Sirdalud Drug Interactions

Concomitant administration of drugs known to inhibit the activity of CYP1A2 may increase the plasma levels of tizanidine (see CLINICAL PHARMACOLOGY: Pharmacokinetics under Actions). The increased plasma levels of tizanidine may result in overdose symptoms such as QT(c) prolongation (see also OVERDOSAGE).
Concomitant administration of drugs known to induce the activity of CYP1A2 may decrease the plasma levels of tizanidine (see CLINICAL PHARMACOLOGY: Pharmacokinetics under Actions). The decreased plasma levels of tizanidine may reduce the therapeutic effect of Sirdalud.
Observed interactions resulting in a contraindication: Concomitant use of Sirdalud with fluvoxamine or ciprofloxacin, both CYP1A2 inhibitors is contraindicated. Concomitant use of Sirdalud with fluvoxamine or ciprofloxacin resulted in a 33-fold and 10-fold increase in tizanidine AUC, respectively (see CONTRAINDICATIONS). Clinically significant and prolonged hypotension may result along with somnolence, dizziness and decreased psychomotor performance (see PRECAUTIONS). The increased plasma levels of tizanidine may result in overdose symptoms such as QT(c) prolongation (see also OVERDOSAGE).
Observed interactions resulting in a concomitant use not recommended: Co-administration of Sirdalud with other inhibitors of CYP1A2 such as antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives, and ticlopidine is not recommended (see PRECAUTIONS).
Observed interactions to be considered: Caution should be exercised when Sirdalud is given with drugs known to prolong the QT interval (including but not limited to cisapride, amytriptyline and azithromycin) (see PRECAUTIONS).
Antihypertensives: Concomitant use of Sirdalud with antihypertensives, including diuretics, may occasionally cause hypotension (see PRECAUTIONS) and bradycardia. In some patients rebound hypertension and tachycardia have been observed upon abrupt discontinuation of Sirdalud when concomitantly used with antihypertensive drugs. In extreme cases, rebound hypertension might lead to cerebrovascular accident (see PRECAUTIONS and ADVERSE REACTIONS).
Rifampicin: Concomitant administration of Sirdalud with rifampicin results in 50% decrease in tizanidine concentrations. Therefore, the therapeutic effects of Sirdalud may be reduced during treatment with rifampicin, which may be of clinical significance in some patients. Long term co-administration should be avoided and if co-administration is considered a careful dose adjustment (increase) may be required.
Cigarette smoke: Administration of Sirdalud in smokers (>10 cigarettes per day) results in about 30% decrease in tizanidine systemic exposure. Long-term therapy with Sirdalud in heavy smokers may require higher doses than the average doses.
Alcohol: While on Sirdalud therapy, alcohol consumption should be minimized or avoided as it may increase the potential for adverse events (e.g. sedation and hypotension). The central nervous system depressant effects of alcohol may be enhanced by Sirdalud.
Anticipated interactions to be considered: Sedatives, hypnotics (e.g. benzodiazepine or baclofen), and other drug such as antihistamines may enhance the sedative action of tizanidine.
Sirdalud should be avoided when using with other alpha-2 adrenergic agonists (such as clonidine) because of their potential additive hypotensive effect.