Revalgin (Pitofenone + Metamizole sodium + Fenpiverinium bromide) tablets, ampoules

The composition and form of issue: 

1 tablet contains: metamizol sodium 500 mg, pitofenon hydrochloride 5 mg, fenpiverinia bromide 0,1 mg and excipients (starch, lactose, MCC, silicon dioxide colloidal, magnesium stearate, talc) in a contour bezgyachakova packing 10 PCs., in a cardboard bundle 2 or 10 packs.

1 ml solution for injection contains sodium metamizol 500 mg, pitofenone hydrochloride 2 mg, fenpiverinia bromide 0, 02 mg and auxiliary substances (sodium metabisulphite, disodium edetate, potassium dihydrogen phosphate, sodium hydroxide, water for injection) in vials of dark glass 1, 2 and 5 ml, in a cardboard bundle 5 ampoules.

Feature:

Tablets, flat round, white, with cut edges and a dividing groove.

Solution for injection transparent, from colorless to pale yellow.

Pharmacological action:

Has analgesic, antipyretic and anti-inflammatory effects (Metamizole sodium), relaxes smooth muscles of internal organs due to direct myotropic (pitofenone hydrochloride) and holinoblokirutego (fenpiverinia bromide) actions.

Indications:

Pain with cramps smooth muscles of internal organs (renal and biliary colic, intestinal spasms, dysmenorrhea, etc.), headache, migraine, joint pain, neuralgia, sciatica, and myalgia (short-term symptomatic treatment), pain after surgical and diagnostic interventions (adjuvant), increased body temperature in cold and infectious and inflammatory diseases (if necessary).

Contraindications:

Hypersensitivity, expressed human liver or kidney disease, a genetic deficiency of glucose?6-fosfatdegidrogenaza, tachyarrhythmia, angle-closure form of glaucoma, prostatic hypertrophy with a tendency to urinary retention, gastrointestinal obstruction, megacolon, diseases of the blood system, collaptoid state, the first trimester and last 6 weeks of pregnancy, breast-feeding, age up to 5 years (tablets), up to 3 months/body weight less than 5 kg (solution for injection in/m introduction) and up to 3-5 months/body weight of 5-8 kg (solution for injection, in/in the introduction).

Application of pregnancy and breast-feeding:

Contraindicated in the first trimester and last 6 weeks of pregnancy. At the time of treatment should stop breastfeeding.

Side effects:

From the nervous system and sensory organs: dizziness, headache.

From the cardiovascular system and blood (hematopoiesis, hemostasis): demotion AD, tachycardia, cyanosis, prolonged use — anemia, leukopenia, agranulocytosis.

On the part of the digestive tract in rare cases — a burning sensation in the epigastric region, dry mouth.

Allergic reactions: rarely — skin rash, itching, rarely — anaphylactic shock.

Other: the tendency to bronchospasm may provoke attack.

Drug interactions:

Do (mutually) toxic effects of other non-narcotic analgesics. Tricyclic antidepressants, contraceptives for admission inside, allopurinol violate metabolism of metamizol sodium in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizol sodium, sedatives and tranquilizers increase the analgesic effect. Lowers the concentration of cyclosporine in the blood.

Method of application and dose:

Tablets: inside, after eating, adults and adolescents over 15 years — table 1-2. 2-3 times a day for 5 days (no more). Daily intake — 6 table. (no more). Children: 6-8 years of age — 1/2 tab., 9-12 years — 3/4 table. 13-15 years — 1 table. 2-3 times a day. Increase in daily dose or duration of treatment only under the supervision of a physician.

Solution for injection: in/in slowly (1 ml for 1 min), the patient in the supine position, monitoring of blood pressure, heart rate and breathing, or in/m, adults and adolescents over 15 years single dose of 2-5 ml (in/in a dose more than 2 ml (1 g) is possible only after careful clarification of the indications) daily up to 10 ml, child:/: 1-2 years (9-15 kg) — 0, 1-0, 2 ml, 3-4 years (16-23 kg) — 0, 2-0, 3 ml, 5-7 years (24-30 kg) — 0, 3-0, 4 ml, 8-12 years (31-45 kg) — 0, 5-0, 6 ml, 12-15 years (46 to 53 kg) — 0, 8-1 ml/m: 3-5 months (5-8 kg) — 0, 1-0, 2 ml, 1-2 years (9-15 kg) — 0, 2-0, 3 ml, 3-4 years (16-23 kg) — 0, 3-0, 4 ml, 5-7 years (24-30 kg) — 0, 4-0, 5 ml, 8-12 years (31-45 kg) — 0, 6-0, 7 ml, 12-15 years (46 to 53 kg) — 0, 8-1 ml.

Overdose:

Symptoms: vomiting, dryness in mouth, change in sweating, disturbance of accommodation, hypotension, drowsiness, confusion, impaired liver function and kidney cramps.

Treatment: symptomatic therapy.

Precautions:

With caution and under the supervision of a physician should be avoided in patients with impaired liver and/or kidneys, with tendency to hypotension, bronchospasm, and increased individual sensitivity to NSAIDs or narcotic analgesics. Prolonged (more than 1 week) application needed to be monitored picture peripheral blood and functional state of the liver. Increase in daily dose or duration of treatment only under the supervision of a physician.

Special instructions:

Enter the solution for injection must be body temperature. It should be borne in mind the possibility of staining of urine red due to the metabolites of metamizol sodium.