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PRESCRIBING INFORMATION 0.9% Sodium Chloride Injection, USP in Fleboflex Plastic Container Solution, 0.9% Sodium Chloride, Intravenous Infusion Intravenous Fluid and Electrolyte Replenisher Manufactured by: Laboratorios Grifols, S.A. Can Guasch, 2 Parets del Vallès 08150 Barcelona SPAIN Imported and Distributed by: Gri... | 0.9% Sodium Chloride Injection, USP.pdf | 1 | 0 | 0 | null | null |
Prescribing Information 0.9% Sodium Chloride Injection, USP in Fleboflex Plastic Containers Summary Product Information 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The composition, osmolarity, a... | 0.9% Sodium Chloride Injection, USP.pdf | 2 | 0 | 0 | null | null |
. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system. Actions 0.9% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. Solutions which are ... | 0.9% Sodium Chloride Injection, USP.pdf | 2 | 0 | 1 | null | null |
Indications 0.9% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP can be used as a vehicle or diluent for compatible products for parenteral administration. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodi... | 0.9% Sodium Chloride Injection, USP.pdf | 3 | 0 | 0 | null | null |
infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, have been reported with 0.9% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures must be instituted as... | 0.9% Sodium Chloride Injection, USP.pdf | 3 | 0 | 1 | null | null |
- clinically relevant electrolyte disturbances and acid-base imbalance. In general, the risk of fluid/solute overload causing congested states and/or electrolyte disturbances is directly proportional to the volume of the products intravenously administered. Clinical evaluation and periodic laboratory determinations may... | 0.9% Sodium Chloride Injection, USP.pdf | 4 | 0 | 0 | null | null |
halopathy (brain edema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. **Use in Patients with Severe Renal Impairment** 0.9% Sodium Chloride Injection, USP should be administered with particu... | 0.9% Sodium Chloride Injection, USP.pdf | 4 | 0 | 1 | null | null |
Risk of Air Embolism Do not connect flexible plastic containers of intravenous solutions in series connections. Such use could result in air embolism due to possible residual air being drawn from one container before administration of the fluid from a secondary container is completed. Pressurizing intravenous solutions... | 0.9% Sodium Chloride Injection, USP.pdf | 5 | 0 | 0 | null | null |
or concomitant drug therapy. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Bec... | 0.9% Sodium Chloride Injection, USP.pdf | 5 | 0 | 1 | null | null |
Monitoring and Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluati... | 0.9% Sodium Chloride Injection, USP.pdf | 6 | 0 | 0 | null | null |
.] Caution is advised in patients treated with lithium. Renal lithium clearance may be increased during administration of 0.9% Sodium Chloride Injection, USP, resulting in decreased lithium levels. Caution is advised when administering 0.9% Sodium Chloride Injection, USP to patients treated with drugs leading to an inc... | 0.9% Sodium Chloride Injection, USP.pdf | 6 | 0 | 1 | null | null |
ifosfamide, antipsychotics, opioids. **Drugs potentiating vasopressin action** such as chlorpropamide, non steroidal anti-inflammatories (NSAIDS), cyclophosphamide. **Vasopressin analogues** such as desmopressin, oxytocin, vasopressin, terlipressin. Caution is advised when administering 0.9% Sodium Chloride Injection, ... | 0.9% Sodium Chloride Injection, USP.pdf | 7 | 0 | 0 | null | null |
Sodium Chloride Injection, USP is appropriate. The instructions for use of the medication to be added and other relevant literature must be consulted. When introducing additives to 0.9% Sodium Chloride Injection, USP, aseptic technique must be used. After addition, check for a possible color change and/or the appearanc... | 0.9% Sodium Chloride Injection, USP.pdf | 7 | 0 | 1 | null | null |
Overdosage An excessive volume of 0.9% Sodium Chloride Injection, USP may lead to hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral edema and death) and sodium overload (which can lead to central and/or peripheral edema). When assessing an overdose, any additives in the solution mu... | 0.9% Sodium Chloride Injection, USP.pdf | 8 | 0 | 0 | null | null |
. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Moisture and some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solu... | 0.9% Sodium Chloride Injection, USP.pdf | 8 | 0 | 1 | null | null |
Medication" directions below. Preparation for Administration Caution: Do not use plastic containers in series connections. Caution: Use only with a non-vented set or a vented set with the vent closed. 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attac... | 0.9% Sodium Chloride Injection, USP.pdf | 9 | 0 | 0 | null | null |
* Find the full Prescribing Information that is prepared for healthcare professionals by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1-866-482-5226. This leaflet was prepared by Laboratorios Grifols, S... | 0.9% Sodium Chloride Injection, USP.pdf | 10 | 0 | 0 | null | null |
PRODUCT MONOGRAPH ANTI-ALLERGY EYE DROPS Sodium Cromoglycate Ophthalmic Solution, USP 2% W/V Anti-allergic Agent Pendopharm, Division of/de Pharmascience Inc. 8580 Esplanade Ave. Montreal, Quebec H2P 2R8 Control # 105602 Date of Preparation: May 4, 2006 | 00002301.pdf | 1 | 0 | 0 | null | null |
PRODUCT MONOGRAPH ANTI-ALLERGY EYE DROPS Sodium Cromoglycate Ophthalmic Solution, USP 2% W/V THERAPEUTIC CLASSIFICATION Anti-allergic Agent ACTION AND CLINICAL PHARMACOLOGY In the immediate allergic reaction (Type I) the union of antigen with reaginic antibody leads to the formation and release of the mediators of the ... | 00002301.pdf | 2 | 0 | 0 | null | null |
ANTI-ALLERGY EYE DROPS (sodium cromoglycate) should not be used in the treatment of eye injury or infection. A doctor should be consulted immediately if the patient experiences any of the following: * eye pain * changes in vision * pain on exposure to light * redness of the eye * excessive discharge * abnormal pupils *... | 00002301.pdf | 3 | 0 | 0 | null | null |
DOSAGE AND ADMINISTRATION Adults and children 5 years of age and older: 1–2 drops in each eye 4 times a day at regular intervals; Maximum single dose per eye: 2 drops or 1.6 mg. Maximum total daily dose: 16 drops or 12.8 mg, 8 drops per eye. ANTI-ALLERGY EYE DROPS (sodium cromoglycate) should be used continually throug... | 00002301.pdf | 4 | 0 | 0 | null | null |
PHARMACEUTICAL INFORMATION Drug Substance Proper Name: Sodium Cromoglycate Chemical Name: 4H-1-Benzopyran-2-carboxylic acid, 5,5'-[(2-hydroxy-1,3-propanediyl)bis(oxy)]bis[4-oxo-, disodium salt] Structural Formula: [Chemical structure showing two chromone rings linked by a 2-hydroxy-1,3-propanediyl bridge, with sodium c... | 00002301.pdf | 5 | 0 | 0 | null | null |
Stability and Storage Recommendations Store at 15°-30°C. Protect from light. AVAILABILITY OF DOSAGE FORMS ANTI-ALLERGY EYE DROPS (sodium cromoglycate) is supplied in plastic dropper bottles containing 5mL, 10mL, or 15 mL of a sterile 2% (W/V) solution of sodium cromoglycate. | 00002301.pdf | 6 | 0 | 0 | null | null |
INFORMATION FOR THE PATIENT ANTI-ALLERGY EYE DROPS (Sodium Cromoglycate Ophthalmic Solution) ANTI-ALLERGY EYE DROPS is a nonprescription drug intended to be used for the **prevention** of the symptoms of **seasonal allergic conjunctivitis**. Please read the following information carefully as it will guide you in the sa... | 00002301.pdf | 7 | 0 | 0 | null | null |
REQUIRING THE ATTENTION OF A DOCTOR * Pain * Changes in vision (double vision, spotty vision, etc.) * Pain on exposure to light (photophobia) * Acute redness of the eye * Excessive or milky (non-clear) discharge * Abnormal pupils * Injury (chemical, mechanical, etc.) * Conditions lasting longer than 72 hours | 00002301.pdf | 7 | 0 | 1 | null | null |
What is ANTI-ALLERGY EYE DROPS, and how does it work? During an allergic reaction, various substances are released by certain cells in your eyes. These are called mast cells. The substances released by these cells affect your eyes in different ways. For example, they affect blood vessels, nerves, and glands — causing r... | 00002301.pdf | 8 | 0 | 0 | null | null |
requiring the attention of a doctor. If you experience eye pain, changes in vision, pain on exposure to light, acute redness of the eye, excessive or milky (non-clear) discharge, abnormal pupils, if condition worsens or if relief is not obtained within 72 hours, consult your doctor immediately. | 00002301.pdf | 8 | 0 | 1 | null | null |
Do not wear soft contact lenses during treatment with ANTI-ALLERGY EYE DROPS. Do not use ANTI-ALLERGY EYE DROPS with any other eye treatment except on the advice of your doctor. If you are pregnant or nursing a baby, consult your doctor before using ANTI-ALLERGY EYE DROPS. Protect this medication from direct sunlight. ... | 00002301.pdf | 9 | 0 | 0 | null | null |
PHARMACOLOGY Animal Pharmacology: Sodium cromoglycate appears to act mainly through a local effect on the lung mucosa, nasal mucosa, and eyes. Sodium cromoglycate prevents release of the mediators of type I allergic reactions, including histamine and slow-reacting substance of anaphylaxis (SRS-A), from sensitized mast ... | 00002301.pdf | 10 | 0 | 0 | null | null |
to provide any protective activity against either aerosol or intravenous antigen-induced bronchospasm. Furthermore sodium cromoglycate did not have any effect on the release of histamine or slow-reacting substance A(SRS-A) from actively or passively sensitized guinea-pig in vitro chopped lung when challenged with antig... | 00002301.pdf | 10 | 0 | 1 | null | null |
cromoglycate had negative or only weak inconsistent effects on the respiratory or cardiovascular systems of the rat, cat, guinea-pig and pig. However in the marmoset and dog there were marked effects. In anaesthetized marmosets sodium cromoglycate produced a large rise in blood pressure and heart rate with doses of 20 ... | 00002301.pdf | 11 | 0 | 0 | null | null |
photometric methods have been used in human studies. Inhalation Studies: After administration of sodium cromoglycate as a fine powder aerosol into the lungs of rats, rabbits and monkeys, all animals showed rapid clearance of the drug from the lungs. The rate of absorption was such that 75% of the inhaled dose had been ... | 00002301.pdf | 11 | 0 | 1 | null | null |
In the monkey, 6 hours after intravenous administration, 80-90% of the total dose could be accounted for by biliary and renal excretion. At this stage, there is general distribution of the sodium cromoglycate throughout the tissues, with a higher concentration in the kidneys and liver. After intranasal administration o... | 00002301.pdf | 12 | 0 | 0 | null | null |
TOXICOLOGY Acute Toxicity: In acute toxicity tests in small laboratory animals the LD50 on parenteral administration was usually between 2000 and 4000 mg/kg. Subacute and Chronic Toxicity: In a prolonged test in rats no toxic effects resulted from 90 daily subcutaneous injections except at doses greater than 30 mg/kg. ... | 00002301.pdf | 13 | 0 | 0 | null | null |
toxicological evaluation of the monkeys was carried out prior to and throughout the study. No histopathological changes were seen in any variable. Studies of Sodium Cromoglycate Ophthalmic Solution: A 28 day irritancy test of rabbit eyes was conducted using 4% sodium cromoglycate ophthalmic solution applied to one eye ... | 00002301.pdf | 13 | 0 | 1 | null | null |
- Topicamide 0.5% (Mydriacyl 0.5% ophthalmic solution) - Phenylephrine hydrochloride 10% (Neo-Synephrine 10% ophthalmic solution) - Cyclopentolate hydrochloride 0.5% (Cyclogyl 0.5% ophthalmic solution) B. Drugs given once daily for 28 days: VASOCONSTRICTORS - Tetrahydrozoline HCl 0.05% (Visine ophthalmic solution) - Mu... | 00002301.pdf | 14 | 0 | 0 | null | null |
up to 540 mg/kg. Cytotoxicity: At the cellular level, no effects of sodium cromoglycate were observed at concentrations up to and including 1 mg/mL upon the following: - Migration characteristics of guinea-pig macrophages - Morphology of chick embryo-fibroblasts - Morphology of human epithelial cells from a cell line -... | 00002301.pdf | 14 | 0 | 1 | null | null |
Effect on immune system: The effect of the drug on microbiological neutralizing systems, including viruses in vivo and in vitro, was studied. No effect was observed on: various antibody neutralizing or agglutinating systems; development of active immunity or antibody production; protection conferred by passive or activ... | 00002301.pdf | 15 | 0 | 0 | null | null |
17. Farmer JB, Richards IM, Sheard P, et al. Mediators of passive lung anaphylaxis in the rat. Br. J. Pharmac 1975; 55:57-64. 18. Fisher AN, Browns K, Davis SS, et al. The nasal absorption of sodium cromoglycate in the albino rat. J. Pharm. Pharmacol 1985; 37:38-41. 19. Goose J, Blair AMJN. Passive cutaneous anaphylaxi... | 00002301.pdf | 17 | 0 | 0 | null | null |
the treatment of seasonal allergic conjunctivitis. Clin Allergy 1979; 9(3):271-275. 26. McCarthy D, et al. Recurrent allergic conjunctivitis: an assessment of 2% sodium cromoglycate eye drops. The Practitioner 1979; 222:854-856. 27. Moss GF, Jones KM, Ritchie JT, et al. Distribution and metabolism of disodium cromoglyc... | 00002301.pdf | 17 | 0 | 1 | null | null |
35. Simon-Licht IF, Dieges PH. A double-blind clinical trial with cromoglycate eye drops in patients with atopic conjunctivitis. Ann. Allergy, 1982; 49(4):220-224. 36. Smith A, Fisher N. Age related changes in the clearance and oral absorption of sodium cromoglycate in the developing albino rat. J. Pharm. Pharmac 1980;... | 00002301.pdf | 18 | 0 | 0 | null | null |
PRODUCT MONOGRAPH Pr5-ASA (5-aminosalicylic acid) 400 mg Enteric Coated Tablets Lower Gastrointestinal, Anti-inflammatory Sanis Health Inc. 333 Champlain Street, Suite 102 Dieppe, New Brunswick Canada, E1A 1P2 Tel: 1-866-236-4076 Submission Control No: 141955 Date of Preparation: October 21, 2010 | 00011722.pdf | 1 | 0 | 0 | null | null |
PRODUCT MONOGRAPH Pr5-ASA (5-aminosalicylic acid) 400 mg Enteric Coated Tablets THERAPEUTIC CLASSIFICATION Lower Gastrointestinal, Anti-inflammatory ACTION AND CLINICAL PHARMACOLOGY 5-ASA (5-aminosalicylic acid) is thought to be the major active component of sulphasalazine for the treatment of inflammatory bowel diseas... | 00011722.pdf | 2 | 0 | 0 | null | null |
of mild to moderate active ulcerative colitis. Long-term treatment may be necessary to prevent recurrent relapses of active colitis. Abrupt discontinuation may result in relapse. CONTRAINDICATIONS 5-ASA (5-aminosalicylic acid) is contraindicated in patients with: a history of sensitivity to salicylates, existing gastri... | 00011722.pdf | 2 | 0 | 1 | null | null |
WARNINGS 5-ASA (5-aminosalicylic acid) should be discontinued if toxic or hypersensitivity reactions occur. In assessing liver and joint complications, it should be kept in mind that these are frequently associated with ulcerative colitis (See PRECAUTIONS). PRECAUTIONS General Caution should be exercised in patients wi... | 00011722.pdf | 3 | 0 | 0 | null | null |
pregnant women has not been established yet, hence it should not be administered to pregnant women, unless in the judgement of the physician the potential benefit to the mother outweighs the risk to the fetus. Small amounts of 5-aminosalicylic acid and higher concentrations of acetyl-5-aminosalicylic acid were detected... | 00011722.pdf | 3 | 0 | 1 | null | null |
The safety and effectiveness of 5-aminosalicylic acid therapy in children have not been established. Information for the Patient 1. Swallow tablets whole, taking care not to break the outer coating. The outer coating is designed to remain intact, to protect the active ingredient until it reaches the terminal ileum, whe... | 00011722.pdf | 4 | 0 | 0 | null | null |
, malaise, pruritis, rash and conjunctivitis has been infrequently reported to occur shortly after the initiation of 5-aminosalicylic acid. Therapy should be discontinued if these symptoms occur. Symptoms usually disappear after discontinuation. Hepatic Asymptomatic elevations of liver function tests have occurred in p... | 00011722.pdf | 4 | 0 | 1 | null | null |
The following events have been reported rarely during 5-aminosalicylic acid use: pancreatitis, pericarditis, transverse myelitis, peripheral neuropathy, intestinal perforation, hepatitis, interstitial pneumonitis, leukopenia, agranulocytosis, minimal change nephropathy and acute and chronic interstitial nephritis. SYMP... | 00011722.pdf | 5 | 0 | 0 | null | null |
PHARMACEUTICAL INFORMATION DRUG SUBSTANCE: Proper Name: 5-aminosalicylic acid Chemical Name: 5-amino-2-hydroxybenzoic acid Structural Formula: [Chemical structure with a benzene ring, COOH group, OH group, and H2N group attached] Molecular Formula: C7H7NO3 Molecular Weight: 153.1 Description: 5-aminosalicylic acid is a... | 00011722.pdf | 6 | 0 | 0 | null | null |
PHARMACOLOGY Pharmacokinetics 5-ASA tablets have an acrylic based resin coating, which does not allow the drug to be released below pH 5.5. Thus the coating delays release of the 5-aminosalicylic acid until it reaches the terminal ileum and colon. In a randomized, double-blind, placebo controlled clinical trial, a 4.8 ... | 00011722.pdf | 7 | 0 | 0 | null | null |
/globulin ratios occurred only at the 1080 mg/kg/day level. A similar study conducted in rabbits resulted in diarrhea during the first week in male rabbits at the 1080 mg/kg/day dose level. Urinalysis revealed slight increases in proteinuria, bilirubinuria and urinary acetone in the high dose group. No drug related eff... | 00011722.pdf | 7 | 0 | 1 | null | null |
Reproduction Studies No effects on fertility or gestation parameters were observed in rats at doses of 5-aminosalicylic acid up to 480 mg/kg/day. Carcinogenesis and Mutagenesis The long term carcinogenicity of 5- aminosalicylic acid has not been investigated in animals, but sulfasalazine, containing the 5- aminosalicyl... | 00011722.pdf | 8 | 0 | 0 | null | null |
14. Hawkey CJ, Langman MJS, Dew MJ. Maintenance of remission in ulcerative colitis with oral preparation of 5-aminosalicylic acid. Br Med J 1982; 285: 1656. 15. Jeness H, Weber P, Hartman F. Letters to the editor: 5-aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol 1990; 85:331.... | 00011722.pdf | 10 | 0 | 0 | null | null |
1988; 94:1383-9. 23. Rutgeerts P. Comparative efficacy of coated, oral 5-aminosalicylic acid (Claversal) and sulphasalazine for maintaining remission of ulcerative colitis. Aliment Pharmacol Therapy 1989 24. Schroeder KW, Tremain WJ. Oral 5-aminosalicylic acid (Asacol) for treatment of symptomatic chronic ulcerative co... | 00011722.pdf | 10 | 0 | 1 | null | null |
28. Sircar JC, et al. Inhibition of soybean lipoxygenase by sulfasalazine and 5-aminosalicylic acid: A possible mode of action in ulcerative colitis. Biochem Pharmacol 1983; 32:170. 29. Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol®) for mildly to moderately active ulcerative colitis. A multicenter st... | 00011722.pdf | 11 | 0 | 0 | null | null |
PRESCRIBING INFORMATION Lidocaine Hydrochloride Injection, USP 1% Lidocaine Hydrochloride Injection USP 2% 2% Lidocaine and Epinephrine 1:100,000 Injection USP Local Anesthetic Alveda Pharmaceuticals Inc. 40 Holly Street, Suite 801 Toronto, Ontario M4S 3C3 Date of Revision: January 4, 2012 Submission Control No.: 15027... | 00015216.pdf | 1 | 0 | 0 | null | null |
Lidocaine Hydrochloride Injection, USP 1% Lidocaine Hydrochloride Injection USP 2% 2% Lidocaine and Epinephrine 1:100,000 Injection USP PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION | Route of Administration | Dosage Form / Strength | Nonmedicinal Ingredients | |---|---|---| | Parenteral | Sterile... | 00015216.pdf | 3 | 0 | 0 | null | null |
Geriatrics (> 65 years of age): Elderly patients should be given reduced doses commensurate with their age and physical condition (see DOSAGE AND ADMINISTRATION-Special Populations). Pediatrics (<18 years of age): Children should be given reduced doses commensurate with their age, weight and physical condition (see DOS... | 00015216.pdf | 4 | 0 | 0 | null | null |
preservatives should not be used in doses greater than 15 mL for other types of blockades. WARNINGS AND PRECAUTIONS General LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE | 00015216.pdf | 4 | 0 | 1 | null | null |
EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE REACTIONS AND OVERDOSAGE). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UND... | 00015216.pdf | 5 | 0 | 0 | null | null |
infusions. The majority of reported cases of irreversible chondrolysis have involved the shoulder joint; cases of gleno-humeral irreversible chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hour... | 00015216.pdf | 5 | 0 | 1 | null | null |
Use of Parenteral Solutions Containing Epinephrine: Lidocaine hydrochloride parenteral solutions containing epinephrine should not be used in areas of the body supplied by end arteries, such as digits, nose, ears or penis, or otherwise having a compromised blood supply (see also DRUG INTERACTIONS). Inflammation and Sep... | 00015216.pdf | 6 | 0 | 0 | null | null |
and caudal epidural anesthesia should be used with extreme caution in persons with severe hypertension. Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolemia. Epidural anesthesia should be used with caution in patients with impaired cardiovascular function. Epidural anesthe... | 00015216.pdf | 6 | 0 | 1 | null | null |
heart block, cerebral vascular insufficiency, peripheral vascular disorder, and any other pathological condition that may be aggravated by the effects of epinephrine. Patients treated with antiarrhythmic drugs (e.g., amiodarone, mexiletine) should be under close surveillance and ECG monitoring, since cardiac effects of... | 00015216.pdf | 7 | 0 | 0 | null | null |
BE MADE SLOWLY, WITH FREQUENT ASPIRATIONS BEFORE AND DURING THE INJECTION TO AVOID INTRAVASCULAR INJECTION. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be performed after each local anesthetic injection. It shoul... | 00015216.pdf | 7 | 0 | 1 | null | null |
Neurologic Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with existing neurological disease or spinal deformities. Epilepsy: Lidocaine should be used with caution in patients with epilepsy. The risk of central nervous system side effects when using lidocaine in patients with epile... | 00015216.pdf | 9 | 0 | 0 | null | null |
are contraindicated in patients with known hypersensitivities to local anesthetics of the amide type, to other components in the formulation, parabens and their metabolite para amino benzoic acid (PABA). The use of paraben-containing lidocaine preparations should also be avoided in patients who are allergic to ester lo... | 00015216.pdf | 9 | 0 | 1 | null | null |
commensurate with their age, weight and physical condition because they may be more sensitive to systemic effects due to increased blood levels of lidocaine following repeated doses. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with septicemia. **Pregnant Women:** There are no ad... | 00015216.pdf | 10 | 0 | 0 | null | null |
AND PRECAUTIONS-Cardiovascular). The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. In one stud... | 00015216.pdf | 10 | 0 | 1 | null | null |
monitored during paracervical anesthesia. The physician should weigh the possible advantages against risks when considering paracervical block in prematurity, toxaemia of pregnancy, and fetal distress. Careful adherence to recommended dosage is of the utmost importance in obstetrical paracervical block. The recommended... | 00015216.pdf | 11 | 0 | 0 | null | null |
AND ADMINISTRATION). Lidocaine should be used with caution in children under the age of 2 as there is insufficient data to support the safety and efficacy of this product in this patient population at this time. **Geriatrics:** Elderly patients may be more sensitive to systemic effects due to increased blood levels of ... | 00015216.pdf | 11 | 0 | 1 | null | null |
ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by overdosage, rapid absorption, or inadvertent intravas... | 00015216.pdf | 12 | 0 | 0 | null | null |
consciousness, respiratory depression and arrest. The excitatory manifestations (e.g., twitching, tremors, convulsions) may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administrat... | 00015216.pdf | 12 | 0 | 1 | null | null |
**Allergic:** Allergic reactions are characterized by cutaneous lesions, urticaria, edema or, in the most severe instances, anaphylactic shock. Allergic reactions of the amide type are rare (<0.1%) and may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation (s... | 00015216.pdf | 13 | 0 | 0 | null | null |
es from loss of cerebrospinal fluid. **DRUG INTERACTIONS** **Overview** Lidocaine is mainly metabolized in the liver by CYP1A2 and CYP3A4 to its two major metabolites, monoethylglycinexylidine (MEGX) and glycinexylidine (GX), both of which are pharmacologically active. Lidocaine has a high hepatic extraction ratio. Onl... | 00015216.pdf | 13 | 0 | 1 | null | null |
Clinically relevant pharmacodynamic drug interactions may occur with lidocaine and other local anesthetics or structurally related drugs, and Class I and Class III antiarrhythmic drugs due to additive effects. Drug-Drug Interactions Local anesthetics and agents structurally related to amide-type local anesthetics Lidoc... | 00015216.pdf | 14 | 0 | 0 | null | null |
ption can cause a metabolic interaction leading to an increased lidocaine plasma concentration. The plasma clearance of a single intravenous dose of lidocaine was reduced by 41 to 60% during co-administration of fluvoxamine, a selective and potent CYP1A2 inhibitor, to healthy volunteers. Erythromycin and Itraconazole: ... | 00015216.pdf | 14 | 0 | 1 | null | null |
lidocaine when co-administered with these drugs is probably due to reduced liver blood flow and/or inhibition of microsomal liver enzymes. The potential for clinically significant interactions with these drugs should be considered during long-term treatment with high doses of lidocaine. Non-cardioselective betablockers... | 00015216.pdf | 15 | 0 | 0 | null | null |
and tachycardia. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Sedatives If sedatives are employed to reduce patient apprehension, they should be used in reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combinati... | 00015216.pdf | 15 | 0 | 1 | null | null |
Interactions of lidocaine with herbal products have not been established. **Drug-Laboratory Tests Interactions** The intramuscular injection of lidocaine may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test for the pre... | 00015216.pdf | 16 | 0 | 0 | null | null |
sible. The use of lidocaine hydrochloride with epinephrine will prolong the anesthetic action. When lidocaine hydrochloride parenteral solutions are used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Preservative containing solutions (i.e. t... | 00015216.pdf | 16 | 0 | 1 | null | null |
be used in doses greater than 15 mL for other types of blockades (see CONTRAINDICATIONS). Special Populations Lidocaine should be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic or renal function and in severe shock (see WARNINGS AND PRECAUTIONS). Debilitated pati... | 00015216.pdf | 17 | 0 | 0 | null | null |
lidocaine hydrochloride will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of lidocaine hydrochloride may result in a more profound fall in blood pres... | 00015216.pdf | 17 | 0 | 1 | null | null |
The duration of effect can be increased by using solutions containing epinephrine (see Table 2). The risk of epinephrine systemic effects with solutions containing large volumes of epinephrine should be considered. Epidural Anesthesia The lowest dosage that will produce the desired effect should be given. The amount va... | 00015216.pdf | 18 | 0 | 0 | null | null |
ion of a large volume of lidocaine hydrochloride parenteral solutions through the catheter should be avoided and when feasible, fractional doses should be administered. The main dose should be injected slowly at a rate of 100-200 mg/min, or in incremental doses, while keeping in constant verbal contact with the patient... | 00015216.pdf | 18 | 0 | 1 | null | null |
Type of Block | Conc. (%) | Each Dose1 | Onset (min) | Duration (h) Without Epinephrine | Indication ---|---|---|---|---|--- | | | mL | mg | | infiltration | 1 | ≤ 40 | ≤ 400 | 1-2 | 2-3 | Digital2 | 1 | 1-5 | 10-50 | 2-5 | 1.5-2 | Surgical operations. Intercostal (per nerve) | 1 | 2-5 | 20-50 | 3-5 | 1-2 | Surgical op... | 00015216.pdf | 19 | 0 | 0 | null | null |
| 15-30 | 1.5-2 | | 1.5 | 30-50 | 450-600 | 15-30 | 1.5-3 | Surgical operations. Supraclavicular interscalene and subclavian perivascular | 1.0 | 30-40 | 300-400 | 15-30 | 1.5-2 | | 1.5 | 20-30 | 300-450 | 15-30 | 1.5-3 | Sciatic | 1.5 | 15-20 | 225-300 | 15-30 | 2-3 | Surgical operations. | 2 | 15-20 | 300-400 | 15-30... | 00015216.pdf | 19 | 0 | 1 | null | null |
OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre. Acute systemic toxicity from local anesthetics is generally related to high plasma levels encountered during therapeutic use of local anesthetics and originates mainly in the central nervous and the cardiovascular syste... | 00015216.pdf | 20 | 0 | 0 | null | null |
ia and cardiovascular collapse may be the result in such cases. Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anesthetic or is heavily sedated with drugs such as a benzodiazepine or barbiturate. Treatment The first consi... | 00015216.pdf | 20 | 0 | 1 | null | null |
acute systemic toxicity appear, injection of the local anesthetic should be immediately stopped. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection consists of immediate attention to the establishment and maintenance of a patent... | 00015216.pdf | 21 | 0 | 0 | null | null |
necessary. Children should be given doses of epinephrine commensurate with their age and weight. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic actio... | 00015216.pdf | 21 | 0 | 1 | null | null |
Hemodynamics Lidocaine, like other local anesthetics, may also have effects on other excitable membranes (e.g. brain and myocardium). If excessive amounts of drug reach systemic circulation, symptoms and signs of toxicity may appear, emanating from the central nervous and cardiovascular systems. Central nervous system ... | 00015216.pdf | 22 | 0 | 0 | null | null |
tion of lidocaine from the subarachnoid space is monophasic with an absorption half-life of 71 min. Distribution: Lidocaine has a total plasma clearance of 0.95 L/min and a volume of distribution at steady state of 91 L. Lidocaine readily crosses the placenta, and equilibrium with regard to the unbound concentration is... | 00015216.pdf | 22 | 0 | 1 | null | null |
and CYP3A4. The metabolite 2,6-dimethylaniline is converted to 4-hydroxy- 2,6-dimethylaniline by CYP2A6, and the latter is the major urinary metabolite in man. Only 3% of lidocaine is excreted unchanged. About 70% appears in the urine as 4-hydroxy-2,6- dimethylaniline. Excretion: Lidocaine has a terminal half-life of 1... | 00015216.pdf | 23 | 0 | 0 | null | null |
HANDLING INSTRUCTIONS Sterilization, and Technical Procedures Adequate precautions should be taken to avoid prolonged contact between local anesthetic solutions containing epinephrine (low pH) and metal surfaces (e.g., needles or metal parts of syringes), since dissolved metal ions, particularly copper ions, may cause ... | 00015216.pdf | 23 | 0 | 1 | null | null |
The solubility of lidocaine is limited at pH>6.5. This must be taken into consideration when alkaline solutions, i.e. carbonates, are added, since precipitation might occur. In the case of epinephrine-containing solutions, mixing with alkaline solutions may cause rapid degradation of epinephrine. Lidocaine hydrochlorid... | 00015216.pdf | 24 | 0 | 0 | null | null |
) | Multidose Glass Vials (20 and 50 mL) | |---|---|---|---| | Lidocaine Hydrochloride Injection, USP 1% | Hydrochloric acid1 and/or sodium hydroxide1, sodium chloride2 and water for injection | Hydrochloric acid1 and/or sodium hydroxide1, sodium chloride2 and water for injection | Methyl paraben3, hydrochloric acid1 a... | 00015216.pdf | 24 | 0 | 1 | null | null |
Strength Plastic Ampoules (2, 5, and 10 mL) Single Use Glass Ampoules (5 mL) Multidose Glass Vials (20 and 50 mL) 2% Lidocaine and Epinephrine 1:100,000 Injection USP Citric acid, methyl paraben3, sodium chloride2, sodium hydroxide1, sodium metabisulfite4, and water for injection 1 pH adjustment 2 for isotonicity 3 1 m... | 00015216.pdf | 25 | 0 | 0 | null | null |
PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION Drug Substance Proper Name: lidocaine hydrochloride Chemical Name: 2-Diethylamino-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate Molecular Formula and Molecular Mass: C14H22N2O.HCl.H2O 288.8 g/mol Structural Formula: Chemical structure showing a... | 00015216.pdf | 26 | 0 | 0 | null | null |
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