Tekturna (Aliskiren) - Uses, Indications, Warnings

Tekturna (Generic name: Aliskiren) belongs to the class of drugs called "direct renin inhibitors".

Tekturna Uses:

It is used to treat hypertension. It may be used to treat proteinuria in patients with type 2 diabetes mellitus, hypertension and nephropathy despite using other agents.

(Tekturna) Aliskiren and Valsartan:

It has been studied in combination with valsartan for the treatment of hypertension. At the maximum recommended doses, it was found to be superior to monotherapy with either of the drugs and was well tolerated [Ref].

Aliskiren and Losartan in Type 2 Diabetes with nephropathy:

Aliskiren (Tekturna) has been studied in patients with diabetes type 2  in combination with losartan. The authors concluded that aliskiren may have renoprotective effects that are independent of its blood pressure lowering effects in patients with diabetes, hypertension, and nephropathy [Ref].

(Tekturna) Aliskiren and Enalapril in heart failure:

Aliskiren given in combination with an ACE inhibitor like enalapril in patients with heart failure may be hazardous. It was studied in patients with heart failure and reduced ejection fraction. The authors of the study concluded that patients in the combination group were more likely to have hypotensive episodes, raised creatinine levels, and hyperkalemia [Ref].

Tekturna Contraindications

  Patients with the following conditions are not recommended:

  • Hypersensitivity to the formulation
  • Patients with diabetes mellitus should not take an ACE inhibitor or ARB concurrently.
  • Angioedema: History
  • Angioedema idiopathic or hereditary

Precautions and Warnings from Tekturna

  • Patients who use a direct renin inhibiter are at greater risk of hyperkalemia, especially if they have predisposing factors such as diabetes mellitus, kidney failure, patients taking potassium-sparing diuretics or ACE inhibitors.
  • Angioedema and anaphylaxis have been reported.
  • Volume depleted patients may develop hypotension.
  • It is best to not use strong inhibitors of Pglycoprotein (eg cyclosporine, itraconazole) concurrently.

Tekturna Dose in Adults

Tekturna Dosage:

  • Start with 150 mg once daily. The dose may be increased to a maximum of 300 mg once daily.

Tekturna Dosage in Children:

  • The recommended starting dose for the treatment of high blood pressure in children (20 kg to 50 kg) is 37.5 mg or 75 mg once daily. The maximum recommended dose is 150 mg.

Aliskiren dose in Kidney disease:

  • Use with caution in patients with renal dysfunction.
  • Dose adjustment is not necessary with a creatinine clearance of  ≥30 mL/minute.
  • It should be used with extreme caution in patients with ESRD and a creatinine clearance of < 30 ml/min because of the risk of hyperkalemia. Dose adjustment may not be necessary.

Aliskiren dose in liver disease:

  • No dosage adjustment is necessary.

How to take the drug?

It may best be taken with meals at the same time of the day.

Aliskiren Pregnancy Risk Factor X

[U.S.-Bound Warning]

  • Aliskiren should, along with other drugs that affect the renin/angiotensin systems, be stopped immediately after pregnancy is confirmed. 
  • It can cause injury or death for the developing foetus.
  • Direct renin inhibitors, such as Aliskiren, or other drugs that act on the renin–angiotensin systems, are often associated with oligohydramnios, which can lead to fetal lung hypoplasia, and skeletal malformations.
  • It can also be associated with hypotension, anuria and renal failure. It is found in breast milkIt is not recommended to be used during pregnancy.

Tekturna Side effects:

Common side effects include

  • Arthralgia, dizziness, hyperkalemia, and diarrhea Other side effects include renal failure (reversible on discontinuation of treatment), hypotension,  palpitation, peripheral edema, cough, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, Anemia, angioedema, and erythema.

Monitorinf Parameters

  • Blood pressure; serum potassium, BUN, and serum creatinine

Aliskiren (Tekturna) Mechanism of Action:

  • Aliskiren is a direct renin inhibitor that blocks renin, thus inhibiting the whole pathway of the renin-angiotensin-aldosterone system.
  • Angiotensin II, the main hormone responsible to elevating blood pressure through vasoconstriction is also responsible for stimulating the production aldosterone in the adrenal cortex.
  • Within 2 weeks, the maximum antihypertensive effect can be seen.

Absorption isPoor, especially when combined with a high-fat diet.

Metabolism: Unknown extent of metabolismIn vitroStudies show that metabolism is controlled by CYP3A4.

Bioavailability is approximately3%

Elimination of Half-lifeIt takes approximately 24 hours (ranging between 16-32 hours).

Peak plasma concentration can be reached at a certain time.It takes 1-3 hours

ExcretionIt is excreted through urine and feces. About 25% of the dose absorbed is excreted unchanged by the urine.

Aliskiren Brand Names (International):

  • Enviage
  • Rasilez
  • Sprimeo
  • Tekturna

ALEVIA (ATCO LABORATORIES LIMITED)

Tablet: 300 mg

1 tablet pack : Rs. 117.00

Tablet: 150 mg

7 tablets pack ; Rs. 490.00

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


ALLDAY (WERRICK PHARMACEUTICALS)

Tablet: 300 mg

1 tablet pack : Rs. 117.00

Tablet: 150 mg

7 tablets pack ; Rs. 490.00

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


ASILEZ (EFROZE CHEMICAL INDUSTRIES (PVT) LTD)

Tablet: 150 mg

7 tablets pack ; Rs. 490.00

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


EASRIN (DON VALLEY PHARMACEUTICALS (PVT) LTD)

Tablet: 150 mg

7 tablets pack ; Rs. 490.00

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


MASILEZ (MAPLE PHARMACEUTICALS (PVT) LTD)

Tablet: 150 mg

1 tablets pack ; Rs. 117

Tablet: 150 mg :

20 tablets pack : Rs. 449

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


RASILEZ (NOVARTIS PHARMA (PAK) LTD)

Tablet: 150 mg

7 tablets pack ; Rs. 490.00

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


SKIREN (GETZ PHARMA PAKISTAN (PVT) LTD)

Tablet: 150 mg

7 tablets pack ; Rs. 490.00

Tablet: 300 mg

7 tablets pack ; Rs. 819.00


AKSILEZ-V (CONSOLIDATED CHEMICAL LABORATORIES (PVT) LTD)

Tablets : Aliskiren : 150 mg , Valsartan : 160 mg

14 tablets pack : Rs. 1100.00

7 tablets pack : Rs. 550.00


ALEVIA-V (ATCO LABORATORIES LIMITED)

Tablets : Aliskiren : 150 mg , Valsartan : 160 mg

14 tablets pack : Rs. 1100.00

7 tablets pack : Rs. 550.00

Tablets : Aliskiren : 300 mg , Valsartan : 320 mg

14 tablets pack : Rs. 1834

7 tablets pack : Rs. 917


ALLDAY-H (WERRICK PHARMACEUTICALS)

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

10 tablets pack ; Rs. 652.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

10 tablets pack ; Rs. 652.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

10 tablets pack ; Rs. 1087.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

10 tablets pack ; Rs. 1087.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 1521.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 1521.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

20 tablets pack ; Rs. 1239.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

20 tablets pack ; Rs. 1239.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

20 tablets pack ; Rs. 2065.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

20 tablets pack ; Rs. 2065.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

28 tablets pack ; Rs. 1735.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

28 tablets pack ; Rs. 1735.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

28 tablets pack ; Rs. 2890.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

28 tablets pack ; Rs. 2890.00


CO-KIREN (TABROS PHARMA)

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 1521.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 1521.00


ERIN (GENIX PHARMA (PVT) LTD)

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 1521.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 1521.00


RENRID (GLOBAL PHARMACEUTICALS)

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

28 tablets pack ; Rs. 1735.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

20 tablets pack ; Rs. 1239.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

10 tablets pack ; Rs. 652.00


RENRID H (GLOBAL PHARMACEUTICALS)

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

28 tablets pack ; Rs. 1735.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

20 tablets pack ; Rs. 1239.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

10 tablets pack ; Rs. 652.00


SKIREN PLUS (GETZ PHARMA PAKISTAN (PVT) LTD)

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

10 tablets pack ; Rs. 652.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

10 tablets pack ; Rs. 1087.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 913.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

14 tablets pack ; Rs. 1521.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

14 tablets pack ; Rs. 1521.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

20 tablets pack ; Rs. 1239.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

20 tablets pack ; Rs. 1239.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

20 tablets pack ; Rs. 2065.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

20 tablets pack ; Rs. 2065.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 12.5 mg :

28 tablets pack ; Rs. 1735.00

Tablets : Aliskiren : 150 mg , Hydrochlorothiazide : 25 mg :

28 tablets pack ; Rs. 1735.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 12.5 mg :

28 tablets pack ; Rs. 2890.00

Tablets : Aliskiren : 300 mg , Hydrochlorothiazide : 25 mg :

28 tablets pack ; Rs. 2890.00

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