Saluron (Page 2 of 2)

Drug Interactions

Anticoagulants (oral): effects may be decreased when used concurrently with thiazide diuretics; dosage adjustments may be necessary.

Antigout medications: thiazide diuretics may raise the level of blood uric acid; dosage adjustment of antigout medications may be necessary to control hyperuricemia and gout.

Other antihypertensive medications, especially diazoxide; pre-anesthetic and anesthetic agents used in surgery; skeletal muscle relaxants, nondepolarizing, used in surgery: effects may be potentiated when used concurrently with thiazide diuretics; dosage adjustments may be necessary.

Amphotericin B or Corticosteroids, including Corticotropin (ACTH): concurrent use with thiazide diuretics may intensify electrolyte imbalance, particularly hypokalemia.

Cardiac glycosides: concurrent use with thiazide diuretics may enhance the possibility of digitalis toxicity associated with hypokalemia.

Colestipol: may inhibit gastrointestinal absorption of the thiazide diuretics; administration 1 hour before or 4 hours after colestipol is recommended.

Hypoglycemics: thiazide diuretics may raise blood glucose levels. For adult-onset diabetics, dosage adjustment of hypoglycemic medications may be necessary during and after thiazide diuretic therapy; insulin requirements may be increased, decreased, or unchanged.

Lithium salts: concurrent use with thiazide diuretics is not recommended, as they may provoke lithium toxicity because of reduced renal clearance.

Methenamine: effectiveness may be decreased when used concurrently with thiazide diuretics, because of alkalinization of the urine.

Diagnostic Interference

With expected physiologic effects.

Blood and urine glucose levels: usually only in patients with a predisposition to glucose intolerance.

Serum bilirubin levels: displacement from albumin binding.

Serum calcium levels: thiazide diuretics should be discontinued before parathyroid function tests are carried out.

Serum uric acid levels: may be increased.

Serum magnesium, potassium, and sodium levels: may be decreased, serum magnesium levels may increase in uremic patients.

Serum protein-bound iodine (PBI) levels: may be decreased.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

Pregnancy Category D. See “WARNINGS” Section.

Teratogenic Effects

Saluron® can cause fetal harm when administered to a pregnant woman. The hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in adults. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Nonteratogenic Effects

Fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in adults.

Nursing Mothers

Thiazides appear in breast milk. If use of the drug is deemed essential, the patient may consider stopping nursing.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

The following adverse reactions have been observed, but there has not been 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, parathesias, headache, xanthopsia.

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

Dermatologic-Hypersensitivity reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis).

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

Other: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness.

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

Overdosage

Signs and Symptoms

Diuresis, lethargy progressing to coma, with minimal cardiorespiratory depression and with or without significant serum electrolyte changes or dehydration; GI irritation; hypermotility; transient elevation of BUN level.

Treatment

Empty stomach by gastric lavage, taking care to avoid aspiration. Monitor serum electrolyte levels and renal function, and institute supportive measures, as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function. Treat GI effects symptomatically.

Dosage and Administration

In the treatment of edema, the usual initial dose is 50 to 200 mg daily, in 1 or 2 divided doses, reduced to a dose of 25 to 50 mg on alternate days or intermittently. In the treatment of hypertension, the usual dose is 25 to 50 mg daily in 1 or 2 divided doses, either alone, or in conjunction with other antihypertensive agents. A suggested initial dose for children is 1 mg per kg of body weight daily, reduced for maintenance.

Therapy should be individualized according to patient response. This therapy should be titrated to gain maximal therapeutic response, as well as the minimal dose possible to maintain that therapeutic response.

How Supplied

Saluron® Tablets, scored, 50 mg in bottles of 100.

NDC 54092-055-01

Store from 15° to 25°C (59° to 77°F).

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

CAUTION: Federal law prohibits dispensing without prescription.

SALURON
hydroflumenthiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54092-055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydroflumethiazide (hydroflumethiazide) hydroflumethiazide 50 mg
Inactive Ingredients
Ingredient Name Strength
microcrystalline cellulose
lactose
magnesium stearate
colloidal silicon dioxide
sodium starch glycolate
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code RPC;055
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54092-055-01 100 TABLET (100 TABLET) in 1 BOTTLE None
Labeler — Shire

Revised: 07/2006 Shire

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