Dentro Capsule
Dantrolene Sodium
25mg
Healthcare Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 10.00 AED |
Available as:
Indications
Dentro Capsule is used for:
Muscle tightness, muscle cramping (spasms), muscle pain caused by spinal cord injury, stroke, cerebral palsy, multiple sclerosis.
Adult Dose
Oral
Spasticity
Adult: Initially, 25 mg daily increased gradually at 7-day intervals over 7 weeks.
Discontinue if no response after 45 days of treatment.
Max: 100 mg 4 times daily.
Child Dose
Oral
Spasticity
Child: Initially, 0.5 mg/kg once daily, may increase gradually to 2 mg/kg 3-4 times daily. Max: 100 mg 4 times daily.
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Active liver disease; acute muscle spasm; patients who use their spasticity to maintain posture or function. Lactation.
Precautions
The incidence of symptomatic (fatal and nonfatal) hepatitis is lower with doses up to 400 mg daily compared to >800 mg daily
Overt hepatitis has been most frequently observed during third and twelfth months, but may occur at anytime. Risk higher in females and patients >35 years, and with concurrent therapy
Use only in conjunction with liver monitoring
Should not be used in conditions other than those recommended; discontinue therapy if benefits not observed within 45 days in chronic spasticity
Possibility of severe hepatotoxicity
Risk of muscle weakness
Risk of photosensitivity reactions
Females, >35 years, receiving other drugs, history of liver disease
Not indicated in muscle spasms due to rheumatic disorder or musculoskeletal trauma
Ineffective in ALS
Use caution when administering oral therapy in patients with severely impaired cardiac function resulting from myocardial disease
Use caution when administering oral therapy in patients with impaired pulmonary function
In combination with calcium channel blockers, IV dantrolene may increase risk for hyperkalemia and cardiac arrest (combination not recommended)
Severely impaired cardiac function due to myocardial disease
Associated with pleural effusion with associated eosinophilia
MONITORING PARAMETERS
With oral use: Test liver function before and at intervals during therapy.
Pregnancy-Lactation
Pregnancy & Lactation
Pregnancy
Available data on use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; the drug readily crosses placenta; however, no serious adverse events reported in neonate following maternal administration of drug prior to delivery; there are risks to pregnant woman and fetus associated with untreated malignant hyperthermia
Malignant hyperthermia is a medical emergency that can be fatal for the pregnant woman and fetus if left untreated; life-sustaining therapy should not be withheld due to pregnancy
Labor or Delivery
In uncontrolled study, 100 mg per day of prophylactic oral dantrolene sodium was administered to term pregnant patients awaiting labor and delivery; the drug readily crossed placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply; no neonatal respiratory and neuromuscular side effects were observed in this study
Animal data
In animal reproduction studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose
Lactation
Dantrolene is reported to be present in human milk following intravenous administration over 3 days; there are no data on effects on breastfed infant or effects on milk production; because of potential for serious adverse reactions in breastfed infant, including respiratory depression and muscle weakness, advise patients that breastfeeding is not recommended during treatment and for 3 days after last dose
A lactating woman should interrupt breastfeeding and pump and discard breast milk during treatment and for 3 days after last dose administered
Interactions
CNS depressants; oestrogens; calcium-channel blockers.
CNS effects enhanced by alcohol or CNS depressants.
Contraindicated (8)
amlodipine
diltiazem
felodipine
levamlodipine
nicardipine
nisoldipine
vecuronium
verapamil
Serious (35)
apalutamide
benzhydrocodone/acetaminophen
buprenorphine subdermal implant
buprenorphine transdermal
buprenorphine, long-acting injection
calcium/magnesium/potassium/sodium oxybates
carbamazepine
enzalutamide
fentanyl
fentanyl intranasal
fentanyl iontophoretic transdermal system
fentanyl transdermal
fentanyl transmucosal
fexinidazole
fosphenytoin
hydrocodone
idelalisib
ivosidenib
lonafarnib
methohexital
metoclopramide intranasal
oliceridine
olopatadine intranasal
opicapone
pexidartinib
phenobarbital
phenytoin
primidone
remifentanil
sodium oxybate
sufentanil SL
thalidomide
tolcapone
tucatinib
zuranolone
Adverse Effects
Side effects of Dantrolene Sodium :
Frequency Not Defined
Increased serum AST (SGOT), ALT (SGPT), alkaline phosphatase, LDH, BUN, and total serum bilirubin concentrations
Fatal/nonfatal hepatitis
Diarrhea
Anorexia
Nausea
Vomiting
Gastric irritation
Abdominal cramps
Constipation
Dysphagia
GI bleeding
Adynamic ileus
Speech disturbance
Headache
Visual disturbances
Dysgeusia
Mental depression
Confusion
Auditory/visual hallucinations
Increased nervousness
Insomnia
Drooling
Exacerbation/precipitation of seizures
Muscle weakness
Drowsiness
Dizziness
Urinary frequency/incontinence
Nocturia
Difficult urination/urinary retention
Crystalluria, hematuria
Difficult erection
Abnormal hair growth
Acneiform rash
Eczematoid eruption
Pruritus, urticaria
Sweating
Tachycardia
Erratic blood pressure
Phlebitis
Heart failure
Aplastic anemia
Anemia
Leukopenia
Lymphocytic
Lymphoma
Thrombocytopenia
Respiratory depression
Pleural effusion with associated eosinophilia
Potentially Fatal: Hepatotoxicity, pleural effusion with pericarditis.
Mechanism of Action
Dantrolene has a direct action on skeletal muscle. It uncouples muscular contraction from excitation, probably by interfering with calcium release from sarcoplasmic reticulum.
Note
Dentro 25mg Capsule manufactured by Healthcare Pharmaceuticals Ltd.. Its generic name is Dantrolene Sodium. Dentro is availble in Bangladesh.
Farmaco BD drug index information on Dentro Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.