LOPINAVIR + RITONAVIR

COMMON BRAND NAME(S): Kaletra

GENERIC NAME(S): LOPINAVIR/RITONAVIR

 

Description: Lopinavir inhibits HIV protease, causing the enzyme incapable of processing the polyprotein precursor. This leads to the production of non-infectious and immature HIV particles. Ritonavir is a selectively competitive reversible inhibitor of HIV protease that interferes with the formation of essential proteins and enzymes. After which, the formation of immature and non-infectious viruses follows. It also interferes with the production of infectious HIV and limits further infectious spread of the virus.

This combination product contains two medications: lopinavir and ritonavir. This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. Ritonavir increases (“boosts”) the levels of lopinavir. This helps lopinavir work better.

Lopinavir/ritonavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.

How to use lopinavir-ritonavir

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking lopinavir/ritonavir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. Swallow the tablets whole. Do not crush, break or chew the tablets.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

For children, the dosage is also based on age, weight, and height. Once-daily dosing of this medication is not recommended for children younger than 18 years of age.

If you are taking didanosine in addition to this product, you can take it at the same time as this product, but take them both without food.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Tell your doctor or pharmacist promptly if any of these effects persist or worsen:

  • Diarrhea
  • Nausea
  • Vomiting
  • stomach upset
  • gas
  • headache
  • trouble sleeping

Tell your doctor right away if you have any serious side effects, including:

  • unexplained weight loss
  • persistent muscle aches/weakness
  • joint pain
  • numbness/tingling of the hands/feet/arms/legs
  • severe tiredness
  • vision changes
  • severe/persistent headaches
  • signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores)
  • signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
  • signs of Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech)
  • increased thirst
  • increased urination
  • confusion
  • persistent nausea/vomiting
  • stomach/abdominal pain
  • yellowing eyes/skin
  • dark urine

Get medical help right away if you have any very serious side effects, including:

  • severe dizziness
  • fainting
  • slow/fast/irregular heartbeat
  • symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs).

This medication may cause an increase in blood fat levels (cholesterol and triglycerides).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

  • Allergic reaction to medication
  • Patients with medical history of:
  • liver disease
  • diabetes
  • pancreatitis
  • high blood fat levels (cholesterol/triglycerides)
  • heart problems (coronary artery disease, heart attack)
  • bleeding problems (such as hemophilia)
  • previous infection with certain diseases (such as hepatitis B infection, hepatitis C infection, tuberculosis)
  • may cause QT prolongation (problem in heart rythm)
  • Tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before having surgery.
  • Older adults may be more sensitive to the side effects of this drug
  • Can now be usually given to pregnant women with HIV
  • Do not breast-feed because breast milk can transmit HIV

Consult your doctor regarding the precautions mentioned above.

 

Interactions:

Lopinavir/ritonavir interacts with certain HIV medications (such as fosamprenavir, tipranavir).

Other medications can affect the removal of lopinavir/ritonavir from your body. Examples include boceprevir, rifampin, St. John’s wort, among others.

Lopinavir/ritonavir can speed up or slow down the removal of other medications from your body. Examples of affected drugs include:

  • certain alpha blockers (such as alfuzosin, tamsulosin)
  • certain inhaled drugs to treat breathing problems (such as fluticasone, salmeterol)
  • cisapride
  • drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil)
  • ergot drugs (such as ergotamine, dihydroergotamine)
  • pimozide
  • rivaroxaban
  • simeprevir
  • telaprevir
  • certain sedatives (such as midazolam, triazolam)
  • certain statins (such as lovastatin, simvastatin)
  • among others

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring.

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Keep all medical and laboratory appointments. Laboratory and/or medical tests (such as liver function, blood count, blood cholesterol/triglyceride levels, blood sugar) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Lopinavir/ritonavir is available in tablets, capsules, and oral solution. Do not switch types of this medication without instructions on how to do so by your doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature with the container tightly closed, away from light and moisture. Avoid exposure to high heat. Also, in high humidity, avoid storing this product for more than 2 weeks outside of the manufacturer’s original container. If this does occur, ask your pharmacist for instructions on what to do with your medication. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.

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