Friday 28 January 2011

Cloviril




Cloviril may be available in the countries listed below.


Ingredient matches for Cloviril



Acyclovir

Aciclovir is reported as an ingredient of Cloviril in the following countries:


  • Peru

International Drug Name Search

Wednesday 26 January 2011

Alsporin




Alsporin may be available in the countries listed below.


Ingredient matches for Alsporin



Cefalexin

Cefalexin is reported as an ingredient of Alsporin in the following countries:


  • Bangladesh

International Drug Name Search

Tuesday 25 January 2011

Cortaméthasone




Cortaméthasone may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Cortaméthasone



Dexamethasone

Dexamethasone is reported as an ingredient of Cortaméthasone in the following countries:


  • France

International Drug Name Search

Cloval




Cloval may be available in the countries listed below.


Ingredient matches for Cloval



Clobutinol

Clobutinol hydrochloride (a derivative of Clobutinol) is reported as an ingredient of Cloval in the following countries:


  • Chile

International Drug Name Search

Sunday 23 January 2011

Dolzam Uno




Dolzam Uno may be available in the countries listed below.


Ingredient matches for Dolzam Uno



Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Dolzam Uno in the following countries:


  • Luxembourg

International Drug Name Search

Vastan




Vastan may be available in the countries listed below.


Ingredient matches for Vastan



Simvastatin

Simvastatin is reported as an ingredient of Vastan in the following countries:


  • Poland

  • Venezuela

International Drug Name Search

Saturday 22 January 2011

Gastrum




Gastrum may be available in the countries listed below.


Ingredient matches for Gastrum



Famotidine

Famotidine is reported as an ingredient of Gastrum in the following countries:


  • Colombia

International Drug Name Search

Friday 21 January 2011

Carbaspirin Calcium




Carbaspirin Calcium may be available in the countries listed below.


Ingredient matches for Carbaspirin Calcium



Carbasalate Calcium

Carbaspirin Calcium (USAN) is also known as Carbasalate Calcium (Rec.INN)

International Drug Name Search

Glossary

Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Tuesday 18 January 2011

Berberin Domesco




Berberin Domesco may be available in the countries listed below.


Ingredient matches for Berberin Domesco



Berberine

Berberine chloride hydrate (a derivative of Berberine) is reported as an ingredient of Berberin Domesco in the following countries:


  • Vietnam

International Drug Name Search

Sunday 16 January 2011

Clox-F




Clox-F may be available in the countries listed below.


Ingredient matches for Clox-F



Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Clox-F in the following countries:


  • Bangladesh

International Drug Name Search

Friday 14 January 2011

Cisdyne




Cisdyne may be available in the countries listed below.


Ingredient matches for Cisdyne



Carbocisteine

Carbocisteine is reported as an ingredient of Cisdyne in the following countries:


  • Japan

  • Taiwan

International Drug Name Search

Thursday 13 January 2011

Trimol




Trimol may be available in the countries listed below.


Ingredient matches for Trimol



Piroheptine

Piroheptine hydrochloride (a derivative of Piroheptine) is reported as an ingredient of Trimol in the following countries:


  • Japan

Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Trimol in the following countries:


  • Oman

  • Tunisia

Trimethoprim

Trimethoprim is reported as an ingredient of Trimol in the following countries:


  • Oman

  • Tunisia

International Drug Name Search

Monday 10 January 2011

Moxonidine PCH




Moxonidine PCH may be available in the countries listed below.


Ingredient matches for Moxonidine PCH



Moxonidine

Moxonidine is reported as an ingredient of Moxonidine PCH in the following countries:


  • Netherlands

International Drug Name Search

Cortiespec




Cortiespec may be available in the countries listed below.


Ingredient matches for Cortiespec



Fluocinolone

Fluocinolone Acetonide is reported as an ingredient of Cortiespec in the following countries:


  • Spain

International Drug Name Search

Thursday 6 January 2011

Dibenzyline



phenoxybenzamine hydrochloride

Dosage Form: capsule
Dibenzyline® (phenoxybenzamine hydrochloride, USP) Capsules 10 mg 

adrenergic, alpha-receptor-blocking agent

Dibenzyline Description


Each Dibenzyline capsule, with red cap and body, is imprinted WPC 001 and 10 mg, and contains 10 mg of Phenoxybenzamine Hydrochloride USP. Inactive ingredients consist of D&C Red No. 33, FD&C Red No. 3, FD&C Yellow No. 6, Gelatin NF, Lactose NF, Sodium Lauryl Sulfate NF and Silicon Dioxide NF.


Dibenzyline is N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl)benzylamine hydrochloride:



Phenoxybenzamine hydrochloride is a colorless, crystalline powder with a molecular weight of 340.3, which melts between 136°and 141°C. It is soluble in water, alcohol and chloroform; insoluble in ether.



Dibenzyline - Clinical Pharmacology


Dibenzyline (phenoxybenzamine hydrochloride) is a long-acting, adrenergic, alpha-receptor-blocking agent, which can produce and maintain "chemical sympathectomy" by oral administration. It increases blood flow to the skin, mucosa and abdominal viscera, and lowers both supine and erect blood pressures. It has no effect on the parasympathetic system.


Twenty to 30 percent of orally administered phenoxybenzamine appears to be absorbed in the active form.¹


The half-life of orally administered phenoxybenzamine hydrochloride is not known; however, the half-life of intravenously administered drug is approximately 24 hours. Demonstrable effects with intravenous administration persist for at least 3 to 4 days, and the effects of daily administration are cumulative for nearly a week.¹



INDICATION AND USAGE


Dibenzyline is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.



Contraindications


Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.



Warning


Dibenzyline-induced alpha-adrenergic blockade leaves beta-adrenergic receptors unopposed. Compounds that stimulate both types of receptors may, therefore, produce an exaggerated hypotensive response and tachycardia.



Precautions


General−Administer with caution in patients with marked cerebral or coronary arteriosclerosis or renal damage. Adrenergic blocking effect may aggravate symptoms of respiratory infections.



Drug Interactions ²


Dibenzyline (phenoxybenzamine hydrochloride) may interact with compounds that stimulate both alpha- and beta-adrenergic receptors (i.e., epinephrine) to produce an exaggerated hypotensive response and tachycardia.(See WARNING.)


Dibenzyline blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.



Carcinogenesis and Mutagenesis


Case reports of carcinoma in humans after long-term treatment with phenoxybenzamine have been reported. Hence long-term use of phenoxybenzamine is not recommended.³,⁴ Carefully weigh the benefits and risks before prescribing this drug.


Phenoxybenzamine hydrochloride showed in vitro mutagenic activity in the Ames test and mouse lymphoma assay; it did not show mutagenic activity in vivo in the micronucleus test in mice. In rats and mice, repeated intraperitoneal administration of phenoxybenzamine hydrochloride (three times per week for up to 52 weeks) resulted in peritoneal sarcomas. Chronic oral dosing in rats (for up to 2 years) produced malignant tumors of the small intestine and non-glandular stomach, as well as ulcerative and/or erosive gastritis of the glandular stomach. Whereas squamous cell carcinomas of the non-glandular stomach were observed at all tested doses of phenoxybenzamine hydrochloride, there was a no-observed-effect-level of 10 mg/kg for tumors (carcinomas and sarcomas) of the small intestine. This dose is, on a body surface area basis, about twice the maximum recommended human dosage of 20 mg b.i.d.



Pregnancy


Teratogenic Effects - Pregnancy Category C

Adequate reproductive studies in animals have not been performed with Dibenzyline (phenoxybenzamine hydrochloride). It is also not known whether Dibenzyline can cause fetal harm when administered to a pregnant woman. Dibenzyline should be given to a pregnant woman only if clearly needed.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from phenoxybenzamine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Adverse Reactions


The following adverse reactions have been observed, but there are insufficient data to support an estimate of their frequency.



Autonomic Nervous System* :Postural hypotension, tachycardia, inhibition of ejaculation, nasal congestion, miosis.


*These so-called "side effects" are actually evidence of adrenergic blockade and vary according to the degree of blockade.



Miscellaneous: Gastrointestinal irritation, drowsiness, fatigue.



To report SUSPECTED ADVERSE REACTIONS, contact WellSpring Pharmaceutical Corporation at 1-866-337-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage


SYMPTOMS-These are largely the result of blocking of the sympathetic nervous system and of the circulating epinephrine. They may include postural hypotension, resulting in dizziness or fainting; tachycardia, particularly postural; vomiting; lethargy; shock.



TREATMENT


When symptoms and signs of overdosage exist, discontinue the drug. Treatment of circulatory failure, if present, is a prime consideration. In cases of mild overdosage, recumbent position with legs elevated usually restores cerebral circulation. In the more severe cases, the usual measures to combat shock should be instituted. Usual pressor agents are not effective. Epinephrine is contraindicated because it stimulates both alpha- and beta- receptors; since alpha- receptors are blocked, the net effect of epinephrine administration is vasodilation and a further drop in blood pressure (epinephrine reversal).


The patient may have to be kept flat for 24 hours or more in the case of overdose, as the effect of the drug is prolonged. Leg bandages and an abdominal binder may shorten the period of disability.


I.V. Infusion of levarterenol bitartrate** may be used to combat severe hypotensive reactions, because it stimulates alpha-receptors primarily. Although Dibenzyline (phenoxybenzamine hydrochloride) is an alpha -adrenergic blocking agent, a sufficient dose of levarterenol bitartrate will overcome this effect.


The oral LD50 for phenoxybenzamine hydrochloride is approximately 2000 mg/kg in rats and approximately 500 mg/kg in guinea pigs.



Dibenzyline Dosage and Administration


The dosage should be adjusted to fit the needs of each patient. Small initial doses should be slowly increased until the desired effect is obtained or the side effects from blockade become troublesome. After each increase, the patient should be observed on that level before instituting another increase. The dosage should be carried to a point where symptomatic relief and/or objective improvement are obtained, but not so high that the side effects from blockade become troublesome.


Initially, 10 mg of Dibenzyline (phenoxybenzamine hydrochloride) twice a day. Dosage should be increased every other day, usually to 20 to 40 mg 2 or 3 times a day, until an optimal dosage is obtained, as judged by blood pressure control.


Long-term use of phenoxybenzamine is not recommended (see PRECAUTIONS Carciongenesis and Mutagenesis)



STORAGE


Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature].



How is Dibenzyline Supplied


Dibenzyline (phenoxybenzamine hydrochloride) capsules, 10 mg, in bottles of 100 (NDC 65197-001-01).



REFERENCES


  • Weiner, N.: Drugs That Inhibit Adrenergic Nerves and Block Adrenergic Receptors, in Goodman, L., and Gilman, A., The Pharmacological Basis of Therapeutics, ed. 6, New York, Macmillan Publishing Co., 1980, p. 179; p. 182.

  • Martin, E.W.: Drug Interactions Index 1978/1979, Philadelphia, J.B. Lippincott Co., 1978, pp. 209-210.

  • Nettesheim O, Hoffken G, Gahr M, Breidert M: Haematemesis and dysphagia in a 20-year-old woman with congenital spine malformation and situs inversus partialis [German]. Zeitschrift fur Gastroenterologie. 2003; 41(4):319-24.

  • Vaidyanathan S, Mansour P, Soni BM, Hughes PL, Singh G: Chronic lymphocytic leukaemia, synchronous small cell carcinoma and squamous neoplasia of the urinary bladder in a paraplegic man following long-term phenoxybenzamine therapy. Spinal Cord. 2006;44(3):188-91.


** Available as Levophed® Bitartrate (brand of norepinephrine bitartrate) from Abbott Laboratories.



DATE OF ISSUANCE MARCH 2009


©WellSpring, 2009


Manufactured for

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243 USA

By WellSpring Pharmaceutical

Canada Corp.

Oakville, Ontario L6H 1M5 Canada


Rev. 03/09



PACKAGE LABEL










Dibenzyline 
phenoxybenzamine hydrochloride  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)65197-001
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOXYBENZAMINE HYDROCHLORIDE (PHENOXYBENZAMINE)PHENOXYBENZAMINE HYDROCHLORIDE10 mg


















Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C RED NO. 3 
FD&C YELLOW NO. 6 
GELATIN 
LACTOSE 
SODIUM LAURYL SULFATE 
SILICON DIOXIDE 


















Product Characteristics
ColorRED (red)Scoreno score
ShapeCAPSULESize10mm
FlavorImprint CodeWPC;001;10;mg
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165197-001-01100 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00870810/01/1999


Labeler - WellSpring Pharmaceutical Corporation (110999054)









Establishment
NameAddressID/FEIOperations
WellSpring Pharmaceutical Corporation110999054MANUFACTURE
Revised: 12/2010WellSpring Pharmaceutical Corporation

More Dibenzyline resources


  • Dibenzyline Side Effects (in more detail)
  • Dibenzyline Dosage
  • Dibenzyline Use in Pregnancy & Breastfeeding
  • Drug Images
  • Dibenzyline Drug Interactions
  • Dibenzyline Support Group
  • 0 Reviews for Dibenzyline - Add your own review/rating


  • Dibenzyline Concise Consumer Information (Cerner Multum)

  • Dibenzyline Monograph (AHFS DI)

  • Dibenzyline Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dibenzyline MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Dibenzyline with other medications


  • Pheochromocytoma

Wednesday 5 January 2011

Zolpidem La Santé




Zolpidem La Santé may be available in the countries listed below.


Ingredient matches for Zolpidem La Santé



Zolpidem

Zolpidem is reported as an ingredient of Zolpidem La Santé in the following countries:


  • Colombia

International Drug Name Search