Diclofenac Potassium for Oral Solution

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Overview

What is Diclofenac Potassium for Oral Solution?

Diclofenac Potassium for Oral Solution is a benzeneacetic acid derivative NSAID. Diclofenac Potassium for Oral Solution is available as a flavored soluble powder, designed to be mixed with water prior to oral administration.

Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose

The chemical name for diclofenac potassium is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight of diclofenac potassium is 334.25. Its molecular formula is CHClNKO, and it has the following structural formula:

The inactive ingredients in Diclofenac Potassium for Oral Solution include: Aspartame (equivalent to 22.45 mg phenylalanine), peppermint flavor, glyceryl behenate, mannitol, polacralin potassium, and saccharin sodium.

What does Diclofenac Potassium for Oral Solution look like?

What are the available doses of Diclofenac Potassium for Oral Solution?

Packets: Each containing white to off-white, flavoured powder of diclofenac potassium 50 mg in a soluble powder (3)

What should I talk to my health care provider before I take Diclofenac Potassium for Oral Solution?

How should I use Diclofenac Potassium for Oral Solution?

Diclofenac Potassium for Oral Solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).

Administer one packet (50 mg) of Diclofenac Potassium for Oral Solution for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 mL) of water mix well and drink immediately. Do not use liquids other than water.

Taking Diclofenac Potassium for Oral Solution with food may cause a reduction in effectiveness compared to taking Diclofenac Potassium for Oral Solution on an empty stomach

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The safety and effectiveness of a second dose have not been established.

What interacts with Diclofenac Potassium for Oral Solution?

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What are the warnings of Diclofenac Potassium for Oral Solution?

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What are the precautions of Diclofenac Potassium for Oral Solution?

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What are the side effects of Diclofenac Potassium for Oral Solution?

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What should I look out for while using Diclofenac Potassium for Oral Solution?

Diclofenac Potassium for Oral Solution is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to diclofenac

Diclofenac Potassium for Oral Solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients

Diclofenac Potassium for Oral Solution is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

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Gastrointestinal Risk

NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events Warnings and Precautions (5.2)

What might happen if I take too much Diclofenac Potassium for Oral Solution?

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

How should I store and handle Diclofenac Potassium for Oral Solution?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Diclofenac Potassium for Oral Solution, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets.Individual Diclofenac Potassium for Oral Solution Packet - NDC 49884-905-52Boxes of three (3) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-24 Boxes of nine (9) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-64 Store at 25°C (77°F) Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Diclofenac Potassium for Oral Solution, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets.Individual Diclofenac Potassium for Oral Solution Packet - NDC 49884-905-52Boxes of three (3) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-24 Boxes of nine (9) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-64 Store at 25°C (77°F) Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Diclofenac Potassium for Oral Solution, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets.Individual Diclofenac Potassium for Oral Solution Packet - NDC 49884-905-52Boxes of three (3) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-24 Boxes of nine (9) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-64 Store at 25°C (77°F) Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Diclofenac Potassium for Oral Solution, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets.Individual Diclofenac Potassium for Oral Solution Packet - NDC 49884-905-52Boxes of three (3) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-24 Boxes of nine (9) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-64 Store at 25°C (77°F) Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Diclofenac Potassium for Oral Solution, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets.Individual Diclofenac Potassium for Oral Solution Packet - NDC 49884-905-52Boxes of three (3) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-24 Boxes of nine (9) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-64 Store at 25°C (77°F) Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Diclofenac Potassium for Oral Solution, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac Potassium for Oral Solution is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets.Individual Diclofenac Potassium for Oral Solution Packet - NDC 49884-905-52Boxes of three (3) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-24 Boxes of nine (9) Diclofenac Potassium for Oral Solution Packets - NDC 49884-905-64 Store at 25°C (77°F) Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Diclofenac Potassium for Oral Solution is a non-steroidal anti-inflammatory drug (NSAID). The mechanism of action of Diclofenac Potassium for Oral Solution, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Non-Clinical Toxicology

Diclofenac Potassium for Oral Solution is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to diclofenac

Diclofenac Potassium for Oral Solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients

Diclofenac Potassium for Oral Solution is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

·

·

Gastrointestinal Risk

NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events Warnings and Precautions (5.2)

ACE-inhibitors:Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin:When nabumetone is administered with aspirin, its protein binding is reduced, although the clearance of free nabumetone is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of nabumetone and aspirin is not generally recommended because of the potential of increased adverse effects.

Diuretics: Clinical studies, as well as post marketing observations, have shown that nabumetone can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.

LithiumNSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Methotrexate:NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

In vitro studies have shown that, because of its affinity for protein, 6MNA may displace other protein-bound drugs from their binding site. Caution should be exercised when administering nabumetone with warfarin since interactions have been seen with other NSAIDs.

Concomitant administration of an aluminum-containing antacid had no significant effect on the bioavailability of 6MNA. When administered with food or milk, there is more rapid absorption; however, the total amount of 6MNA in the plasma is unchanged (see ).

Array

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years’ duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Inform patients about the signs and symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID increases the risk of serious GI events

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following coronary artery bypass graft (CABG) surgery found an increased incidence of myocardial infarction and stroke

The following serious adverse reactions are discussed elsewhere in the labeling:

The most common adverse reactions reported with Diclofenac Potassium for Oral Solution are nausea and dizziness.

The most common adverse events resulting in discontinuation of patients following Diclofenac Potassium for Oral Solution dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).

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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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