Braul - instructions for use, dose, side effects, contraindications

Bral® is a combined drug, which includes: non-narcotic analgesic metamizol sodium (analgin), myotropic antispasmodic pituophenone hydrochloride and M-anticholinic blocking agent fenpiverinia bromide.

Metamizole has analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fentipierinium bromide due to M-holinoblokiruyuschego action has an additional antispasmodic effect on smooth muscle.

Indications:

Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of ureter and bladder, biliary colic, intestinal colic, dyskinesia of bile ducts, postcholecystectomy syndrome, algodismenorea.

For short-term symptomatic treatment: arthralgia, neuralgia, myalgia, ishialgia.

As an auxiliary medicine: pain syndrome after surgical interventions and diagnostic procedures.

Contraindications:

Hypersensitivity to pyrazolone derivatives (butadione) and other components of the drug; oppression of bone marrow hematopoiesis; stable and unstable angina; chronic heart failure in the stage of decompensation;severe violations of the liver and / or kidney function; deficit glucose-6-phosphate dehydrogenase; tachyarrhythmias; acute "intermittent" porphyria; closed-angle form of glaucoma; hyperplasia of the prostate (with clinical manifestations); intestinal obstruction and megacolon; collapse; pregnancy (first trimester and the last 6 weeks); lactation period; children's age (up to 3 months or body weight less than 5 kg).

Carefully:

With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, with a tendency to arterial hypotension, bronchial asthma, increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics (including the "aspirin" triad in the anamnesis). For children and adolescents under 18, the drug should be used only as directed by the doctor.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Parenterally (intravenously, intramuscularly).

Adults and adolescents over 15 years of age with acute severe colic are injected slowly by 2 ml (1 ml per 1 minute); if necessary, again after 6-8 hours.For slow intravenous administration, usually 2 ml of the drug is sufficient.

Intramuscularly inject 2 ml of solution 2 times a day; daily dose should not exceed 4 ml. The duration of treatment is not more than 5 days.

Intramuscularly or intravenously, Bral® is administered to children, depending on
age and body weight in the following single doses:

Body weight / age	Solution for injection, Intravenous injection	Solution for injection, Intramuscular injection
infants 5-8 kg; 3-11 months	Intravenous administration is contraindicated	0.1-0.2 ml
children 9-15 kg; 1-2 years	0.1-0.2 ml	0.2-0.3 ml
children 16-23 kg; 3-4 years	0.2-0.3 ml	0.3-0.4 ml
children 24-30 kg; 5-7 years	0.3-0.4 ml	0.4-0.5 ml
children 31-45 kg; 8-12 years old	0.5-0.6 ml	0.6-0.7 ml
children 46-53 kg; 12-15 years old	0.8-1.0 ml	0.8-1.0 ml

If necessary, repeated administration of the drug in the same doses may be prescribed.

The solution is incompatible in one syringe with other drugs.

Before the injection of the injection solution, it should be warmed in the hand.

Side effects:

In therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions are possible (skin rash, itching, very rarely anaphylactic shock, urticaria), angioedema. In rare cases - a burning sensation in the epigastric region, dry mouth, headache.

Perhaps dizziness, lower blood pressure, tachycardia, cyanosis.Chronic administration - violations of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (can be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of the phenomena of vaginitis or proctitis). With propensity to bronchospasm may provoke an attack.

In very rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). Rarely (usually with prolonged administration or administration of high doses) - a violation of kidney function: oliguria, anuria, proteinuria, interstitial nephritis, staining the urine in red. Very rarely - reducing sweating, paresis of accommodation, difficulty urinating.

Local reactions: with intramuscular injection, infiltrates are possible at the site of administration.

All side effects should be reported to your doctor.

Overdose:

SymptomsVomiting, lower blood pressure, drowsiness, confusion, nausea, epigastric pain, liver and kidney, convulsions.

Treatment: symptomatic therapy.

Interaction:

The simultaneous use of Brala® with other non-narcotic analgesics can lead to a mutual enhancement of toxic effects. Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

Simultaneous use with cyclosporine reduces the level of the latter in the blood.

Sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

When co-administered with H1-histamin blockers, butyrophenones, phenothiazines, amantadine and quinidine, M-cholinolytic action may be enhanced.

When combined with ethanol - mutual enhancement of effects. The simultaneous use of chloropropromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia. Radiopaque drugs and colloid blood substitutes should not be used during treatment with drugs containing metamizol sodium.

Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, can increase the severity of their action.

Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced codeine, H2-histamin blockers and propranolol (slows the inactivation of metamizole sodium).

The solution for injection is pharmaceutically incompatible with other drugs.

If you need to use these and other medications at the same time, you should consult your doctor.

Special instructions:

Do not use to relieve acute pain in the abdomen (until finding out the cause).

During the treatment, the drug should not be taken alcohol;

Parenteral administration is usually used in emergency cases and in those cases when ingestion is impossible (or absorption from the gastrointestinal tract is impaired). Special caution is required with the introduction of 2 ml of solution and more (the risk of a sharp drop in blood pressure). Intravenous injection should be carried out slowly, in the supine position and under the control of blood pressure, heart rate and respiratory rate.With prolonged (more than a week) application of the drug, control of the picture of peripheral blood and the functional state of the liver is necessary.

Effect on the ability to drive transp. cf. and fur:It is not recommended to drive vehicles and engage in other potentially A dangerous activity requiring rapid physical and mental reaction.

Form release / dosage:

Solution for intramuscular and intravenous administration.

Packaging:

5 ampoules per cell pack of PVC film without coating (pallet).

For 1 unit pack (pallet) together with instructions for use in a cardboard bundle.

Storage conditions:

In the dark place at temperature not higher than 25 ° С.

Keep out of the reach of children place!

Shelf life:

3 years. Do not use later than the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012121 / 02

Date of registration:27.08.2010 / 13.02.2014

Expiration Date:Unlimited

Date of cancellation:2018-05-11

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp11.05.2018

Illustrated instructions

Instructions

Braul® (Bral®)