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ZIPSOR
Overview
What is ZIPSOR?
ZIPSOR (diclofenac potassium) Liquid Filled Capsule is a nonsteroidal anti-inflammatory drug, available as liquid-filled capsules of 25 mg for oral administration. Diclofenac potassium is a white to slight yellowish crystalline powder. It is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6- dichlorophenyl) amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.24. Its molecular formula is CHClNKO, and it has the following chemical structure.
The inactive ingredients in ZIPSOR include: ProSorb (a proprietary combination of polyethylene glycol 400, glycerin, sorbitol, povidone, polysorbate 80, and hydrochloric acid), isopropyl alcohol, and mineral oil. The capsule shells contain gelatin, sorbitol, isopropyl alcohol, glycerin, and mineral oil.
What does ZIPSOR look like?
What are the available doses of ZIPSOR?
ZIPSOR (diclofenac potassium) Liquid Filled Capsule: 25 mg ()
What should I talk to my health care provider before I take ZIPSOR?
Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation
How should I use ZIPSOR?
ZIPSOR is indicated for relief of mild to moderate acute pain in adults
(18 years of age or older).
Carefully consider the potential benefits and risks of ZIPSOR and other treatment options before deciding to use ZIPSOR. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [].
For treatment of mild to moderate acute pain, the dosage is 25 mg four times a day.
What interacts with ZIPSOR?
Sorry No Records found
What are the warnings of ZIPSOR?
Sorry No Records found
What are the precautions of ZIPSOR?
Sorry No Records found
What are the side effects of ZIPSOR?
Sorry No records found
What should I look out for while using ZIPSOR?
ZIPSOR is contraindicated in the following patients:
Cardiovascular Thrombotic Events
Gastrointestinal Risk Bleeding, Ulceration, and Perforation
What might happen if I take too much ZIPSOR?
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 overdosage (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 ZIPSOR?
VORICONAZOLE Tablets should be stored at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. ZIPSOR (diclofenac potassium) 25 mg, are translucent, pale yellow, liquid-filled capsules printed with “X592” in black ink supplied as: Bottles of 100 Capsules NDC# 13913-008-11. Bottles of 120 Capsules NDC# 13913-008-12.StorageStore at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from moistureDispense in tight container (USP).ZIPSOR (diclofenac potassium) 25 mg, are translucent, pale yellow, liquid-filled capsules printed with “X592” in black ink supplied as: Bottles of 100 Capsules NDC# 13913-008-11. Bottles of 120 Capsules NDC# 13913-008-12.StorageStore at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from moistureDispense in tight container (USP).ZIPSOR (diclofenac potassium) 25 mg, are translucent, pale yellow, liquid-filled capsules printed with “X592” in black ink supplied as: Bottles of 100 Capsules NDC# 13913-008-11. Bottles of 120 Capsules NDC# 13913-008-12.StorageStore at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from moistureDispense in tight container (USP).ZIPSOR (diclofenac potassium) 25 mg, are translucent, pale yellow, liquid-filled capsules printed with “X592” in black ink supplied as: Bottles of 100 Capsules NDC# 13913-008-11. Bottles of 120 Capsules NDC# 13913-008-12.StorageStore at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from moistureDispense in tight container (USP).ZIPSOR (diclofenac potassium) 25 mg, are translucent, pale yellow, liquid-filled capsules printed with “X592” in black ink supplied as: Bottles of 100 Capsules NDC# 13913-008-11. Bottles of 120 Capsules NDC# 13913-008-12.StorageStore at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from moistureDispense in tight container (USP).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of ZIPSOR, 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 in vitro. Diclofenac concentrations reached during therapy have produced in vivo 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
ZIPSOR is contraindicated in the following patients:Cardiovascular Thrombotic Events
Gastrointestinal Risk Bleeding, Ulceration, and Perforation
Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of sucralfate to alter the absorption of some drugs, sucralfate should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
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 CV disease. 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, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the 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, such as diclofenac, increases the risk of serious gastrointestinal (GI) events [].
Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [].
Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of ZIPSOR in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ZIPSOR is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
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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