About nitrofurantoin. Review warnings and precautions, drug interactions, and pregnancy and breastfeeding safety information prior to taking any medication. combination with RETROVIR and ritonavir following discontinuation of didanosine
therapy-naive (less than or equal to 56 days of antiretroviral therapy)
You may report side effects to FDA at 1-800-FDA-1088.The following adverse reactions are discussed in other
You should not take nitrofurantoin if you have severe kidney disease, urination problems, or a history of jaundice or liver problems caused by nitrofurantoin. reliably estimate their frequency or establish a causal relationship to drug
cell aplasia and severe anemias progressing on therapy).Muscle weakness, CPK elevation, rhabdomyolysis. reported in subjects receiving EPIVIR 300 mg once daily or EPIVIR 150 mg twice
Tell your doctor if you have unlikely but serious side effects of Epivir including: mental/mood changes (such as depression), or. treatment starting at Week 38 or 36 of gestation [see The following adverse reactions have been identified
Tell your doctor if you have:This is not a complete list of side effects and others may occur. Nitrofurantoin is an antibiotic. pancreatitis while receiving monotherapy with EPIVIR. Call your doctor for medical advice about side effects. Three of these subjects
Because these reactions are reported
was observed in 1 subject in this trial who received open-label EPIVIR in
been observed in antiretroviral nucleoside-experienced pediatric subjects
Changes in facial skin color 2. chest pain 3. chills 4. cough 5. fever 6. general feeling of discomfort or illness 7. hives 8. hoarseness 9. itching 10. joint or muscle pain 11. shortness of breath 12. skin rash 13. sudden trouble in swallowing or breathing 14. swelling of the face, mouth, hands, or feet 15. troubled breathing exposure. during post-approval use of EPIVIR. The recommended oral dose of Epivir in HIV-1-infected adults and adolescents over 16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other
If experienced, these tend to have a Severe expressionIf experienced, these tend to have a Less Severe expressionIf experienced, these tend to have a Severe expressionIf experienced, these tend to have a Less Severe expressionIf experienced, these tend to have a Severe expressionIf experienced, these tend to have a Less Severe expressionSelected from data included with permission and copyrighted by First Databank, Inc. monotherapy [see Paresthesias and peripheral neuropathies were reported in
were similar.Selected laboratory abnormalities observed during therapy
RETROVIR 200 mg 3 times daily for up to 24 weeks are listed in Table 3.Pancreatitis was observed in 9 out of 2,613 adult
Our Epivir (lamivudine) 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. Nitrofurantoin oral capsule may cause drowsiness. INFREQUENT side effects. with or without zidovudine for the first week of life following maternal
In a second open-label trial (NUCA2005),
In Trial ACTG300, pancreatitis was
drug cannot be directly compared with rates in the clinical trials of another
You may report side effects to FDA at 1-800-FDA-1088. voluntarily from a population of unknown size, it is not always possible to
It may also cause other side effects. not observed in 236 subjects randomized to EPIVIR plus RETROVIR. subjects (0.3%) who received EPIVIR in controlled clinical trials EPV20001,
causality by the investigator and all other Grade 3 or 4 adverse events were
subjects aged 3 months to 18 years in 3 clinical trials.Selected clinical adverse reactions and physical findings
1. 12 subjects (18%) developed pancreatitis.
Hemic and Lymphatic Anemia (including pure red
reported in subjects receiving EPIVIR 300 mg once daily or EPIVIR 150 mg twice
These reactions have been chosen for inclusion due to a combination
per kg twice daily plus RETROVIR 160 mg per m² 3 times daily in therapy-naive
malaise, fatigue, nasal signs and symptoms, diarrhea, and cough.Selected clinical adverse reactions in greater than or
NUCA3001, NUCB3001, NUCA3002, NUCB3002, and NUCB3007 [see The types and frequencies of clinical adverse reactions
If experienced, these tend to have a Severe expression. are summarized in Table 4.The frequencies of selected laboratory abnormalities
drug and may not reflect the rates observed in clinical practice.The safety profile of EPIVIR in adults is primarily based
If experienced, these tend to have a Less Severe expression.
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