NO-shpalgina

Active material: Codeine, Drotaverine, Paracetamol
When ATH: N02BE51
CCF: Spazmoanalgetik
ICD-10 codes (testimony): R52.0, R52.2
When CSF: 03.03
Manufacturer: CHINOIN Pharmaceutical and Chemical Works Co. Ltd. (Hungary)

Pharmaceutical form, composition and packaging

◊ Pills Light yellow, interspersed with lighter and more dark color, elongated, with dividing risk on both sides.

Excipients: polyvidone, iron oxide yellow (E172), magnesium stearate, vitamin C, krospovydon, talc, corn starch, microcrystalline cellulose, pre-gelatinized starch.

6 PC. – aluminum blisters (2) – packs cardboard.

Pharmacological action

Spazmoanalgetik.

Paracetamol okazыvaet analygeziruyushtee and zharoponizhayushtee action. The mechanism of action is associated mainly with the ability to inhibit the synthesis of prostaglandins in the central nervous system and to a lesser extent – with the influence on the center of thermoregulation in the hypothalamus.

Drotaverine – derivative of isokhinolin, It has an antispasmodic effect on smooth muscles by inhibiting the phosphodiester enzyme 4 (PDE4). In this case, the concentration of C-amp, inactivating the enzyme myosinkinase, which leads to relaxing the smooth muscles. Besides, Drotaverin has a weak inhibitory effect on calmodulin-dependent calcium channels; acts on the smooth muscles of the vessels, GI, biliary system and urogenital tract. The effectiveness of the drotaverine action depends on the content of the FDE4 enzyme4, in different fabrics it is different.

Codeine – central anti -cash, phenanthrene alkaloid of opium series. Has its own analgesic effect and potentiates the action of paracetamol.

Pharmacokinetics

Paracetamol and codeine do not affect each other's pharmacokinetics. When taking the drug, their pharmacokinetics also does not change.

Absorption

In the acceptance of the preparation of no-spalgin^® C values_max Drotaverine are within the limits 132-171 ng / ml, Paracetamol – within 5496-6752 ng / ml; AUC_0-24 – 463-830.2 dog hi / l i 21760.8-26524.7 ng x h/l, respectively.

Distribution

The equilibrium state can be achieved on the 6th day when taking 1 tab. 1 once/day and on the 3rd day – when receiving 2 tab. 1 time / day.

There is no interaction between paracetamol and drotaverine at the level of binding with blood plasma proteins.

Metabolism and excretion

The clearance of paracetamol is 365-418 ml / min. In in vitro studies show, that paracetamol (In the therapeutic dose) Non -specific inhibits the metabolism of drotaverine, which leads to an increase in T_1/2 Drotaverine in 2-7 time. In vivo is also possible inhibition of the metabolism of drotaverine.

Testimony

- pain syndrome of weak and moderate intensity of various etiologies.

Dosage regimen

Adults with headache The drug is prescribed inside once in an average single dose 1-2 tab. If necessary, it is recommended a second technique^® through 8 no.

With short (no more 3 days) taking the drug maximum dose of no-shpalgin^® – 6 tab. / day; With a longer one – no more 4 tab. / day.

For the rapid development of the clinical effect, the drug should not be taken simultaneously with food.

Children aged 6 to 12 years drug administered in an average single dose 1/2-1 tab. If necessary, repeated use of no-shpalgin is possible^® through 10-12 no, the maximum dose – 2 tab. / day.

Elderly patients with the normal function of the liver and kidneys, the dose change is not required.

In patients with hepatic and/or renal failure The dose of the drug must be reduced and installed individually. At CC less than 10 ml / min The interval between the methods of the drug should be more 12 no; In this category of patients, only the episodic use of No-Shpalgin is possible^®.

The use of the drug is more 3 days is possible only under the supervision of a doctor.

Side effect

CNS: headache, dizziness, drowsiness.

Cardio-vascular system: hypotension, tachycardia, tides.

From the digestive system: nausea, constipation; rarely (when taking high doses and prolonged use) – Toxic liver damage.

From the hematopoietic system: agranulocytosis, thrombocytopenia.

Allergic reactions: skin rash; rarely – bronchospasm, swelling of the mucous membrane of the nasal cavity.

When taking the drug in very high doses, death is possible (irreversible tissue necrosis).

When using the drug according to indications in recommended doses, side effects are rare.

Contraindications

- renal failure in the terminal stage;

- Severe hepatic impairment;

- Heart failure decompensation;

— AV-blockade II and III degrees;

- Respiratory failure;

- Bronchial asthma;

- Alcoholism;

- Addiction;

- State after traumatic brain injury;

-increased intracranial pressure;

- Thrombocytopenia, leukopenia, agranulocytosis;

- Deficiency of glucose-6-fosfatdegidrogenazы;

- Simultaneous reception of MAO inhibitors and the period up to 14 days after their cancellation;

-simultaneous intake of other paracetamol-containing drugs;

- Pregnancy;

- Lactation (breast-feeding);

- Children up to age 6 years;

- Hypersensitivity to the drug.

Pregnancy and lactation

No-spalgin preparation^® contraindicated during pregnancy.

If necessary, use during lactation should decide the issue of termination of breastfeeding.

Cautions

With caution, the drug is prescribed to patients with constitutional hyperbilirubinemia (Gilber syndrome) and elderly patients.

With prolonged use of No-Shpalgin^® the risk of bleeding increases due to paracetamol, part of the drug.

If necessary, it is possible to use no-shpalgin^® patients, taking indirect anticoagulants of long -term action.

Patients, taking the drug No-Shpalgin^®, should refrain from drinking alcohol.

Monitoring of laboratory parameters

When using the drug in high doses or with prolonged use of no-nohpalgin^® necessary to monitor patterns of peripheral blood, Assessment of the level of creatinine and functional state of the liver.

Effects on ability to drive vehicles and management mechanisms

The possibility of activities potentially hazardous activities, require increased attention and psychomotor speed reactions, It should be solved only after assessing the individual reaction of the patient to the drug.

Overdose

Symptoms: nausea, vomiting, Blood circulation and respiratory depression – The main symptoms of an overdose of codeine. The condition of the patient, accepting an excessively high dose of paracetamol, can be satisfactory during the first 3 days, And only after that there are signs of liver damage. Changes, developing in the liver cells as a result of an overdose, cause the accumulation of toxic intermediate metabolism products.

Treatment: gastric lavage, The use of saline laxatives. With severe damage to the central nervous system to control the state, Ivl may be needed and oxygen providing, as well as the introduction of Naloxson. Antidotes of paracetamol are n-acetylcystein or methionine, showing hepatoprotective effects.

Drug Interactions

Drug Interactions, due to drotaverine

With the simultaneous use of No-Shpalgin^® with Levodop Drotaverin reduces its action, which can lead to an increase in tremor and muscle rigidity.

Drug Interactions, due to paracetamol

With the simultaneous use of No-Shpalgin^® with inducers of liver microsomal enzymes (salicylamide, barbiturates, antiepileptic drugs, tricyclic antidepressants, ethanol, rifampicin) an increase in the toxicity of paracetamol is noted.

With the simultaneous use of No-Shpalgin^® with chlomaphenicol lengthens t_1/2 chloramphenicol and its toxicity increases.

With the simultaneous use of No-Shpalgin^® with doxorubicin, the risk of developing hepatotoxic effect is noted.

Paracetamol while applying reduces the effectiveness of uricosuric agents.

Metoclopramide and domperidone enhance the absorption of paracetamol, and collaxes reduces it.

Drug Interactions, caused by codeine

With the simultaneous use of No-spargin^® enhances the effect of sleeping pills and anxiolytic drugs, as well as analgesics.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug is recommended to be stored in a dry, inaccessible to children at temperature not exceeding 30 ° C. Shelf life - 3 year.