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
Pindolol Tablets, USP are available containing 5 mg or 10 mg of pindolol, USP.
The 5 mg tablets are white, round, scored tablets debossed with M above the score and 52 below the score on one side of the tablet and blank on the other side. They are available as follows:
NDC 0378-0052-01
bottles of 100 tablets
The 10 mg tablets are white, round, scored tablets debossed with M above the score and 127 below the score on one side of the tablet and blank on the other side. They are available as follows:
NDC 0378-0127-01
bottles of 100 tablets
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A
Revised: 11/2016
PIND:R9
PRINCIPAL DISPLAY PANEL — 5 mg
NDC 0378-0052-01
Pindolol
Tablets, USP
5 mg
Rx only 100 Tablets
Each tablet contains:
Pindolol, USP 5 mg
Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.
Keep container tightly closed.
Keep this and all medication
out of the reach of children.
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]
Protect from light.
Usual Adult Dosage: One tablet
twice daily. See accompanying
prescribing information.
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Mylan.com
RM0052A6
PRINCIPAL DISPLAY PANEL — 10 mg
NDC 0378-0127-01
Pindolol
Tablets, USP
10 mg
Rx only 100 Tablets
Each tablet contains:
Pindolol, USP 10 mg
Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.
Keep container tightly closed.
Keep this and all medication
out of the reach of children.
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]
Protect from light.
Usual Adult Dosage: One tablet
twice daily. See accompanying
prescribing information.
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Mylan.com
RM0127A6
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| Labeler — Mylan Pharmaceuticals Inc. (059295980) |
Revised: 11/2016 Mylan Pharmaceuticals Inc.
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