The package insert of the medicine Citavir

the package insert of the medicine Citavir.

what For?

Monotherapy for patients with advanced infection by HIV (CD4 count below 300/mm3), intolerant, or resistant to zidovudine. Combined treatment with zidovudine in HIV infection (CD4 count below 300/mm3).

Contraindications

When should I not use?

Patients with proven hypersensitivity to any components of the formula.

Dosage

How to use?

Monotherapy: adult patients with advanced infection by HIV, the recommended oral dose of Citavir is 0.75 mg, administered every 8 hours (total dose daily of 2.25 mg). Dosage adjustment: patients who are developing signs or symptoms of moderate to severe, indicative of peripheral neuropathy should discontinue treatment with Citavir, especially if these symptoms are bilateral and have more than 72 hours of evolution. Citavir (with the dose 50%, that is, 1 pill of 0,375 mg every 8 hours) should only be reintroduced when all the symptoms related to peripheral neuropathy have dropped by at least mild symptoms. On the occurrence of other adverse reactions clinical or laboratory abnormalities to severe, the daily dose of Citavir should be temporarily discontinued until they are reduced adverse reactions. The treatment with Citavir should then be summarised in 50% of the initial dose. If the adverse reactions engaging with this level of dose, the treatment should be stopped. Combined treatment: the scheme of the combined treatment is 1 tablet of 0.75 mg of Citavir orally, administered concomitantly with 200 mg of zidovudine every 8 hours, daily (total dose daily of 2.25 mg of Citavir and 600 mg of zidovudine). Dose adjustment: the adjustments posológicos for patients in the combined treatment should be based on the toxicity profile of zalcitabine and zidovudine. To the adverse reactions most suggestive of being arising from the use of Citavir (such as peripheral neuropathy and ulcerations of the oral cavity severe), the drug should be stopped or have their dosage reduced. For patients with toxicity related to zidovudine (such as anemia, granulocytopenia), the drug should be discontinued or have their dose reduced first. For any interruption of Citavir and especially if the Citavir is to be discontinued permanently, the administration of zidovudine should be adjusted to 100 mg every 4 hours (600 mg total dose daily) as recommended. In the case of severe adverse reactions or reactions where the drug responsible is not clear, or still, reactions persisted after discontinuation or dose reduction of a drug, the other drug should also be interrupted or have their dose reduced. Physicians should consult the package insert of the complete zidovudine as to the adverse effects of the drug. Monitoring of patients: blood counts and complete biochemical tests should be performed periodically. The levels of amylase in serum should be monitored in those patients with a prior history of amylase serum high, pancreatitis, alcoholism, parenteral nutrition, or with high risk of developing pancreatitis. Careful monitoring of signs and symptoms suggestive of peripheral neuropathy is recommended, particularly in individuals with low levels of CD4, which have a higher risk of developing peripheral neuropathy during the treatment. Dose adjustment in clinical situations private: dose adjustment in patients with impairment of renal function should be considered as follows: clearance of creatinine is estimated to be between 10 and 40 ml/min: reduce dose of Citavir to 0.75 mg every 12 hours. Clearance of creatinine.

Side Effects

What are the evils that can cause me?

the data on adverse reactions are based on the oral administration of Citavir, as a single agent and combined with zidovudine in the recommended doses and adult patients with HIV infection. The majority of effects were mild to moderate. Many of the HIV-infected adults who participated in these clinical studies is presented, in the form of parameters compared to baseline, signs and symptoms of the pathology of HIV, which were recorded as adverse effects, during any stage of the study, demonstrating, therefore, the difficulty in distinguishing between these signs and symptoms, which are manifestations of the underlying disease or illness intercorrente of the adverse effects associated with the administration of the Citavir and/or zidovudine. The main effect of the Citavir is peripheral neuropathy. Other adverse effects reported: gastrointestinal: ulceration of oral, nausea, dysphagia, anorexia, diarrhea, abdominal pain, vomiting and constipation. Skin and appendages: rash, pruritus, sweating. Musculoskeletal: myalgia, arthralgia. Systemic effects: weight loss, fatigue, fever, chest pain. Respiratory: pharyngitis. Adverse effects that occur less frequently or rarely: body as a whole: asthenia, pain, chest pain subesternal, fatigue, generalized edema. Cardiovascular: tachycardia, hypertension, syncope, atrial fibrillation. Gastrointestinal: dry mouth, ulcers of esophagus, esophagitis, pain, esophageal reux, glossite, stomatitis, bleeding, rectal, hemorrhoids, ulcers, rectal, abdominal distention, flatulence, belching, changes in the gums, gastritis, hemorrhage, gastrointestinal, pancreatitis, enlargement of the salivary glands, jaundice. Liver: damage liver, hepatitis, abnormal liver function. Musculoskeletal: shoulder pain and cramps in the lower limbs, arthritis, arthropathy, cold extremities, myositis, pain in the arms and legs. Nervous: hypertonia, tremors in general and tremors of the hands, seizures, ataxia, coordination abnormal, dysphonia, hyperkinesia, hipocinesia, migraine, neuralgia, stupor, vertigo. Psychiatric: confusion, disturbances in attention, amnesia, insomnia, drowsiness, depression, agitation, depersonalization, emotional lability, nervousness, anxiety, euphoria, mania, and dementia. Respiratory: cyanosis, dyspnea, cough. Skin: dermatitis, rash maculopapular, alopecia, urticaria, skin injuries, acne, rash bullous, flushing. Special senses and vision: perversion of taste, visual change, eye pain, as xerophthalmia, deafness, anosmia. The urinary system: increased frequency of urinary urge, abnormal kidney function, cyst on kidney, gout, nephropathy toxic, polyuria, calculose renal, hyperuricemia.

Warnings and Precautions

what should I know before using?

The safety of the administration of Citavir in patients under the age of 13 years and in asymptomatic individuals with HIV infection has not yet been established. Peripheral neuropathy: the main toxicity of Citavir is peripheral neuropathy. Neuropathy related to the Citavir is of type sensomotor characterized initially by disestesia in the distal ends with feeling of numbness and burning. The these symptoms may following the onset of severe pain on stabbing pains, or a sensation of continuous burning, if the drug is not discontinued. The neuropathy may progress to severe pain requiring the use of powerful painkillers, being potentially irreversible, especially if the Citavir is not stopped. With immediate discontinuation of Citavir the neuropathy is usually slowly reversible. Patients who were already carriers of peripheral neuropathy, moderate or severe, should avoid the use of Citavir. Citavir should be administered with extreme caution in patients with CD4 counts < 50 cells/mm3, for which the risk of developing peripheral neuropathy is higher. Careful control is especially recommended for these patients. Pancreatitis fatal was observed with the administration isolated Citavir or in combination with zidovudine. Pancreatitis is a rare complication in monotherapy with Citavir, occurring in