Диаремикс

General characteristics. Structure:

Active ingredients: 60 million dispute of Lactic Acid Bacillus (Bacillus coagulans/Lb.sporogenes), 2 mg of loperamide of a hydrochloride, 10 mg of a ditsikloverin of a hydrochloride.

Excipients: silicon dioxide colloid anhydrous, talc, lactoses monohydrate, starch corn.

Capsule cover: кармоизин (Е 122), понсо 4R (Е 124), yellow decline of FCF (Е 110), titanium dioxide (Е 171), gelatin, ferrous oxide red (Е 172).

The innovative combined drug for bystry and effective treatment of diarrhea of any origin, single-step disposal of all manifestations of a diarrheal syndrome.

Pharmacological properties:

Pharmacodynamics. Диаремикс is the combined drug which part are loperamide, a ditsikloverina a hydrochloride and Lactic Acid Bacillus (Bacillus coagulans (Lb.sporogenes).

Loperamide has the anti-diarrheal effect caused by decrease in a vermicular movement of intestines that provides delay of advance of its contents and increase in time of absorption of water and electrolytes.

Loperamide increases a tone of a proctal sphincter that provides deduction of fecal masses and to decrease in desires to defecation, practically does not get through a blood-brain barrier and does not cause dependence and accustoming.

Ditsikloverina a hydrochloride has anticholinergic activity and directly relaxes smooth muscles.

Lb.sporogenes contain in a form viable a dispute. Disputes of bacteria become more active in a stomach, then in a duodenum pass into a live vegetative form and form favorable conditions for development of useful intestinal microflora at the expense of a producing L (+) lactic acid. The inhibiting effect is shown concerning such pathogenic microorganisms as: enterococci, colibacillus, salmonella, shigella, proteas, pyocyanic stick, vibrio, barmy mushrooms, etc. Lb.sporogenes.

Pharmacokinetics. Loperamide is highly specific substance for intestines walls, reaches system circulation in limited volume and practically does not get through a blood-brain barrier. The threshold of the central action much more exceeds a dose that has the maximum effect against diarrhea.

Loperamide the hydrochloride is easily absorbed from intestines, but is almost completely extracted and metabolized by a liver where it is conjugated and allocated with bile.

Loperamide elimination half-life at the person it is on average equal 11 hours (9-14 hours). Linkng with proteins of plasma makes 95%, is preferential with albumine. Allocation happens generally to a stake.

Half-life of a ditsikloverin in a blood plasma – 4-6 hours

Ditsikloverin is excreted preferential by kidneys (79,5%).

Lb.sporogenes are rather stable, they are steady against high temperatures, acidity of a stomach, bile and many antibacterial drugs. Disputes after formation of a vegetative form are resumed by simple nuclear fission of a cell in intestines, increasing stationary quantity of bacteria and gradually producing lactic acid.

Indications to use:

Diarrhea of various etiology: acute and chronic, allergic, psychoemotional, it is connected with a resection or radiation/radiotheraphy of various tumors of intestines, the caused change of a diet and qualitative structure of food (diarrhea of the traveler), at a syndrome of the angry intestines with diarrhea.

Route of administration and doses:

To apply to adults and children 6 years 2-3 times a day irrespective of meal are more senior. To swallow of capsules without chewing, to wash down with a large amount of liquid.

To adults and children 12 years at acute diarrhea are more senior the first dose makes 2 capsules, in the further ambassador of each liquid chair to accept on 1 capsule.

At chronic diarrhea the first dose makes 2 capsules, further — on 1 capsule after each chair, gradually reducing a dose depending on specific features of the patient and the nature of a disease to 1 capsule a day.

In the first day of treatment to appoint to children at the age of 6-8 years — on 1 capsule 2 times a day, 8-12 years — on 1 capsule 3 times a day. After achievement of a normal consistence of a chair or in the absence of defecation within 12 hours administration of drug should be stopped.

Daily and single doses for adults and children depending on age

Диаремикс	Children age from 6 to 8 years	Children age from 8 to 12 years	Children age of 12 years and adults
Single dose	1 capsule	1 capsule	2 capsules
Daily dose	2 capsules	3 capsules	4 capsules
Maximum single dose	1 capsule	1 capsule	2 capsules
Maximum daily dose	3 capsules	4 capsules	8 capsules

At acute diarrhea if within 2 days it is not possible to reach therapeutic effect, it is necessary to reconsider treatment tactics.

Drug is contraindicated to children under 6 years.

Features of use:

Treatment of diarrhea has symptomatic character. Use of drug does not replace carrying out causal treatment of diarrhea if it is possible to define a disease etiology (or it is specified that it is necessary to make it), then whenever possible it is necessary to carry out specific treatment and to hold events for compensation of disturbance of water and electrolytic balance.

Patients with diarrhea, especially at children, can have dehydration and an imbalance of electrolytes. In such cases the major action is use of replacement therapy for replenishment of liquid and electrolytes.

Patients with acquired immunodeficiency syndrome who accept Diaremiks need to stop immediately treatment at emergence of the first signs of abdominal distention. There are separate messages on cases of emergence of toxic megacolon in the patients sick with AIDS, with infectious colitis of both a virus, and bacterial origin, at loperamide treatment by a hydrochloride.

It is necessary to be to patients, careful at Diaremiks's use, with an abnormal liver function. Patients with an abnormal liver function should be under careful observation for the purpose of early detection of signs of toxic damage of the central nervous system.

With care it is necessary to apply Diaremiks at neuropathy, a renal failure (decrease in removal by kidneys can increase risk of side effects), a hyperthyroidism, arterial hypertension, heart diseases (coronary heart disease, congestive heart failure, a tachyarrhythmia), hernias of an esophageal opening of a diaphragm at elderly people, at diarrheas of the infectious nature.

It is necessary to exclude existence at the patient of tachycardia as дицикловерин can increase heart rate.

Drug contains lactoses monohydrate therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is impossible to apply.

At acute diarrhea if within 48 hours clinical improvement is not observed, use of drug it is necessary to stop and see a doctor.

Ditsikloverin with care it is necessary to appoint at a prostatauxe, nonspecific ulcer colitis (danger of emergence of paralytic impassability).

Use during pregnancy or feeding by a breast. It is contraindicated during pregnancy or feeding by a breast. In need of drug use feeding by a breast should be stopped.

Ability to influence speed of response at control of motor transport or work with other mechanisms. During treatment by Diaremiks it is necessary to abstain from control of vehicles and the work demanding the increased concentration of attention.

Side effects:

From skin and hypodermic cellulose: rashes, urticaria, itch, Quincke's disease, violent rashes, multiformny erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis (Lyell's disease), xeroderma and other dermatological manifestations.

From immune system: hypersensitivity reactions, including an acute anaphylaxis and anaphylactoid reactions.

From digestive tract: a lock, a meteorism, feeling of swelling, spasms, gripes, an abdominal pain, dryness in a mouth, thirst, taste loss, anorexia, dyspepsia, nausea, vomiting, megacolon, including toxic megacolon, intestinal impassability.

From an urinary system: disturbance of an urination, ischuria.

Neurologic frustration: dizziness, headache, tremor, loss of consciousness, confusion of consciousness, alalia, nervousness (contagious excitation), stupor, nervousness, drowsiness, lethargy, sleeplessness, paresthesias, sensitivity disturbances, numbness, incoordination, dyskinesia.

From organs of sight: sight opacification/illegibility, diplopia, mydriasis, sight tsikloplegiya (accommodation paralysis), increase in intraocular pressure, miosis.

Cardial frustration: tachycardia, heart consciousness, increase in arterial pressure, arterial hypertension.

Respiratory frustration: диспноэ, apnoea, asphyxia, nose congestion, sneezing, throat hyperemia.

Others: increased fatigue, the general weakness, weakness in muscles, impotence, oppression of a lactation, sexual dysfunction, the lowered sweating, fervescence.

Interaction with other medicines:

Because loperamide is Diaremiksu's part, it is not recommended to appoint it together with atropine and other cholinolytic drugs (for prevention to mutual strengthening of effects), erythromycin, Metoclopramidum. Holestiramin is recommended to appoint not later than 2 hours before Diaremiks's reception.

To children not to use at the same time medicines which have the oppressing action on the central nervous system. The combined use of an itrakonazol and gemfibrozil led to 4-fold increase in the maximum content of loperamide in a blood plasma and 13-fold increase in the general exposure in a blood plasma. This increase was not connected with influence on the central nervous system.

Simultaneous use of loperamide (16 mg once) and a ketokonazola, SURZA4 inhibitor and the R-glycoprotein, led to 5-fold increase in concentration of loperamide in a blood plasma. This increase was not connected with increase in pharmakodinamichesky effects that decided on the help of a pupilometriya.

The accompanying treatment by desmopressin for oral administration led to triple increase in concentration of desmopressin in a blood plasma probably owing to slower motility of digestive tract.

Effects of a ditsikloverin who is a part of drug including collateral, can strengthen medicines with anticholinergic activity: амантадин, antiarrhytmic drugs (for example, квинидин), antihistaminic, antipsychotic drugs (for example fenotiazina), benzodiazepines, MAO inhibitors, hypnotic drugs, anesthetics (for example, Meperidinum), the nitrates and nitrites, sympathomimetic drugs, tricyclic antidepressants and other drugs having anticholinergic effect.

Anticholinergic drugs which treats дицикловерин strengthen effect of drugs against glaucoma. Anticholinergic drugs in case of the increased intraocular pressure can be harmful if to accept them together with such drugs as corticosteroids. They can affect absorbability in digestive tract of various drugs, such as digoxin that can lead to increase in concentration of digoxin in blood serum, can strengthen effect of drugs, changing motility of digestive tract, such as Metoclopramidum. Because antiacid drugs can interfere with absorption of anticholinergic drugs, it is necessary to avoid a concomitant use of these means. Delay by anticholinergics of secretion of hydrochloric acid counteracts effect of the substances applied to treatment of an achlorhydria or testing of gastric secretion.

Contraindications:

Hypersensitivity to drug components, intestinal impassability (including if necessary to avoid suppression of a vermicular movement), the megacolon and toxic megacolon, acute ulcer colitis or pseudomembranous colitis connected using antibiotics of a broad spectrum of activity, a hemocolitis, the bacterial coloenteritis caused by microorganisms of the Salmonella, Shigella and Campylobacter family, acute diarrhea with the accompanying fever and excrements with blood impurity, heavy abnormal liver functions, necessary for drug metabolism as it can lead to relative overdose.

Digestive tract obstruction/stenosis, round ulcer of a stomach and duodenum, reflux esophagitis, prostate adenoma with the complicated urination, glaucoma, a myasthenia.

It is necessary to stop immediately reception if the lock, abdominal distention or partial intestinal obstruction develops.

Overdose:

Symptoms. At overdose oppression of TsNS is possible (confusion of consciousness, a disorientation, short-term loss of memory, a hallucination, a dysarthtia, an ataxy, a coma, euphoria, uneasiness reduction, weakness, an insomniya, agitation and airs and graces, inadequate emotional reactions, a stupor, a lack of coordination, drowsiness, a miosis, a hyper tone of skeletal muscles, respiratory depression, intestinal impassability, an ischuria, a dysuria, a headache, vomiting, nausea, tachycardia, arterial hypertension or strengthening of manifestations of other side reactions.

Treatment. If there are overdose symptoms as an antidote it is possible to apply Naloxonum intravenously in a dose of 0,4 mg/ml. As duration of effect of loperamide is longer than Naloxonum (1-3 hours), repeated purpose of Naloxonum can be required. For identification of possible oppression цнс the patient has to be under careful observation not less than 48 hours, and also it is necessary to carry out symptomatic therapy (a gastric lavage, purpose of absorbent carbon).

Storage conditions:

To store at a temperature not above 25 °C in original packaging in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

Without recipe

Packaging:

On 10 capsules in the blister, 3 blisters in a cardboard box or on 8 capsules in the blister on 1 blister in a cardboard box.