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(aliskiren and hydrochlorothiazide) Tablets, for Oral Use
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue Tekturna HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [See WARNINGS AND PRECAUTIONS].
Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic that is provided as tablets for oral administration.
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 crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water.
Hydrochlorothiazide 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. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-l,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is
Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.
What are the possible side effects of hydrochlorothiazide and aliskiren (Tekturna HCT)?
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 hydrochlorothiazide and aliskiren and call your doctor at once if you have a serious side effect such as:
- eye pain, vision problems;
- feeling like you might pass out;
- high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle...
What are the precautions when taking aliskren and hydrochlorothiazide tablets (Tekturna HCT)?
Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine (anuria).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, loss of too much body water (dehydration), kidney disease, liver disease, lupus, gout, untreated mineral imbalance (e.g., high/low potassium, low magnesium, high calcium), high levels of fats...
Last reviewed on RxList: 11/1/2011
This monograph has been modified to include the generic and brand name in many instances.
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