Pentalginum

Pentalginum – drug of the combined structure with spasmolytic, analgeziruyushchy, antiinflammatory and febrifugal action.

Form of release and structure

Dosage form – tablets, film coated: a kapsuloobrazny form, biconvex, with slanted edges, from light green till green color, on one party – a stamping of "PENTALGIN", on another – risk; on a cut a tablet of light green color with white impregnations (on 2, 6, 10 or 12 tablets in a blister strip packaging, on 1 or 2 packagings in a pack cardboard).

The active ingredients which are contained in 1 tablet:

• Paracetamol – 325 mg;
• Pheniramine a maleate – 10 mg;
• Naproxenum – 100 mg;
• Drotaverinum a hydrochloride – 40 mg;
• Caffeine – 50 mg.

Additional components: citric acid monohydrate, magnesium stearate, croscarmellose sodium, potato starch, talc, cellulose microcrystallic, butyl hydroxytoluene (E321), a hypro rod (hydroxypropyl cellulose) (klutset EF), indigo carmine (E132), dye quinolinic yellow (E104).

Structure of the covering tablet of a film cover: povidone (polyvinylpirrolidone middlemolecular medical), titanium dioxide, indigo carmine (E132), gipromelloz (gidroksipropilmetiltsellyuloz), dye quinolinic yellow (E104), talc, polysorbate 80 (twin 80).

Indications to use

• Pain syndrome of various genesis, including headache (including pain owing to brain vasospasms), a dentagra, альгодисменорея, neuralgia, radiculitis, muscle and joints pains;
• The pain syndrome caused by a spasm of smooth muscles including at a postcholecystectomy syndrome, cholelithiasis and chronic cholecystitis, and also renal colic;
• Postoperative and posttraumatic pains, including in the presence of an inflammation;
• Catarrhal diseases with fever (symptomatic therapy).

Contraindications

Absolute:

• Age up to 18 years;
• Pregnancy;
• Lactation period;
• Heavy renal failure;
• Gastrointestinal bleeding;
• Erosive cankers of the digestive tract (DT) in the period of an aggravation;
• Hyperpotassemia;
• State after performing aortocoronary shunting;
• Acute myocardial infarction and other serious organic illness of cardiovascular system;
• Heavy arterial hypertension;
• Frequent ventricular premature ventricular contraction;
• Bouveret's disease;
• Heavy liver failure;
• Full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms, and also intolerance of non-steroidal anti-inflammatory drugs (NPVS), including acetylsalicylic acid (now or in the anamnesis);
• Oppression of a marrowy hemopoiesis;
• Hypersensitivity to drug components.

Relative:

• High-quality hyperbilirubinemias (syndromes Cudgel Johnson, Rotor, Gilbert);
• Viral hepatitis;
• Renal/liver failure easy or moderate severity;
• Alcoholic damage of a liver;
• Diabetes mellitus;
• GIT cankers in the anamnesis;
• Diseases of peripheral arteries;
• Deficit glyukozo-6-fosfatdegidrogenazy;
• Cerebrovascular diseases;
• Epilepsy and tendency to convulsive attacks;
• Advanced age.

Route of administration and dosage

Accept Pentalginum inside on 1 tablet to 3 times a day. Increase in a daily dose up to 4 tablets is in some cases possible.

Duration of use of drug depends on indications: for stopping of a pain syndrome – no more than 5 days, for decrease in the increased body temperature – it is no more than 3 days. Increase in duration of treatment is possible only to destination the attending physician.

Side effects

• From an urinary system: renal failure;
• From cardiovascular system: arrhythmias, heartbeat, increase in arterial pressure;
• From sense bodys: sonitus, decrease in hearing; patients with closed-angle glaucoma have an increase in intraocular pressure;
• From the central nervous system (CNS): sleep disorders, strengthening of reflexes, decrease in concentration of attention, uneasiness, headache, excitement, dizziness, tremor;
• From system of a hemopoiesis: decrease in blood of level of agranulocytes, leukocytes, erythrocytes or thrombocytes, increase in quantity of a methemoglobin;
• From the alimentary system: discomfort in epigastriums, nausea, vomiting, a lock, abdominal pains, GIT erosive cankers, an abnormal liver function;
• Allergic and skin reactions: itch, urticaria, skin rash, dermatitis, Quincke's disease;
• Others: tachypnea (breath increase).

Special instructions

It is not necessary to apply Pentalginum along with NPVS, paratsetamolsoderzhashchy drugs and means intended for a symptomatic treatment of catarrhal diseases.

At long therapy (more than 5-7 days) it is necessary to keep a condition of function of a liver and indicators of peripheral blood under control.

Influence of caffeine on the central nervous system depends on its type and can be shown in different degree – from excitement before braking of higher nervous activity.

Under the influence of paracetamol results of laboratory researches on contents in a blood plasma of glucose and uric acid are distorted.

Naproxenum which is a part of drug promotes increase in a bleeding time.

Pentalginum should be cancelled in 48 hours prior to the appointed research on definition of 17 ketosteroids.

During treatment it is necessary to refuse alcohol intake, to be careful at control of motor transport and performance of potentially unsafe types of the works demanding speed of reactions and special attention.

Medicinal interaction

The barbiturates received by the patient for a long time reduce efficiency of paracetamol.

Diflunizal increases plasma concentration of paracetamol for 50% owing to what the risk of development of its hepatotoxic increases.

Paracetamol reduces effect of uricosuric drugs, strengthens effect of indirect anticoagulants.

The ethanol accepted during treatment by Pentalginum increases risk of development of acute pancreatitis.

Inhibitors of a microsomal oxidation (for example, Cimetidinum) reduce probability of a hepatotoxic action of paracetamol.

Drotaverinum which is a part of Pentalginum can weaken protivoparkinsonichesky effect of a levodopa.

Pheniramine – one of active ingredients of drug – at interaction with ethanol, monoamine oxidase inhibitors, tranquilizers and hypnagogues strengthens the oppressing influence on TsNS.

At simultaneous use of ethanol, tricyclic antidepressants, barbiturates or rifampicin the risk of toxic impact on a liver therefore similar combinations should be avoided increases.

One more active ingredient of Pentalginum – Naproxenum – can reduce diuretic effect of furosemide, strengthen effect of indirect anticoagulants, increase toxicity of a methotrexate and streptocides, to reduce removal of lithium and to increase its concentration in a blood plasma.

At simultaneous use of other drugs stimulating the central nervous system, or the use of kofeinsoderzhashchy drinks excessive stimulation of TsNS is possible.

The anticonvulsants which are hydantoin derivatives (especially Phenytoinum), barbiturates and Primidonum can strengthen metabolism and increase clearance of caffeine.

Oral contraceptives, Disulfiramum, Cimetidinum, norfloxacin and ciprofloxacin reduce metabolism of caffeine in a liver, than slow down its removal and increase concentration in blood.

Terms and storage conditions

To store at a temperature which is not exceeding 25 °C in dry, protected from light and the place, unavailable to children.

Period of validity – 2 years.