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Neuralgin RX (methampirone thiamine pyridoxine cyanocobalamin, trimethylxanthine)



NEURALGIN RX

Methampirone, Thiamine HCl, Pyridoxine HCl, Cyanocobalamin, Trimethylxanthine.


COMPOSITION

Each film coaterd caplet contains :
Methampyrone                                     500 mg
Thiamine HCl                                                     50 mg
Pyridoxine HCl                                       10 mg
Cyanocobalamin                                                  10 mg
Trimethylxanthine                                                 50 mg


PHARMACOLOGY

Methampyrone is a potent nonnarcotic analgesic – antipyretic drug. It is a pyrazolon derivative with therapeutic efficacy equivalent to that of acetosal, the standard drug for  the nonnarcotic analgesic – antipyretic class. It cause less gastric irritation that acetosal and does not produce the acid – base or metabolic effect of salicylate.
Hewever, it has been implicated for many heares to cause a high incident of agranulocytosis. An epidemiologic study of international scale involving about 30 million people had been especially designed to study this matter.
The study was completed just recently and the results showed that methampurone , in fact, accounted for only a very low incidence of agranulocytosis.
Trimethylxanthine is commonly added to an analgesic as an analgesic adjuvant. In a dose of 50 mg or more, trimethylxanthine has been shown to enhance the analgesic efficacy of acetosal adan acetaminophen; in this case methampyrone should not be an exception.
Thiamine HCl, pyridoxine HCl and cyanocobalamin are neurotropic vitamins; deficiency of any of these vitamins may cause some form of neurologic disturbance.


INDICATIONS
Relief of mild to severe pain, such as headache especially tension headache, myalgia, arthralgia, neuralgia, lumbago, tootache, menstrual pain, pain from cancer, biliary and renal colic, postpartum pain, postoperative pain.


CONTRAINDICATION
1.      Hypersensitivity to methampurone and other nonsteroidal anti inflammatory drugs.
2.      Concomitant administration with chlorpromazine (may result in serious hypothermia)


PRECAUTIONS
1.      Use with caution in        - peptic ulcer (active/history)
- hemostatic defect (avoid) or anticoagulant therapy
- severe liver disease
- pregnancy (not recommended) especially late pregnancy.
- nursing mother (not recommended)
- infants
- history of blood dyscasia.
             
2.      Discontinue the drug if the following develops :
·        Fever, some throat or stomatitis (may indicated agranulocytosis, hematologic evaluation should be performed)
·        Evidence of peptic ulceration or gastrointestinal bleeding.


ADVERSE REACTIONS

The most frequent are gastrointestinal symtoms, such as nausea, vomiting, epigastric discomfort etc.
NERUALGIN RX may also cause hypersensitivity reactions, e.g. skin rashes and pruritus. Side effect occuring rarely are gastrointestinal bleeding and ulceration, leukopenia and agranulcytosis.


DOSAGE
Adult                : 1-2 caplets 3 to 4 times daily
Children           : ½ -1 caplet 3 to 4 times daily
If gastrointestinal discomfort occurs, administer NEURALGIN RX with or after meals


STORAGE
Sore below 300C


PRESENTATION

Box of 10 strips x 10 film coated caplets.
Reg.No. DKL8511603809A1
PT KALBE FARMA




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