Pipolphenum

Pipolphenum – drug with antihistaminic, antiallergic, somnolent, sedative and antiemetic action.

Form of release and structure

Dosage forms of release of Pipolphenum:

• Dragee (tablets, coated): light blue, with a brilliant surface, a lenticular form, almost without or inodorous (on 20 pieces in blisters, on 1 blister in a cardboard pack or on 25 blisters in a cardboard box);
• Solution for intravenous and intramuscular administration: with a green shade or colourless, transparent, almost without or inodorous (on 2 ml in colourless glass ampoules with a blue code ring and a point of a break, on 5 ampoules in blister strip packagings, on 2 packagings in a cardboard pack).

Is a part of 1 dragee:

• Active agent: a promethazine hydrochloride – 25 mg;
• Auxiliary components: potato starch, stearic acid, gelatin, magnesium stearate, talc, monohydrate of lactose;
• Cover: sucrose, ariavit blue, глицерол, talc, gelatin, a macrogoal 35 000, titanium dioxide.

Is a part of 1 ml of injection solution:

• Active agent: a promethazine hydrochloride – 25 mg;
• Auxiliary components: dipotassium sulfite – 0,75 mg, hydrochinone – 0,2 mg, sodium chloride – 7 mg, anhydrous sodium sulfite – 1 mg, water for injections – to 1 ml.

Indications to use

• Anaphylactic reactions (as additional therapy after stopping of acute manifestations by other drugs, for example, adrenaline);
• Allergic diseases, including a small tortoiseshell, a Quincke's disease, a serum disease, hay fever, allergic rhinitis and conjunctivitis, an itch;
• Before - and the postoperative period (as sedative);
• Kinetoz (for elimination and the prevention of nausea and dizziness during trips on transport);
• Postoperative pains (along with the anesthetizing medicines);
• Nausea and vomiting which is connected with an anesthesia and/or develops during the postoperative period (for stopping or the prevention of development).

Injection solution in surgical practice is also appointed as a component of lytic mixes which are applied to potentiation of an anesthesia.

Contraindications

Absolute:

• Comas or other types of deep oppression of the central nervous system;
• Apnoea syndrome in a dream;
• Drunkenness, acute intoxications opioid analgetics and/or somnolent drugs;
• Closed-angle glaucoma;
• Incidentally arising vomiting of not specified genesis at children;
• Simultaneous use with monoamine oxidase inhibitors, and also the period of 2 weeks after the end of their use;
• Pregnancy and period of a lactation;
• Children's age up to 2 months (injection solution) or 6 years (dragee);
• Hypersensitivity to promethazine, other derivatives of a fenotiazin, and also other components of drug.

Relative (Pipolphenum is appointed with care in the presence of the following diseases / states):

• Peptic ulcer with piloroduodenalny obstruction;
• Acute and chronic respiratory diseases (in view of suppression of a tussive reflex);
• Oppression of function of marrow;
• Open angle glaucoma;
• Diseases of cardiovascular system;
• Predisposition to an ischuria;
• Functional disturbances of kidneys and liver;
• Stenosis of a neck of a bladder and/or prostatauxe;
• Syndrome to Reja;
• Epilepsy;
• Advanced age (because of high risk of development of side reactions).

Route of administration and dosage

Pipolphenum is applied inside, intramusculary and intravenously.

The maximum adult daily dose makes 150 mg.

Intramusculary Pipolphenum is appointed the adult on 25 mg once a day, if necessary introduction each 4-6 hours of 12,5-25 mg of solution is possible.

The recommended dosing mode:

• Allergic diseases: inside on 25 mg 1 (evening) or 2 (in the morning and in the evening) once a day (it is recommended – in the smallest effective dose);
• Nausea and vomiting (treatment and prevention): once 25 mg inside or intramusculary. In case of need perhaps repeated use of Pipolphenum each 4-6 hours;
• Kinetoz: in 2 times a day on 25 mg (the first reception – in 30-60 minutes prior to a trip, following – in 8-12 hours);
• Surgeries (as calmative): once for night of 25-50 mg (inside or intramusculary) on the eve of carrying out operation. As a part of lytic mixes for preoperative preparation in 2,5 hours prior to carrying out operation intramusculary enter 50 mg of Pipolphenum, perhaps repeated introduction of the same dose in 60 minutes;
• Diagnostic and surgical interventions, including ophthalmologic operations, a repeated bronkhoskopiya (for induction of an anesthesia and an analgesia): intravenously on 0,15-0,3 mg/kg.

Children of 2 months can enter Pipolphenum 3-5 times a day intramusculary on 0,5-1 mg/kg. In hard cases increase in a single dose up to 1-2 mg/kg is possible.

To children of 6-14 years drug is appointed inside by 3-4 times a day on 25 mg. It is not recommended to divide a dragee therefore Pipolphenum in this dosage form is not appointed to children of younger age.

Side effects

• Alimentary system: a cholestasia, nausea, anesthesia of a mucous membrane of an oral cavity, a lock, vomiting, dryness in a mouth, a throat, a nose;
• Central nervous system: drowsiness, sedation, disorientation, visual acuity disturbance, dreadful dreams, increase of a night apnoea, uneasiness, psychomotor arousing, confusion of consciousness, dizziness; use of high doses – increase in convulsive activity (at children), extrapyramidal frustration;
• Hemopoietic system: seldom – an agranulocytosis, a leukopenia and/or thrombocytopenia;
• Cardiovascular system: bradycardia, lowering of arterial pressure, tachycardia;
• Sense bodys: accommodation paresis, ring or sonitus, vision disorder;
• Dermatological reactions: photosensitization and/or skin rash;
• Allergic reactions: bronchospasm, dermatitis, urticaria, photosensitization;
• Others: the painful or complicated urination, the increased sweating.

Special instructions

Pipolphenum can mask ototoksichesky action (in the form of a sonitus and dizziness) jointly the applied medicines.

At long therapy it is necessary to control systematically a functional condition of a liver and a formula of peripheral blood.

Pipolphenum can lower a threshold of convulsive readiness that should be considered at its appointment as the patient inclined to development of spasms, or together with other drugs with similar action.

As the antiemetic Pipolphenum needs to be applied only at long vomiting of the known etiology.

At a long course because of decrease in salivation the probability of development of dental diseases (a periodontal disease, caries, candidiasis) increases.

During therapy it is forbidden to take alcohol.

Obtaining false positive result when conducting diagnostic test on pregnancy is possible. It is also necessary to consider possible increase in level of glucose in blood at execution of the test on tolerance to glucose.

To prevent distortion of results of skin scarifying tests on allergens Pipolphenum should be cancelled in 72 hours prior to carrying out allergological tests.

At a lactose intolerance it is necessary to consider that lactose is a part of a dragee.

Children should appoint Pipolphenum with care as it can complicate diagnosis of a basic disease (syndrome symptoms to Reja and not diagnosed encephalopathy can be mistakenly taken for side effects of drug).

At the beginning of therapy it is necessary to abstain from control of motor transport and performance of other potentially dangerous types of works. Further extent of restriction is defined individually.

Medicinal interaction

At the combined use of Pipolphenum with some medicinal means / substances the following effects can be observed:

• Derivative m cholinomimetics, ephedrine, amphetamine, antikholinesterazny medicines, levodopa, guanetidin, dopamine: weakening of their action;
• Opioid analgetics, somnolent, anxiolytic (tranquilizers) and antipsychotic drugs (neuroleptics), and also medicines for the general anesthesia, local anesthetics, m-holinoblokatory and hypotensive medicines: strengthening of their effects (medical control and carrying out correction of doses is necessary);
• Beta adrenoblockers: increase in concentration of promethazine in a blood plasma;
• Barbiturates: acceleration of elimination and reduction of activity of promethazine;
• Prolactin: increase in its concentration;
• Bromocriptinum: weakening of its action;
• Clonidine, ethanol, antiepileptic drugs: strengthening of the oppressing influence of promethazine on the central nervous system;
• Anticholinergic medicines and tricyclic antidepressants: strengthening of m-holinoblokiruyushchey of activity of promethazine;
• Quinidine: increase in probability of cardiodepressive effect of promethazine;
• Monoamine oxidase inhibitors derivative of a fenotiazin: increase in probability of development of extrapyramidal frustration and arterial hypotension (co-administration with monoamine oxidase inhibitors is not recommended).

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 5 years.