Rasilez Tablets / Film-coated
Aliskiren
300mg
Novartis Pharma AG
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 137.50 AED |
Available as:
Indications
Rasilez Tablets / Film-coated is used for:
Hypertension
Adult Dose
Oral
Essential hypertension
Adult: >18 yr 150 mg once daily, increased to 300 mg once daily if needed.
Elderly: No dosage adjustment needed.
Hepatic impairment: No dosage adjustment needed.
Child Dose
Renal Dose
Renal Impairment Mild to moderate: No dosage adjustment needed. Severe: Contraindicated.
Administration
Administration May be taken with or without food. Take consistently w/ or w/o meals. Avoid taking w/ high fat meals.
Contra Indications
History of angioedema; severe renal impairment. Concomitant use w/ ACE inhibitors or angiotensin II receptor antagonists in patients w/ DM and renal impairment (GFR <60 mL/min). Concomitant use w/ ciclosporin, itraconazole and quinidine. Pregnancy.
Precautions
Serious CHF, sodium or volume depletion. Discontinue if diarrhoea is severe and persistent. Lactation. Monitoring Parameters Periodically monitor serum potassium concentration and renal function.
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death.
Lactation: Excretion in milk unknown/not recommended.
Pregnancy-Lactation
Pregnancy
Fetal harm may occur when administered to a pregnant woman
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
Fetal or neonatal adverse reactions
Use of drugs that act on the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death
Perform serial ultrasound examinations to assess the intra-amniotic environment
Observe infants with histories of in utero exposure to aliskiren for hypotension, oliguria, and hyperkalemia; if oliguria or hypotension occur in neonates with a history of in utero exposure to aliskiren, support blood pressure and renal perfusion
Lactation
There is no information regarding the presence of aliskiren in human milk, the effects on the breastfed infant, or the effects on milk production
Owing to the potential for serious adverse reactions, including hypotension, hyperkalemia and renal impairment in nursing infants
Advise a nursing woman that breastfeeding is not recommended during therapy
Interactions
Increased risk of hypotension w/ other antihypertensives. Increased risk of acute renal failure w/ ACE inhibitors, angiotensin II receptor antagonists or NSAIDs. Antihypertensive effect may be reduced w/ NSAIDs. Increased serum levels w/ atorvastatin, itraconazole, ketoconazole, verapamil. Significant decrease in furosemide concentrations w/ aliskiren. Increased risk of hyperkalaemia w/ potassium-sparing diuretics, potassium supplements or any substances that may increase serum potassium levels.
Potentially Fatal: Increased risk of renal impairment, hypotension and hyperkalaemia w/ ACE inhibitors or angiotensin II receptor antagonists. Markedly increased plasma concentration w/ ciclosporin, itraconazole and quinidine.
Adverse Effects
Side effects of Aliskiren :
1-10%
Diarrhea (2.3%), Cough (1.1%), Rash (1%), Increase in serum creatinine (<7%), Hyperkalemia (<1%)
<1%
Angioedema, Headache, Gout, Renal stones, Seizure, Severe hypotension, Rhabomyolysis, Toxic epidermal necrolysis, Increase in uric acid, Angina
Potentially Fatal: Anaphylactic reactions.
Mechanism of Action
Aliskiren is an orally active, potent, non-peptide and selective direct renin inhibitor used in the management of HTN. By inhibiting the enzyme renin, it prevents conversion of angiotensinogen into angiotensin I and therefore inhibits subsequent production of angiotensin II and aldosterone. Unlike ACE inhibitors and angiotensin II receptor antagonists which cause a compensatory rise in plasma renin activity, treatment w/ aliskiren decreases plasma renin activity and concentrations of angiotensin I, angiotensin II and aldosterone .
Note
Rasilez 300mg Tablets / Film-coated manufactured by Novartis Pharma AG. Its generic name is Aliskiren. Rasilez is availble in United Arab Emirates.
Farmaco UAE drug index information on Rasilez Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.