Lopinavir-Ritonavir

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Overview

What is Lopinavir-Ritonavir?

Lopinavir and Ritonavir Oral Solution, USP is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.

Lopinavir is chemically designated as [1-[1*,(*), 3*, 4*]]--[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2)-pyrimidineacetamide. Its molecular formula is CHNO, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:

Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5-(5*,8*,10*,11*)]. Its molecular formula is CHNOS, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:

Lopinavir and ritonavir oral solution is available for oral administration as 80 mg lopinavir and 20 mg ritonavir per milliliter with the following inactive ingredients: bubble gum flavor, ethanol, glycerin, high fructose corn syrup, malic acid, polyoxyl 40 hydrogenated castor oil, povidone, sodium hydroxide, sucralose, and water.

Lopinavir and ritonavir oral solution contains approximately 42% (v/v) ethanol and approximately 15% (w/v) propylene glycol.

What does Lopinavir-Ritonavir look like?

What are the available doses of Lopinavir-Ritonavir?

What should I talk to my health care provider before I take Lopinavir-Ritonavir?

Lactation: Breastfeeding not recommended. ()

How should I use Lopinavir-Ritonavir?

Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older.

Limitations of Use:

Lopinavir and ritonavir oral solution must be taken with food.

What interacts with Lopinavir-Ritonavir?

Sorry No Records found

What are the warnings of Lopinavir-Ritonavir?

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What are the precautions of Lopinavir-Ritonavir?

Sorry No Records found

What are the side effects of Lopinavir-Ritonavir?

Sorry No records found

What should I look out for while using Lopinavir-Ritonavir?

Table 13

Table 13

Table 13

What might happen if I take too much Lopinavir-Ritonavir?

Overdoses with lopinavir and ritonavir oral solution have been reported. One of these reports described fatal cardiogenic shock in a 2.1 kg infant who received a single dose of 6.5 mL of lopinavir and ritonavir oral solution (520 mg lopinavir, approximately 10-fold above the recommended lopinavir dose) nine days prior. The following events have been reported in association with unintended overdoses in preterm neonates: complete AV block, cardiomyopathy, lactic acidosis, and acute renal failure . Healthcare professionals should be aware that lopinavir and ritonavir oral solution is highly concentrated and therefore, should pay special attention to accurate calculation of the dose of lopinavir and ritonavir, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors and overdose. This is especially important for infants and young children.

Lopinavir and ritonavir oral solution contains approximately 42% (v/v) ethanol and approximately 15% (w/v) propylene glycol. Ingestion of the product over the recommended dose by an infant or a young child could result in significant toxicity and could potentially be lethal.

Human experience of acute overdosage with lopinavir and ritonavir is limited. Treatment of overdose with lopinavir and ritonavir should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with lopinavir and ritonavir. If indicated, elimination of unabsorbed drug should be achieved by gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since lopinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the drug. However, dialysis can remove both ethanol and propylene glycol in the case of overdose with lopinavir and ritonavir oral solution.

How should I store and handle Lopinavir-Ritonavir?

Store gabapentin capsules and tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Lopinavir and Ritonavir Oral Solution USP is a colorless to yellow colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL) packaged with a marked syringe and bottle adapter in the following size: 160 mL bottle …………………………………NDC 0527-1947-48Recommended Storage: Store lopinavir and ritonavir oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use: refrigerated lopinavir and ritonavir oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.Lopinavir and Ritonavir Oral Solution USP is a colorless to yellow colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL) packaged with a marked syringe and bottle adapter in the following size: 160 mL bottle …………………………………NDC 0527-1947-48Recommended Storage: Store lopinavir and ritonavir oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use: refrigerated lopinavir and ritonavir oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.Lopinavir and Ritonavir Oral Solution USP is a colorless to yellow colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL) packaged with a marked syringe and bottle adapter in the following size: 160 mL bottle …………………………………NDC 0527-1947-48Recommended Storage: Store lopinavir and ritonavir oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use: refrigerated lopinavir and ritonavir oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.Lopinavir and Ritonavir Oral Solution USP is a colorless to yellow colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL) packaged with a marked syringe and bottle adapter in the following size: 160 mL bottle …………………………………NDC 0527-1947-48Recommended Storage: Store lopinavir and ritonavir oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use: refrigerated lopinavir and ritonavir oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Lopinavir and ritonavir is a fixed-dose combination of HIV-1 antiviral drugs lopinavir and ritonavir. As co-formulated in lopinavir and ritonavir, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.

Non-Clinical Toxicology

Table 13

Table 13

Table 13

Drug interactions:

Initiation of lopinavir and ritonavir, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving lopinavir and ritonavir, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of lopinavir and ritonavir, respectively. These interactions may lead to:

See Table 13 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations . Consider the potential for drug interactions prior to and during lopinavir and ritonavir therapy; review concomitant medications during lopinavir and ritonavir therapy, and monitor for the adverse reactions associated with the concomitant medications and .

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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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

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