Pracalog 1/Pracalog 2

Pracalog 1/Pracalog 2

prucalopride

Manufacturer:

Unison

Distributor:

F.C.P.

Marketer:

F.C.P.
Concise Prescribing Info
Contents
Prucalopride
Indications/Uses
Symptomatic treatment of chronic constipation in adults in whom laxative fall to provide adequate relief.
Dosage/Direction for Use
Adult 2 mg once daily. Geriatric >65 yr Initially 1 mg once daily & may be increased to 2 mg once daily. Severe renal impairment (GFR <30 mL/min/1.73 m2) 1 mg once daily. Severe hepatic impairment (Child-Pugh class C) 1 mg once daily & may be increased to 2 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Intestinal perforation or obstructive due to gut wall structural or functional disorder, obstructive ileus, severe inflammatory condition of GI tract (eg, Crohn's disease, ulcerative colitis, toxic megacolon/mega rectum). Renal impairment requiring dialysis.
Special Precautions
Discontinue therapy if severe or persistent diarrhea; severe &/or worsening abdominal symptoms, bloody diarrhea, or rectal bleeding occur. History of arrhythmia, ischemic CV disease, pre-excitation syndromes (eg, Wolff-Parkinson-White syndrome) or AV nodal rhythm disorders. Patients w/ severe & unstable concomitant disease eg, cancer, AIDs, psychiatric, hepatic, pulmonary, insulin dependent DM. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndromes. May impair ability to drive & operate machinery. Severe hepatic impairment (Child-Pugh C). Renal impairment & patients requiring dialysis. Women of childbearing potential should use effective contraception during therapy. Not recommended during pregnancy & lactation. Not to be used in childn & adolescents <18 yr.
Adverse Reactions
Dizziness, fatigue, headache, malaise; pollakiuria; abdominal pain, abnormal bowel sounds, anorexia diarrhea, dyspepsia, flatulence, gastroenteritis, nausea, upper abdominal pain, vomiting; muscle spasm; fever; angina pectoris, anxiety, atrial arrhythmia, cardiac arrhythmia, bronchitis, chest pain, cholecystitis, cholelithiasis, confusion, constipation, depression, dyspnea, hyperhidrosis, migraine, MI, ovarian cyst, pancreatitis, pneumonia, sinusitis, stomach discomfort, supraventricular tachycardia, syncope, tremor, urinary incontinence, UTI, vag hemorrhage.
MIMS Class
Laxatives, Purgatives
ATC Classification
A06AX05 - prucalopride ; Belongs to the class of other laxatives.
Presentation/Packing
Form
Pracalog 1 FC tab 1 mg
Packing/Price
4 × 7's
Form
Pracalog 2 FC tab 2 mg
Packing/Price
4 × 7's
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