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Pipolphen - histamine H1-receptor blocker, a derivative of phenothiazine. It has a pronounced antihistamine activity and has a significant effect on the central nervous system (it has a sedative, hypnotic, antiemetic, antipsychotic and hypothermic effect). Warns and soothes hiccups.
Prevents effects mediated by histamine (including urticaria and pruritus). The anticholinergic effect causes a drying effect on the mucous membranes of the nasal cavity and mouth.
The antiemetic effect of promethazine is due to its central anticholinergic effect, a decrease in the excitability of the vestibular system, suppression of the maze function, and a direct inhibitory effect on the trigger chemoreceptor zones of the medulla oblongata.
Sedative effect due to inhibition of histamine-K-methyltransferase and blockade of central histamine receptors. It is also possible blockade and other receptors of the CNS, such as serotonin and cholinergic receptors; stimulation of α-adrenoreceptors indirectly weakens the stimulation of the brainstem reticular formation. Since its chemical structure is different from that of other antipsychotics from the phenothiazine group, promethazine has a weaker antipsychotic effect.
In therapeutic doses, does not affect the cardiovascular system.
The clinical effect is manifested 20 minutes after ingestion (on average 15-60 minutes), 2 minutes after i / m administration or 3-5 minutes after i / v administration and usually lasts 4-6 h (sometimes persisting 12h)
- Allergic diseases (including urticaria, serum sickness, hay fever, allergic rhinitis, allergic conjunctivitis, angioedema, pruritus);
- adjuvant therapy of anaphylactic reactions (after relief of acute manifestations by other means, for example, epinephrine / adrenaline /);
- as a sedative in the pre- and postoperative period;
- to prevent or relieve nausea and vomiting associated with anesthesia and / or appearing in the postoperative period;
- postoperative pain (in combination with analgesics);
- kinetosis (to prevent and eliminate dizziness and nausea while traveling by vehicle);
- as a component of lytic mixtures used to potentiate anesthesia in surgical practice (for parenteral use).
- promethazine hydrochloride 25 mg
Excipients: hydroquinone, potassium disulfite, anhydrous sodium sulfite, sodium chloride, water d / i.
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Dosage and Administration
Assign inside, in / m and / in.
The maximum daily dose for adults is 150 mg.
V / m drug is prescribed to adults for 25 mg 1 time / day. If necessary, 12.5-25 mg every 4-6 hours.
In the treatment of allergic diseases, Pipolfen® is prescribed orally at a dose of 25 mg 1 time / day. in the evening or 25 mg 2 times / day. (in the morning and in the evening). The drug should be prescribed in the minimum effective dose.
For the prevention and treatment of nausea and vomiting, the drug is administered orally or intramuscularly in a dose of 25 mg once. If necessary, you can assign 25 mg every 4-6 hours.
In case of kinetosis, Pipolfen® is administered orally for 25 mg 2 times / day, the first dose is 0.5–1 hours before the trip, the next is after 8–12 hours.
As a sedative in surgery on the eve of the operation, it is prescribed orally or intramuscularly at a dose of 25-50 mg once a night. For preoperative preparation, 2.5 mg of Pipolphen is injected into the composition of the lytic mixtures 2.5 hours before the operation, if necessary, the administration can be repeated after 1 hour.
For induction of anesthesia and analgesia with certain diagnostic and surgical procedures, such as repeated bronchoscopy, ophthalmic surgery, Pipolfen® can be administered IV dose of 0.15-0.3 mg / kg body weight.
For children over the age of 2 months, the drug can be administered intramuscularly 3-5 times / day. at a dose rate of 0.5-1 mg / kg body weight. In severe cases, a single dose for i / m administration can be increased to 1-2 mg / kg body weight.
Children between the ages of 6 and 14 are prescribed an oral dose of 25 mg (1 tablet) 3-4 times / day. Pipolphen dragee is not recommended to be divided, therefore, the use of this dosage form for children under 6 years of age is not shown.
From the side of the central nervous system: sedation, drowsiness, nightmares, increased sleep apnea, visual acuity, anxiety, psychomotor agitation, dizziness, confusion, disorientation; after administration in high doses - extrapyramidal disorders, increased seizure activity (in children).
Since the cardiovascular system: may decrease blood pressure, tachycardia, bradycardia.
On the part of the digestive system: nausea, vomiting, constipation, dry mouth, nose, throat, anesthesia of the oral mucosa, cholestasis are possible.
From the hematopoietic system: rarely - thrombocytopenia and / or leukopenia, agranulocytosis.
Dermatological reactions: skin rash and / or photosensitization are possible.
On the part of the senses: noise or tinnitus, accommodation paresis, blurred vision.
Allergic reactions: urticaria, dermatitis, photosensitivity, bronchospasm.
Other: increased sweating, difficulty or painful urination.
- coma or other types of deep depression of the central nervous system;
- simultaneous use of MAO inhibitors and the period within 14 days after completion of their admission;
- angle-closure glaucoma;
- alcohol intoxication, acute intoxication with hypnotic drugs, opioid analgesics;
- sleep apnea syndrome;
- occasionally occurring vomiting in children of unspecified genesis;
- lactation period;
- children's age up to 2 months (for parenteral administration);
- children's age up to 6 years (for oral administration);
- hypersensitivity to promethazine, other phenothiazine derivatives and any other component of the drug Pipolphen.
Precautions should be prescribed for acute and chronic respiratory diseases (due to suppression of the cough reflex), open-angle glaucoma, bone marrow suppression, cardiovascular diseases, liver and kidney function disorders, peptic ulcer with pyloroduodenal obstruction, bladder neck stenosis and / or prostatic hypertrophy, susceptibility to urinary retention, epilepsy, Reye's syndrome, as well as elderly patients.
Pipolfen® enhances the effects of opioid analgesics, hypnotics, anxiolytics (tranquilizers) and antipsychotics (neuroleptics), as well as general anesthetic drugs, local anesthetics, m-anticholinergics and antihypertensive drugs (dose adjustment is required).
Pipolfen® reduces the effects of amphetamine derivatives, m-cholinomimetics, anticholinesterase drugs, ephedrine, guanethidine, levodopa, dopamine.
Barbiturates accelerate elimination and reduce the activity of promethazine.
Beta-blockers increase (mutually) the concentration of promethazine in the blood plasma.
Pipolfen® weakens the effect of bromocriptine and increases the concentration of prolactin in the blood serum.
Tricyclic antidepressants and anticholinergic drugs enhance the m-anticholinergic activity of promethazine.
Ethanol, clofelyn, antiepileptic drugs increase the inhibitory effect of promethazine on the central nervous system.
MAO inhibitors (simultaneous administration is not recommended) and phenothiazine derivatives increase the risk of arterial hypotension and extrapyramidal disorders. Quinidine increases the likelihood of the cardiodepressive action of promethazine.
With prolonged use of the drug, it is necessary to systematically monitor the formula of peripheral blood and liver function.
With extreme caution, especially in high doses, Pipolfen® should be administered to elderly patients, since this category of patients has an increased risk of side effects.
When used simultaneously with Pipolphen analgesics and hypnotics should be prescribed in smaller doses.
Pipolfen® should be used under strict medical supervision simultaneously with opioid analgesics, sedatives and hypnotics, anesthetics, tricyclic antidepressants and tranquilizers.
Pipolfen® can mask the ototoxic effect (tinnitus and dizziness) of commonly used drugs.
Pipolfen® reduces the threshold of convulsive readiness. This should be taken into account when prescribing the drug to patients prone to the development of seizures, or simultaneously with other drugs with a similar effect.
As an antiemetic drug Pipolfen® should be used only with prolonged vomiting of known etiology.
With prolonged use increases the risk of developing dental diseases (caries, periodontitis, candidiasis) due to a decrease in salivation.
During the period of treatment is prohibited the use of alcohol.
During the period of taking Pipolphen, a diagnostic pregnancy test may give a false positive result.
Consideration should be given to a possible increase in the blood glucose level of patients taking Pipolfen® when performing a glucose tolerance test.
To prevent distortion of the results of skin scarification tests for allergens, the drug should be canceled 72 hours before the allergological tests.
Each dragee contains 95 mg of lactose, which should be considered when lactose intolerance.
Use in Pediatrics
Pipolfen® should be prescribed with caution to children, as this makes it difficult to diagnose the underlying disease. Symptoms of undiagnosed encephalopathy and Reye's syndrome may be mistaken for the side effects of Pipolphen.
Influence on ability to drive motor transport and control mechanisms
In the initial period of use of Pipolphen, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions. In the future, the degree of restriction is determined depending on the individual tolerance of the patient.
Symptoms: in children - agitation, anxiety, hallucinations, convulsions, mydriasis and stiffness of the pupils, flushing of the skin of the face, hyperthermia; in adults - psychomotor agitation, convulsions, lethargy. In acute overdose - marked reduction in blood pressure, vascular collapse, respiratory depression, coma.
Treatment: due to the absence of antidotes, symptomatic and supportive therapy is carried out. Gastric lavage, the appointment of activated carbon inside (when carrying out detoxification in the early period after ingestion); According to indications - antiepileptic drugs. Dialysis is ineffective. Intake of sodium sulfate or magnesium may have a beneficial effect.
Measures should be taken to restore adequate pulmonary ventilation by ensuring the airway is passable and conducting auxiliary or artificial ventilation of the lungs. Correction of acidosis and / or electrolyte balance is necessary. In severe hypotension, norepinephrine (norepinephrine) or mezaton should be administered. Epinephrine (adrenaline) in a paradoxical way can increase arterial hypotension.
- Brand name: Pipolphen
- Active ingredient: Promethazine
- Dosage form: Solution for intravenous and intramuscular administration.
- Manufacturer: Egis
- Country of Origin: Hungary
Studies and clinical trials of Promethazine (Click to expand)
- Spectrofluorimetric Determination of Diethazine and Promethazine in Pharmaceutical Preparations
- Chiral separation of promethazine by capillary electrophoresis with end-column amperometric detection
- Synthesis of pH dependent chitosan-EPI hydrogel films and their application for in vitro release of promethazine hydrochloride
- Synthesis of Some Metabolites of Promethazine
- Comparison of the bioavailability of oral, rectal and intramuscular promethazine
- Bioequivalency and dose proportionality of three tableted promethazine products
- Rotary pursuit, a measure of human performance, and plasma concentrations of promethazine
- Interaction of carbamazepine and promethazine in rabbits
- Correlations between common tests for assessment of liver damage: Indices of the hepatoprotective activity of promethazine in carbon tetrachloride hepatotoxicity
- Preconcentration and determination of promethazine at lipid-modified carbon paste electrodes
- Electroanalytical Determination of Promethazine Hydrochloride in Pharmaceutical Formulations on Highly Boron-Doped Diamond Electrodes Using Square-Wave Adsorptive Voltammetry
- Electroanalytical Performance of (SiPy+Cl−/CuTsPc)5 LbL Film for Detecting Promethazine Hydrochloride
- Reduction of erythema in hairless guinea pigs after cutaneous sulfur mustard vapor exposure by pretreatment with niacinamide, promethazine and indomethacin
- Chiral derivatization of promethazine with (−)-menthyl chloroformate for enantiomeric separation by RP-HPLC
- Analysis of promethazine hydrochloride in syrups
- Distribution, excretion, and metabolism of 14C-labeled quaternary ammonium salt of mepazine and promethazine in rats
- Kinetics and mechanism of oxidation of promazine and promethazine by ferric perchlorate
- Oxidative degradation of pharmaceutically important phenothiazines I: Isolation and identification of oxidation products of promethazine
- Oxidative degradation of pharmaceutically important phenothiazines II: Quantitative determination of promethazine and some degradation products
- Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation
- Human whole blood and parotid saliva concentrations of oral and intramuscular promethazine
- High-pressure liquid chromatographic determination of promethazine plasma levels in the dog after oral, intramuscular, and intravenous dosage
- Thermal and photolytic degradation studies of promethazine hydrochloride: A stability-indicating assay