Tolnim

Uses

Nimesulide is used for acute pain; extra-articular disorders; osteoarthritis; post-op pain; primary dysmenorrhoea

Treatment of painful musculoskeletal disorders with hypermyotonia and decreased motility, especially those resulting from spinal cord injuries, osteoporosis, arthritis, and spasticity. It has also been effective in lumboischial pain, neurolathyrism, knee arthritis, peripheral circulatory diseases, climacteric muscular and vascular complaints, trismus, myogenous headaches, rheumatic diseases accompanied by muscular hypertonia, spasms, pain, inflammatory symptoms and limited motion, and in the post-surgical treatment of traumatologic patients.

Tolperisone Hydrochloride is a centrally acting muscle relaxant that has been used for the symptomatic treatment of spasticity and muscle spasm. It effectively reduces muscular hypertonicity, improves peripheral blood flow by vasodilatation and reduces pain

Tolnim is also used to associated treatment for these conditions: Menstrual Distress (Dysmenorrhea), Pain, Pain, Acute, NSAIDsSpasticity

How Tolnim works

The therapeutic effects of Nimesulide are the result of its complete mode of action which targets a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins, free radicals, proteolytic enzymes and histamine.

Dosage

Tolnim dosage

100 mg twice daily.Should be taken with food. Take after meals.

Adult: 150-450 mg daily, administered in 2 or 3 divided doses. The maximum dosage is 450 mg/day.

Children:

• 3 months to 6 years: 1-2 mg/kg/day in 3 divided doses.
• 6 years to 14 years: 2-4 mg/kg/day in 3 divided doses

Side Effects

Epigastric discomfort, heartburn or abdominal cramps, nausea, vomiting and diarrhoea; skin rash, pruritus, oedema, headache, dizziness, drowsiness; hypersensitivity reactions (e.g. bronchospasm, rhinitis, angioedema urticaria); GI haemorrhage/perforation; bullous/erosive stomatitis, purpura, thrombocytopenia, toxic epidermal necrolysis, haematuria, oliguria, and renal failure; increases in liver enzymes.

Diarrhea, dizziness, drowsiness, dryness of the mouth, fall of blood pressure, fatigue, gastric complaints, headaches, hypersensitivity, itching, muscle pain, muscle weakness, rash, and somnolence.

Toxicity

Oral TDLO (human): 1.429 mg/kg; Oral TDLO (woman): 2 mg/kg; Oral LD50 (rat): 200 mg/kg; Oral LD50 (mouse): 392 mg/kg

Precaution

History of GI tract disease, infections, oedema, hypertension, elderly, lactation.

In case of children, the prescribed dose and duration of treatment should closely be observed.

Interaction

Additive hepatotoxic effects with known hepatotoxins: anti-convulsants (e.g. valproic acid), anti-fungals (e.g. ketoconazole), anti-tuberculous drugs (e.g. isoniazid), tacrine, pemoline, amiodarone, methotrexate, methyldopa, amoxicillin/clavulanic acid. May decrease the oral bioavailability of furosemide and the natriuretic and diuretic response to furosemide. Increased risks of GI and hepatic adverse effects with other NSAIDs, including aspirin. May increase anti-coagulant effect of warfarin. Potentiates the action of phenytoin. May be displaced from binding sites with fenofibrate, salicylic acid, and tolbutamide. Interactions between NSAIDs and lithium, probenecid and ciclosporin, have been documented.

Concomitant use of Methocarbamol with Tolperisone Hydrochloride has been reported to cause disturbance of visual accommodation.

Elimination Route

Rapidly absorbed following oral administration.

Half Life

1.8–4.7 hours

Elimination Route

Renal (50%), fecal (29%)

Pregnancy & Breastfeeding use

Category not classified

Tolperisone Hydrochloride should be used in pregnancy according to physician's advice. Tolperisone hydrochloride should not be used during breast-feeding.

Contraindication

Hypersensitivity; GI bleeding, active peptic ulcer disease; severe renal and heart failure; hepatic impairment or known liver disease; coagulation disorders; pregnancy; children <12 yr.

Hypersensitivity, Myasthenia Gravis and nursing mother.

Acute Overdose

Epigastric pain, nausea, vomiting, drowsiness, lethargy, GI haemorrhage, seizures, hypertension, apnoea, coma, anaphylactic reactions and renal failure. Treatment is supportive.

Excitability has been noted after ingestion of high doses by children. In suicide studies of three isolated cases, it is believed that ingestion of tolperisone was the cause of death.

Storage Condition

Protect from heat and humidity; store at <25°C.

Tolperisone Hydrochloride should be stored below 30° C. Keep out of reach of children

Innovators Monograph

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