Resolor Tablets / Film-coated
Prucalopride
2mg
JANSSEN-CILAG S.p.A.
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | ITALY |
| Agent | CITY MEDICAL STORE |
| Retail Price | 266.00 AED |
Available as:
Indications
Resolor Tablets / Film-coated is used for:
Chronic idiopathic constipation
Adult Dose
Oral
Chronic idiopathic constipation
Adult: 2 mg once daily.
Elderly: Initially, 1 mg once daily, may increase to 2 mg once daily if necessary.
Hepatic Impairment
Severe (Child-Pugh Class C): Initially, 1 mg once daily, may increase to 2 mg once daily if necessary.
Child Dose
Renal Dose
Severe (GFR <30 mL/min/1.73 m2): 1 mg once daily.
Patient on dialysis: Contraindicated.
Administration
May be taken with or without food.
Contra Indications
Intestinal obstruction or perforation, obstructive ileus, active severe inflammatory bowel conditions (e.g. Crohn’s disease, toxic megacolon/megarectum, and ulcerative colitis). Renal impairment requiring dialysis. Pregnancy and lactation.
Precautions
Patient w/ history of arrhythmias or ischaemic CV disease, severe and unstable concomitant disease (e.g. cancer, AIDS, neurological or psychiatric, pulmonary, IDDM or other endocrine disroders). Severe hepatic (Child-Pugh Class C) and renal (GFR <30 mL/min/1.73 m2) impairment. Elderly.
This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery.
Monitoring Parameters: Monitor bowel movement frequency.
Pregnancy-Lactation
Pregnancy
Available data from case reports with use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes
Animal data
In animal reproduction studies, no adverse developmental effects were observed with prucalopride during organogenesis in pregnant rats and rabbits at doses up to ~390x and 780x, respectively, the recommended human dose of 2 mg/day
Lactation
Prucalopride is present in breast milk
No data are available of effects on breastfed children or milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from prucalopride or from the underlying maternal condition
Interactions
May decrease serum concentration of contraceptives (i.e. oestrogens, progestins). May enhance adverse effect of levosulpiride. Increased serum concentration w/ P-glycoprotein/ABCB1 inhibitors. Reduced effect w/ atropine-like substance.
Adverse Effects
Side effects of Prucalopride :
Nervous: Headache, dizziness, fatigue, malaise, tremors.
CV: Palpitations.
GI: Nausea, abdominal pain and distention, diarrhoea, vomiting, flatulence, dyspepsia, anorexia, rectal bleeding, gastroenteritis.
Genitourinary: Polyuria, pollakiuria.
Musculoskeletal: Muscle spasm.
Others: Fever.
Mechanism of Action
Prucalopride is a selective 5-HT4 receptor agonist w/ prokinetic effect. It stimulates peristaltic reflex, intestinal secretions, and GI motility.
Note
Resolor 2mg Tablets / Film-coated manufactured by JANSSEN-CILAG S.p.A.. Its generic name is Prucalopride. Resolor is availble in United Arab Emirates.
Farmaco UAE drug index information on Resolor Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.