Generic name: Telvas 20mg
Dosage form: tablet
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Dosage must be individualized. The usual starting dose of Telvas tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg.
Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telvas is required, a diuretic may be added.
No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.
Telvas tablets may be administered with other antihypertensive agents.
Telvas tablets may be administered with or without food.
The recommended dose of Telvas tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of Telvas are effective in reducing the risk of cardiovascular morbidity and mortality.
When initiating Telvas therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Telvas, especially:
a diuretic or "water pill";
NSAIDs (non-steroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, or meloxicam, and others; or
ramipril or other blood pressure medicines.
This list is not complete. Other drugs may interact with Telvas, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Interaction Studies have only been Performed in Adults: As with other medicinal products acting on the renin-angiotensin-aldosterone system, Telvas may provoke hyperkalemia. The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalemia [salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus) and trimethoprim].
The occurrence of hyperkalemia depends on associated risk factors. The risk is increased in case of the previously mentioned treatment combinations. The risk is particularly high in combination with potassium sparing-diuretics and when combined with salt substitutes containing potassium. A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Concomitant Use Not Recommended: Potassium-Sparing Diuretics or Potassium Supplements: Angiotensin II receptor antagonists eg, Telvas, attenuate diuretic induced potassium loss. Potassium-sparing diuretics eg, spironolactone, eplerenone, triamterene or amiloride, potassium supplements or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors and with angiotensin II receptor antagonists, including Telvas. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Concomitant Use Requiring Caution: Nonteroidal Anti-Inflammatory Medicinal Products: NSAIDs (ie, acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
In some patients with compromised renal function (eg, dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
In 1 study the co-administration of Telvas and ramipril led to an increase of up to 2.5-fold in the AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known.
Diuretics (Thiazide or Loop Diuretics): Prior treatment with high dose diuretics eg, furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with Telvas.
To be Taken into Account with Concomitant Use: Other Antihypertensive Agents: The blood pressure lowering effect of Telvas can be increased by concomitant use of other antihypertensive medicinal products.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including Telvas: Baclofen, amifostine. Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Corticosteroids (Systemic Route): Reduction of the antihypertensive effect.
Teli 80: Digoxin: When Telvas was co-administered with digoxin, median increases in digoxin Cmax (49%) and in trough concentration (20%) were observed. It is therefore recommended that digoxin levels be monitored when initiating, adjusting and discontinuing Telvas to avoid possible over- or under-digitalization.
Warfarin: Telvas administered for 10 days slightly decreased the mean warfarin trough plasma concentration; this decrease did not result in a change in international normalized ratio (INR).
Other Drugs: Co-administration of Telvas did not result in a clinically significant interaction with acetaminophen, amlodipine, glibenclamide, simvastatin, hydrochlorothiazide or ibuprofen. Telvas is not metabolized by the CYP450 system and had no effects in vitro on CYP450 enzymes, except for some inhibition of CYP2C19. Telvas is not expected to interact with drugs that inhibit CYP450 enzymes; it is also not expected to interact with drugs metabolized by CYP450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.
Incompatibilities: Not applicable.
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Information checked by Dr. Sachin Kumar, MD Pharmacology