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

Metamizole sodium is a derivative of pyrazolone. Has analgesic, antipyretic and anti-inflammatory action, the mechanism of which is associated with the inhibition of the synthesis of prostaglandins. Pitofenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation (papaverin-like action).

Fenpiverinia bromide has m-holinoblokiruyuschim action and has an additional effect on smooth muscle.

The combination of the three components of the drug leads to mutual reinforcement of their pharmacologic action, are expressed in relieving pain, relaxing smooth muscles and reducing elevated temperature.

Pharmacokinetics:Data on the pharmacokinetics of the drug are not available.

Indications:

- weakly or moderately severe pain spasms of smooth muscles of internal organs (renal colic, spasms of the ureter and bladder, intestinal colic, chronic colitis, biliary dyskinesia, biliary colic, postcholecystectomical syndrome, tuberculosis, diseases of the pelvic organs);

- for short-term symptomatic treatment of arthralgia, myalgia, neuralgia, sciatica (pain relief);

- as an adjuvant to reduce pain after surgery and diagnostic procedures;

- to reduce high fever with "colds" and other infectious and inflammatory diseases.

Contraindications:

- hypersensitivity to the drug, other derivatives of pyrazolone and other components of the drug;

- severe violations of the liver and / or kidney function;

- decompensation of chronic heart failure;

- severe angina;

- tachyarrhythmia;

- genetic deficiency of glucose-6-phosphate dehydrogenase;

- angle-closure glaucoma;

- hyperplasia of the prostate (with clinical manifestations);

- oppression of bone marrow hematopoiesis;

- intestinal obstruction;

- megacolon;

- collapse;

- acute porphyria;

- granulocytopenia;

- pregnancy;

- lactation period;

For intravenous administration - infant age (up to 1 year) or body weight less than 9 kg. For intramuscular injection - infant age (up to 3 months) or body weight less than 5 kg.

Carefully:

- renal and / or liver failure;

- bronchial asthma;

- urticaria or acute rhinitis;

- propensity to arterial hypotension;

hypersensitivity to other non-steroidal anti-inflammatory drugs or non-opioid analgesics (including a history of urticaria or acute rhinitis triggered by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs).

Pregnancy and lactation:contraindicated

Dosing and Administration:

Parenterally - intravenously or intramuscularly. Before administration, the solution should be warmed to body temperature.

Intravenous - adults and adolescents over 15 years of age with acute severe colic are administered 2 ml each; if necessary, re-enter the same dose after 6-8 hours.

Intramuscularly - adults and children over 15 years of age are administered 2-5 ml 2-3 times a day. The daily dose should not exceed 10 ml. Duration of treatment should not exceed 5 days.

For children under 15 years of age and infants, the daily dose is set taking into account the body weight (see table).

Age / body weight	I / O Introduction	Introduction in / m
Infants 3-5 months (5-8 kg)	-	0.1-0.2 ml
Children 1-2 years (9-15 kg)	0.1-0.2 ml	0.2-0.3 ml
Children 3-4 years (16-23 kg)	0.2-0.3 ml	0.3-0.4 ml
Children 5-7 years (24-30 kg)	0.3-0.4 ml	0.4-0.5 ml
Children 8-12 years old (31-45 kg)	0.5-0.6 ml	0.6-0.7 ml
Children 12-15 years (46-53 kg)	0.8-1.0 ml	0.8-1.0 ml

Intravenous administration should be slow (1 ml for at least 1 minute), in the patient's lying position and under control

blood pressure, heart rate and respiration.

Side effects:

Allergic reactions: skin rash, itching, urticaria (including on conjunctiva and mucous membranes of the nasopharynx),angioedema; in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospastic syndrome, anaphylactic shock.

From the central nervous system: headache, dizziness, paresis of accommodation.

From the digestive system: dry mouth, burning sensation in the epigastric region.

From the urinary system: renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining red (due to metamizol sodium metabolites), difficulty urinating.

From the cardiovascular system: lowering of blood pressure, tachycardia.

From the hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (can be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of phenomena of vaginitis or proctitis). Anticholinergic effects: lowering of sweating, difficulty urinating.

Local reactions: when administered intramuscularly infiltrates at the site of administration.

Overdose:

Symptoms: dry mouth, nausea, vomiting, epigastric pain, lowering blood pressure, sweating, drowsiness, disruption of accommodation, confusion, impaired liver and kidney function, convulsions.

Treatment: symptomatic therapy.

Interaction:

With simultaneous application of Pllalgin and:

- non-narcotic analgesics there may be a mutual increase in toxic effects; allopurinol, oral contraceptives and tricyclic antidepressants the toxicity of Pllangin is increased;

- thiamazole and cytostatics increases the risk of developing leukopenia;

- cyclosporine reduces the concentration in the blood of cyclosporine;

- Butyrophenones, phenothiazines, tricyclic antidepressants, Hi- histamin blockers, amantadine and quinidine, the m-cholinoblocking effect of fenpiperinium bromide is enhanced;

- chlorpromazine or other phenothiazine derivatives may develop marked hyperthermia;

- Ethanol is enhanced by the effect of ethanol;

- phenylbutazone, barbiturates and other inducers of microsomal liver enzymes, the effectiveness of metamizole sodium decreases;

- sedative and anxiolytic drugs, the analgesic effect of metamizole sodium is enhanced;

- codeine, blockers of Hg-histamine receptors and propranolol, the action of Plenolgin is enhanced.

Metamizole sodium, displacing from the connection with proteins, oral hypoglycemic agents, indomethacin, indirect anticoagulants and glucocorticosteroids, can enhance their effect.

Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizol sodium.

Pharmaceutical interaction.

Plenolgin solution is pharmaceutically incompatible with solutions of other medications.

Special instructions:

During treatment with the drug is not recommended to take ethanol.

With prolonged (more than a week) treatment, control of the peripheral blood picture and the functional state of the liver is necessary. Intolerance is very rare, but the threat of anaphylactic shock after IV injection is relatively higher than after oral administration.

When treating children under 5 years of age and patients,receiving cytostatic drugs, metamizole sodium intake should only be done under the supervision of a doctor. Possible staining of urine in red

color due to the release of metabolite (has no clinical significance).

If suspected of agranulocytosis or in the presence of thrombocytopenia, the drug should be discontinued.

Admission of the drug to patients with atopic bronchial asthma and pollinosis increases the risk of allergic reactions.

It is unacceptable (until finding out the causes of the onset of pain syndrome) use of the drug for the purpose of relief of acute pain in the abdomen. Parenteral administration of the drug should be used only in cases where oral administration is not possible (or absorption from the gastrointestinal tract is impaired).

For intramuscular injection, a long needle should be used.

Effect on the ability to drive transp. cf. and fur:Care should be taken during vehicle administration for drivers of vehicles and for persons involved in potentially hazardous activities requiring quick physical and mental reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection.

5 ml of the drug in a vial of dark hydrolytic glass (type 1).

5 ampoules are placed in a tray of PVC. One pallet with instructions for use in a cardboard box.

Packaging:ampoules of dark glass (5) -packing contour plastic (pallets)

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014258 / 01

Date of registration:01.07.2009

The owner of the registration certificate:Plethiko Pharmaceuticals Co., Ltd. Plethiko Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

PLETHICO PHARMACEUTICALS, Ltd. India

Representation: & nbspREZLOV ZAO REZLOV ZAO Kazakhstan

Information update date: & nbsp29.12.2009

Illustrated instructions

Instructions

Plenlangin (Plenalgin)