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Cambia
Overview
What is Cambia?
CAMBIA (diclofenac potassium) for oral solution is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets.
The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is CHClNKO, and it has the following structure.
The inactive ingredients in CAMBIA include: flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and sucralose.
What does Cambia look like?
What are the available doses of Cambia?
Packets: Each containing buffered diclofenac potassium 50 mg in a soluble powder ()
What should I talk to my health care provider before I take Cambia?
How should I use Cambia?
CAMBIA is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
Limitations of Use:
Administer one packet (50 mg) of CAMBIA for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of water, mix well and drink immediately.
Do not use liquids other than water.
Taking CAMBIA with food may cause a reduction in effectiveness compared to taking CAMBIA 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 Cambia?
Sorry No Records found
What are the warnings of Cambia?
Sorry No Records found
What are the precautions of Cambia?
Sorry No Records found
What are the side effects of Cambia?
Sorry No records found
What should I look out for while using Cambia?
CAMBIA is contraindicated in the following patients:
Cardiovascular Thrombotic Events
Gastrointestinal Bleeding, Ulceration, and Perforation
What might happen if I take too much Cambia?
Symptoms following acute NSAID overdoses 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).
Anaphylactic reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
How should I store and handle Cambia?
XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.CAMBIA (diclofenac potassium) 50 mg, is a white to off-white, buffered, flavored powder for oral solution, supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water.NDC 13913-012-01 Individual CAMBIA PacketsNDC 13913-012-03 Boxes of nine (9) CAMBIA PacketsStorageCAMBIA (diclofenac potassium) 50 mg, is a white to off-white, buffered, flavored powder for oral solution, supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water.NDC 13913-012-01 Individual CAMBIA PacketsNDC 13913-012-03 Boxes of nine (9) CAMBIA PacketsStorageCAMBIA (diclofenac potassium) 50 mg, is a white to off-white, buffered, flavored powder for oral solution, supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water.NDC 13913-012-01 Individual CAMBIA PacketsNDC 13913-012-03 Boxes of nine (9) CAMBIA PacketsStorageCAMBIA (diclofenac potassium) 50 mg, is a white to off-white, buffered, flavored powder for oral solution, supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water.NDC 13913-012-01 Individual CAMBIA PacketsNDC 13913-012-03 Boxes of nine (9) CAMBIA PacketsStorage
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CAMBIA has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of CAMBIA, 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
CAMBIA is contraindicated in the following patients:Cardiovascular Thrombotic Events
Gastrointestinal Bleeding, Ulceration, and Perforation
As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).
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 CAMBIA in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If CAMBIA is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
The following serious 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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