CHLORTHALIDONE (Page 2 of 2)

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, please call RiconPharma LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency.

Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia.

Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia.

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

Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics.

Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence.

Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn

OVERDOSAGE:

Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

DOSAGE AND ADMINISTRATION:

Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.

Hypertension
Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. If additional control is required, the dosage of chlorthalidone may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added. Dosage above 100 mg daily usually does not increase effectiveness. Increases in serum uric acid and decreases in serum potassium are dose-related over the 25 to 100 mg/day range.

Maintenance: Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

Edema
Initiation: Adults, initially 50 to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals or up to 200 mg daily. Dosages above this level, however, do not usually produce a greater response.

Maintenance: Maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

HOW SUPPLIED:

Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP.

The 25 mg tablets are green colored, biconvex, round shaped tablets debossed with ‘010’ on one side, and plain on the other side. They are available as follows:

NDC 64980-303-01
Bottles of 100 tablets

NDC 64980-303-10
Bottles of 1000 tablets

The 50 mg tablets are green colored, capsule shaped tablets debossed with ‘011’ on one side, and a break-line on the other side. They are available as follows:

NDC 64980-304-01
Bottles of 100 tablets

Store at 20ºC to 25º C (68º to 77º F). [See USP for Controlled Room Temperature.]
Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

ANIMAL PHARMACOLOGY:

Biochemical studies in animals have suggested reasons for the prolonged effect of chlorthalidone. Absorption from the gastrointestinal tract is slow due to its low solubility. After passage to the liver, some of the drug enters the general circulation, while some is excreted in the bile, to be reabsorbed later. In the general circulation, it is distributed widely to the tissue, but is taken up in highest concentrations by the kidneys, where amounts have been found 72 hours after ingestion, long after it has disappeared from other tissues. The drug is excreted unchanged in the urine.

Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663
Rx Only
553001 Rev. 08/18

———PRINCIPAL DISPLAY PANEL — 25 mg———

Rising® NDC 64980-303 -01
Chlorthalidone
Tablets, USP
25 mg 100 Tablets Rx only

Chlorthalidone-Tablets-25mg-100ct
(click image for full-size original)


———PRINCIPAL DISPLAY PANEL — 50 mg———

Rising® NDC 64980-304 -01
Chlorthalidone
Tablets, USP
50 mg 100 Tablets Rx only

Chlorthalidone-Tablets-50mg-100ct
(click image for full-size original)
CHLORTHALIDONE chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-303
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color GREEN Score no score
Shape ROUND (Biconvex, Round) Size 5mm
Flavor Imprint Code 010
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-303-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:64980-303-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206904 05/17/2017
CHLORTHALIDONE chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-304
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color GREEN (Green) Score 2 pieces
Shape CAPSULE (Capsule) Size 10mm
Flavor Imprint Code 011
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-304-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206904 05/17/2017
Labeler — Rising Pharmaceuticals, Inc. (041241766)
Registrant — Novast Laboratories Ltd. (527695995)
Establishment
Name Address ID/FEI Operations
Ingenus Pharmaceuticals NJ, LLC 964680206 MANUFACTURE (64980-303), MANUFACTURE (64980-304)

Revised: 09/2021 Rising Pharmaceuticals, Inc.

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