Negrinpin

General characteristics. Structure:

Active ingredients: 500 mg of paracetamol, 25 mg of pheniramine of a maleate, 220 mg of ascorbic acid in 3 g of powder.

Excipients: citric acid, E 951 aspartame, E 102 tartrazine, oil lemon, granulated sugar.

The combined medicine, renders the antiallergenic, broncholitic, antiinflammatory, febrifugal, analgeziruyushchy, antioxidant action which is followed by reduction of a rhinorrhea, dacryagogue, sneezing and recovery of nasal breath.

Pharmacological properties:

Pharmacodynamics. Effect of medicine is caused by effects of the components which are its part. Pheniramine – a blocker histamine H1 receptors. Has antiallergic effect, lowers a tone of smooth muscles of bronchial tubes, normalizes microcirculation, reduces permeability of a vascular wall of capillaries, than provides reduction of hypostasis of fabrics and the phenomena of exudation or their prevention (recovery of nasal breath, disappearance of a rhinorrhea, dacryagogue). Paracetamol inhibits synthesis of prostaglandins and reduces excitability of the center of thermal control of a hypothalamus what its analgeziruyushchy and febrifugal action is connected with. At normal body temperature febrifugal action is not shown. Ascorbic acid is powerful antioxidant, has the expressed recovery properties. Regulates oksilitelno-recovery processes, carbohydrate metabolism, an angenesis. Participates in synthesis of collagen and procollagen, than also contributes to normalization of permeability of capillaries, reduction of hypostasis of fabrics and exudation. In the period of a disease the need for vitamin C sharply increases.

Pharmacokinetics. Pheniramine the maleate is well adsorbed from a GIT. Plasma elimination half-life makes 1,5 – 2 h. Medicine has big affinity to fabrics. Out of an organism it is brought in the hepatic way.

Paracetamol: intestinal absorption happens quickly and almost completely. It is quickly distributed in fluid mediums of an organism. The maximum concentration in plasma is reached in 30-60 min. Poorly contacts proteins of a blood plasma. Plasma elimination half-life makes about 2 h. Metabolism in a liver goes on the 2nd main ways: medicine is removed with urine in a glyukurosvyazanny and sulfoconnected look and only 5% - in not changed look. An insignificant part of medicine (less than 4%) – with the participation of P450 cytochrome turns into the metabolite entering connection with glutathione. At intoxication the quantity of this metabolite increases.

Ascorbic acid is well absorbed from a GIT, surplus it is removed with urine.

Indications to use:

The symptomatic treatment of catarrhal, grippopodobny states at adults and children of 15 years is also more senior, followed:
- headache and/or fever;
- sneezing;
- transparent allocations from a nose and dacryagogue.

Route of administration and doses:

Before the use contents of a package are dissolved in 100 ml of the svezheprokipyachenny and cooled drinking water. Ready solution is used inside.

Medicine is appointed by the adult on 1 bag by 2-3 times a day.

Between receptions it is necessary to observe an interval not less than four hours. In case of a renal failure the period between receptions of medicine has to be not less than 8 hours.

Medicine use duration no more than 5 days.

Features of use:

It is impossible to exceed the recommended dose or to accept drug longer than 5 days in a row. It is necessary to consult with the doctor if symptoms:
- do not improve within 5 days;
- are followed by fever which keeps more than 3 days;
- include a pharyngalgia which does not pass more than 3 days, are followed by fever, a headache, rashes, nausea or vomiting.

It is necessary to be careful at prescription of medicine to patients with pathology of kidneys and to patients with a liver failure because this means contains the paracetamol and pheniramine increasing risk paracetamol of the connected injuries of a liver.

The use of alcoholic beverages or demulcents (in particular, barbiturates), strengthens sedation of antihistamines therefore it is necessary to avoid their inclusion in treatment time.

Each package contains sugar that should be considered in total quantity of the consumed sucrose in days at patients with a diabetes mellitus and at observance of a diet with the low content of sugar.

For adults with body weight more than 50 kg the general dose of paracetamol should not exceed 4 g a day.

Use at pregnancy and a lactation. Drug is contraindicated during pregnancy and a lactation for independent use, consultation with the doctor is necessary.

Influence on ability to drive the car and to work with mechanisms. During treatment it is not recommended to manage motor transport and to work with the difficult mechanisms demanding the increased concentration of attention and high speed of psychomotor reactions. Because of anticholinergic properties pheniramine can cause drowsiness, dizziness, opacification of sight and psychomotor disturbance in some patients that can seriously affect ability to drive the car and to use the equipment. At simultaneous use of sedatives of tranquilizers or alcohol drowsiness can amplify.

Side effects:

Connected with paracetamol. Frequency of these reactions is not determined, but usually they arise seldom:
- thrombocytopenia;
- anaphylaxis;
- skin reactions of hypersensitivity, including skin rash, Quincke's edema and Stephen-Johnson's syndrome;
- a bronchospasm at the patients sensitive to aspirin and other NPVS;
- liver dysfunction.

Connected with pheniramine. Neurovegetative effects:
- sedation or drowsiness, especially in an initiation of treatment;
- dryness of mucous membranes, lock, accommodation disturbances, mydriasis, strong heartbeat, risk of an ischuria;
- orthostatic hypotension;
- balance disturbances, вертиго, easing of memory or concentration that often occurs at elderly people;
- lack of coordination of movements, shiver;
- confusion of consciousness, hallucination;
- in more exceptional cases – effects as excitement: agitation, nervousness, sleeplessness.
Hypersensitivity reactions (seldom):
- eritrema, itch, eczema, urticaria;
- hypostasis, is more rare – a Quincke's edema;
- acute anaphylaxis.

Hematologic effects:
- leykotsitopeniya, neutropenia;
- thrombocytopenia;
- hemolitic anemia.

Interaction with other medicines:

Medicamentous interactions with paracetamol are usually insignificant, but amplify when the accompanying medicines are anticoagulants (warfarin and coumarin) and anticonvulsant medicines with a low therapeutic index.

Simultaneous use of paracetamol with NPVP can increase their nephrotoxicity. Pharmakodinamichesky interactions can arise with other soothing drugs, such as caffeine, opiates; barbiturates reduce febrifugal effect.

Probenetsid, холестирамин suppress paracetamol metabolism.

Antitubercular medicines (rifampicin, isoniazid) increase a paracetamol hepatotoxic. Antiepileptic means (phenobarbital, Phenytoinum, carboazepine) do not increase risk of a hepatotoxic action.

 

Pheniramine strengthens effect of the medicines oppressing the central nervous system (for example, antiparkinsonichesky and antipsychotic means), and also alcohol, suppresses effect of anticoagulants and interacts with progesterone, Reserpinum, thiazide diuretics.

Oral contraceptives can lead to reduction of efficiency of antihistamines.

Contraindications:

- hypersensitivity to drug components;
- heavy abnormal liver functions and/or kidneys;
- glaucoma;
- the ischuria connected with dysfunctions of a prostate;
- alcoholism;
- fenilketonuriya;
- stomach ulcer and a duodenum in an aggravation stage;
- severe form of a diabetes mellitus;
- intolerance of fructose, a sprue of glucose galactose or sakharozo-isomaltose insufficiency because of availability of sucrose in drug;
- children up to 15 years;
- pregnancy, lactation period.

Overdose:

Caused by paracetamol. There is a risk of injury of a liver at adults who accepted 10 g and more paracetamol. Reception of 5 g and more paracetamol can lead to injury of a liver if the patient has the following risk factors:
- is on prolonged treatment by carbamazepine, phenobarbital, Phenytoinum, primidomny, rifampicin, a St. John's Wort and other medicines which induce liver enzymes;
- regularly consumes ethanol over the recommended quantities;
- it is exhausted (HIV infection, a mucoviscidosis, hunger).

Symptoms: the nausea, vomiting, anorexia, abdominal pains which are usually shown in the first days. Injury of a liver can be shown from 12 to 48 hours after reception. At a serious poisoning the liver failure can progress to encephalopathy, bleeding, a hypoglycemia, wet brain and death. An acute renal failure with an acute necrosis, the back pain, a hamaturia and a proteinuria can develop even in the absence of serious injuries of a liver.

Treatment: at manifestation of symptoms of poisoning immediately see a doctor. Blood test on determination of level of paracetamol in plasma, a gastric lavage, introduction of an antidote of N-Acetylcysteinum (in/in or inside) within 24 hours after paracetamol reception, a symptomatic treatment is recommended.

Caused by pheniramine. The overdose can cause spasms, disturbance of consciousness, change of behavior, dystonic reactions, cardiovascular insufficiency, bradycardia, drowsiness, a vision disorder, a depression, atropine similar "psychosis".

Storage conditions:

To store in the place protected from moisture at a temperature not above +25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

Without recipe

Packaging:

On 3,0 g in the thermowelded packages placed together with a leaf insert for consumers in packs from a cardboard No. 10 and No. 20.