Atenolol and Chlorthalidone (Page 4 of 4)

Chlorthalidone

Cardiovascular: orthostatic hypotension;

Gastrointestinal: anorexia, gastric irritation, vomiting, cramping, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis;

CNS: vertigo, paresthesia, xanthopsia;

Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia;

Hypersensitivity: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis);

Miscellaneous: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness.

Clinical trials of atenolol and chlorthalidone tablets conducted in the United States (89 patients treated with atenolol and chlorthalidone tablets) revealed no new or unexpected adverse effects.

POTENTIAL ADVERSE EFFECTS

In addition, a variety of adverse effects not observed in clinical trials with atenolol but reported with other beta-adrenergic blocking agents should be considered potential adverse effects of atenolol. 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, decreased performance on neuropsychometrics; Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress.

Miscellaneous

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small, and, in most cases, the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy (See DOSAGE AND ADMINISTRATION).

The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with atenolol. Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to atenolol therapy with subsequent resolution or quiescence of the reaction.

Clinical Laboratory Test Findings

Clinically important changes in standard laboratory parameters were rarely associated with the administration of atenolol and chlorthalidone tablets. The changes in laboratory parameters were not progressive and usually were not associated with clinical manifestations. The most common changes were increases in uric acid and decreases in serum potassium.

OVERDOSAGE

No specific information is available with regard to overdosage and atenolol and chlorthalidone tablets in humans. Treatment should be symptomatic and supportive and directed to the removal of any unabsorbed drug by induced emesis, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Further consideration should be given to dehydration, electrolyte imbalance and hypotension by established procedures.

Atenolol

Overdosage with atenolol has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely.

The predominant symptoms reported following atenolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause, and bradycardia. Additionally, common effects associated with overdosage of any beta-adrenergic blocking agent are congestive heart failure, hypotension, bronchospasm, and/or hypoglycemia. Other treatment modalities should be employed at the physician’s discretion and may include:

Bradycardia:

Atropine 1 to 2 mg intravenously. If there is no response to vagal blockade, give isoproterenol cautiously. In refractory cases, a transvenous cardiac pacemaker may be indicated. Glucagon in a 10 mg intravenous bolus has been reported to be useful. If required, this may be repeated or followed by an intravenous infusion of glucagon 1 to 10 mg/h depending on response.

Heart block (second or third degree):

Isoproterenol or transvenous pacemaker.

Congestive heart failure:

Digitalize the patient and administer a diuretic. Glucagon has been reported to be useful.

Hypotension:

Vasopressors such as dopamine or norepinephrine (levarterenol). Monitor blood pressure continuously.

Bronchospasm:

A beta 2 -stimulant such as isoproterenol or terbutaline and/or aminophylline.

Hypoglycemia:

Intravenous glucose.

Electrolyte disturbance:

Monitor electrolyte levels and renal function. Institute measures to maintain hydration and electrolytes.

Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.

Chlorthalidone

Symptoms of chlorthalidone overdose include nausea, weakness, dizziness and disturbances of electrolyte balance.

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED (See INDICATIONS AND USAGE).

Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one atenolol and chlorthalidone 50mg/25mg tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one atenolol and chlorthalidone 100mg/25mg tablet given once a day.

When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.

Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m 2 (normal range is 100 to 150 mL/min/1.73m 2); therefore, the following maximum dosages are recommended for patients with renal impairment.

Creatinine Clearance (mL/min/1.73m 2) Atenolol Elimination Half-life (hrs.) Maximum Dosage
15 to 35 16 to 27 50 mg daily
< 15 > 27 50 mg every other day

HOW SUPPLIED

Atenolol and Chlorthalidone Tablets, USP are uncoated tablets.

Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg are white to off white, round, biconvex, bevelled tablets, with debossing of ’11′ above breakline and ’67′ below breakline on one side and plain on the other side and are supplied as follows:

NDC 70710-1167-1 in bottle of 100 tablets

Atenolol and Chlorthalidone Tablets USP, 100 mg/25 mg are white to off white, round, biconvex, beveled tablets, with debossing of ’11′ over ’68′ on one side and plain on the other side and are supplied as follows:

NDC 70710-1168-1 in bottle of 100 tablets

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please address medical inquiries to, MedicalAffairs@zydususa.com Tel.: 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 03/2019

DRUG: Atenolol and Chlorthalidone

GENERIC: Atenolol and Chlorthalidone

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2446-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 11;68

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • ATENOLOL 100mg in 1
  • CHLORTHALIDONE 25mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS CITRIC ACID
  • SILICON DIOXIDE
  • MAGNESIUM STEARATE
  • CROSCARMELLOSE SODIUM
  • STARCH, PREGELATINIZED CORN
Remedy_Label
(click image for full-size original)
ATENOLOL AND CHLORTHALIDONE atenolol and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2446(NDC:70710-1168)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL (ATENOLOL) ATENOLOL 100 mg
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color white (WHITE TO OFF WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code 11;68
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2446-0 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210028 11/22/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 11/2019 REMEDYREPACK INC.

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