Online PLR Articles Directory South Africa: 2011

Sunday 25 December 2011

Italclar

Italclar may be available in the countries listed below.

Ingredient matches for Italclar

Clarithromycin

Clarithromycin is reported as an ingredient of Italclar in the following countries:

Ecuador

International Drug Name Search

Friday 23 December 2011

Clarimax

Clarimax may be available in the countries listed below.

Ingredient matches for Clarimax

Clarithromycin

Clarithromycin is reported as an ingredient of Clarimax in the following countries:

Argentina

Chile

International Drug Name Search

Thursday 22 December 2011

Triamcinolona

Triamcinolona may be available in the countries listed below.

Ingredient matches for Triamcinolona

Triamcinolone

Triamcinolone is reported as an ingredient of Triamcinolona in the following countries:

Argentina

Peru

Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Triamcinolona in the following countries:

Colombia

Peru

International Drug Name Search

Tuesday 13 December 2011

Nilefrin

Nilefrin may be available in the countries listed below.

Ingredient matches for Nilefrin

Phenylephrine

Phenylephrine is reported as an ingredient of Nilefrin in the following countries:

Romania

International Drug Name Search

Friday 9 December 2011

Eto-cell

Eto-cell may be available in the countries listed below.

Ingredient matches for Eto-cell

Etoposide

Etoposide is reported as an ingredient of Eto-cell in the following countries:

Germany

International Drug Name Search

Wednesday 7 December 2011

Sulfalutyl

Sulfalutyl may be available in the countries listed below.

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

Ingredient matches for Sulfalutyl

Sulfadimidine

Sulfadimidine sodium salt (a derivative of Sulfadimidine) is reported as an ingredient of Sulfalutyl in the following countries:

France

Sulfaguanidine

Sulfaguanidine is reported as an ingredient of Sulfalutyl in the following countries:

France

International Drug Name Search

Friday 2 December 2011

Penhexal

Penhexal may be available in the countries listed below.

Ingredient matches for Penhexal

Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penhexal in the following countries:

Australia

Germany

Luxembourg

International Drug Name Search

Thursday 24 November 2011

Generic Name: Levobunolol Hydrochloride
Class: beta-Adrenergic Blocking Agents
VA Class: OP101
Chemical Name: (-)-5-(3-tert-Butylamino-2-hydroxypropoxy)-1,2,3,4-tetrahydronaphthalen-1-one hydrochloride
Molecular Formula: C₁₇H₂₅NO₃•ClH [Molecular Formula]
CAS Number: 27912-14-7[CAS number]

Introduction

Nonselective β-adrenergic blocking agent.² ³ ⁹ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ²⁰ ²¹ ²² ²³ ²⁷ ²⁸ ^a ^b ^c

Uses for Betagan

Ocular Hypertension and Glaucoma

Reduction of elevated IOP in patients with chronic open-angle glaucoma² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁸ ⁹² ^a ^b ^c or ocular hypertension.² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁹² ^a ^b ^c

Used alone² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁹² ^a ^b ^c or in conjunction wth a topical miotic (e.g., pilocarpine), topical dipivefrin, topical epinephrine, and/or a systemic carbonic anhydrase inhibitor.² ¹⁰¹ ^a ^b ^c

Betagan Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁹² ^a ^b ^c

Avoid contamination of the solution container.⁸⁰

Dosage

Available as levobunolol hydrochloride; dosage expressed in terms of the salt.^a ^b ^c

Adults

Ocular Hypertension and Glaucoma

Ophthalmic Administration

Initially, 1 or 2 drops of a 0.5% ophthalmic solution in the affected eye(s) once daily² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁸ ⁹² ⁹³ ^a ^b ^c or, alternatively, 1 or 2 drops of a 0.25% ophthalmic solution twice daily.^b ^c

May increase dosage, if necessary, to 1 drop of a 0.5% ophthalmic solution in the affected eye(s) twice daily in patients with more severe or uncontrolled glaucoma.^a ^b ^c

Adjust dosage according to individual requirements and response as determined by tonometric readings of IOP before and during therapy.⁷ ^a ^b ^c

If further reduction of IOP is required, a topical miotic and/or a systemically administered carbonic anhydrase inhibitor may be added to the regimen.² ^a ^b ^c

Prescribing Limits

Adults

Ocular Hypertension and Glaucoma

Ophthalmic Administration

Dosages >1 drop of a 0.5% ophthalmic solution twice daily generally have not been more effective.^a ^b ^c

Cautions for Betagan

Contraindications

Cardiogenic shock or overt cardiac failure that is not adequately compensated.⁹⁸ ⁹⁹ ^a ^b ^c (See Cardiac Failure under Cautions.)

Bronchial asthma, history of bronchial asthma, or severe COPD.^a ^b ^c (See Respiratory Disease under Cautions.)

Sinus bradycardia⁵² ^a ^b ^c or AV block greater than first degree.¹⁸ ^a ^b ^c

Known hypersensitivity to levobunolol or any ingredient in the formulation.^a ^b ^c

Warnings/Precautions

Warnings

Systemic Effects

Levobunolol may be absorbed systemically following topical application to the eye;² ^a ^b ^c consider the usual precautions associated with systemic use of nonselective β-adrenergic blocking agents when using topical levobunolol.^a ^b ^c

Cardiac Failure

Severe cardiac reactions, including death associated with cardiac failure, have been reported in patients receiving topical (ocular) levobunolol.^a ^b ^c May precipitate more severe cardiac failure in patients with preexisting heart failure and may cause cardiac failure in patients without a history of heart failure.^a ^b ^c (See Actions.)

Avoid use in patients with cardiogenic shock or with overt cardiac failure^a ^b ^c that is not adequately compensated (e.g., treated with cardiac glycosides and/or diuretics).⁹⁸ ⁹⁹ In patients without a history of cardiac failure, discontinue therapy at the first sign or symptom of cardiac failure.^a ^b ^c

Respiratory Disease

Patients with mild or moderately severe COPD (e.g., chronic bronchitis, emphysema), bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma, in which levobunolol is contraindicated) generally should not receive β-adrenergic blocking agents.^a ^b ^c (See Contraindications.) If levobunolol is required, use with caution in such patients since it may antagonize bronchodilation produced by endogenous and exogenous catecholamines.^a ^b ^c

Use with caution in other patients with diminished pulmonary function.^a ^b ^c

Major Surgery

Possible increased risks associated with general anesthesia (e.g., severe hypotension, difficulty restarting or maintaining heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.^a ^b ^c

Need for withdrawal of β-adrenergic blocking agents prior to major surgery controversial; in some patients, gradual withdrawal of β-adrenergic blocking agents prior to elective surgery may be appropriate.⁶⁰ ⁹³ ^a ^b ^c

Diabetes Mellitus

β-Adrenergic blocking agents may mask signs and symptoms of acute hypoglycemia; administer with caution in patients subject to spontaneous hypoglycemia and in diabetic patients (especially those with labile diabetes) who are receiving hypoglycemic agents.⁶⁴ ^a ^b ^c

Thyrotoxicosis

β-Adrenergic blocking agents may mask signs of hyperthyroidism (e.g., tachycardia).^a ^b ^c

Possible thyroid storm if β-adrenergic blocking agent is abruptly withdrawn; carefully monitor patients suspected of developing thyrotoxicosis.^a ^b ^c

Sensitivity Reactions

History of Anaphylactic or Hypersensitivity Reactions

Patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenges with such allergens while taking β-adrenergic blocking agents; such patients may be unresponsive to usual doses of epinephine used to treat anaphylactic reactions.^a ^b ^c

Use with caution in patients with known hypersensitivity to other β-adrenergic blocking agents.^a ^b ^c

Sulfite Sensitivity

Levobunolol hydrochloride ophthalmic solution contains sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.⁸² ⁸³ ⁸⁴ ⁸⁵ ⁸⁶ ⁸⁷ ⁸⁸ ⁸⁹ ¹¹⁰ ^a ^b ^c ^d

General Precautions

Cerebrovascular Insufficiency

Caution advised in patients with cerebrovascular insufficiency due to the potential effects of β-adrenergic blocking agents on BP and pulse.^a ^b ^c

Consider alternative therapy if signs or symptoms of reduced cerebral blood flow occur.^a ^b ^c

Angle-closure Glaucoma

Levobunolol has little or no effect on pupil size.² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁸ ^a ^b ^c Do not use alone in patients with angle-closure glaucoma; use only in combination with a miotic in these patients.⁷ ⁹⁸ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ^a ^b ^c

Muscle Weakness

β-Adrenergic blocking agents reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, generalized weakness).^a ^b ^c

Specific Populations

Pregnancy

Category C.^a ^b ^c

Lactation

Not known whether levobunolol is distributed into milk following topical application to the eye.^a ^b ^c Caution if used in nursing women.^a ^b ^c

Pediatric Use

Safety and efficacy not established.^a ^b ^c

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^a ^b ^c

Common Adverse Effects

Ocular stinging² ⁵² ⁵³ ⁵⁸ ^a ^b ^c or burning² ⁵¹ ⁵² ⁵³ ⁵⁸ ^a ^b ^c on instillation,² ⁵¹ ⁵² ⁵³ ⁵⁸ ^a ^b ^c blepharoconjunctivitis.² ⁵¹ ^a ^b ^c

Interactions for Betagan

Specific Drugs

Drug	Interaction	Comments
β-Adrenergic blocking agents, systemic or topical	Possible additive effects on IOP and/or systemic β-adrenergic blockade^a ^b ^c	Caution recommended if used concomitantly with systemic β-adrenergic blocking agents^a ^b ^c Concomitant administration of ≥2 topical ophthalmic β-adrenergic blocking agents generally not recommended^a ^b ^c
Calcium-channel blocking agents	Potential AV conduction disturbances, hypotension, and left ventricular failure ^a ^b ^c	Monitor for adverse cardiovascular effects during concomitant use^a ^b ^c Avoid concomitant use in patients with impaired cardiac function^a ^b ^c
Catecholamine-depleting drugs (e.g., reserpine)	Possible additive cardiovascular effects (e.g., hypotension, marked bradycardia); may be manifested as vertigo, syncope, or postural hypotension^a ^b ^c	Observe closely^a ^b ^c
Digitalis	Potential additive effect in prolonging AV conduction time^a ^b ^c
Epinephrine	Possible mydriasis^a ^b ^c
Ocular hypotensive agents (e.g., topical miotic and/or systemically administered carbonic anhydrase inhibitor)	Additive IOP-lowering effects² ^a ^b ^c	Used to therapeutic advantage² ^a ^b ^c
Phenothiazines	Possible additive hypotensive effects caused by inhibition of phenothiazine and levobunolol metabolism^a ^b ^c

Betagan Pharmacokinetics

Absorption

Bioavailability

Some systemic absorption occurs following topical administration.² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁸ ⁹² ^a ^b ^c

Onset

Following topical application to the eye, reduction in IOP is usually evident within 1 hour and reaches a maximum within about 2–6 hours.⁵⁵ ⁵⁷ ¹¹¹ ^a ^b ^c

Duration

Reduction in IOP may persist for up to 24 hours.⁵⁵ ⁵⁷ ¹¹¹ ^a ^b ^c

Distribution

Extent

Following topical application in rabbits, rapidly distributed throughout ocular tissues and fluids (e.g., cornea, iris, ciliary body, aqueous humor).²

Levobunolol crosses the placenta in some animals;² not known whether distributed into human milk.^a ^b ^c

Elimination

Metabolism

Extensively metabolized in the liver³⁶ ³⁸ ³⁹ ⁴⁰ ⁴¹ ⁴² ⁴³ ⁴⁶ ⁴⁷ ⁹⁸ ⁹⁹ principally to dihydrolevobunolol, an active metabolite.³⁶ ³⁸ ³⁹ ⁴⁰ ⁴² ⁴⁴ ⁴⁵ ⁴⁶ ⁴⁷ ⁴⁸ ⁹⁹ ¹⁰⁹

Elimination Route

Approximately 93% of topically applied dose is excreted in urine and feces in rabbits.² ⁹⁹

Half-life

Following ophthalmic administration of racemic bunolol in rabbits: 60–90 min.⁹⁸ ¹⁰⁹

Stability

Storage

Ophthalmic

Solution

Light-resistant containers at 15–30°C.^a ^b ^c

ActionsActions

Nonselective β-adrenergic blocking agent that has some direct myocardial depressant activity² ³ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁹ ²⁰ ²¹ ²² ²³ ²⁷ ²⁸ ^a ^b ^c but does not have substantial local anesthetic activity² ²³ ^a ^b ^c or intrinsic sympathomimetic activity.² ¹⁴ ²⁰ ²¹ ²³ ^a ^b ^c

Reduces both elevated² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁹² ^a ^b ^c and normal IOP² ^a ^b ^c with little or no effect on pupillary size² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁹² ^a ^b ^c or accommodation.^a ^b ^c

Reduces IOP by about 25–40% from baseline in patients with elevated IOP.² ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁹² ^a ^b ^c

Exact mechanism of action not fully elucidated;² ⁷ ⁸ ²⁹ ³⁴ ⁵⁰ ⁵⁹ ^a ^b ^c fluorophotometric studies suggest that reduced aqueous humor formation is the predominant effect.² ⁷ ⁸ ⁹⁷ ⁹⁸ ^a ^b ^c

May block endogenous catecholamine-stimulated increases in cyclic adenosine monophosphate (AMP) concentrations within the ciliary processes and subsequent formation of aqueous humor.² ⁶ ⁷ ⁸ ³⁰ ³² ³⁴ ⁵⁹

Does not appear to affect aqueous humor outflow facility.⁸ ³⁴ ⁵⁹

Tolerance may develop with prolonged use;⁹⁸ ⁹⁹ however, IOP-lowering effect maintained for at least 2 years with continuous use in some patients.²

Advice to Patients

Importance of learning and adhering to proper administration techniques to avoid contamination of the product.⁸⁰

Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, bronchospastic disease).^a ^b ^c

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^a ^b ^c

Importance of informing patients of other important precautionary information.^a ^b ^c (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Levobunolol Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.25%	Betagan (with benzalkonium chloride and sodium metabisulfite)	Allergan
			Levobunolol Hydrochloride Ophthalmic Solution	Apotex, Bausch & Lomb, Falcon
		0.5%	Betagan (with benzalkonium chloride and sodium metabisulfite)	Allergan
			Levobunolol Hydrochloride Ophthalmic Solution	Apotex, Bausch & Lomb, Falcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Betagan 0.5% Solution (ALLERGAN): 15/$94.99 or 45/$271.98

Levobunolol HCl 0.25% Solution (BAUSCH & LOMB): 10/$22.99 or 30/$45.97

Levobunolol HCl 0.5% Solution (BAUSCH & LOMB): 10/$47.99 or 30/$135.97

Levobunolol HCl 0.5% Solution (BAUSCH & LOMB): 15/$65.99 or 45/$175.97

Levobunolol HCl 0.5% Solution (BAUSCH & LOMB): 5/$29.99 or 15/$75.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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48. Schwender CF, Farber S, Blaum C et al. Derivatives of 3,4-dihydro-1(2H)-naphthalenone as β-adrenergic blocking agents: 1. bunolol and related analogs. J Med Chem. 1970; 13:684-8. [PubMed 4393796]

49. Shell JW. Pharmacokinetics of topically applied ophthalmic drugs. Surv Ophthalmol. 1982; 26:207-18. [PubMed 7041308]

50. Zimmerman TJ. Timolol maleate—a new glaucoma medication? Invest Ophthalmol Visual Sci. 1977; 16:687-8. Editorial.

51. Levobunolol Study Group. Levobunolol: a beta-adrenoceptor antagonist effective in the long-term treatment of glaucoma. Ophthalmology. 1985; 92:1271-6. [PubMed 2865710]

52. Berson FG, Cohen HB, Foerster RJ et al. Levobunolol compared with timolol for the long-term control of elevated intraocular pressure. Arch Ophthalmol. 1985; 103:379-82. [IDIS 196928] [PubMed 3883972]

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55. Duzman E, Ober M, Scharrer A et al. A clinical evaluation of the effects of topically applied levobunolol and timolol on increased intraocular pressure. Am J Ophthalmol. 1982; 94:318-27. [IDIS 157783] [PubMed 6751091]

56. Long D, Zimmerman T, Spaeth G et al. Minimum concentration of levobunolol required to control intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 1985; 99:18-22. [IDIS 195698] [PubMed 3881033]

57. Partamian LG, Kass MA, Gordon M. A dose-respone study of the effect of levobunolol on ocular hypertension Am J Ophthalmol. 1983; 95:229-32.

58. Cinotti A, Cinotti D, Grant W et al. Levobunolol vs timolol for open-angle glaucoma and ocular hypertension. Am J Ophthalmol. 1985; 99:11-7. [IDIS 195697] [PubMed 3881032]

59. Thomas JV, Epstein DL. Timolol and epinephrine in primary open angle glaucoma. Arch Ophthalmol. 1981; 99:91-5. [IDIS 130036] [PubMed 7006581]

60. Martin DE, Kammerer WS. The hypertensive surgical patient: controversies in management. Surg Clin North Am. 1983; 63:1017-33. [PubMed 6138862]

61. Zimmerman TJ, Leader BJ, Golob DS. Potential side effects of timolol therapy in the treatment of glaucoma. Ann Ophthalmol. 1981; 13:683-9. [PubMed 7020551]

62. Van Buskirk M. Adverse reactions from timolol administration. Ophthalmology. 1980; 87:447-50. [PubMed 7402590]

63. McMahon CD, Shaffer RN, Hoskins HD Jr et al. Adverse effects experienced by patients taking timolol. Am J Ophthalmol. 1979; 88:736-8. [IDIS 104858] [PubMed 507146]

64. Jackson JE, Bressler R. Clinical pharmacology of sulphonylurea hypoglycaemic agents: part 2. Drugs. 1981; 22:295-320. [IDIS 143257] [PubMed 7030708]

65. Anon. Additions to Timoptic contraindications. FDA Drug Bull. 1981; 11:17-8. [PubMed 7319166]

66. Schoene RB, Abuan T, Ward RL et al. Effects of topical betaxolol, timolol, and placebo on pulmonary function in asthmatic bronchitis. Am J Ophthalmol. 1984; 97:86-92. [IDIS 180609] [PubMed 6141730]

67. Hernandez y Hernandez HH, Cervantes R, Frati A et al. Cardiovascular effects of topical glaucoma therapies in normal subjects. J Toxicol Cutaneous Ocul Toxicol. 1983; 2:99-106.

68. McMahon CD, Shaffer RN, Hoskins HD Jr et al. Adverse effects experienced by patients taking timolol. Am J Ophthalmol. 1979; 88:736-8. [IDIS 104858] [PubMed 507146]

69. Van Buskirk M. Adverse reactions from timolol administration. Ophthalmology. 1980; 87:447-50. [PubMed 7402590]

70. Zimmerman TJ, Leader BJ, Golob DS. Potential side effects of timolol therapy in the treatment of glaucoma. Ann Ophthalmol. 1981; 13:683-9. [PubMed 7020551]

71. Levy NS, Boone L, Ellis E. A controlled comparison of betaxolol and timolol with long-term evaluation of safety and efficacy. Glaucoma. 1985; 7:54-62.

72. Munroe WP, Rindone JP, Kershner RM. Systemic side effects associated with the ophthalmic administration of timolol. Drug Intell Clin Pharm. 1985; 19:85-9. [IDIS 195453] [PubMed 3882377]

73. Leier CV, Baker ND, Weber PA. Cardiovascular effects of ophthalmic timolol. Ann Intern Med. 1986; 104:197-9. [IDIS 213654] [PubMed 3946944]

74. Schwender CF, Farber S, Blaum C et al. Derivatives of 3,4-dihydro-1(2H)-naphthalenone as β-adrenergic blocking agents. 1. bunolol and related analogs. J Med Chem. 1970; 13:684-8. [PubMed 4393796]

75. Gosselin RE, Smith RP, Hodge HC. Clinical toxicology of commercial products. 5th ed. Baltimore, MD: Williams & Wilkins; 1984:I-6.

76. Kitazawa Y, Horie T. Diurnal variation of intraocular pressure in primary open-angle glaucoma. Am J Ophthalmol. 1975; 79:557-66. [PubMed 1168023]

77. Caldwell DR, Salisbury CR, Guzek JP. Effects of topical betaxolol in ocular hypertensive patients. Arch Ophthalmol. 1984; 102:539-40. [IDIS 183932] [PubMed 6704008]

78. Radius RL. Use of betaxolol in the reduction of elevated intraocular pressure. Arch Ophthalmol. 1983; 101:898-900. [IDIS 171713] [PubMed 6860201]

79. Levy NS, Boone L. Effect of 0.25% betaxolol placebo. Glaucoma. 1985; 5:230-2.

80. American Society of Health-System Pharmacists, Inc..

Tuesday 22 November 2011

Nifedipin Helvepharm

Nifedipin Helvepharm may be available in the countries listed below.

Ingredient matches for Nifedipin Helvepharm

Nifedipine

Nifedipine is reported as an ingredient of Nifedipin Helvepharm in the following countries:

Switzerland

International Drug Name Search

Saturday 19 November 2011

Ciclobiotico

Ciclobiotico may be available in the countries listed below.

Ingredient matches for Ciclobiotico

Tetracycline

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

Portugal

International Drug Name Search

Saturday 12 November 2011

Oxcord

Oxcord may be available in the countries listed below.

Ingredient matches for Oxcord

Nifedipine

Nifedipine is reported as an ingredient of Oxcord in the following countries:

Brazil

International Drug Name Search

Gastac

Gastac may be available in the countries listed below.

Ingredient matches for Gastac

Ranitidine

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

Venezuela

International Drug Name Search

Tuesday 1 November 2011

Lanexat

Lanexat may be available in the countries listed below.

Ingredient matches for Lanexat

Flumazenil

Flumazenil is reported as an ingredient of Lanexat in the following countries:

Argentina

Brazil

Chile

Colombia

Ecuador

Finland

Iceland

Mexico

Peru

Sweden

Venezuela

International Drug Name Search

Friday 14 October 2011

Almiral Gel

Almiral Gel may be available in the countries listed below.

Ingredient matches for Almiral Gel

Diclofenac

Diclofenac diethylamine (a derivative of Diclofenac) is reported as an ingredient of Almiral Gel in the following countries:

Singapore

Sri Lanka

Taiwan

International Drug Name Search

Wednesday 5 October 2011

Ambroxol Jaba

Ambroxol Jaba may be available in the countries listed below.

Ingredient matches for Ambroxol Jaba

Ambroxol

Ambroxol is reported as an ingredient of Ambroxol Jaba in the following countries:

Portugal

International Drug Name Search

Monday 3 October 2011

Trisagon

Trisagon may be available in the countries listed below.

Ingredient matches for Trisagon

Indobufen

Indobufen is reported as an ingredient of Trisagon in the following countries:

Italy

International Drug Name Search

Sulpezole

Sulpezole may be available in the countries listed below.

Ingredient matches for Sulpezole

Cefoperazone

Cefoperazone sodium salt (a derivative of Cefoperazone) is reported as an ingredient of Sulpezole in the following countries:

Japan

Sulbactam

Sulbactam sodium salt (a derivative of Sulbactam) is reported as an ingredient of Sulpezole in the following countries:

Japan

International Drug Name Search

Moxisilite

Moxisilite may be available in the countries listed below.

Ingredient matches for Moxisilite

Moxisylyte

Moxisilite (DCIT) is also known as Moxisylyte (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Friday 23 September 2011

Cimizia

Cimizia may be available in the countries listed below.

Ingredient matches for Cimizia

Certolizumab

Certolizumab Pegol is reported as an ingredient of Cimizia in the following countries:

France

International Drug Name Search

Memax

Memax may be available in the countries listed below.

Ingredient matches for Memax

Memantine

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

Chile

International Drug Name Search

Tuesday 20 September 2011

Redupar

Redupar may be available in the countries listed below.

Ingredient matches for Redupar

Leflunomide

Leflunomide is reported as an ingredient of Redupar in the following countries:

Tunisia

International Drug Name Search

Thursday 15 September 2011

Crotétamide

Crotétamide may be available in the countries listed below.

Ingredient matches for Crotétamide

Crotetamide

Crotétamide (DCF) is also known as Crotetamide (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Saturday 27 August 2011

Isoclar

Isoclar may be available in the countries listed below.

Ingredient matches for Isoclar

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Isoclar in the following countries:

Italy

International Drug Name Search

Friday 26 August 2011

butalbital, acetaminophen, caffeine, and codeine

bue-TAL-bi-tal, a-seet-a-MIN-oh-fen, KAF-een, KOE-deen FOS-fate

Oral route(Capsule)

This product contains butalbital, acetaminophen, caffeine, and codeine phosphate. Acetaminophen has been associated with cases of acute liver failure, including cases of death and transplantation. Most of the cases of liver injury are associated with the use of acetaminophen doses that exceed 4000 milligrams per day and often involve more than one acetaminophen containing product .

Commonly used brand name(s)

In the U.S.

Fioricet with Codeine

Phrenilin with Caffeine and Codeine

Available Dosage Forms:

Capsule

Therapeutic Class: Opioid/Barbiturate Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

Uses For butalbital, acetaminophen, caffeine, and codeine

Butalbital, acetaminophen, caffeine, and codeine combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Codeine is a narcotic analgesic that acts in the CNS to relieve pain. Many of its side effects are also caused by actions in the CNS.

When you take butalbital or codeine for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital and codeine may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Butalbital, acetaminophen, caffeine and codeine combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.

Butalbital, acetaminophen, caffeine, and codeine combination is available only with your doctor's prescription.

Before Using butalbital, acetaminophen, caffeine, and codeine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For butalbital, acetaminophen, caffeine, and codeine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to butalbital, acetaminophen, caffeine, and codeine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.

For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

For caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.

For acetaminophen: Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

For codeine: Breathing problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of codeine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking butalbital, acetaminophen, caffeine, and codeine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using butalbital, acetaminophen, caffeine, and codeine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Using butalbital, acetaminophen, caffeine, and codeine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Anisindione

Aprobarbital

Bromazepam

Brotizolam

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Dezocine

Diazepam

Dicumarol

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Flurazepam

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nitrazepam

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pentazocine

Pentobarbital

Phenindione

Phenobarbital

Phenprocoumon

Prazepam

Primidone

Propoxyphene

Quazepam

Quetiapine

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiopental

Triazolam

Using butalbital, acetaminophen, caffeine, and codeine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Cannabis

Carbamazepine

Imipramine

Isoniazid

Phenytoin

Prednisone

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using butalbital, acetaminophen, caffeine, and codeine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use butalbital, acetaminophen, caffeine, and codeine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using butalbital, acetaminophen, caffeine, and codeine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use butalbital, acetaminophen, caffeine, and codeine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Ethanol

Proper Use of butalbital, acetaminophen, caffeine, and codeine

Take butalbital, acetaminophen, caffeine, and codeine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital, acetaminophen, caffeine, and codeine combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of butalbital, acetaminophen, caffeine, and codeine may also lead to liver damage or other medical problems.

butalbital, acetaminophen, caffeine, and codeine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take butalbital, acetaminophen, caffeine, and codeine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose of butalbital, acetaminophen, caffeine, and codeine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of butalbital, acetaminophen, caffeine, and codeine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules):
- For tension headaches:
  - Adults—One or 2 capsules every four hours as needed. You should not take more than six capsules a day.
  - Children—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of butalbital, acetaminophen, caffeine, and codeine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using butalbital, acetaminophen, caffeine, and codeine

Check with your doctor:

If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.

If you are having headaches more often than you did before you started taking butalbital, acetaminophen, caffeine, and codeine. This is especially important if a new headache occurs within 1 day after you took your last dose of butalbital, acetaminophen, caffeine, and codeine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take butalbital, acetaminophen, caffeine, and codeine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate, acetaminophen, caffeine, or codeine, check with your health care professional . Taking them together with butalbital, acetaminophen, caffeine, and codeine may cause an overdose.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine".Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects . For nursing mothers taking butalbital, acetaminophen, caffeine, and codeine:

Talk to your doctor if you have any questions about taking codeine or about how butalbital, acetaminophen, caffeine, and codeine may affect your baby.

Call your doctor if you become extremely tired and have difficulty caring for your baby.

Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.

Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

The butalbital and codeine in butalbital, acetaminophen, caffeine, and codeine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking butalbital, acetaminophen, caffeine, and codeine may increase the chance of liver damage or stomach problems, especially if you take more of butalbital, acetaminophen, caffeine, and codeine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using butalbital, acetaminophen, caffeine, and codeine.

butalbital, acetaminophen, caffeine, and codeine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to butalbital, acetaminophen, caffeine, and codeine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking butalbital, acetaminophen, caffeine, and codeine. Caffeine interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital, acetaminophen, caffeine and codeine combination.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking butalbital, acetaminophen, caffeine, and codeine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital or codeine.

If you have been taking large amounts of butalbital, acetaminophen, caffeine, and codeine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of butalbital, acetaminophen, caffeine, and codeine, get emergency help at once. Taking an overdose of butalbital, acetaminophen, caffeine, and codeine or taking alcohol or CNS depressants with butalbital, acetaminophen, caffeine, and codeine may lead to unconsciousness or possibly death. Signs of butalbital or codeine overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

butalbital, acetaminophen, caffeine, and codeine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Bleeding or crusting sores on lips

chest pain

fever with or without chills

convulsions, hallucinations, trembling, and/or uncontrolled muscle movements

hive-like swellings (large) on eyelids, face, lips, and/or tongue

mental depression

muscle cramps or pain

red, thickened, or scaly skin

shortness of breath, troubled breathing, tightness in chest, or wheezing

skin rash, itching, or hives

sores, ulcers, or white spots in mouth (painful)

sore throat

Symptoms of overdose

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe)

cold and clammy skin

convulsions (seizures)

diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain

dizziness, light-headedness, drowsiness, or weakness, (severe)

frequent urination

hallucinations (seeing, hearing, or feeling things that are not there)

increased sensitivity to touch or pain

muscle trembling or twitching

nausea or vomiting, sometimes with blood

ringing or other sounds in ears

seeing flashes of "zig-zag" lights

shortness of breath or unusually slow or troubled breathing

slow, fast, or irregular heartbeat

slurred speech

staggering

swelling, pain, or tenderness in the upper abdomen or stomach area

unusual movements of the eyes

Difficulty breathing

difficulty nursing

increased sleepiness (more than usual)

limpness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Confusion (mild)

mental depression

unusual excitement (mild)

Rare

Bloody or black, tarry stools

bloody urine

pinpoint red spots on skin

swollen or painful glands

unusual bleeding or bruising

unusual tiredness or weakness (mild)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated or "gassy" feeling

dizziness or light-headedness (mild)

drowsiness (mild)

nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: butalbital, acetaminophen, caffeine, and codeine side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More butalbital, acetaminophen, caffeine, and codeine resources

Butalbital, acetaminophen, caffeine, and codeine Side Effects (in more detail)
Butalbital, acetaminophen, caffeine, and codeine Dosage
Butalbital, acetaminophen, caffeine, and codeine Use in Pregnancy & Breastfeeding
Drug Images
Butalbital, acetaminophen, caffeine, and codeine Drug Interactions
Butalbital, acetaminophen, caffeine, and codeine Support Group
8 Reviews for Butalbital, acetaminophen, caffeine, and codeine - Add your own review/rating

Compare butalbital, acetaminophen, caffeine, and codeine with other medications

Headache

Wednesday 24 August 2011

Hydromet

In the US, Hydromet (homatropine/hydrocodone systemic) is a member of the drug class upper respiratory combinations and is used to treat Cough.

US matches:

Hydromet Syrup

Hydromet

Ingredient matches for Hydromet

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Hydromet in the following countries:

Greece

Methyldopa

Methyldopa is reported as an ingredient of Hydromet in the following countries:

Greece

International Drug Name Search

Tuesday 23 August 2011

Saphris

Saphris is a brand name of asenapine, approved by the FDA in the following formulation(s):

SAPHRIS (asenapine maleate - tablet; sublingual)

Manufacturer: ORGANON USA INC

Approval date: August 13, 2009

Strength(s): EQ 10MG BASE ^[RLD], EQ 5MG BASE

Has a generic version of Saphris been approved?

No. There is currently no therapeutically equivalent version of Saphris available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Saphris. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Sublingual or buccal pharmaceutical composition
Patent 5,763,476
Issued: June 9, 1998
Inventor(s): Delbressine; Leonardus Petrus Carla & Wieringa; Johannes Hubertus
Assignee(s): Akzo Noble N.V.
The invention relates to a sublingual or buccal pharmaceutical composition comprising trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz›2,3:6,7!oxepino-›4 ,5-c!pyrrole or a pharmaceutically acceptable salt thereof, and pharmaceutically acceptable auxiliaries suitable for use in sublingual or buccal compositions, and the use thereof for the manufacture of a sublingual or buccal pharmaceutical composition for the treatment of mental disorders, such as psychosis and schizophrenia.
Patent expiration dates:
- June 9, 2015
  ✓
  Patent use: METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
  ✓
  Drug product

Crystal form of asenapine maleate
Patent 7,741,358
Issued: June 22, 2010
Inventor(s): Heeres; Gerhardus Johannes
Assignee(s): N.V. Organon
The invention relates to an orthorhombic crystal form of compound trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz [2,3:6,7]oxepino[4,5-c]pyrrole (Z)-2-butenedioate, to methods for the preparation of this crystal form and to pharmaceutical compositions comprising an orthorhombic crystal form.
Patent expiration dates:
- April 6, 2026
  ✓
  Patent use: TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
  ✓
  Drug substance
  ✓
  Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- September 3, 2013 - ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
- September 3, 2013 - MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS
- August 13, 2014 - NEW CHEMICAL ENTITY