Tikosyn Capsule
Product Images NDC 0069-5800

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Tikosyn (NDC 0069-5800). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pfizer Laboratories Div Pfizer Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Chemical Structure (Tikosyn 01)

Chemical structure of dofetilide, the active ingredient in Tikosyn, a human prescription oral capsule drug. The structure shows the molecular arrangement with sulfonamide and ether functional groups linked to benzene rings.*

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Figure 1 (Tikosyn 02)

A scatter plot showing the mean change from baseline QTc (msec) versus mean plasma dofetilide concentration (ng/mL). Data points are distinguished for Day 1 and Day 23 (steady state), with fitted lines for each day illustrating the relationship between plasma dofetilide levels and QTc change.*

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Figure 2 (Tikosyn 03)

A bar chart comparing the effects of placebo and three dosages of dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID) on QTc change from baseline and the probability of remaining in NSR at 6 months. QTc change is shown with 95% confidence intervals on the left y-axis, and the probability of remaining in NSR at 6 months is on the right y-axis expressed as a percentage.*

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Figure 3 (Tikosyn 04)

A Kaplan-Meier survival curve chart showing the probability of remaining in normal sinus rhythm (NSR) over 12 months. The chart compares three dosages of dofetilide (125 mcg, 250 mcg, and 500 mcg twice daily) with a placebo group. A boxed inset displays p-values from a log-rank test for each dosage versus placebo.*

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Figure 4 (Tikosyn 05)

A Kaplan-Meier survival curve graph depicting the probability of remaining in normal sinus rhythm (NSR) over a 12-month period for subjects taking different doses of dofetilide (125 mcg, 250 mcg, 500 mcg BID) compared to placebo. The graph shows higher probabilities for increasing dofetilide doses versus placebo, with statistical significance noted by p-values from a log rank test.*

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Flow Chart (Tikosyn 06)

A flowchart outlining dosing and monitoring instructions for dofetilide (Tikosyn). It starts with placing the patient on telemetry, checking baseline QTc/QT intervals, calculating creatinine clearance to determine dosing or contraindication, followed by dose adjustments based on QTc/QT changes after administration, including criteria for dose continuation, reduction, or discontinuation.*

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Logo (Tikosyn 07)

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Logo (Tikosyn 07a)

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Principal Display Panel (0.125 mg Capsule Bottle Label)

Label for Tikosyn (dofetilide) capsules, 125 mcg (0.125 mg) strength, with 60 capsules per container. The product is distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY. The label includes storage instructions, a barcode, NDC 0069-5800-60, and a QR code. The capsules require dispensing with a medication guide and are for prescription use only.*

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Principal Display Panel (0.125 mg Capsule Blister Pack)

Sheet of packaging labels for Tikosyn (dofetilide) capsules, each label indicating 125 mcg (0.125 mg) strength. Labels show brand and generic names, dosage form, Pfizer Labs as the labeler, lot number, expiration date, and barcodes. Designed for institutional use.*

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Principal Display Panel (0.125 mg Capsule Blister Pack Carton)

The packaging label for Tikosyn (dofetilide) capsules shows the 125 mcg (0.125 mg) strength. The label includes the Pfizer logo, prescription only designation, 40 capsules count, and unit dose format. It states distribution by Pfizer Labs and storage instructions. The label emphasizes dispensing with a medication guide and is marked for in-institution use only.*

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Principal Display Panel (0.25 mg Capsule Bottle Label)

Tikosyn (dofetilide) Capsules 250 mcg (0.25 mg) label for oral capsules, distributed by Pfizer Laboratories, Division of Pfizer Inc. The label indicates a package containing 60 capsules and includes storage instructions at controlled room temperature (15°C to 30°C). It emphasizes protection from moisture and humidity and child-resistant packaging.*

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Principal Display Panel (0.25 mg Capsule Blister Pack)

Sheet of multiple Tikosyn capsules labels showing 250 mcg (0.25 mg) dofetilide strength. Each label indicates Tikosyn as an oral capsule for human prescription. The manufacturer is Pfizer Labs, with barcodes, lot numbers, and expiration dates printed for institutional use.*

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Principal Display Panel (0.25 mg Capsule Blister Pack Carton)

Packaging label for Tikosyn (dofetilide) capsules 250 mcg (0.25 mg) by Pfizer Laboratories. The label indicates the product is for in-institution use only, contains 40 capsules in unit dose format, and is Rx only. Storage instructions and distributor information are also included.*

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Principal Display Panel (0.5 mg Capsule Bottle Label)

Label for Tikosyn (dofetilide) capsules, 500 mcg (0.5 mg) strength. The label indicates the product is distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY, and is packaged as 60 capsules. Storage instructions specify controlled room temperature (15° to 30°C) and protection from moisture and humidity. Additional notes include dispensing in child-resistant containers and reference to accompanying prescribing information.*

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Principal Display Panel (0.5 mg Capsule Blister Pack)

Multiple small rectangular labels for Tikosyn (dofetilide) 500 mcg (0.5 mg) capsules, manufactured by Pfizer Labs. Each label includes barcodes, lot number, expiration date, and usage note for institutional use. The label design repeats in a grid pattern on a sheet.*

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Principal Display Panel (0.5 mg Capsule Blister Pack Carton)

Tikosyn 0.5 mg (500 mcg) capsules packaging label by Pfizer Laboratories Div Pfizer Inc. The label indicates this human prescription drug, containing dofetilide as the active ingredient, is for oral use. The package contains 40 unit dose capsules, with instructions to always dispense with the medication guide. Storage instructions and regulatory information are also included on the label.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.