Flulaval Quadrivalent 2013/2014
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Uses
Telmisartan and amlodipine tablets are 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 angiotensin II receptor blockers and dihydropyridine calcium channel blockers. There are no controlled trials demonstrating risk reduction with telmisartan and amlodipine tablets.
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. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Telmisartan and amlodipine tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
Base the choice of telmisartan and amlodipine tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of telmisartan and amlodipine tablets.
Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use telmisartan and amlodipine tablets as initial therapy. Individual blood pressure goals may vary based upon the patient’s risk.
Data from an 8-week, placebo-controlled, multidose, factorial trial provide estimates of the probability of reaching a blood pressure goal with telmisartan and amlodipine tablets compared to telmisartan or amlodipine monotherapy and placebo [see Clinical Studies (14.1)].
The figures below provide estimates of the likelihood of achieving systolic and diastolic blood pressure control with telmisartan and amlodipine 80 mg/10 mg tablets, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.
Figure 1a: Probability of Achieving Systolic Blood Pressure < 140 mmHg at Week 8
Figure 1b: Probability of Achieving Systolic Blood Pressure < 130 mmHg at Week 8
Figure 2a: Probability of Achieving Diastolic Blood Pressure < 90 mmHg at Week 8
Figure 2b: Probability of Achieving Diastolic Blood Pressure < 80 mmHg at Week 8
The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal at 8 weeks. For example, a patient with a baseline blood pressure of 160/110 mmHg has about a 16% likelihood of achieving a goal of < 140 mmHg (systolic) and 16% likelihood of achieving < 90 mmHg (diastolic) on placebo. The likelihood of achieving these same goals on telmisartan is about 46% (systolic) and 26% (diastolic). The likelihood of achieving these same goals on amlodipine is about 69% (systolic) and 22% (diastolic). These likelihoods rise to 79% for systolic and 55% for diastolic with telmisartan and amlodipine tablets.
History
There is currently no drug history available for this drug.
Other Information
Telmisartan and amlodipine tablets are a fixed dose combination of telmisartan and amlodipine.
Telmisartan and amlodipine tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is a white or slightly yellowish crystalline powder. It is practically insoluble in water, slightly soluble in methanol and sparingly soluble in methylene chloride. Telmisartan is chemically described as 4′-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2yl)-2-propyl-1H-benzimidazol-1yl]methyl]biphenyl-2-carboxylic acid. Its molecular formula is C33H30N4O2 and its structural formula is:
Telmisartan and amlodipine tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate, USP is a white or almost white powder, slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol. Amlodipine besylate’s chemical name is 3-ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5•C6H6O3S and its structural formula is:
Telmisartan and amlodipine tablets are formulated in four strengths for oral administration with a combination of 6.935 mg or 13.87 mg of amlodipine besylate, USP, equivalent to 5 mg or 10 mg of amlodipine free base, with 40 mg or 80 mg of telmisartan, USP provided in the following four combinations: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg and 80 mg/10 mg.
Telmisartan and amlodipine tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, povidone, pregelatinized starch (corn) and sodium hydroxide.
Telmisartan and amlodipine tablets are hygroscopic and require protection from moisture.
Telmisartan and amlodipine tablets require protection from light.
Sources
Flulaval Quadrivalent 2013/2014 Manufacturers
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Id Biomedical Corporation Of Quebec
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Flulaval Quadrivalent 2013/2014 | Mylan Pharmaceuticals Inc.
2.1 General ConsiderationsTelmisartan is an effective treatment of hypertension in once daily doses of 20 mg to 80 mg while amlodipine is effective in doses of 2.5 mg to 10 mg.
Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan and amlodipine tablets is 80 mg/10 mg once daily.
The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see Adverse Reactions (6.1)].
Telmisartan and amlodipine tablets may be taken with or without food.
2.2 Replacement TherapyPatients receiving amlodipine and telmisartan from separate tablets may instead receive telmisartan and amlodipine tablets containing the same component doses once daily. When substituting for individual components, increase the dose of telmisartan and amlodipine tablets if blood pressure control has not been satisfactory.
2.3 Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Antihypertensive MonotherapyTelmisartan and amlodipine tablets may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone.
Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to telmisartan and amlodipine 40 mg/5 mg tablets once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response [see Adverse Reactions (6.1)].
2.4 Initial TherapyA patient may be initiated on telmisartan and amlodipine tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of telmisartan and amlodipine tablets is 40 mg/5 mg once daily. Patients requiring larger blood pressure reductions may be started on telmisartan and amlodipine tablets 80 mg/5 mg once daily.
Initial therapy with telmisartan and amlodipine tablets is not recommended in patients ≥ 75 years old or with hepatic impairment [see Dosage and Administration (2.5), Warnings and Precautions (5.4), and Use in Specific Populations (8.5, 8.6)].
Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with telmisartan and amlodipine tablets [see Warnings and Precautions (5.2)].
2.5 Dosing in Specific Populations Renal ImpairmentNo initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic ImpairmentIn most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients with hepatic impairment.
Patients 75 Years of Age and OlderIn most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients 75 years of age and older.
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