Promedolum

Promedolum – narcotic analgetic drug.

Form of release and structure

• Tablets: ploskotsilindrichesky, white color, with a facet and a stamping in the form of a letter "P" (on 10 таб. in blister strip packagings, 1 or 2 packagings in a cardboard pack);
• Solution for injections of 1% and 2%: transparent, colourless (for drugstores – on 1 ml in the syringe tubes, in a pack of cardboard 20, 50 or 100 syringes; on 1 ml in ampoules, on 5 ampoules in a blister strip packaging, in a pack cardboard 1 or 2 packagings (if it is necessary, with an ampoule knife or the scarificator); for medical institutions – on 1 ml in ampoules, on 5 ampoules in a blister strip packaging, in a box cardboard or a box from corrugated fibreboard 20, 30, 40, 50 or 100 of packagings (if it is necessary, with an ampoule knife or the scarificator)).

Active agent: Trimeperidini hydrochloridum (Promedolum):

• 1 tablet – 25 mg;
• 1 ml of solution – 10 or 20 mg.

Excipients of tablets: potato starch, sugar, stearic acid.

Additional components of solution: Acidum hydrochloricum, water for injections.

Indications to use

Tablets and solution appoint Promedolum at a pain syndrome of average and strong degree of manifestation, resistant to non-narcotic analgesics, including in the following cases:

• Injuries;
• Burns;
• Lumbosacral radiculitis;
• Acute neuritis;
• Thalamic syndrome;
• Protrusion of an intervertebral disk;
• Postoperative period;
• Acute prostatitis;
• Peptic ulcer of a stomach and 12-perstny gut;
• The pains caused by a spasm of smooth muscles of internals: renal, hepatic, intestinal gripes (in combination with atropinopodobny and antispasmodics);
• Chronic pancreatitis;
• Oncological diseases.

In the form of solution drug is appointed, besides, at the following diseases / states:

• Myocardial infarction;
• The stratifying aortic aneurysm;
• Unstable stenocardia;
• Thromboembolism of arteries of extremities or pulmonary artery;
• Thrombosis of a renal artery;
• Lung heart attack;
• Acute pericardis;
• Air embolism;
• Acute pleurisy;
• Kauzalgiya;
• Bad attack of glaucoma;
• Acute vesiculitis;
• Paranephritis;
• Perforation of a gullet;
• Spontaneous pheumothorax;
• Acute dysuria;
• Priapism;
• Paraphimosis;
• Foreign bodys of an urethra, bladder, rectum;
• Fluid lungs;
• Acute left ventricular failure;
• Cardiogenic shock;
• Preoperative, operational and postoperative periods;
• Childbirth (for anesthesia and stimulation);
• Neuroleptanalgesia (in a combination with neuroleptics).

Contraindications

For both dosage forms:

• Oppression of a respiratory center;
• Hypersensitivity to any of drug components.

In addition for tablets:

• Cachexia;
• Children's age (because of impossibility of exact dosing).

In addition for solution:

• Infectious diseases (because of risk of penetration of an infection into the central nervous system);
• Toxic dyspepsia (delay of removal of toxins and the aggravation connected with it and prolongation of diarrhea);
• Diarrhea owing to the pseudomembranous colitis caused by use of cephalosporins, linkozamid or penicillin;
• Blood coagulation disturbance, including owing to performing anticoagulating therapy (for epidural and spinal anesthesia);
• Simultaneous use of monoamine oxidase inhibitors and within 21 days after their cancellation;
• Children's age up to 2 years.

Tablets with care should be applied:

• Hypothyroidism;
• Craniocereberal injury with psychosis;
• Oppression of the central nervous system;
• Myxedema;
• Respiratory insufficiency;
• Urethra stricture;
• Prostate hyperplasia;
• Adrenal insufficiency;
• Liver/renal failure;
• Alcoholism;
• Advanced age.

Solution with care should be applied:

• The expressed inflammatory diseases of intestines;
• Suicide bent;
• Spasms;
• Emotional lability;
• Craniocereberal injury;
• Oppression of the central nervous system;
• Intracranial hypertensia;
• Alcoholism;
• Drug addiction (in the anamnesis including);
• Arterial hypotonia;
• Arrhythmia;
• Chronic obstructive pulmonary disease;
• Bronchial asthma;
• Cachexia;
• Surgical interventions on digestive tract or an urinary system;
• Urethra stricture;
• Prostate hyperplasia;
• Myxedema;
• Adrenal insufficiency;
• Respiratory insufficiency;
• Chronic heart failure;
• Liver/renal failure;
• Hypothyroidism;
• The weakened condition of patients;
• Children's age;
• Advanced age;
• Period of pregnancy and lactation.

Route of administration and dosage

In the tablets Promedolum it is necessary to accept inside 1-2 pieces. At pains owing to a spasm of smooth muscles (intestinal, renal and hepatic colic) drug is combined with spasmolytic and atropinopodobny means, treatment is carried out under careful control of the patient. The most admissible single dose – 50 mg (2 таб.), daily – 200 mg (8 таб.).

Solution Promedolum is entered intravenously (in/in) and intramusculary (in oil), into the syringe tubes – only intramusculary and subcutaneously (п / to).

The adult depending on a clinical situation appoint 10-40 mg (from 1 ml of 1% of solution to 2 ml of 2% of solution). To children of 2 years depending on age – on 3-10 mg.

For premedication before an anesthesia the drug is administered п / to or in oil 20-30 mg in a dose along with 0,5 mg of atropine in 30-45 minutes prior to operation.

During an anesthesia Promedolum is entered in/in fractional doses on 3-10 mg.

For a labor pain relief appoint in oil or п / to in a dose of 20-40 mg at disclosure of a pharynx to 3-4 cm and satisfactory condition of a fruit. In order to avoid a narcotic depression of a fruit and the newborn the last dose has to be entered not later than in 30-60 minutes prior to delivery.

The maximum single dose for adults – 40 mg, daily – 160 mg.

Side effects

At reception of Promedolum in tablets are possible:

• From a nervous system: oppression of a respiratory center, asthma, disorientation, block, headache, euphoria, delay of speed of psychomotor reactions;
• From digestive tract: nausea and vomiting;
• Others: the increased sweating, a lowering of arterial pressure, allergic reactions, medicinal dependence, accustoming.

At use of drug in the form of solution are possible:

• From the alimentary system: more often – nausea, vomiting, a lock; less often – irritation of digestive tract, anorexia, dryness of a mucous membrane of an oral cavity, a spasm of biliary tract; seldom (at inflammatory diseases of intestines) – paralytic intestinal impassability, toxic megacolon (spasms in a stomach, nausea, vomiting, a meteorism, a lock, a gastralgia); frequency is unknown – a hepatotoxic (a pale chair, dark urine, an ikterichnost of integuments and scleras);
• From a nervous system and sense bodys: more often – drowsiness, вертиго, weakness; less often – an illegibility of visual perception, a headache, a diplopia, an uneasy dream, unusual dreams, nightmares, nervousness, discomfort, fatigue, involuntary muscular twitchings, a tremor, spasms, confusion of consciousness, euphoria; seldom – the depression, hallucinations, at children is concern, paradoxical excitement; frequency is unknown – a disorientation, delay of speed of psychomotor reactions, a ring in ears, muscle tension (especially respiratory), spasms;
• From cardiovascular system: more often – a lowering of arterial pressure (ABP); less often – arrhythmias; frequency is unknown – increase in the ABP;
• From an urinary system: less often – a spasm of ureters (frequent desires to an urination, pain and difficulty at an urination), decrease in a diuresis;
• From respiratory system: less often – oppression of a respiratory center;
• Allergic reactions: less often – a Quincke's disease, a laryngospasm, a bronchospasm; seldom – a skin itch, rash, a face edema;
• Local reactions: burning, a hyperemia and hypostasis in the place of an injection;
• Others: less often – the strengthened sweating; frequency is unknown – medicinal dependence, accustoming.

Special instructions

During treatment it is forbidden to take alcoholic beverages, it is necessary to refrain from driving and performance of potentially dangerous types of the works demanding the speed of reactions and high concentration of attention.

Medicinal interaction

Promedolum strengthens the respiratory depression and the central nervous system caused by use of ethanol, means for the general anesthesia, monoamine oxidase inhibitors, hypnotic drugs and sedative drugs, anxiolytics, neuroleptics, muscle relaxants and other narcotic analgetics.

The barbiturates (especially phenobarbital) applied systematically can reduce analgeziruyushchy action of Promedolum.

Naloxonum eliminates the analgesia caused by trimeperidine, recovers breath and reduces oppression of the central nervous system.

Nalorfinum eliminates the breath depression caused by drug, keeping its analgeziruyushchy effect.

Trimeperidine reduces action of Metoclopramidum, strengthens hypotensive effect of anti-hypertensive drugs, including diuretics and ganglioblokator.

In case of simultaneous use antidiarrheal means (including loperamide) and drugs with anticholinergic activity increase risk of an ischuria and emergence of a lock, up to intestinal impassability.

Promedolum strengthens effect of anticoagulants therefore in need of use of this combination it is necessary to control a plasma prothrombin.

Buprenorphine (including if it was applied during the previous therapy) reduces effect of trimeperidine.

Because of overexcitation or braking of the central nervous system at simultaneous use of monoamine oxidase inhibitors the risk of development of heavy reactions with emergence hypo - or hypertensive crises increases.

At the same time applied naltrexone reduces efficiency of Promedolum, can accelerate emergence of symptoms of a withdrawal in patients with drug addiction (these signs can appear already 5 minutes later after administration of drug, remain within 48 hours and are characterized by difficulty of their elimination).

Terms and storage conditions

To store in dry (tablets), protected from light, the place, unavailable to children, tablets – at the room temperature, solution – at a temperature up to 15 ºС.

Period of validity of tablets and solution in ampoules – 5 years, solution in the syringe tubes – 3 years.