Mebread

Mebread may be available in the countries listed below.

Ingredient matches for Mebread

Mefruside

Mefruside is reported as an ingredient of Mebread in the following countries:

• Japan

International Drug Name Search

Beractant

Class: Pulmonary Surfactants
VA Class: RE900
CAS Number: 108778-82-1
Brands: Survanta

Introduction

Exogenous natural pulmonary surfactant preparation; bovine lung extract containing mostly phospholipids.^{1 2}

Uses for Beractant

Respiratory Distress Syndrome (RDS)

Prevention of RDS (hyaline membrane disease) in premature neonates with birth weight <1250 g or in those with evidence of surfactant deficiency (designated an orphan drug by FDA for this use).^{1 2}

Treatment (rescue) of RDS in premature neonates whose disease is confirmed by radiograph and who require mechanical ventilation (designated an orphan drug by FDA for this use).^{1 2 10}

Beractant therapy associated with lower incidence of rhonchi, wheezing, and tachypnea at 24 months follow-up.^{1 11}

Beractant Dosage and Administration

General

• 
  

  Observe clinical status and monitor systemic oxygenation frequently to avoid hyperoxia.¹ (See Oxygenation and Lung Compliance under Cautions.)

  
  


• 
  

  Following completion of dosing procedure, resume usual ventilator management and clinical care.¹ Do not suction airways for 1 hour after dosing unless substantial obstruction occurs.¹ (See Experience of Supervising Clinician under Cautions.)

  
  

Administration

Intratracheal Administration

Administer only by intratracheal instillation using specialized techniques.^{1 2} Consult manufacturer’s labeling and/or specialized references for guidelines on administration techniques.^{1 2}

Warm drug at room temperature for ≥20 minutes or warm in the hand for ≥8 minutes before administration.¹ Avoid artificial warming methods.¹

Gently swirl vial to obtain a uniform suspension; do not shake.¹ Do not filter.¹

Do not administer doses more frequently than every 6 hours.¹

Contains no preservatives; discard unused portion.¹

Dosage

Dosage expressed in terms of phospholipids.¹

Each mL of the commercially available formulation contains 25 mg of phospholipids (including 11–15.5 mg disaturated phosphatidylcholine) and <1 mg of surfactant proteins (SP-B, SP-C).¹

Pediatric Patients

RDS

Prevention of RDS

Intratracheal

Premature neonates: 100 mg/kg (4 mL/kg) of birth weight, given in 4 divided doses.¹ Give first quarter-dose as soon as possible (preferably within 15 minutes after birth).¹

Administer repeat doses (100 mg/kg of birth weight) if neonate has radiographically confirmed RDS, remains intubated, and requires ≥30% inspired oxygen to maintain a PaO₂ ≤80 torr.¹

Treatment (Rescue) of RDS

Intratracheal

Premature neonates: 100 mg/kg (4 mL/kg) of birth weight, given in 4 divided doses.¹ Give first quarter-dose as soon as possible (preferably within 8 hours after birth).¹

Administer repeat doses (100 mg/kg of birth weight) if neonate remains intubated and requires ≥30% inspired oxygen to maintain a PaO₂ ≤80 torr.¹

Prescribing Limits

Pediatric Patients

RDS

Intratracheal

Premature neonates: Maximum 4 doses within first 48 hours of life.¹ Safety and efficacy not established for single doses >100 mg/kg of birth weight or for administration beyond 48 hours of life.¹

Cautions for Beractant

Contraindications

• 
  

  No known contraindications.¹

  
  

Warnings/Precautions

Warnings

Experience of Supervising Clinician

Use by or under supervision of clinicians experienced in intubation, ventilatory management, and general care of premature neonates.¹

Oxygenation and Lung Compliance

Therapy can rapidly affect oxygenation and lung compliance.¹ Perform arterial or transcutaneous measurement of systemic oxygen and carbon dioxide frequently to avoid hyperoxia.¹

Transient episodes of decreased oxygen saturation reported.¹ If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.¹

Cardiovascular Effects

Transient episodes of bradycardia reported.¹ If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.¹

Major Toxicities

Infectious Complications

Possible post-treatment nosocomial sepsis.¹ Sepsis not associated with increased mortality.¹

General Precautions

Respiratory Effects

Rales and moist breath sounds may occur transiently.¹ Endotracheal suctioning or other corrective measures not necessary unless obvious signs of airway obstruction are present.¹

Use with Investigational Treatments for RDS

Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation, extracorporeal membrane oxygenation) not established.¹

Specific Populations

Pregnancy

Not intended for use in adults.¹

Lactation

Not intended for use in adults.¹

Pediatric Use

Safety and efficacy not established in neonates with birth weights <600 g or >1750 g.¹

Common Adverse Effects

Transient bradycardia, oxygen desaturation, endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, apnea.¹

Interactions for Beractant

No drug interactions reported.¹

Beractant Pharmacokinetics

No pharmacokinetic studies in humans.¹

Absorption

Onset

Marked improvements in oxygenation occur within minutes of administration.^{1 2}

Duration

Improvements in arterial-alveolar oxygen ratio (a/APO₂), FiO₂, and mean airway pressure (MAP) sustained for 48–72 hours following administration.¹

Stability

Storage

Intratracheal

Suspension

2–8° C in carton.¹ Protect from light.¹ Usual color of commercially available suspension is off-white to light brown.¹

Prior to use, warm at room temperature for up to 24 hours (see Intratracheal Administration under Dosage and Administration); record date and time whenever vial is removed from refrigerator.¹

May return unopened, unused vials to refrigerator within 24 hours of warming.¹ Do not warm and return to refrigeration more than once.¹

ActionsActions

• 
  

  Natural bovine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).¹

  
  


• 
  

  Endogenous pulmonary surfactant reduces alveolar surface tension and increases alveolar stability.¹

  
  


• 
  

  Beractant compensates for surfactant deficiency in premature neonates.¹ Restores pulmonary compliance and improves lung pressure-volume measurements and oxygenation in animals.¹

  
  

Advice to Patients

• 
  

  Advise patient's parent(s) or guardian of risk of bradycardia and decreased oxygen saturation.¹

  
  


• 
  

  Importance of informing parent(s) or guardian of other important precautionary information. (See Cautions.)

  
  

Preparations

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

Beractant (Bovine)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Intratracheal	Suspension, sterile	25 mg (of phospholipids) per mL	Survanta	Ross

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 May 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Ross Laboratories. Survanta (beractant) intratracheal suspension prescribing information. Columbus, OH: 2004 May

2. Ross Laboratories. Neonatal respiratory distress syndrome. Columbus, OH: 1991 Mar.

3. Ross Laboratories, Columbus, OH: Personal communication.

4. Whitsett JA, Ohning BL, Ross G et al. Hydrophobic surfactant-associated protein in whole lung surfactant and its importance for biophysical activity in lung surfactant extracts used for replacement therapy. Pediatr Res. 1986; 20:460-7. [PubMed 3754957]

5. Reynolds MS, Wallander KA. Use of surfactant in the prevention and treatment of neonatal respiratory distress syndrome. Clin Pharm. 1989; 8:559-76. [IDIS 257816] [PubMed 2670398]

6. Jobe A, Ikegami M. Surfactant for the treatment of respiratory distress syndrome. Am Rev Respir Dis. 1987; 136:1256-76. [IDIS 236107] [PubMed 3314618]

7. Weaver TE, Whitsett JA. Structure and function of pulmonary surfactant proteins. Semin Perinatol. 1988; 12:213-20. [PubMed 3041604]

8. Chida S, Phelps DS, Cordle C et al. Surfactant-associated proteins in tracheal aspirates of infants with respiratory distress syndrome after surfactant therapy. Am Rev Respir Dis. 1988; 137:943-7. [IDIS 240444] [PubMed 3355003]

9. Taeusch HW, Keough KMW, Williams M et al. Characterization of bovine surfactant for infants with respiratory distress syndrome. Pediatrics. 1986; 77:572-81. [PubMed 3634296]

10. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.

11. Anon. Two-year folow-up of infants treated for neonatal respiratory distress syndrome with bovine surfactant. Survanta Multidose Study Group. J Pediatr. 1994; 124:962-7.

More Beractant resources

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

• Beractant


• Beractant Professional Patient Advice (Wolters Kluwer)


• beractant Concise Consumer Information (Cerner Multum)

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  Approval date: June 25, 1991
  
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Has a generic version of Lotensin been approved?

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benazepril hydrochloride tablet; oral

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Robaxin Tablets

Generic Name: methocarbamol

Dosage Form: tablet, film coated
robaxin®/robaxin®-750 (methocarbamol tablets, USP)

Rx Only

Robaxin Tablets Description

robaxin®/robaxin®-750 (methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.

The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below.

Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.

robaxin® is available as a light orange, round, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, FD&C Yellow 6, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 20, povidone, propylene glycol, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide.

robaxin®-750 is available as an orange capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. In addition to the inactive ingredients present in robaxin®, robaxin®-750 also contains D&C Yellow 10.

Robaxin Tablets - Clinical Pharmacology

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Pharmacokinetics

In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and

0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.

Special populations

Elderly

The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean

(± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age,

53.3 (± 8.8) years), healthy population (1.5 (± 0.4) hours versus 1.1 (±0.27) hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).

Renally impaired

The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (±0.3) hours, respectively.

Hepatically impaired

In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and

weight-matched normal subjects. The mean (± SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (± 1.62) hours and 1.11 (± 0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

Indications and Usage for Robaxin Tablets

robaxin® and robaxin®-750 are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Contraindications

robaxin® and robaxin®-750 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Warnings

Since methocarbamol may possess a general CNS depressant effect, patients receiving robaxin® or robaxin®-750 should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of robaxin® and robaxin®-750 has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxin® and robaxin®-750 should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, Pregnancy).

Use In Activities Requiring Mental Alertness

Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

Precautions

Information for Patients

Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.

Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

Drug Interactions

See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.

Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

Drug/Laboratory Test Interactions

Methocarbamol may cause a color interference in certain screening tests for

5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. robaxin® and robaxin®-750 should be given to a pregnant woman only if clearly needed.

Safe use of robaxin® and robaxin®-750 has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxin® and robaxin®-750 should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS).

Nursing Mothers

Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when robaxin® or robaxin®-750 is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of robaxin® and robaxin®-750 in pediatric patients below the age of 16 have not been established.

Adverse Reactions

Adverse reactions reported coincident with the administration of methocarbamol include:

Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache

Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and lymphatic system: Leukopenia

Immune system: Hypersensitivity reactions

Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

Overdosage

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

Treatment

Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

Robaxin Tablets Dosage and Administration

robaxin® (methocarbamol), 500 mg – Adults:

Initial dosage: 3 tablets q.i.d.

Maintenance dosage: 2 tablets q.i.d.

robaxin®-750 (methocarbamol): 750 mg – Adults:

Initial dosage: 2 tablets q.i.d.

Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

How is Robaxin Tablets Supplied

robaxin® (methocarbamol tablets, USP)

500 mg tablets are light orange, round, film-coated tablets engraved with ROBAXIN 500 on the unscored side and SP above the score on the other side. They are supplied as follows:

Bottles of 100

NDC 0091-7429-63

robaxin®-750 (methocarbamol tablets, USP)

750 mg tablets are orange, capsule-shaped, film-coated tablets engraved with ROBAXIN 750 on one side and SP on the other. They are supplied as follows:

Bottles of 100	NDC 0091-7449-63
Bottles of 500	NDC 0091-7449-70

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Dispense in tight container.

Manufactured for:

SCHWARZ PHARMA, LLC

a subsidiary of UCB, Inc.

Smyrna, GA 30080

Printed in USA

Rev. 1E 09/2009

PRINCIPAL DISPLAY PANEL - 500 mg Label

NDC 0091-7429-63

robaxin®

(methocarbamol tablets, USP)

500 mg

Rx Only

100 tablets

PRINCIPAL DISPLAY PANEL - 750 mg Label

NDC 0091-7449-63

robaxin®- 750

(methocarbamol tablets, USP)

750 mg

Rx Only

100 tablets

ROBAXIN  methocarbamol  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0091-7429 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Methocarbamol (Methocarbamol) Methocarbamol 500 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN   FD&C YELLOW NO. 6   HYDROXYPROPYL CELLULOSE   HYPROMELLOSES   MAGNESIUM STEARATE   POLYSORBATE 20   POVIDONE   PROPYLENE GLYCOL   SACCHARIN SODIUM   SODIUM LAURYL SULFATE   STEARIC ACID   TITANIUM DIOXIDE

Product Characteristics Color ORANGE (light orange) Score 2 pieces Shape ROUND (ROUND) Size 13mm Flavor Imprint Code Robaxin;500;SP Contains

Packaging # NDC Package Description Multilevel Packaging 1 0091-7429-63 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011011	01/15/2003

ROBAXIN  methocarbamol  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0091-7449 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Methocarbamol (Methocarbamol) Methocarbamol 750 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6   HYDROXYPROPYL CELLULOSE   HYPROMELLOSES   MAGNESIUM STEARATE   POLYSORBATE 20   POVIDONE   PROPYLENE GLYCOL   SACCHARIN SODIUM   SODIUM LAURYL SULFATE   STEARIC ACID   TITANIUM DIOXIDE   D&C YELLOW NO. 10

Product Characteristics Color ORANGE (ORANGE) Score no score Shape OVAL (Capsule-shaped) Size 19mm Flavor Imprint Code Robaxin;750;SP Contains

Packaging # NDC Package Description Multilevel Packaging 1 0091-7449-63 100 TABLET In 1 BOTTLE None 2 0091-7449-70 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011011	01/20/2003

Labeler - Schwarz Pharma Inc. (167526990)

Revised: 01/2011Schwarz Pharma Inc.

More Robaxin Tablets resources

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