See Supplemental Patient Information
- Drugs acting directly on the renin-angiotensin-aldosterone system can cause fetal and neonatal morbidity and death when administered to pregnant women. This combination drug may cause fetal harm when administered during pregnancy; if pregnancy is detected during therapy, suspend the drug as early as possible [US Black Box warning]. On usage during pregnancy or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus
- Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis or larynx may occur in patients treated with aliskiren requiring hospitalization and intubation, which can occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACE inhibitors or angiotensin receptor antagonists. If angioedema involves the throat, tongue, glottis or larynx, or if patient has a history of upper respiratory surgery, airway obstruction may occur, which could be fatal. Prolonged observation may be required in patients who experience these effects, even without respiratory distress since treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement. Immediate administration of subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 ml) and measures to ensure a patent airway may be necessary. Discontinue therapy immediately in case of angioedema and do not re-administer
- In patients with an activated renin-angiotensin-aldosterone system (e.g., volume- and/or salt-depleted patients receiving high doses of diuretics), symptomatic hypotension may occur in patients receiving renin-angiotensin-aldosterone system (RAAS) blockers. Treat these conditions prior to administration of aliskiren/amlodipine or start treatment under close medical supervision. Upon excessive fall in BP with this therapy, place the patient in supine position and, if required, give an IV infusion of normal saline
- Exacerbation of angina or acute myocardial infarction may develop on initiation or increasing dose of amlodipine, especially in patients with severe obstructive coronary artery disease
- Information is unavailable regarding the use of this drug in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. However, increases in serum creatinine or BUN may occur in such patients
- Avoid concurrent use of this combination drug with cyclosporine or itraconazole
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Volume depletion
- Hyponatremia
- CHF
- Renal artery stenosis
- Severe aortic stenosis
- Geriatric patients
Supplemental Patient Information
- Apprise female patients of childbearing age about the adverse effects of the drug on the fetus; discuss other treatment options with female patients planning to become pregnant
- Caution patients that lightheadedness may occur during therapy, especially during the first few days of therapy; advise patients to promptly consult their physician should lightheadedness occur
- Inform patients to discontinue therapy and promptly report any signs or symptoms suggesting angioedema to their physician
- Instruct patients not to use potassium supplements or salt substitutes containing potassium without consulting their prescribing physician
- Advise patients to establish a routine pattern for taking the medication with regard to meals; inform patients that high-fat meals significantly decrease absorption
Pregnancy Category:D
Breastfeeding: No information is available regarding the use of amlodipine during breastfeeding; hence, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed on 8 August 2011. As per the manufacturer's data, it is unknown whether aliskiren or amlodipine is excreted in human milk, although both aliskiren and amlodipine are secreted in the milk of lactating rats. Due to the potential for serious adverse effects in the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, analyzing the importance of the drug to the mother.
US Trade Name(s)
US Availability
Tekamlo (aliskiren/amlodipine)
- TABS:
- 150 mg/5 mg
- 150 mg/10 mg
- 300 mg/5 mg
- 300 mg/10 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Tekamlo 300-10 MG TABS [Bottle] (NOVARTIS)
30 mg = $119.99
90 mg = $339.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
