Drug ID: 1d00000055
Drug Name: Aliskiren, Amlodipine and Hydrochlorothiazide
Generic Names: Amturnide
Category: Anti- Hypertensives
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: Adult- The maximum recommended dose is 300/10/25 mg.
Recommended In: This combination medication contains an anti-hypertensive agent, a calcium channel blocker, and a thiazide diuretic, prescribed for high blood pressure (hypertension).
Directions For Use: It comes as a tablet to take by mouth, with or without food.
Storage: Store it at room temperature (25°C). Protect from heat and moisture.
Dosage Forms: Tablet
Side Effects: Most Common - Swelling in the extremities, dizziness, headache and throat inflammation.
Heart - Abnormal heart rhythm, slow heart rate, chest pain, peripheral ischemia, fainting, low blood pressure and inflammation of blood vessels.
Central Nervous System - Peripheral neuropathy, tingling, tremor, sexual dysfunction, sleeplessness, nervousness, depression, abnormal dreams, anxiety and depersonalization.
Gastrointestinal - Loss of appetite, constipation, indigestion, difficulty in swallowing, diarrhea, flatulence, pancreatitis, vomiting and gum inflammation.
General - Allergic reaction, weakness, back pain, hot flushes, uneasiness, pain, rigors, tiredness, weight gain.
Musculoskeletal - Joint pain, muscle cramps and muscle pain.
Respiratory - Difficulty in breathing and nosebleed.
Skin - Redness, itching and rash.
Eye and ENT - Abnormal vision, eye inflammation, double vision, eye pain and ringing in the ear.
Genitourinary - Urination frequency and nighttime urination.
Metabolic - Increased blood sugar, thirst, sweating and dry mouth.
Blood - Decrease in the number of white blood cells and platelets, bruising.
In Case of Overdose: Aliskiren
Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension should occur, provide supportive treatment.
Aliskiren is poorly dialyzed. Therefore, hemodialysis is not adequate to treat aliskiren overexposure.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which HCTZ is removed by hemodialysis has not been established.
Avoid If: Caution should be exercised in patients with history of kidney or liver disease, increased eye pressure, lupus, asthma, congestive heart failure, angioedema, chest pain, seizures, coronary artery disease, electrolyte imbalance, urinary obstruction, any allergy, who are taking other medications, during pregnancy and breastfeeding.
Avoid alcohol consumption.
It may cause drowsiness, dizziness, or blurred vision, do not drive a car or operate machinery while taking this medication.
Patient may develop with an increased risk of angioedema with the following symptoms: swelling in the hands, face, lips, eyes, throat, or tongue; difficulty in swallowing or breathing. If it is so consult with your doctor.
Avoid exposure to sunlight.
Monitor blood pressure, kidney function, sugar level, and blood electrolyte levels regularly while taking this medication.
Do not use aliskiren with angiotensin receptor blockers (ARBs) and the angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes and hypersensitivity.
Drug Interaction: No drug interaction studies have been conducted with aliskiren and amlodipine besylate and Hydrochlorthiazide, although studies with the individual aliskiren and amlodipine besylate components are described below.
Cyclosporine: Avoid co-administration of cyclosporine with aliskiren.
Itraconazole: Avoid co-administration of itraconazole with aliskiren.
Non-Steroidal Anti-Inflammatory Agents(NSAIDs) including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with agents that affect the renin-angiotensin-aldosterone system, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy.
Dual Blockade of the renin-angiotensin-aldosterone system: The concomitant use of aliskiren with other agents acting on the renin-angiotensin-aldosterone system such as ACEIs or ARBs is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Monitor blood pressure, renal function, and electrolytes in patients on aliskiren and other agents that affect the renin-angiotensin-aldosterone system.
Furosemide: Oral co-administration of aliskiren and furosemide reduced exposure to furosemide. Monitor diuretic effects when furosemide is co-administered with aliskiren.
Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
CYP3A4 Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) result in increased systemic exposure to amlodipine warranting dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A4 inhibitors to determine the need for dose adjustment.
CYP3A4 Inducers: No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Blood pressure should be monitored when amlodipine is co-administered with CYP3A4 inducers.
When administered concurrently, the following drugs may interact with thiazide diuretics.
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: Additive effect or potentiation.
Cholestyramine and colestipol resins: Absorption of HCTZ is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the HCTZ and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia.
Pressor amines (e.g., norepinephrine): Possible decreased response to pressor amines but not sufficient to preclude their use.
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible increased responsiveness to the muscle relaxants.
Lithium: Should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and increase the risk of lithium toxicity.
Nonsteroidal anti-inflammatory drugs: In some patients, the administration of a nonsteroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.