Rasilez HCT 150/12.5 Tablet

Aliskiren Hemifumarate + Hydrochlorothiazide

150/12.5

Novartis Farma SpA, Italy

Pack size	28's pack
Dispensing mode
Source
Agent
Retail Price	1750 AED

Indications

Rasilez HCT 150/12.5 Tablet is used for: Hypertension

Adult Dose

Adult: PO Hypertension Add-on or initial therapy: Initiate with 12.5 mg/150 mg PO qDay; after 2-4 weeks, may increase the dose if needed; not to exceed 25 mg/300 mg

Child Dose

Renal Dose

Renal Impairment CrCl <30 mL/min: Use with caution >30 mL/min: Dose adjustment not necessary

Administration

Administration May be taken with or without food.

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 ACEIs in patients with renal impairment (GFR<60 mL/min). Anaphylactic Reactions and Head and Neck Angioedema: Discontinue Aliskiren + Hydrochlorothiazide and monitor until signs and symptoms resolve. Hypotension in volume and/or salt-depleted patients or with the combined use of other agents acting on RAAS: Correct imbalances prior to initiating therapy with Aliskiren + Hydrochlorothiazide. Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can also result in hypokalemia Impaired renal function: Monitor serum creatinine periodically. Hypersensitivity Reactions: May occur from HCTZ component. Hyperkalemia: Monitor potassium levels periodically. Hydrochlorothiazide has been associated with acute angle-closure glaucoma. Monitoring Parameters Monitor serum creatinine periodically. Monitor potassium levels periodically. Monitor serum lithium concentrations during concurrent use. Correct volume and salt imbalances prior to initiating therapy with Aliskiren + Hydrochlorothiazide.

Pregnancy-Lactation

Pregnancy Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly Aliskiren Use of drugs that act on renin-angiotensin system in second and third trimesters of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death In patients taking this combination drug during pregnancy, perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury; closely observe infants with histories of in utero exposure to the drug combination for hypotension, oliguria, and hyperkalemia; if oliguria or hypotension occur in neonates with a history of in utero exposure to the drug combination, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function Lactation Limited published studies report that hydrochlorothiazide is present in human milk; however, there is insufficient information to determine the effects hydrochlorothiazide on the breastfed infant or effects of hydrochlorothiazide on milk production; because of potential for serious adverse reactions, including hypotension, electrolyte imbalances and renal impairment in nursing infants, advise a nursing woman that breastfeeding is not recommended during therapy

Interactions

Cyclosporine: Avoid concomitant use Itraconazole: Avoid concomitant use NSAIDs use may lead to an increased risk of renal impairment and loss of antihypertensive effect Antidiabetic Drugs: Dosage adjustment of antidiabetic may be required Cholestyramine and Colestipol: Reduced absorption of thiazides Lithium: Increased risk of lithium toxicity when used with diuretics 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. 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 (20) aminolevulinic acid oral aminolevulinic acid topical azilsartan captopril carbamazepine cyclophosphamide cyclosporine dofetilide erdafitinib isocarboxazid itraconazole lasmiditan lofexidine methyl aminolevulinate nirmatrelvir/ritonavir potassium phosphates, IV sotorasib squill tepotinib tretinoin

Adverse Effects

Side effects of Aliskiren Hemifumarate + Hydrochlorothiazide : >10% Increased BUN 1-10% Dizziness (2%),Vertigo (1%),Hypokalemia (2%),Increased uric acid level (2%),Hyperkalemia (1%),Diarrhea (2%),Increased ALT (1%),Flu-like syndrome (2%),Cough (1%),Weakness (1%),Arthralgia (1%) Aliskiren Diarrhea (2.3%),Cough (1.1%),Rash (1%),Increased creatinine kinase (1%),Increased BUN (≤ 7%),Hyperkalemia (≤1%) <1% Decreased hematocrit,Decreased hemoglobin Aliskiren Gastroesophageal reflux,Periorbital edema,Toxic epiderma necrolysis,Increased uric acid,Severe hypotension,Stevens Johnson syndrome 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 . Hydrochlorothiazide inhibits the reabsorption of Na and chloride in the distal tubules causing increased excretion of Na and water K and hydrogen ions.

Note

Rasilez HCT 150/12.5 150/12.5 Tablet manufactured by Novartis Farma SpA, Italy. Its generic name is Aliskiren Hemifumarate + Hydrochlorothiazide. Rasilez HCT 150/12.5 is availble in Bangladesh. Farmaco BD drug index information on Rasilez HCT 150/12.5 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.