Dentro 50 mg (Capsule)

Indications

• Controlling manifestations of clinical spasticity
• Benefit for patients with upper motor neuronal disorders
• Benefit for patients with spinal cord injury, stroke, cerebral palsy, or multiple sclerosis
• Benefit for patients with presumably reversible spasticity
• Reduction in painful and/or disabling spasticity
• Reduction in intensity and/or degree of nursing care required
• Benefit for patients with malignant hyperthermia
• Prevention or attenuation of signs of malignant hyperthermia
• Post-crisis follow-up for malignant hyperthermia
• Significant reduction in spasticity manifestations
• Rids the patient of annoying manifestations of spasticity

Pharmacology

• Produces relaxation in skeletal muscle
• Affects the contractile response of skeletal muscle
• Interferes with the release of Ca++ from the sarcoplasmic reticulum
• Dissociates excitation-contraction coupling

Dosage & Administration

• Gradual titration schedule for adults
• Gradual titration schedule for paediatric patients
• Maximum accepted dosage is 400 mg per day for adults
• Starting dose of 25 mg twice per day for adults
• Dose escalation for paediatric patients
• Administering oral Dentro preoperatively for malignant hyperthermia
• Administering oral Dentro post-crisis for malignant hyperthermia

Interactions

• Drowsiness may occur with Dentro therapy
• Concomitant administration of CNS depressants may result in further drowsiness
• Hepatotoxicity risk with concomitant 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 in pregnancy only if potential benefit justifies the potential risk to the fetus
• Not to be used in nursing mothers

Precautions & Warnings

• Potential for liver damage in long-term use
• Therapy should be stopped if benefits are not evident within 45 days
• Caution against driving or participating in hazardous occupations
• Possible photosensitivity reaction
• Monitoring of liver function during therapy
• Potential for fatal and non-fatal liver disorders
• Caution in females and patients over 35 years of age
• 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
• Protect from light

Related Brands

• Denbac 50 mg (Capsule) - beacon-pharmaceuticals-plc
• Denbac 25 mg (Capsule) - beacon-pharmaceuticals-plc