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RX ITEM-Tekamlo 300Mg/5Mg Tab 30 By Novartis

NDC 00078-0605-15 UPC/GTIN No.3-00780-60515-1 Mfg.Part No.60515BRAND: TEKAMLO NDC: 00078-0605-15,78060515 UPC: 3-00780-60515-1,300780605151 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Tekamlo 300Mg/5Mg Tab 30 By Novartis

$0.00

Item No.: RX020805 NDC No.78060515 UPC No.:300780605151 NDC No. 00078-0605-15 UPC/GTIN No. 3-00780-60515-1 MPN 60515 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx020805 Tekamlo 300mg/5mg Tab 30 by Novartis Item No. 3020805 NDC No. 00078060515 UPC No. 300780605151 Other Name Tekamlo, ALISKIREN-

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TEKAMLO- aliskiren hemifumarate and amlodipine besylate tablet, film coated
Novartis Pharmaceuticals Corporation
WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Tekamlo as soon as possible. (5.1)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)

1 INDICATIONS AND USAGE

Tekamlo is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. There are no controlled trials demonstrating risk reduction with Tekamlo.
DOSAGE AND ADMINISTRATION
2.1 General Considerations

The recommended initial once-daily dose of Tekamlo is 150 mg/5 mg. Titrate as needed to a maximum of 300 mg/10 mg.

The blood pressure lowering effects are largely attained within 1 to 2 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, titrate the dose to a maximum of Tekamlo 300 mg/10 mg once daily.
DESCRIPTION

Tekamlo is a single tablet for oral administration of aliskiren hemifumarate (an orally active, nonpeptide, potent direct renin inhibitor) and amlodipine besylate (a dihydropyridine calcium channel blocker).

Aliskirenhemifumarate

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.
Molecular formula: C30 H53 N3 O6 � 0.5 C4 H4 O4

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

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.
CLINICAL PHARMACOLOGY
Figure 5: The impact of co-administered drugs on the pharmacokinetics of aliskiren.Figure 6: The impact of aliskiren on the pharmacokinetics of co-administered drugs.
12.1 Mechanism of Action

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.
Amlodipine besylate

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.

NDC 00078-0605-15 UPC/GTIN No.3-00780-60515-1 Mfg.Part No.60515
RX ITEM-Tekamlo 300Mg/5Mg Tab 30 By Nova
NDC 00078-0605-15 UPC/GTIN No.3-00780-60515-1 Mfg.Part No.60515

BRAND: TEKAMLO NDC: 00078-0605-15,78060515 UPC: 3-00780-60515-1,300780605151
Tekamlo 300Mg/5Mg Tab 30 By Novartis
BRAND: TEKAMLO NDC: 00078-0605-15,78060515 UPC: 3-00780-60515-1,300780605151

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.