Candesartan Cilexetil and Hydrochlorothiazide (Page 5 of 5)

Post-Marketing Experience

The following have been very rarely reported in post-marketing experience with candesartan cilexetil:

Digestive: Abnormal hepatic function and hepatitis.

Hematologic: Neutropenia, leukopenia, and agranulocytosis.

Immunologic: Angioedema

Metabolic and Nutritional Disorders: Hyperkalemia, hyponatremia.

Respiratory System Disorders: Cough

Skin and Appendages Disorders: Pruritus, rash and urticaria.

Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Hydrochlorothiazide

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

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

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, urticaria, purpura

Musculoskeletal: muscle spasm

Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia

Special Senses: transient blurred vision, xanthopsia

Urogenital: impotence

OVERDOSAGE

Candesartan Cilexetil and Hydrochlorothiazide

No lethality was observed in acute toxicity studies in mice, rats and dogs given single oral doses of up to 2000 mg/kg of candesartan cilexetil or in rats given single oral doses of up to 2000 mg/kg of candesartan cilexetil in combination with 1000 mg/kg of hydrochlorothiazide. In mice given single oral doses of the primary metabolite, candesartan, the minimum lethal dose was greater than 1000 mg/kg but less than 2000 mg/kg.

Limited data are available in regard to overdosage with candesartan cilexetil in humans. The most likely manifestations of overdosage with candesartan cilexetil would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be initiated. For hydrochlorothiazide, the most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

Candesartan cannot be removed by hemodialysis. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

Treatment

To obtain up-to-date information about the treatment of overdose, consult your Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient.

DOSAGE AND ADMINISTRATION

The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

Use in Renal Impairment: Dosing recommendations for candesartan cilexetil and hydrochlorothiazide tablets in patients with creatinine clearance < 30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency).

Use in moderate to severe Hepatic Impairment: Candesartan cilexetil and hydrochlorothiazide tablets are not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see SPECIAL POPULATIONS, Hepatic Insufficiency).

Replacement Therapy: The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg and serum potassium may improve.

A patient whose blood pressure is not controlled on 32 mg of candesartan cilexetil tablets can expect incremental blood pressure effects from candesartan cilexetil and hydrochlorothiazide tablets 32 mg/12.5 mg and then 32 mg/25 mg. The maximal antihypertensive effect of any dose of candesartan cilexetil and hydrochlorothiazide tablets can be expected within 4 weeks of initiating that dose.

Candesartan cilexetil and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Candesartan cilexetil and hydrochlorothiazide tablets may be administered with or without food.

HOW SUPPLIED

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied in

NDC:70518-2720-00 90 in 1 BOTTLE PLASTIC

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured under the license from Takeda Pharmaceutical Company, Ltd.

Manufactured by:

AstraZeneca AB, SE-151 85

Södertälje, Sweden

Distributed by:

ANI Pharmaceuticals, Inc.

Baudette, MN 56623

10118 Rev 05/20

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Candesartan Cilexetil and Hydrochlorothiazide

GENERIC: Candesartan Cilexetil and Hydrochlorothiazide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2720-0

COLOR: yellow

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 11 mm

IMPRINT: ACJ

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • HYDROCHLOROTHIAZIDE 12.5mg in 1
  • CANDESARTAN CILEXETIL 32mg in 1

INACTIVE INGREDIENT(S):

  • CARBOXYMETHYLCELLULOSE CALCIUM
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • STARCH, CORN
  • POLYETHYLENE GLYCOL 8000
  • FERRIC OXIDE YELLOW
Remedy_Label
(click image for full-size original)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2720(NDC:62559-661)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 32 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOL 8000
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL (biconvex) Size 11mm
Flavor Imprint Code ACJ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2720-0 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021093 05/01/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2020 REMEDYREPACK INC.

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