Pindolol (Page 4 of 4)

POTENTIAL ADVERSE EFFECTS

In addition, other adverse effects not aforementioned have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of pindolol tablets.

Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.

Cardiovascular: Intensification of AV block. (See CONTRAINDICATIONS.)

Allergic: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.

Hematologic: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis; ischemic colitis.

Miscellaneous: Reversible alopecia; Peyronie’s disease.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with pindolol tablets during investigational use and extensive foreign experience amounting to over 4 million patient-years.

OVERDOSAGE

No specific information on emergency treatment of overdosage is available. Therefore, on the basis of the pharmacologic actions of pindolol tablets, the following general measures should be employed as appropriate in addition to gastric lavage:

Excessive Bradycardia: administer atropine; if there is no response to vagal blockade, administer isoproterenol cautiously.

Cardiac Failure: digitalize the patient and/or administer diuretic. It has been reported that glucagon may be useful in this situation.

Hypotension: administer vasopressors, e.g., epinephrine or norepinephrine, with serial monitoring of blood pressure. (There is evidence that epinephrine may be the drug of choice.)

Bronchospasm: administer a beta2 stimulating agent such as isoproterenol and/or a theophylline derivative.

A case of an acute overdosage has been reported with an intake of 500 mg of pindolol tablets by a hypertensive patient. Blood pressure increased and heart rate was ≥ 80 beats/min. Recovery was uneventful. In another case, 250 mg of pindolol tablets was taken with 150 mg diazepam and 50 mg nitrazepam, producing coma and hypotension. The patient recovered in 24 hours.

DOSAGE AND ADMINISTRATION

The dosage of pindolol tablets should be individualized. The recommended initial dose of pindolol tablets is 5 mg b.i.d. alone or in combination with other antihypertensive agents. An antihypertensive response usually occurs within the first week of treatment. Maximal response, however, may take as long as or occasionally longer than 2 weeks. If a satisfactory reduction in blood pressure does not occur within 3 to 4 weeks, the dose may be adjusted in increments of 10 mg/day at these intervals up to a maximum of 60 mg/day.

HOW SUPPLIED

Product: 68151-1320

NDC: 68151-1320-0 1 TABLET in a PACKAGE

Pindolol 5 mg tabs

Label ImageLabel Image
PINDOLOL
pindolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-1320(NDC:0378-0052)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINDOLOL (PINDOLOL) PINDOLOL 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code M;52
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-1320-0 1 TABLET in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074019 09/03/1992
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-1320)

Revised: 07/2017 Carilion Materials Management

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