tongue, stomatitis, abdominal swelling, dry mouth, microscopic
colitis. During treatment with omeprazole, gastric fundic gland
polyps have been noted rarely. These polyps are benign and appear to
be reversible when treatment is discontinued.
Gastroduodenal carcinoids have been reported in patients with ZE
syndrome on long-term treatment with PRILOSEC. This finding is
believed to be a manifestation of the underlying condition, which is
known to be associated with such tumors.
Hepatic: Liver disease including hepatic failure (some fatal), liver
necrosis (some fatal), hepatic encephalopathy hepatocellular disease,
cholestatic disease, mixed hepatitis, jaundice, and elevations of liver
function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]
Infections and Infestations: Clostridium difficile associated diarrhea
Metabolism and Nutritional disorders: Hypoglycemia,
hypomagnesemia, hyponatremia, weight gain
Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint
pain, leg pain, bone fracture
Nervous System/Psychiatric: Psychiatric and sleep disturbances
including depression, agitation, aggression, hallucinations, confusion,
insomnia, nervousness, apathy, somnolence, anxiety, and dream
abnormalities; tremors, paresthesia; vertigo
Respiratory: Epistaxis, pharyngeal pain
Skin: Severe generalized skin reactions including toxic epidermal
necrolysis (some fatal), Stevens-Johnson syndrome, and erythema
multiforme; photosensitivity; urticaria; rash; skin inflammation;
pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis
Special Senses: Tinnitus, taste perversion
Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic
neuritis, dry eye syndrome, ocular irritation, blurred vision, double
vision
Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated
serum creatinine, microscopic pyuria, urinary tract infection,
glycosuria, urinary frequency, testicular pain
Hematologic: Agranulocytosis (some fatal), hemolytic anemia,
pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia,
leucocytosis
7 DRUG INTERACTIONS
7.1 Interference with Antiretroviral Therapy
Concomitant use of atazanavir and nelfinavir with proton pump
inhibitors is not recommended. Co-administration of atazanavir with
proton pump inhibitors is expected to substantially decrease
atazanavir plasma concentrations and may result in a loss of
therapeutic effect and the development of drug resistance. Co-
administration of saquinavir with proton pump inhibitors is expected
to increase saquinavir concentrations, which may increase toxicity
and require dose reduction.
Omeprazole has been reported to interact with some antiretroviral
drugs. The clinical importance and the mechanisms behind these
11
Reference ID: 3196017