Ritonavir film coated 100 mg/1
ritonavir 100 mg · TABLET · Cipla USA Inc.
Ritonavir film coated is a tablet containing ritonavir 100 mg at 100 mg/1, taken oral. Manufactured by Cipla USA Inc..
Key Facts
- Brand Name
- Ritonavir film coated
- Generic Name
- ritonavir 100 mg
- NDC Code (Product)
69097-655- Manufacturer
- Cipla USA Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202573
- Drug Class
- Cytochrome P450 3A Inhibitor [EPC]; Protease Inhibitor [EPC]
- Marketing Start
- 03/23/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Ritonavir tablets are HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult patients: 600 mg twice-daily with meals. ( 2.3 ) Pediatrics patients: The recommended twice daily dose for children greater than one month of age is based on body surface area and should not exceed 600 mg twice daily with meals. ( 2.4 , 5.2 ) Ritonavir oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 44 weeks has been attained. ( 2.4 , 5.2 ) Ritonavir oral powder can only be used for dosing increments of 100 mg. ( 2.4 ) Dose modification for ritonavir is necessary when used with other protease inhibitors. ( 2.6 ) 2.1 General Administration Recommendations Ritonavir must be used in combination with other antiretroviral agents. Ritonavir is administered orally. Ritonavir tablets should be swallowed whole, and not chewed, broken or crushed. Take ritonavir with meals. General Dosing Guidelines: Patients who take the 600 mg twice daily soft gel capsule ritonavir dose may experience more gastrointestinal side effects such as nausea, vomiting, abdominal pain or diarrhea when switching from the soft gel capsule to the tablet formul…
Contraindications
4 CONTRAINDICATIONS When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. Ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients. Ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . o Alpha 1- Adrenoreceptor Antagonist: alfuzosin o Antianginal: ranolazine o Antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine o Antifungal: voriconazole o Anti-gout: colchicine o Antipsychotics: lurasidone, pimozide o Ergot Derivatives: dihydroergotamine, ergotamine, methylergonovine o GI Motility Agent: cisapride o HMG-CoA Reductase Inhibitors: lovastatin, simvastatin o Microsomal triglyceride transfer protein (MTTP) Inhibitor: lomitapide o PDE5 Inhibitor: sildenafil (Revatio ® ) when used for the treatment of pulmonary arterial hyper…
Drug Interactions
7 DRUG INTERACTIONS When co-administering ritonavir with other protease inhibitors (atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir), see the full prescribing information for that protease inhibitor including important information for drug interactions. Co-administration of ritonavir can alter the concentrations of other drugs. The potential for drug-drug interactions must be considered prior to and during therapy. ( 4 , 5.1 , 7 , 12.3 ) 7.1 Potential for Ritonavir to Affect Other Drugs Ritonavir is an inhibitor of cytochrome P450 3A (CYP3A) and may increase plasma concentrations of agents that are primarily metabolized by CYP3A. Agents that are extensively metabolized by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in AUC (greater than 3-fold) when co-administered with ritonavir. Thus, co-administration of ritonavir with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring as shown in Table 4. Ritonav…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. Drug Interactions [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Pancreatitis [see Warnings and Precautions ( 5.4 )] Allergic Reactions/Hypersensitivity [see Warnings and Precautions ( 5.5 )] When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions. The most frequently reported adverse drug reactions among patients receiving ritonavir alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd., India at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in …
Frequently Asked Questions
What is Ritonavir film coated used for?
Ritonavir film coated contains ritonavir 100 mg. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ritonavir film coated a controlled substance?
Ritonavir film coated is not classified as a controlled substance by the DEA.
What is the generic name for Ritonavir film coated?
The generic name for Ritonavir film coated is ritonavir 100 mg. There are no other listed brand versions of ritonavir 100 mg.
What is the NDC code for Ritonavir film coated 100 mg/1?
The NDC (National Drug Code) for Ritonavir film coated 100 mg/1 is 69097-655, listed by Cipla USA Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)