Denbac 50 mg (Capsule)

Indications

• Control manifestations of clinical spasticity
• Beneficial for patients with upper motor neuronal disorders
• Beneficial for patients with spinal cord injury, stroke, cerebral palsy, or multiple sclerosis
• Not indicated for skeletal muscle spasm resulting from rheumatic disorders
• Aid in restoring residual function
• Prevent or attenuate signs of malignant hyperthermia
• Use in chronic spasticity
• Use in malignant hyperthermia

Pharmacology

• Relaxation of skeletal muscle
• Affects contractile response of skeletal muscle
• Interferes with release of Ca++ from sarcoplasmic reticulum

Dosage & Administration

• Gradual titration schedule for adults
• Gradual titration schedule for pediatric patients
• Maximum accepted dosage
• Preoperative administration for malignant hyperthermia
• Post-crisis follow-up dosage

Interaction

• Potential drowsiness
• Concomitant administration with CNS depressants
• Hepatotoxicity occurrence in women over 35 years on estrogen therapy

Contraindications

• Active hepatic disease such as hepatitis and cirrhosis

Side Effects

• Drowsiness
• Dizziness
• Weakness
• General malaise
• Fatigue
• Diarrhea
• Transient side effects early in treatment

Pregnancy & Lactation

• Pregnancy category C
• Use during pregnancy if potential benefit justifies potential risk to fetus
• Not to be used in nursing mothers

Precautions & Warnings

• Potential for liver damage in long-term use
• Caution against driving or participating in hazardous occupations
• Caution in concomitant administration of tranquilizing agents
• Possibility of photosensitivity reaction
• Risk of fatal and non-fatal liver disorders
• Baseline liver function studies at the start of therapy
• Liver function studies at appropriate intervals during therapy
• Caution in patients with impaired pulmonary function
• Caution in patients with severely impaired cardiac function
• Caution in patients with a history of previous liver disease or dysfunction

Use in Special Populations

• Long-term safety not established in pediatric patients under 5 years
• Benefit-risk consideration of long-term use in pediatric patients

Therapeutic Class

• Centrally acting Skeletal Muscle Relaxants

Storage Conditions

• Store in a cool & dry place
• Protected from light

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