Norvir Capsules

Last updated on RxList: 10/29/2020
Norvir Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Norvir Capsules?

Norvir (ritonavir) soft gelatin capsules, soft gelatin for oral use is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Norvir is available in generic form.

What Are Side Effects of Norvir Capsules?

Common side effects of Norvir soft gelatin capsules include:

Dosage for Norvir Capsules

The dose of Norvir soft gelatin capsules for adult patients is 600 mg twice-daily with meals if possible. The dose of Norvir soft gelatin capsules for pediatric patients is based on body surface area and should not exceed 600 mg twice daily with meals if possible.

What Drugs, Substances, or Supplements Interact with Norvir Capsules?

Norvir soft gelatin capsules may interact with other HIV-1 protease inhibitors, non-nucleoside reverse transcriptase inhibitors (NNRTIs), narcotics, anesthetics, anticancer drugs, anticoagulants, antioconvulsants, antidepressants, antibiotics, beta-blockers, calcium channel blockers, steroids, oral contraceptives, alpha1-adrenoreceptor antagonists, antiarrhythmics, antifungals, anti-gout medications, antipsychotics, ergot drugs, GI motility agents, St. John's Wort, HMG-CoA reductase inhibitors, PDE5 inhibitors, sedatives, hypnotics. Tell your doctor all medications and supplements you use.

Norvir Capsules During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using Norvir. You may be advised to register with the Antiretroviral Pregnancy Registry to monitor maternal-fetal outcomes of pregnant women exposed to Norvir. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, breastfeeding while taking Norvir is not recommended.

Additional Information

Our Norvir (ritonavir) capsules, soft gelatin for oral use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Norvir Capsules Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, skin sores, difficult breathing, fast or pounding heartbeats, sweating, mouth sores, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • irregular heartbeats, or a light-headed feeling (like you might pass out);
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination;
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
  • signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes).

Ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;
  • numbness or tingling in your hands or feet or around your mouth;
  • feeling weak or tired;
  • rash; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Norvir Capsules (Ritonavir)

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Norvir Capsules Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions In Adults

The safety of NORVIR alone and in combination with other antiretroviral agents was studied in 1,755 adult patients. Table 2 lists treatment-emergent Adverse Reactions (with possible or probable relationship to study drug) occurring in greater than or equal to 1% of adult patients receiving NORVIR in combined Phase II/IV studies.

The most frequently reported adverse drug reactions among patients receiving NORVIR 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.

Table 2. Treatment-Emergent Adverse Reactions (With Possible or Probable Relationship to Study Drug) Occurring in greater than or equal to 1% of Adult Patients Receiving NORVIR in Combined Phase II/IV Studies (N = 1,755)

Adverse Reactions n %
Eye disorders
  Blurred vision 113 6.4
Gastrointestinal disorders
  Abdominal Pain (upper and lower)* 464 26.4
  Diarrhea including severe with electrolyte imbalance* 1,192 67.9
  Dyspepsia 201 11.5
  Flatulence 142 8.1
  Gastrointestinal hemorrhage* 41 2.3
  Gastroesophageal reflux disease (GERD) 19 1.1
  Nausea 1,007 57.4
  Vomiting* 559 31.9
General disorders and administration site conditions
  Fatigue including asthenia* 811 46.2
Hepatobiliary disorders
  Blood bilirubin increased (including jaundice)* 25 1.4
  Hepatitis (including increased AST, ALT, GGT)* 153 8.7
Immune system disorders
  Hypersensitivity including urticatria and face edema* 114 8.2
Metabolism and nutrition disorders
  Edema and peripheral edema* 110 6.3
  Gout* 24 1.4
  Hypercholesterolemia* 52 3.0
  Hypertriglyceridemia* 158 9.0
  Lipodystrophy acquired* 51 2.9
Musculos keletal and connective tissue disorders
  Arthralgia and back pain* 326 18.6
  Myopathy/creatine phosphokinase increased* 66 3.8
  Myalgia 156 8.9
Nervous system disorders
  Dizziness* 274 15.6
  Dysgeusia* 285 16.2
  Paresthesia (including oral paresthesia)* 889 50.7
  Peripheral neuropathy 178 10.1
  Syncope* 58 3.3
Psychiatric disorders
  Confusion* 52 3.0
  Disturbance in attention 44 2.5
Renal and urinary disorders
  Increased urination* 74 4.2
Respiratory, thoracic and mediastinal disorders
  Coughing* 380 21.7
  Oropharyngeal Pain* 279 15.9
Skin and subcutaneous tissue disorders
  Acne* 67 3.8
  Pruritus* 214 12.2
  Rash (includes erythematous and maculopapular)* 475 27.1
Vascular disorders
  Flushing, feeling hot* 232 13.2
  Hypertension* 58 3.3
  Hypotension including orthostatic hypotension* 30 1.7
  Peripheral coldness* 21 1.2
* Represents a medical concept including several similar MedDRA PTs

Laboratory Abnormalities in Adults

Table 3 shows the percentage of adult patients who developed marked laboratory abnormalities.

Table 3. Percentage of Adult Patients, by Study and Treatment Group, with Chemistry and Hematology Abnormalities Occurring in greater than 3% of Patients Receiving NORVIR

Variable Limit Study 245 Naive Patients Study 247 Advanced Patients Study 462 PI-Naive Patients
NORVIR plus ZDV NORVIR ZDV NORVIR Placebo NORVIR plus Saquinavir
Chemistry High            
Cholesterol > 240 mg/dL 30.7 44.8 9.3 36.5 8.0 65.2
CPK > 1000 IU/L 9.6 12.1 11.0 9.1 6.3 9.9
GGT > 300 IU/L 1.8 5.2 1.7 19.6 11.3 9.2
SGOT (AST) > 180 IU/L 5.3 9.5 2.5 6.4 7.0 7.8
SGPT (ALT) > 215 IU/L 5.3 7.8 3.4 8.5 4.4 9.2
Triglycerides > 800 mg/dL 9.6 17.2 3.4 33.6 9.4 23.4
Triglycerides > 1500
mg/dL
1.8 2.6 - 12.6 0.4 11.3
Triglycerides
Fasting
> 1500
mg/dL
1.5 1.3 - 9.9 0.3 -
Uric Acid > 12 mg/dL - - - 3.8 0.2 1.4
Hematology Low            
Hematocrit < 30% 2.6 - 0.8 17.3 22.0 0.7
Hemoglobin < 8.0 g/dL 0.9 - - 3.8 3.9 -
Neutrophils ≤ 0.5 x 109 /L - - - 6.0 8.3 -
RBC < 3.0 x 1012 /L 1.8 - 5.9 18.6 24.4 -
WBC < 2.5 x 109 /L - 0.9 6.8 36.9 59.4 3.5
- Indicates no events reported.

Adverse Reactions In Pediatric Patients

NORVIR has been studied in 265 pediatric patients greater than 1 month to 21 years of age. The adverse event profile observed during pediatric clinical trials was similar to that for adult patients.

Vomiting, diarrhea, and skin rash/allergy were the only drug-related clinical adverse events of moderate to severe intensity observed in greater than or equal to 2% of pediatric patients enrolled in NORVIR clinical trials.

Laboratory Abnormalities in Pediatric Patients

The following Grade 3-4 laboratory abnormalities occurred in greater than 3% of pediatric patients who received treatment with NORVIR either alone or in combination with reverse transcriptase inhibitors: neutropenia (9%), hyperamylasemia (7%), thrombocytopenia (5%), anemia (4%), and elevated AST (3%).

Postmarketing Experience

The following adverse events have been reported during post-marketing use of NORVIR. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to NORVIR exposure.

Body As A Whole

Dehydration, usually associated with gastrointestinal symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency has been reported. Syncope, orthostatic hypotension, and renal insufficiency have also been reported without known dehydration.

Co-administration of ritonavir with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system.

Cardiovascular System

First-degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported [see WARNINGS AND PRECAUTIONS].

Cardiac and neurologic events have been reported when ritonavir has been co-administered with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. The possibility of drug interaction cannot be excluded.

Endocrine System

Cushing’s syndrome and adrenal suppression have been reported when ritonavir has been coadministered with fluticasone propionate or budesonide.

Nervous System

There have been postmarketing reports of seizure. Also, see Cardiovascular System.

Skin And subcutaneous Tissue Disorders

Toxic epidermal necrolysis (TEN) has been reported.

Read the entire FDA prescribing information for Norvir Capsules (Ritonavir)

© Norvir Capsules Patient Information is supplied by Cerner Multum, Inc. and Norvir Capsules Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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