Rasilez Tablet
Aliskiren
300mg
Novartis Farma SpA, Italy
| Pack size | 7's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 0.80 AED |
Available as:
Indications
Rasilez Tablet is used for:
Hypertension
Adult Dose
Oral
Essential hypertension
Adult: >18 yr 150 mg once daily, increased to 300 mg once daily if needed.
Child Dose
Hypertension
Indicated for treatment of hypertension in adults and children >6 years
<2 years: Contraindicated
2 to <6 years: Safety and efficacy not established
6 to 17 years
<20 kg: Not recommended
20 to <50 kg: Starting dose is 75 mg PO qDay; not to exceed 150 mg PO once daily
>50 kg: 150 mg PO once daily; may increase to 300 mg PO qDay based on response and tolerability
Renal Dose
Renal impairment
CrCl >30 mL/min: No dose adjustment is required
CrCl <30 mL/min: No dose adjustment is required, but risk of hyperkalemia and renal dysfunction may occur; use caution
End-stage renal disease (ESRD): No dosage adjustment required
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
Discontinue as soon as possible when pregnancy is detected; affects the renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death.
Avoid concomitant use with ARBs or ACEI in patients with renal impairment (GFR<60 mL/min).
Head and neck angioedema. Discontinue the use of Aliskiren and monitor until signs and symptoms resolve.
Hypotension in volume and/or salt-depleted patients: Correct imbalances before initiating therapy with Aliskiren.
Impaired renal function: Monitor serum creatinine periodically.
Hyperkalemia: Monitor potassium levels periodically.
Monitoring Parameters
Monitor patients with a history of angioedema closely during treatment.
Periodically monitor serum potassium concentration and serum creatinine.
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
Cyclosporine or itraconazole increase aliskiren levels; avoid concomitant use
Oral coadministration of aliskiren and furosemide reduced exposure to furosemide
Coadministration of nonsteroidal anti-inflammatory drug (NSAIDs), including selective COX-2 inhibitors with aliskiren, may result in deterioration of renal function, including possible acute renal failure; effects are usually reversible; monitor renal function periodically in patients receiving aliskiren and NSAID therapy
Coadministration with ACE inhibitors or ARBs
Concomitant use of aliskiren with other agents acting on the RAAS (eg, ACEIs or ARBs) is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared with monotherapy)
Coadministration of 2 drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy
Potentially Fatal: Increased risk of renal impairment, hypotension and hyperkalemia w/ ACE inhibitors or angiotensin II receptor antagonists. Markedly increased plasma concentration w/ ciclosporin, itraconazole and quinidine.
Contraindicated (20)
azilsartan
benazepril
candesartan
captopril
enalapril
eprosartan
fosinopril
irbesartan
lisinopril
losartan
moexipril
olmesartan
perindopril
quinapril
ramipril
sacubitril/valsartan
sparsentan
telmisartan
trandolapril
valsartan
Serious - Use Alternative (10)
azilsartan
captopril
cyclosporine
erdafitinib
itraconazole
lasmiditan
nirmatrelvir/ritonavir
potassium phosphates, IV
sotorasib
tepotinib
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 Tablet manufactured by Novartis Farma SpA, Italy. Its generic name is Aliskiren. Rasilez is availble in Bangladesh.
Farmaco BD drug index information on Rasilez Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.