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Author: Admin | 2025-04-28
Renal Impairment: Use of NSAIDs, including Hydrocodone Bitartrate and Aspirin Tablets, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit Hydrocodone Bitartrate and Aspirin Tablets use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Hydrocodone Bitartrate and Aspirin Tablets treatment extends beyond 48 hours. Discontinue Hydrocodone Bitartrate and Aspirin Tablets if oligohydramnios occurs and follow up according to clinical practice [see PRECAUTIONS; Pregnancy]. Risks of Driving and Operating Machinery Hydrocodone Bitartrate and Aspirin Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Hydrocodone Bitartrate and Aspirin Tablets and know how they will react to the medication [see PRECAUTIONS; Information for Patients/Caregivers]. Hypersensitivity to Hydrocodone of Aspirin, (e.g. angioedema) Hydrocodone Bitartrate and Aspirin Tablets are contraindicated in patients with known hypersensitivity to hydrocodone or aspirin, and in any situation where opioids or aspirin are contraindicated. Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma). Coagulation Abnormalities and Bleeding Risks Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders. Aspirin is contraindicated in patients
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