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Diclofenac Sodium, Methyl Salicylate/Menthol/Capsaicin

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Overview

What is NuDroxiPAK DSDR-50?

Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium, USP is a white to almost white crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C H Cl NNaO , and it has the following structural formula

Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.



What does NuDroxiPAK DSDR-50 look like?



What are the available doses of NuDroxiPAK DSDR-50?

Sorry No records found.

What should I talk to my health care provider before I take NuDroxiPAK DSDR-50?

Sorry No records found

How should I use NuDroxiPAK DSDR-50?

Shake before each use. Prior to first use rub small amount to check for sensitivity. Apply product directly to affected area. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Product may be used as necessary, but should not be used more than four times per day.

STORE BELOW (90°F/32°C)


What interacts with NuDroxiPAK DSDR-50?

Sorry No Records found


What are the warnings of NuDroxiPAK DSDR-50?

Sorry No Records found


What are the precautions of NuDroxiPAK DSDR-50?

Sorry No Records found


What are the side effects of NuDroxiPAK DSDR-50?

Sorry No records found


What should I look out for while using NuDroxiPAK DSDR-50?

Diclofenac sodium delayed-release tablets are contraindicated in the following patients:

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes or genitals. Do not cover or tightly bandage area. on wounds or damaged skin. Do not use with heating pad.


What might happen if I take too much NuDroxiPAK DSDR-50?

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare .

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).


How should I store and handle NuDroxiPAK DSDR-50?

Storage and HandlingSIMPONI must be refrigerated at 2 °C to 8 °C (36 °F to 46 °F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector.Storage and HandlingSIMPONI must be refrigerated at 2 °C to 8 °C (36 °F to 46 °F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector.Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2550-06). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184Revised — October 2017


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of diclofenac sodium delayed-release, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Diclofenac is a potent inhibitor of prostaglandin synthesis . Diclofenac concentrations reached during therapy have produced effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Non-Clinical Toxicology
Diclofenac sodium delayed-release tablets are contraindicated in the following patients:

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes or genitals. Do not cover or tightly bandage area. on wounds or damaged skin. Do not use with heating pad.

See Table 2 for clinically significant drug interactions with diclofenac.

Diclofenac sodium delayed-release tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

The pharmacological activity of diclofenac sodium delayed-release in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.

Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Additional adverse experiences reported occasionally include:

Body as a Whole:

Cardiovascular System:

Digestive System:

Hemic and Lymphatic System:

Metabolic and Nutritional:

Nervous System:

Respiratory System:

Skin and Appendages:

Special Senses:

Urogenital System:

Other adverse reactions, which occur rarely are:

Body as a Whole:

Cardiovascular System:

Digestive System:

Hemic and Lymphatic System:

Metabolic and Nutritional:

Nervous System:

Respiratory System:

Skin and Appendages:

Special Senses:

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

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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

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