Relaxo 25

Indications of Relaxo 25

In Chronic Spasticity: Dantrolene is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuronal disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patients whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrolene therapy. In such instances, information regarding improvement should be solicited from the patient. Brief withdrawal of Dantrolene for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.

A decision to continue the administration of Dantrolene on a long-term basis is justified if introduction of the drug into the patient's regimenproduces a significant reduction in painful and/or disabling spasticity such as clonus, orpermits a significant reduction in the intensity and/or degree of nursing care required, orrids the patient of any annoying manifestation of spasticity considered important by the patient himself.

In Malignant Hyperthermia: Oral Dantrolene is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Oral Dantrolene should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.

 

Pharmaceutical Name

Ziska Pharmaceuticals Ltd.

 

Pharmacology

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.

 

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 of Relaxo 25

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

Hepatitis and cirrhosis are examples of active hepatic illness.

 

Side Effects of Relaxo 25

The most frequently occurring side effects of Dantrolene have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of Dantrolene therapy. If diarrhea recurs upon readministration of Dantrolene, therapy should probably be withdrawn permanently.

 

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. 

 

Therapeutic Class

Centrally acting Skeletal Muscle Relaxants.

 

Storage Conditions

Store in a cold, dry, and light-protected location.

 

Generic Name of Relaxo 25

Dantrolene Sodium

 

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