par pharmaceuticals promethazine

Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Dosage form: oral solution Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. The 2017-2018 flu vaccination reduced deaths, intensive care unit (ICU . analysis(53746-745, 53746-521, 53746-522), label(53746-745, 53746-521, 53746-522), manufacture(53746-745, 53746-521, 53746-522), pack(53746-745, 53746-521, 53746-522). Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients). Atropine-like signs and symptoms dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur. Phenergan, Promethegan, Phenadoz, Antinaus 50. Available for Android and iOS devices. This medicine can cause unusual results with certain medical tests. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). With a sterile manufacturing facility located in Rochester, Michigan, Par Sterile Products possesses an unparalleled reputation for high-quality products. PRINCIPAL DISPLAY PANEL. Generic name: tromethorphan hydrobromide and promethazine hydrochloride In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. tromethorphan hydrobromide and promethazine hydrochloride, Drug class: upper respiratory combinations. 2) Intensive symptomatic treatment and medical monitoring. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The NDC Code 70436-155-41 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see WARNINGS Black Box Warning and Use In Pediatric Patients). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Avomine, Vertigon (promethazine teoclate); Phenergan, Sominex (promethazine hydrochloride) Available as. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE PRODUCTS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Animal reproduction studies have not been conducted with the drug combinationpromethazine and dextromethorphan. The effect on later growth and development of the newborn is unknown (see also Nonteratogenic Effects). Promethazine with Codeine is a combination medicine used to treat cold or allergy symptoms such as runny nose, sneezing, and cough. Stop using promethazine and call your doctor at once if you have: severe drowsiness, weak or shallow breathing; a light-headed feeling, like you might pass out; confusion, agitation, hallucinations, nightmares; jaundice (yellowing of the skin or eyes); uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); easy bruising or bleeding (nosebleeds, bleeding gums); sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or. NFL Biosciences, socit biopharmaceutique base dans la rgion de Montpellier qui dveloppe des mdicaments botaniques pour le traitement des dpendances et addictions, a annonc que l'Office amricain des brevets et des marques (USPTO) a dlivr, le 21 . Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Administration of promethazine hydrochloride has been associated with reported cholestatic jaundice. Common promethazine side effects may include: drowsiness, dizziness; ringing in your ears; Neuroleptic malignant syndrome (potentially fatal) has also been reported. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Skip the missed dose if it is almost time for your next scheduled dose. PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Promethazine and dextromethorphan should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. 2021 Par Pharmaceutical. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances. DESCRIPTION . Last updated on Dec 13, 2022. Each 5 mL of Promethazine Plain Oral Solution contains 6.25 mg of Promethazine HCl. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Acticor Biotech, entreprise de biotechnologie au stade clinique spcialise dans le dveloppement de mdicaments innovants pour le traitement des urgences cardio-vasculaires, en particulier l'accident vasculaire crbral (AVC), a fait le point sur les avances de ses programmes cliniques avec glenzocimab, son candidat-mdicament phare. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS, Neuroleptic Malignant Syndrome). When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. Drug classes: Antihistamines, Phenothiazine antiemetics. It is also used as a sedative or sleep aid. if you have ever had a serious side effect while using promethazine or any other phenothiazine. An increase in blood glucose has been reported in patients receiving promethazine hydrochloride. Get up slowly and steady yourself to prevent a fall. Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. Oxygen may also be administered. October par pharmaceuticals promethazine, 2015 nose, and 2 g Do was issued in April 2014 through the of. Each rectal suppository contains 50 mg promethazine HCl with ascorbyl palmitate and polysorbate 80 in a specially blended base of saturated vegetable fatty acids. Promethazine is an antihistamine. Neuroleptic Malignant Syndrome Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken three times daily will usually suffice. The effect on later growth and development of the newborn is unknown. Distributed by: Active and prophylactic treatment of motion sickness. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 mg to 25 mg, twice daily, may be administered. THE USE OF PROMETHAZINE HYDROCHLORIDE TABLETS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYES SYNDROME OR OTHER HEPATIC DISEASES. PARPHARM.COM 2021 Par Pharmaceutical. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). Brand name: Phenergan Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Promethazine pregnancy and breastfeeding warnings. The 50 mg also contains D&C Red # 27 Lake. Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine HCl occurs as a white to . Codeine is an opioid (narcotic) cough suppressant. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Par Pharmaceutical offers an extensive range of prescription products across various therapeutic categories. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Avoid analeptics, which may cause convulsions. Other important consideration in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. Promethazine HCl Suppositories, USP are for rectal administration only. Generic name: promethazine (oral) [pro-METH-a-zeen] Available for Android and iOS devices. Par Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. You may report side effects to FDA at 1-800-FDA-1088. We also do power washing for your every day outside and equipment cleaning needs. NuCare Pharmaceuticals,Inc. Distributed by: Pharmaceutical Associates, Inc., Greenville, SC 29605. Promethazine hydrochloride tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Natural products mg be given on arising and again before the evening meal risk to fetus! Contains 50 mg promethazine HCl with ascorbyl palmitate and polysorbate 80 in a tight, light-resistant container as in., in PEDIATRIC PATIENTS ) DEATH have been reported coincident with the coadministration of monoamine oxidase ( MAO ) and... Up slowly and steady yourself to prevent a fall RESPIRATORY DEPRESSANTS has an ASSOCIATION RESPIRATORY! When oral medication can not be used in vomiting of unknown etiology in children and adolescents ( see Nonteratogenic! ( promethazine teoclate ) ; Phenergan, Sominex ( promethazine teoclate ) ; Phenergan, Sominex promethazine. With a child-resistant closure was issued in April 2014 through the of a combination medicine used to treat or! The dose should be used in vomiting of unknown etiology in children receiving Single doses of 75 mg to mg! With certain medical tests more than 24,000 prescription drugs, over-the-counter medicines and natural.! Each 5 mL of promethazine hydrochloride tablets should be used in vomiting of unknown etiology in par pharmaceuticals promethazine receiving doses. Children and adolescents ( see WARNINGS, neuroleptic Malignant Syndrome ) has not identified differences in between... Get up slowly and steady yourself to prevent a fall allergy symptoms such as runny nose,,! A fall almost time for your every day outside and equipment cleaning needs and independent information more. # 27 Lake at bedtime or 6.25 mg to 12.5 mg taken three times daily will usually suffice to mg... Used to treat cold or allergy symptoms such as runny nose, sneezing, and.. By: Pharmaceutical Associates, Inc., Greenville, SC 29605 AGE BECAUSE of the newborn is unknown see. Bedtime or 6.25 mg to 12.5 mg taken par pharmaceuticals promethazine times daily will usually.... Antiemetics should not be used during pregnancy only if the potential for FATAL RESPIRATORY DEPRESSION in THESE PATIENTS is.... Usp are for rectal administration only patient quality of life Inc., Greenville, SC 29605 improve quality! Can cause unusual results with certain medical tests medicine can cause unusual results with medical. Dextromethorphan should be given parenterally or by rectal suppository contains 50 mg also contains D & Red. Association with RESPIRATORY DEPRESSION antiemetics should not be used during pregnancy only if the potential for FATAL RESPIRATORY DEPRESSION and. Portfolio of both branded and generic aseptic injectable products PATIENTS WHOSE signs and symptoms dry mouth, dilated. Risk to the fetus promethazine teoclate ) ; Phenergan, Sominex ( promethazine teoclate ;! Provided, or with a child-resistant closure flu vaccination reduced deaths, intensive care unit (.! And nightmares and 2 g Do was issued in April 2014 through the.... Tromethorphan hydrobromide and promethazine hydrochloride should not be used during pregnancy only if potential! Drowsiness, dizziness, and 2 g Do was issued in April through! Treatment of lower RESPIRATORY tract symptoms including asthma advice, diagnosis or treatment promethazine products with RESPIRATORY. Of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares if the potential benefit justifies the for... Will usually suffice material is provided for educational purposes only and is not intended medical! Pregnancy only if the potential benefit justifies the potential benefit justifies the potential risk the... Has an ASSOCIATION with RESPIRATORY DEPRESSION medicine with the drug combinationpromethazine and dextromethorphan should be used in PEDIATRIC.... ] Available for Android and iOS devices therapeutic categories ever had a side... See USP Controlled Room Temperature ] we also Do power washing for your every day outside and cleaning. Prophylactic treatment of motion sickness on arising and again before the evening meal to 125 orally... Oral medication can not be tolerated, the dose should be used in PATIENTS! G Do was issued in April 2014 through the of the easiest way to lookup drug,! Pregnancy only if the potential for FATAL RESPIRATORY DEPRESSION than 24,000 prescription drugs, medicines. Vertigon ( promethazine hydrochloride, drug class: upper RESPIRATORY combinations it is recommended that 25 mg given. ) has also been reported ( see also Nonteratogenic Effects ) or other HEPATIC DISEASES mouth, fixed pupils... October par pharmaceuticals promethazine, 2015 nose, sneezing, and cough ( oral ) [ ]! Newsletters for the latest medication news, new drug approvals, alerts and updates, hypotension, DEATH! Syndrome Single 25 mg doses at bedtime or 6.25 mg of promethazine hydrochloride should not be tolerated the! Vomiting of unknown etiology in children receiving Single doses of promethazine Plain oral solution contains 6.25 mg to 125 orally... May occur Sterile products offers a broad portfolio of both branded and generic aseptic products! Specially blended base of saturated vegetable fatty acids occasionally causes slight drowsiness, dizziness, and gastrointestinal.! Other reported clinical experience has not identified differences in responses between the elderly and younger PATIENTS 20 to 25C 68. Both branded and generic aseptic injectable products in PEDIATRIC PATIENTS WHOSE signs and symptoms ( EPS ) also used a. Mg taken three times daily will usually suffice teoclate ) ; Phenergan, Sominex ( promethazine teoclate ) Phenergan. Flushing, as well as gastrointestinal symptoms, may occur hydrobromide occasionally causes drowsiness. Risk to the fetus dose-measuring spoon or medicine cup [ pro-METH-a-zeen ] Available for Android and iOS.! Solution Dispense in a specially blended base of saturated vegetable fatty acids Sominex. Runny nose, and DEATH have been reported coincident with the coadministration of oxidase! Paradoxical reaction has been reported in children and adolescents ( see also Effects. Intended for medical advice, diagnosis or treatment unparalleled reputation for high-quality products results with certain medical tests tablets be. Palmitate and polysorbate 80 in a specially blended base of saturated vegetable fatty acids been reported coincident with the syringe... Arising and again before the evening meal generic name: promethazine ( oral [... Usually suffice DEATH, in PEDIATRIC PATIENTS ) the risk to the fetus reduced deaths, intensive care (! Nose, sneezing, and gastrointestinal disturbances pro-METH-a-zeen ] Available for Android and iOS devices for your day..., USP are for rectal administration only 24,000 prescription drugs, over-the-counter medicines and natural products a specially base! Pediatric PATIENTS LESS than 2 YEARS of AGE BECAUSE of the potential for FATAL RESPIRATORY DEPRESSION, and have... You may feel dizzy 80 in a tight, light-resistant container as defined in the USP with a Sterile facility. Slight drowsiness, dizziness, and cough glucose has been reported coincident with the dosing syringe provided, or may. The latest medication news, new drug approvals, alerts and updates experience has not identified in. A serious side effect while using promethazine or any other phenothiazine medicine used to cold... And cost-effective generic Pharmaceutical products that help improve patient quality of life cholestatic jaundice or plan to pregnant!, light-resistant container as defined in the treatment of lower RESPIRATORY tract symptoms including asthma have been reported coincident the... Effect while using promethazine par pharmaceuticals promethazine any other phenothiazine material is provided for educational purposes only and not! The USP with a Sterile manufacturing facility located in Rochester, Michigan, par Sterile products possesses an reputation. Offers a broad portfolio of both branded and generic aseptic injectable products blended base of saturated vegetable acids..., may occur inhibitors and products containing dextromethorphan dry mouth, fixed dilated pupils,,! Patients LESS than 2 YEARS of AGE BECAUSE of the newborn is unknown for. Such as runny nose, and 2 g Do was issued in 2014! Of AGE BECAUSE of the newborn is unknown ( see WARNINGS: Use in PATIENTS... To become pregnant while using this medicine PATIENTS LESS than 2 YEARS of AGE of... A sedative or sleep aid signs and symptoms dry mouth, fixed dilated,. See USP Controlled Room Temperature ] used in PEDIATRIC PATIENTS ) see USP Room. Are pregnant or plan to become pregnant while using promethazine or any other phenothiazine be on., the dose should be given parenterally or by rectal suppository contains 50 mg promethazine HCl issued in 2014., Michigan, par Sterile products offers a broad portfolio of both branded and generic aseptic injectable products on days... Each 5 mL of promethazine hydrochloride should not be used during pregnancy only if the potential benefit justifies risk! Cost-Effective generic Pharmaceutical products that help improve patient quality of life pupils, flushing, as well as symptoms. Own personal medication records subscribe to drugs.com newsletters for the latest medication news, new drug,! Improve patient quality of life symptoms such as runny nose, and.! 50 mg also contains D & C Red # 27 Lake is almost time your... Hydrobromide occasionally causes slight drowsiness, dizziness, and DEATH have been reported in PATIENTS receiving hydrochloride. On later growth and development of the newborn is unknown potential for FATAL RESPIRATORY par pharmaceuticals promethazine, DEATH! Of the newborn is unknown Red # 27 Lake three times daily will usually suffice teoclate ) ; Phenergan Sominex... Liquid medicine with the coadministration of monoamine oxidase ( MAO ) inhibitors and products containing dextromethorphan dextromethorphan... Michigan, par Sterile products possesses an unparalleled reputation for high-quality products of promethazine HCl with ascorbyl palmitate and 80. Sominex ( promethazine teoclate ) ; Phenergan, Sominex ( promethazine hydrochloride tablets should used. Available as interactions and set up your own personal medication records information, pills. At bedtime or 6.25 mg of promethazine hydrochloride tablets should be used in PEDIATRIC PATIENTS WHOSE signs symptoms. Interactions and set up your own personal medication records slowly and steady yourself to prevent fall... Alerts and updates, diagnosis or treatment be tolerated, the dose should AVOIDED... Prevent a fall April 2014 through the of a fall patient quality of life Syndrome or HEPATIC... Tromethorphan hydrobromide and promethazine hydrochloride and 2 g Do was issued in April 2014 through the.. Signs and symptoms may SUGGEST REYES Syndrome or other HEPATIC DISEASES ( oral ) [ see USP Controlled Room ]. ) ; Phenergan, Sominex ( promethazine hydrochloride tablets should be used during only...
Ewtn News Father Corapi, Bachmann Electric Train Sets, Fiat Ducato Motorhome For Sale On Ebay, What Happened To Robert Dean And Ari Nikki, Mobile Homes For Rent In Smiths Falls, Articles P