Itopride

Anticholinergic agents may reduce the action of itopride.

Itopride is metabolised in liver. Itopride and its metabolites are excreted mainly via kidneys. Patients with reduced hepatic or renal functions should be carefully monitored and in case of adverse reactions it is necessary to take appropriate measures, as e.g. to reduce the dosage or to discontinue the therapy.

The safety of itopride use in pregnancy has not been established. Therefore itopride should be administered to pregnant women only if the benefit outweighs the potential risk.

Itopride is excreted into the milk of lactating rats. There are no data about itopride use during breastfeeding in humans.

Because of the possibility of adverse effects to the infant, a decision should be made either to discontinue breast-feeding, or itopride use, taking into account the importance of the drug to the breast-feeding mother.

Although no effects on ability to drive and use machines have been found, impairment of alertness cannot be ruled out since dizziness may occur very rarely.

Adverse reactions during clinical trials

During the clinical trials, itopride was well tolerated and no serious adverse reactions were reported. In 14 clinical trials, 19 from a total of 572 patients reported adverse reactions (the incidence of the adverse reactions was 2.4%).

Most of the adverse reactions that occurred in more than one patient were diarrhea in 4 cases (0.7%), headache in 2 cases (0.3%) and abdominal pain in 2 cases (0.3%). Abnormal laboratory results reported during clinical trials were decrease in white blood cells (leucocytopenia) in 4 cases (0.7%) and elevated prolactin in 2 cases (0.3%).

Adverse reactions from clinical practice

Adverse reactions have been ranked according to MedDRA terminology under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Patients treated with itopride reported the following adverse effects:

Blood and lymphatic system disorders

Uncommon: leukopenia

Not known: thrombocytopenia

Immune system disorders

Not known: anaphylactic reactions

Endocrine disorders

Uncommon: elevated prolactin levels

Not known: gynecomastia

Nervous system disorders

Uncommon: dizziness, headache, sleep disorders

Not known: tremor

Gastrointestinal disorders

Uncommon: diarrhoea, constipation, abdominal pain, sialorrhoea

Not known: nausea

Renal and urinary disorders

Uncommon: BUN (blood urea nitrogen) and creatinine increased

Hepatobiliary disorders

Not known: jaundice

Skin and subcutaneous tissue disorders

Rare: rash, redness and pruritus

Investigations

Not known: AST, increased ALT, increased gamma-GTP, increased alkaline phosphatase and bilirubin

Musculoskeletal and connective tissue disorders

Uncommon: chest or back pain

General disorders and administration site conditions

Uncommon: fatigue

Psychiatric disorders

Uncommon: irritability