Approval Date: 09/01/2007
Revision Date: 07/01/2009
Revision Date: 01/10/2010
Revision date: December 01, 2015
Revision Date: 01/28/2016
Revision Date: 09/05/2016
Revision date: May 09, 2016
Promethazine Hydrochloride Tablets InstructionsPlease read the instructions carefully and use under the guidance of your physician
Forbidden to take when the drug properties are changed.
Keep this medicine out of the reach of children
This product is contraindicated if you are allergic to it
[Drug Name].
Generic Name: Promethazine Hydrochloride Tablets
English Name: Promethazine Hydrochloride Tablets
Hanyu Pinyin: Yansuan Yibingqin Pian
[Ingredients]
Chemical name: The main ingredient of this product is promethazine hydrochloride, whose chemical name is (±)-N,N,α-trimethyl-10H-phenothiazine-10-ethylamine hydrochloride.
Chemical structure formula.
Molecular Formula: C17H20N2S-HCl
Molecular weight: 320.89
[Properties]This product is a film-coated tablet, which appears white to slightly yellow after removing the coating.
[Indications]1. Allergy of skin mucous membrane: for long-term, seasonal allergic rhinitis, vascular diastolic rhinitis, allergic conjunctivitis due to contact with allergens or food, urticaria, angioneurotic edema, allergic reactions to blood or plasma products, cutaneous scratchiness. It can be used in combination with epinephrine as an adjuvant to this drug if necessary. 2. Motion sickness: Prevention and control of motion sickness, seasickness, and airsickness.
3. Sedation and hypnosis: for preoperative, postoperative and obstetrics. In addition, it can also be used to reduce fear in adults and children in a light sleep state. 4. Treatment of nausea and vomiting: indicated for nausea and vomiting after some anesthesia and surgery, also used to prevent and control radiculopathic or pharmacogenic nausea and vomiting.
5. Postoperative pain: It can be used in combination with painkillers as an adjunctive medicine.
[Specification]25mg
[dosage]
1. Take the medication early when used to prevent motion sickness.
2.Decrease dosage when dehydrated or oliguric to avoid toxic reactions.
3.When taking orally, take with food or milk to reduce irritation to the gastric mucosa.
4. Common dosage for adults: Orally: ①Anti-allergic, 12.5mg (0.5 tablets) once, 4 times daily, after meals and at bedtime (2) Antiemetic, 25mg (1 tablet) once at the beginning, 12.5-25mg (0.5-1 tablet) every 4-6 hours if necessary; (3) Anti-vertigo, 25mg (1 tablet) once, twice daily if necessary; (4) Sedative-hypnotic, 25-50mg (1-2 tablets) once. 50mg (1~2 tablets), doubled if necessary.
5. Common dosage for pediatric use: Oral.
①Anti-allergic, 0.125mg/kg by body weight or 3.75mg/m2 by body surface area every 4-6 hours, or 0.25～0.5mg/kg by body weight at bedtime or 0.25～0.5mg/m2 by body surface area at bedtime. 0.5mg/kg or 7.5 to 15mg/m2 by body surface area; daily doses of 5 to 10mg by age up to 1 year, 5 to 15mg by age 1 to 5 years, and 10 to 25mg by age 6 years or older, given in 1 or 2 divided doses.
② Antiemetic, 0.25-0.5 mg/kg by body weight or 7.5-15 mg/m2 by body surface area; administered every 4-6 hours if necessary.
③Anti-vertigo, 0.25-0.5mg/kg per body weight or 7.5-15mg/m2 by body surface area; every 12 hours if necessary , or 12.5 to 25 mg twice daily.
④ Sedation and hypnosis, 0.5 to 1 mg/kg by body weight or 15 to 30 mg/m2 by body surface area if necessary.
[Adverse Reactions]Promethazine is a phenothiazine derivative with no significant side effects in small doses, but thiazide can occur in large amounts and prolonged applications. Common side effects.
Children may exhibit paradoxical hyperexcitability. Older patients are susceptible to promethazine-induced anticholinergic effects and confusion.
1. Increased skin sensitivity to light and avoidance of intense sunlight during treatment. Multiple nightmares, excitability, agitation, hallucinations, toxic delirium, headache, fatigue and disorientation, and children are prone to extrapyramidal reactions. The incidence of these reactions is not high.
2. Signs and symptoms of overdose include clumsy or erratic movements of the arms and legs, severe sleepiness or flushing, fever, shortness of breath or dyspnea, increased heart rate (antimuscarinic (M) receptor effect), and muscle cramps, especially in the muscles of the neck and back. Restlessness in sitting and lying, difficulty in walking, spasmodic twitching of the head and facial muscles or tremor of the hands (the latter is an extrapyramidal effect).
3. The following should be noted if they persist: more commonly, drowsiness; less commonly, blurred vision or color blindness (mild), dizziness, dryness of the mouth, nose, and throat, urinary retention, tinnitus, hives, rash, itching, anorexia, stomach pain or upset stomach sensation, unresponsiveness (children more often), nausea or vomiting [when surgery is performed and/or other drugs are used], and even jaundice. Rectal burning or tingling can occur with suppositories.
4. Cardiovascular adverse effects are rare and may be seen as increased blood pressure, occasionally mildly decreased blood pressure, and cardiac arrhythmias. The results of the study were very positive.
[Contraindication].
Contraindicated in patients in coma or with central nervous system depression for any reason.
It is contraindicated in patients with hypersensitivity to this product and other components of this product.
This product is contraindicated within 14 days after administration of monoamine oxidase inhibitors.
[Precautions].
1. Cross-sensitization. Patients who are known to be highly hypersensitive to phenothiazines are also hypersensitive to this product.
2. Interference with diagnosis: Increased glucose tolerance may be demonstrated in glucose tolerance tests. May interfere with urine pregnancy immunoassay with false-positive or false-negative results.
3. Use with caution in the following conditions: acute asthma, bladder neck obstruction, bone marrow suppression, cardiovascular disease, coma, closed-angle glaucoma, hepatic insufficiency, hypertension, gastric ulcer, those with significant symptoms of prostatic hypertrophy, pyloric or duodenal obstruction, respiratory disease (especially children, sputum thickening after administration of this product, which interferes with sputum excretion and inhibits the cough reflex), patients with epilepsy (the severity of convulsions may be increased when administered by injection), jaundice, various liver diseases, and renal failure, Reyesyndrome (extrapyramidal symptoms due to iproniazid are easily confused with Reye syndrome).
4. When using promethazine, special attention should be paid to the presence of intestinal obstruction, or overdose or toxicity of the drug, as the signs and symptoms can be masked by the antiemetic effect of promethazine.
5. Effects on the ability to drive and operate machinery: Because the effects may last up to 12 hours, patients should not drive or operate heavy machinery if they are drowsy.
6. Avoid use in patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
7. Promethazine hydrochloride should not be used for more than 7 days and should be used under the supervision of a physician if more than 7 days are needed.
[For Pregnant and Lactating Women].
The administration of this drug to pregnant women may induce jaundice and extrapyramidal symptoms in the infant. Promethazine should not be used during pregnancy unless deemed necessary by a physician. Given the risk of irritability and excitement in the newborn, the use of promethazine is not recommended in the 2 weeks prior to delivery.
2. Antihistamines in general are associated with greater risk to infants, especially newborns and preterm infants. The available evidence suggests that isoprostanes are secreted in very low amounts in breast milk, but there is still a risk of neonatal irritability and excitement. The benefits and harms need to be weighed when applying this product to breastfeeding women.
[Pediatric Use] Contraindicated in children under 2 years of age. Newborns or premature infants, children with acute illness or dehydration, and children with acute infections are susceptible to dystonia after promethazine injection. In children, abnormal reactions such as hyperexcitability, agitation, or (and) nightmares can occur with a single oral dose of 75 to 125 mg.
[Geriatric Use] The elderly are prone to dizziness, dullness, confusion, and hypotension with this drug. The elderly are also prone to extrapyramidal symptoms, inability to sit still (akathisia), and persistent dyskinesia with this drug, more so with high dosage or extra-gastrointestinal administration.
[Drug Interactions]
1. Ethanol or other CNS depressants, especially narcotics, barbiturates, monoamine oxidase inhibitors, or tricyclic antidepressants may potentiate the effects of promethazine or (and) these drugs when used with this product, and the dosage should be adjusted separately. Alcohol should be avoided during treatment.
2. The antimuscarinic-like effects of anticholinergics, especially atropine analogs, are enhanced when the latter are used with promethazine.
3. The antihypertensive effect of the former is enhanced when antihypertensive drugs such as bromelain, isoquinoguanidine, or guanethidine are used with iproniazid. When epinephrine is used with promethazine, the alpha effect of epinephrine can be blocked, and the beta effect predominates.
4. The ototoxic symptoms of cisplatin, balonamycin and other aminoglycoside antibiotics, salicylate preparations, and vancomycin can be masked when ototoxic drugs such as cisplatin are used with iproniazid.
5. Isoprostanes may interfere with immunuria pregnancy tests, resulting in false-positive or false-negative results.
6. This product may inhibit the skin response to histamine, so when skin testing is required, it should be done 72 hours after discontinuation of the drug.
[Drug overdose]
Symptoms of severe overdose vary. Children are characterized by euphoria, ataxia, motor incoordination, inattention, and hallucinations, while adults may appear drowsy and fall into a coma. Both adults and children may experience convulsions, which may be preceded by coma or euphoria. Cardiopulmonary depression is uncommon. If a patient is detected soon after an overdose, emetic root may be used to induce vomiting despite the antiemetic effect of promethazine; or gastric lavage may be performed.
In addition, supportive therapy should be administered, with oxygen and intravenous fluids if necessary. Patients presenting with convulsions may be treated with diazepam or other appropriate anticonvulsants symptomatically when rescued.
[Pharmacology and Toxicology] Promethazine is a phenothiazine derivative, an antihistamine, and is used for antiemetic, anti-dizziness, motion sickness, and sedation-hypnotism.
1. Antihistamine effect: Competes with histamine released from tissues for H1 receptors, antagonizes the contraction or contracture of histamine on smooth muscle of gastrointestinal tract, trachea, bronchus or fine bronchus, and relieves the spasmogenic and congestive effects of histamine on bronchial smooth muscle.
2. Anti-vomiting effect: May be related to the inhibition of the emetic chemoreceptor area of the medulla oblongata.
3. Anti-hypoparasitic effect: Probably through central anticholinergic properties, acting on vestibular and vomiting centers and midbrain medullary receptors, mainly by blocking excitation of cholinergic synaptic vagal impulses in the vestibular nucleus region.
4. Sedative-hypnotic effect: The mechanism regarding the inhibition of the central nervous system has not been precisely elucidated, probably due to an indirect reduction in the stress of the brainstem reticular activation system.
[Pharmacokinetics] Fast and complete absorption and high protein binding after oral or injectable administration. The onset of action is 20 minutes after oral or rectal administration. The antihistamine effect generally lasts 6-12 hours, and the sedative effect can last 2-8 hours. Promethazine is widely distributed in the body. It can cross the brain and placental barrier. It is mainly metabolized in the liver, and inactive metabolites can be excreted via urine and bile, with a small amount excreted via feces. Phenothiazines are secreted into breast milk in small amounts.
[Storage]Store under shade and seal.
[Package]Packaged in high-density polyethylene bottles of 100 tablets each for oral solid dosage.
[Expiration date]18 months
[Executive Standard]
[Approval number]State Pharmacopoeia H12020237
[Manufacturer]
Company Name: Tianjin Lisheng Pharmaceutical Co.
Manufacturing Address: No. 16, Saeda North Road, Xiqing Economic Development Zone, Tianjin
Postal Code: 300385
Tel: 022-27366012
Fax Number: 022-27364239
Website: www. lishengpharma. com
Toll free consultation: 4006490098