DOCSLIB.ORG

Belladonna Leaf Ph Between 9.0 and 9.5

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Belladonna Leaf Ph Between 9.0 and 9.5 Printed on: Wed Jan 06 2021, 02:36:16 AM Official Status: Currently Official on 06-Jan-2021 DocId: 1_GUID-DF1FD0EE-AAC1-4D8A-972E-9D5AEED0CE9A_1_en-US (EST) Printed by: Jinjiang Yang Official Date: Official as of 01-Aug-2017 Document Type: USP @2021 USPC 1 buffer and sufficient 1 N sodium hydroxide to yield a final Belladonna Leaf pH between 9.0 and 9.5. Add 15 mL of chloroform, shake DEFINITION vigorously, and allow the layers to separate. Filter the Belladonna Leaf consists of the dried leaf and flowering or organic phase through 10 g of anhydrous sodium sulfate fruiting top of Atropa belladonna L. or of its variety acuminata (see Reagents, Indicators, and SolutionsÐSodium Sulfate, Royle ex Lindley (Fam. Solanaceae). Belladonna Leaf yields Anhydrous, Suitability for Alkaloid Assays), previously NLT 0.35% of the alkaloids of belladonna leaf. washed with chloroform and supported in a funnel with a small pledget of glass wool, into a suitable container. ASSAY Extract again with two 15-mL portions of chloroform, · PROCEDURE again collecting the clarified organic phase. Wash the Phosphate buffer: 34.8 g of dibasic potassium phosphate sodium sulfate and the tip of the funnel with 5 mL of in 900 mL of water. Adjust to a pH of 9.5 by the addition chloroform. Evaporate the combined organic phases of 3 N hydrochloric acid or sodium hydroxide, with mixing. under reduced pressure at a temperature below 45°, add Diluent: Dilute sulfuric acid (1 in 350) 1 mL of chloroform, and mix to dissolve the alkaloids, Internal standard solution: 0.8 mg/mL of USP taking care to wet the sides of the container. Homatropine Hydrobromide RS in Diluent. [NOTE—Prepare Chromatographic system fresh on the day of use.] (See Chromatography á621ñ, System Suitability.) Standard stock solution A: 1.0 mg/mL of USP Scopolamine Mode: GC Hydrobromide RS in Diluent Detector: Flame ionization Standard stock solution B: Dissolve 20 mg of USP Atropine Column: 1.2-m × 4-mm glass; packed with 3% G3 on Sulfate RS in 25 mL of Diluent in a 50-mL volumetric flask, S1AB. [NOTE—The column may be cured and conditioned add 2.0 mL of Standard stock solution A, and mix. Add as specified under Chromatography á621ñ, General Diluent to volume. [NOTE—Prepare fresh on the day of use.] Procedures, Gas Chromatography.] Standard solutions: Pipet into three separate 60-mL Temperatures separators 1.0-, 2.0-, and 3.0-mL portions, respectively, of Injection port: 240° Standard stock solution A, and add 9.0, 8.0, and 7.0 mL, Detector: 240° respectively, of Diluent. Add 1.0 mL of Internal standard Column: 215° solution, then add 15 mL of chloroform, shake vigorously, Carrier gas: Dry helium allow the layers to separate, and discard the chloroform Flow rate: 65 mL/min layer. Injection volume: 5 µL Sample solution: Moisten 10 g, previously reduced to a System suitability moderately coarse powder, with a mixture of 8 mL of Sample: Sample solution ammonium hydroxide, 10 mL of alcohol, and 20 mL of Suitability requirements ether, and extract the alkaloids by either Method I or Resolution: NLT 3.0 between atropine and Method II as follows. If necessary, reduce the volume of the homatropine peaks extract to 100 mL by evaporation on a steam bath. Tailing factor: NMT 2.0 for atropine peak Extraction blank: Place 10 mL of Diluent in a 60-mL Relative standard deviation: The analytical system is separator. Prepare as directed under Standard solutions, suitable for conducting this Assay if the relative standard beginning with “then add 15 mL of chloroform”. The blank deviation for the ratio, RA, is NMT 2.0%, for the atropine chromatogram contains no significant interferences at the peak in repeated injections. locus of atropine, scopolamine, or homatropine. Analysis Method I: Place the moistened drug in a Samples: Standard solutions and Sample solution continuous-extraction thimble, and allow maceration to Measure the areas, aA, aH, and aS, of the atropine, proceed overnight, then extract with etherOfficial for 3 h, or longer homatropine, and scopolamine peaks, respectively, in if necessary, to effect complete extraction. each chromatogram of Standard solution, and calculate Method II: Place the moistened drug in a small percolator, the ratios AA and AS: and allow maceration to proceed overnight. Percolate slowly with a mixture of three volumes of ether and one AA = aA/aH volume of chloroform. Continue the percolation until the residue from 3–4 mL of percolate last passed, when AS = aS/aH dissolved in dilute sulfuric acid (1 in 70) and treated with mercuric iodide TS, shows NMT a faint turbidity. Plot the standard curves of the values of RA and RS against Transfer the extract from Method I or Method II to a the amounts, in milligrams, of atropine and scopolamine separator with the aid of ether. Extract with five 15-mL in the solutions. (The ratio of the molecular weight of portions of dilute sulfuric acid (1 in 70), filtering each atropine to that of anhydrous atropine sulfate is 0.8551, portion drawn off into a 100-mL volumetric flask. Wash and the ratio of the molecular weight of scopolamine to the filter with dilute sulfuric acid (1 in 70), and collect the that of anhydrous scopolamine hydrobromide is washings in the flask. Add dilute sulfuric acid (1 in 70) to 0.7894.) Inject a portion of the Sample solution into the volume, and mix. Dilute 20.0 mL of the resulting solution chromatograph, measure the peak areas, and calculate with the same dilute acid to 100.0 mL. Pipet 10 mL of this the area ratios, as with the Standard solutions. Record solution into a 60-mL separator. Add 1.0 mL of Internal from the standard curves the quantities, in milligrams, of standard solution, then add 15 mL of chloroform, shake atropine and scopolamine in the weight of the specimen vigorously, allow the layers to separate, and discard the taken. Add the quantity, in milligrams, of atropine and chloroform layer. [NOTE—If emulsions are formed, a mixed scopolamine, and multiply by 50 to obtain the weight, solvent consisting of chloroform-isopropyl alcohol (10:3) in milligrams, of alkaloids in the portion of Belladonna may be substituted for chloroform throughout the Leaf taken. extraction procedure.] Acceptance criteria: NLT 0.35% of the alkaloids of Add another 15 mL of chloroform, and extract again, belladonna leaf discarding the chloroform phase. Add 15 mL of Phosphate https://online.uspnf.com/uspnf/document/1_GUID-DF1FD0EE-AAC1-4D8A-972E-9D5AEED0CE9A_1_en-US 1/2 Printed on: Wed Jan 06 2021, 02:36:16 AM Official Status: Currently Official on 06-Jan-2021 DocId: 1_GUID-DF1FD0EE-AAC1-4D8A-972E-9D5AEED0CE9A_1_en-US (EST) Printed by: Jinjiang Yang Official Date: Official as of 01-Aug-2017 Document Type: USP @2021 USPC 2 CONTAMINANTS microcrystals. The midrib contains an arc of bicollateral · ARTICLES OF BOTANICAL ORIGIN á561ñ, Methods of Analysis, bundles, collenchyma beneath upper epidermis, and Acid-Insoluble Ash: NMT 3.0% scattered parenchyma cells with microcrystals. · ARTICLES OF BOTANICAL ORIGIN á561ñ, Pesticide Residue Stem: The stem shows an epidermis with striated cuticle Analysis: Meets the requirements and few hairs; a distinct endodermis; small strands of long, · BELLADONNA STEMS: The proportion of belladonna stems thin-walled, slightly lignified pericyclic fibers; and a circle over 10 mm in diameter does not exceed 3.0%. of bicollateral bundles. The parenchyma of the cortex and pith is interspersed with crystal cells. SPECIFIC TESTS Flower: The calyx possesses numerous glandular hairs with · BOTANICAL CHARACTERISTICS uniseriate stalks and one- to three-celled glandular heads. Macroscopic: Usually partly matted together, crumpled or The corolla shows a papillose inner epidermis and an outer broken leaves, together with some smaller stems and a epidermis with glandular hairs similar to those of the number of flowers and fruits. The leaves are thin and brittle, calyx. The pollen grains, when mounted in chloral hydrate mostly light green to moderate olive-green. The lamina is solution, are subspherical, 40 µm in diameter, tricolpate, mostly 5–25 cm in length and 4–12 cm in width and having three germinal furrows and rows of pits between possesses an ovate-lanceolate to broadly ovate outline, an the ridges on the exine. acute to acuminate apex, an entire margin, an acute to Fruit: The epicarp exhibits polygonal epidermal cells with a somewhat decurrent base and slightly hairy surface, the striated cuticle and stomata. The mesocarp consists of hairs being more abundant along the veins; when broken large pulp cells some of which contain rosette aggregate transversely, it shows numerous light-colored dots (crystal crystals of calcium oxalate. cells) visible with a lens. The petiole is slender and usually Seed: The seed is characterized by an epidermis of large, up to 4 cm in length. The flowers possess a campanulate wavy-walled cells with prominent ridges over the corolla with five small, reflexed lobes, purplish to yellowish anticlinal walls. purple, becoming faded to brown or dusky yellow or Powdered Belladonna Leaf: Light olive-brown to yellow; a green, five-lobed calyx; five epipetalous stamens; moderate olive-green in color. The following are among and a superior, bilocular ovary with numerous ovules. The the elements of identification: the separate microcrystals, fruit is subglobular, dark yellow to yellowish brown to dusky the dark gray crystal cells, the cuticular striping of the red or black, up to 12 mm in width, and sometimes epidermal cells, the vessels with ellipsoidal bordered pits, subtended by the persistent calyx and containing the fibers of the stem, and occasional hairs and pollen numerous flattened, somewhat reniform seeds, the latter grains.
Load more

Recommended publications
  • Medication List
    Medication List Walgreens Plus™ members receive discounts on thousands of generic and brand-name medications included on this Medication List, which is divided into two sections, “Value Priced” Medications and “Discounted” Medications*. The price for a medication identified as “Value-Priced” is listed below: Get savings up to 85% off Cash Prices • 30-day-supply drugs cost $5 (tier 1), $10 (tier 2) or $15 (tier 3) on Atorvastatin (generic Lipitor) and • 90-day-supply drugs cost $10 (tier 1), $20 (tier 2) or $30 (tier 3) Rosuvastatin (generic Crestor) †† The Discounted Medications section lists the discounts offered to Walgreens Plus members on other generic and brand-name medications not included in the Value-Priced Medication section. The price for a medication is based on its tier and whether it is a 30-day or 90-day supply†. There may be an additional cost for quanities greater than those listed. This discount prescription pricing applies only to Walgreen Plus members on prescriptions purchased in select Walgreens stores that are not billed to insurance and/or used in combination with other health or pharmacy benefit programs. For further details, see your pharmacist or Walgreens.com/Plus. VALUE GENERICS NAPROXEN 250MG TAB 2 60 180 Antifungal NAPROXEN 500MG TAB 2 60 180 Quantity NAPROXEN 375MG TAB 2 60 180 Drug Name Tier 30 90 NAPROXEN DR 500MG TAB 3 60 180 FLUCONAZOLE 150MG TAB 2 1 3 TERBINAFINE 250MG TAB 2 30 90 Asthma Quantity Antiviral Drug Name Tier 30 90 Quantity ALBUTEROL 0.083% INH SOLN 25X3ML 2 75 225 Drug Name Tier 30 90 AMINOPHYLLINE
    [Show full text]
  • World Health Organization Model List of Essential Medicines, 21St List, 2019
    World Health Organizatio n Model List of Essential Medicines 21st List 2019 World Health Organizatio n Model List of Essential Medicines 21st List 2019 WHO/MVP/EMP/IAU/2019.06 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. World Health Organization Model List of Essential Medicines, 21st List, 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.
    [Show full text]
  • Asis with Tropicamide and Phenylephrine on Intraocular Pressure
    Adediji AK, et al., J Ophthalmic Clin Res 2019, 6: 049 DOI: 10.24966/OCR-8887/100049 HSOA Journal of Ophthalmology and Clinical Research Research Article line at all the follow up periods except at 45 minutes where it was Effects of Diagnostic Mydri- slightly higher (12.11±2.87mmHg). These differences in mean IOP change were statistically significant (p<0.05). At all the follow-up asis with Tropicamide and periods, 8.8%-14.6% of participant’s right eyes had large IOP ele- vations (>5mmHg but <10mmHg). Multiple linear regression anal- Phenylephrine on Intraocular ysis showed that pre dilatation IOPs were positively correlated to post dilatation IOPs. Pressure Conclusion: There is need to recheck IOP post dilatation prefera- Adediji AK, Adio AO and Fiebai B* bly at 45 minutes in all patients who have had diagnostic mydriasis to prevent damage to the optic nerve. Diagnostic mydriasis could Department of Ophthalmology, University of Port Harcourt Teaching Hospi- safely be done using small concentrations of tropicamide and phen- tal, Port Harcourt, Nigeria ylephrine. Keywords: Diagnostic mydriasis; Intraocular pressure; Mydriasis; Phenylephrine; Tropicamide Introduction Intraocular Pressure (IOP) is the tissue pressure within the eye which is determined by the balance between aqueous humor produc- tion and outflow, which under normal circumstances is nearly equal. The normal distribution of IOP within the general population is 11- 21mmHg [1]. Intraocular pressure can be affected by a range of fac- tors like time of the day, heartbeat, respiration, exercise, fluid intake, Abstract posture, blinking, eye movements, valsalva manoeuvres and med- ications; including those used for pupillary dilatation [2-4].
    [Show full text]
  • Appendix 1 BNF Codes of Drugs Lists Used to Define Exposure Groups
    Appendix 1 BNF Codes of drugs lists used to define exposure groups. Anticholinergic antipsychotics d411. Chlorpromazine d412. Chlorpromazine d413. Chlorpromazine d414. Chlorpromazine d415. Chlorpromazine d41a. Chlorpromazine d41b. Chlorpromazine d41c. Chlorpromazine d41d. Chlorpromazine d4b1. Perphenazine d4e1. PROMAZINE d4ex. PROMAZINE d4g.. Thioridazine d4g1. Thioridazine d4g2. Thioridazine d4g3. Thioridazine d4g5. Thioridazine d4g7. Thioridazine d4gp. Thioridazine d4gt. Thioridazine d4gu. Thioridazine d4gv. Thioridazine d4gw. Thioridazine d4gz. Thioridazine d4h.. Trifluoperazine d4h1. Trifluoperazine d4h2. Trifluoperazine d4h3. Trifluoperazine d4h4. Trifluoperazine d4hs. Trifluoperazine d4ht. Trifluoperazine d4hu. Trifluoperazine d4hx. Trifluoperazine d4l2. CLOZAPINE d4r1. OLANZAPINE d4r3. OLANZAPINE d4r7. OLANZAPINE d4s1. QUETIAPINE d4s2. QUETIAPINE d4s3. QUETIAPINE d4s5. QUETIAPINE d4ss. QUETIAPINE d4sx. QUETIAPINE Tricyclic antidepressants d7... d71.. Amitriptyline d711. Amitriptyline d712. Amitriptyline d713. Amitriptyline d719. Amitriptyline d71a. Amitriptyline d71b. Amitriptyline d71c. Amitriptyline d71d. Amitriptyline d71e. Amitriptyline d71f. Amitriptyline d71u. Amitriptyline d71v. Amitriptyline d71w. Amitriptyline d71y. Amitriptyline d71z. Amitriptyline d73.. Clomipramine d731. Clomipramine d732. Clomipramine d733. Clomipramine d736. Clomipramine d73s. Clomipramine d73t. Clomipramine d73u. Clomipramine d73v. Clomipramine d73w. Clomipramine d73z. Clomipramine d75.. DOSULEPIN d751. DOSULEPIN d752. DOSULEPIN d755. DOSULEPIN d756.
    [Show full text]
  • Queensland Health List of Approved Medicines
    Queensland Health List of Approved Medicines Drug Form Strength Restriction abacavir * For use in accord with PBS Section 100 indications * oral liquid See above 20 mg/mL See above tablet See above 300 mg See above abacavir + lamivudine * For use in accord with PBS Section 100 indications * tablet See above 600 mg + 300 mg See above abacavir + lamivudine + * For use in accord with PBS Section 100 indications * zidovudine tablet See above 300 mg + 150 mg + 300 mg See above abatacept injection 250 mg * For use in accord with PBS Section 100 indications * abciximab (a) Interventional Cardiologists for complex angioplasty (b) Interventional and Neuro-interventional Radiologists for rescue treatment of thromboembolic events that occur during neuroendovascular procedures. * Where a medicine is not TGA approved, patients should be made fully aware of the status of the medicine and appropriate consent obtained * injection See above 10 mg/5 mL See above abiraterone For use by medical oncologists as per the PBS indications for outpatient and discharge use only tablet See above 250 mg See above 500 mg See above acamprosate Drug and alcohol treatment physicians for use with a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence. enteric tablet See above 333 mg See above acarbose For non-insulin dependent diabetics with inadequate control despite diet; exercise and maximal tolerated doses of other anti-diabetic agents tablet See above 50 mg See above 100 mg See above acetazolamide injection 500 mg tablet 250 mg acetic acid ear drops 3% 15mL solution 2% 100mL green 3% 1 litre 6% 1 Litre 6% 200mL Generated on: 30-Aug-2021 Page 1 of 142 Drug Form Strength Restriction acetylcysteine injection For management of paracetamol overdose 2 g/10 mL See above 6 g/30 mL See above aciclovir cream Infectious disease physicians, haematologists and oncologists 5% See above eye ointment For use on the advice of Ophthalmologists only.
    [Show full text]
  • Drugs Which Can Affect Near Vision: a Useful List
    Drugs Which Can Affect Near Vision: A Useful List Joanne L. Smith B.Sc., Ph.Phm.* J. Raymond Buncic, M.D., F.R.C.S.(C)t ABSTRACT This paper documents a list of drugs that cause problems with near vision, by virtue of effects on accommodation, occasionally refractive error and diplopia. It is meant as a reference aid to the clinician when confronted with problems of focusing on near objects or print. There are many drugs that have been reported to interfere with near or reading vision, producing blurring, decreased accommodation and diplopia. This paper lists the drugs that have been reported in the literature to produce symptoms which interfere with near vision. Case reports for the listed drugs vary greatly from many to few. The drugs have been divided into the following categories: those causing (A) blurring at near, (B) diplopia and (C) induced myopia. Those drugs which only rarely cause these symptoms have been omitted. From the Departments of Pharmacy* and Ophthalmologyt, The Hospital For Sick Children, Toronto, Ontario, Canada Requests for reprints should be addressed to: Dr. J. Raymond Buncic, Department of Ophthalmology, The Hospital For Sick Children, 555 University Ave., Toronto, Ontario, Canada M5G lX8 TABLE 1 DRUGS COMMONLY CAUSING DIFFICULTY WITH FOCUSING AT NEAR OR BLURRED VISION. DRUG INCIDENCE REFERENCE Antipsychotics Chlorpromazine 14-23 8 Clozapine 5 8,14 Fluphenazine 1.2-4.3 8 Haloperidol 6.8-16 8 Loxapine 12,14 Perphenazine 7.4-17.8 8 Pimozide 20 8 Risperidone 1-2%, >/= 10% 11 Thioridazine 0.6-18 8 Thiothixene 20 8
    [Show full text]
  • Reclassification of Hyoscine Butylbromide for Oral Use
    Reclassification of Hyoscine butylbromide for oral use in medicines containing not more than 20 milligrams per dose (Addition of oral liquids in the current classification) Present classification: Restricted Proposed classification: Restricted AFT Pharmaceuticals Limited Level 1, Nielsen Building 129 Hurstmere Rd Takapuna, Auckland, 0622 PO Box 33-203, Takapuna, Auckland Page 1 of 16 Objective: This application seeks reclassification of hyoscine butylbromide for oral use in medicines containing not more than 20 milligrams per dose. Page 2 of 16 PART A 1. International Non-Proprietary Name of the Medicine Hyoscine butylbromide 2. Proprietary name(s) Gastrosoothe (Proposed) (hyoscine butylbromide 1 mg/mL) 3. Name of the company/organisation/individual requesting a reclassification AFT Pharmaceuticals Ltd 129 Hurstmere Road Takapuna 0622 Auckland New Zealand 4. Dose form(s) and strength(s) for which a change is sought Dose form: Oral liquid Strength: 1 mg/mL Pack size: 200 mL. 5. Proposed pack size, storage conditions and any other qualifications Proposed pack size: Bottle containing 200 mL (1 mg/mL) of hyoscine butylbromide oral liquid Storage conditions: Store below 30 °C. 6. Indications for which change is sought Indication: for the relief of muscle spasm of the gastrointestinal tract 7. Present classification of the medicine Ingredient Conditions (if any) Classification Hyoscine except when specified elsewhere in this schedule Prescription butylbromide Hyoscine for oral use in medicines containing not more than 10 milligrams per Restricted butylbromide dose form and in packs containing not more than 20 tablets or capsules; for oral use in medicines containing not more than 20 milligrams per dose form and in packs containing not more than 10 tablets or capsules for the relief of muscle spasm of the gastrointestinal tract Page 3 of 16 8.
    [Show full text]
  • Axert , a New “Triptan”
    Rx Details January 1, 2014 Formulary Update The January 2014 Drug Formulary update is included as an attachment. Significant updates include: Oxycodone ER (OxyContin). Quantity Limits for OxyContin have been updated for Commercial Drug Formularies and State Health Care Programs, effective April 1 2014. Quantity limits now allow a maximum of 120mg morphine equivalents per day (MED), similar to other opioid medications. New Daily New Daily mg Strength MED* Quantity Limit limit 10 mg 4 (no change) 40 60 15 mg 4 (no change) 60 90 20 mg 4 (no change) 80 120 30 mg 2 60 90 40 mg 2 80 120 60 mg 0 0 0 80 mg 0 0 0 * MED (morphine equivalents per day) is used to determine dosage levels of different opioids by converting them to morphine equivalents. Additional communications are being sent to affected providers and members. Exceptions allowing higher quantities can be requested if medically necessary. Requests should include a treatment plan, and must include an assessment of the risk of addiction, abuse, and diversion. Tricyclic antidepressants. These tricyclic antidepressants will be limited for elderly members (ages 65 and older) in Commercial and State Health Care Programs, effective April 1 2014. • amitriptyline (Elavil), chlordiazepoxide/ amitriptyline (Limbitrol), and perphenazine/ amitriptyline (Etrafon) • doxepin (Silenor) • imipramine (Tofranil) • trimipramine (Surmontil) • clomipramine (Anafranil). Clomipramine will be approved for obsessive‐compulsive disorder (no additional coverage criteria). These tricyclic antidepressants are anticholinergic, with a high rate of side effects in the elderly. Nortriptyline (Pamelor) and desipramine (Norpramin) remain on formulary for all age groups. Additional communications are being sent to affected providers and members.
    [Show full text]
  • SUPPLEMENT Etable 1
    SUPPLEMENT eTable 1. List of medications used for exclusions and prescription drug history variables Anticonvulsants (past use Medications used for prescription drug history variables evaluated as an exclusion criterion) Antidepressants Anticholinergics Carbamazepine Bupropion Aclidinium Clobazam Atropine Clonazepam Other antidepressants: Cyclopentolate Clorazepate Amitriptyline Glycopyrrolate Diazepam Amoxapine Homatropine Divalproex Butriptyline Ipratropium Ethosuximide Citalopram Methscopolamine Ethotoin Clomipramine Scopolamine Ezogabine Desipramine Tiotropium Felbamate Desvenlafaxine Tropicamide Fosphenytoin Dibenzepin Gabapentin Dotheipin Lacosamide Doxepin Lamotrigine Duloxetine Levetiracetam Escitalopram Lorazepam Fluoxetine Mephenytoin Fluvoxamine Mephobarbital Imipramine Metharbital Iprindole Methsuximide Isocarboxazid Oxcarbazepine Levomilnacipran Paramethadione Lofepramine Phenacemide Maprotiline Phenobarbital Melitracen Phensuximide Mianserin Phenytoin Milnacipran Pregabalin Mirtazapine Primidone Nefazodone Rufinamide Nortriptyline Tiagabine Opipramol Topiramate Paroxetine Trimethadione Phenelzine Valproate Sodium Protriptyline Valproic Acid Sertraline Vigabatrin Tranylcypromine Zonisamide Trazodone Trimipramine Tryptophan Venlafaxine Vilazodone 1 eTable 2. Diagnostic codes used for medical history variables Medical condition Diagnostic codes (ICD-9)a Stroke 431.xx, 433.xx, 434.xx, 436.xx Other cerebrovascular 430.xx, 432.xx, 435.xx, 437.xx, 438.xx disease Brain injury 850.xx-854.xx, 907.0x Hypoxemia 799.02 Infection 001.xx-039.xx
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Homatropine > Printer-Friendly PDF
    Published on British Columbia Drug and Poison Information Centre (BC DPIC) ( http://www.dpic.org) Home > Drug Product Listings > Homatropine > Printer-friendly PDF Homatropine Trade Name: Isopto Homatropine Manufacturer/Distributor: Alcon Canada Classification: Mydriatic agent ATC Class: S01FA - Anticholinergic Status: discontinued Presentation: Eye Drops: 2%. DIN: 00000779 Eye Drops: 5%. DIN: 00000787 Comments: May 2016: The product has been discontinued by the company. There are no other suppliers of this medication in Canada. There are other anticholinergic eye drops available (e.g. atropine, cyclopentolate, tropicamide). Keywords: homatropine drug discontinuation Access: public Back to: Please note - this is not a complete list of products available in Canada. For a complete list of drug products marketed in Canada, visit the Health Canada Drug Product Database Status: <Any> ? Search Terms: Apply A (37) | B (20) | C (24) | D (37) | E (40) | F (12) | G (11) | H (9) | I (24) | K (1) | L (26) | M (12) | N (7) | O (12) | P (28) | R (14) | S (27) | T (33) | U (4) | V (13) | W (2) | Z (4) Date Marketed in Common Generic Name Classification Canada Trade Name(s) (yyyy/mm/dd) Estropipate Ogen Apo-digoxin; Digoxin pms-Digoxin; Lanoxin Panoxyl Clear Salicylic acid + Triclosan Acne Cleansing Gel Risedronate + Calcium Actonel APC carbonate Sibutramine Meridia 2010/10/08 Rosiglitazone + Avandaryl 2011/03/31 glimepiride Phosphate Phosphate Effervescent 2017/01/01 Sandoz Metronidazole with Flagystatin nystatin vaginal cream vaginal cream Orajel teething
    [Show full text]
  • Cross Discipline Team Leader Review
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208151Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW NDA 208151 William M. Boyd, M.D. Cross Discipline Team Leader Review Other dosage forms of atropine are marketed in the United States. Some of these products have approved new drug applications and others do not. Pupillary dilation and cycloplegia impair visual function. When these actions are necessary for greater than 72 hours either for diagnostic or therapeutic action, there are no pharmacologic alternatives. When maximal cycloplegia is required, there are no therapeutic alternatives. Table of Currently Available Treatments for Proposed Indications Drug Substance Duration Action Subject of an (normal individual) approved ophthalmic application Phenylephrine ~ 4 hours Mydriasis Yes Tropicamide ~ 4 hours Mydriasis & Cycloplegia Yes Cyclopentolate ~ 12 hours Mydriasis & Cycloplegia Yes Scopolamine ~ 72 hours Mydriasis & Cycloplegia No Homatropine ~ 48 hours Mydriasis & Cycloplegia No Atropine ~14 days Mydriasis, Cycloplegia, and in Yes the treatment of amblyopia The Applicant requested a “Pre-IND” meeting with the Division of Transplant and Ophthalmology Products. The meeting took place on February 11, 2013, during which the Agency agreed that a 505(b)(2) application was an acceptable pathway for a new drug application in which the applicant did not have a right to reference studies conducted in support of the drug product. There are numerous literature articles supporting the clinical use of atropine ophthalmic solution. Many of the articles identify a specific brand name product (the current applicant’s unapproved, marketed product). None of the literature articles necessary to support approval specifically identify the listed drug that is a pharmaceutical equivalent to the proposed product (NDA 206289).
    [Show full text]