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Ritonavir
Overview
What is Ritonavir?
Ritonavir is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV).
Ritonavir is chemically designated as 2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C
H
N
O
S
, and its molecular weight is 720.94. Ritonavir has the following structural formula:
Ritonavir USP is a white to almost white powder. It is freely soluble in methanol and in methylene chloride; very slightly soluble in acetonitrile; practically insoluble in water.
Ritonavir Tablets USP are available for oral administration containing 100 mg ritonavir USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, hypromellose, isopropyl alcohol, polysorbate 80, polyethylene glycol, purified water, sodium stearyl fumarate, sorbitan monolaurate and titanium dioxide.
What does Ritonavir look like?
What are the available doses of Ritonavir?
Ritonavir Tablets USP, 100 mg are a white-colored, oval shaped, shallow, film-coated tablet with "54" debossed on one side and "247" debossed on the other side.
What should I talk to my health care provider before I take Ritonavir?
When co-administering ritonavir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations.
How should I use Ritonavir?
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
General Dosing Guidelines:
[see Clinical Pharmacology (
)]
max
What interacts with Ritonavir?
Sorry No Records found
What are the warnings of Ritonavir?
Sorry No Records found
What are the precautions of Ritonavir?
Sorry No Records found
What are the side effects of Ritonavir?
Sorry No records found
What should I look out for while using Ritonavir?
Ritonavir is contraindicated in patients with known hypersensitivity to ritonavir (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome) or any of its ingredients. (
)
Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events. (
)
Co-administration with drugs that significantly reduce ritonavir. (
)
Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir
What might happen if I take too much Ritonavir?
Acute Overdosage - Human Overdose Experience:
Management of Overdosage:
Treatment of overdose with ritonavir consists 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 ritonavir. If indicated, elimination of unabsorbed drug should be achieved by gastric lavage; usual precautions should be observed to maintain the airway. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since ritonavir is extensively metabolized by the liver and 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 ritonavir oral solution. A Certified Poison Control Center should be consulted for up-to-date information on the management of overdose with ritonavir.
How should I store and handle Ritonavir?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Ritonavir Tablets USP100 mg tablet is supplied as a white-colored, oval shaped, shallow, film coated tablet with “54” debossed on one side and “247” debossed on the other sideRecommended StorageStore at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.FOR YOUR PROTECTION:Ritonavir Tablets USP100 mg tablet is supplied as a white-colored, oval shaped, shallow, film coated tablet with “54” debossed on one side and “247” debossed on the other sideRecommended StorageStore at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.FOR YOUR PROTECTION:Ritonavir Tablets USP100 mg tablet is supplied as a white-colored, oval shaped, shallow, film coated tablet with “54” debossed on one side and “247” debossed on the other sideRecommended StorageStore at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.FOR YOUR PROTECTION:Ritonavir Tablets USP100 mg tablet is supplied as a white-colored, oval shaped, shallow, film coated tablet with “54” debossed on one side and “247” debossed on the other sideRecommended StorageStore at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.FOR YOUR PROTECTION:Ritonavir Tablets USP100 mg tablet is supplied as a white-colored, oval shaped, shallow, film coated tablet with “54” debossed on one side and “247” debossed on the other sideRecommended StorageStore at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.FOR YOUR PROTECTION:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ritonavir is an antiretroviral drug
Non-Clinical Toxicology
Ritonavir is contraindicated in patients with known hypersensitivity to ritonavir (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome) or any of its ingredients. ( )Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events. ( )
Co-administration with drugs that significantly reduce ritonavir. ( )
Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
Initiation of ritonavir, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving ritonavir, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of ritonavir, respectively. These interactions may lead to:
When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including important Warnings and Precautions.
See Table 5 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 ritonavir therapy; review concomitant medications during ritonavir therapy, and monitor for the adverse reactions associated with the concomitant medications .
The following adverse reactions are discussed in greater detail in other sections of the labeling.
When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions.
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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