Aliskiren-Amlodipine-Hydrochlorothiazide

Aliskiren-Amlodipine-Hydrochlorothiazide  is a combination medication used for the treatment of hypertension (high blood pressure).

• Aliskiren-Amlodipine-Hydrochlorothiazide  is available under the following different brand names: Amturnide

Common side effects of Aliskiren-Amlodipine-Hydrochlorothiazide  include:

• dizziness, and
• lightheadedness

Serious side effects of Aliskiren-Amlodipine-Hydrochlorothiazide  include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• extreme thirst,
• very dry mouth,
• muscle cramps,
• weakness,
• fast, slow, or irregular heartbeat,
• confusion,
• decreased urination,
• fainting,
• severe tiredness,
• big toe or joint pain,
• swelling hands, ankles, or feet,
• muscle weakness,
• little or no urination,
• decrease in vision,
• eye pain,
• rash,
• itching, and
• severe dizziness

Rare side effects of Aliskiren-Amlodipine-Hydrochlorothiazide  include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 150 mg/5 mg/12.5 mg
• 300 mg/5 mg/12.5 mg
• 300 mg/5 mg/25 mg
• 300 mg/10 mg/12.5 mg
• 300 mg/10 mg/25 mg

Hypertension

Adult dosage

• Initial: Dose once daily
  • May increase the dose after 2 weeks; maximum recommended dose is 300 mg/10 mg/25 mg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Aliskiren-Amlodipine-Hydrochlorothiazide  has no noted severe interactions with any other drugs.
• Aliskiren-Amlodipine-Hydrochlorothiazide  has no noted serious interactions with any other drugs.
• Aliskiren-Amlodipine-Hydrochlorothiazide  has no noted moderate interactions with any other drugs.
• Aliskiren-Amlodipine-Hydrochlorothiazide  has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to aliskiren, amlodipine, hydrochlorothiazide, sulfonamide-derived drugs, or components of the formulation
• Anuria
• Pregnancy (2nd and 3rd trimesters): significant risk of fetal and neonatal morbidity/mortality
• Concomitant use of ACEIs or ARBs in patients with diabetes

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aliskiren-Amlodipine-Hydrochlorothiazide ?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aliskiren-Amlodipine-Hydrochlorothiazide ?”

Cautions

• Avoid the use of aliskiren with ARBs or ACEIs in moderate to severe renal impairment (i.e., GFR less than 60 mL/min); contraindicated in patients with diabetes
• Symptomatic hypotension may occur after initiation of treatment in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin-aldosterone system (RAAS); volume or salt depletion should be corrected prior to administration of therapy, or treatment should start under close medical supervision; a transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized
• Increased angina or myocardial infarction may occur on dosage initiation or increase in amlodipine
• Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been reported in patients treated with aliskiren and have necessitated hospitalization and intubation; this may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACEIs or angiotensin receptor antagonists; patients who experience these effects, even without respiratory distress, require prolonged observation and appropriate monitoring measures; treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement; prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and measures to ensure a patent airway may be necessary; discontinue therapy immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister
• Hydrochlorothiazide may exacerbate or activate systemic lupus erythematosus
  • Acute transient myopia and acute angle-closure glaucoma have been reported, particularly with a history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
• Gradual titration is necessary for patients with hepatic impairment
• Patients whose renal function may depend in part on the activity of the renin-angiotensin-aldosterone system (RAAS; e.g., patients with renal artery stenosis, severe heart failure, postmyocardial infarction or volume depletion) or patients receiving ARB, ACE inhibitors or nonsteroidal anti-inflammatory drug (NSAID), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), therapy may be at particular risk of developing acute renal failure; monitor renal function periodically; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function
• Serum potassium levels: Hydrochlorothiazide can cause hypokalemia and hyponatremia, whereas aliskiren may cause hyperkalemia; monitor serum electrolytes periodically
• Hydrochlorothiazide may alter glucose tolerance and increase serum cholesterol and triglycerides
• Cyclosporine or itraconazole increase aliskiren levels; avoid concomitant use
• Preclinical studies indicate a potential for a substantial increase in exposure to aliskiren in pediatric patients
• Coadministration with NSAIDs increases the risk for renal impairment; monitor renal function periodically
• Coadministration with ACE inhibitors or ARBs
• When aliskiren was prescribed with ACE inhibitors or angiotensin receptor blockers (ARBs) in the ALTITUDE study, an increased incidence of nonfatal stroke, renal complications, hyperkalemia, and hypotension was observed after 18-24 months
• The ALTITUDE trial included patients with hypertension plus type 2 diabetes and renal impairment who were at high risk of cardiovascular and renal events
• Hyperkalemia: Increases in serum potassium above 5.5 mEq/L were infrequent with aliskiren (0.9% compared to 0.6% with placebo); however, when used in combination with an ACE inhibitor in a diabetic population, increases in serum potassium were more frequent (5.5%)

Pregnancy and Lactation

• Pregnancy: Can cause fetal harm when administered to a pregnant woman; use of drugs that act on the renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; when pregnancy is detected discontinue therapy as soon as possible
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
• Aliskiren: If oliguria or hypotension occurs in neonates with a history of in-utero exposure to therapy, 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
  • There is no information regarding therapy in human milk, effects on the breastfed infant, or the effects on milk production; amlodipine and hydrochlorothiazide reported by some studies to be present in human milk; there is insufficient information to determine the effects of amlodipine and hydrochlorothiazide on breastfed infant and effects of hydrochlorothiazide on milk production; there is no available information on effects of amlodipine 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.