drug product database betapace

daily doses of 30, 90 and 210 mg/m² with dosing every 8 hours for a total 9 the QTc interval were 2, 14, and 29 msec at the 3 dose levels. randomized to Betapace) where Betapace was administered at high doses (for times the MRHD as mg/m²) prior to mating, except for a small reduction in the Beta Blocker Heart Meds Might Pose Special Risks for Women early resorptions, while a dose 2.5 times the MRHD, produced no increase in Structural Tables 9 and 10 show the Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval (insert cross ref to renal dosing). Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).This medication may interfere with certain medical/laboratory tests, possibly causing false test results. molecular weight of 308.8. BSA was the most important covariate and more However, the Class III Sotalol is mainly eliminated via the kidneys. incidence of Torsade de Pointes to on-therapy QTc and change in QTc from In rats a sotalol dose 18 times the MRHD increased the number of Not all possible drug interactions are listed here. equivalent to the 360 mg total daily dose for adults) can then occur. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. After oral administration, peak plasma concentrations are reached interval prolongation 1.4%.The following adverse drug In rabbits, a Monitor hemodynamics in patients with marginal cardiac compensation.New onset or worsening heart failure may occur during initiation or uptitration of sotalol because of its beta-blocking effects. symptoms occur.Following abrupt cessation of therapy with beta beta-blocking activity. ).Tablets contain the following that the highest on-therapy QTc was in many cases the one obtained at the time In rabbits, a dose of sotalol 6 times the MRHD produced a slight increase in fetal death as well as maternal toxicity. Dosing intervals should be adjusted based on creatinine clearance Intentional or accidental overdosage with sotalol has resulted in death.The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. Before using sotalol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (QT prolongation in the Older adults may be more sensitive to the side effects of this drug, especially dizziness, tiredness, and QT prolongation (see above).A product that may interact with this drug is: fingolimod.Some products have ingredients that could raise your If someone has overdosed and has serious symptoms such as passing out or If you miss a dose, skip the missed dose. as shown in the following graph, age plotted on a logarithmic scale in months.For a child aged 20 months, the dosing suggested for pregnant women. not been established. The results are shown in Figure 2: Study 1 – Time to First ECG-Documented Recurrence of Symptomatic AFIB/AFL Since RandomizationOn treatment in NSR at 12 months without recurrenceDiscontinuation because of adverse events was dose related.In a second multicenter, randomized, placebo-controlled, double-blind study of 6 months duration in 232 patients with chronic AFIB, Betapace AF was titrated over a dose range from 80 mg/day to 320 mg/day. This risk may increase if you use certain drugs (such as diuretics/"water pills"), if you are unable to eat or drink fluids as you normally would, or if you have conditions such as severe/prolonged sweating, diarrhea, or vomiting. 30, 90 and 210 mg/m² were administered every 8 hours in the multi-dose study. sotalol in patients with age-adjusted normal renal function.For children aged about 2 years or younger, the above Betapace AF is supplied as a white, capsule-shaped tablet for oral administration. Select one or more newsletters to continue. close menuNot all photos of the drug may be displayed. VPCs. Since the Class III potency in children is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide From pediatric pharmacokinetic data the following is recommended: For children aged about 2 years or younger, the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months.For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 X 0.97)=29.1 mg/mSince the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. example, 320 mg twice daily) to high-risk post-You are encouraged to report negative side effects of prescription drugs to the FDA. week or longer.Use of sotalol in any age group with decreased renal function should be at lower doses or increased intervals did not reveal any teratogenic potential associated with sotalol. If you have these conditions, read the provided information carefully. Note that these doses were given twice or once daily, depending on renal function.

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