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dolutegravir sodium and rilpivirine hydrochloride
Overview
What is Juluca?
JULUCA is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an INSTI, and rilpivirine (as rilpivirine hydrochloride), an NNRTI.
The chemical name of dolutegravir sodium is sodium (4,12a)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2-pyrido[1',2':4,5]pyrazino[2,1-][1,3]oxazin-7-olate. The empirical formula is CHFNNaO and the molecular weight is 441.36 g per mol. It has the following structural formula:
Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water.
The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is CHN • HCl and its molecular weight is 402.88g per mol. Rilpivirine hydrochloride has the following structural formula:
Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.
JULUCA tablets are for oral administration. Each film-coated tablet contains the active ingredients 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride) and the inactive ingredients croscarmellose sodium, D-mannitol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K29/32 and K30, silicified microcrystalline cellulose, sodium starch glycolate, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.
What does Juluca look like?
What are the available doses of Juluca?
Each tablet contains: 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride). ()
What should I talk to my health care provider before I take Juluca?
How should I use Juluca?
JULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.
The recommended dosage of JULUCA is one tablet taken orally once daily with a meal . One tablet of JULUCA contains 50 mg of dolutegravir and 25 mg of rilpivirine.
What interacts with Juluca?
Sorry No Records found
What are the warnings of Juluca?
Sorry No Records found
What are the precautions of Juluca?
Sorry No Records found
What are the side effects of Juluca?
Sorry No records found
What should I look out for while using Juluca?
JULUCA is contraindicated in patients:
What might happen if I take too much Juluca?
There is no known specific treatment for overdose with JULUCA. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required, including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. Administration of activated charcoal may be used to aid in removal of unabsorbed active substance. As both dolutegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that either would be significantly removed by dialysis.
How should I store and handle Juluca?
Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side.Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13.Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side.Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13.Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side.Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13.Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side.Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13.Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].