodified).

Indications 

Mycoticvaginitisandurethritisinwomen, mycoticurethritisinmen, lambliasis, amebic  dysentery, anaerobicinfectionscausedbybacteriasensitivetothedrug. Combinedtherapyinseveremixedaerobic-anaerobicinfections. Preventionofanaerobicinfectionsinsurgery (inparticular, abdominalcavity, urinarytracts). Chronicalcoholism.

In combination with amoxicylline: chronic gastritis in acute conditions, ulcer stomach and duodena in acute conditions, associated with Helicobacter pylori.

special indication

During treatment it is not recommended to drive vehicles and to perform other potentially dangerous kinds of works requiring heightened attention and fast response in psychological and motion activity due to appearance of sleepiness and poor eyesight.

Precautions

Novitropan should be prescribed  with care at compromised liver and kidneys function. It is necessary to be careful with patients suffering hernia of esophagus opening, connected with gastroesophagal reflux. Bering prescribed to patients with ulcerative colitis novitropan suppresses intestinal peristalsis that may cause paralytic bowel obstruction. Using novitropan may increase hyperthyrea symptoms, neurocirculatory dystonia, coronary heart disease, congestive heart failure, cardiac arrhythmia, arterial hypertension, prostatic hypertrophy.

At high ambient temperature Novitropan may cause appearance of fever and cardiac asthenia (sweating impairment).

special warning

Not established

Dosage and method of administration

In amoebiasis metronidazole is administered for oral intake. In adults for 7 days 1.5 g three times a day. In children 30-40 mg/kg a day and three times a day for 7 days.

Lambliosis: for 5 days in adults 750—1000 mg of metronidazole 3 times a day. In children of 2-5 years old 250 mg, in children of 5-10 years old 375 mg, inchildreof 10-15 years old 500 mg a day (3 intakes).

Mycotic vaginitis and urethritis in women: single dose of metronidazole 2 g or course for 10 days 1 tablet (250 mg) 2 times a day.

Mycotic urethritis in men: single dose of metronidazole 2 g or course for 10 days 1 tablet (250 mg) 2 times a day.

Non-specific vaginitis: 500 mg of metronidazole 2 times a day for 7 days.

Anaerobic infections in adults and children after 12: metronidazole 400 mg 3 times a day for 7-10 days. Inchildrenunder 12 7.5 mg/kg 3 timesaday.

overdosage

  excitation of central nervous system – anxiety, irritability, tremor,  cramps, delusion, hallucinations, nausea, vomiting, reddening of face, tachycardia, hyper- and hypotensia, respiratory failure, coma.

Treatment: to maintain breathing, to bring on vomiting followed by gastric lavage and using absorbed carbon and purgatives. For regression of symptoms of anticholinergic intoxication there is prescribed physostigmine (choline esterase blocker), at hyperpyrexia there are administered cold compresses (including ice, spirit rub-downs).

safety measures

During the period of lactation the drug should be prescribed with care.

Side effects

Rare nausea, metal taste, anorexia, epigastric pain, vomit, diarrhea, headache, vertigo, and local skin reaction as urticaria and itch. Very rare convulsions, mental confusion, hallucinations.

In long treatment of high doses possible leucopenia, peripheral neuropathia, usually regressed after termination of treatment.

Very rare reversible cases described of pancreatitis. Possible coloring of urine into brown-reddish color die to pigments related to metabolism of metronidazole.

Contraindications

Hypersensitivity to imidazole, organic injury of CNS, hepatic disorder, blood diseases, I term of pregnancy.

II and II terms of pregnancy: administration under vital necessity only.

Metronidazole is not recommended in feeding mothers as it penetrates to breast milk (cancel breast feeding).

Interactions with other medicinal preparations

Undesirable combination with disulphiram (esperal), anticoagulants of indirect action (varpharin) and non-depolarizing myorelaxants (vecuronium), lithium preparations. Metronidazole in concurrent administration potentiates varpharine/vecuronium actions, increases toxic effect of 5-phtoruracile, increases lithium level in blood plasma.

The form of release

Tablets0.25 g. 10 tablets in blister or packs.