warnings
WARNINGS Methocarbamol Since methocarbamol may possess a general central nervous system depressant effect, patients receiving methocarbamol should be cautioned about combined effects with alcohol and other CNS depressants. Aspirin Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs, including Methocarbamol and Aspirin Tablets , in pregnant women at about 30 weeks gestation and later. NSAIDs including Methocarbamol and Aspirin Tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. Oligohydramnios/Neonatal Renal Impairment: Use of NSAIDs, including Methocarbamol 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 post marketing 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 Methocarbamol and Aspirin Tablets use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Methocarbamol and Aspirin Tablets treatment extends beyond 48 hours. Discontinue Methocarbamol and Aspirin Tablets if oligohydramnios occurs and follow up according to clinical practice (see PRECAUTIONS; Pregnancy ). Use In Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities. Serious Skin Reactions NSAIDs, including aspirin, a component of Methocarbamol and Aspirin Tablets, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of Methocarbamol and Aspirin Tablets at the first appearance of skin rash or any other sign of hypersensitivity. Methocarbamol and Aspirin Tablets is contraindicated in patients with previous serious skin reactions to NSAIDs [see CONTRAINDICATIONS ]. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Methocarbamol and Aspirin Tablets. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively presents with fever, rash, lymphadenopathy and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Methocarbamol and Aspirin Tablets and evaluate the patient immediately.