Schedule H

Oral

• Tablets: 150 mg, 300 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Essential Hypertension (Monotherapy or Combination Therapy)

Parameter Recommendation

Starting dose 150 mg once daily

Titration Increase to 300 mg once daily after 2–4 weeks if BP target not achieved

Usual maintenance dose 150–300 mg once daily

Maximum dose 300 mg/day

Clinical Notes:

• Administer at the same time each day, preferably with a light meal

• Avoid high-fat meals as they significantly reduce absorption

• Onset of antihypertensive effect: within 1 week; maximal effect: 2–4 weeks

• Avoid combination with ACE inhibitors or ARBs in patients with diabetes or eGFR <60 mL/min/1.73 m²

Secondary Indications – Adults (Off-label, if any)

Not applicable.

• No established off-label indications supported by Indian practice or guidelines

• NOT RECOMMENDED off-label for heart failure or diabetic nephropathy — no proven cardiovascular or renal outcome benefit

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

NOT APPROVED for use in children in India.

Age Group Recommendation

< 18 years Not recommended; safety and efficacy not established

• Indian regulatory sources (CDSCO, NFI, AIIMS) do not list paediatric indications

• Should not be used in paediatric population outside specialist supervision or clinical trials

Secondary Indications – Paediatrics (Off-label, if any)

Not applicable.

• Insufficient Indian data to support off-label paediatric use

60 No dose adjustment required

30–60 Use with caution; avoid concurrent ACE inhibitor or ARB use; monitor potassium and creatinine

<30 Not recommended — increased risk of hyperkalaemia and acute kidney injury

Haemodialysis Avoid use; dialysability data not available

• Pregnancy (all trimesters — teratogenic risk)

• Known hypersensitivity to aliskiren or any excipient

• History of angioedema with aliskiren

• Concomitant use with ACE inhibitors or ARBs in patients with diabetes mellitus

• Concomitant use with ACE inhibitors or ARBs in patients with eGFR <60 mL/min/1.73 m²

• Bilateral renal artery stenosis or stenosis in a solitary kidney

• Concomitant cyclosporine therapy

• Renal impairment (eGFR <60 mL/min) — increased risk of hyperkalaemia and renal deterioration

• Volume or salt-depleted patients (e.g., on high-dose diuretics) — risk of symptomatic hypotension

• Elderly patients — higher susceptibility to hypotension and renal dysfunction

• Concurrent use of potassium supplements or potassium-sparing diuretics

• Patients with history of angioedema (non-aliskiren related)

• Aortic or mitral valve stenosis, hypertrophic cardiomyopathy

Parameter Details

Risk Category Contraindicated in all trimesters

Known Risks Fetal renal dysgenesis, oligohydramnios, skull hypoplasia, limb contractures, pulmonary hypoplasia, fetal death

Preferred Alternatives Labetalol, methyldopa, nifedipine (as per Indian obstetric practice)

Action if Exposed Discontinue immediately upon confirmation of pregnancy

Fetal Monitoring Ultrasonography for amniotic fluid volume, fetal renal structure if inadvertent exposure occurs

Parameter Details

Compatibility Not recommended during breastfeeding

Excretion in Milk Unknown — potential risk to infant cannot be excluded

Preferred Alternatives Nifedipine, amlodipine, labetalol (if antihypertensive required)

Infant Monitoring Monitor for hypotension, poor feeding, lethargy if inadvertent exposure

Parameter Recommendation

Starting dose 150 mg once daily (same as adults)

Titration Slower titration recommended; reassess at 4 weeks before escalating

Special Considerations Higher risk of hypotension (especially postural), hyperkalaemia, and renal impairment

Monitoring BP, renal function, serum potassium at baseline and regularly thereafter

Alternatives to Consider ACE inhibitors, ARBs, or calcium channel blockers with established cardiovascular outcome data in elderly

Interacting Drug Effect / Risk Recommendation

ACE inhibitors / ARBs Increased risk of hypotension, hyperkalaemia, renal impairment Avoid combination, especially in diabetes or CKD

Cyclosporine Markedly increases aliskiren levels (P-gp inhibition) Contraindicated

Itraconazole Significantly increases aliskiren plasma concentration Avoid combination

Potassium-sparing diuretics (spironolactone, amiloride, eplerenone) Additive hyperkalaemia risk Avoid or monitor potassium closely

NSAIDs (especially in elderly/volume-depleted) Reduced antihypertensive effect; increased renal impairment risk Avoid if possible; monitor renal function

Interacting Drug Effect / Risk Recommendation

Furosemide Reduced oral bioavailability of furosemide Monitor diuretic response

Atorvastatin Increases aliskiren levels by approximately 50% (P-gp inhibition) Monitor BP and for adverse effects

Ketoconazole Moderate increase in aliskiren concentration Monitor BP; clinical significance uncertain

Digoxin Slight increase in digoxin levels (~20%) Monitor digoxin levels if clinically indicated

Amlodipine May enhance hypotensive effect Monitor BP; generally safe combination

• Diarrhoea (most common)

• Dizziness

• Headache

• Fatigue

• Nasopharyngitis / upper respiratory symptoms

• Elevated serum potassium

• Cough (less frequent than with ACE inhibitors)

Adverse Effect Action Required

Angioedema (face, lips, tongue, glottis, larynx) Discontinue immediately; supportive airway management; do not rechallenge

Severe hypotension Supportive care; volume resuscitation; discontinue or reduce dose

Hyperkalaemia (especially with CKD or dual RAAS blockade) Discontinue; manage hyperkalaemia; avoid rechallenge without specialist input

Acute kidney injury Discontinue; supportive management

Fetal toxicity (if used in pregnancy) Refer to obstetrics urgently

Timing Parameters to Monitor

Baseline Blood pressure, serum creatinine, eGFR, serum potassium

1–2 weeks post-initiation or dose change Renal function, serum potassium

Long-term (every 2–3 months) Blood pressure, renal function, potassium — more frequently in high-risk patients (elderly, CKD, diabetes)

Any time during treatment Signs of angioedema (swelling of face, lips, tongue, difficulty breathing)

• Rasilez (Novartis)

• Alsisave

• Renikem

• Renilen

Note: Fixed-dose combinations with hydrochlorothiazide are less commonly available in India.

• Not included in NLEM; pricing not NPPA-controlled

• Cost may vary across brands and pharmacies

• Reserve aliskiren for patients intolerant to ACE inhibitors (e.g., persistent dry cough) or ARBs, as cardiovascular outcome data are less robust

• Never combine with ACE inhibitors or ARBs in diabetic patients or those with eGFR <60 — this increases adverse events without improving outcomes (ALTITUDE trial)

• Useful option when RAAS blockade is needed but cough limits ACE inhibitor use

• High-fat meals reduce bioavailability substantially — advise patients to take with light meals consistently

• Monitor serum potassium and renal function closely after initiation and with any dose escalation

• Angioedema can occur at any point during therapy — counsel patients to seek immediate care for facial or throat swelling

Aliskiren; hypertension; direct renin inhibitor; RAAS blocker; ACEI-intolerant; pregnancy-contraindicated; renal-monitoring; Schedule H

RxIndia v1.0 — 12 Apr 2025

• CDSCO approved product information

• Indian National Formulary (NFI)

• Indian Pharmacopoeia (IP)

• API Textbook of Medicine — Hypertension chapter

• AIIMS Hypertension Management Protocols

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics

• Novartis India Product Insert

• WHO Essential Medicines List (supportive reference only — not for paediatric endorsement)