Danlene

Indications of Danlene 25mg Capsule

Danlene 25mg Capsule is used to reduce the symptoms of clinical spasticity caused by upper motor neuron diseases (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is especially beneficial to patients whose functional rehabilitation has been slowed by spasticity complications. Such individuals must have reversible spasticity, with spasticity relief assisting in the restoration of residual function. Dantrolene should not be used to treat skeletal muscular spasms caused by rheumatic diseases. Dantrolene therapy can sometimes result in a slight but significant reduction in spasticity. 

Oral Dantrolene is also used preoperatively to prevent or reduce the development of signs of malignant hyperthermia in individuals who are known to be vulnerable to malignant hyperthermia and who require anesthesia and/or surgery. To prevent the recurrence of malignant hyperthermic symptoms, oral Dantrolene should be given after a malignant hyperthermic crisis.

 

Pharmacology of Danlene 25mg Capsule

Dantrolene causes relaxation by altering the contractile response of skeletal muscle directly on the muscle itself, beyond the myoneural junction. Dantrolene disrupts the excitation-contraction coupling in skeletal muscle, most likely through interfering with the release of Ca++ from the sarcoplasmic reticulum.

 

Danlene 25mg Capsule Dosage & Administration

For Use in Chronic Spasticity:

• Adults: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.
• Starting dose is 25 mg twice per day and it can be increased to 25-50 mg per day per week. Maximum accepted dosage is 400 mg per day.
• Paediatric Patients: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.
• 0.5 mg/kg once daily for seven days, then 0.5 mg/kg 3 times for 7 days, 1 mg/kg 3 times for 7 days, 2 mg/kg 3 times a day, Therapy with a dose 4 times daily may be necessary for some individuals.

For Malignant Hyperthermia

• Preoperatively: Administer 4 to 8 mg/kg/day of oral Dantrolene in 3 or 4 divided doses for one or two days prior to surgery, with the last dose being given approximately 3 to 4 hours before scheduled surgery with a minimum of water.
• Post Crisis Follow-up: Oral Dantrolene should also be administered following a malignant hyperthermia crisis, in doses of 4 to 8 mg/kg per day in four divided doses, for a one to three day period to prevent recurrence of the manifestations of malignant hyperthermia.

 

Interaction

Dantrolene therapy can cause sleepiness, and concomitant administration of CNS depressants such sedatives and tranquilizers might cause even more drowsiness. Hepatotoxicity has been seen more frequently in women over 35 who are taking estrogen medication at the same time.

 

Contraindications

Active hepatic disease, such as hepatitis and cirrhosis.

 

Danlene 25mg Capsule Side Effects

Drowsiness, dizziness, weakness, general malaise, lethargy, and diarrhea have been the most common Dantrolene side effects. These are usually temporary and occur early in therapy. They may typically be avoided by starting with a low dose and progressively increasing it until an appropriate regimen is found. Diarrhea can be severe, necessitating temporary discontinuation of Dantrolene medication. If diarrhea recurs after reintroduction of Dantrolene, treatment should most likely be discontinued completely.

 

Pregnancy & Lactation

Pregnancy Category C. Dantrolene capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dantrolene should not be used in nursing mothers.

 

Precautions & Warnings

In view of the potential for liver damage in long-term Dantrolene use, therapy should be stopped if benefits are not evident within 45 days. Patients should be cautioned against driving a motor vehicle or participating in hazardous occupations while taking Dantrolene. Caution should be exercised in the concomitant administration of tranquilizing agents. Dantrolene might possibly evoke a photosensitivity reaction; patients should be cautioned about exposure to sunlight while taking it. It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrolene therapy. At the start of Dantrolene therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is preexisting liver disease. Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during Dantrolene therapy. 

Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, Dantrolene should be discontinued. If caused by Dantrolene and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Dantrolene therapy has been reinstituted in a few patients who have developed clinical and/ or laboratory evidence of hepatocellular injury. If such reinstitution of therapy is done, it should be attempted only in patients who clearly need Dantrolene and only after previous symptoms and laboratory abnormalities have cleared

 

Therapeutic Class

Centrally acting Skeletal Muscle Relaxants

 

Storage Conditions

Store in a cool and dry place, protected from light. Keep all medicines out of reach of the children.

 

Pharmaceutical Name

Incepta Pharmaceuticals Ltd

 

Generic

Dantrolene Sodium