Kaletra. 100 mg. 25 mg. 60 tablets
- Kaletra be administered to children at 2 years of age and older and children infected with HIV, which causes acquired immunodeficiency syndrome disease (AIDS).
Kaletra. 100 mg. / 25 mg. 60 tablets
KALETRA WHAT IS AND WHAT IT IS USED FOR ?
- Your doctor has prescribed Kaletra, to help control the infection with human immunodeficiency virus (HIV). Kaletra does this by slowing down the spread of the infection in your body.
- Kaletra be administered to children at 2 years of age and older and children infected with HIV, which causes acquired immunodeficiency syndrome disease ( AIDS ) . Kaletra should not be used in children under 2 years of age unless specifically directed by their doctor.
- Kaletra is an antiretroviral drug. It belongs to a group of medicines called protease inhibitors.
- Kaletra is prescribed in combination with other antiviral drugs. Your doctor will discuss with you and determine which medicines are best for you.
2 . BEFORE YOU TAKE KALETRA
Do not take Kaletra
- If you are allergic ( hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra.
- If you have severe liver problems.
- Astemizole or terfenadine ( commonly used to treat allergy symptoms - these medicines may be available without prescription) ;
- Midazolam administered orally (taken by mouth), triazolam (used to relieve anxiety and / or trouble sleeping);
- Pimozide (used to treat schizophrenia) ;
- Cisapride (used to relieve certain stomach problems);
- Ergotamine, ergonovine , methylergonovine (used to treat headaches ) ;
- Amiodarone (used to treat abnormal heart rhythm) ;
- Lovastatin, simvastatin ( used to lower blood holeterola )
- Alfuzosin (used to treat symptoms of an enlarged prostate in men ( benign prostatic hyperplasia ) ( BPH )
- Fusidic acid ( used to treat skin infections caused by bacteria such as Staphylococus impetigo and infected dermatitis. Fusidic acid for the treatment of long-term infections of bones and joints can be administered under medical supervision (see Taking other medicines ) ;
- Colchicine ( anti-gout agent ) patients with renal or hepatic impairment ;
- Vardenafil (used for the treatment of erectile dysfunction) .
- Sildenafil (used for the treatment of pulmonary arterial hypertension ) (high blood pressure in the pulmonary artery ) . Sildenafil used to treat erectile dysfunction can be taken under medical supervision ( see Take special care with Kaletra)
- Products containing St. John's wort (Hypericum perforatu m).
Read the list of medicines under 'Taking other medicines' for information on certain other medications that require special attention .
If you are currently taking any of these medicines, ask your doctor to make the necessary changes or treatment of your other disease ( s) or your antiretroviral treatment.
Take special care with Kaletra
- Kaletra is not a cure for HIV infection or AIDS.
- People taking Kaletra may still develop infections or other diseases associated with HIV disease and AIDS . Therefore, it is important to remain under the supervision of your doctor while taking Kaletra.
- Kaletra does not reduce the risk of transmitting HIV to others. You should take appropriate precautions to prevent transmission of the disease through sexual contact ( eg use of a condom) or blood .
Tell your doctor if you have / had :
- Hemophilia type A and B as Kaletra might increase the risk of bleeding.
- Diabetes , as reported elevated blood sugar levels in patients taking Kaletra.
- History of liver problems as patients with liver disease including chronic hepatitis B or C are at increased risk for severe and potentially fatal hepatic adverse reactions.
Tell your doctor if you experience:
- Nausea, vomiting , abdominal pain, difficulty breathing and severe muscle weakness in the legs and arms, as these symptoms may indicate an increased level of lactic acid.
- Thirst, frequent urination , blurred vision , or weight loss, as this could be indicative of an elevated level of blood glucose .
- Nausea, vomiting , abdominal pain, as large increases in triglycerides ( fats in the blood ) is considered a risk factor for pancreatitis ( inflammation of the pancreas ) and these symptoms may be due to this condition.
- Changes in body shape due to changes in fat distribution. This may include loss of fat from legs, arms and face, increased fat in the abdomen ( belly) and other internal organs , breast enlargement and fatty lumps on the back of the neck ( 'buffalo hump'). The cause and long-term effects of these conditions on health are not known at this time .
- In some patients with advanced HIV infection and history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after the initiation of anti-HIV treatment . It is believed that these symptoms are due to an improvement in the immune response, enabling the body to fight infections which may be present with no obvious symptoms altogether . if
notice any symptoms of infection, please inform your doctor immediately implementing the necessary treatment.
- Joint stiffness , aches and pains ( especially of the hip , knee and shoulder) and difficulty in movement , as some patients taking these drugs may develop a bone disease called osteonecrosis ( death of bone tissue caused by loss of flow blood supply to the bone). The length of combination antiretroviral therapy , corticosteroid use , alcohol consumption , severe immunosuppression ( reduced activity of the immune system) , higher body mass index may be some of the many risk factors for developing this disease.
- Muscle pain, tenderness or weakness, particularly in combination with these drugs. On rare occasions these muscle disorders have been serious .
- Symptoms such as dizziness , fainting, weakness or feeling of abnormal heartbeat . Kaletra may cause changes in heart rhythm and electrical activity of the heart. These changes can be seen on the ECG (electrocardiogram) .
Tell your doctor if you are taking any of the following medicines, as then you need to pay particular attention to :
- Tell your doctor if you are taking any of the following medicines, as then you need to pay particular attention to :
- Antibiotics (e.g., rifabutin, rifampicin , clarithromycin ) ;
- Anti-cancer drugs (e.g., most of the tyrosine kinase inhibitors such as dasatinib and nilotinib , also vincristine and vinblastine) ;
- Anti- coagulants (eg warfarin , rivaroxaban ) ;
- Antidepressants (eg trazodone , bupropion ) ;
- Antiepileptic drugs ( eg, carbamazepine , phenytoin , phenobarbital , lamotrigine and valproate) ;
- Antifungals (eg, ketoconazole , itraconazole , voriconazole ) ;
- Anti-gout drugs (eg colchicine )
- Medicines used to treat chronic hepatitis C in adults ( napr.botseprevir and telaprevir ) ;
- Medicines for erectile dysfunction ( eg, sildenafil , tadalafil) ;
- Fusidic acid used for the treatment of long-term infections of the bones and joints ( e.g. osteomyelitis ) ;
- Heart medicines , including:
- Digoxin ;
- Calcium channel blockers (eg, felodipine, nifedipine, nicardipine ), medicines used to correct heart rhythm (eg bepridil, systemic lidocaine , quinidine ) ;
- HIV CCR5- antagonist (e.g. mavirok ) ;
- HIV- 1 integrase inhibitor ( napr.raltegravir ) ;
- Medicines used to lower blood cholesterol ( eg atorvastatin , lovastatin , rosuvastatin , or simvastatin) ;
- Drugs used to treat asthma and other lung problems such as chronic obstructive pulmonary disease ( COPD ) ( e.g. salmeterol )
- Drugs used in the treatment of pulmonary arterial hypertension (high blood pressure in the pulmonary artery ) (e.g., bosentan , sildenafil , tadalafil ) ;
- Drugs affecting the immune system ( eg, cyclosporine, sirolimus ( rapamycin ) , tacrolimus ) ;
- Pain relievers (eg, fentanyl) ;
- Medicines used for smoking cessation ( eg bupropion ) ;
- Morphine drugs (eg methadone) ;
- Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz , nevirapine )
- Oral contraceptives or using a patch contraceptive to prevent pregnancy ( see the section below titled " Contraceptives " ) ;
- Protease inhibitors ( eg, amprenavir, fosamprenavir , indinavir , nelfinavir , ritonavir , saquinavir ) ;
- Sedatives (eg midazolam administered by injection) ;
- Steroids ( napr.budezonid , dexamethasone , fluticasone propionate, ethinyl estradiol ) ;
- Warfarin ;
- Drugs that interact with alcohol ( eg disulfiram )
Read the list of medicines under 'Taking other medicines' for information on drugs that should not take with Kaletra.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Erectile dysfunction ( vardenafil , sildenafil, tadalafil )
- Do not take Kaletra, if you are currently taking vardenafil.
- Do not take Kaletra with sildenafil used to treat pulmonary hypertension (high blood pressure in the pulmonary artery) (see "Do not take Kaletra")
- If you are taking sildenafil or tadalafil and Kaletra, you may be at risk of side effects such as hypotension, syncope, visual changes, and penile erection lasting more than 4 hours. If an erection lasts more than 4 hours, you should seek immediate medical assistance to avoid permanent damage to your penis (penis ) . Your doctor can explain these symptoms .
- If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy should use an additional or different type of contraception (eg condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives .
- Kaletra does not reduce the risk of transmitting HIV to others .. You should take the appropriate precautions (eg condom use ) to prevent transmission of the disease through sexual contact.
Pregnancy and lactation
- If you are pregnant or think you may be pregnant , or breast-feeding , tell your doctor.
- Pregnant or nursing women should not take Kaletra, unless specifically directed by the doctor.
- It is recommended that HIV-infected women should not breast-feed , since there is a possibility of infection with HIV to the baby through breast milk.
Driving and using machines
Kaletra is not specifically tested for its possible effects on the ability to drive or operate machinery. Do not drive or operate machinery if you experience side effects ( eg nausea ) that impact your ability to perform such activities safely. Instead, contact your doctor.
3 . HOW TO TAKE KALETRA?
It is important that Kaletra tablets are swallowed whole and not chewed, broken or crushed .
Always take Kaletra exactly as your doctor tells you .
If you are not sure how to take your medicine , ask your doctor or pharmacist.
How Kaletra should be taken and when
Use in adults
- The usual adult dose is 400 mg/100 mg twice a day, i.e., every 12 hours , in combination with other anti-HIV drugs. Adult patients who have not previously taken other antiviral medicines can take Kaletra tablets once daily at a dose of 800/200 mg.Vashiyat doctor will advise you how many tablets you should take . Adult patients who have previously taken other antiviral medicines can take Kaletra once daily dose of 800/200 mg, if their physician determines that this is appropriate.
- Kaletra should not be taken once daily with amprenavir , efavirenz , nevirapine , nelfinavir , carbamazepine, phenobarbital and phenytoin.
- Kaletra tablets can be taken with or without food.
In children 2 years of age and children over age 2
- For children, your doctor will determine the appropriate dosage ( number of tablets) based on height and weight of the child.
- Kaletra tablets can be taken with or without food.
Kaletra is available as 200 mg/50 mg film-coated tablets. Kaletra also as an oral solution is available for patients who can not swallow tablets .
If you take more than the dose of Kaletra
- If you find that you take more than prescribed Kaletra , contact your doctor immediately .
- If you can not contact your doctor, go to the hospital. If you forget to take
- If you miss a dose , take the missed dose as soon as possible , and then continue with your regular dose schedule as prescribed by your doctor .
- Do not take a double dose to make up for a missed dose.
If you have stopped taking Kaletra
- Do not stop taking Kaletra or change your daily dose without first checking with your doctor.
- Kaletra should not be taken every day to help control your HIV infection, no matter how much better you feel.
- The adoption of Kaletra, as recommended , is to provide the best opportunity to slow the development of resistance to the product.
- If a side effect is preventing you from taking Kaletra as prescribed , immediately tell your doctor.
- Always keep handy enough Kaletra, in order not to run out . When you travel or need to stay in hospital make sure you have enough Kaletra to the moment you will be able to get a new supply .
- Keep taking this medicine until your doctor tells you otherwise .
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Kaletra can cause side effects, although not everybody gets them. It may be difficult to distinguish adverse events caused by Kaletra and those caused by other medicines taken at the same time or by the complications of infection with HIV.
You should tell your doctor immediately if these or any other symptoms. If the condition does not improve or worsens, seek medical attention.
VERY COMMON side effects (affects more than 1 in 10 patients):
- Diarrhea ;
- Nausea ;
- Infections of the upper respiratory tract.
COMMON side effects ( affects 1 to 10 users in 100 ):
- Inflammation of the pancreas ;
- Vomiting, enlarged abdomen , pain in the lower and upper stomach area, gas , indigestion, decreased appetite, reflux from the stomach to the esophagus, which can cause pain;
- Swelling or inflammation of the stomach , small intestine and colon.
- Increased levels of cholesterol, triglyceride levels ( in the form of fat) in the blood high blood pressure ;
- Decreased ability of the body to absorb sugar , including diabetes, weight loss;
- Low numbers of red blood cells, low white blood cells, which fight infection ;
- Rash , eczema, accumulation of scales of greasy skin;
- Dizziness, anxiety , difficulty sleeping ;
- Feeling of fatigue, loss of strength and energy , headache including migraine ;
- Hemorrhoids ;
- Inflammation of the liver , including elevated liver enzymes;
- Allergic reactions including hives and inflammation in the mouth ;
- Changes in body shape or face shape due to changes in fat distribution;
- Infections of the lower respiratory tract ;
- Enlargement of lymph nodes;
- Impotence, abnormally heavy or prolonged menstrual bleeding or cessation of menstruation ;
- Muscle disorders such as weakness and cramps , pain in joints, muscles and back;
- Damage to the nerves of the peripheral nervous system ;
- Night sweats, itching, bumps appear on the skin, a skin infection, inflammation of the skin pores or hair , fluid accumulation in the cells or tissues .
Additional information about nausea, vomiting or abdominal pain
Tell your doctor if you experience nausea , vomiting or abdominal pain , as these may be signs of pancreatitis (inflammation of the pancreas).
Additional information about high cholesterol and triglycerides
- So far there are no known long-term risks for complications such as heart attack or stroke due to elevated cholesterol and triglycerides.
- Your doctor will monitor and prescribe other medicines if needed.
- Increasing the amount of triglycerides ( fats in the blood) is considered a risk factor for pancreatitis (inflammation of the pancreas).
Changes in body shape due to changes in the distribution of body fat
Combination antiretroviral therapy , which may include Kaletra, may cause changes in body shape due to changes in the distribution of body fat . This may include loss of fat from legs, arms and face, increased fat in the abdomen ( belly) and other internal organs , breast enlargement and fatty lumps on the back of the neck ( 'buffalo hump'). The cause and long-term effects of these conditions on health are not known at this time . Tell your doctor
If you notice any changes in body shape due to changes in the distribution of body fat .
Uncommon side effects (affects 1 to 10 of 1000 patients):
- Abnormal dreams ;
- Loss or change in taste ;
- Loss ;
- Deviations in your electrocardiogram called atrioventricular block;
- Plaque in the arteries which can lead to heart attack and stroke ;
- Inflammation of the blood vessels and capillaries ;
- Inflammation of the gall bladder ;
- Uncontrollable shaking of the body ;
- Constipation ;
- Deep vein inflammation associated with the formation of clots ;
- Dry mouth ;
- Inability to control bowels;
- Inflammation of the first section of the small intestine just after the stomach wound or ulcer in the digestive tract bleeding from the intestinal tract or rectum ;
- Red blood cells in the urine;
- Deposition of fat in the liver, enlargement of the liver ;
- Lack of functioning of the testes ;
- Flare pronounced symptoms associated with active infection in your body (immune reconstitution ) ;
- Increased appetite ;
- Abnormally high level of bilirubin (a pigment produced from the breakdown of red blood cells ) in the blood ;
- Decreased sexual desire ;
- Inflammation of the kidneys;
- Bone death caused by poor blood supply to the area;
- Mouth sores or ulcers, inflammation of the stomach and intestines ;
- Renal failure;
- Destruction of the muscle fibers , resulting in the release of the contained in the muscle fiber in the bloodstream Myoglobin
- A sound in one ear or both ears, such as buzzing , ringing or whistling;
- Tremor ;
- Abnormal closure of one of the valves (tricuspid valve )
- Vertigo (sensation of dizziness ) ;
- Eye problems , impaired vision ;
- Weight gain.
Other side effects have been reported with Kaletra: yellowing of the skin or whites of the eyes ( jaundice), severe or life-threatening skin rashes and blisters (Stevens -Johnson syndrome and erythema multiforme) . It is not clear how often these effects may occur .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE KALETRA?
- Keep out of reach of children.
- Do not use Kaletra after the expiry date stated on the pack . The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions .
How to dispose of any unused Kaletra
- Medicines should not be disposed of via wastewater or household waste.
- Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . ADDITIONAL INFORMATION
What does Kaletra?
The active substances are lopinavir and ritonavir.
Each tablet contains 100 mg Kaletra lopinavir and 25 mg ritonavir. Other ingredients are:
Colloidal anhydrous silica , copovidone , sodium stearyl fumarate , sorbitan laurate .
Polyvinyl alcohol, talc , titanium dioxide , macrogol 3350, yellow ferric oxide E172.
Kaletra looks like and contents of the pack ?
- The tablets are pale yellow debossed with [Abbott logo] and " KC " .
- Kaletra 100 mg/25 mg film-coated tablets are packaged in plastic bottles containing 60 tablets.