Pharmacodynamics and pharmacokinetics
Many people use a combined analgesic and antispasmodic drug - Spazgan, what helps and what the mechanism of action is has been thoroughly studied. It has been established that the active components provide analgesic, antipyretic and mild anti-inflammatory effects.
Thus, metamizole sodium is a non-narcotic analgesic , pitofenone hydrochloride is a myotropic antispasmodic that has a direct effect on the smooth muscles of internal organs, and fenpiverinium bromide is an anticholinergic blocker that complements the relaxing effect. It is in this combination that the pharmacological effects mutually enhance, which reduce elevated body temperature and relieve pain by relaxing smooth muscles.
Pharmacokinetics of metamizole
Resorption is rapid and complete; after 30 minutes, an amount of 5% of the maximum serum concentration is in the bloodstream. Partial binding to plasma proteins occurs in the bloodstream. In general, the substance in the human body is subject to intense biotransformation, resulting in the formation of active metabolites. Only 3% that is excreted is unchanged metamizole . It has been established that individual components can be excreted in breast milk.
Features of the composition and action of Spazgan
The medicine is prepared in tablets and solution for injection. The instructions note that the tablet form of the medication contains:
- sodium metamizole;
- pitofenone hydrochloride;
- fenpiverinium bromide.
Spazgan has a slight anti-inflammatory effect; the drug is aimed at relieving pain and reducing fever. The product contains a non-narcotic analgesic, a myotropic antispasmodic and an anticholinergic blocker. The interaction of three active components relaxes smooth muscles, providing the expected effect.
Indications for use of Spazgan
- reduction of pain after surgical or diagnostic interventions;
- reduction of increased body temperature in patients with colds or infectious and inflammatory diseases .
Indications for the use of Spazgan for mild or moderate pain syndrome are:
- intestinal spasms;
- spastic state of internal organs;
- biliary or renal colic;
- dysmenorrhea;
- joint pain;
- symptomatic treatment for neuralgia , myalgia , sciatica .
Attention!
Do not use the drug to relieve abdominal pain until the cause of its occurrence is determined.
Adverse reactions
During therapeutic procedures, Spazgan can cause non-standard responses of the body. Side effects appear:
- allergies - with dermatological rash, redness of the skin, obsessive itching, and occasionally anaphylaxis may develop;
- accelerated heart contractions, drop in blood pressure;
- cyanosis, dizziness;
- increased dryness of the mucous membranes in the oral cavity;
- cephalgia, discomfort in the epigastric region;
- short-term loss of consciousness, disturbances of accommodation;
- a decrease in the number of platelets, leukocytes, etc. in the blood;
- attacks of bronchospasm – in patients with previously registered manifestations of pathology.
The appearance of non-standard symptoms requires consultation with the attending physician and a review of the prescribed therapeutic regimen.
Contraindications
Metamizole sodium , pitofenone hydrochloride , fenpiverinium bromide are included in Spazgan tablets. What are they contraindicated for:
- with hypersensitivity to pyrazolone (including Butadione , Tribuzon ) and other components of the drug;
- with severe functional disorders of the kidneys or liver;
- with tachyarrhythmia ;
- in the absence of glucose-6-phosphate dehydrogenase ;
- with angle-closure glaucoma ;
- with prostatic hypertrophy leading to urinary retention ;
- for gastrointestinal obstruction ;
- with megacolon ;
- in the presence of various diseases of the blood system;
- patients in a collaptoid state ;
- pregnant women in the first trimester and the last 6 weeks;
- nursing mothers;
- children under 5 years old.
Side effects
- allergic reactions , manifested in the form of skin rash , itching anaphylactic shock develops ;
- tachycardia , dizziness , decreased blood pressure , cyanosis ;
- Isolated cases of epigastric burning, dry mouth and headache have been reported;
- with prolonged use, the anticholinergic effect can lead to fainting and impaired accommodation ;
- long-term therapy can lead to disorders of the blood system, for example, thrombocytopenia , leukopenia , agranulocytosis ;
- Patients prone to bronchospasm must beware of the risk of provoking an attack.
Instructions for use of Spazgan (Method and dosage)
It is recommended to take the tablets after meals, orally. Dosage regimen: 1-2 tablets up to 3 times a day.
The maximum daily dose is 6 tablets.
Duration of therapy is up to 5 days, otherwise monitoring of peripheral blood parameters and assessment of the functional state of the liver is required.
Spazgan tablets, instructions for use in children
Use is possible only as prescribed by a doctor. The dosage differs depending on the age of the child:
- from 6 to 8 years - no more than 0.5 tablets;
- 9–12 - you can give 3/4 tablets;
- adolescents 13–15 years old are prescribed 1 tablet. up to 3 times during the day.
With intravenous or intramuscular administration of Spazgan solution
- patients with acute severe colic: 5 ml is administered slowly intravenously over 5-8 minutes, if necessary, repeated administration is allowed after 6-8 hours;
- standard single dose – no more than 2 ml;
- the maximum permissible daily dose is no more than 10 ml.
Spazgan No. 20
SPASGAN.RU
INSTRUCTIONS
on medical use of the drug
SPAZGAN™
Registration number: P N011958/01
Trade name of the drug: Spazgan™
International nonproprietary or grouping
Name:
Metamizole sodium + pitofenone + fenpiverinium bromide
Dosage form: tablets
Compound
1 tablet contains:
active ingredients: metamizole sodium monohydrate – 500.0 mg,
pitofenone hydrochloride - 5.0 mg, fenpiverinium bromide - 0.1 mg;
excipients: lactose monohydrate – 165.0 mg, povidone K-30 – 6.0 mg;
magnesium stearate – 5.0 mg, colloidal silicon dioxide – 1.0 mg.
Description
Round, flat, with a beveled edge, white tablets with a slightly yellowish tint, with a dividing line on one side and the “” emblem on the other.
Pharmacotherapeutic group: non-narcotic analgesic and antispasmodic agent.
ATX code: N02BB52
Pharmacological properties
The drug contains: the non-narcotic analgesic metamizole sodium (analgin), the myotropic antispasmodic drug pitofenone and the m-anticholinergic drug fenpiverinium bromide.
Metamizole is a pyrazolone derivative. It has analgesic, antipyretic and anti-inflammatory effects. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation. Phenpiverinium, due to its m-anticholinergic effect, has an additional relaxing effect on smooth muscles.
The combination of the three components of the drug leads to pain relief, relaxation of smooth muscles, and a decrease in elevated body temperature.
Indications for use
Mild or moderate pain syndrome due to spasms of the smooth muscles of internal organs - renal and hepatic colic, spastic pain along the intestine, algodismenorrhea. Can be used for short-term symptomatic treatment of joint pain, neuralgia, sciatica, myalgia.
As an adjuvant it can be used to reduce pain after surgical and diagnostic interventions.
If necessary, the drug can be used to reduce elevated body temperature during colds and infectious and inflammatory diseases.
Contraindications
Hypersensitivity to pyrazolone derivatives (butadione, tribuzone), to other components of the drug. Suppression of bone marrow hematopoiesis, stable and unstable angina pectoris, chronic heart failure in the decompensation stage, severe liver or kidney dysfunction, glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmias, angle-closure glaucoma, prostatic hyperplasia with a tendency to urinary retention, intestinal obstruction and megacolon, granulocytopenia, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, pregnancy, lactation, children under 8 years of age.
Directions for use and doses
Adults and children over 14 years of age take orally (preferably after meals), usually 1-2 tablets 3-4 times a day. The daily dose should not exceed 8 tablets. Duration of treatment is no more than 5 days .
Increasing the daily dose of the drug or the duration of treatment is possible only on the recommendation and under the supervision of a physician.
Dosages for children. In children, the drug is used only as prescribed by a doctor. Dosage for children 8-11 years old - one tablet no more than 4 times a day, 12-14 years old - 1 - 1.5 tablets no more than 4 times a day. Other dosage regimens are possible only after consultation with a doctor.
Precautions for use
with caution and under the supervision of a physician in patients with impaired liver or kidney function, with a tendency to arterial hypotension (systolic pressure below 100 mm Hg), bronchospasm, as well as with increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics. With long-term (more than a week) use of the drug, monitoring of the peripheral blood picture (leukocyte content) and the functional state of the liver is necessary. If agranulocytosis is suspected or thrombocytopenia is present, the drug should be discontinued.
During treatment with the drug, you should not drink alcohol.
Overdose
In case of an overdose of the drug, the following symptoms may be observed: vomiting, a feeling of dry mouth, changes in sweating, impaired accommodation, decreased blood pressure, drowsiness, confusion, impaired liver and kidney function, convulsions. Treatment: gastric lavage, administration of activated carbon, symptomatic therapy.
Side effect
Allergic reactions are possible (urticaria, Quincke's edema); exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome); burning sensation in the epigastric region, dry mouth, headache.
Dizziness, decreased blood pressure, tachycardia, cyanosis, red urine color. With long-term use - thrombocytopenia, leukopenia, agranulocytosis.
Interaction with other drugs
The simultaneous use of SPAZGAN with other non-narcotic analgesics can lead to mutual enhancement of toxic effects. Tricyclic antidepressants, oral contraceptives, and allopurinol disrupt the metabolism of metamizole in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizole. Simultaneous use with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers enhance the analgesic effect of SPAZGAN. If it is necessary to use these and other medications simultaneously, you should consult your doctor.
Use during pregnancy and breastfeeding
The use of the drug in nursing mothers requires cessation of breastfeeding.
special instructions
During treatment, it is not recommended to drive vehicles or engage in potentially hazardous activities that require quick physical and mental reactions.
Release form
6 tablets in Aluminum/PVC blister. 1 blister with instructions for use in plastic packaging. 10 plastic packages in a cardboard box.
10 tablets in Aluminum/PVC blister. 2 blisters with instructions for use in a cardboard box. 10 blisters with an equal number of instructions in a cardboard box.
Storage conditions
In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children!
Best before date
3 years. Do not use the drug after the expiration date!
Vacation conditions
Over the counter.
Manufacturer
Wockhard Limited, India
Wockhard Towers, Bandra-Kurla Complex, Bandra (East), Mumbai - 400051, India.
Manufacturer's address:
N-14/2, MIDS, Waluj, Aurangabad - 431136, Maharashtra, India.
Consumer complaints should be sent to:
121471, Russia, Moscow, st. Ryabinovaya, house 43, building 1.
Tel./fax, E-mail
There are contraindications, it is necessary to consult a specialist
Interaction
- combination with other non-narcotic analgesics causes mutual enhancement of toxic effects;
- with tricyclic antidepressants , oral contraceptives , Allopurinol metabolism in the liver is disrupted and the toxicity of metamizole ;
- with barbiturates , phenylbutazone and other inducers of hepatic microsomal enzymes, metamizole is weakened ;
- with Cyclosporine - the level of the latter in the bloodstream decreases;
- with sedatives and tranquilizers, the analgesic effect of Spazgan is potentiated.
Overdose and interaction with other drugs
The instructions recommend taking Spazgan only as prescribed by your doctor. If the dosage is accidentally exaggerated, patients may experience:
- vomiting, convulsive syndrome;
- increased dryness of the mucous membranes of the oral cavity;
- active sweating, accommodation disturbances;
- low blood pressure, drowsiness;
- confusion, renal or hepatic dysfunction.
To reduce intoxication, the patient needs to rinse the stomach, give activated charcoal and undergo symptomatic therapy.
The combination of Spazgan with other drugs can provoke:
- severe toxic reactions - together with non-narcotic analgesics;
- changes in metabolism and increased toxicity - with oral contraceptives and tricyclic antidepressants;
- reducing the effect of metamizole - when using barbiturates, Phenylbutazone;
- a drop in Cyclosporine levels in the systemic circulation;
- enhanced analgesic effect - in combination with tranquilizers, sedatives.
If the patient is taking third-party medications, he must notify the attending physician about this in advance, before the final calculation of the therapeutic regimen. It is prohibited to take the medication together with alcoholic beverages. Violation of the rules can provoke depression of the central nervous system and affect the psychophysical state of the patient.
Changing the color of urine to red during therapy does not matter - the problem is associated with arbitrary coloring of the liquid by the active components of the drug.
Analogs
Level 4 ATC code matches:
Analdim
Reopirin
Tempalgin
Benalgin
Pentalgin ICN
Pentalgin N
Pentalgin
Analgin
Renalgan
Tetralgin
Spasmalin
Maxigan
Sedal-M
Piralgin
Baralgin M
Sedalgin Plus
Baralgetas
Revalgin
Andipal
Spazgan substitutes that match all 3 active ingredients:
- Baralgetas solution and tablets ;
- Realgin solution and tablets ;
- Maxigan tablets ;
- Renalgan and Realgan , Reonalgan ;
- Spazmadol , Spazmalgon , Spasmoblock , Spazmil .
Differences between Spazgan and Spazmalgon
Most often, patients using modern antispasmodics ask the question: which is better Spazgan or Spazmalgon ?
Spazmalgon is a structural analogue of Spazgan, produced in Bulgaria, which is slightly cheaper in price. Due to the same active ingredients and their quantity in 1 tablet, the instructions for use, indications, and contraindications for these drugs are the same. However, on the forums you can find different comments in favor of one or another analogue. But this is more of a personal individual reaction of the body rather than a pattern.
The main difference between Spazgan and Spazmalgon is the price and manufacturer.
Nosological classification (ICD-10)
- K59.8.1* Intestinal dyskinesia
- K82.8.0* Dyskinesia of the gallbladder and biliary tract
- M25.5 Joint pain
- M54.3 Sciatica
- M79.1 Myalgia
- M79.2 Neuralgia and neuritis, unspecified
- N23 Renal colic, unspecified
- N94.6 Dysmenorrhea, unspecified
- R10.4 Other and unspecified abdominal pain
- R25.2 Cramp and spasm
- R50.0 Fever with chills
- R52.9 Pain, unspecified
- T88.9 Complication of surgical and therapeutic intervention, unspecified
Spazgan price, where to buy
The average cost of Spazgan solution (5 ampoules of 5 ml) is 140-150 rubles, while the price of Spazgan tablets differs depending on the number of tablets in the package:
- a package of tablets No. 20 costs approximately 130 rubles;
- pack of tablets No. 100 - approximately 410 rubles.
- Online pharmacies in RussiaRussia
ZdravCity
- Spazgan tablets 20 pcs. Wockhardt
RUB 139 order - Spazgan tablets 100 pcs. Wockhardt
RUB 393 order
- Spazgan NEO tablets p.p.o. 400mg+5mg+0.1mg 20 pcs. Wockhard Limited
RUB 183 order
