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Tekturna HCT
Overview
What is Tekturna HCT?
Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.
A
liskiren
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: CHNO • 0.5 CHO
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.
H
ydrochlorothiazide
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 -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-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is CHClNOS, its molecular weight is 297.73, and its structural formula is
Tekturna HCTtablets 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 does Tekturna HCT look like?
What are the available doses of Tekturna HCT?
Tablets (mg aliskiren/mg HCTZ): 150/12.5, 150/25, 300/12.5, 300/25 (3)
What should I talk to my health care provider before I take Tekturna HCT?
Nursing Mothers:
How should I use Tekturna HCT?
Tekturna HCT is indicated for the treatment of hypertension.
Add-On Therapy
A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT.
A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCTcontaining a lower dose of that component in combination with the other to achieve similar blood pressure reductions.
Replacement Therapy
Tekturna HCT may be substituted for the titrated components.
Initial Therapy
Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks.
Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Data from the high-dose multifactorial study [] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures.
At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg. A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and37% (diastolic).
The recommended once-daily doses of Tekturna HCT in order of increasing mean effect are 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg.
What interacts with Tekturna HCT?
Sorry No Records found
What are the warnings of Tekturna HCT?
Sorry No Records found
What are the precautions of Tekturna HCT?
Sorry No Records found
What are the side effects of Tekturna HCT?
Sorry No records found
What should I look out for while using Tekturna HCT?
Because of the hydrochlorothiazide component, Tekturna HCT is contraindicated in patients with anuria or hypersensitivity to sulfonamide-derived drugs [
]. Hypersensitivity reactions may range from urticaria to anaphylaxis [
].
When pregnancy is detected, discontinue
Tekturna
HCT
as soon as possible.
D
rugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
[
See Warnings and Precautions
(5.1)
]
What might happen if I take too much Tekturna HCT?
Aliskiren
Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension should occur, supportive treatment should be initiated.
H
ydrochlorothiazide
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 hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
How should I store and handle Tekturna HCT?
Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule Controlled Substance. Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule Controlled Substance. Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule Controlled Substance. Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.All strengths are packaged in bottles as described below.StorageStore at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.All strengths are packaged in bottles as described below.StorageStore at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.All strengths are packaged in bottles as described below.StorageStore at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.All strengths are packaged in bottles as described below.StorageStore at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.All strengths are packaged in bottles as described below.StorageStore at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets.All strengths are packaged in bottles as described below.StorageStore at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Aliskiren
Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by angiotensin-converting enzyme (ACE) and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits renin release, thus providing a negative feedback to the system. This cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS). Aliskiren is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I. Whether aliskiren affects other RAAS components, e.g., ACE or non-ACE pathways, is not known.
All agents that inhibit the RAAS, including renin inhibitors, suppress the negative feedback loop, leading to a compensatory rise in plasma renin concentration. When this rise occurs during treatment with ACE inhibitors and ARBs, the result is increased levels of PRA. During treatment with aliskiren, however, the effect of increased renin levels is blocked, so that PRA, Ang I and Ang II are all reduced, whether aliskiren is used as monotherapy or in combination with other antihypertensive agents.
H
ydrochlorothiazide
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of agents that block the production or function of angiotensin II tends to reverse the potassium loss associated with these diuretics.
The mechanism of action of the antihypertensive effect of thiazides is unknown.
Non-Clinical Toxicology
Because of the hydrochlorothiazide component, Tekturna HCT is contraindicated in patients with anuria or hypersensitivity to sulfonamide-derived drugs [ ]. Hypersensitivity reactions may range from urticaria to anaphylaxis [ ].When pregnancy is detected, discontinue
Tekturna
HCT
as soon as possible.
D
rugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
[
See Warnings and Precautions
(5.1)
]
Patients receiving narcotics, antihistaminics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.
Tekturna HCT can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. In several dozen published cases, ACE inhibitors use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. In addition, first trimester use of ACE inhibitors has been associated with birth defects. Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possible other adverse reactions that have occurred in adults.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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