Adult Dosing

Mild-moderate arterial hypertension

• 20-40 mg PO qd
• Starting dose: 20 mg PO qd
• Max: 80 mg/day
• Alt. dose: 10 mg PO qd

Pediatric Dosing

• Safety and effectiveness of in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Mild-moderate arterial hypertension

• Hypersensitivity to any of the ingredients of the product
• Sinus bradycardia
• 2nd or 3rd degree AV block
• Uncompensated heart failure
• Cardiogenic shock
• Sick sinus syndrome without pacemaker
• Bronchial asthma

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments, caution advised

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Use with caution in patients with a history of cardiac failure who are well compensated, on treatment with vasodilators, digitalis and/or diuretics
• Chronic use may lead to cardiac failure. Institute appropriate treatment at the first evidence of heart failure and the response should be closely observed. Despite this if cardiac failure continues, therapy should be withdrawn
• Abrupt discontinuation may cause exacerbation of angina including myocardial infarction. When discontinuing therapy reduce dosage gradually over a period of 1-2 weeks and carefully monitor patients
• Patients with bronchospastic diseases should not receive beta-blockers
• Take particular care if penbutolol is continued when using anesthetic agents that depress the myocardium for anesthesia and major surgery as it may lead excessive myocardial depression and difficulty in restarting and maintaining the heart beat
• Appropriately adjust the concomitant dose of hypoglycemic drugs in labile diabetes/diabetes mellitus patients as it may prevent the appearance of signs and symptoms of acute hypoglycemia, such as tachycardia and blood pressure changes
• Masking of certain clinical signs of hyperthyroidism has been reported. Carefully manage patients suspected of developing thyrotoxicosis to avoid abrupt withdrawal of penbutolol that might precipitate a thyroid storm
• Avoid abrupt withdrawal or discontinuation in patients with evidence of coronary artery insufficiency. If symptoms of heart failure occur report it immediately to the physician

Cautions: Use cautiously in

• Coronary artery insufficiency
• Diabetes mellitus and hypoglycemia
• Elderly patients
• Thyrotoxicosis
• Peripheral vascular disease
• WPW syndrome
• Pheochromocytoma
• Renal impairment
• Myasthenia gravis
• History of severe anaphylactic reaction

Supplemental Patient Information

• Patients should be warned against interruption or discontinuation of therapy without the physician's advice

Levatol interacts with :

	Actos
	Adrenaclick
	Adrenalin
	Alogliptin
	Amaryl
	Aricept
	Aricept ODT
	Auvi-Q
	Avandia
	Chlorpropamide
	DiaBeta
	Diabinese
	Donepezil
	Epinephrine
	Epipen
	Epipen JR
	Exelon
	Fortamet
	Galantamine
	Glimepiride
	Glipizide
	Glucophage
	Glucophage XR
	Glucotrol
	Glucotrol XL
	Glucovance
	Glumetza
	Glyburide
	Glynase
	Insulin
	Linagliptin
	Metformin
	Nateglinide
	Nesina
	Onglyza
	Orinase
	Pioglitazone
	Prandin
	Razadyne
	Razadyne ER
	Repaglinide
	Riomet
	Rivastigmine
	Rosiglitazone
	Saxagliptin
	Starlix
	Systemic doses
	Tolbutamide
	Tradjenta
	Twinject

Pregnancy Category:C

Breastfeeding: Safety unknown; penbutolol appears to present a low-risk to the breastfed infant. As there is no published experience with penbutolol during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 November 2010). Manufacturer advises caution while administering to a nursing woman.

• CV: CHF, heart block, severe bradycardia, Raynaud's phenomenon, chest pain
• CNS: Headache, dizziness, insomnia
• DERM: Lupus erythematosus
• RESP: Bronchospasm, URI, cough, dyspnea
• GI: Nausea, diarrhea, dyspepsia
• DERM: Excessive sweating
• GU: Impotence
• MISC: Hypersensitivity reactions, fatigue, limb pain, asthenia

• Nonselective Beta-adrenergic receptor antagonist; primarily affecting the CV system including decreased heart rate, decreased cardiac contractility, decreased BP
• Extensively metabolized by liver; CYP450: unknown
• Excreted 90% in urine (<10% unchanged)
• Half-life: 5 hrs

US Trade Name(s)

• Levatol

US Availability

Levatol

• TABS: 20 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Cardiovascular

Beta-adrenergic Blockers

Non-cardioselective

Pricing data from www.DrugStore.com in U.S.A.

• Levatol 20 MG TABS [Bottle] (ACTIENT PHARMACEUTICALS)
  30 mg = $110.99
  90 mg = $310.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Levatol 20 MG Oral Tablet

Ingredient(s): Penbutolol

Imprint: SP;22

Color(s): Yellow

Shape: Oval

Size (mm): 14.00

Score: 2

Inactive Ingredient(s): corn starch / d&c yellow no. 10 / lactose / magnesium stearate / povidone / silicon dioxide / talc / titanium dioxide / synthetic black iron oxide / hypromellose / simethicone

Drug Label Author:
SRZ Properties, Inc.

DEA Schedule:
Non-Scheduled