Adalat GITS拜新同

Adalat GITS

nifedipine

Manufacturer:

Bayer

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Nifedipine
Indications/Uses
All grades of HTN. Prophylaxis of chronic stable angina pectoris, as monotherapy or in combination w/ a β-blocker.
Dosage/Direction for Use
Mild to moderate HTN Initially 20 mg once daily, can be increased up to max 90 mg once daily. Severe HTN; prophylaxis of angina pectoris Initially 30 mg once daily, can be increased up to max 90 mg once daily. Patient switched from other Ca antagonist Initially 30 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush. Avoid grapefruit juice.
Contraindications
Hypersensitivity to nifedipine or other dihydropyridines. Cardiogenic shock, clinically significant aortic stenosis, unstable angina, during or w/in 1 mth of MI. Not for the treatment of acute attacks of angina. Not for secondary prevention of MI. Safety has not been established in malignant HTN. Concomitant administration w/ rifampicin. History of GI obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of GI tract; inflammatory bowel disease or Crohn's disease. Patient w/ a Kock pouch. Hepatic impairment.
Special Precautions
Patients w/ hypotension; poor cardiac reserve; diabetes. Reports of heart failure deterioration. Risk of marked BP reduction in dialysis patients w/ malignant HTN & hypovolaemia. Possible postural hypotension w/ β-blocking drugs & other antihypertensives. Excessive BP reduction in pregnant patients when co-administered w/ IV Mg sulfate. Concomitant use w/ CYP3A4 inducers or inhibitors. Careful monitoring, & in severe cases, dose reduction in patients w/ impaired liver function. May falsely increase spectrophotometric values of urinary vanillylmandelic acid. May impair ability to drive or operate machinery. Childn <18 yr. Risk of obstructive symptoms. False +ve effect in barium contrast x-ray exam. Should not be used during pregnancy unless necessary. Not recommended during breastfeeding.
Adverse Reactions
Headache; oedema (including peripheral oedema), vasodilation; constipation; feeling unwell.
Drug Interactions
Increased exposure w/ CYP3A4 inhibitors eg, macrolide antibiotics (eg, erythromycin), anti-HIV PIs (eg, ritonavir), azole antimycotics (eg, ketoconazole), fluoxetine, nefazodone, quinupristin/dalfopristin, cisapride, valproic acid, cimetidine, diltiazem. Decreased exposure w/ CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, phenobarb. Increased BP-lowering effect w/ other antihypertensives. Risk of deterioration of heart failure w/ β-blockers. Reduced clearance & increased plasma level of digoxin. Lowered plasma levels of quinidine. Monitor plasma conc of tacrolimus when co-administered w/ nifedipine; consider reduction in tacrolimus dose. Elevated plasma conc w/ grapefruit juice.
MIMS Class
Calcium Antagonists / Anti-Anginal Drugs / Cardiac Drugs
ATC Classification
C08CA05 - nifedipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Adalat GITS tab 30 mg
Packing/Price
30's
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