Product Overview
[Drug name]
Generic name: Racecadotril Granules
Trade name: Du La Bao
English name: Racecadotril Granules
Chinese Pinyin: Xiaoxuankaduoqu Keli
[Ingredients]
Main ingredient: Racecadotril.
[Properties]
This product is white or off-white granules with aromatic smell and slightly sweet taste.
[Indications]
For acute diarrhea in infants and children over 1 month old, oral or intravenous rehydration is given when necessary.
[Usage and Dosage]
Oral, 3 times a day, 1.5 mg per kilogram of body weight each time; the total daily dose should not exceed 6 mg per kilogram of body weight. Continuous use should not exceed 7 days.
Recommended dose:
1. Infant dosage: 1 to 9 months old (weight <9Kg), 10 mg each time, 3 times a day; 9 to 30 months old (weight 9 to 13Kg), 20 mg each time, 3 times a day.
2. Children's dosage: 30 months to 9 years old (13Kg to 27Kg), 30mg each time, 3 times a day; 9 years old and above (weight>27Kg), 60mg each time, 3 times a day.
[Adverse reactions]
Occasionally, drowsiness, rash, constipation, nausea and abdominal pain are seen.
[Contraindications]
The following groups are prohibited: patients with impaired liver and kidney function; patients who cannot ingest fructose, have poor absorption of glucose or galactose, lack sucrase and maltase; patients who are allergic to racecadotril.
[Precautions]
After taking this product for 5 consecutive days, if diarrhea symptoms still persist, further medical treatment or other drug treatment options should be adopted; this product can be taken with food, water or breast milk, please pay attention to dissolving and mixing evenly. Do not take double doses of this product at one time. Use with caution when treating with cytochrome P450-3A4 inhibitors such as erythromycin and ketoconazole (which may reduce the metabolism of racecadotril); use with caution when treating with cytochrome P450-3A4 inducers such as rifampicin (which may reduce the anti-diarrhea effect of racecadotril).
[Medication for special populations]
Precautions for children: Dosage for children: 30 months to 9 years old (13 kg to 27 kg), 30 mg each time, 3 times a day; over 9 years old (weight > 27 kg), 60 mg each time, 3 times a day.
Precautions for pregnancy and lactation: No such experiment has been conducted and no reliable references are available.
Precautions for the elderly: No such experiment has been conducted and no reliable references are available.
[Drug Interactions]
1. Cytochrome P450-3A4 inhibitors such as erythromycin and ketoconazole may reduce the metabolism of racecadotril and increase its toxicity; 2. Cytochrome P450-3A4 inducers such as rifampicin may reduce the anti-diarrhea effect of racecadotril.
[Pharmacological Actions]
1. Cytochrome P450-3A4 inhibitors such as erythromycin and ketoconazole may reduce the metabolism of racecadotril and increase its toxicity; 2. Cytochrome P450-3A4 inducers such as rifampicin may reduce the anti-diarrhea effect of racecadotril. Pharmacological Actions Racecadotril is an enkephalinase inhibitor. Enkephalinase can degrade enkephalins. This product can selectively and reversibly inhibit enkephalinase, thereby protecting endogenous enkephalins from degradation, prolonging the physiological activity of endogenous enkephalins in the digestive tract, and reducing excessive secretion of water and electrolytes. Oral racecadotril acts on peripheral enkephalinase, does not affect the enkephalinase activity of the central nervous system, and has no significant effect on gastrointestinal motility and intestinal basal secretion. Toxicity studies have been reported in the literature that primates took 100 times the therapeutic dose of racecadotril for 12 months without any toxic reactions. Mice were intraperitoneally injected with racecadotril at a dose of 50 mg/Kg (twice/day) for 10 days, and no toxic reactions were found during the medication period and after withdrawal.
[Storage] Sealed and stored in a dry place.
[Specification] 10 mg
[Packing specification] Medicinal composite film, 6 bags, 10 bags, 12 bags, 18 bags per box.
[Validity period] 18 months.
[Implementation standard] State Food and Drug Administration standard (trial) YBH05012005
[Approval number] National Medicine Standard H20050411
[Instructions revision date] March 28, 2011
[Manufacturer] Company name: Sichuan Baili Pharmaceutical Co., Ltd.
