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Sodium Iodide I 131

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Overview

What is HICON?

HICON, a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I 131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq of no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. The pH of the concentrated solution is between 7.5 and 10. The concentrated solution provided with HICON is used for the preparation of sodium iodide I 131 capsules or sodium iodide I 131 solution of varying strengths for oral administration for therapy.

Sodium iodide I 131 solution is designated chemically as Na 131I and has a molecular weight of 153.99. Hard gelatin capsules, provided for the preparation of the sodium iodide I 131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer.



What does HICON look like?



What are the available doses of HICON?

Vials: Sodium Iodide I 131 Solution (9,250 MBq, 18,500 MBq, and 37,000 MBq at time of calibration) for the preparation of sodium iodide I 131 capsules, therapeutic or sodium iodide I 131 solution, therapeutic.

What should I talk to my health care provider before I take HICON?

How should I use HICON?

HICON is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.


What interacts with HICON?

Sorry No Records found


What are the warnings of HICON?

Sorry No Records found


What are the precautions of HICON?

Sorry No Records found


What are the side effects of HICON?

Sorry No records found


What should I look out for while using HICON?

HICON is contraindicated in:


What might happen if I take too much HICON?

In case of exposure to a radioactive dose of sodium iodide I 131 exceeding the intended therapeutic dose, provide general supportive care, promote frequent voiding, monitor for bone marrow and thyroid suppression. Consider administering a thyroid blocking agent (e.g. potassium iodide (KI) or perchlorate) promptly within 4 to 6 hours after the exposure. Assess the benefit of administering a thyroid blocking agent against the risk of failure of sodium iodide I 131 therapy. Appropriate replacement therapy is recommended if hypothyroidism occurs.


How should I store and handle HICON?

HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as2.5 mg/6.25 mgRound, convex, orange, film-coated tablets, plain on one side and debossed "" over "701" on the other side and supplied as:NDC 0185-0701-30 bottles of 30NDC 0185-0701-01 bottles of 100NDC 0185-0701-05 bottles of 5005 mg/6.25 mgRound, convex, red, film-coated tablets, plain on one side and debossed "" over "704" on the other side and supplied as:NDC 0185-0704-30 bottles of 30NDC 0185-0704-01 bottles of 100NDC 0185-0704-05 bottles of 50010 mg/6.25 mgRound, convex, white, film-coated tablets, plain on one side and debossed "" over "707" on the other side and supplied as:NDC 0185-0707-30 bottles of 30NDC 0185-0707-01 bottles of 100NDC 0185-0707-05 bottles of 500Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.KEEP TIGHTLY CLOSEDProtect from light and moisture.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Distributed bySandoz Inc.Princeton, NJ 08540OS7596Rev. April 2016MF0701REV04/16


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Iodide is actively transported by the sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells to levels up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I) which in turn iodinates tyrosine residues of thyroglobulin (tri or tetra-iodinated tyrosine). The beta emission of I 131 is responsible for the therapeutic effect.

Non-Clinical Toxicology
HICON is contraindicated in:

Bisoprolol fumarate and hydrochlorothiazide may potentiate the action of other antihypertensive agents used concomitantly. Bisoprolol fumarate and hydrochlorothiazide should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that bisoprolol fumarate and hydrochlorothiazide be discontinued for several days before the withdrawal of clonidine.

Bisoprolol fumarate and hydrochlorothiazide should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

The following serious adverse reactions are described below and elsewhere in labeling:

The following adverse reactions have been identified during post-approval use of sodium iodide I 131. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

* In patients with iodide-avid brain metastases** In patients with iodide-avid lung metastases

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).