 |
| Novalgin |
Metamizole Sodium
sanafi aventis
Composition
Novalin tablets
Active ingredient: Each tablet contai-ns 500 -mg-metamizole sodium.
Excipients: Maize starch, lactose monohydrate, sodium bicarbonate, talc and magnesium stearate.
Oblong Novalgin film coated tablets
Active ingredient: Each film coated tablet contains 500 mg metamizole sodium.
Excipients: Macrogol 4000, macrogol 8000, magnesium stearate, saccharin, titanium dioxide, talc,
hydroxypropylmethyl cellulose.
Novalin suppositories for children
Active ingredient: Each suppository contains 300 mg metamizole sodium.
Excipients: Soja lecithin and hard fat.
Pharmaceutical form
Tablets, Film coated tablets and Suppositories.
Pharmacological actions
Metamizole is a non-narcotic pyrazolone derivative with analgesic. antipyretic and spasmolytic effects. The mechanism of action is not completely investigated, some data indicate that metamizole and its main metabolite
(4-N-methylaminoantipyrine) might have a combined central and peripheral mode of action.
Pharmacoki netics
After oral administration, metamizole is completely hydrolyzed to the pharmacologically active 4-N-methylaminoanti pyrt ne (MM). The absolute bioavailabilit-y of MM is approx. 90% and is somewhat higher after oral compared to intravenous administration; the pharmacokinetics of MM does not change to any appreciable extent when metamizole is taken together with food.
Indications
- Severe life threatening fever.
- Cancer pain.
- * Not used as a routine analgesic
Dosage and administration
Generally, the dosage is based on the desired effect and patient’s condition. The effect of Novalgin sets within 30 to 60 minutes and lasts for approximately four hours. Unless otherwise directed, the following dosage guidelines should be applied:
Single dosing
sanafi aventis
Composition
Novalin tablets
Active ingredient: Each tablet contai-ns 500 -mg-metamizole sodium.
Excipients: Maize starch, lactose monohydrate, sodium bicarbonate, talc and magnesium stearate.
Oblong Novalgin film coated tablets
Active ingredient: Each film coated tablet contains 500 mg metamizole sodium.
Excipients: Macrogol 4000, macrogol 8000, magnesium stearate, saccharin, titanium dioxide, talc,
hydroxypropylmethyl cellulose.
Novalin suppositories for children
Active ingredient: Each suppository contains 300 mg metamizole sodium.
Excipients: Soja lecithin and hard fat.
Pharmaceutical form
Tablets, Film coated tablets and Suppositories.
Pharmacological actions
Metamizole is a non-narcotic pyrazolone derivative with analgesic. antipyretic and spasmolytic effects. The mechanism of action is not completely investigated, some data indicate that metamizole and its main metabolite
(4-N-methylaminoantipyrine) might have a combined central and peripheral mode of action.
Pharmacoki netics
After oral administration, metamizole is completely hydrolyzed to the pharmacologically active 4-N-methylaminoanti pyrt ne (MM). The absolute bioavailabilit-y of MM is approx. 90% and is somewhat higher after oral compared to intravenous administration; the pharmacokinetics of MM does not change to any appreciable extent when metamizole is taken together with food.
Indications
- Severe life threatening fever.
- Cancer pain.
- * Not used as a routine analgesic
Dosage and administration
Generally, the dosage is based on the desired effect and patient’s condition. The effect of Novalgin sets within 30 to 60 minutes and lasts for approximately four hours. Unless otherwise directed, the following dosage guidelines should be applied:
Single dosing
With oral and rectal applications, the single doseforall age groups is 8 mg to 16 mg metamizole per kilogram body weight. For children with high temperature, a dose of 10 mg metamizole per kilogram bodyweight is usually sufficient.
Multiple dosing If the effect of a single dose is inadequate or has subsided, the dose can usually be administered up to 4 times a day. The lowest pain-and fever- controlling dose should be selected. Generally speaking, in adult, 5 g metamizole per day or 70 mg metamizole per kilogram bodyweight in 24 hoursshould not be exceeded unless special clinical circumstances make this necessary. Dosing in patients with renal or hepatic impairment As the elimination rate is reduced in impaired kidney or liver functions, high doses and long term use should be avoided. For only short-term use, it is not necessary to reduce the dose. No data is available on the dosage for long-term use. Consideration must be given to the possibility of such impairment in elderly patients and patients whose general state of health is poor.
Duration of use: The duration of use depends on the nature and seventy of the disorder. In relatively long-term treatment with Novalgin, regular monitonng of the blood pictuiv induding differential blood count is required.
Method of administration: For oral forms, it is best to swallow the tablet whole with sufficient amount of liquid (about 1/2 to 1 glass).
Contraindications
Novalgin must not be used in patients with:
-Allergy to metamizole or to other pyrazolones (e.g. phenazone, propyphenazone) or to pyrazolidines (e.g. phenylbutazone, oxyphenbutazone) including, for example, previously
experienced agranulocytosis to one of these substances.
-Impaired bone marrow function (e.g following cytostatic treatment) or diseases of the haernatopoietic system.
-Patients known to develop bronchospasm or other anaphylactoid reactions (e.g. urticaria, rhinitis, anioedema) to analgesics such as: salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen.
-Allergy to any of the excipients of Novalgin.
-Acute intermittent hepatit porphyria (risk of induction of porphyria attacks).
-Congenital glucose 6 phosphate dehyd rogenase deficiency (risk of haemolysis).
-Infants under 3 months of age or 5 kg body weight.
-In infants between 3 and 11 months of age, Novalgin must not be injected by the intravenous route.
-Novalgin must not be given parenterally in patients with hypotension or unstable hemodynamicL
Side Effects
Anaphylactic/anaphylactoid reactions:
In rare instances, metamizole may cause anaphylactic / anaphylactoid reactions, which in very cases may be severe and life-threatening. They may occur even after Novalgin has previously been used on many occasions without complications. Applies only to tablets: Such drug reactions may develop immediately after administration of metamizole or hours later; however, the usual pattern is for them to occur within the first hour after administration.
Applies to all formulations: Typically, milder anaphylactic / anaphylactoid reactions manifest themselves in cutaneous and mucosal symptoms (such as itching, burning, reddening, urticaria, swellings), dyspnea and less frequently gastrointestinal complaints. Milder reactions may progress to severe forms with generalized urticaria, severe angio-oedema (even involving the larynx), severe bronchospasm, cardiac arrhythmias, drop in blood pressure (sometimes preceded by a rise in blood pressure), and circulatory shQçk, In analgesic intolerant patients
Multiple dosing If the effect of a single dose is inadequate or has subsided, the dose can usually be administered up to 4 times a day. The lowest pain-and fever- controlling dose should be selected. Generally speaking, in adult, 5 g metamizole per day or 70 mg metamizole per kilogram bodyweight in 24 hoursshould not be exceeded unless special clinical circumstances make this necessary. Dosing in patients with renal or hepatic impairment As the elimination rate is reduced in impaired kidney or liver functions, high doses and long term use should be avoided. For only short-term use, it is not necessary to reduce the dose. No data is available on the dosage for long-term use. Consideration must be given to the possibility of such impairment in elderly patients and patients whose general state of health is poor.
Duration of use: The duration of use depends on the nature and seventy of the disorder. In relatively long-term treatment with Novalgin, regular monitonng of the blood pictuiv induding differential blood count is required.
Method of administration: For oral forms, it is best to swallow the tablet whole with sufficient amount of liquid (about 1/2 to 1 glass).
Contraindications
Novalgin must not be used in patients with:
-Allergy to metamizole or to other pyrazolones (e.g. phenazone, propyphenazone) or to pyrazolidines (e.g. phenylbutazone, oxyphenbutazone) including, for example, previously
experienced agranulocytosis to one of these substances.
-Impaired bone marrow function (e.g following cytostatic treatment) or diseases of the haernatopoietic system.
-Patients known to develop bronchospasm or other anaphylactoid reactions (e.g. urticaria, rhinitis, anioedema) to analgesics such as: salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen.
-Allergy to any of the excipients of Novalgin.
-Acute intermittent hepatit porphyria (risk of induction of porphyria attacks).
-Congenital glucose 6 phosphate dehyd rogenase deficiency (risk of haemolysis).
-Infants under 3 months of age or 5 kg body weight.
-In infants between 3 and 11 months of age, Novalgin must not be injected by the intravenous route.
-Novalgin must not be given parenterally in patients with hypotension or unstable hemodynamicL
Side Effects
Anaphylactic/anaphylactoid reactions:
In rare instances, metamizole may cause anaphylactic / anaphylactoid reactions, which in very cases may be severe and life-threatening. They may occur even after Novalgin has previously been used on many occasions without complications. Applies only to tablets: Such drug reactions may develop immediately after administration of metamizole or hours later; however, the usual pattern is for them to occur within the first hour after administration.
Applies to all formulations: Typically, milder anaphylactic / anaphylactoid reactions manifest themselves in cutaneous and mucosal symptoms (such as itching, burning, reddening, urticaria, swellings), dyspnea and less frequently gastrointestinal complaints. Milder reactions may progress to severe forms with generalized urticaria, severe angio-oedema (even involving the larynx), severe bronchospasm, cardiac arrhythmias, drop in blood pressure (sometimes preceded by a rise in blood pressure), and circulatory shQçk, In analgesic intolerant patients
Drug Interactions
When cyclosporine is given concomitantly, a fall in the cyclosporine serum level may occur therefore, the cyclosporine level must be monitored.
Pregnancy
Metamizole crosses the placenta. There is no evidence that the drug is harmful to the fetus: metamizole did not show teratogenic effects in rats and rabbits, and fetotoxicity was observed only at high dose levels those were maternally toxic. There is, however, insufficientclinical data on the use of NovaIin during pregnancy Therefore, it is recommended that Novalgin is not used during the first three months of pregnancy, and that it is used in the following three months only after careful weighing of potential benefit and risk by a physician. Novalgin must, however, not be used during the last three months of pregnancy. This is because, although metamizole is only a week inhibitor of prostaglandin synthesis, the possibility of premature ductus arteriosus closure and perinatal complications due to impairment of both maternal and neonatal platelet aggregability cannot be ruled out.
Lactation
Metamizole metabolites are excreted into the breast milk. Breast-feeding must be avoided during and for 48 hours after administration of Novalgin.
Precautions and warnings
Precautions:
Ananhvladidanaohylactoid reactions: The following patients are at special risk for possibly severe anaphylactoid reactions to meta m izole (see contra Indications).
-Patients with bronchial asthma, particularly those with concomitant rhinosinusitis polyposa.
-Patients with chronic urticaria.
-Patients with alcohol intolerance, i.e. patients reacting to even minor quantities of certain alcoholic beverages with symptoms such as sneezing, lacrimation and pronounced redness of the face. Alcohol intolerance may be indicative of a previously undiagnosed analgesic asthma syndrome.
-Patients with intolerance to dyes (e.g. tartrazine) or to preservatives (e.g. benzoates).
-Before Novalgin is administered, the patient must be questioned specifically, in patients found to be at special risk for anaphylactoid reactions, Novalgin must only be used after carefully weighing the possible risks against the expected benefit. If Novalgin is to be administered in such circumstances, close medical supervision is required and the facilities for immediate emergency treatment must be available.
Isolated hypotensive reactions: Administration of metamizole may cause isolated hypotensive reactions (see side effects). These reactions are possibly dose-dependent and are more likely to occur following parenteral administration. In order to avoid severe hypotensive reactions of this kind:
-The intravenous injectron should be given slowly.
-Reverse hemodynamic in patients with pre-existing hypotension, with volume depletion or dehydration, or with circulatory instability or with incipient circulatory failure.
-Care should be taken in patients with high fever.
In such patients, the indication for metamizole must be established with particular care and, if Novalgin is to be administered in such circu mstarices, close medica I supervision is req u i red. Prevention measures (hemodynamic stabilization) may be necessary to reduce the risk of a hypotensive reaction. Concerning patients with hypotension or unstable circulation see contraindications. Metamizole must only be used under close hemodynamic monitoring in patients in whom lowering of blood pressure must be avoided, such as in patients with severe coronary heart disease or stenosis of blood vessels supplying the brain. In patients with renal or hepatic impairment, it is recommended that high metamizole doses be avoided,since its rate of elimination is reduced in these patients.
Warnings:
Agranulocytosis induced by metamizole is an accident of immuno-allergic origin lasting for at least one week. These reactions are very rare, may be severe and life threatening, and could be fatal. They are not dose dependent and may occur at any time during treatment. All patients should be advised to stop medication and consult their physician immediately if any of the following signs or symptoms possibly related to neutropenia occur: fever, chills, sore throat, ulcerations in oral cavity. In the event of neutropenia (<1,500 neutrophils/mm3) treatment should be immediately discontinued and complete blood count should be urgently controlled and monitored until they return to normal values. It may lead to reduction of number of white blood cells. Anaphylactic shock: These reactions occur principally in sensitive patients. Therefore, metamizole should be prescribed with caution in asthmatic or atopic patients (see Contraindications).
Storage
Store below 30° C
Expiry date
Do not use later than the date of expiry on the pack.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Presentation
Novalgin tablets: Box of 10 blisters of 10 tablets.
Oblong Novalgin: Box of 10 film coated tablets. Economy pack of 300 film coated tablets.
Nova 1gm suppositories: Box of S suppositories
Produced by sanofi-aventis egypt s.a.e.
Under license of sanofi-aventis I ermanv
When cyclosporine is given concomitantly, a fall in the cyclosporine serum level may occur therefore, the cyclosporine level must be monitored.
Pregnancy
Metamizole crosses the placenta. There is no evidence that the drug is harmful to the fetus: metamizole did not show teratogenic effects in rats and rabbits, and fetotoxicity was observed only at high dose levels those were maternally toxic. There is, however, insufficientclinical data on the use of NovaIin during pregnancy Therefore, it is recommended that Novalgin is not used during the first three months of pregnancy, and that it is used in the following three months only after careful weighing of potential benefit and risk by a physician. Novalgin must, however, not be used during the last three months of pregnancy. This is because, although metamizole is only a week inhibitor of prostaglandin synthesis, the possibility of premature ductus arteriosus closure and perinatal complications due to impairment of both maternal and neonatal platelet aggregability cannot be ruled out.
Lactation
Metamizole metabolites are excreted into the breast milk. Breast-feeding must be avoided during and for 48 hours after administration of Novalgin.
Precautions and warnings
Precautions:
Ananhvladidanaohylactoid reactions: The following patients are at special risk for possibly severe anaphylactoid reactions to meta m izole (see contra Indications).
-Patients with bronchial asthma, particularly those with concomitant rhinosinusitis polyposa.
-Patients with chronic urticaria.
-Patients with alcohol intolerance, i.e. patients reacting to even minor quantities of certain alcoholic beverages with symptoms such as sneezing, lacrimation and pronounced redness of the face. Alcohol intolerance may be indicative of a previously undiagnosed analgesic asthma syndrome.
-Patients with intolerance to dyes (e.g. tartrazine) or to preservatives (e.g. benzoates).
-Before Novalgin is administered, the patient must be questioned specifically, in patients found to be at special risk for anaphylactoid reactions, Novalgin must only be used after carefully weighing the possible risks against the expected benefit. If Novalgin is to be administered in such circumstances, close medical supervision is required and the facilities for immediate emergency treatment must be available.
Isolated hypotensive reactions: Administration of metamizole may cause isolated hypotensive reactions (see side effects). These reactions are possibly dose-dependent and are more likely to occur following parenteral administration. In order to avoid severe hypotensive reactions of this kind:
-The intravenous injectron should be given slowly.
-Reverse hemodynamic in patients with pre-existing hypotension, with volume depletion or dehydration, or with circulatory instability or with incipient circulatory failure.
-Care should be taken in patients with high fever.
In such patients, the indication for metamizole must be established with particular care and, if Novalgin is to be administered in such circu mstarices, close medica I supervision is req u i red. Prevention measures (hemodynamic stabilization) may be necessary to reduce the risk of a hypotensive reaction. Concerning patients with hypotension or unstable circulation see contraindications. Metamizole must only be used under close hemodynamic monitoring in patients in whom lowering of blood pressure must be avoided, such as in patients with severe coronary heart disease or stenosis of blood vessels supplying the brain. In patients with renal or hepatic impairment, it is recommended that high metamizole doses be avoided,since its rate of elimination is reduced in these patients.
Warnings:
Agranulocytosis induced by metamizole is an accident of immuno-allergic origin lasting for at least one week. These reactions are very rare, may be severe and life threatening, and could be fatal. They are not dose dependent and may occur at any time during treatment. All patients should be advised to stop medication and consult their physician immediately if any of the following signs or symptoms possibly related to neutropenia occur: fever, chills, sore throat, ulcerations in oral cavity. In the event of neutropenia (<1,500 neutrophils/mm3) treatment should be immediately discontinued and complete blood count should be urgently controlled and monitored until they return to normal values. It may lead to reduction of number of white blood cells. Anaphylactic shock: These reactions occur principally in sensitive patients. Therefore, metamizole should be prescribed with caution in asthmatic or atopic patients (see Contraindications).
Storage
Store below 30° C
Expiry date
Do not use later than the date of expiry on the pack.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Presentation
Novalgin tablets: Box of 10 blisters of 10 tablets.
Oblong Novalgin: Box of 10 film coated tablets. Economy pack of 300 film coated tablets.
Nova 1gm suppositories: Box of S suppositories
Produced by sanofi-aventis egypt s.a.e.
Under license of sanofi-aventis I ermanv
:rJ’ 1 - syndrpme.these reactions typically appear in theform of
:y’.ri4, Other cutaneous and mucosal reactions:
Aside from the cutaneous and mucosal manifestations of
. anaphylactic/ anaphylactoid reactions mentioned above, fixed drug eruptions may occur occasionally, rash may occur rarely. as may Stevens-Johnson syndrome or Lyell’s syndrome in isolated cases. Hoematological reactions:
Rarely, leucopenia and, in very rare cases, agranulocytosis or thrombocytopenia may develop. These reactions are regarded to
be immunological in nature. They may occur even after Novalin
- - has previously been used on many occasions without complications.
Agranulocytosis may be life-threatening, and could be fatal. Typical signs of agranulocytosis include inflammatory mucosal lesions (e.g. oropharyngeal, anorectal, genital), sore throat, and fever (evenunexpectedly persistent.or recurring lever). However, in patients receiving antibiotic therapy typical signs of agranulocytosis may be minimal. [rythrocyte sedimentation rate is greatly increased, whereas enlargement of lymph nodes is typically slight or absent. Typical signs of thrombocytopenia include an increased tendency to bleeding and petechiae on the skin and mucous membranes. Isolated hypotensive reactions:
Applies only to tablets: Occasionally, isolated transitory hypotensive reactions (possibly pharmacologically mediated and not accompanied by other signs of an anaphylactid anaphylactoid reaction) may occur after administration; in rare cases, this reaction takes the form of a critical drop in blood pressure. Other reactions: In very rare instances, especially in patients with a history of renal disease, acute worsening of renal function (acute renal failure), in some cases with oliguria, anuria or proteinuria may occur. Acute interstitial nephritis may occur in isolated cases. Pain and local reactions may occur at the injection site. These may sometimes include phlebitis. A red coloration has been sometimes observed in the urine, which may be due to a metabolite present at a low concentration: rubazonic acid.
:y’.ri4, Other cutaneous and mucosal reactions:
Aside from the cutaneous and mucosal manifestations of
. anaphylactic/ anaphylactoid reactions mentioned above, fixed drug eruptions may occur occasionally, rash may occur rarely. as may Stevens-Johnson syndrome or Lyell’s syndrome in isolated cases. Hoematological reactions:
Rarely, leucopenia and, in very rare cases, agranulocytosis or thrombocytopenia may develop. These reactions are regarded to
be immunological in nature. They may occur even after Novalin
- - has previously been used on many occasions without complications.
Agranulocytosis may be life-threatening, and could be fatal. Typical signs of agranulocytosis include inflammatory mucosal lesions (e.g. oropharyngeal, anorectal, genital), sore throat, and fever (evenunexpectedly persistent.or recurring lever). However, in patients receiving antibiotic therapy typical signs of agranulocytosis may be minimal. [rythrocyte sedimentation rate is greatly increased, whereas enlargement of lymph nodes is typically slight or absent. Typical signs of thrombocytopenia include an increased tendency to bleeding and petechiae on the skin and mucous membranes. Isolated hypotensive reactions:
Applies only to tablets: Occasionally, isolated transitory hypotensive reactions (possibly pharmacologically mediated and not accompanied by other signs of an anaphylactid anaphylactoid reaction) may occur after administration; in rare cases, this reaction takes the form of a critical drop in blood pressure. Other reactions: In very rare instances, especially in patients with a history of renal disease, acute worsening of renal function (acute renal failure), in some cases with oliguria, anuria or proteinuria may occur. Acute interstitial nephritis may occur in isolated cases. Pain and local reactions may occur at the injection site. These may sometimes include phlebitis. A red coloration has been sometimes observed in the urine, which may be due to a metabolite present at a low concentration: rubazonic acid.
Agefweight
|
Tablets (number)
|
Oblong
(number) |
Suppositories (number)
|
Adults: Over 5 years (>53kg)
|
1-2
|
1-2
|
1
|
Children: 13-14 years (46.53 kg)
|
1
| ||
10-12 years (31-45 kg)
|
1
| ||
7-9 years (24-30 kg)
|
1
| ||
4-6years
(16-23 kg) |
1
| ||
1-3 years (9-15 kg)
| |||
3-11 Month (5-8 kg)
|
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