NOVALGIN

Generic Name

Analgin

About Generic

Pyrazolone derived NSAID, Antipyretic , Anti-inflammatory and analgesic.

Contents

Metamizole sodium.

Indications

- Severe pain, acute or chronic (eg : 1.Toothache 2. Headache 3. Arthralgia 4.

Neuralgia 5. Myositis
6. Visceral pain 7. High fever 8. Post operative pain 9. Pain in trauma 10. Pain
in cancer
11. Association with rheumatic diseases 12. Febrile state)
- Severe pain associated with smooth muscle spasms, acute or chronic (eg :
muscular spasm or colic
affecting the gastrointestinal tract, biliary passages, kidneys or lower urinary tract
- Novalgin is not to be used in trivial (sepele/biasa) complaints.

Mechanism of
Action

This pyrazolone group containing NSAID has potent analgesic, antipyretic and
moderate anti inflammatory activity. It blocks the synthesis of Pyrogens. It also
reduces Prostaglandin D&E synthesis by Cyclo-oxigenase enzim inhibition. These
peripheral interaction are the cause for its analgesic and antipyretic activity. There is
a small fraction of reduction in sensitivity of nerve endings due to this decrese
prostaglandin synthesis. Centrally it stimulate the synthesis of beta endorphin it
cause the analgesic action on visceral pain. In the muscles of biliary tract, urinary
tract, and in uterus it has some spasmolytic activity.

Pharmacokinetic

Absorption : Rapidly absorbed after oral, intravenous, and intramuscular

administration.
Distribution : Widely distributed in the body.
Metabolism : Metabolized in the liver.
Excretion
: Excreted via renal and non-renal clearance.

Onset of Action

30 to 60 minutes

Duration of Action 3 to 6 hours

Dosage &
Administration

Tablet : Adult & adolescent 15 yr 1 tab.

Syrup : Adult & adolescent 15 yr (10-20 mL). Children 13-14 yr (8.75-17.5
mL) ; 10-12 yr (7.5-15 mL) ;
7-9 yr (5-10 mL) ; 4-6 yr (3.75-7.5 mL) ; 1-3 yr (2.5-5 mL) ; 3-11 mth
(1.25-2.5 mL.)
Drops : Adult & adolescent 15 yr (20-40 drops). Children 13-14 yr (15-35
drops) ; 10-12 yr (10-30 drops);
7-9 yr (8-20 drops) ; 4-6 yr (5-15 drops) ; 1-3 yr (3-10 drops) ; 3-11
mth (2-5 drops).
*All oral doses may be taken up to 4 times daily.
Injection : Adult & adolescent 15 yr (2-5 mL) IM/IV as a single daily dose, up to
(10 mL) may be administered daily.

Overdosage

In the event of an overdosage, medical aid is imperative. If the patient is not

unconscious, attempts should be made to induce vomiting by rapidly drinking -1 L
of lukewarm salt water (1-2 tbsp of salt in a glass of water) followed by mechanical
stimulation of the posterior pharyngeal wall (eg, with the handle of a spoon). Instead
of salt solution, small children (1-6 years) should be made to drink warm fruit juice

in amounts appropriate to their age.

Contraindications

- Patients with pyrazolone allergy (hypersensitivity to medicines containing

metamizole
isopropylaminophenazone, propyphenazone, phenazone or phenylbutazone).
- Metabolic diseases (hepatic porphyria, congenital glucose-6-phosphate
dehydrogenase deficiency).
- Impaired bone marrow function or diseases of the hematopoetic system (Blood
disorder).
- Bronchospasm or other anaphylactoid reaction to analgesics.
- Renal or hepatic disease.
- Pregnancy and lactation (see also Precaution).

Warnings

*Excretion of a harmless metabolite may cause a red colouration of the urine, which
disappears on discontinuation of treatment.
*Pain-relieving drugs must not be used over prolonged periods of time or in high
doses without the doctors or dentists advice.

Special
Precautions
( Prior to its use,
patients should
consult their doctor)

- Patients who suffer from preexisting defective blood formation (eg, from cytostatic
therapy) should take
Novalgin only under medical supervision.
- Patients suffering from bronchial asthma or chronic respiratory tract infections
(especially when
combined with hay fever-like manifestations), and patients with hypersensitivity to
pain-relieving and
antirheumatic drugs of any kind are at risk of attacks of asthma or shock (analgesic
asthma/analgesic
intolerance) from the administration of Novalgin.
- Patients who react to alcoholic beverages, even to small amounts, with sneezing,
lacrimation and
pronounced reddening of the face, as well as to patients who are allergic (cutaneou
reactions, itching,
urticaria) to other substances (eg, foodstuffs, furs, hair dyes and preservative
agents).
- Novalgin is not recommended to be taken continuously in long periods of time as
it may lead to agranulocytosis, neuropathy (reversible if Novalgin is discontinued).
Use in pregnancy: During pregnancy, especially in the first 3 months and the last 6
weeks, Novalgin must
not be used except upon the instructions of the doctor.
Use in children: Novalgin tablet is not suitable for the treatment of children <15
years.
Because of the possibility of interference with renal function,
Novalgin should not be
given to infants <3 months or <5 kg body weight, unless there is
a compelling indication.
Medical supervision is also recommended for infants >3 months
and for young children.

Adverse Drug
Reactions

- The principal adverse reactions of Novalgin are due to hypersensitivity

reactions.
- The most serious are blood dyscrasias (agranulocytosis, leucopenia,

thrombocytopenia) and shock.

Both reactions are rare, but life-threatening, and they may occur even after
Novalgin has previously
been taken on many occasions without complications.
- The manifestations of agranulocytosis include high fever, chills, sore throat,
difficulty in swallowing,
inflammatory lesions in the mouth, nose, throat, as well as in the genital or anal
regions.
Immediate discontinuation is decisive for recovery.
For this reason, in the event of any unexpected deterioration in general condition, if
fever fails to
subside or begins anew, or if painful mucosal lesions appear, especially in the
mouth, nose or throat,
Novalgin must be stopped immediately and the doctor consulted.
- Thrombocytopenia causes an increased tendency to bleeding with or without
minute haemorrhagic
spots in the skin and mucous membranes.
- The other major form of hypersensitivity reactions is shock.
The warning signs of imminent shock are cold sweat, giddiness, stupor, nausea,
change of skin colour
and shortness of breath. In addition, there may be swelling of the face, itching, a
feeling of constriction
in the heart region, rapid pulse and a sensation of coldness in the arms and legs.
These symptoms may occur at once or up to 1 hr after administration.
If one or more of these signs is recognized, medical aid must be sought immediately
Until the doctor arrives, ensure that the patient remains lying with legs raised and
airways patent.
- In occasional instances, mainly in patients with a history of preexisting renal
disease or in cases of
overdose, there have been transient renal disorders with reduction or cessation
of urine production
(oliguria, anuria), accompanied by excretion of protein in the urine (proteinuria) and
inflammation of the
kidney tissue (interstitial nephritis).
- Further unwanted effects which may be encountered include hypersensitivity
reactions affecting the
skin (eg, urticarial eruptions), the conjunctivae and the nasopharyngeal mucosa
in very rare cases
progressing to severe, sometimes life-threatening bullous skin reactions usually
with mucosal
involvement (Stevens-Johnson syndrome or Lyells syndrome).
In the event of such skin reactions, Novalgin should be discontinued at once and a
doctor consulted.
- Attacks of asthma in patients predisposed to that condition may also be observed.
Drug Interactions

In case of concomitant treatment with cyclosporin, a fall in cyclosporin level may

occur.
Regular controls are therefore necessary.
Novalgin and alcohol may have a reciprocal influence on their effects.

Storage

Store at room temperature.

Drug Classification G
Presentation/Packi Tab 500 mg (oblong) x 100's, 500's.
ng
Syrup 50 mg/mL x 60 mL x 1's.
Drops 500 mg/mL x 10 mL x 1's.
Amp 500 mg/mL x 2 mL x 5's.