Description LOOPERAMIDE HEXAL 15 2MGDenomination capsules: LOOPERAMIDE HEXAL 2 mg Rigid capsules
Pharmacotherapeutic category: Anti-security.
Active principles: loperamide hydrochloride.
Excipients: lactose, corn starch, magnesium stearate, talco.corpo della capsule: jelly, black oxide iron (E172), titanium dioxide (E171). Color: jelly, black oxide iron (E172), yellow oxide iron (E172), BL U Patent (E131), titanium dioxide (E171).
Indications: Treatment of acute and chronic diarrheas. After ileostomy it allows to reduce the number and volume of the discharges and to increase its consistency.
Contraindications / EFF.Secondar: hypersensitivity to the active ingredient or to any of the listed excipients; Loperamide hydrochloride should not be used in children under 2 years of age.loperamide hydrochloride must not be u tilised as primary therapy: or in patients with acute dysentery, characterized by blood in faeces and high fever or in patients with ulcerative colitis Acute or in patients with bacterial enterocoliths caused by invasive organisms, including Salmonella, Shigella and Campilobacter or in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.Operamide hydrochloride should not be used when peristals inhibition must be avoided to Cause of the possible risk of significant sequel, including ileo, megacolon and toxic megacolon.Operamide hydrochloride must be interrupted medically if constipated, abdominal distension or ileo are developed.
Posology: Adults and children of age between 6 and 17 years: the medicine should be taken with a bit of liquid. Acute divertia: the initial dose is 2 capsules for adults and 1 capsule for children; Subsequently 1 c apsula after each subsequent evacuation of non-formed feces (soft) and 1 capsule for children.This initial dose is adapted up to obtaining 1 or 2 evacuating I of stools formed per day, which is generally possible with a maintenance dose of 1 – 6 capsules (2 mg – 12 mg) per day. For GL adults the maximum daily dose in case of acute and chronic diarrhea is 8 capsules (16 mg). For children the dose must be correlated to body weight (3 capsules / 20 kg) but not It must pass a maximum of 8 capsules per day. Deputy the dose just obtained the normalization of the feces; interrupt the treatment in the event of stipsi.bambin I under the age of 6: Loperamide should not be used in children under 6 years old: it is not necessary for dose adjustment. Renal calling: a Date adjustment. 2 days.
Storage: This medicine does not require any particular conservation condition.
WARNINGS: The treatment of diarrhea with loperamide hydrochloride is only tico synthoma.ogne time a basic etiology can be determined, dev and be given specific treatment when appropriate. Any patients with diarrhea, especially in children, can occur Deplion of liquids and electrolytes. In these cases the most important countermeasure is the administration of adequate replacement therapy based on liquids and electrolyti.Operamide hydrochloride should not be administered to children from 2 to 6 years of age Without prescribers and medical supervision. In the acute diarrhea, if you do not observe a mig Liorating of clinical symptomatology within 48 hours, the administration of loperamide hydrochloride must be interrupted and you have advice are to patients to consult your doctor. Patients with AIDS treated With loperamide hydrochloride for diarrhea must interrupt therapy to the first signs of abdominal distension.Nei patients suffice from AIDS With infectious colitis caused by viral and bacterical pathogens treated with a hydrochloride, isolated cases of constipation have been reported with an increase in the risk of toxic megacolon. It is not available pharmacokinetic data in patients with hepatic impairment, in such patients loperamide hydrochloride D Eve being used with caution, due to the reduction of the first passage metabolism. Patients with hepatic dysfunction must be carefully monitored for toxicity signs to be paid by the central nervous system (SNC). Cardiac events were reported including the extension of the QT and point twists in association with overdose. Some cases have been a fatal outcome. It is appropriate that patients do not exceed the recommended dose and / or do not protect the duration of therapy. Keep lactose.
Interactions: Non-clinical data showed that Loperamide is a substrate of La P-glicoprotein. The concomitant administration of Loperamide (in a single dose of 16 mg) with quinidina or ritonavir, both pklicoprotein inhibitors, showed an increase from 2 3 times the plasma live Lles of Loperamide. The clinical relevance of this pharmacokinetic interaction with p-glycoprotein inhibitors, when LOP Eramide is administered to recommended dosages, is not known. The concomitant administration of Loperamide (in single dose from 4 mg) and Itraconazole, a CYP3A4 and P-Glycoprotein inhibitor, showed a 3 to 4-fold increase in plasma concentrations of Loperamide.In the same study the gemfibrozil, a CYP2 C8 inhibitor, has increased plasma concentrations of the Loperamide of about 2 times. The combination of Itraconazole and Gemfibrozil showed a 4-fold increase in loperamide peak plasma levels and an Aumen 13 times total plasma exposure. These NTI Aura were not associated with effects to the Nervous System CENTR ALE (SNC), as noted by psychomotor tests (eg subjective drowsiness and the replacement test of symbols and figures – Digit Symbol Substitution Test). The concomitant administration of Loperamide (in a single dose of 16 mg) and ketoconazole, a p-glycoprotein cyp3a4 and cyp3a4 inhibitor, has led to a 5-time increase of loperamide plasma actions. This increase was not Associated with an increase in pharmacodynamic effects, as detected by pupilometry. The concomitant treatment with oral desmopressin has led to a 3-fold increase of plasma desmopressin concentrations, presumably due to a slowdown in gastrointestinal motion.Possible interactions can occur With: drugs that slow down intestinal peristals (such as ant ulinergic), as GL The effects of loperamide can be enhanced. The treatment with substances with pharmacological properties simi can enhance the effect of the loperamide and the drugs that accelerate intestinal transit can decrease its effect. You should not recommend the concomitant use of CYP cytochrome inhibitors 450 and Glycoprotein P. Inhibitors P.
Undesirable effects: the frequency categories present in Table 1 are defined according to the following Convention: very common (> = 1/10), Municipality (> = 1/100, <1/10), uncommon (> = 1 / 1,000, <1/100), rare (> = 1/10,000, <1 / 1,000) and very rare (<1 / 10,000). Frequency of adverse drug reactions reported with the use of loperamide hydrochloride during clinical trials in Adults and children of age> = 12 years. >> Acute Diarrhea.PA Nervous System Tologie.comune: headache; Uncommon: dizziness.pa gastrointestinal tologi.comune: constipation, nausea, flatulence; No NO common: abdominal pain, abdominal malaise, dry mouth, pain of the top of the abdomen, vomiting; rare: distension and abdominal. Cute and subcutaneous tissue addicts Municipality: dizziness.Patologies gastrointestinals.comune: constipation, nausea, flatulence; Uncommon: abdominal pain, abdominal malaise, dry mouth, dyspepsia. >> Post-marketing data on adverse reactions from Loperamide hydrochloride. The evaluation process of reports of post-marketing adverse reactions for Lope Ramis did not differ between the indications for treatment of chronic iarreas from acute or between adults and children; As a result, post-marketing adverse reactions for Loperamide listed below are cumulative for the two indications and patient populations. The adverse actions identified during the post marketing phase and for Loperamide hydrochloride are listed below based on the “Classification for systems and Organs “and the preferred terms (PT) of the dictionaries or meddra. immune system Disturbances: hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction.Pathes of the nervous system: drowsiness, loss of consciousness, amazement, level depression of conscience, hypertonia, disturb the coordination. Appathes: Miosi. Gastrointestinal addicts: ileo (including paralytic ileo), megacolon (including toxic megacolon) and glossinia.Patologie of cute and subcutaneous tissue: Bollosa eruption (including syndrome of Stevens-Johnson, toxic epidermal necrolisi and multiform erythema), Angioedema, hives, itching . to 13 clinical studies controlled and not against llati with loperamide hydrochloride used for the treatment of acute halter.In general the profile of the ADR in this patient’s population was similar to that observed in clinical trials with operamide hydrochloride in adults and in Children of age equal to or over 12 years. The signal of suspected adverse reactions occurring after the authorization of the medicine is important, in quan to allows a continuous monitoring of the benefit / risk report of the medicinal product.
Pregnancy and breastfeeding: although there are no indications that loperamide hydrochloride possesses teratogenic or embryotoxic oprieta, the planned therapeutic benefits must be evaluated with respect to potential risks before somminis draws loperamide hydrochloride during pregnancy, especially during the first quarter. Piccole quantity ‘Loperamide can comparate in human breast milk. Therefore the operamide hydrochloride is not commanded during breastfeeding.