Konverge Plus Tablets
Konverge Plus (Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide) is indicated for the treatment of hypertension, 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 the class to which this drug principally belongs.
Pharmacist - M.B.A. (Public Health) D.I.C.
Konverge Plus Tablets
What is Konverge Plus? Control of high blood…
What is Konverge Plus?
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
This fixed combination drug is not indicated for the initial therapy of hypertension.
How do I use Konverge Plus?
Use Konverge Plus as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Talk to your pharmacist if you have questions about this information.
- Take Konverge Plus by mouth with or without food.
- Konverge Plus may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
- Take Konverge Plus on a regular schedule to get the most benefit from it. Taking Konverge Plus at the same time each day will help you remember to take it.
- If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Konverge Plus.
- Continue to take Konverge Plus even if you feel well. Do not miss any doses.
- If you miss a dose of Konverge Plus, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Konverge Plus.
Konverge Plus Dosage
Dose once daily.
Dosage may be increased after 2 weeks. The full blood pressure lowering effects are attained within 2 weeks after a change in dose. The maximum recommended dose of Konverge Plus is 40/10/25 mg. Konverge Plus may be taken with or without food.
Konverge Plus may be administered with other antihypertensive agents.
The usual regimens of therapy with Konverge Plus may be followed if the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Konverge Plus.
Patients ≥ 75 years of age should start Amlodipine (Konverge Plus) at 2.5 mg, which is not available with Konverge Plus.
Patients with severe hepatic impairment should start Amlodipine (Konverge Plus) at 2.5 mg, which is not available with Konverge Plus.
Konverge Plus may be substituted for its individually titrated components.
Konverge Plus may be used to provide additional blood pressure lowering for patients not adequately controlled on maximally tolerated, labeled, or usual doses of any two of the following antihypertensive classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and diuretics.
A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Konverge Plus may be switched to Konverge Plus containing a lower dose of that component to achieve similar blood pressure reductions.
Drug Interactions With Konverge Plus
The pharmacokinetics of Olmesartan Medoxomil (Konverge Plus), Amlodipine (Konverge Plus), and Hydrochlorothiazide (Konverge Plus) are not altered when the drugs are co-administered.
No drug interaction studies have been conducted with other drugs and Konverge Plus, although studies have been conducted with the Olmesartan Medoxomil (Konverge Plus), Amlodipine (Konverge Plus), and Hydrochlorothiazide (Konverge Plus) components of Konverge Plus, as described below.
Drug Interactions With Olmesartan Medoxomil
No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with digoxin or warfarin in healthy volunteers.
Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolised by those enzymes are not expected.
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, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Olmesartan Medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Olmesartan Medoxomil and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.
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 Konverge Plus and other agents that affect the RAS.
Do not co-administer aliskiren with Konverge Plus in patients with diabetes. Avoid use of aliskiren with Konverge Plus in patients with renal impairment.
Use With Colesevelam Hydrochloride
Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration ofolmesartan. Administration of olmesartan at least 4 hours prior to colesevelamhydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose.
Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics. Monitor lithium levels in patients receiving Konverge Plus and lithium.
Drug Interactions With Amlodipine
In vitro data indicate that Amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.
Effect of Other Agents on Amlodipine
- Cimetidine: Co-administration of Amlodipine with cimetidine did not alter the pharmacokinetics of Amlodipine.
- Grapefruit juice: Co-administration of 240 mL of grapefruit juice with a single oral dose of Amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of Amlodipine.
- Maalox (antacid): Co-administration of the antacid Maalox with a single dose of Amlodipine had no significant effect on the pharmacokinetics of Amlodipine.
- Sildenafil: A single 100 mg dose of sildenafil in patients with essential hypertension had no effect on the pharmacokinetic parameters of Amlodipine. When Amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Effect of Amlodipine on Other Agents
- Atorvastatin: Co-administration of multiple 10 mg doses of Amlodipine with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin.
- Digoxin: Co-administration of Amlodipine with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.
- Ethanol (alcohol): Single and multiple 10 mg doses of Amlodipine had no significant effect on the pharmacokinetics of ethanol.
- Warfarin: Co-administration of Amlodipine with warfarin did not change the warfarin prothrombin response time.
- Simvastatin: Co-administration of multiple doses of 10 mg of Amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Amlodipine to 20 mg daily.
- In clinical trials, Amlodipine has been safely administered with thiazide diuretics, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
Drug Interactions With Hydrochlorothiazide
When administered concurrently the following drugs may interact with thiazide diuretics:
- Alcohol, Barbiturates, or Narcotics: Potentiation of orthostatic hypotension may occur.
- Antidiabetic Drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required.
- Other Antihypertensive Drugs: Additive effect or potentiation.
- Cholestyramine and Colestipol Resins: Absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single dose of either cholestyramine or colestipol resins bind the Hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.
- Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia.
- Pressor Amines (e.g., Norepinephrine): Possible decreased response to pressor amines but not sufficient to preclude their use.
- Skeletal Muscle Relaxants, Non-depolarizing (e.g., Tubocurarine): Possible increased responsiveness to the muscle relaxant.
- Lithium: Monitor lithium levels
- Non-steroidal Anti-inflammatory Drugs: In some patients the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Hydrochlorothiazide (Konverge Plus) tablets and nonsteroidal anti-inflammatory agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained.
Get emergency medical help if you have signs of an allergic reaction to Konverge Plus: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- worsening chest pain;
- a light-headed feeling, like you might pass out;
- an unusual skin rash;
- pain or burning when you urinate;
- severe or ongoing diarrhea with weight loss;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- signs of an electrolyte imbalance - dry mouth, increased thirst, lack of energy, confusion, vomiting, muscle pain or weakness, fast heartbeats, feeling restless, little or no urine, or a seizure (convulsions); or
- kidney problems - little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.
Common Konverge Plus side effects may include:
- headache, tired feeling;
- nausea, diarrhea;
- runny or stuffy nose, sore throat;
- swollen joints; or
- painful urination.
This is not a complete list of side effects and others may occur.