Diclofenac Sodium Delayed Release 75 mg/1

Diclofenac Sodium · TABLET, DELAYED RELEASE · Carlsbad Technology, Inc.

No Recall History

Plain English

Diclofenac Sodium Delayed Release is a tablet, delayed release containing diclofenac sodium at 75 mg/1, taken oral. Manufactured by Carlsbad Technology, Inc..

Key Facts

Brand Name: Diclofenac Sodium Delayed Release
Generic Name: Diclofenac Sodium
NDC Code (Product): 61442-103
Manufacturer: Carlsbad Technology, Inc.
Strength: 75 mg/1
Dosage Form: TABLET, DELAYED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA075185
Marketing Start: 11/13/1998

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective7,501 reports

pain7,262 reports

fatigue6,863 reports

rheumatoid arthritis6,257 reports

rash5,933 reports

abdominal discomfort5,905 reports

systemic lupus erythematosus5,737 reports

alopecia5,681 reports

pemphigus5,566 reports

glossodynia5,565 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac is indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Dosage & Administration

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ) . After observing the response to initial therapy with diclofenac, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day). For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day.). For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary.

Warnings

WARNINGS Cardiovascular Thromboic Events 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, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CVdisease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, t…

Contraindications

CONTRAINDICATIONS Diclofenac sodium delayed-release tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product ( see WARNINGS; Anaphylactic Reactions , Serious Skin Reactions ). History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients ( see WARNINGS; Anaphylactic Reaction , Exacerbation of Asthma Related to Aspirin Sensitivity ). In the setting of coronary artery bypass graft (CABG) surgery ( see Warnings; Cardiovascular Thrombotic Events ).

Drug Interactions

Drug Interactions See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding ( see PRECAUTIONS ; Hematological Toxicity ). Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than t…

Adverse Reactions

ADVERSE REACTIONS SECTION The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS ) GI Bleeding, Ulceration and Perforation (see WARNINGS ) Hepatotoxicity (see WARNINGS ) Hypertension (see WARNINGS ) Heart Failure and Edema (see WARNINGS ) Renal Toxicity and Hyperkalemia (see WARNINGS ) Anaphylactic Reactions (see WARNINGS ) Serious Skin Reactions (see WARNINGS ) Hematologic Toxicity (see WARNINGS ) 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%-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, …

Frequently Asked Questions

What is Diclofenac Sodium Delayed Release used for?

Diclofenac Sodium Delayed Release contains Diclofenac Sodium. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Diclofenac Sodium Delayed Release a controlled substance?

Diclofenac Sodium Delayed Release is not classified as a controlled substance by the DEA.

What is the generic name for Diclofenac Sodium Delayed Release?

The generic name for Diclofenac Sodium Delayed Release is Diclofenac Sodium. There are 12 other brand versions of Diclofenac Sodium.

What is the NDC code for Diclofenac Sodium Delayed Release 75 mg/1?

The NDC (National Drug Code) for Diclofenac Sodium Delayed Release 75 mg/1 is 61442-103, listed by Carlsbad Technology, Inc..

Product NDC

61442-103

Package NDC

61442-103-01

Other Diclofenac Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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