Hydrochlorothiazide (Page 2 of 2)

Pregnancy:

Teratogenic Effects –

Pregnancy Category B: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus.

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. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers: Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue hydrochlorothiazide, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e. >65 years) with hydrochlorothiazide. Starting treatment with the lowest available dose of hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.

ADVERSE REACTIONS

The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the order of decreasing severity.

Body as a whole: Weakness.

Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, 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, fever, urticaria, rash, purpura.

Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal: Muscle spasm.

Nervous System/Psychiatric: Vertigo, paresthesia, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS).

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

Special Senses: Transient blurred vision, xanthopsia.

Urogenital: Impotence.

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

OVERDOSAGE

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.

In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

The oral LD₅₀ of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

DOSAGE AND ADMINISTRATION

For Control of Hypertension: The adult initial dose of Hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other anti-hypertensives. Total daily doses greater than 50 mg are not recommended.

HOW SUPPLIED

Hydrochlorothiazide capsules 12.5 mg are #4 Blue Opaque / White Opaque hard gelatin capsules imprinted with TL382 in black ink and are available in the following package sizes:

Bottle of 90	NDC 69375-001-09
Bottle of 1000	NDC 69375-001-11

Storage:
Keep container tightly closed. Protect from light, moisture, freezing, -20°C (-4°F) and store at 20°-25°C (68° — 77°F) [See USP Controlled Room temperature].

Keep this and all medication out of the reach of children.

Manufactured For:
Nationwide Pharmaceutical, LLC.
San Antonio, TX, 78216, USA

Mfg Iss. Rev. 03/11

NWP 02/16

PRINCIPAL DISPLAY PANEL — 12.5 mg Capsule Bottle Label

NDC 69375-001-11

NATIONWIDE PHARMACEUTICAL

Hydrochlorothiazide Capsules

12.5 mg

1000 Capsules
Rx Only

HYDROCHLOROTHIAZIDE hydrochlorothiazide capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69375-001(NDC:59746-382) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrochlorothiazide (Hydrochlorothiazide) Hydrochlorothiazide 12.5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 GELATIN FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE STARCH, CORN

Product Characteristics Color BLUE, WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code TL;382 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69375-001-09 90 CAPSULE, GELATIN COATED in 1 BOTTLE None 2 NDC:69375-001-11 1000 CAPSULE, GELATIN COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078391 03/01/2015

Labeler — Nationwide Pharmacetuical, LLC (079265801)

Establishment
Name	Address	ID/FEI	Operations
Legacy Pharmaceutical Packaging, LLC		143213275	REPACK (69375-001), RELABEL (69375-001)

Revised: 03/2016 Nationwide Pharmacetuical, LLC