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Tivorbex

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Overview

What is Tivorbex?

TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is CHClNO, and it has the following chemical structure.

Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol.  Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali.

The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink. 



What does Tivorbex look like?



What are the available doses of Tivorbex?

TIVORBEX (indomethacin) Capsules: 20 mg and 40 mg ()

What should I talk to my health care provider before I take Tivorbex?

Pregnancy

Infertility

 

How should I use Tivorbex?

TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.

Carefully consider the potential benefits and risks of TIVORBEX and other treatment options before deciding to use TIVORBEX. 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 20 mg three times daily or 40 mg two or three times daily. 


What interacts with Tivorbex?

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What are the warnings of Tivorbex?

Sorry No Records found


What are the precautions of Tivorbex?

Sorry No Records found


What are the side effects of Tivorbex?

Sorry No records found


What should I look out for while using Tivorbex?

TIVORBEX is contraindicated in the following patients: 

Cardiovascular

Thrombotic Events

 

Gastrointestinal

Bleeding, Ulceration, and Perforation


What might happen if I take too much Tivorbex?

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 Tivorbex?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TIVORBEX (indomethacin) are supplied as: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].Store in the original container and keep the bottle tightly closed to protect from moisture and light.  Dispense in a tight container if package is subdivided.TIVORBEX (indomethacin) are supplied as: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].Store in the original container and keep the bottle tightly closed to protect from moisture and light.  Dispense in a tight container if package is subdivided.TIVORBEX (indomethacin) are supplied as: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].Store in the original container and keep the bottle tightly closed to protect from moisture and light.  Dispense in a tight container if package is subdivided.TIVORBEX (indomethacin) are supplied as: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].Store in the original container and keep the bottle tightly closed to protect from moisture and light.  Dispense in a tight container if package is subdivided.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Indomethacin has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of TIVORBEX, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Indomethacin is a potent inhibitor of prostaglandin synthesis in vitro. Indomethacin 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 indomethacin is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Non-Clinical Toxicology
TIVORBEX is contraindicated in the following patients: 

Cardiovascular

Thrombotic Events

 

Gastrointestinal

Bleeding, Ulceration, and Perforation

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 indomethacin, increases the risk of serious gastrointestinal (GI) events [ ]. 

Status

P

ost

C

oronary

A

rtery

B

ypass

G

raft (CABG)

S

urgery

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

P

atients

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 TIVORBEX in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If TIVORBEX 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:

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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