Chlorthalidone (Page 2 of 2)
Drug/Laboratory Test Interactions
Chlorthalidone and related drugs may decrease serum PBI levels without signs of thyroid disturbance.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No information is available.
Pregnancy
Teratogenic Effects. Pregnancy Category B
Reproduction studies have been performed in the rat and the rabbit at doses up to 420 times the human dose and have revealed no evidence of harm to the fetus due to chlorthalidone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nonteratogenic Effects
Thiazides cross the placental barrier and appear in cord blood. The use of chlorthalidone and related drugs in pregnant women requires that the anticipated benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.
Nursing Mothers
Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from chlorthalidone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children have not been established.
ADVERSE REACTIONS
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.
To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 mg/day 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 white to off-white, round flat beveled edge, uncoated tablets debossed with ‘C’ on one side and ’25’ on other side. They are available as follows:
NDC 27241-216-01
Bottles of 100 tablets with child-resistant closures
The 50 mg tablets are white to off-white, round flat beveled edge, uncoated tablets with breakline on one side with notch on both side of periphery and debossed ‘C’ over ’50’ on other side. They are available as follows:
NDC 27241-217-01
Bottles of 100 tablets with child-resistant closures
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°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.
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.
Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.
Made in INDIA
Revised: 10/2019
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 27241-216-01
100 Tablets
Chlorthalidone Tablets, USP
25 mg
Rx Only
ajanta
NDC 27241-217-01
100 Tablets
Chlorthalidone Tablets, USP
50 mg
Rx Only
ajanta
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| Labeler — Ajanta Pharma USA Inc. (557554156) |
| Registrant — Ajanta Pharma Limited (918594859) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Ajanta Pharma Ltd., Dahej | 862199968 | MANUFACTURE (27241-216), MANUFACTURE (27241-217) | |
Revised: 11/2021 Ajanta Pharma USA Inc.
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