Metipranolol: Difference between revisions

Metipranolol
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 15:02, 19 February 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Metipranolol is a non-selective beta-adrenergic receptor blocking agent that is FDA approved for the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.. Common adverse reactions include Burning sensation in eye, Blurred vision, Conjunctivitis, Blepharitis, photophobia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Metipranolol ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.

Dosage

The recommended dose is one drop of metipranolol ophthalmic solution in the affected eye(s) twice a day.

If the patient's IOP is not at a satisfactory level on this regimen, use of more frequent administration or a larger dose of metipranolol ophthalmic solution is not known to be of benefit. Concomitant therapy to lower intraocular pressure can be instituted.

In clinical trials, metipranolol ophthalmic solution was safely used during concomitant therapy with pilocarpine, epinephrine, or acetazolamide.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Metipranolol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Metipranolol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Metipranolol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Metipranolol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Metipranolol in pediatric patients.

Contraindications

Hypersensitivity to any component of this product.

Metipranolol ophthalmic solution is contraindicated in patients with bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease; symptomatic sinus bradycardia; greater than a first degree atrioventricular block; cardiogenic shock; or overt cardiac failure.

Warnings

As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. Thus, the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely, death in association with cardiac failure, have been reported following topical application of beta-adrenergic blocking agents (see CONTRAINDICATIONS).

Since metipranolol ophthalmic solution had a minor effect on heart rate and blood pressure in clinical studies, caution should be observed in treating patients with a history of cardiac failure. Treatment with metipranolol ophthalmic solution should be discontinued at the first evidence of cardiac failure.

Metipranolol ophthalmic solution, or other beta-blockers, should not, in general, be administered to patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity (see CONTRAINDICATIONS). However, if the drug is necessary in such patients, then it should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.

Precautions

General Because of potential effects of beta-adrenergic receptor blocking agents relative to blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with metipranolol ophthalmic solution, alternative therapy should be considered.

Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents in patients undergoing elective surgery. If necessary during surgery, the effects of beta-adrenergic receptor blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol.

While metipranolol ophthalmic solution has demonstrated a low potential for systemic effect, it should be used with caution in patients with diabetes (especially labile diabetes) because of possible masking of signs and symptoms of acute hypoglycemia.

Beta-adrenergic receptor blocking agents may mask certain signs and symptoms of hyperthyroidism, and their abrupt withdrawal might precipitate a thyroid storm.

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness).

Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Adverse Reactions

Clinical Trials Experience

In clinical trials, the use of metipranolol ophthalmic solution has been associated with transient local discomfort.

Other ocular adverse reactions, such as abnormal vision, blepharitis, blurred vision, browache, conjunctivitis, edema, eyelid dermatitis, photophobia, tearing, and uveitis have been reported in small numbers of patients.

Other systemic adverse reactions, such as allergic reaction, angina, anxiety, arthritis, asthenia, atrial fibrillation, bradycardia, bronchitis, coughing, depression, dizziness, dyspnea, epistaxis, headache, hypertension, myalgia, myocardial infarct, nausea, nervousness, palpitation, rash, rhinitis, and somnolence have also been reported in small numbers of patients.

Postmarketing Experience

There is limited information regarding Metipranolol Postmarketing Experience in the drug label.

Drug Interactions

Metipranolol ophthalmic solution should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade.

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia.

Caution should be used in the coadministration of beta-adrenergic receptor blocking agents, such as metipranolol, and oral or intravenous calcium channel antagonists, because of possible precipitation of left ventricular failure, and hypotension. In patients with impaired cardiac function, who are receiving calcium channel antagonists, coadministration should be avoided.

The concomitant use of beta-adrenergic receptor blocking agents with digitalis and calcium channel antagonists may have additive effects, prolonging atrioventricular conduction time.

Caution should be used in patients using concomitant adrenergic psychotropic drugs.

Ocular: In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent. Metipranolol ophthalmic solution has little or no effect on the pupil, therefore, when it is used to reduce intraocular pressure in angle-closure glaucoma, it should be used only with concomitant administration of a miotic agent.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

No drug related effects were reported for the segment II teratology study in fetal rats after administration, during organogenesis, to dams of up to 50 mg/kg/day. Metipranolol ophthalmic solution has been shown to increase fetal resorption, fetal death, and delayed development when administered orally to rabbits at 50 mg/kg/day during organogenesis.

There are no adequate and well-controlled studies in pregnant women. Metipranolol ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

It is not known whether metipranolol ophthalmic solution is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when metipranolol ophthalmic solution is administered in nursing women

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Y-Site

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Admixture

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Syringe

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

TPN/TNA

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Overdosage

No information is available on overdosage of metipranolol ophthalmic solution in humans. The symptoms which might be expected with an overdose of a systemically administered beta-adrenergic receptor blocking agent are bradycardia, hypotension and acute cardiac failure.

Pharmacology


Metipranolol
Systematic (IUPAC) name
?
Identifiers
CAS number	?
ATC code	?
PubChem	?
Chemical data
Formula	?
Mol. mass	?
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility Lifetime studies with metipranolol have been conducted in mice at oral doses of 5, 50 and 100 mg/kg/day and in rats at oral doses of up to 70 mg/kg/day. Metipranolol demonstrated no carcinogenic effect. In the mouse study, female animals receiving the low, but not the intermediate or high dose, had an increased number of pulmonary adenomas. The significance of this observation is unknown. In a variety of in vitro and in vivo bacterial and mammalian cell assays, metipranolol was nonmutagenic.

Reproduction and fertility studies of metipranolol in rats and mice showed no adverse effect on male fertility at oral doses of up to 50 mg/kg/day, and female fertility at oral doses of up to 25 mg/kg/day.

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Metipranolol Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Metipranolol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Metipranolol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

Patients should be instructed to avoid allowing the tip of the dispensing containers to contact the eye or surrounding structures. Patients should be advised that metipranolol contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following metipranolol administration.

Precautions with Alcohol

Alcohol-Metipranolol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Metipranolol Brand Names in the drug label.

Look-Alike Drug Names

(Paired Confused Name 1a) — (Paired Confused Name 1b)
(Paired Confused Name 2a) — (Paired Confused Name 2b)
(Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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-|adverseReactions=a list of adverse reactions, separated by commas.
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-|fdaLIADAdult======Condition 1=====
+|fdaLIADAdult=====Indications====
+* Metipranolol ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.
-* Dosing Information
+====Dosage====
+* The recommended dose is one drop of metipranolol ophthalmic solution in the affected eye(s) twice a day.
-:* (Dosage)
+If the patient's IOP is not at a satisfactory level on this regimen, use of more frequent administration or a larger dose of metipranolol ophthalmic solution is not known to be of benefit. Concomitant therapy to lower intraocular pressure can be instituted.
-=====Condition 2=====
+In clinical trials, metipranolol ophthalmic solution was safely used during concomitant therapy with pilocarpine, epinephrine, or acetazolamide.
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-* Dosing Information/Recommendation
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-* Dosing Information/Recommendation
-:* (Dosage)
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-* Developed by: (Organisation)
-* Class of Recommendation: (Class) (Link)
-* Strength of Evidence: (Category A/B/C) (Link)
-* Dosing Information/Recommendation
-:* (Dosage)
-|offLabelPedNoGuideSupport======Condition 1=====
-* Dosing Information
-:* (Dosage)
-=====Condition 2=====
+Metipranolol ophthalmic solution is contraindicated in patients with bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease; symptomatic sinus bradycardia; greater than a first degree atrioventricular block; cardiogenic shock; or overt cardiac failure.
+|warnings=As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. Thus, the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely, death in association with cardiac failure, have been reported following topical application of beta-adrenergic blocking agents (see CONTRAINDICATIONS).
-* Dosing Information
+Since metipranolol ophthalmic solution had a minor effect on heart rate and blood pressure in clinical studies, caution should be observed in treating patients with a history of cardiac failure. Treatment with metipranolol ophthalmic solution should be discontinued at the first evidence of cardiac failure.
-:* (Dosage)
+Metipranolol ophthalmic solution, or other beta-blockers, should not, in general, be administered to patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity (see CONTRAINDICATIONS). However, if the drug is necessary in such patients, then it should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.
-=====Condition 3=====
+====Precautions====
-* Dosing Information
+General
+Because of potential effects of beta-adrenergic receptor blocking agents relative to blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with metipranolol ophthalmic solution, alternative therapy should be considered.
-:* (Dosage)
+Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents in patients undergoing elective surgery. If necessary during surgery, the effects of beta-adrenergic receptor blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol.
-|contraindications=* Condition 1
-* Condition 2
-* Condition 3
-* Condition 4
-* Condition 5
-|warnings======Conidition 1=====
-(Description)
+While metipranolol ophthalmic solution has demonstrated a low potential for systemic effect, it should be used with caution in patients with diabetes (especially labile diabetes) because of possible masking of signs and symptoms of acute hypoglycemia.
-|clinicalTrials=======Central Nervous System======
+Beta-adrenergic receptor blocking agents may mask certain signs and symptoms of hyperthyroidism, and their abrupt withdrawal might precipitate a thyroid storm.
-: (list/description of adverse reactions)
+Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness).
-======Cardiovascular======
+Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
+|clinicalTrials=In clinical trials, the use of metipranolol ophthalmic solution has been associated with transient local discomfort.
-: (list/description of adverse reactions)
+Other ocular adverse reactions, such as abnormal vision, blepharitis, blurred vision, browache, conjunctivitis, edema, eyelid dermatitis, photophobia, tearing, and uveitis have been reported in small numbers of patients.
-======Respiratory======
+Other systemic adverse reactions, such as allergic reaction, angina, anxiety, arthritis, asthenia, atrial fibrillation, bradycardia, bronchitis, coughing, depression, dizziness, dyspnea, epistaxis, headache, hypertension, myalgia, myocardial infarct, nausea, nervousness, palpitation, rash, rhinitis, and somnolence have also been reported in small numbers of patients.
+|drugInteractions=Metipranolol ophthalmic solution should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade.
-: (list/description of adverse reactions)
+Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia.
-======Gastrointestinal======
+Caution should be used in the coadministration of beta-adrenergic receptor blocking agents, such as metipranolol, and oral or intravenous calcium channel antagonists, because of possible precipitation of left ventricular failure, and hypotension. In patients with impaired cardiac function, who are receiving calcium channel antagonists, coadministration should be avoided.
-: (list/description of adverse reactions)
+The concomitant use of beta-adrenergic receptor blocking agents with digitalis and calcium channel antagonists may have additive effects, prolonging atrioventricular conduction time.
-======Hypersensitive Reactions======
+Caution should be used in patients using concomitant adrenergic psychotropic drugs.
-: (list/description of adverse reactions)
+Ocular: In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent. Metipranolol ophthalmic solution has little or no effect on the pupil, therefore, when it is used to reduce intraocular pressure in angle-closure glaucoma, it should be used only with concomitant administration of a miotic agent.
+|FDAPregCat=C
+|useInPregnancyFDA=* No drug related effects were reported for the segment II teratology study in fetal rats after administration, during organogenesis, to dams of up to 50 mg/kg/day. Metipranolol ophthalmic solution has been shown to increase fetal resorption, fetal death, and delayed development when administered orally to rabbits at 50 mg/kg/day during organogenesis.
-======Miscellaneous======
+There are no adequate and well-controlled studies in pregnant women. Metipranolol ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
-: (list/description of adverse reactions)
-=====Condition 2=====
-======Central Nervous System======
-: (list/description of adverse reactions)
-======Cardiovascular======
-: (list/description of adverse reactions)
-======Respiratory======
-: (list/description of adverse reactions)
-======Gastrointestinal======
-: (list/description of adverse reactions)
-======Hypersensitive Reactions======
-: (list/description of adverse reactions)
-======Miscellaneous======
-: (list/description of adverse reactions)
-|postmarketing=(Description)
-|drugInteractions=* Drug 1
-* Drug 2
-* Drug 3
-* Drug 4
-* Drug 5
-=====Drug 1=====
-(Description)
-=====Drug 2=====
-(Description)
-=====Drug 3=====
-(Description)
-=====Drug 4=====
-(Description)
-=====Drug 5=====
-(Description)
-|useInPregnancyFDA=(Description)
 |useInPregnancyAUS=(Description)
 |useInLaborDelivery=(Description)
-|useInNursing=(Description)
+|useInNursing=* It is not known whether metipranolol ophthalmic solution is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when metipranolol ophthalmic solution is administered in nursing women
-|useInPed=(Description)
+|useInPed=Safety and effectiveness in pediatric patients have not been established.
-|useInGeri=(Description)
+|useInGeri=No overall differences in safety or effectiveness have been observed between elderly and younger patients.
 |useInGender=(Description)
 |useInRace=(Description)
@@ Line 208: / Line 79: @@
 |othersTitle=Others
 |useInOthers=(Description)
 |administration=(Oral/Intravenous/etc)
 |monitoring======Condition 1=====
@@ Line 350: / Line 220: @@
 * Solution 2
 * Solution 3
-|overdose====Acute Overdose===
+|overdose=* No information is available on overdosage of metipranolol ophthalmic solution in humans. The symptoms which might be expected with an overdose of a systemically administered beta-adrenergic receptor blocking agent are bradycardia, hypotension and acute cardiac failure.
-====Signs and Symptoms====
-(Description)
-====Management====
-(Description)
-===Chronic Overdose===
-====Signs and Symptoms====
-(Description)
-====Management====
-(Description)
 |drugBox={{Drugbox2
 | verifiedrevid =
@@ Line 426: / Line 278: @@
 |PD=(Description)
 |PK=(Description)
-|nonClinToxic=(Description)
+|nonClinToxic=Carcinogenesis, Mutagenesis, Impairment of Fertility
+Lifetime studies with metipranolol have been conducted in mice at oral doses of 5, 50 and 100 mg/kg/day and in rats at oral doses of up to 70 mg/kg/day. Metipranolol demonstrated no carcinogenic effect. In the mouse study, female animals receiving the low, but not the intermediate or high dose, had an increased number of pulmonary adenomas. The significance of this observation is unknown. In a variety of in vitro and in vivo bacterial and mammalian cell assays, metipranolol was nonmutagenic.
+Reproduction and fertility studies of metipranolol in rats and mice showed no adverse effect on male fertility at oral doses of up to 50 mg/kg/day, and female fertility at oral doses of up to 25 mg/kg/day.
 |clinicalStudies======Condition 1=====
@@ Line 439: / Line 294: @@
 (Description)
 |howSupplied=(Description)
-|fdaPatientInfo=(Patient Counseling Information)
+|fdaPatientInfo=* Patients should be instructed to avoid allowing the tip of the dispensing containers to contact the eye or surrounding structures. Patients should be advised that metipranolol contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following metipranolol administration.
-|nlmPatientInfo=(Link to patient information page)
+|alcohol=Alcohol-Metipranolol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 |lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
 * (Paired Confused Name 2a) — (Paired Confused Name 2b)
 * (Paired Confused Name 3a) — (Paired Confused Name 3b)
+|nlmPatientInfo=(Link to patient information page)
 |drugShortage=Drug Shortage
 }}