HDRASEC 30mg powder treatment for acute diarrhea in children (30 packs)

Dosage form 30 package box
Specifications Racecadotril

Ingredient

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Composition information	Content
Racecadotril	30mg

Uses

Indications

Hidrasec Children are appointed to supplement, treat acute diarrhea symptoms in young children (over 3 months old) and children along with oral rehydration.

In case of treatment, the cause of diarrhea, RaceCadotril may be used as an additional treatment.

Pharmacokology

Pharmaceutical group: Other diarrhea treatments.

ATC code: A07xa04.

racecadotril is a precursor that needs to be hydrolyzed into thiorphan activity metabolites, an enkephalinase inhibitor, a cell membrane peptidase in different tissues, mainly epithelium of the small intestine.

This enzyme is involved in external hydrolysis processes and destroys endogenous peptides like enkephaline. Therefore, RaceCadotril protects endogenous Enkephalins with physiological activity in the gastrointestinal tract, prolonging their secretion effect.

racecadotril is an anti -secreting substance, which is limited to the small intestine.

It reduces the secretion of water and electrolytes in the small intestine, caused by the toxicity or inflammation and does not affect the basic excretory activity. Racecadotril quickly acts against diarrhea without changing the time of transportation in the small intestine.

In 2 clinical studies in children, Racecadotril reduced by 40% and 46% of the fertilizer weight in the first 48 hours. It is also noticed that diarrhea and water compensation are significantly reduced.

A data synthetic analysis study (9 random clinical trials of racecadotril compared to placebo along with orally rehydration) collected personal data from 1384 boys and girls with acute diarrhea at serious levels and inpatient or outpatient treatment. The average age is 12 months old (about 6 - 39 months of age).

A total of 714 patients under 1 year of age and 670 patients over 1 year of age.

Average weight ranges from 7.4kg to 12.2kg. The total diarrhea time is 2.81 days for the placebo group and 1.75 days for the raceCadotril group.

The proportion of patients recovering in Racecadotril group is higher than placebo (risk ratio (HR): 2.04; 95% CI: 1.85 - 2.32; P

Similar results to children's children (under 1 year old) (HR: 2.01; 95% CI: 1.71 - 2.36; P

For study in boarding patients (n = 637 patients), the average ratio of fertilizer of the group using racecadotril compared to the placebo is 0.59 (95% CI: 0.51 - 0.74); P

For research on outpatient patients (n = 695 patients), the average rate of fertilizer of the group using racecadotril compared to the placebo is 0.63 (95% CI: 0.47-0.85; p

racecadotril does not cause bloating.

During clinical research, Racecadotril causes secondary constipation at the ratio equivalent to placebo.

When used orally, the drug only acts on the periphery, without the influence on the central nervous system.

pharmacokinetic

absorption

racecadotril is quickly absorbed after drinking. The inhibition of enzyme enzyme begins after about 30 minutes. Racecadotril's bioavailability is not changed by food, but the peak concentration is slowed about 1 hour and 30 minutes.

Distribution

After taking a dose of Racecadotril is marked by C-14, measuring the exposure of radioactive carbon in plasma is many times higher than blood cells and is 3 times higher than the total blood.

Therefore, the drug is not attached to any blood cells. The distribution of radioactive carbon in other tissues of the body is moderate, expressed by the average appsed distribution in plasma of 66.4kg.

90% of the active metabolites of racecadotril, thiorphan (= (rs) -N- (1-oxo-2- (mercaptomethyl) -3-phenylpr flycine), are linked to plasma proteins, mainly with albumin. The pharmacokinetic properties of racecadotril are not changed due to repeated dose or for the elderly.

The time and range of influence of racecadotril depends on the dose.

In children, the time to inhibit Enkephalinase has peaked in plasma approximately 2 hours and is equivalent to 90% of inhibition at a dose of 1.5mg/kg.

In adults, the time to inhibit Enkephalinase has peaked in plasma approximately 2 hours and is equivalent to 75% of the inhibition with a dose of 100mg.

Enkephalinase inhibitor time is about 8 hours.

Metabolism

Racecadotril's biological sale time is calculated according to plasma enkephalinase inhibition, approximately 3 hours. RaceCadotril is quickly hydrolyzed into thiorphan metabolites that are active, transformed back into no longer active metabolites. The repetition of raceCadotril does not cause drug accumulation in the body.

In vitro data shows racecadotril/thiorphan and 4 main metabolic substances inactive inhibited enzyme CYP of forms 3A4, 2D6, 2C9, 1A2 and 2C19 for clinical effects.

In vitro data shows racecadotril/thiorphan and 4 main substances metabolized in non -active metabolism CYP enzymes (family 3A, 2A6, 2B6, 2C9/2C19, family 1A, 2E1) and enzymes combine UGTS for clinical effects.

racecadotril does not change the protein cohesion of active ingredients that are strongly connected to protein such as Tolbutamide, Warfarin, Niflumic Acid, Digoxin or Phenytoin.

In patients with hepatic impairment (cirrhosis, the B level of Child-Pugh classification), the dynamic section of the metabolic substance with the activity of Racecadotril has shown the similarity between TMAX and T1/2 and lower than CMAX (-65%) and AUC (-29%) when compared to healthy subjects.

In patients with severe renal impairment (the clearance coefficient of 11 - 39ml/min) the dynamic section of RaceCadotril's metabolites has shown that the amount is lower than CMAX (-49%) and higher than the AUC (+16%) and T1/2 when compared to a healthy volunteer (clearing coefficient> 70ml/minute).

In children, pharmacokinetic results are similar to adults, reaching a concentration of 2 hours and 30 minutes after drinking. There is no accumulation after use 8 hours/dose in 7 days.

Elimination

racecadotril is eliminated in the form of active and non -active metabolism, mainly through urine, and there is much less level through feces. Elimination through the lungs is not meaningful.

Before taking HDRASEC 30mg powder treatment for acute diarrhea in children (30 packs)

How to use

always use Hidrasec exactly as prescribed by the doctor. If you have questions, ask your doctor or pharmacist.

Take Hidrasec Children along with water and electrolytes.

Can put nuggets in food or mix a little water (about 1 teaspoon). Mix well and give children immediately.

Dosage

Dosage is determined by children's body weight

1.5 mg/kg body weight/dose (equivalent to 1 to 2 packs), drink 3 times a day evenly.

Children from 13kg - 27kg

1 pack of 30mg x 3 times/day.

Children over 27kg

2 packs 30mg x 3 times/day.

Should continue treatment until the child returns to normal.

The treatment time does not last more than 7 days.

Do not treat long -term with racecadotril.

There are no clinical studies for children under 3 months of age.

Special subjects

There are no studies conducted for children with liver or kidney failure.

What to do when overdose?

What to do when forgetting 1 dose? If you need more information, ask the advice of a doctor or pharmacist.

Side Effects

Like other drugs, Hidrasec can cause side effects, although not all patients encounter. If you see any side effects are not mentioned in this tutorial, or any side effects become serious, notify your doctor or pharmacist.

The following undesirable reactions with racecadotril often occur more than placebo or reported during post -marketing monitoring.

The frequency of unwanted reactions is determined according to the following convention: very common (> 1/10), common (> 1/100 to 1 1/10,000 to 1,000), very rare (

Infections and parasites

Uncommon: tonsillitis.

Skin and tissue disorders

Uncommon: rash, Red Red.

Unknown: There are many types of erythematosus, including many types of erythema, the erythema has many lumps, rashes, itching, urticaria; Swelling (edema) tongue, face, lips and eyelids, as well as swelling of the face and nose, itching.

Warnings

Contraindications

Do not use Hidrasec for children if children have allergies (sensitive) with active ingredients or any component of excipients.

Due to the containing sucrose, Hrrasec is contraindicated to patients with rare genetic problems about fructose intolerance, Glucose - Galactose or Sucrase - Isomtase deficiency.

Caution when using

Hidrasec use does not replace the child's drinking needs.

Swedishes are very important in the control of acute diarrhea in infants and young children.

The rehydration needs to be suitable for the age, weight of the child and the stage, the severity of this condition, especially in a serious case or prolonged diarrhea with children vomiting or poor appetite.

In addition, constantly feeding regularly (including breastfeeding) and monitoring adequate drinking water is very important.

Master appears blood or latex in children's stools and children with fever may show an infection or another serious illness, guaranteeing the cause of the cause (for example, using antibiotics) or identifying additional causes.

Therefore, racecadotril is not used in these cases. Racecadotril can be used simultaneously with antibiotics in case of acute diarrhea as a bacterial treatment as an additional treatment.

Do not use raceCadotril in the case of diarrhea related to antibiotic stop and chronic diarrhea that does not have enough data.

If a child has diabetes, pay attention to each Hidrasec Children 30mg package contains 2,899g of sucrose.

If the amount of sucrose (source of glucose and fructose) is put in excess of 5g per day, then it is necessary to calculate the daily ratio of sugar for children.

It is not recommended to use this product for babies under 3 months of age because no clinical trial is done on this object.

It is not recommended to use this product for any young child with liver or kidney disease regardless of the severity of the disease, because there is no enough information on these patients.

Hidrasec may also have no effect (reducing bioavailability) if the child has prolonged vomiting or uncontrolled vomiting.

The ability to drive and operate machinery

racecadotril does not affect or affect the ability to drive and operate machinery.

Pregnancy and lactation

Pregnancy

Pregnancy: There is no enough data on use, racecadotril in pregnant women. Animal research does not see direct or indirect harm related to pregnancy or fetal development, reproduction or after birth.

However, because there is no specific clinical studies, Hidrasec should not be used if you are pregnant.

Breastfeeding period

Due to the lack of information related to Hidrasec, you should not use Hidrasec if you are breastfeeding.

Drug interaction

There are no drug interactions described in humans so far.

Both Loperamide and Nifuroxazide do not change the way RaceCadotril's action in the body is used when these drugs are used simultaneously.

Please inform your doctor or pharmacist if your child is taking or recently taking any other drugs including non -prescribing drugs.

Storage

Store drugs at room temperature.

Other drugs

Disclaimer

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