• Dosage of Dafiro in details
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Dosage of Dafiro in details

Dafiro Dosage

Generic name: Amlodipine (Dafiro) BESYLATE 5mg, Valsartan (Dafiro) 160mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1 General Considerations

Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.

Dafiro may be administered with or without food.

Dafiro may be administered with other antihypertensive agents.

2.2 Add-on Therapy

A patient whose blood pressure is not adequately controlled with Amlodipine (Dafiro) (or another dihydropyridine calcium-channel blocker) alone or with Valsartan (Dafiro) (or another angiotensin II receptor blocker) alone may be switched to combination therapy with Dafiro.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Dafiro containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Dafiro should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg.

2.3 Replacement Therapy

For convenience, patients receiving Amlodipine (Dafiro) and Valsartan (Dafiro) from separate tablets may instead wish to receive tablets of Dafiro containing the same component doses.

2.4 Initial Therapy

A patient may be initiated on Dafiro if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is Dafiro 5/160 mg once daily in patients who are not volume-depleted.

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What other drugs will affect Dafiro?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Dafiro, especially:

• any other blood pressure medicines;

• cyclosporine;

• lithium;

• ritonavir;

• a diuretic or "water pill";

• heart medication;

• vitamin or mineral supplements that contain potassium;

• an antibiotic - clarithromycin, rifabutin, rifapentine, rifampin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole;

• cholesterol-lowering medicines - simvastatin, Zocor, and others; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others.

This list is not complete. Other drugs may interact with Amlodipine (Dafiro) and Valsartan (Dafiro), including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Dafiro interactions

No drug interaction studies have been conducted with Dafiro and other drugs, although studies have been conducted with the individual Amlodipine (Dafiro) and Valsartan (Dafiro) components.

Amlodipine (Dafiro)

Impact of Other Drugs on Amlodipine (Dafiro)

CYP3A Inhibitors

Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to Amlodipine (Dafiro) and may require dose reduction. Monitor for symptoms of hypotension and edema when Amlodipine (Dafiro) is co-administered with CYP3A inhibitors to determine the need for dose adjustment.

CYP3A Inducers

No information is available on the quantitative effects of CYP3A inducers on Amlodipine (Dafiro). Blood pressure should be closely monitored when Amlodipine (Dafiro) is co-administered with CYP3A inducers.

Sildenafil

Monitor for hypotension when sildenafil is co-administered with Amlodipine (Dafiro).

Impact of Amlodipine (Dafiro) on Other Drugs

Simvastatin

Co-administration of simvastatin with Amlodipine (Dafiro) increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on Amlodipine (Dafiro) to 20 mg daily.

Immunosuppressants

Amlodipine (Dafiro) may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate.

Valsartan (Dafiro)

No clinically significant pharmacokinetic interactions were observed when Valsartan (Dafiro) was coadministered with Amlodipine (Dafiro), atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The Valsartan (Dafiro)-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.

Warfarin: Coadministration of Valsartan (Dafiro) and warfarin did not change the pharmacokinetics of Valsartan (Dafiro) or the time-course of the anticoagulant properties of warfarin.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Valsartan (Dafiro), may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Valsartan (Dafiro) and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Valsartan (Dafiro), may be attenuated by NSAIDs including selective COX-2 inhibitors.

Potassium: Concomitant use of Valsartan (Dafiro) with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.

CYP 450 Interactions: In vitro metabolism studies indicate that CYP 450 mediated drug interactions between Valsartan (Dafiro) and coadministered drugs are unlikely because of low extent of metabolism.

Transporters: The results from an in vitro study with human liver tissue indicate that Valsartan (Dafiro) is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to Valsartan (Dafiro).

Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on Dafiro and other agents that affect the RAS.

Do not coadminister aliskiren with Dafiro in patients with diabetes. Avoid use of aliskiren with Dafiro in patients with renal impairment (GFR < 60 mL/min).

Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Valsartan (Dafiro). Monitor serum lithium levels during concomitant use.

References

1. DailyMed. "AMLODIPINE BESYLATE; VALSARTAN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "80M03YXJ7I: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology