Candesartan Cilexetil and Hydrochlorothiazide: Package Insert and Label Information (Page 3 of 3)

ADVERSE REACTIONS

Candesartan CilexetilHydrochlorothiazide

Candesartan cilexetil and hydrochlorothiazide tablets have been evaluated for safety in more than 2800 patients treated for hypertension. More than 750 of these patients were studied for at least six months and more than 500 patients were treated for at least one year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse events reported with candesartan cilexetil and hydrochlorothiazide tablets was comparable to placebo. The overall frequency of adverse experiences was not related to dose, age, gender, or race.

In placebo-controlled trials that included 1089 patients treated with various combinations of candesartan cilexetil (doses of 2-32 mg) and hydrochlorothiazide (doses of 6.25-25 mg) and 592 patients treated with placebo, adverse events, whether or not attributed to treatment, occurring in greater than 2% of patients treated with candesartan cilexetil and hydrochlorothiazide tablets and that were more frequent for candesartan cilexetil and hydrochlorothiazide tablets than placebo were: Respiratory System Disorder: upper respiratory tract infection (3.6% vs 3.0%); Body as a Whole: back pain (3.3% vs 2.4%); influenza-like symptoms (2.5% vs 1.9%); Central/Peripheral Nervous System: dizziness (2.9% vs 1.2%).

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

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 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 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 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 16 mg/12.5 mg, are white to off-white, oval, biconvex, non-film-coated tablets, scored on both sides and debossed with “588” on one side and “P” on the other side. They are supplied as follows:

NDC 43547-459-09 bottles of 90

NDC 43547-459-50 bottles of 500

Candesartan cilexetil and hydrochlorothiazide tablets 32 mg/12.5 mg, are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and debossed with “589” on one side and “P” on the other side. They are supplied as follows:

NDC 43547-460-09 bottles of 90

NDC 43547-460-50 bottles of 500

Candesartan cilexetil and hydrochlorothiazide tablets 32 mg/25 mg, are white to off-white, oval, biconvex, non-film-coated tablets, scored on both sides and debossed with “590” on one side and “P” on the other side. They are supplied as follows:

NDC 43547-461-09 bottles of 90

NDC 43547-461-50 bottles of 500

Storage:

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

You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088.

Distributed by: Solco Healthcare US, LLC
Cranbury, NJ 08512, USA
Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang, 317024, China

Revised: 04/2018

26179-01

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label-16 mg/12.5 mg-90 tablets

NDC 43547-459-09 Rx only
Candesartan Cilexetil and Hydrochlorothiazide Tablets
16 mg/12.5 mg
90 Tablets

Each tablet contains 16 mg candesartan cilexetil, USP,and 12.5 mg hydrochlorothiazide, USP.

USUAL ADULT DOSAGE: See package insert.

Keep container tightly closed.

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

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLCCranbury, NJ 08512, USA

Rev.: 04/2018

26173-01

Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16 mg/12.5 mg -- 90 tablets
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label-32 mg/12.5 mg-90 tablets

NDC 43547-460-09 Rx only

Candesartan Cilexetil and Hydrochlorothiazide Tablets
32 mg/12.5 mg
90 Tablets

Each tablet contains 32 mg candesartan cilexetil, USP,and 12.5 mg hydrochlorothiazide, USP.

USUAL ADULT DOSAGE: See package insert.

Keep container tightly closed.

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

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLCCranbury, NJ 08512, USA

Rev.: 04/2018

26175-01

Candesartan Cilexetil and Hydrochlorothiazide Tablets, 32 mg/12.5 mg -- 90 tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label-32 mg/25 mg-90 tablets

NDC 43547-461-09 Rx only

Candesartan Cilexetil and Hydrochlorothiazide Tablets
32 mg/25 mg
90 Tablets

Each tablet contains 32 mg candesartan cilexetil, USP,and 25 mg hydrochlorothiazide, USP.

USUAL ADULT DOSAGE: See package insert.

Keep container tightly closed.

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

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLCCranbury, NJ 08512, USA

Rev.: 04/2018

26177-01

Candesartan Cilexetil and Hydrochlorothiazide Tablets, 32 mg/25 mg -- 90 tablets
(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:43547-459
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL (CANDESARTAN) CANDESARTAN CILEXETIL 16 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
CARBOXYMETHYLCELLULOSE CALCIUM
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 588;P
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43547-459-09 90 TABLET in 1 BOTTLE None
2 NDC:43547-459-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207455 11/20/2017
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-460
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
CARBOXYMETHYLCELLULOSE CALCIUM
POLYETHYLENE GLYCOL 6000
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 589;P
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43547-460-09 90 TABLET in 1 BOTTLE None
2 NDC:43547-460-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207455 11/20/2017
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-461
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 25 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
CARBOXYMETHYLCELLULOSE CALCIUM
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 590;P
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43547-461-09 90 TABLET in 1 BOTTLE None
2 NDC:43547-461-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207455 11/20/2017
Labeler — Solco Healthcare LLC (828343017)

Revised: 02/2020 Solco Healthcare LLC

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