SODIUM IODIDE I 131

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Overview

What is SODIUM IODIDE I 131?

Sodium Iodide I 131 (Na I-131) Capsules Therapeutic is supplied for oral administration in opaque white gelatin capsules. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. Sodium iodide I-131 capsules are packaged in shielded, plastic vials containing one capsule per vial.

Sodium Iodide I 131 Capsules are prepared by absorbing a solution of carrier-free sodium iodide I-131 that may contain sodium bisulfite into inert filler. The iodine-131 utilized in the preparation of the capsules contains not less than 99% iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label.

What does SODIUM IODIDE I 131 look like?

What are the available doses of SODIUM IODIDE I 131?

Capsules: available in 15 strengths from 0.75 mCi to 100 mCi at the time of calibration. See full prescribing information for details. ()

What should I talk to my health care provider before I take SODIUM IODIDE I 131?

How should I use SODIUM IODIDE I 131?

Sodium Iodide I 131 Capsules Therapeutic is indicated for the treatment of hyperthyroidism and thyroid carcinomas that take up iodide. Palliative effects may be observed in patients with advanced thyroid malignancy if the metastatic lesions take up iodide.

Sodium Iodide I 131 Capsules emit radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions ()].

What interacts with SODIUM IODIDE I 131?

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What are the warnings of SODIUM IODIDE I 131?

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What are the precautions of SODIUM IODIDE I 131?

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What are the side effects of SODIUM IODIDE I 131?

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What should I look out for while using SODIUM IODIDE I 131?

Sodium Iodide I 131 Capsules Therapeutic is contraindicated in:

What might happen if I take too much SODIUM IODIDE I 131?

In case of exposure to a radioactive dose of sodium iodide I-131 exceeding the intended therapeutic dose provide general supportive care, monitor for bone marrow and thyroid suppression and consider administering a thyroid blocking agent such as potassium iodide (KI) or perchlorate promptly within 4 to 6 hours after the exposure. Thyroid blockade may reduce radiation exposure of thyroid tissue but would not prevent radiation injury to the rest of the body. Assess the benefit of administering a blocking agent against the risk of failure of sodium iodide I-131 therapy.

How should I store and handle SODIUM IODIDE I 131?

StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Taken orally, sodium iodide I-131 is rapidly absorbed and distributed within the extracellular fluid of the body. The iodide is concentrated in the thyroid via the sodium/iodide symporter, and subsequently oxidized to iodine. The destruction of thyroidal tissue is achieved by the beta emission of sodium iodide I-131.

Non-Clinical Toxicology

Sodium Iodide I 131 Capsules Therapeutic is contraindicated in:

Olmesartan medoxomil

No significant drug interactions were reported in studies in which olmesartan medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. The bioavailability of olmesartan was not significantly altered by the co-administration of antacids [Al(OH)/Mg(OH)]. 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 metabolized by those enzymes are not expected.

Dual Blockade of the Renin- Angiotensin System (RAS)

Do not co-administer aliskiren with Benicar HCT in patients with diabetes (see ). Avoid use of aliskiren with Benicar HCT in patients with renal impairment (GFR <60ml/min).

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.

Colesevelam hydrochloride

Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose (see ).

Lithium

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 BENICAR HCT and lithium.

Hydrochlorothiazide

When administered concurrently the following drugs may interact with thiazide diuretics:

Alcohol, Barbiturates, Or Narcotics

Antidiabetic Drugs (oral agents and insulin)

Other Antihypertensive Drugs

Cholestyramine and Colestipol Resins

Corticosteroids, ACTH

Pressor Amines (e.g. Norepinephrine)

Skeletal Muscle Relaxants, Non depolarizing (e.g. Tubocurarine)

Non-steroidal Anti-inflammatory Drugs

Sodium iodide I-131 may cause thyroiditis with gland enlargement and release of thyroid hormone, particularly when used to treat hyperthyroidism. The thyroiditis may cause or worsen hyperthyroidism, and may cause thyroid storm. When treating hyperthyroidism, consider pre-treatment with anti-thyroid medication to help deplete the thyroid hormone content within the gland. Discontinue the anti-thyroid medication at least three days before administration of sodium iodide I-131. Consider beta-blocker therapy before administration of sodium iodide I-131 to minimize the risk of hyperthyroidism and thyroid storm.

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

Radiation-related adverse reactions are a function of the dose level received by the patient.

The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of benign disease, such as hyperthyroidism:

The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of malignant disease:

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

Adverse reactions that occur after treatment of benign disease may also occur after treatment of malignant disease. Tenderness, pain on swallowing, sore throat, and cough have been reported, generally around the third day after sodium iodide I-131 administration.

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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

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).

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