METAMIZOLE SODIUM Oral drops, solution Ref.[7661] Active ingredients: Metamizole sodium

Posology

Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to metamizole sodium.

It is essential to choose the lowest dose that controls pain and fever.

In all age groups, apart from infants, 8–16 mg metamizole sodium monohydrate per kg body weight can be given as a single dose. The following table shows recommended single doses and maximum daily doses depending on weight or age:

In dependence on the daily maximum dose a single dose can be taken up to 4 times daily at intervals of 6–8 hours.

Duration of use

The duration of treatment depends upon the type and severity of disease.

In long-term treatment with <Invented Name>, regular monitoring of the blood count, including the differential blood count, is necessary.

Older people, debilitated patients, and patients with reduced creatinine clearance

The dose should be reduced in older people, in debilitated patients and in those with reduced creatinine clearance, as elimination of the metabolic products of metamizole sodium may be prolonged.

Patients with severe hepatic and renal impairment

To date, there has been insufficient experience with long-term use of metamizole sodium in patients with severe hepatic and renal impairment.

Paediatric population

In the case of fever, a dose of 10 mg metamizole sodium monohydrate per kilogram body weight is generally sufficient for children.

A clear effect can be expected 30 to 60 minutes after oral administration.

In the case of children and adolescents up to 14 years old, 8 to 16 mg metamizole sodium monohydrate per kilogram body weight is to be administered as an individual dose. Metamizole sodium should not be used in children aged under 3 months (see section 4.3)

Method of administration

Oral use.

The drops are taken in some water.

Symptoms

Acute overdose is followed by nausea, vomiting, abdominal pain, renal impairment/acute renal failure (e.g. with the clinical picture of interstitial nephritis) and, more rarely, central nervous system symptoms (dizziness, somnolence, coma, convulsions) and a fall in blood pressure, sometimes including shock and tachycardia.

Following very high doses, elimination of rubazonic acid may cause a red discoloration of the urine.

Therapeutic measures

No specific antidote is known for metamizole sodium. If metamizole sodium intake was recent, measures to reduce absorption into the body (e.g. administration of activated charcoal) can be attempted. The major metabolite (4-N-methylaminoantipyrine) can be eliminated by means of haemodialysis, haemofiltration, haemoperfusion or plasma filtration.

Treatment of intoxication and prevention of severe complications may require general and specific intensive care monitoring and treatment.

Treatment of severe hypersensitivity reactions (shock)

Emergency measures in accordance with the valid guidelines should be initiated.

Shelf life: 30 months.

Shelf life after first opening: 3 months.

Do not refrigerate or freeze.

Dropper container, consisting of amber glass bottle (type III), fitted with a LDPE dropper applicator and closed with a child-resistant, tamper-evident screw cap, consisting of HDPE/polypropylene.

Dropper container containing 10 ml, 20 ml, 50 ml or 100 ml oral drops, solution

Not all pack sizes may be marketed.

No special requirements.