Debridat medication Uses, Dosage, Side Effects, Precautions
debridat trimebutine Generic drug of the Therapeutic class: Gastro-Entero-Hepatology
active ingredients: Trimebutine
What is Debridat medication?
- This drug is indicated in the pains of digestive or biliary diseases.
- It corrects the associated transit disorders.
What is Debridat used for and indications?
Symptomatic treatment :
- Pain related to functional disorders of the digestive tract and bile ducts,
- Pain, transit disorders and intestinal discomfort related to intestinal functional disorders.
ANSM alert of 02/08/2017 :
- The indications are now limited to the symptomatic treatment of pain, transit disorders and intestinal discomfort related to intestinal functional disorders.
Debridat Dosage
Reconstitute the oral suspension by addition of non-carbonated mineral water to the mark on the vial.
Adult
- 1 graduation of the measuring cup of 15 ml, 3 times / day.
- Exceptionally this dosage can be increased up to 6 graduations of the measuring cup of 15 ml per day.
Child
In children under 5 years, it is recommended to use preferably Debridat Trimebutine CHILD AND NOURISHMENT 4.8 mg / ml, granulated for oral suspension in bottle, better suited to this age group.
However, the usual doses in children are:
- Up to 6 months: 1 graduation of the measuring cup of 2.5 ml, 2 to 3 times / day
- From 6 months to 1 year: 1 graduation of the measuring cup of 5 ml, 2 times / day
- From 1 to 5 years: 1 graduation of the measuring cup of 5 ml, 3 times / day
- Above 5 years: 1 graduation of the measuring cup of 10 ml, 3 times / day
about 1 graduation of the measuring cup of 5 ml per 5 kg of weight per day.
The suspension can be administered directly or mixed with a liquid.
Rinse the measuring cup carefully after use.
Debridat Contraindications
- Trimebutine hypersensitivity
- Child under 2 years old
- Yellow-orange hypersensitivity S
- Fructose intolerance
- Glucose galactose malabsorption syndrome
- Sucrase / isomaltase deficiency
- Pregnancy
- Feeding with milk
Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
HOW TO STORE DEBRIDAT 200 mg/100 mg film-coated tablet?
- Keep this medication out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month.
- No special storage conditions.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
How To Take Debridat ?
Administration mode
Oral route.
Duration of the treatment
Treatment with DEBRIDAT 200 mg should be of short duration.
How it works Debridat
ANTISPASMODIC MUSCULOTROPE
ATC CODE: A03AA05
(A: digestive tract and metabolism)
- The effects of trimebutine are exerted on the digestive tract on intestinal motility.
- Trimebutine has enkephalinergic agonist properties. It stimulates intestinal motility by triggering propagated phase III waves of the migrating motor complex and inhibiting it during prior stimulation (in animals).
- In vitro , it acts by blocking the sodium channels at a value (IC50 = 8.4 μM) and inhibits the release of a mediator of nociception (glutamate).
- In the rat, it inhibits the animal’s reaction to rectal and colonic distension in different experimental models.
Debridat Side Effects
- The following list of adverse reactions is derived from the experience of clinical trials and data reported since marketing.
- According to the organ classification system, adverse reactions are listed below in order of frequency using the following categories: very common (≥1 / 10); frequent (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10000 to <1/1000); very rare (<1/10000); indeterminate frequency (can not be estimated based on available data).
Immune system disorders
Not known: hypersensitivity reactions (pruritus, urticaria, angioedema and exceptionally anaphylactic shock)
Skin and subcutaneous tissue disorders
Uncommon: rash
Frequency not known: generalized maculopapular rash, erythema, eczematiform reactions and exceptionally severe skin reactions including cases of generalized acute exanthematous pustulosis (PEAG), erythema multiforme, febrile toxidermia.
Debridat Interactions
Not applicable.
Debridat Warnings and Precautions
Special warnings
- This medicine contains 3.7 g of sucrose per dose (per sachet) which must be taken into account in the daily ration in case of low sugar diet or diabetes.
- The use of this drug is not recommended in patients with intolerance to sucrose (rare hereditary disease).
- This medicine contains an azo coloring agent (E110) and may cause allergic reactions.
Precautions for use
- This form is not suitable for children under 5 years old.
- In case of diabetes, take into account the sugar content: 3.7 g of sucrose per sachet.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Effects on ability to Drive and use machines
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
PREGNANCY / BREAST FEEDING / FERTILITY
debridat pregnancy
- Studies in animals have not shown any teratogenic effect.There are currently no sufficiently relevant data to evaluate the possible malformative or fetotoxic effect of trimebutine when administered during pregnancy.
- Therefore, as a precaution, it is best not to use trimebutine during the first trimester of pregnancy.
- In the absence of adverse effects expected for the mother or the child, the use of trimebutine during the 2e and 3 rd trimesters of pregnancy should only be considered if necessary.
Breastfeeding
- The passage into the breast milk of trimebutine is not known.As a precaution, it is best to avoid using trimebutine during breastfeeding.
What happens if I overdose from Debridat ?
IN CASE OF OVERDOSAGE, CONSULT YOUR DOCTOR.
What happens if you stop taking Debridat ?
If you stop taking DEBRIDAT 200 mg/100 mg film-coated tablet:
Not applicable.
What is Forms and Composition?
| FORMS and PRESENTATIONS |
Film-coated tablet 100 mg (white) and 200 mg (white):
- Boxes of 30, in blister packs. Granules for oral suspension: 250 ml bottle (brown glass type III) containing 152.5 g of granules, with cup (polypropylene) graduated to 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml. Sachets, box of 30.
- Injection solution (IM or IV) 50 mg / 5 ml: Ampoules (colorless glass) 5 ml, box of 25.
COMPOSITION |
| Coated tablet : | p cp |
| Trimebutine maleate | 100 mg |
| or | 200mg |
Excipients:
- 100 mg tablet: lactose monohydrate, pregelatinized maize starch, hypromellose, sodium carboxymethyl starch, tartaric acid, anhydrous colloidal silica, magnesium stearate. Film coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide.
- 200 mg tablet: lactose monohydrate, pregelatinized maize starch, hypromellose, sodium carboxymethyl starch (type A), tartaric acid, anhydrous colloidal silica, magnesium stearate.
- Coating : Opadry OY-LS-28900 white (hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide [E171]).
- Excipient with known effect: lactose monohydrate (73.40 mg / cp at 100 mg, 146.80 mg / cp at 200 mg).
| Granules p susp buv in fl: | p 100 g | p dose * | |
| of 5 ml | 15 ml | ||
| trimebutine | 0.787 g | 24 mg | 72 mg |
* Reconstituted suspension.
Excipients: polysorbate 80, orange flavor (orange essential oil, gum arabic), orange yellow S E110, sucrose.
Excipients with known effect: yellow orange S E110 (1.8 mg / 100 g, 2.745 mg / fl of 152.5 g); sucrose (97.144 g / 100 g, 148.144 g / fl of 152.5 g).
| Granules p susp buv in sach: | p bag |
| trimebutine | 74.4 mg |
- Excipients: aspartame, natural orange flavor powder (orange essential oil, gum arabic), xanthan gum, orange yellow S E110, polysorbate 80, gum arabic, colloidal anhydrous silica, sucrose.
- Excipients with known effect: Aspartame (15 mg / sachet); yellow-orange S E110 (0.16 mg / sachet); sucrose (3,696 g / sachet).
| Solution for injection: | p light bulb |
| Trimebutine maleate | 50 mg |
- Excipients: sodium chloride, benzyl alcohol, water for injections.
- Excipients with known effect: sodium (45 mg / ampoule), benzyl alcohol (25 mg / ampoule).
NOT’s
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general information:
- Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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