SNEPDOL
Manufacturer Details
SUN PHARMA
Compositions:
Flupirtine maleate 100mg capsules,
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Strength
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Rate
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Packing Style
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100mg
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0.00
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Tab
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List of Related Indications:
List Of Drugs:
- Flupirtine maleate - Anti-inflammatory
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
No published information on pharmacokinetic interactions between flupritine and other hepatically metabolized drugs.
Flupirtine is reported to delay the diuretic response to furosemide without affecting the magnitude of response There is a possible potentiation of anticoagulant effects of co-administration of flupirtine with other oral anticoagulants and the need for regular monitoring of blood coagulation times during treatment.
Indication:
Acute and chronic pain especially of musculoskeletal origin
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Flupirtine Meleate capsules 100mg 12-06-2010
For the acute and chronic treatment of-
1.For painful increased muscle tone of the posture and motor muscles,
primary headache, tumor pain, dysmenorrhoea, and pain after
traumotologic/ orthopaedic operations and injuries
Adverse Reaction:
Common adverse events reported are- Insomnia, Dizziness, Drowsiness, Sweating, Vomiting Headache, Blurred vision,Dry mouth, Nausea, impaired taste Poor concentration, Pruritis, Pain in forehead, Gastric fullness Muscular tremor
Contra-Indications:
Information not available
Dosages/ Overdosage Etc:
Acute and chronic pain especially of musculoskeletal origin
Dosage-
Available in 50 and 100mg oral capsules
and 75 and 150mg rectal suppositories
Recommeded dose-
One 100mg capsule or 150mg suppository 3 to 4 times daily. Maximum of 6 doses daily
For more severe pain- single 200mg oral dose may be taken upto 3 times daily.
Children- ( 6 years) is 50mg orally or 75mg rectally 3 or 4 times daily. Maximum 6 doses per daily.
Duration of treatment should not exceed 8 days without revew bya medical practioner or 4 weeks on repeated prescription
Monitoring of transaminases is recommended on prolonged administration.
Elderly patients and or those with mild to moderate renal impairment, therapy should be initiated with the lowest dose which will acheive pain relief.
Dosage of flupiritine 100mg 3 times daily has been suggested
Creatinine clearance should be monitored in these patients if therapy is prolonged
Patients with hypoalbuminaema may require a reduction in dose of flupiritine
Pharmacology/ Pharmacokinetics:
Pharmacolgy- Flupirtine maleate is a non-opioid drug without antipyretic and anti-inflammatory properties The analgesic effect of fupiritine does not appear to be associated with central opioid effect. Flupiritine can be classified as a centrally acting non- opioid analgesic with a novel mechanism of action. The analgesic properties are not diminished by the opiod antagonist naloxone Flupirtine does not induce any physical dependence seen with opioid drugs Flupirtine does not induce drug tolerance or the need for an increase of dosage to maintain the clinical effect. Flupiritine has not demonstrated any affinity for any of the known opiate receptors Its chemical struucture does not resemble morphine or any of its analogs Flupiritine does not demonstrate the classic side effects of opiods or NSAIDs Pharmacokinetics- Flupiritine is a freely soluble in water and undergoes rapid gastric absorption After a a single dose admininstration of flupirtine 100 or 200mg to healthy volunteers, flupiritine appeared in plama within 15-30 minutes resulting in peak concentration Cmax of appoximately 0.8 and 2.0 mg/L at 1.6 to 2 hours Plasma flupiritine concentrations reached steady-stae after 2 days in 54 healthy volunteers receiving 75 to 150mg at 12-hour intervals Plasma drug accumulation was not observed after oral administration of flupiritine 100mg times daily for 28 days.
