Kaletra Side Effects
Please note - some side effects for Kaletra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Kaletra - for the Consumer
Kaletra
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaletra:
Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra:Diarrhea; headache; nausea; stomach pain or upset; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of appetite; loss of consciousness; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising; yellowing of the skin or eyes.
Kaletra Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaletra Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra Capsules:Abnormal stools; chills; depression; diarrhea; fever; gas; headache; indigestion; loss of appetite; muscle pain; nausea; pain; prickling or tingling sensation on the skin; shift in body fat to stomach and upper body; sleeplessness; stomach pain; tiredness; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in stool; dark urine; drowsiness; fatigue; flushed face; increased blood sugar; increased thirst or urination; persistent fever; severe stomach pain with nausea and vomiting; unusual bleeding or bruising; unusual hunger; vision changes; yellowing of the skin or eyes.
Kaletra Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaletra Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra Solution:Diarrhea; headache; nausea; stomach pain or upset; tiredness; vomiting; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of appetite; loss of consciousness; pale stools; red, swollen, blistered. or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising; yellowing of the skin or eyes.
Kaletra Side Effects - for the Professional
Kaletra Oral Solution
Adults
Treatment-Emergent Adverse EventsKaletra has been studied in 891 patients as combination therapy in Phase I/II and Phase III clinical trials. The most common adverse event associated with Kaletra therapy was diarrhea, which was generally of mild to moderate severity. Rates of discontinuation of randomized therapy due to adverse events were 5.8% in Kaletra-treated and 4.9% in nelfinavir-treated patients in Study 863. The incidence of diarrhea was greater for Kaletra once-daily compared to Kaletra twice-daily in Study 418.
Treatment-Emergent clinical adverse events of moderate or severe intensity in ≥ 2% of patients treated with combination therapy for up to 48 weeks (Phase III) and for up to 360 weeks (Phase I/II) are presented in Table 12. For other information regarding observed or potentially serious adverse events, please see WARNINGS and PRECAUTIONS.
| Study 863 (48 Weeks) |
Study 418 (48 Weeks) |
Study 720 (360 Weeks) |
|||
| Kaletra 400/100 mg BID + d4T + 3TC (N=326) |
Nelfinavir 750 mg TID + d4T + 3TC (N=327) |
Kaletra 800/200 mg QD + TDF + FTC (N=115) |
Kaletra 400/100 mg BID + TDF + FTC (N=75) |
Kaletra BID2 + d4T + 3TC (N=100) |
|
|
1 Includes adverse events of possible, probable, or unknown relationship to study drug. 2 Includes adverse event data from dose group I (200/100 mg BID [N=16] and 400/100 mg BID [N=16]) and dose group II (400/100 mg BID [N=35] and 400/200 mg BID [N=33]). Within dosing groups, moderate to severe nausea of probable/possible relationship to Kaletra occurred at a higher rate in the 400/200 mg dose arm compared to the 400/100 mg dose arm in group II. |
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| Body as a Whole | |||||
| Abdominal Pain |
4% | 3% | 3% | 3% | 11% |
| Asthenia | 4% | 3% | 0% | 0% | 9% |
| Headache | 2% | 2% | 3% | 3% | 6% |
| Cardiovascular System | |||||
| Vein distended | 0% | 0% | 0% | 0% | 3% |
| Digestive System | |||||
| Anorexia | 1% | <1% | <1% | 1% | 2% |
| Diarrhea | 16% | 17% | 16% | 5% | 28% |
| Dyspepsia | 2% | <1% | 0% | 1% | 6% |
| Flatulence | 2% | 1% | 2% | 1% | 4% |
| Nausea | 7% | 5% | 9% | 8% | 16% |
| Vomiting | 2% | 2% | 3% | 4% | 6% |
| Metabolic and Nutritional | |||||
| Weight Loss | 1% | <1% | 0% | 0% | 2% |
| Musculoskeletal | |||||
| Myalgia | 1% | 1% | 0% | 0% | 2% |
| Nervous System | |||||
| Depression | 1% | 2% | 1% | 0% | 0% |
| Insomnia | 2% | 1% | 0% | 0% | 3% |
| Libido decreased |
<1% | <1% | 0% | 1% | 2% |
| Paresthesia | 1% | 1% | 0% | 0% | 2% |
| Respiratory | |||||
| Bronchitis | 0% | 0% | 0% | 0% | 2% |
| Skin and Appendages | |||||
| Rash | 1% | 2% | 1% | 0% | 5% |
| Urogenital | |||||
| Hypogonadism male |
0% | 0% | 0% | 0% | 2% |
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | ||
| Kaletra 400/100 mg BID + NVP + NRTIs (N=148) |
Investigator-selected protease inhibitor(s) + NVP + NRTIs (N=140) |
Kaletra BID + NNRTI + NRTIs (N=127) |
|
|
1 Includes adverse events of possible,probable, or unknown relationship to study drug. 2 Includes adverse event data from patients receiving 400/100 mg BID (n=29) or 533/133 mg BID (n=28) for 84 weeks. Patients receiving Kaletra in combination with NRTIs and efavirenz. 3 Includes adverse event data from patients receiving 400/100 mg BID (n=36) or 400/200 mg BID (n=34) for 144 weeks. Patients received Kaletra in combination with NRTIs and nevirapine. |
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| Body as a Whole | |||
| Abdominal Pain | 2% | 2% | 4% |
| Asthenia | 3% | 6% | 9% |
| Chills | 2% | 0% | 0% |
| Fever | 2% | 1% | 2% |
| Headache | 2% | 3% | 2% |
| Cardiovascular | |||
| Hypertension | 0% | 0% | 2% |
| Digestive System | |||
| Anorexia | 1% | 3% | 0% |
| Diarrhea | 7% | 9% | 23% |
| Dyspepsia | 1% | 1% | 2% |
| Dysphagia | 2% | 1% | 0% |
| Flatulence | 1% | 2% | 2% |
| Nausea | 7% | 16% | 5% |
| Vomiting | 4% | 12% | 2% |
| Metabolic and Nutritional | |||
| Weight loss | 0% | 1% | 3% |
| Musculoskeletal | |||
| Myalgia | 1% | 1% | 2% |
| Nervous System | |||
| Depression | 1% | 2% | 2% |
| Insomnia | 0% | 2% | 2% |
| Paresthesia | 1% | 0% | 2% |
| Skin and Appendages | |||
| Rash | 2% | 1% | 2% |
Treatment-emergent adverse events occurring in less than 2% of adult patients receiving Kaletra in all phase II/III clinical trials and considered at least possibly related or of unknown relationship to treatment with Kaletra and of at least moderate intensity are listed below by body system.
Body as a Whole
Allergic reaction, back pain, chest pain, chest pain substernal, cyst, drug interaction, drug level increased, face edema, flu syndrome, hypertrophy, infection bacterial, malaise, neoplasm, and viral infection.
Cardiovascular System
Atrial fibrillation, cerebral infarct, deep thrombophlebitis, deep vein thrombosis, migraine, myocardial infarct, palpitation, postural hypotension, thrombophlebitis, varicose vein, and vasculitis.
Digestive System
Cholangitis, cholecystitis, constipation, dry mouth, enteritis, enterocolitis, eructation, esophagitis, fecal incontinence, gastritis, gastroenteritis, hemorrhagic colitis, hepatitis, hepatomegaly, increased appetite, jaundice, liver fatty deposit, liver tenderness, mouth ulceration, pancreatitis, periodontitis, sialadenitis, stomatitis, and ulcerative stomatitis.
Endocrine System
Cushing's syndrome, diabetes mellitus, and hypothyroidism.
Hemic and Lymphatic System
Anemia, leukopenia, and lymphadenopathy.
Metabolic and Nutritional Disorders
Avitaminosis, dehydration, edema, glucose tolerance decreased, lactic acidosis, obesity, peripheral edema, and weight gain.
Musculoskeletal System
Arthralgia, arthrosis, bone necrosis, joint disorder, and myasthenia.
Nervous System
Abnormal dreams, agitation, amnesia, anxiety, apathy, ataxia, confusion, convulsion, dizziness, dyskinesia, emotional lability, encephalopathy, extrapyramidal syndrome, facial paralysis, hypertonia, nervousness, neuropathy, peripheral neuritis, somnolence, thinking abnormal, tremor, and vertigo.
Respiratory System
Asthma, cough increased, dyspnea, lung edema, pharyngitis, rhinitis, and sinusitis.
Skin and Appendages
Acne, alopecia, dry skin, eczema, exfoliative dermatitis, furunculosis, maculopapular rash, nail disorder, pruritis, seborrhea, skin benign neoplasm, skin discoloration, skin striae, skin ulcer, and sweating.
Special Senses
Abnormal vision, eye disorder, otitis media, taste loss, taste perversion, and tinnitus.
Urogenital System
Abnormal ejaculation, amenorrhea, breast enlargement, gynecomastia, impotence, kidney calculus, nephritis, and urine abnormality.
Post-marketing ExperienceThe following adverse reactions have been reported during post-marketing use of Kaletra. 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 Kaletra exposure.
Body as a Whole
Redistribution/accumulation of body fat has been reported.
Cardiovascular
Bradyarrhythmias.
Skin and Appendages
Stevens Johnson Syndrome and erythema multiforme.
Laboratory AbnormalitiesThe percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 14 and Table 15.
| Study 863 (48 Weeks) | Study 418 (48 Weeks) | Study 720 (360 Weeks) | ||||
| Variable | Limit1 | Kaletra 400/100 mg BID + d4T +3TC (N=326) |
Nelfinavir 750 mg TID + d4T + 3TC (N=327) |
Kaletra 800/200 mg QD + TDF + FTC (N=115) |
Kaletra 400/100 mg BID + TDF + FTC (N=75) |
Kaletra BID + d4T + 3TC (N=100) |
|
1 ULN = upper limit of the normal range; N/A = Not Applicable. |
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| Chemistry | High | |||||
| Glucose | >250 mg/dL | 2% | 2% | 3% | 1% | 4% |
| Uric Acid | >12 mg/dL | 2% | 2% | 0% | 3% | 5% |
| SGOT/ AST |
>180 U/L | 2% | 4% | 5% | 3% | 10% |
| SGPT/ ALT |
>215 U/L | 4% | 4% | 4% | 3% | 11% |
| GGT | >300 U/L | N/A | N/A | N/A | N/A | 10% |
| Total Cholesterol |
>300 mg/dL | 9% | 5% | 3% | 3% | 27% |
| Triglycerides | >750 mg/dL | 9% | 1% | 5% | 4% | 29% |
| Amylase | >2 x ULN | 3% | 2% | 7% | 5% | 4% |
| Hematology | Low | |||||
| Neutrophils | 0.75 x 109/L | 1% | 3% | 5% | 1% | 5% |
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | |||
| Variable | Limit1 | Kaletra 400/100 mg BID + NVP + NRTIs (N=148) |
Investigator-selected protease inhibitor(s) + NVP + NRTIs (N=140) |
Kaletra BID + NNRTI + NRTIs (N=127) |
|
1 ULN = upper limit of the normal range; N/A = Not Applicable. 2 Includes clinical laboratory data from patients receiving 400/100 mg BID (n=29) or 533/133 mg BID (n=28) for 84 weeks. Patients received Kaletra in combination with NRTIs and efavirenz. 3 Includes clinical laboratory data from patients receiving 400/100 mg BID (n=36) or 400/200 mg BID (n=34) for 144 weeks. Patients received Kaletra in combination with NRTIs and nevirapine. |
||||
| Chemistry | High | |||
| Glucose | >250 mg/dL | 1% | 2% | 5% |
| Total Bilirubin | >3.48 mg/dL | 1% | 3% | 1% |
| SGOT/AST | >180 U/L | 5% | 11% | 8% |
| SGPT/ALT | >215 U/L | 6% | 13% | 10% |
| GGT | >300 U/L | N/A | N/A | 29% |
| Total Cholesterol |
>300 mg/dL | 20% | 21% | 39% |
| Triglycerides | >750 mg/dL | 25% | 21% | 36% |
| Amylase | >2 x ULN | 4% | 8% | 8% |
| Chemistry | Low | |||
| Inorganic Phosphorus |
<1.5 mg/dL | 1% | 0% | 2% |
| Hematology | Low | |||
| Neutrophils | 0.75 x 109/L | 1% | 2% | 4% |
Pediatrics
Treatment-Emergent Adverse EventsKaletra has been studied in 100 pediatric patients 6 months to 12 years of age. The adverse event profile seen during a clinical trial was similar to that for adult patients.
Taste aversion, vomiting, and diarrhea were the most commonly reported drug related adverse events of any severity in pediatric patients treated with combination therapy including Kaletra for up to 48 weeks in Study 940. A total of 8 children experienced moderate or severe adverse events at least possibly related to Kaletra. Rash (reported in 3%) was the only drug-related clinical adverse event of moderate to severe intensity observed in ≥ 2% of children enrolled.
Laboratory AbnormalitiesThe percentages of pediatric patients treated with combination therapy including Kaletra with Grade 3-4 laboratory abnormalities are presented in Table 16.
| Variable | Limit1 | Kaletra BID+ RTIs (N = 100) |
|
1 ULN = upper limit of the normal range. 2 Subjects with Grade 3-4 amylase confirmed by elevations in pancreatic amylase. |
||
| Chemistry | High | |
| Sodium | > 149 mEq/L | 3% |
| Total Bilirubin | ≥ 3.0 x ULN | 3% |
| SGOT/AST | > 180 U/L | 8% |
| SGPT/ALT | > 215 U/L | 7% |
| Total Cholesterol | > 300 mg/dL | 3% |
| Amylase | > 2.5 x ULN | 7%2 |
| Chemistry | Low | |
| Sodium | < 130 mEq/L | 3% |
| Hematology | Low | |
| Platelet Count | < 50 x 109/L | 4% |
| Neutrophils | < 0.40 x 109/L | 2% |
Side Effects by Body System
General
Diarrhea, usually of mild to moderate severity, is the most common side effect associated with lopinavir-ritonavir. During 48 weeks of one study, diarrhea (any severity) occurred in 60% of patients receiving lopinavir-ritonavir tablets once a day compared to 57% receiving the tablets twice a day. In the same trial, treatment was discontinued in 4.8% of patients receiving lopinavir-ritonavir tablets once a day as compared to 3% receiving twice daily dosing due to any adverse effects. During another clinical trial, discontinuations due to side effects were observed in 3.4% of patients receiving lopinavir-ritonavir versus 3.7% receiving comparator.
Cardiovascular
Cardiovascular side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included hypertension (3%), distended veins (3%), and atrial fibrillation, atrioventricular (AV) block, myocardial infarction, cerebral infarct, deep vein thrombosis, chest pain, hypertension, palpitation, postural hypotension, thrombophlebitis, varicose vein, and vasculitis in less than 2% of adult patients. Sinus arrest and bradycardia-tachycardia syndrome have also been reported. Bradyarrhythmias, first-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, and torsades de pointes have been reported during postmarketing experience.
Dermatologic
Dermatologic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included rash (up to 5%) and acne, alopecia, dry skin, eczema, acneiform dermatitis, allergic dermatitis, exfoliative dermatitis, cellulitis, folliculitis, furunculosis, lipomatosis, idiopathic capillaritis, maculopapular rash, generalized rash, nail disorder, seborrhea, pruritus, benign skin neoplasm, skin discoloration, skin hypertrophy, skin ulcer, skin striae, swelling face, and hyperhidrosis in less than 2% of patients. Stevens-Johnson syndrome, erythema multiforme, and acute generalized exanthematous pustulosis have also been reported.
Endocrine
Endocrine side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included Cushing's syndrome, diabetes mellitus, and hypothyroidism in less than 2% of patients. Ketoacidosis has been reported.
Episodes of hyperglycemia, new onset diabetes mellitus, and exacerbation of preexisting diabetes mellitus have been reported during postmarketing studies in HIV-infected patients receiving protease inhibitors. In some cases, diabetic ketoacidosis has occurred. No causal relationship has been established. Careful monitoring of blood glucose levels should be done and either initiation or dose adjustments of insulin or oral hypoglycemic agents may be needed.
Gastrointestinal
Gastrointestinal side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included diarrhea (7% to 28%), nausea (5% to 16%), vomiting (2% to 6%), abdominal pain (1% to 11%), abnormal stools (up to 6%), dyspepsia (up to 6%), dysphagia (up to 2%), flatulence (1% to 4%), and anorexia (up to 2%). Cholangitis, cholecystitis, abdominal distention, upper abdominal pain, constipation, dry mouth, enterocolitis, eructation, esophagitis, fecal incontinence, gastric disorder, gastritis, gastroesophageal reflux disease, hemorrhoids, gastroenteritis, hemorrhagic enterocolitis, increased and decreased appetite, pancreatitis, periodontitis, sialadenitis, stomatitis, stomach discomfort, and ulcerative stomatitis have been reported in less than 2% of patients.
Pancreatitis, including fatalities, has occurred in patients receiving lopinavir-ritonavir therapy, including those who developed hypertriglyceridemia. Although a causal relationship has not been established, marked triglyceride elevation is a risk factor for the development of pancreatitis. Patients who experience signs or symptoms of pancreatitis should be evaluated and lopinavir-ritonavir should be stopped if a diagnosis of pancreatitis is made.
Genitourinary
Genitourinary side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included hypogonadism (2%) and ejaculation disorder, breast enlargement, gynecomastia, impotence, and urine abnormality in less than 2% of patients.
Hematologic
Hematologic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included decreased neutrophil counts (1% to 5%) and anemia, leukopenia, splenomegaly, and lymphadenopathy in less than 2% of patients. Hemolytic anemia and spontaneous bleeding in hemophiliacs have been reported rarely.
Hepatic
Hepatic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included elevated AST (1% to 10%), ALT (1% to 11%), and GGT (up to 29%) levels, and jaundice, fatty liver deposit, cytolytic hepatitis, hepatitis, hepatomegaly, and liver tenderness (less than 2% each). Hepatic failure has also been reported.
Metabolic
Metabolic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included elevations in amylase (3% to 8%), bilirubin (1% to 3%), blood glucose (up to 5%), total cholesterol (3% to 39%), triglycerides (3% to 36%), uric acid (up to 5%), and lipase (3% to 5%), decreased phosphorus levels (up to 2%), and weight loss (up to 3%). Avitaminosis, hypovitaminosis, dehydration, decreased glucose tolerance, lactic acidosis, obesity, and weight gain have been reported in less than 2% of patients.
Musculoskeletal
Musculoskeletal side effects have included myalgia (up to 2%) and arthralgia, back pain, arthrosis, bone necrosis, joint disorder, osteoarthritis, extremity pain, and myasthenia in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.
Nervous system
Nervous system side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included headache (2% to 7%), depression (up to 2%), insomnia (up to 3%), decreased libido (up to 2%), and paresthesia (1% to 2%). Amnesia, ataxia, convulsion, dizziness, dyskinesia, encephalopathy, facial paralysis, hypertonia, migraine, neuropathy, peripheral neuropathy, peripheral neuritis, somnolence, hyperacusis, tinnitus, tremor, extrapyramidal syndrome, ageusia, dysgeusia, and vertigo have been reported in less than 2%.
Ocular
Ocular side effects have included visual disturbance and eye disorder in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.
Other
Other side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included asthenia (up to 9%), pyrexia (2%), chills (up to 2%), and generalized pain, back pain, back and abdomen enlargement, chest pain, cyst, edema, peripheral edema, fatigue, face edema, flu syndrome, hypertrophy, malaise, lymphadenopathy, drug interaction, and increased drug level in less than 2% of patients. Elevated creatine kinase has also been reported.
Other
Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.
Oncologic
Oncologic side effects have included neoplasm and lipoma in less than 2% of patients when lopinavir-ritonavir was administered with other antiretroviral agents.
Renal
Renal side effects have included decreased calculated creatinine clearance (2%) and kidney calculus, nephritis, and renal disorder in less than 2% of patients when lopinavir-ritonavir was administered with other antiretroviral agents.
Respiratory
Respiratory side effects have included bronchitis (up to 2%) and asthma, dyspnea, lung edema, rhinitis, increased cough, and sinusitis in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.
Hypersensitivity
Hypersensitivity side effects have included drug hypersensitivity and hypersensitivity in less than 2% of patients receiving lopinavir-ritonavir in combination with other antiretroviral agents. At least one case of a severe skin and mucous hypersensitivity reaction with transient multiorgan failure has been reported.
TopMore resources:
Kaletra - Includes detailed dosage instructions.
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