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COLYTE
Overview
What is COLYTE?
DESCRIPTION:
When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is isosmotic and has a mild salty taste. This preparation can be used without the flavor packs and is administered orally or via nasogastric tube.
Each lemon lime flavor pack (3.22 g) contains hypromellose, natural and artificial lemon lime powder, Prosweet Powder Natural, saccharin sodium, colloidal silicon dioxide. Each cherry flavor pack (3.22 g) contains hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide.
What does COLYTE look like?
What are the available doses of COLYTE?
Sorry No records found.
What should I talk to my health care provider before I take COLYTE?
Sorry No records found
How should I use COLYTE?
INDICATIONS AND USAGE:
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DOSAGE AND ADMINISTRATION:
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What interacts with COLYTE?
Sorry No Records found
What are the warnings of COLYTE?
Sorry No Records found
What are the precautions of COLYTE?
Sorry No Records found
What are the side effects of COLYTE?
Sorry No records found
What should I look out for while using COLYTE?
Colyte is contraindicated in the following conditions:
WARNINGS:
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What might happen if I take too much COLYTE?
Sorry No Records found
How should I store and handle COLYTE?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight, light-resistant containers (USP).Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight, light-resistant containers (USP).HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc. HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc. HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc. HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc. HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc. HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc. HOW SUPPLIED: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.Rx OnlyCL-682004-01 Rev. 2/2014Manufactured for: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 ©2014 Meda Pharmaceuticals Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLINICAL PHARMACOLOGY:
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Non-Clinical Toxicology
Colyte is contraindicated in the following conditions:WARNINGS:
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Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors and angiotensin II antagonists. These interactions should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors or angiotensin II antagonists. In some patients with compromised renal function, the co-administration of an NSAID and an ACE-inhibitor or an angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Acetaminophen had no effect on the plasma levels of sulindac or its sulfide metabolite.
The concomitant administration of aspirin with sulindac significantly depressed the plasma levels of the active sulfide metabolite. A double-blind study compared the safety and efficacy of sulindac 300 or 400 mg daily given alone or with aspirin 2.4 g/day for the treatment of osteoarthritis. The addition of aspirin did not alter the types of clinical or laboratory adverse experiences for sulindac; however, the combination showed an increase in the incidence of gastrointestinal adverse experiences. Since the addition of aspirin did not have a favorable effect on the therapeutic response to sulindac, the combination is not recommended.
Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. NSAIDs should be used with caution in patients taking cyclosporine, and renal function should be carefully monitored.
The concomitant administration of sulindac and diflunisal in normal volunteers resulted in lowering of the plasma levels of the active sulindac sulfide metabolite by approximately one-third.
Clinical studies, as well as post marketing observations, have shown that sulindac can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.
DMSO should not be used with sulindac. Concomitant administration has been reported to reduce the plasma levels of the active sulfide metabolite and potentially reduce efficacy. In addition, this combination has been reported to cause peripheral neuropathy.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
The concomitant use of sulindac with other NSAIDs is not recommended due to the increased possibility of gastrointestinal toxicity, with little or no increase in efficacy.
Although sulindac and its sulfide metabolite are highly bound to protein, studies in which sulindac was given at a dose of 400 mg daily have shown no clinically significant interaction with oral anticoagulants. However, patients should be monitored carefully until it is certain that no change in their anticoagulant dosage is required. Special attention should be paid to patients taking higher doses than those recommended and to patients with renal impairment or other metabolic defects that might increase sulindac blood levels. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Although sulindac and its sulfide metabolite are highly bound to protein, studies in which sulindac was given at a dose of 400 mg daily, have shown no clinically significant interaction with oral hypoglycemic agents. However, patients should be monitored carefully until it is certain that no change in their hypoglycemic dosage is required. Special attention should be paid to patients taking higher doses than those recommended and to patients with renal impairment or other metabolic defects that might increase sulindac blood levels.
Probenecid given concomitantly with sulindac had only a slight effect on plasma sulfide levels, while plasma levels of sulindac and sulfone were increased. Sulindac was shown to produce a modest reduction in the uricosuric action of probenecid, which probably is not significant under most circumstances.
Propoxyphene hydrochloride had no effect on the plasma levels of sulindac or its sulfide metabolite.
General:
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ADVERSE REACTIONS:
Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of Colyte. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.
To report Suspected Adverse Reactions contact Meda Pharmaceuticals Inc. at toll free 1-866-210-5953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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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