Sirdalud Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Tizanidine HCl

Indications/Uses

Tab: Painful muscle spasm associated w/ static & functional disorders of spine (cervical & lumbar syndromes) & following surgery eg, herniated intervertebral disc or OA of hip. Tab & MR cap: Spasticity due to neurological disorders eg, multiple sclerosis, chronic myelopathy, degenerative spinal cord diseases, CVA, cerebral palsy.

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Dosage/Direction for Use

Relief of painful muscle spasms 2-4 mg tid. Severe cases May take extra dose of 2 mg or 4 mg preferably at night. Spasticity due to neurological disorders Initial dose: Not to exceed 6 mg daily in 3 divided doses. May be increased stepwise ½ wkly- or wkly-interval by 2-4 mg. Optimum therapeutic response: 12-24 mg in 3 or 4 equally spaced doses. Max daily dose: Not to exceed 36 mg. Elderly Start treatment at lowest dose, & may increase dose according to tolerability & efficacy. Renal impairment (CrCl <25 mL/min) Start treatment at 2 mg once daily, & may increase dose according to tolerability & efficacy.

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Overdosage

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Administration

Should be taken on an empty stomach.

Contraindications

Hypersensitivity. Concomitant use w/ strong CYP1A2 inhibitors eg, fluvoxamine or ciprofloxacin. Severely impaired hepatic function.

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Special Precautions

Discontinue use if anaphylaxis or angioedema w/ anaphylactic shock or difficulty of breathing is observed; serum levels of SGPT or SGOT are persistently >3x ULN range. Gradually down titrated & not to be stopped abruptly. Hypotension; rebound HTN & tachycardia. Monitor LFTs mthly for 1st 4 mth in patients receiving doses of ≥12 mg & who develop unexplained nausea, anorexia, or tiredness. Not recommended in concomitant use w/ moderate CYP1A2 inhibitors. Drugs known to increase QT interval. May affect ability to drive & use machines. Consider pregnancy testing prior to starting treatment; use of effective contraception during treatment & for 1 day after discontinuation of treatment in sexually active females of reproductive potential. Not to be used during pregnancy. Not to be given in lactating women. Not recommended in childn <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Somnolence, dizziness; GI disorder, dry mouth; muscular weakness; fatigue. Insomnia, sleep disorder; hypotension; nausea; decreased BP, increased transaminases.

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Drug Interactions

Increased plasma levels w/ drugs known to inhibit CYP1A2 activity. Decreased plasma levels w/ drugs known to induce CYP1A2 activity. Increased AUC w/ fluvoxamine or ciprofloxacin. Co-administration w/ other CYP1A2 inhibitors eg, antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, OCs, & ticlopidine. Drugs known to prolong QT interval (including but not limited to cisapride, amytriptyline & azithromycin). Concomitant use w/ antihypertensives, including diuretics. Decreased conc w/ rifampicin. Decreased systemic exposure w/ cigarettes. Enhanced CNS depressant effects of alcohol. Enhanced sedative action w/ sedatives, hypnotics (eg, benzodiazepine or baclofen), & other drug eg, antihistamines. Potential additive hypotensive effect w/ other α-2 adrenergic agonists (eg, clonidine).

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Muscle Relaxants

ATC Classification

M03BX02 - tizanidine ; Belongs to the class of other centrally-acting muscle relaxants.

Thai FDA Category

Presentation/Packing

Form

Sirdalud tab 2 mg

Packing/Price

10 × 10's

Form

Sirdalud tab 4 mg

Packing/Price

3 × 10's

Sirdalud

tizanidine

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma