Methampyrone, Thiamine HCl, Pyridoxine HCl, Cyanocobalamin, Trimethylxanthine
film coated caplets
Composition
Each film coated caplet contains :
Methampyrone | 500 | mg |
Thiamine HCl | 50 | mg |
Pyridoxine HCl | 10 | mg |
Cyanocobalamin | 10 | mcg |
Trimethylxanthine | 50 | mg |
Pharmacology
Methampyrone is a potent non narcotic analgesic - antipyretic drug. It is a pyrazolon derivative with therapeutic efficacy equivalent to that of acetosal, the standard drug for the non narcotic analgesic - antipyretic class. It causes less gastric irritation than acetosal and does not produce the acid - base or metabolic effects of salicylate.
However, it has been implicated for many years to cause a high incidence 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 methampyrone, 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 and 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 disturbances.
Indications
Relief of mild to severe pain, such as headache especially tension headache, myalgia, arthralgia, neuralgia, lumbago, toothache, menstrual pain, pain from cancer, biliary and renal colic, postpartum pain, postoperative pain.
Contraindications
- Hypersensitivity to methampyrone and other nonsteroidal anti inflammatory drugs.
- Concomitant administration with chlorpromazine (may result in serious hypothermia).
- Use with caution in:
- peptic ulcer (active/history).
- hemostatic defects (avoid) or anticoagulant therapy.
- severe liver disease.
- pregnancy (not recommended) especially late pregnancy.
- nursing mothers (not recommended).
- infants.
- history of blood dyscrasia.
- Discontinue the drug if the following develops :
- lever, sore throat or stomatitis ( may indicate agranulocytosis, hematologic evaluation should be performed). .
- evidence of peptic ulceration or gastrointestinal bleeding.
The most frequent are gastrointestinal symptoms, such as nausea, vomiting, epigastric discomfort etc.
NEURALGIN RX® may also cause hypersensitivity reactions, e.g. skin rashes and pruritus. Side effects occuring rarely are gastrointestinal bleeding and ulceration, leukopenia and agranulocytosis.
Dosage
Adults : 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.
Presentation
Box of 10 strips x 10 film coated caplets.
Reg. No. DKL8511603809A1
Store below 30°C.
ON MEDICAL PRESCRIPTION ONLY.
HARUS DENGAN RESEP DOKTER.
Manufactured by :
PT KALBE FARMA Tbk.
Bekasi-Indonesia
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