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Tekturna
Overview
What is Tekturna?
Tekturna contains aliskiren hemifumarate, adirect renin inhibitor. 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.
Tekturna is available as film-coated tablets, which contains 165.75 mg or 331.5 mg aliskiren hemifumerate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: crospovidone; magnesium stearate; microcrystalline cellulose; povidone; silica, colloidal anhydrous; hypromellose; macrogol; talc; iron oxide, black (E 172); iron oxide, red (E 172); titanium dioxide (E 171).
Tekturna is available as 37.5 mg pellets for oral administration which contains the following excipients: basic butylated methacrylate copolymer, colloidal silicon dioxide, crospovidone, povidone, dibutyl sebacate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate. Each oral pellet contains 3.125 mg of aliskiren, equivalent to 3.45 mg of aliskiren hemifumarate. Each 37.5 mg dose of oral pellets is equivalent to 41.44 mg of aliskiren hemifumarate. The oral pellets are provided in a hypromellose capsule dispensing aid. The hypromellose capsule shell is not intended for administration.
What does Tekturna look like?
What are the available doses of Tekturna?
Tablets: 150 mg, 300 mg ()
Tekturna Oral Pellets: 37.5 mg pellets in capsules ()
What should I talk to my health care provider before I take Tekturna?
Lactation: Breastfeeding not recommended. ()
How should I use Tekturna?
Tekturna is a renin inhibitor (RI) indicated for:
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
The usual recommended starting dose of Tekturna is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg. Doses above 300 mg did not give an increased blood pressure response but resulted in an increased rate of diarrhea. The antihypertensive effect of a given dose is substantially attained (85% to 90%) by 2 weeks.
What interacts with Tekturna?
Sorry No Records found
What are the warnings of Tekturna?
Sorry No Records found
What are the precautions of Tekturna?
Sorry No Records found
What are the side effects of Tekturna?
Sorry No records found
What should I look out for while using Tekturna?
Do not use aliskiren with ARBs or ACEIs in patients with diabetes
Tekturna is contraindicated in patients with known hypersensitivity to any of the components
Tekturna is contraindicated in pediatric patients less than 2 years of age
When pregnancy is detected, discontinue Tekturna as soon as possible.
(, )
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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What might happen if I take too much Tekturna?
Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, supportive treatment should be initiated.
Aliskiren is poorly dialyzed. Therefore, hemodialysis is not adequate to treat aliskiren overexposure .
How should I store and handle Tekturna?
Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not be stored at room temperature for more than 48 hours. Vials that develop particulate matter should not be used.Injection vials are single-dose only. After opening, any unused product should be discarded.Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not be stored at room temperature for more than 48 hours. Vials that develop particulate matter should not be used.Injection vials are single-dose only. After opening, any unused product should be discarded.Product: 50090-2985NDC: 50090-2985-0 30 TABLET, FILM COATED in a BOTTLEProduct: 50090-2985NDC: 50090-2985-0 30 TABLET, FILM COATED in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 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 ACEIs 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.
Non-Clinical Toxicology
Do not use aliskiren with ARBs or ACEIs in patients with diabetesTekturna is contraindicated in patients with known hypersensitivity to any of the components
Tekturna is contraindicated in pediatric patients less than 2 years of age
When pregnancy is detected, discontinue Tekturna as soon as possible.
(, )
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
(, )
Furosemide tablets may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
Furosemide tablets should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Furosemide tablets, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and Furosemide tablets are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if Furosemide tablets are not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide tablets have a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
Furosemide tablets combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of Furosemide tablets, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide tablets may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and Furosemide tablets may reduce the natriuretic and antihypertensive effects of Furosemide tablets. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved. The intake of Furosemide tablets and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of Furosemide tablets within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of Furosemide tablets concomitantly with chloral hydrate is, therefore, not recommended.
Phenytoin interferes directly with renal action of Furosemide tablets. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of Furosemide tablets, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like Furosemide tablets, undergo significant renal tubular secretion may reduce the effect of Furosemide tablets. Conversely, Furosemide tablets may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both Furosemide tablets and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of Furosemide tablets.
Furosemide tablets can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and Furosemide tablets is associated with increased risk of gouty arthritis secondary to Furosemide tablets-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Furosemide tablets (furesomide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and Furosemide tablets should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Tekturna as soon as possible
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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