- 1 Important to know about Debridat Trimebutine ?
- 2 Debridat Trimebutine indication and Uses :
- 3 Debridat Trimebutine Dosage :
- 4 How it works Debridat Trimebutine :
- 5 Debridat Trimebutine Side Effects :
- 6 Debridat Trimebutine Interactions :
- 7 Debridat Trimebutine Warnings and Precautions :
- 8 Drive and use machines:
- 9 Debridat Trimebutine and PREGNANCY / BREAST FEEDING / FERTILITY:
- 10 Pregnancy :
- 11 e and 3 rd trimesters of pregnancy should only be considered if necessary. Breastfeeding:
- 12 What happens if I overdose from Debridat Trimebutine ?
- 13 What is Forms and Composition Debridat Trimebutine?
Important to know about Debridat Trimebutine ?
This drug is indicated in the pains of digestive or biliary diseases.
It corrects the associated transit disorders.
Debridat Trimebutine indication and Uses :
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 Trimebutine Dosage :
Reconstitute the oral suspension by addition of non-carbonated mineral water to the mark on the vial.
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.
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.
How it works Debridat Trimebutine :
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 Trimebutine 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
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 Trimebutine Interactions :
Debridat Trimebutine Warnings and Precautions :
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.
Drive and use machines:
Debridat Trimebutine and PREGNANCY / BREAST FEEDING / FERTILITY:
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 2
e and 3 rd trimesters of pregnancy should only be considered if necessary.
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 Trimebutine ?
IN CASE OF OVERDOSAGE, CONSULT YOUR DOCTOR.
What is Forms and Composition Debridat Trimebutine?
|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.
|Coated tablet :||p cp|
|Trimebutine maleate||100 mg|
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|
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).