Nobatol: Product Information (Page 2 of 2)

ADVERSE REACTIONS

All adverse effects noted below have been reported very rarely.

During start of therapy ataxia and sedation can occur, but these effects are usually transitory and disappear in most, but not all, with continued medication. Some animals can demonstrate a paradoxical hyperexcitability, particularly after first starting therapy. As this hyperexcitability is not
linked to overdosage, no reduction of dosage is needed. Polyuria, polydipsia, and polyphagia can occur at average or higher therapeutic active serum concentrations; these effects can be diminished by limiting intake of food. Sedation and ataxia often become significant concerns as serum levels reach the higher ends of the therapeutic range. High plasma concentrations may be associated with hepatotoxicity. Phenobarbital can have deleterious effects on stem cells from bone marrow. Consequences are immunotoxic pancytopenia and/or neutropenia. These reactions disappear after the treatment’s withdrawal. Treating dogs with phenobarbital may lower their TT4 or FT4 serum levels, however this may not be an indication of hypothyroidism. Treatment with thyroid hormone replacement should only be started if there are clinical signs of the disease.

If adverse effects are severe, a decrease in the administered dose is recommended.

In case of accidental human ingestion, seek medical attention immediately.

In case of accidental overdose in dogs, call 1-561-570-1875.

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Phenobarbital is a Schedule IV controlled substance.

OVERDOSAGE

Symptoms of overdose are:

  • depression of the central nervous system demonstrated by signs ranging from sleep to coma,
  • respiratory problems,
  • cardiovascular problems, hypotension and shock leading to renal failure and death.

In case of overdose, remove ingested product from the stomach and give respiratory and cardiovascular support as
necessary.

There is no specific antidote, but CNS stimulants, (like Doxapram) may stimulate the respiratory center.

STORAGE CONDITIONS

Store in a dry place at controlled room temperature, between 59 and 77°F (15-25°C). Store unused tablets in the original closed container.

Store product according to state and local requirements.

HOW SUPPLIED

NOBATOL® 30 mg: Brown, round, tablets scored on one side and debossed “MB” above the score and “30” below the score. The other side is plain. Available in bottles of 30 tablets, NDC 86039-030-30, 60 tablets, NDC 86039-030-61, 180 tablets, NDC 86039-030-80 and 1000 tablets, NDC 86039-030-10.

NOBATOL® 60 mg: Brown, round, tablets scored on one side and debossed “MB” above the score and “60” below the score. The other side is plain. Available in bottles of 30 tablets, NDC 86039-060-30, 60 tablets, NDC 86039-060-61, 180 tablets, NDC 86039-060-80 and 1000 tablets, NDC 86039-060-10.

REFERENCES

  1. Lepitil 60mg Flavoured Tablets for Dogs. Summary of Product Characteristics. Chanelle Pharmaceuticals Manufacturing Ltd; July 2018.
  2. Epityl 60mg Flavoured Tablets for Dogs. Summary of Product Characteristics. Chanelle Pharmaceuticals Manufacturing Ltd; June 2018.
  3. 2015 ACVIM Small Animal Consensus Statement on Seizure Management in Dogs. Journal of Veterinary Internal Medicine. 2016: (30):477-490
  4. Phenobarbital/Phenobarbital Sodium. Plumbs Veterinary Medication Handbook. 7th Edition. 2011. Pages 1081-1086
  5. Management of canine epilepsy with phenobarbital and potassium bromide. Clinical Pharmacology. Can Veterianry Journal. 1994: (35)

Manufactured For:
Mizner Bioscience, LLC
Boca Raton, FL 33432
500530-01

Rev. 01/2021

PRINCIPAL DISPLAY PANEL

NOBATOL® (phenobarbital) tablets, 30 mg
WARNING: May be habit forming.

FOR USE IN DOGS ONLY
CAUTION: Federal (USA) law restricts this
drug for use by or on the order of a
licensed veterinarian
Net contents: 30 tablets
30 mg each

Nobatol 30 mg, 30ct.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NOBATOL® (phenobarbital) tablets, 60 mg
WARNING: May be habit forming.

FOR USE IN DOGS ONLY
CAUTION: Federal (USA) law restricts this
drug for use by or on the order of a
licensed veterinarian
Net contents: 30 tablets
60 mg each

Nobatol 60 mg, 30ct.
(click image for full-size original)

NOBATOL phenobarbital tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86039-030
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 30 mg
Product Characteristics
Color BROWN Score 2 pieces
Shape ROUND Size 8mm
Flavor MEAT (beef) Imprint Code MB;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86039-030-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (86039-030-30)
2 NDC:86039-030-61 1 BOTTLE in 1 CARTON contains a BOTTLE
2 60 TABLET in 1 BOTTLE This package is contained within the CARTON (86039-030-61)
3 NDC:86039-030-80 1 BOTTLE in 1 CARTON contains a BOTTLE
3 180 TABLET in 1 BOTTLE This package is contained within the CARTON (86039-030-80)
4 NDC:86039-030-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/28/2021
NOBATOL phenobarbital tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86039-060
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 60 mg
Product Characteristics
Color BROWN Score 2 pieces
Shape ROUND Size 10mm
Flavor MEAT (beef) Imprint Code MB;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86039-060-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (86039-060-30)
2 NDC:86039-060-61 1 BOTTLE in 1 CARTON contains a BOTTLE
2 60 TABLET in 1 BOTTLE This package is contained within the CARTON (86039-060-61)
3 NDC:86039-060-80 1 BOTTLE in 1 CARTON contains a BOTTLE
3 180 TABLET in 1 BOTTLE This package is contained within the CARTON (86039-060-80)
4 NDC:86039-060-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/28/2021
Labeler — Mizner Bioscience, LLC (104644394)

Revised: 06/2021 Mizner Bioscience, LLC

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