"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
(aliskiren, amlodipine and hydrochlorothiazide) Tablets
- When pregnancy is detected, discontinue Amturnide as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Amturnide is a single tablet for oral administration of aliskiren hemifumarate (an orally active, nonpeptide, potent direct renin inhibitor), amlodipine besylate (a dihydropyridine calcium channel blocker) and HCTZ (a thiazide diuretic).
Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate, and its structural formula is:
Molecular formula: C30H53N3O6 •0.5 C4H4O4
Aliskiren hemifumarate is a white to slightly yellowish powder with a molecular weight of 609.8 (free base- 551.8). It is highly soluble in water, and freely soluble in methanol, ethanol and isopropanol.
Amlodipine besylate, USP is chemically described as 3-ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate and its structural formula is:
Molecular formula: C20H25CIN2O5•C6H6O3S
Amlodipine besylate is a white to pale yellow crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol.
HCTZ, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. HCTZ is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
HCTZ is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is:
The inactive ingredients for all strengths of the tablets may contain colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.
What are the possible side effects of aliskiren, amlodipine, and hydrochlorothiazide (Amturnide)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using aliskiren, amlodipine, and hydrochlorothiazide and call your doctor at once if you have a serious side effect such as:
- swelling in your hands, ankles, or feet;
- feeling like you might pass out;
- vision problems, eye pain, or seeing halos around lights;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg...
What are the precautions when taking aliskiren, amlodipine and hydrochlorothiazide tablets (Amturnide )?
Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren, amlodipine, or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, kidney disease, liver disease, severe loss of body water and minerals (dehydration), untreated mineral imbalance (such as high/low potassium, low magnesium, high calcium), gout, lupus, a certain heart valve disorder (aortic stenosis).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...
Last reviewed on RxList: 1/3/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Amturnide Information
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