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DICLOFENAC SODIUM
Overview
What is PrevidolRx Analgesic Pak?
The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:
Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
What does PrevidolRx Analgesic Pak look like?
What are the available doses of PrevidolRx Analgesic Pak?
Omeprazole delayed-release capsules, USP 10 mg are hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink.
What should I talk to my health care provider before I take PrevidolRx Analgesic Pak?
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
8.8 Asian Population
How should I use PrevidolRx Analgesic Pak?
for persons under 18 years of age, ask a doctor before using
apply a thin film of cream to the affected area and gently rub in until fully absorbed
for optimum relief, apply 3 to 4 times daily
for best results typically occur after 2 to 4 weeks of continuous use unless treating hands, wash hands thoroughly with soap and water immediately after use
if applying cream to hands, wait 30 minutes before washing hands
What interacts with PrevidolRx Analgesic Pak?
Known Hypersensitivity to any component of the formulation or substituted benzimidazoles (angioedema and anaphylaxis have occured) 4)
What are the warnings of PrevidolRx Analgesic Pak?
Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE .
Cardiovascular EffectsCardiovascular Thrombotic Events
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
What are the precautions of PrevidolRx Analgesic Pak?
GeneralDiclofenac 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.
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Cyclosporine: Diclofenac Sodium Delayed-release Tablets, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Diclofenac Sodium Delayed-release Tablets may increase cyclosporine’s nephrotoxicity. Caution should be used when Diclofenac Sodium Delayed-release Tablets are administered concomitantly with cyclosporine.
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What are the side effects of PrevidolRx Analgesic Pak?
Adults: Most common adverse reactions in adults (incidence ? 2%) are
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What should I look out for while using PrevidolRx Analgesic Pak?
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].
For external use only
Do not apply to wounds or to damaged or irritated skin.
What might happen if I take too much PrevidolRx Analgesic Pak?
Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [see Adverse Reactions (6)]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
How should I store and handle PrevidolRx Analgesic Pak?
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published . There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12.1 Mechanism of Action
12.2 Pharmacodynamics
Single daily oral doses of omeprazole ranging from a dose of 10 mg to 40 mg have produced 100% inhibition of 24-hour intragastric acidity in some patients.
12.3 Pharmacokinetics
Omeprazole delayed-release capsules contain an enteric-coated granule formulation of omeprazole (because omeprazole is acid-labile), so that absorption of omeprazole begins only after the granules leave the stomach. Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg.
The bioavailability of omeprazole increases slightly upon repeated administration of omeprazole delayed-release capsules.
Table 2 Clarithromycin Tissue Concentrations 2 hours after Dose1
1Mean ± SD (mcg/g)
Concomitant Use with Clopidogrel
Geriatric Population
Note: * = plasma concentration adjusted to an oral dose of 1 mg/kg.
12.4 Microbiology
a Includes only patients with pretreatment clarithromycin susceptibility test results
For susceptibility testing information about Helicobacter pylori, see Microbiology section in prescribing information for clarithromycin and amoxicillin.
Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile.
Non-Clinical Toxicology
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].For external use only
Do not apply to wounds or to damaged or irritated skin.
Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see under ) and anaphylactoid reactions (see ).
Concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymixin B, colistin, viomycin, or cisplatin, when indicated, requires careful monitoring.
GeneralDiclofenac 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.
Cyclosporine: Diclofenac Sodium Delayed-release Tablets, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Diclofenac Sodium Delayed-release Tablets may increase cyclosporine’s nephrotoxicity. Caution should be used when Diclofenac Sodium Delayed-release Tablets are administered concomitantly with cyclosporine.
6.1 Clinical Trials Experience with Omeprazole Monotherapy
6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication
6.3 Post-marketing Experience
Body As a WholeHypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise;
CardiovascularChest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema
Endocrine
Gynecomastia
GastrointestinalPancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
HepaticLiver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]Infections and InfestationsClostridium difficile associated diarrhea
Metabolism and Nutritional disorders
Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain
Musculoskeletal
Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture
Nervous System/Psychiatric
Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo
Respiratory
Epistaxis, pharyngeal pain
SkinSevere generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis
Special SensesTinnitus, taste perversion
Ocular
Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision
Urogenital
Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain
Hematologic
Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis
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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