Attributes
- Form
- Dosage mg
- Pack
- Description en
- Pipolfen injection solution for intramuscular and intravenous use. Each 2 ml ampoule contains 50 mg of promethazine hydrochloride. The solution also contains hydroquinone, potassium metabisulfite, sodium sulfite, sodium chloride, water for injection. Pharmacotherapeutic group: H1 histamine receptor blocker. ATC code R06AD02 Indications - Symptomatic treatment of allergic conditions of any origin: (e.g., rhinitis, conjunctivitis, urticaria, angioneurotic edema, and dermographism). - Adjuvant therapy for anaphylactic reactions: after initial treatment of acute symptoms with other drugs, e.g., adrenaline. - The drug can be used as a sedative before and after surgery, and also in obstetrics to achieve a sedative effect. - Anesthesiology and surgery: prevention and treatment of nausea and vomiting associated with anesthesia or occurring in the postoperative period. - Potentiation of narcosis: when used with narcotics and analgesics. - When used with analgesics after surgery, the drug has a positive effect in relieving pain. - Prevention and treatment of kinetosis: prevention and/or treatment of dizziness and "motion sickness" during travel. Contraindications • Hypersensitivity to phenothiazines; • Comatose state or severe depression of central nervous system (CNS) function; • Less than 14 days after taking MAO inhibitors; • Age up to 2 months; • Pregnancy and lactation. Special instructions - Extreme caution is necessary when using the drug in elderly patients (especially at high doses) due to the increased risk of severe adverse effects. - The use of Pipolfen in children should be done with caution until the exact diagnosis of the disease is established. Symptoms of undiagnosed encephalopathy and Reye's syndrome may be mistakenly assessed as manifestations of Pipolfen side effects. - Special caution should be exercised when prescribing the drug to patients with cardiovascular diseases and liver diseases. - Promethazine can cause cholestatic jaundice (mainly after parenteral administration). - The drug lowers the threshold of convulsive readiness. This should be taken into account when treating patients who are prone to seizures or who are taking other drugs with a similar effect along with promethazine. - The course of some diseases (angle-closure glaucoma, stenosing gastric ulcer, bladder neck stenosis and/or prostatic hypertrophy) may be complicated by the anticholinergic action of promethazine. Patients with these diseases should be treated with extreme caution when prescribing this drug. - The drug should be prescribed with caution in asthma or severe respiratory diseases. - Alcohol consumption is prohibited during treatment. - False negative or false positive results of diagnostic allergy tests or pregnancy tests may occur during promethazine administration. Interactions with other drugs: - Sedatives, narcotics, hypnotics, tricyclic antidepressants, and tranquilizers enhance the depressant effect of Pipolfen on the CNS. Therefore, it is recommended to reduce the dose of these drugs; - Pipolfen enhances the action of anticholinergic drugs; - Paradoxical hypotension and tachycardia may develop with simultaneous administration with adrenaline (promethazine blocks alpha-adrenoreceptors, thereby weakening the pressor effect of adrenaline); - Antihypertensive drugs (Pipolfen enhances their action); - Drugs that cause extrapyramidal symptoms (Pipolfen increases the risk of CNS side effects). Method of administration and dosage: The injection solution is administered intramuscularly: in patients with the above indications who cannot take Pipolfen orally; - for adjuvant therapy of anaphylactic reactions; - for achieving a sedative effect before and after surgical operations, for achieving a sedative effect in obstetrics, and also for potentiating the effects of analgesics and narcotics. Intravenously, the drug (0.15 - 0.30 mg/kg body weight) should be used: - for induction of anesthesia and analgesia during special types of surgical interventions, such as, for example: repeated bronchoscopy and ophthalmological operations. Usual doses for adults for allergies: can be prescribed 12.5 mg 3-4 times a day or 25 mg in the evening. The lowest effective dose is prescribed. For prevention of nausea and vomiting: usually, a single dose of 25 mg is effective when oral administration is not tolerated. If necessary, 12.5-25 mg can be administered every 4-6 hours. For prevention and treatment of nausea and "motion sickness" during travel: the usual dose is 25 mg twice a day. This dose is recommended to be taken 1/2 - 1 hour before travel, after which, if necessary, the dose can be repeated in 8-12 hours. For achieving a sedative effect before and after surgical operations, for achieving a sedative effect in obstetrics, and also for potentiating the effect of narcotics and analgesics: a cocktail containing 50 mg of Pipolfen can be taken 2.5 hours before surgery. If necessary, this dose can be repeated in 1 hour. The maximum daily dose of promethazine for adults is 150 mg. In children, it is not recommended for children under 2 months of age! Children over 2 months of age can be administered 0.5 - 1 mg/kg body weight intravenously 3-5 times a day. In severe cases, the single dose can be increased to 1-2 mg/kg body weight intravenously. Overdose Symptoms: drowsiness, disorientation, orthostatic hypotension, collapse, extrapyramidal symptoms, seizures, respiratory distress, and coma. Treatment: Due to the absence of an antidote, symptomatic and supportive therapy is prescribed. Activated charcoal and/or gastric lavage may be administered. Noradrenaline or phenylephrine is used to treat severe hypotension. Adrenaline can cause a paradoxical effect that exacerbates hypotension. Seizures should be managed with benzodiazepine administration. Dialysis is ineffective. Side effects - Neurological: sedative effect, drowsiness, visual disturbances, dry mouth, dizziness, clouded consciousness, disorientation, and also, mainly after high doses or parenteral administration - extrapyramidal symptoms (oculogyric crisis, torticollis, tongue protrusion). - Cardiovascular system: possible decrease in blood pressure. - Gastrointestinal: nausea, vomiting, constipation, dry mouth. - Hematopoietic system: rarely observed thrombocytopenia and/or leukopenia - Other: skin rash and/or photosensitivity. Dosage form 10 ampoules of 2 ml volume are packed in a folding cardboard box with instructions for medical use. Storage conditions Store at room temperature 15 - 250C, protected from light, out of reach of children! Expiration date The expiration date is indicated on the packaging. The drug should not be used after the expiration date indicated on the packaging. Dispensing conditions From the pharmacy By prescription Manufacturer Pharmaceutical Factory Egis Plc. Hungary
- Active
- promethazine
What is it?
Pipolfen injection solution for intramuscular and intravenous use. Each 2 ml ampoule contains 50 mg of promethazine hydrochloride. The solution also contains hydroquinone, potassium metabisulfite, sodium sulfite, sodium chloride, water for injection. Pharmacotherapeutic group: H1 histamine receptor blocker. ATC code R06AD02 Indications - Symptomatic treatment of allergic conditions of any origin: (e.g., rhinitis, conjunctivitis, urticaria, angioneurotic edema, and dermographism). - Adjuvant therapy for anaphylactic reactions: after initial treatment of acute symptoms with other drugs, e.g., adrenaline. - The drug can be used as a sedative before and after surgery, and also in obstetrics to achieve a sedative effect. - Anesthesiology and surgery: prevention and treatment of nausea and vomiting associated with anesthesia or occurring in the postoperative period. - Potentiation of narcosis: when used with narcotics and analgesics. - When used with analgesics after surgery, the drug has a positive effect in relieving pain. - Prevention and treatment of kinetosis: prevention and/or treatment of dizziness and "motion sickness" during travel. Contraindications • Hypersensitivity to phenothiazines; • Comatose state or severe depression of central nervous system (CNS) function; • Less than 14 days after taking MAO inhibitors; • Age up to 2 months; • Pregnancy and lactation. Special instructions - Extreme caution is necessary when using the drug in elderly patients (especially at high doses) due to the increased risk of severe adverse effects. - The use of Pipolfen in children should be done with caution until the exact diagnosis of the disease is established. Symptoms of undiagnosed encephalopathy and Reye's syndrome may be mistakenly assessed as manifestations of Pipolfen side effects. - Special caution should be exercised when prescribing the drug to patients with cardiovascular diseases and liver diseases. - Promethazine can cause cholestatic jaundice (mainly after parenteral administration). - The drug lowers the threshold of convulsive readiness. This should be taken into account when treating patients who are prone to seizures or who are taking other drugs with a similar effect along with promethazine. - The course of some diseases (angle-closure glaucoma, stenosing gastric ulcer, bladder neck stenosis and/or prostatic hypertrophy) may be complicated by the anticholinergic action of promethazine. Patients with these diseases should be treated with extreme caution when prescribing this drug. - The drug should be prescribed with caution in asthma or severe respiratory diseases. - Alcohol consumption is prohibited during treatment. - False negative or false positive results of diagnostic allergy tests or pregnancy tests may occur during promethazine administration. Interactions with other drugs: - Sedatives, narcotics, hypnotics, tricyclic antidepressants, and tranquilizers enhance the depressant effect of Pipolfen on the CNS. Therefore, it is recommended to reduce the dose of these drugs; - Pipolfen enhances the action of anticholinergic drugs; - Paradoxical hypotension and tachycardia may develop with simultaneous administration with adrenaline (promethazine blocks alpha-adrenoreceptors, thereby weakening the pressor effect of adrenaline); - Antihypertensive drugs (Pipolfen enhances their action); - Drugs that cause extrapyramidal symptoms (Pipolfen increases the risk of CNS side effects). Method of administration and dosage: The injection solution is administered intramuscularly: in patients with the above indications who cannot take Pipolfen orally; - for adjuvant therapy of anaphylactic reactions; - for achieving a sedative effect before and after surgical operations, for achieving a sedative effect in obstetrics, and also for potentiating the effects of analgesics and narcotics. Intravenously, the drug (0.15 - 0.30 mg/kg body weight) should be used: - for induction of anesthesia and analgesia during special types of surgical interventions, such as, for example: repeated bronchoscopy and ophthalmological operations. Usual doses for adults for allergies: can be prescribed 12.5 mg 3-4 times a day or 25 mg in the evening. The lowest effective dose is prescribed. For prevention of nausea and vomiting: usually, a single dose of 25 mg is effective when oral administration is not tolerated. If necessary, 12.5-25 mg can be administered every 4-6 hours. For prevention and treatment of nausea and "motion sickness" during travel: the usual dose is 25 mg twice a day. This dose is recommended to be taken 1/2 - 1 hour before travel, after which, if necessary, the dose can be repeated in 8-12 hours. For achieving a sedative effect before and after surgical operations, for achieving a sedative effect in obstetrics, and also for potentiating the effect of narcotics and analgesics: a cocktail containing 50 mg of Pipolfen can be taken 2.5 hours before surgery. If necessary, this dose can be repeated in 1 hour. The maximum daily dose of promethazine for adults is 150 mg. In children, it is not recommended for children under 2 months of age! Children over 2 months of age can be administered 0.5 - 1 mg/kg body weight intravenously 3-5 times a day. In severe cases, the single dose can be increased to 1-2 mg/kg body weight intravenously. Overdose Symptoms: drowsiness, disorientation, orthostatic hypotension, collapse, extrapyramidal symptoms, seizures, respiratory distress, and coma. Treatment: Due to the absence of an antidote, symptomatic and supportive therapy is prescribed. Activated charcoal and/or gastric lavage may be administered. Noradrenaline or phenylephrine is used to treat severe hypotension. Adrenaline can cause a paradoxical effect that exacerbates hypotension. Seizures should be managed with benzodiazepine administration. Dialysis is ineffective. Side effects - Neurological: sedative effect, drowsiness, visual disturbances, dry mouth, dizziness, clouded consciousness, disorientation, and also, mainly after high doses or parenteral administration - extrapyramidal symptoms (oculogyric crisis, torticollis, tongue protrusion). - Cardiovascular system: possible decrease in blood pressure. - Gastrointestinal: nausea, vomiting, constipation, dry mouth. - Hematopoietic system: rarely observed thrombocytopenia and/or leukopenia - Other: skin rash and/or photosensitivity. Dosage form 10 ampoules of 2 ml volume are packed in a folding cardboard box with instructions for medical use. Storage conditions Store at room temperature 15 - 250C, protected from light, out of reach of children! Expiration date The expiration date is indicated on the packaging. The drug should not be used after the expiration date indicated on the packaging. Dispensing conditions From the pharmacy By prescription Manufacturer Pharmaceutical Factory Egis Plc. Hungary