Norvir^® (Tablets) Instructions for Use

Marketing Authorization Holder

AbbVie, LLC (Russia)

Manufactured By

AbbVie Deutschland, GmbH & Co. KG (Germany)

ATC Code

J05AE03 (Ritonavir)

Active Substance

Ritonavir (Rec.INN registered by WHO)

Dosage Form

Norvir®

Film-coated tablets, 100 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval in shape, with an engraving of the Abbott symbol and “NK” on one side.

Excipients: copovidone – 493.1 mg, sorbitan laurate – 66.7 mg, colloidal silicon dioxide – 13.8 mg, sodium stearyl fumarate – 2.3 mg, calcium hydrogen phosphate – 89.6 mg.

Film coating composition Opadry white (Opadry^® 16B18449) – 22 mg (hypromellose 2910 (6 mPa×s) – 58.04%, titanium dioxide – 15.43%, macrogol 400 – 9%, hypromellose 2910 (15 mPa×s) – 5.76%, hypromellose – 5.76%, talc – 4.1%, colloidal silicon dioxide – 0.15%, macrogol 3350 – 1.61%, polysorbate 80 – 0.15%).

30 pcs. – high-density polyethylene bottles (1) – cardboard packs.
30 pcs. – high-density polyethylene bottles (3) – cardboard packs.
60 pcs. – high-density polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug active against HIV

Pharmacotherapeutic Group

Antiviral [HIV] agent

Pharmacological Action

Antiviral agent. It has selective affinity for the HIV aspartyl protease and therefore has a weak inhibitory effect on the corresponding human protease.

In vitro studies have shown that Ritonavir has a pronounced inhibitory effect on the replication of both laboratory and clinical strains of HIV.

Ritonavir is almost completely metabolized in the liver.

Indications

Treatment of infections caused by HIV.

ICD codes

Dosage Regimen

When taken orally, adults – 600 mg twice daily. To reduce side effects, on the first day, 300 mg twice daily can be used, followed by a gradual increase in the dose by 100 mg until the recommended dose is reached.

In children, it is recommended to use in combination with antiviral nucleoside analogues. The recommended dose is 400 mg/m² twice daily. To reduce side effects, administration can be started at a dose of 250 mg/m², with a further increase every 2-3 days by 50 mg/m² per dose until a dose of 400 mg/m² twice daily is reached. Dose determination for children is recommended using a special table-nomogram.

Adverse Reactions

From the digestive system often – anorexia, nausea, vomiting, diarrhea, dry mouth, ulcerative lesions of the oral mucosa, belching, flatulence, abnormal liver function tests; increase in hepatic and digestive enzymes.

From the CNS and peripheral nervous system often – anxiety, insomnia, paresthesia around the mouth and in the periphery, dizziness, drowsiness.

From the respiratory system laryngitis, cough, pharyngitis are possible.

From the hematopoietic system decrease in hemoglobin, decrease in hematocrit, decrease in red blood cell count, decrease in white blood cell count, decrease in neutrophil count, increase in eosinophil count.

From metabolism increase in uric acid, hyperlipidemia, weight loss, decrease in potassium content, increase in triglycerides.

Dermatological reactions skin rash, itching, increased sweating.

Other peripheral vasodilation, myalgia.

Contraindications

Hypersensitivity to ritonavir.

Concomitant use with amiodarone, astemizole, itraconazole, ketoconazole, bepridil, cisapride, bupropion, clozapine, dihydroergotamine, ergotamine, encainide, flecainide, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, terfenadine, sodium clorazepate, flurazepam, diazepam, estazolam, midazolam, triazolam, zolpidem, alprazolam.

Use in Pregnancy and Lactation

Use with caution and only in cases of extreme necessity during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in patients with liver diseases.

During treatment, it is necessary to regularly monitor liver function parameters in patients with a previous increase in liver enzyme levels and with hepatitis, as well as during long-term treatment and in elderly patients.

Pediatric Use

Use is possible according to the dosing regimen.

Geriatric Use

During treatment, it is necessary to regularly monitor liver function parameters in elderly patients.

Special Precautions

Use with caution in patients with liver diseases.

During treatment, it is necessary to regularly monitor liver function parameters in patients with a previous increase in liver enzyme levels and with hepatitis, as well as during long-term treatment and in elderly patients.

In patients with hemophilia types A and B, the likelihood of bleeding (appearance of skin and joint hematomas) increases in some cases.

Drug Interactions

Rifampin, rifabutin, and smoking reduce the effect of ritonavir.

When used concomitantly with ritonavir, a dose reduction of the following drugs is required (due to a decrease in the intensity of their metabolism): clarithromycin in patients with renal failure, desipramine, saquinavir.

When used concomitantly with ritonavir, the doses of oral hormonal contraceptives and theophylline should be increased.

Ritonavir increases the mean AUC values of sildenafil by 11 times, clarithromycin and trimethoprim by 77% and 20%, respectively; the AUC of rifabutin and its metabolite increases by 4 and 35 times, respectively.

Ritonavir decreases the mean AUC values of zidovudine (26%), theophylline (45%), ethinylestradiol (41%), sulfamethoxazole (20%); while these drugs do not have a significant effect on the pharmacokinetics of ritonavir.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.