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SIRTURO

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Overview

What is SIRTURO?

SIRTURO (bedaquiline) for oral administration is available as 100 mg strength tablets. Each tablet contains 120.89 mg of bedaquiline fumarate drug substance, which is equivalent to 100 mg of bedaquiline. Bedaquiline is a diarylquinoline antimycobacterial drug.

Bedaquiline fumarate is a white to almost white powder and is practically insoluble in aqueous media. The chemical name of bedaquiline fumarate is (1, 2)-1-(6-bromo-2-methoxy-3-quinolinyl)-4-(dimethylamino)-2-(1-naphthalenyl)-1-phenyl-2-butanol compound with fumaric acid (1:1). It has a molecular formula of CHBrNO∙CHO and a molecular weight of 671.58 (555.50 + 116.07). The molecular structure of bedaquiline fumarate is the following:

SIRTURO (bedaquiline) contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose 2910 15 mPa.s, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing).



What does SIRTURO look like?



What are the available doses of SIRTURO?

Tablets: 100 mg ()

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

How should I use SIRTURO?

SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by directly observed therapy (DOT).

This indication is approved under accelerated approval based on time to sputum culture conversion . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Emphasize need for compliance with full course of therapy ()

Prior to administration, obtain ECG, liver enzymes and electrolytes. Obtain susceptibility information for the background regimen against isolate if possible. ()

Only use SIRTURO in combination with at least 3 other drugs to which the patient's MDR-TB isolate has been shown to be susceptible . If testing results are unavailable, may initiate SIRTURO in combination with at least 4 other drugs to which patient's MDR-TB isolate is likely to be susceptible ()

Recommended dosage: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week (with at least 48 hours between doses) for 22 weeks ()

Swallow SIRTURO tablets whole with water and take with food. ()


What interacts with SIRTURO?

Sorry No Records found


What are the warnings of SIRTURO?

Sorry No Records found


What are the precautions of SIRTURO?

Sorry No Records found


What are the side effects of SIRTURO?

Sorry No records found


What should I look out for while using SIRTURO?

None.


What might happen if I take too much SIRTURO?

There is no experience with the treatment of acute overdose with SIRTURO. Take general measures to support basic vital functions including monitoring of vital signs and ECG (QT interval) in case of deliberate or accidental overdose. Removal of unabsorbed bedaquiline may be achieved by the administration of activated charcoal. Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.


How should I store and handle SIRTURO?

Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]VIGAMOX® solution is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.3 mL in a 4 mL bottle - NDC 0065-4013-03Storage: Store at 2°C-25°C (36°F-77°F).VIGAMOX® solution is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.3 mL in a 4 mL bottle - NDC 0065-4013-03Storage: Store at 2°C-25°C (36°F-77°F).VIGAMOX® solution is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.3 mL in a 4 mL bottle - NDC 0065-4013-03Storage: Store at 2°C-25°C (36°F-77°F).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Bedaquiline is a diarylquinoline antimycobacterial drug .

Non-Clinical Toxicology
None.

When given concurrently the following drugs may interact with thiazide diuretics.





































An increased risk of death was seen in the SIRTURO treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial (based on the 120-week visit window). One death occurred during the 24 weeks of administration of SIRTURO. The imbalance in deaths is unexplained. No discernible pattern between death and sputum culture conversion, relapse, sensitivity to other drugs used to treat tuberculosis, HIV status, or severity of disease could be observed. Only use SIRTURO when an effective treatment regimen cannot otherwise be provided .

The following serious adverse reactions are discussed elsewhere in 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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