Tizanidne Hydrochloride
Generic Name: tizanidne hydrochloride
Brand Names:
Tizanidne Hydrochloride
11 DESCRIPTION Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9 H 8 ClN 5 S-HCl and a molecular weight of 290.2. Its structural formula is: Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder.
Overview
11 DESCRIPTION Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9 H 8 ClN 5 S-HCl and a molecular weight of 290.2. Its structural formula is: Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder.
Uses
1 INDICATIONS AND USAGE Tizanidine capsules are indicated for the treatment of spasticity in adults. Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Monitoring of aminotransferase levels is recommended at baseline and 1 month after maximum dose is achieved. ( 2.1 ) • Recommended starting dose: 2 mg by mouth every 6 to 8 hours, as needed, up to a maximum of 3 doses in 24 hours ( 2.2 ) • Dosage can be increased by 2 mg to 4 mg per dose every 1 to 4 days; maximum total daily dosage is 36 mg ( 2.2 ) • Tizanidine pharmacokinetics differs between tablets and capsules, and when taken with or without food. These differences could result in a change in tolerability and control of symptoms. Consistent administration with respect to food is recommended. If substitution between dosage forms is necessary, take into consideration these pharmacokinetic differences.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information: • Hypotension [see Warnings and Precautions ( 5.1 )] • Liver Injury [see Warnings and Precautions ( 5.2 )] • Sedation [see Warnings and Precautions ( 5.3 )] • Hallucinosis/Psychotic-Like Symptoms [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Withdrawal Adverse Reactions [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (greater than 10% of patients taking tizanidine and greater than in patients taking placebo) were dry mouth, somnolence, asthenia, and dizziness.
Interactions
7 DRUG INTERACTIONS Moderate or weak CYP1A2 inhibitors: avoid concomitant use; may cause hypotension, bradycardia, or excessive drowsiness; if concomitant use is necessary and adverse reactions occur, reduce tizanidine dosage or discontinue. ( 7.2 , 12.3 ) 7.1 Strong CYP1A2 Inhibitors Concomitant use of tizanidine with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated. Changes in pharmacokinetics of tizanidine when administered with a strong CYP1A2 inhibitor resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.3 )].
Warnings
5 WARNINGS AND PRECAUTIONS • Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other α2-adrenergic agonists ( 5.1 , 7.7) • Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs ( 5.2 ) • Sedation: Tizanidine may interfere with everyday activities; sedative effects of tizanidine, alcohol, and other central nervous system (CNS) depressants are additive ( 5.3 , 7.4 ) • Hallucinations: consider discontinuation of tizanidine ( 5.4 ) 5.1 Hypotension Tizanidine is an α2-adrenergic agonist that can produce hypotension [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.5 )]. 4 CONTRAINDICATIONS Tizanidine capsules are contraindicated in patients: • taking strong CYP1A2 inhibitors [see Drug Interactions ( 7.1 )]. • with a history of hypersensitivity to tizanidine or the ingredients in tizanidine capsules. Symptoms have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.5 )].
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of tizanidine in pregnant women. In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically, which were not associated with maternal toxicity (see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tizanidine capsules • Tizanidine capsules 4 mg have a hard gelatin capsule size "3" blue opaque cap, imprinted "4MG" with white ink and "Tiza" & white opaque body "circle of thin line" with black ink, containing light yellow to yellow color pellets. Tizanidine capsules 4 mg are supplied as follows.
Frequently Asked Questions
What is Tizanidne Hydrochloride used for?▼
1 INDICATIONS AND USAGE Tizanidine capsules are indicated for the treatment of spasticity in adults. Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )
What are the side effects of Tizanidne Hydrochloride?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information: • Hypotension [see Warnings and Precautions ( 5.1 )] • Liver Injury [see Warnings and Precautions ( 5.2 )] • Sedation [see Warnings and Precautions ( 5.3 )] • Hallucinosis/Psychotic-Like Symptoms [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Withdrawal Adverse Reactions [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (greater than 10% of patients taking tizanidine and greater than in patients taking placebo) were dry mouth, somnolence, asthenia, and dizziness.
Can I take Tizanidne Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of tizanidine in pregnant women. In animal studies, administration of tizanidine during pregnancy resulted in developmental toxicity (embryofetal and postnatal offspring mortality and growth deficits) at doses less than those used clinically, which were not associated with maternal toxicity (see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
What are the important warnings for Tizanidne Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS • Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other α2-adrenergic agonists ( 5.1 , 7.7) • Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs ( 5.2 ) • Sedation: Tizanidine may interfere with everyday activities; sedative effects of tizanidine, alcohol, and other central nervous system (CNS) depressants are additive ( 5.3 , 7.4 ) • Hallucinations: consider discontinuation of tizanidine ( 5.4 ) 5.1 Hypotension Tizanidine is an α2-adrenergic agonist that can produce hypotension [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.5 )]. 4 CONTRAINDICATIONS Tizanidine capsules are contraindicated in patients: • taking strong CYP1A2 inhibitors [see Drug Interactions ( 7.1 )]. • with a history of hypersensitivity to tizanidine or the ingredients in tizanidine capsules. Symptoms have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.5 )].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.