41997 udl_8.25 x 8_31952udl_8.25 x 8

41997 UDL_8.25 x 8_31952UDL_8.25 x 8 6/17/13 10:56 AM Page 1 hemo lytic anemia and meg aloblastosis.
TRIAMTERENE
strated that doses of hydrochlorothiazide quivalent to single entity hydrochlorothia- WARNINGS: Hyperkalemia: Abnormal
evidence of teratogenicity at those doses Ophthalmic: xanthopsia, transient
sure still is not controlled, another anti- INDICATIONS AND USAGE: This fixed
HYDROCHLOROTHIAZIDE
Hypersensitivity: anaphylaxis, photo-
combination drug is not indicated for
TABLETS, USP
the initial therapy of edema or hyper-
37.5 mg/25 mg and
Triamterene: Triamterene is a potassi-
tension except in individuals in whom
triamterene and hydrochlorothiazide.
neous vasculitis), fever, respiratory dis- 75 mg/50 mg
the development of hypokalemia can-
Hy per kalemia is more likely to occur in with relatively weak natriuretic properties.
not be risked.
Other: muscle cramps and weakness,
It exerts its diuretic effect on the distal 1. Triamterene and hy dro chlor othiazide renal tubule to inhibit the reabsorption of and well-controlled studies with triamter- DESCRIPTION: Triamterene and hydro -
Hyperuricemia: Hyperuricemia may
PRECAUTIONS: General: Electrolyte Im -
balance and BUN Increases: Pa tients
nificant difference from control incidence bioavailable formulations to this product receiving triamterene and hydrochlorothi- natriuretic agent, hydrochlorothiazide.
only if the potential benefit justifies the Altered Laboratory Findings: Serum
tablets are also indicated for those pa - Hydrochlorothiazide: Two-year feeding azide. Tri am terene is not a competitive fluid or electrolyte imbalances, i.e., hy - Metabolic and Endocrine Effects: The
Electrolytes: hyperkalemia, hypo -
Triamterene: Reproduction studies have HOW SUPPLIED: Triamterene and Hydro-
without signs of thyroid disturbance.
hypokal emia cannot be risked (e.g., pa - observed in pa tients with Addison’s dis- ease, i.e., without aldo ster one. Triamter- azides. Pathological changes in the para - Creatinine, Blood Urea Nitrogen: Re -
ene’s onset and dur ation of activity is thyroid gland with hypercalcemia and hy - round tablets debossed with MYLAN on
should be performed at appropriate inter- lar weak ness, fatigue, flaccid paralysis Triamterene, USP . . . . . . . . . . 75 mg one side of the tablet and TH above the
vals. Serum and urine electrolyte determi- evidence of harm to the fetus due to tri- dictable antihypertensive effect has been few patients on prolonged thiazide thera- score and 2 below the score on the other
patient is vomiting or receiving parenteral Glucose: hyperglycemia, glycosuria and
the following inactive ingredients: col - ing oral administration. Peak plas ma lev- diabetes mellitus (see PRECAUTIONS).
1 mg/kg/day based on a 50 kg patient).
fluid and electrolyte im balance include: Serum Uric Acid, PBI and Calcium: (see
discontinued be fore carrying out tests for dryness of mouth, thirst, weakness, leth - lized to the sulfate conjugate of hydroxy - Hydrochlorothiazide: Hydrochlorothiazide Store at 20° to 25°C (68° to 77°F). [See
Other: Elevated liver enzymes have been
crystalline cellu lose, powdered cel lulose pains or cramps, muscular fatigue, hypo - USP Controlled Room Temperature.]
Usage in Pregnancy: The routine use of
tients may be increased, de creased or un - Protect from light.
alone should be substituted. If the serum trointestinal disturbances such as nausea OVERDOSAGE: No specific data are avail -
vigorous therapy is required. The clinical 50 mg of hydrochlorothiazide in triamter- phenyl pteridine. Triamterene is practically Hypersensitivity: Sensitivity reactions to
of pregnancy, and there is no satisfacto- Mutagenesis: Studies of the mutagenic
for rats, based on body-weight, and equal and no specific antidote is available.
in soluble in water, benzene, chloroform, to 282 for mice and 206 for rats, based on ether and dilute alkali hydroxides. It is without a history of allergy or bronchial tion, sodium bi carbonate solution and/or soluble in formic acid and sparingly solu- ous doses of liquid preparations of triam- stances (as in liver disease or renal dis- Triamterene: Triamterene was not muta- of harm to the fetus. There are, however, ble in methoxyethanol. Triamterene is very glucose with a rapid-acting insulin prep - genic in bacteria (S. typhimurium strains no adequate and well controlled studies in elicit hyperkalemia, dehydration, nausea, slightly soluble in acetic acid, alcohol and aration. Cationic exchange resins such as dilute mineral acids. Its molecular weight quences of pregnancy. Thiazides are indi- sodium polystyrene sulfonate may be oral- Mylan Pharmaceuticals Inc.
daily). Single daily doses of 75 mg triam- restriction, rather than administration of ly or rectally administered. Persistent hy - Drug Interactions: Thiazides may add to
thiazide has been associated with hy po - pathologic causes, just as they are in the or potentiate the action of other antihy- Chinese hamster ovary (CHO) cells in vitro with or without metabolic activa- Mylan Institutional Inc.
in pregnancy, resulting from restriction of coma) and gastro intestinal irritation.
Nonteratogenic Effects: Thiazides and
exchanges in CHO cells in vitro with and properly treated through elevation of the ive. Ther apy with triamterene and hydro- zide therapy, especially with brisk diure- lower extremities and use of support hose; TIONS). Patients with mild renal function- Hydrochlorothiazide: Hydrochlorothiazide chlorothiazide should be discontinued.
to the 25 mg of hy drochlorothiazide in tri- sis, when severe cirrhosis is present, or blood. The use of thiazides and triamter- hy dro-2H-1,2,4, benzothiadiazine-7-sul- use of diuretics to lower intravascular vol- was not genotoxic in in vitro assays using Induce emesis or institute gastric lavage.
fonamide 1,1-dioxide. Hydro chloro thia zide ume in this case is illogical and unneces- Monitor serum electrolyte levels and fluid is slightly soluble in water and freely solu- sary. There is hypervolemia during normal and TA 1538 of Salmonella typhim urium longed thiazide therapy. However, hy po - possible hazards to the fetus. These haz- ble in sodium hydroxide solution, n-buty- pregnancy which is harmful to neither the evaluations in which various doses of liq- kalemia of this type is usually prevented ards in clude fetal or neonatal jaundice, patients with impaired renal function.
trolyte balance, respiratory, cardiovascu- spar ingly soluble in methanol and insolu- cardiovascular disease), but which is as - tions, or in in vivo assays using mouse ble in ether, chloroform and dilute mineral DOSAGE AND ADMINISTRATION: The
acids. Its molecular weight is 297.73. Its insert on lithium before use of such con- thiazide (25 mg given once daily). Single Nursing Mothers: Thiazides and triam-
trolyte intake will also contribute to hy - the Dros ophila sex-linked recessive lethal daily doses of 37.5 mg triamterene result- fort, increased recumbency will often pro- ed in greater in creases in serum potassi- one or two tablets daily, given as a sin- vide relief. In rare in stances, this edema obtained in the in vitro CHO sister chro- ap pears in animal milk and this may oc - hydrochlorothiazide administration to el - the toxic effects of digitalis (e.g., in - matid exchange (clastogenicity) test, and der ly patients and patients with im paired human breast milk. If use of the combina- ty) assays, using concentrations of hydro- no ad ditional elevations in serum po tas - tion drug product is deemed essential, the chlorothiazide of 43 to 1300 mcg/mL.
nitrogen level (BUN), creatinine level or with triamterene and hydrochlorothiazide.
Positive test results were also obtained in ship of triamterene was also evaluated in CONTRAINDICATIONS: Hyperkalemia:
Pediatric Use: Safety and effectiveness
CLINICAL PHARMACOLOGY: Triamterene
both. This is probably not the re sult of the Aspergillus nidulans nondisjunction in pediatric patients have not been estab- renal toxicity but is secondary to a re - used very cautiously, if at all, in conjunc- chlorothiazide given 25 mg twice daily.
should not be used in the presence of ele- anti hypertensive drug product, principally versible reduction of the glomerular fil- due to its hy dro chlorothiazide component; tration rate or a depletion of the intra - Impairment of Fertility: Studies of the
ADVERSE REACTIONS: Side effects ob -
than or equal to 5.5 mEq/liter). If hyper- chlorothiazide) tablet daily or more than served in association with the use of tri- fashion. However, the combination of tri- tassium should be monitored frequently.
trolytes must be frequently monitored.
lets, other combination products contain- Drug/Laboratory Test Inter actions: Tri-
Hydrochlorothiazide: Hydrochlorothia-
increased frequency of elevation in serum Antikaliuretic Therapy or Potassium
properties of angiotensin-converting en - products containing triamterene or hydro- BUN and creatinine levels. The larg est in - Supplementation: Triamterene and
Hydrochlorothiazide: Hydrochlorothiazide agent. It blocks the renal tubular absorp- hydrochlorothiazide should not be given to had no adverse ef fects on the fertility of Gastrointestinal: jaundice (intrahepatic
tiously, if at all, with these a gents (see hepatic disease or renal insufficiencies.
cholestatic jaundice), pancreatitis, nau- Carcinogenesis, Mutagen esis, Impair -
by a secondary loss of potassium and bi - daily, the largest dose tested. Ordinarily, amiloride hydrochloride or other formula- Metabolic or Respiratory Acidosis:
ment of Fertility: Carcinogenesis: Long
carbonate. Onset of hydrochlorothiazide’s triamterene does not en tirely compensate term studies with triamterene and hy dro - diuretic effect oc curs within 2 hours and anorexia, gastric irritation, cramping.
for the kaliuretic effect of hydrochlorothia- also be avoided in severely ill patients in the peak action takes place in 4 hours.
Hepatic Coma: Triamterene and hydro-
Central Nervous System: drowsiness and
Triamterene: In studies conducted under Diuretic activity persists for ap proxi mately chlorothiazide should be used with caution (mice) and 4 (rats) on the basis of body- in patients with impaired hepatic function and hydrochlorothiazide. In some individ- or progressive liver disease, since minor Impaired Renal Function: Triamterene
alterations of fluid and electrolyte balance thiazide’s antihypertensive action is not Cardiovascular: tachycardia, shortness of
and hydrochlorothiazide is contraindicat- Pregnancy: Teratogenic Effects. Cate-
gory C: Triamterene and Hydrochlorothi-
cretion and redistribution of body sodium.
Renal Stones: Triamterene has been re -
chronic renal in sufficiency or significant azide: Animal reproduction studies to absorbed and are bio equivalent to liquid Acute Myopia and Secondary Angle-
posed to the highest tested concentration determine the potential for fetal harm by Renal: acute renal failure, acute in ter -
Hypersensitivity: Triamterene and hydro-
Closure Glaucoma: Hydrochlorothiazide,
stitial nephritis, renal stones com posed of triamterene in association with other cal- influence the ab sorp tion of triamterene or patients who are hypersensitive to triam- cratic reaction, resulting in acute tran- terene or hydrochlorothiazide or other sul- Folic Acid Deficiency: Triamterene is a
about 45 and 60 mg/kg/day, respectively.
Hematologic: leukopenia, agranulocyto-
lar pain and typically occur within hours 41997 UDL_8.25 x 8_31952UDL_8.25 x 8 6/17/13 10:56 AM Page 1 hemo lytic anemia and meg aloblastosis.
TRIAMTERENE
strated that doses of hydrochlorothiazide quivalent to single entity hydrochlorothia- WARNINGS: Hyperkalemia: Abnormal
evidence of teratogenicity at those doses Ophthalmic: xanthopsia, transient
sure still is not controlled, another anti- INDICATIONS AND USAGE: This fixed
HYDROCHLOROTHIAZIDE
Hypersensitivity: anaphylaxis, photo-
combination drug is not indicated for
TABLETS, USP
the initial therapy of edema or hyper-
37.5 mg/25 mg and
Triamterene: Triamterene is a potassi-
tension except in individuals in whom
triamterene and hydrochlorothiazide.
neous vasculitis), fever, respiratory dis- 75 mg/50 mg
the development of hypokalemia can-
Hy per kalemia is more likely to occur in with relatively weak natriuretic properties.
not be risked.
Other: muscle cramps and weakness,
It exerts its diuretic effect on the distal 1. Triamterene and hy dro chlor othiazide renal tubule to inhibit the reabsorption of and well-controlled studies with triamter- DESCRIPTION: Triamterene and hydro -
Hyperuricemia: Hyperuricemia may
PRECAUTIONS: General: Electrolyte Im -
balance and BUN Increases: Pa tients
nificant difference from control incidence bioavailable formulations to this product receiving triamterene and hydrochlorothi- natriuretic agent, hydrochlorothiazide.
only if the potential benefit justifies the Altered Laboratory Findings: Serum
tablets are also indicated for those pa - Hydrochlorothiazide: Two-year feeding azide. Tri am terene is not a competitive fluid or electrolyte imbalances, i.e., hy - Metabolic and Endocrine Effects: The
Electrolytes: hyperkalemia, hypo -
Triamterene: Reproduction studies have HOW SUPPLIED: Triamterene and Hydro-
without signs of thyroid disturbance.
hypokal emia cannot be risked (e.g., pa - observed in pa tients with Addison’s dis- ease, i.e., without aldo ster one. Triamter- azides. Pathological changes in the para - Creatinine, Blood Urea Nitrogen: Re -
ene’s onset and dur ation of activity is thyroid gland with hypercalcemia and hy - round tablets debossed with MYLAN on
should be performed at appropriate inter- lar weak ness, fatigue, flaccid paralysis Triamterene, USP . . . . . . . . . . 75 mg one side of the tablet and TH above the
vals. Serum and urine electrolyte determi- evidence of harm to the fetus due to tri- dictable antihypertensive effect has been few patients on prolonged thiazide thera- score and 2 below the score on the other
patient is vomiting or receiving parenteral Glucose: hyperglycemia, glycosuria and
the following inactive ingredients: col - ing oral administration. Peak plas ma lev- diabetes mellitus (see PRECAUTIONS).
1 mg/kg/day based on a 50 kg patient).
fluid and electrolyte im balance include: Serum Uric Acid, PBI and Calcium: (see
discontinued be fore carrying out tests for dryness of mouth, thirst, weakness, leth - lized to the sulfate conjugate of hydroxy - Hydrochlorothiazide: Hydrochlorothiazide Store at 20° to 25°C (68° to 77°F). [See
Other: Elevated liver enzymes have been
crystalline cellu lose, powdered cel lulose pains or cramps, muscular fatigue, hypo - USP Controlled Room Temperature.]
Usage in Pregnancy: The routine use of
tients may be increased, de creased or un - Protect from light.
alone should be substituted. If the serum trointestinal disturbances such as nausea OVERDOSAGE: No specific data are avail -
vigorous therapy is required. The clinical 50 mg of hydrochlorothiazide in triamter- phenyl pteridine. Triamterene is practically Hypersensitivity: Sensitivity reactions to
of pregnancy, and there is no satisfacto- Mutagenesis: Studies of the mutagenic
for rats, based on body-weight, and equal and no specific antidote is available.
in soluble in water, benzene, chloroform, to 282 for mice and 206 for rats, based on ether and dilute alkali hydroxides. It is without a history of allergy or bronchial tion, sodium bi carbonate solution and/or soluble in formic acid and sparingly solu- ous doses of liquid preparations of triam- stances (as in liver disease or renal dis- Triamterene: Triamterene was not muta- of harm to the fetus. There are, however, ble in methoxyethanol. Triamterene is very glucose with a rapid-acting insulin prep - genic in bacteria (S. typhimurium strains no adequate and well controlled studies in elicit hyperkalemia, dehydration, nausea, slightly soluble in acetic acid, alcohol and aration. Cationic exchange resins such as dilute mineral acids. Its molecular weight quences of pregnancy. Thiazides are indi- sodium polystyrene sulfonate may be oral- Mylan Pharmaceuticals Inc.
daily). Single daily doses of 75 mg triam- restriction, rather than administration of ly or rectally administered. Persistent hy - Drug Interactions: Thiazides may add to
thiazide has been associated with hy po - pathologic causes, just as they are in the or potentiate the action of other antihy- Chinese hamster ovary (CHO) cells in vitro with or without metabolic activa- Mylan Institutional Inc.
in pregnancy, resulting from restriction of coma) and gastro intestinal irritation.
Nonteratogenic Effects: Thiazides and
exchanges in CHO cells in vitro with and properly treated through elevation of the ive. Ther apy with triamterene and hydro- zide therapy, especially with brisk diure- lower extremities and use of support hose; TIONS). Patients with mild renal function- Hydrochlorothiazide: Hydrochlorothiazide chlorothiazide should be discontinued.
to the 25 mg of hy drochlorothiazide in tri- sis, when severe cirrhosis is present, or blood. The use of thiazides and triamter- hy dro-2H-1,2,4, benzothiadiazine-7-sul- use of diuretics to lower intravascular vol- was not genotoxic in in vitro assays using Induce emesis or institute gastric lavage.
fonamide 1,1-dioxide. Hydro chloro thia zide ume in this case is illogical and unneces- Monitor serum electrolyte levels and fluid is slightly soluble in water and freely solu- sary. There is hypervolemia during normal and TA 1538 of Salmonella typhim urium longed thiazide therapy. However, hy po - possible hazards to the fetus. These haz- ble in sodium hydroxide solution, n-buty- pregnancy which is harmful to neither the evaluations in which various doses of liq- kalemia of this type is usually prevented ards in clude fetal or neonatal jaundice, patients with impaired renal function.
trolyte balance, respiratory, cardiovascu- spar ingly soluble in methanol and insolu- cardiovascular disease), but which is as - tions, or in in vivo assays using mouse ble in ether, chloroform and dilute mineral DOSAGE AND ADMINISTRATION: The
acids. Its molecular weight is 297.73. Its insert on lithium before use of such con- thiazide (25 mg given once daily). Single Nursing Mothers: Thiazides and triam-
trolyte intake will also contribute to hy - the Dros ophila sex-linked recessive lethal daily doses of 37.5 mg triamterene result- fort, increased recumbency will often pro- ed in greater in creases in serum potassi- one or two tablets daily, given as a sin- vide relief. In rare in stances, this edema obtained in the in vitro CHO sister chro- ap pears in animal milk and this may oc - hydrochlorothiazide administration to el - the toxic effects of digitalis (e.g., in - matid exchange (clastogenicity) test, and der ly patients and patients with im paired human breast milk. If use of the combina- ty) assays, using concentrations of hydro- no ad ditional elevations in serum po tas - tion drug product is deemed essential, the chlorothiazide of 43 to 1300 mcg/mL.
nitrogen level (BUN), creatinine level or with triamterene and hydrochlorothiazide.
Positive test results were also obtained in ship of triamterene was also evaluated in CONTRAINDICATIONS: Hyperkalemia:
Pediatric Use: Safety and effectiveness
CLINICAL PHARMACOLOGY: Triamterene
both. This is probably not the re sult of the Aspergillus nidulans nondisjunction in pediatric patients have not been estab- renal toxicity but is secondary to a re - used very cautiously, if at all, in conjunc- chlorothiazide given 25 mg twice daily.
should not be used in the presence of ele- anti hypertensive drug product, principally versible reduction of the glomerular fil- due to its hy dro chlorothiazide component; tration rate or a depletion of the intra - Impairment of Fertility: Studies of the
ADVERSE REACTIONS: Side effects ob -
than or equal to 5.5 mEq/liter). If hyper- chlorothiazide) tablet daily or more than served in association with the use of tri- fashion. However, the combination of tri- tassium should be monitored frequently.
trolytes must be frequently monitored.
lets, other combination products contain- Drug/Laboratory Test Inter actions: Tri-
Hydrochlorothiazide: Hydrochlorothia-
increased frequency of elevation in serum Antikaliuretic Therapy or Potassium
properties of angiotensin-converting en - products containing triamterene or hydro- BUN and creatinine levels. The larg est in - Supplementation: Triamterene and
Hydrochlorothiazide: Hydrochlorothiazide agent. It blocks the renal tubular absorp- hydrochlorothiazide should not be given to had no adverse ef fects on the fertility of Gastrointestinal: jaundice (intrahepatic
tiously, if at all, with these a gents (see hepatic disease or renal insufficiencies.
cholestatic jaundice), pancreatitis, nau- Carcinogenesis, Mutagen esis, Impair -
by a secondary loss of potassium and bi - daily, the largest dose tested. Ordinarily, amiloride hydrochloride or other formula- Metabolic or Respiratory Acidosis:
ment of Fertility: Carcinogenesis: Long
carbonate. Onset of hydrochlorothiazide’s triamterene does not en tirely compensate term studies with triamterene and hy dro - diuretic effect oc curs within 2 hours and anorexia, gastric irritation, cramping.
for the kaliuretic effect of hydrochlorothia- also be avoided in severely ill patients in the peak action takes place in 4 hours.
Hepatic Coma: Triamterene and hydro-
Central Nervous System: drowsiness and
Triamterene: In studies conducted under Diuretic activity persists for ap proxi mately chlorothiazide should be used with caution (mice) and 4 (rats) on the basis of body- in patients with impaired hepatic function and hydrochlorothiazide. In some individ- or progressive liver disease, since minor Impaired Renal Function: Triamterene
alterations of fluid and electrolyte balance thiazide’s antihypertensive action is not Cardiovascular: tachycardia, shortness of
and hydrochlorothiazide is contraindicat- Pregnancy: Teratogenic Effects. Cate-
gory C: Triamterene and Hydrochlorothi-
cretion and redistribution of body sodium.
Renal Stones: Triamterene has been re -
chronic renal in sufficiency or significant azide: Animal reproduction studies to absorbed and are bio equivalent to liquid Acute Myopia and Secondary Angle-
posed to the highest tested concentration determine the potential for fetal harm by Renal: acute renal failure, acute in ter -
Hypersensitivity: Triamterene and hydro-
Closure Glaucoma: Hydrochlorothiazide,
stitial nephritis, renal stones com posed of triamterene in association with other cal- influence the ab sorp tion of triamterene or patients who are hypersensitive to triam- cratic reaction, resulting in acute tran- terene or hydrochlorothiazide or other sul- Folic Acid Deficiency: Triamterene is a
about 45 and 60 mg/kg/day, respectively.
Hematologic: leukopenia, agranulocyto-
lar pain and typically occur within hours

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