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Dyazide

Dosage Form: capsule
Dyazide®

(hydrochlorothiazide/triamterene)

Capsules

Dyazide Description

Each capsule of Dyazide (hydrochlorothiazide and triamterene) for oral use, with opaque red cap and opaque white body, contains hydrochlorothiazide 25 mg and triamterene 37.5 mg, and is imprinted with the product name Dyazide and SB. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent.

Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1, 2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is:

At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol.

Triamterene is 2, 4, 7-triamino-6-phenylpteridine and its structural formula is:

Inactive ingredients consist of benzyl alcohol, cetylpyridinium chloride, D&C Red No. 33, FD&C Yellow No. 6, gelatin, glycine, lactose, magnesium stearate, microcrystalline cellulose, povidone, polysorbate 80, sodium starch glycolate, titanium dioxide, and trace amounts of other inactive ingredients.

Capsules of Dyazide meet Drug Release Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules.

Dyazide - Clinical Pharmacology

Dyazide is a diuretic/antihypertensive drug product that combines natriuretic and antikaliuretic effects. Each component complements the action of the other. The hydrochlorothiazide component blocks the reabsorption of sodium and chloride ions, and thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen, and chloride ions. Hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide, and may reduce glomerular filtration rate. The exact mechanism of the antihypertensive effect of hydrochlorothiazide is not known.

The triamterene component of Dyazide exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen ions. Its natriuretic activity is limited by the amount of sodium reaching its site of action. Although it blocks the increase in this exchange that is stimulated by mineralocorticoids (chiefly aldosterone), it is not a competitive antagonist of aldosterone and its activity can be demonstrated in adrenalectomized rats and patients with Addison’s disease. As a result, the dose of triamterene required is not proportionally related to the level of mineralocorticoid activity, but is dictated by the response of the individual patients, and the kaliuretic effect of concomitantly administered drugs. By inhibiting the distal tubular exchange mechanism, triamterene maintains or increases the sodium excretion and reduces the excess loss of potassium, hydrogen and chloride ions induced by hydrochlorothiazide. As with hydrochlorothiazide, triamterene may reduce glomerular filtration and renal plasma flow. Via this mechanism it may reduce uric acid excretion although it has no tubular effect on uric acid reabsorption or secretion. Triamterene does not affect calcium excretion. No predictable antihypertensive effect has been demonstrated for triamterene.

Duration of diuretic activity and effective dosage range of the hydrochlorothiazide and triamterene components of Dyazide are similar. Onset of diuresis with Dyazide takes place within 1 hour, peaks at 2 to 3 hours and tapers off during the subsequent 7 to 9 hours.

Dyazide is well absorbed.

Upon administration of a single oral dose to fasted normal male volunteers, the following mean pharmacokinetic parameters were determined:

	AUC(0-48) ng*hrs/mL (± SD)	Cmax ng/mL (± SD)	Median Tmax Hrs	Ae Mg (± SD)
Triamterene	148.7 (87.9)	46.4 (29.4)	1.1	2.7 (1.4)
hydroxytriamterene   sulfate	1,865 (471)	720 (364)	1.3	19.7 (6.1)
hydrochlorothiazide	834 (177)	135.1 (35.7)	2.0	14.3 (3.8)

where AUC(0-48), Cmax, Tmax and Ae represent area under the plasma concentration versus time plot, maximum plasma concentration, time to reach Cmax, and amount excreted in urine over 48 hours.

A capsule of Dyazide is bioequivalent to a single-entity 25 mg hydrochlorothiazide tablet and 37.5 mg triamterene capsule used in the double-blind clinical trial below (see Clinical Trials).

In a limited study involving 12 subjects, coadministration of Dyazide with a high-fat meal resulted in: (1) an increase in the mean bioavailability of triamterene by about 67% (90% confidence interval = 0.99, 1.90), p-hydroxytriamterene sulfate by about 50% (90% confidence interval = 1.06, 1.77), hydrochlorothiazide by about 17% (90% confidence interval = 0.90, 1.34); (2) increases in the peak concentrations of triamterene and p-hydroxytriamterene; and (3) a delay of up to 2 hours in the absorption of the active constituents.

Clinical Trials

A placebo-controlled, double-blind trial was conducted to evaluate the efficacy of Dyazide. This trial demonstrated that Dyazide (25 mg hydrochlorothiazide/37.5 mg triamterene) was effective in controlling blood pressure while reducing the incidence of hydrochlorothiazide-induced hypokalemia. This trial involved 636 patients with mild to moderate hypertension controlled by hydrochlorothiazide 25 mg daily and who had hypokalemia (serum potassium <3.5 mEq/L) secondary to the hydrochlorothiazide. Patients were randomly assigned to 4 weeks’ treatment with once-daily regimens of 25 mg hydrochlorothiazide plus placebo, or 25 mg hydrochlorothiazide combined with one of the following doses of triamterene: 25 mg, 37.5 mg, 50 mg, or 75 mg.

Blood pressure and serum potassium were monitored at baseline and throughout the trial. All five treatment groups had similar mean blood pressure and serum potassium concentrations at baseline (mean systolic blood pressure range: 137±14 mmHg to 140±16 mmHg; mean diastolic blood pressure range: 86±9 mmHg to 88±8 mmHg; mean serum potassium range: 2.3 to 3.4 mEq/L with the majority of patients having values between 3.1 and 3.4 mEq/L).

While all triamterene regimens reversed hypokalemia, at week 4 the 37.5 mg regimen proved optimal compared with the other tested regimens. On this regimen, 81% of the patients had a significant (p<0.05) reversal of hypokalemia vs. 59% of patients on the placebo/hydrochlorothiazide regimen. The mean serum potassium concentration on 37.5 mg triamterene went from 3.2±0.2 mEq/L at baseline to 3.7±0.3 mEq/L at week 4, a significantly greater (p<0.05) improvement than that achieved with placebo/hydrochlorothiazide (i.e., 3.2±0.2 mEq/L at baseline and 3.5±0.4 mEq/L at week 4). Also, 51% of patients in the 37.5 mg triamterene group had an increase in serum potassium of ≥0.5 mEq/L at week 4 vs. 33% in the placebo group. The 37.5 mg triamterene/25 mg hydrochlorothiazide regimen also maintained control of blood pressure; mean supine systolic blood pressure at week 4 was 138±21 mmHg while mean supine diastolic blood pressure was 87±13 mmHg.

Indications and Usage for Dyazide

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

Dyazide is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.

Dyazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

Dyazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since Dyazide may enhance the action of these agents, dosage adjustments may be necessary.

Usage in Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.

Contraindications

Antikaliuretic Therapy and Potassium Supplementation

Dyazide should not be given to patients receiving other potassium-sparing agents such as spironolactone, amiloride, or other formulations containing triamterene. Concomitant potassium-containing salt substitutes should also not be used.

Potassium supplementation should not be used with Dyazide except in severe cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary.

Impaired Renal Function

Dyazide is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment.

Hypersensitivity

Hypersensitivity to either drug in the preparation or to other sulfonamide-derived drugs is a contraindication.

Hyperkalemia

Dyazide should not be used in patients with preexisting elevated serum potassium.

Warnings

Hyperkalemia: Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including Dyazide. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving Dyazide, when dosages are changed or with any illness that may influence renal function.

If hyperkalemia is suspected (warning signs include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, and shock), an electrocardiogram (ECG) should be obtained. However, it is important to monitor serum potassium levels because hyperkalemia may not be associated with ECG changes.

If hyperkalemia is present, Dyazide should be discontinued immediately and a thiazide alone should be substituted. If the serum potassium exceeds 6.5 mEq/liter more vigorous therapy is required. The clinical situation dictates the procedures to be employed. These include the intravenous administration of calcium chloride solution, sodium bicarbonate solution, and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.

The development of hyperkalemia associated with potassium-sparing diuretics is accentuated in the presence of renal impairment (see CONTRAINDICATIONS section). Patients with mild renal functional impairment should not receive this drug without frequent and continuing monitoring of serum electrolytes. Cumulative drug effects may be observed in patients with impaired renal function. The renal clearances of hydrochlorothiazide and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following administration of Dyazide to elderly patients and patients with impaired renal function.

Hyperkalemia has been reported in diabetic patients with the use of potassium-sparing agents even in the absence of apparent renal impairment. Accordingly, serum electrolytes must be frequently monitored if Dyazide is used in diabetic patients.

Metabolic or Respiratory Acidosis

Potassium-sparing therapy should also be avoided in severely ill patients in whom respiratory or metabolic acidosis may occur. Acidosis may be associated with rapid elevations in serum potassium levels. If Dyazide is employed, frequent evaluations of acid/base balance and serum electrolytes are necessary.

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Precautions

Diabetes

Caution should be exercised when administering Dyazide to patients with diabetes, since thiazides may cause hyperglycemia, glycosuria, and alter insulin requirements in diabetes. Also, diabetes mellitus may become manifest during thiazide administration.

Impaired Hepatic Function

Thiazides should be used with caution in patients with impaired hepatic function. They can precipitate hepatic coma in patients with severe liver disease. Potassium depletion induced by the thiazide may be important in this connection. Administer Dyazide cautiously and be alert for such early signs of impending coma as confusion, drowsiness, and tremor; if mental confusion increases discontinue Dyazide for a few days. Attention must be given to other factors that may precipitate hepatic coma, such as blood in the gastrointestinal tract or preexisting potassium depletion.

Hypokalemia

Hypokalemia is uncommon with Dyazide; but, should it develop, corrective measures should be taken such as potassium supplementation or increased intake of potassium-rich foods. Institute such measures cautiously with frequent determinations of serum potassium levels, especially in patients receiving digitalis or with a history of cardiac arrhythmias. If serious hypokalemia (serum potassium less than 3.0 mEq/L) is demonstrated by repeat serum potassium determinations, Dyazide should be discontinued and potassium chloride supplementation initiated. Less serious hypokalemia should be evaluated with regard to other coexisting conditions and treated accordingly.

Electrolyte Imbalance

Electrolyte imbalance, often encountered in such conditions as heart failure, renal disease or cirrhosis of the liver, may also be aggravated by diuretics and should be considered during therapy with Dyazide when using high doses for prolonged periods or in patients on a salt-restricted diet. Serum determinations of electrolytes should be performed, and are particularly important if the patient is vomiting excessively or receiving fluids parenterally. Possible fluid and electrolyte imbalance may be indicated by such warning signs as: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal symptoms.

Hypochloremia

Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis. Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Renal Stones

Triamterene has been found in renal stones in association with the other usual calculus components. Dyazide should be used with caution in patients with a history of renal stones.

Laboratory Tests

Serum Potassium

The normal adult range of serum potassium is 3.5 to 5.0 mEq per liter with 4.5 mEq often being used for a reference point. If hypokalemia should develop, corrective measures should be taken such as potassium supplementation or increased dietary intake of potassium-rich foods.

Institute such measures cautiously with frequent determinations of serum potassium levels. Potassium levels persistently above 6 mEq per liter require careful observation and treatment. Serum potassium levels do not necessarily indicate true body potassium concentration. A rise in plasma pH may cause a decrease in plasma potassium concentration and an increase in the intracellular potassium concentration. Discontinue corrective measures for hypokalemia immediately if laboratory determinations reveal an abnormal elevation of serum potassium.

Discontinue Dyazide and substitute a thiazide diuretic alone until potassium levels return to normal.

Serum Creatinine and BUN

Dyazide may produce an elevated blood urea nitrogen level, creatinine level or both. This apparently is secondary to a reversible reduction of glomerular filtration rate or a depletion of intravascular fluid volume (prerenal azotemia) rather than renal toxicity; levels usually return to normal when Dyazide is discontinued. If azotemia increases, discontinue Dyazide. Periodic BUN or serum creatinine determinations should be made, especially in elderly patients and in patients with suspected or confirmed renal insufficiency.

Serum PBI

Thiazide may decrease serum PBI levels without sign of thyroid disturbance.

Parathyroid Function

Thiazides should be discontinued before carrying out tests for parathyroid function. Calcium excretion is decreased by thiazides. Pathologic changes in the parathyroid glands with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism such as bone resorption and peptic ulceration have not been seen.

Drug Interactions

Angiotensin-converting Enzyme Inhibitors

Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia.

Oral Hypoglycemic Drugs

Concurrent use with chlorpropamide may increase the risk of severe hyponatremia.

Nonsteroidal Anti-inflammatory Drugs

A possible interaction resulting in acute renal failure has been reported in a few patients on Dyazide when treated with indomethacin, a nonsteroidal anti-inflammatory agent. Caution is advised in administering nonsteroidal anti-inflammatory agents with Dyazide.

Lithium

Lithium generally should not be given with diuretics because they reduce its renal clearance and increase the risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy with Dyazide.

Surgical Considerations

Thiazides have been shown to decrease arterial responsiveness to norepinephrine (an effect attributed to loss of sodium). This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the paralyzing effect of nondepolarizing muscle relaxants such as tubocurarine (an effect attributed to potassium loss); consequently caution should be observed in patients undergoing surgery.

Other Considerations

Concurrent use of hydrochlorothiazide with amphotericin B or corticosteroids or corticotropin (ACTH) may intensify electrolyte imbalance, particularly hypokalemia, although the presence of triamterene minimizes the hypokalemic effect.

Thiazides may add to or potentiate the action of other antihypertensive drugs. See INDICATIONS AND USAGE for concomitant use with other antihypertensive drugs.

The effect of oral anticoagulants may be decreased when used concurrently with hydrochlorothiazide; dosage adjustments may be necessary.

Dyazide may raise the level of blood uric acid; dosage adjustments of antigout medication may be necessary to control hyperuricemia and gout.

The following agents given together with triamterene may promote serum potassium accumulation and possibly result in hyperkalemia because of the potassium-sparing nature of triamterene, especially in patients with renal insufficiency: blood from blood bank (may contain up to 30 mEq of potassium per liter of plasma or up to 65 mEq per liter of whole blood when stored for more than 10 days); low-salt milk (may contain up to 60 mEq of potassium per liter); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).

Exchange resins, such as sodium polystyrene sulfonate, whether administered orally or rectally, reduce serum potassium levels by sodium replacement of the potassium; fluid retention may occur in some patients because of the increased sodium intake.

Chronic or overuse of laxatives may reduce serum potassium levels by promoting excessive potassium loss from the intestinal tract; laxatives may interfere with the potassium-retaining effects of triamterene.

The effectiveness of methenamine may be decreased when used concurrently with hydrochlorothiazide because of alkalinization of the urine.

Drug/Laboratory Test Interactions

Triamterene and quinidine have similar fluorescence spectra; thus, Dyazide will interfere with the fluorescent measurement of quinidine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies have not been conducted with Dyazide (the triamterene/hydrochlorothiazide combination), or with triamterene alone.

Hydrochlorothiazide

Two-year feeding studies in mice and rats, conducted under the auspices of the National Toxicology Program (NTP), treated mice and rats with doses of hydrochlorothiazide up to 600 and 100 mg/kg/day, respectively. On a body-weight basis, these doses are 600 times (in mice) and 100 times (in rats) the Maximum Recommended Human Dose (MRHD) for the hydrochlorothiazide component of Dyazide at 50 mg/day (or 1.0 mg/kg/day based on 50 kg individuals). On the basis of body-surface area, these doses are 56 times (in mice) and 21 times (in rats) the MRHD. These studies uncovered no evidence of carcinogenic potential of hydrochlorothiazide in rats or female mice, but there was equivocal evidence of hepatocarcinogenicity in male mice.

Mutagenesis

Studies of the mutagenic potential of Dyazide (the triamterene/hydrochlorothiazide combination), or of triamterene alone have not been performed.

Hydrochlorothiazide

Hydrochlorothiazide was not genotoxic in in vitro assays using strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of Salmonella typhimurium (the Ames test); in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations; or in in vivo assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained in the in vitro CHO Sister Chromatid Exchange (clastogenicity) test, and in the mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide of 43 to 1300 mcg/mL. Positive test results were also obtained in the Aspergillus nidulans nondisjunction assay, using an unspecified concentration of hydrochlorothiazide.

Impairment of Fertility

Studies of the effects of Dyazide (the triamterene/hydrochlorothiazide combination), or of triamterene alone on animal reproductive function have not been conducted.

Hydrochlorothiazide

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation. Corresponding multiples of the MRHD are 100 (mice) and 4 (rats) on the basis of body-weight and 9.4 (mice) and 0.8 (rats) on the basis of body-surface area.

Pregnancy: Category C

Teratogenic Effects

Dyazide

Animal reproduction studies to determine the potential for fetal harm by Dyazide have not been conducted. However, a One Generation Study in the rat approximated composition of Dyazide by using a 1:1 ratio of triamterene to hydrochlorothiazide (30:30 mg/kg/day); there was no evidence of teratogenicity at those doses which were, on a body-weight basis, 15 and 30 times, respectively, the MRHD, and on the basis of body-surface area, 3.1 and 6.2 times, respectively, the MRHD.

The safe use of Dyazide in pregnancy has not been established since there are no adequate and well-controlled studies with Dyazide in pregnant women. Dyazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Triamterene

Reproduction studies have been performed in rats at doses as high as 20 times the MRHD on the basis of body-weight, and 6 times the human dose on the basis of body-surface area without evidence of harm to the fetus due to triamterene.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Hydrochlorothiazide

Hydrochlorothiazide was orally administered to pregnant mice and rats during respective periods of major organogenesis at doses up to 3,000 and 1,000 mg/kg/day, respectively. At these doses, which are multiples of the MRHD equal to 3,000 for mice and 1,000 for rats, based on body-weight, and equal to 282 for mice and 206 for rats, based on body-surface area, there was 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 and triamterene have been shown to cross the placental barrier and appear in cord blood. The use of thiazides and triamterene in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possible other adverse reactions which have occurred in the adult.

Nursing Mothers

Thiazides and triamterene in combination have not been studied in nursing mothers. Triamterene appears in animal milk; this may occur in humans. Thiazides are excreted in human breast milk. If use of the combination drug product is deemed essential, the patient should stop nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Adverse effects are listed in decreasing order of severity.

Hypersensitivity

Anaphylaxis, rash, urticaria, subacute cutaneous lupus erythematosus-like reactions, photosensitivity.

Cardiovascular

Arrhythmia, postural hypotension.

Metabolic

Diabetes mellitus, hyperkalemia, hypokalemia, hyponatremia, acidosis, hypercalcemia, hyperglycemia, glycosuria, hyperuricemia, hypochloremia.

Gastrointestinal

Jaundice and/or liver enzyme abnormalities, pancreatitis, nausea and vomiting, diarrhea, constipation, abdominal pain.

Renal

Acute renal failure (one case of irreversible renal failure has been reported), interstitial nephritis, renal stones composed primarily of triamterene, elevated BUN, and serum creatinine, abnormal urinary sediment.

Hematologic

Leukopenia, thrombocytopenia and purpura, megaloblastic anemia.

Musculoskeletal

Muscle cramps.

Central Nervous System

Weakness, fatigue, dizziness, headache, dry mouth.

Miscellaneous

Impotence, sialadenitis.

Thiazides alone have been shown to cause the following additional adverse reactions:

Central Nervous System

Paresthesias, vertigo.

Ophthalmic

Xanthopsia, transient blurred vision.

Respiratory

Allergic pneumonitis, pulmonary edema, respiratory distress.

Other

Necrotizing vasculitis, exacerbation of lupus.

Hematologic

Aplastic anemia, agranulocytosis, hemolytic anemia.

Neonate and infancy

Thrombocytopenia and pancreatitis−rarely, in newborns whose mothers have received thiazides during pregnancy.

Skin

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

Dyazide Dosage and Administration

The usual dose of Dyazide is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect (see WARNINGS, Hyperkalemia).

Overdosage

Electrolyte imbalance is the major concern (see WARNINGS section). Symptoms reported include: polyuria, nausea, vomiting, weakness, lassitude, fever, flushed face, and hyperactive deep tendon reflexes. If hypotension occurs, it may be treated with pressor agents such as levarterenol to maintain blood pressure. Carefully evaluate the electrolyte pattern and fluid balance. Induce immediate evacuation of the stomach through emesis or gastric lavage. There is no specific antidote.

Reversible acute renal failure following ingestion of 50 tablets of a product containing a combination of 50 mg triamterene and 25 mg hydrochlorothiazide has been reported. Although triamterene is largely protein-bound (approximately 67%), there may be some benefit to dialysis in cases of overdosage.

How is Dyazide Supplied

Capsules containing 25 mg hydrochlorothiazide and 37.5 mg triamterene, in bottles of 1,000 capsules; in Patient-Pak™ unit-of-use bottles of 100.

They are supplied as follows:

NDC 0007-3650-22–in Patient-Pak™ unit-of-use bottles of 100.

NDC 0007-3650-30–bottles of 1,000.

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Dispense in a tight, light-resistant container.

GlaxoSmithKline

Research Triangle Park, NC 27709

Dyazide is a registered trademark of GlaxoSmithKline.

©2011, GlaxoSmithKline. All rights reserved.

February 2011

DYZ:74PI

Principal Display Panel

NDC 0007-3650-30

Dyazide®

25 MG HYDROCHLOROTHIAZIDEAND 37.5 MG TRIAMTERENE

CAPSULES

Rx only

1000 Capsules

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Protect from light. Dispense in a tight, light-resistant container.

Each capsule contains 25 mg hydrochlorothiazide and 37.5 mg triamterene.

Dyazide capsules meet Drug Release Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules.

Usual Dosage: 1or 2 capsules once daily. See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

GlaxoSmithKline

RTP, NC 27709

Made in Canada

Rev. 7/08

A059478

Dyazide  hydrochlorothiazide and triamterene  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0007-3650 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg TRIAMTERENE (TRIAMTERENE) TRIAMTERENE 37.5 mg

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   D&C RED NO. 33   FD&C YELLOW NO. 6   GELATIN   GLYCINE   LACTOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POVIDONE   POLYSORBATE 80   TITANIUM DIOXIDE   SODIUM STARCH GLYCOLATE TYPE A POTATO   CETYLPYRIDINIUM CHLORIDE

Product Characteristics Color RED (opaque red) , WHITE (opaque white) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code Dyazide;SB Contains

Packaging # NDC Package Description Multilevel Packaging 1 0007-3650-22 100 CAPSULE In 1 BOTTLE None 2 0007-3650-30 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016042	03/30/1994

Labeler - GlaxoSmithKline LLC (167380711)

Revised: 01/2012GlaxoSmithKline LLC

Amikacina Teva

Amikacina Teva may be available in the countries listed below.

Ingredient matches for Amikacina Teva

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Amikacina Teva in the following countries:

• Italy

International Drug Name Search

Gyno miconazolnitraat PCH

Gyno miconazolnitraat PCH may be available in the countries listed below.

Ingredient matches for Gyno miconazolnitraat PCH

Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Gyno miconazolnitraat PCH in the following countries:

• Netherlands

International Drug Name Search

Oxistat

In the US, Oxistat (oxiconazole topical) is a member of the drug class topical antifungals and is used to treat Tinea Corporis, Tinea Cruris, Tinea Pedis and Tinea Versicolor.

US matches:

• Oxistat Cream


• Oxistat Lotion


• Oxistat


• Oxistat Topical

Ingredient matches for Oxistat

Oxiconazole

Oxiconazole is reported as an ingredient of Oxistat in the following countries:

• United States

Oxiconazole nitrate (a derivative of Oxiconazole) is reported as an ingredient of Oxistat in the following countries:

• Mexico


• United States

International Drug Name Search

Targretin

Targretin is a brand name of bexarotene, approved by the FDA in the following formulation(s):

TARGRETIN (bexarotene - capsule; oral)

• 
  Manufacturer: EISAI INC
  
  Approval date: December 29, 1999
  
  Strength(s): 75MG ^[RLD]

Has a generic version of Targretin been approved?

No. There is currently no therapeutically equivalent version of Targretin available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Targretin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Compounds having selective activity for Retinoid X Receptors, and means for modulation of processes mediated by Retinoid X Receptors
  Patent 5,780,676
  Issued: July 14, 1998
  Inventor(s): Boehm; Marcus F. & Heyman; Richard A. & Zhi; Lin & Hwang; Chan Kou & White; Steve & Nadzan; Alex
  Assignee(s): Ligand Pharmaceuticals Incorporated
  Compounds, compositions, and methods for modulating processes mediated by Retinoid X Receptors using retinoid-like compounds which have activity selective for members of the subclass of Retinoid X Receptors (RXRs), in preference to members of the subclass of Retinoic Acid Receptors (RARs). Examples of such compounds are bicyclic benzyl, pyridinyl, thiophene, furanyl, pyrrole, and poiyenoic acid derivatives including carbocyclic polyenoic acids. The disclosed methods employ compounds for modulating processes selectively mediated by Retinoid X Receptors.
  
  Patent expiration dates:
  
  
  • July 14, 2015
    
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• 
  Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors
  Patent 5,962,731
  Issued: October 5, 1999
  Inventor(s): Boehm; Marcus F. & Heyman; Richard A.
  Assignee(s): Ligand Pharmaceuticals Incorporated
  Compounds, compositions, and methods for modulating processes mediated by Retinoid X Receptors using retinoid-like compounds which have activity selective for members of the subclass of Retinoid X Receptors (RXRs), in preference to members of the subclass of Retinoic Acid Receptors (RARs). Examples of such compounds are bicyclic benzyl, pyridinyl, thiophene, furanyl, and pyrrole derivatives. The disclosed methods employ compounds for modulating processes selectively mediated by Retinoid X Receptors.
  
  Patent expiration dates:
  
  
  • October 5, 2016
    
    ✓ 
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• 
  Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors
  Patent 6,043,279
  Issued: March 28, 2000
  Inventor(s): Boehm; Marcus F. & Heyman; Richard A.
  Assignee(s): Ligand Pharmaceuticals, Incorporated
  Compounds, compositions, and methods for modulating processes mediated by Retinoid X Receptors using retinoid-like compounds which have activity selective for members of the subclass of Retinoid X Receptors (RXRs), in preference to members of the subclass of Retinoic Acid Receptors (RARs). Examples of such compounds are bicyclic benzyl, pyridinyl, thiophene, furanyl, and pyrrole derivatives. The disclosed methods employ compounds for modulating processes selectively mediated by Retinoid X Receptors.
  
  Patent expiration dates:
  
  
  • April 22, 2012
    
    ✓ 
    Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
  
  



• 
  Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors
  Patent 6,320,074
  Issued: November 20, 2001
  Inventor(s): Boehm; Marcus F. & Heyman; Richard A. & Zhi; Lin & Koch; Stacie Canan
  Assignee(s): Ligand Pharmaceuticals Incorporated
  Compounds, compositions, and methods for modulating processes mediated by Retinoid X Receptors using retinoid-like compounds which have activity selective for members of the subclass of Retinoid X Receptors (RXRs), in preference to members of the subclass of Retinoic Acid Receptors (RARs). Examples of such compounds are bicyclic benzyl, pyridinyl, thiophene, furanyl, and pyrrole derivatives. The disclosed methods employ compounds for modulating processes selectively mediated by Retinoid X Receptors.
  
  Patent expiration dates:
  
  
  • April 22, 2012
    
    ✓ 
    Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
    ✓ 
    Drug substance
  
  



• 
  Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors
  Patent 7,655,699
  Issued: February 2, 2010
  Inventor(s): Boehm; Marcus F. & Heyman; Richard A.
  Assignee(s): Eisai Inc.
  Compounds, compositions, and methods for modulating processes mediated by Retinoid X Receptors using retinoid-like compounds which have activity selective for members of the subclass of Retinoid X Receptors (RXRs), in preference to members of the subclass of Retinoic Acid Receptors (RARs). Examples of such compounds are bicyclic benzyl, pyridinyl, thiophene, furanyl, pyrrole, and polyenoic acid derivatives including carbocyclic polyenoic acids. The disclosed methods employ compounds for modulating processes selectively mediated by Retinoid X Receptors.
  
  Patent expiration dates:
  
  
  • April 22, 2012
    
    ✓ 
    Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  

See also...

• Targretin Consumer Information (Wolters Kluwer)
• Targretin Consumer Information (Cerner Multum)
• Targretin Advanced Consumer Information (Micromedex)
• Targretin AHFS DI Monographs (ASHP)
• Bexarotene Consumer Information (Wolters Kluwer)
• Bexarotene Consumer Information (Cerner Multum)
• Bexarotene Advanced Consumer Information (Micromedex)
• Bexarotene AHFS DI Monographs (ASHP)

Apex Enrofloxacin

Apex Enrofloxacin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Apex Enrofloxacin

Enrofloxacin

Enrofloxacin is reported as an ingredient of Apex Enrofloxacin in the following countries:

• Australia

International Drug Name Search

Morfina Cloridrato + Atropina Solfato Monico

Morfina Cloridrato + Atropina Solfato Monico may be available in the countries listed below.

Ingredient matches for Morfina Cloridrato + Atropina Solfato Monico

Atropine

Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Morfina Cloridrato + Atropina Solfato Monico in the following countries:

• Italy

Morphine

Morphine hydrochloride (a derivative of Morphine) is reported as an ingredient of Morfina Cloridrato + Atropina Solfato Monico in the following countries:

• Italy

International Drug Name Search

Anxit

Anxit may be available in the countries listed below.

Ingredient matches for Anxit

Flupentixol

Flupentixol dihydrochloride (a derivative of Flupentixol) is reported as an ingredient of Anxit in the following countries:

• Bangladesh

International Drug Name Search

Alfacef

Alfacef may be available in the countries listed below.

Ingredient matches for Alfacef

Ceftazidime

Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Alfacef in the following countries:

• Vietnam

International Drug Name Search

Ibupain

Ibupain may be available in the countries listed below.

Ingredient matches for Ibupain

Ibuprofen

Ibuprofen is reported as an ingredient of Ibupain in the following countries:

• South Africa

Paracetamol

Paracetamol is reported as an ingredient of Ibupain in the following countries:

• South Africa

International Drug Name Search

dichlorphenamide

Generic Name: dichlorphenamide (dye klor FEN a mide)

Brand Names: Daranide

What is dichlorphenamide?

Dichlorphenamide is a carbonic anhydrase inhibitor. Carbonic anhydrase is a protein in your body. Dichlorphenamide reduces the activity of this protein.

Dichlorphenamide is used to treat glaucoma. By inhibiting the actions of carbonic anhydrase, dichlorphenamide reduces the amount of fluid produced in your eyes and therefore also reduces pressure.

Dichlorphenamide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about dichlorphenamide?

Call your doctor immediately if you experience a sore throat, fever, unusual bleeding or bruising, tingling or tremors in your hands or feet, pain in your side or groin, or a rash. These symptoms could be early signs of a serious side effect.

Use caution when driving, operating machinery, or performing other hazardous activities. Dichlorphenamide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid prolonged exposure to sunlight. Dichlorphenamide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What should I discuss with my healthcare provider before taking dichlorphenamide?

Tell your doctor if you have ever had an allergic reaction to a sulfa-based drug such as sulfamethoxazole (e.g., Bactrim, Septra, Gantanol). Dichlorphenamide is also a sulfa-based drug, and you may have a similar reaction to it.

Before taking dichlorphenamide, tell your doctor if you

• 
  

  are on aspirin therapy,

  
  


• 
  

  have liver disease,

  
  


• 
  

  have kidney disease,

  
  


• 
  

  have heart disease,

  
  


• 
  

  have lung disease, or

  
  


• 
  

  have a hormonal disease.

  
  

You may not be able to take dichlorphenamide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Dichlorphenamide is in the FDA pregnancy category C. This means that it is not known whether dichlorphenamide will harm an unborn baby. Do not take dichlorphenamide without first talking to your doctor if you are pregnant. It is not known whether dichlorphenamide passes into breast milk. Do not take dichlorphenamide without first talking to your doctor if you are breast-feeding a baby.

How should I take dichlorphenamide?

Take dichlorphenamide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Store dichlorphenamide at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a dichlorphenamide overdose include drowsiness, decreased appetite, nausea, vomiting, dizziness, numbness or tingling, shaking, and ringing in the ears.

What should I avoid while taking dichlorphenamide?

Use caution when driving, operating machinery, or performing other hazardous activities. Dichlorphenamide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid prolonged exposure to sunlight. Dichlorphenamide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Dichlorphenamide side effects

If you experience any of the following serious side effects, seek emergency medical attention:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  
  


• 
  

  a sore throat or a fever;

  
  


• 
  

  unusual bleeding or bruising;

  
  


• 
  

  side or groin pain;

  
  


• 
  

  tingling or tremors in your hands or feet; or

  
  


• 
  

  a rash.

  
  

Other, less serious side effects may be more likely to occur. Continue to take dichlorphenamide and talk to your doctor if you experience

• 
  

  decreased appetite, nausea, vomiting, constipation, diarrhea, or changes in taste;

  
  


• 
  

  drowsiness, dizziness, fatigue, or weakness;

  
  


• 
  

  nervousness or tremor;

  
  


• 
  

  headache or confusion;

  
  


• 
  

  increased sensitivity of the skin to sunlight;

  
  


• 
  

  worsening gout;

  
  


• 
  

  loss of blood sugar control (if you are diabetic);

  
  


• 
  

  ringing in your ears or hearing problems; or

  
  


• 
  

  changes in your vision.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect dichlorphenamide?

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  cyclosporine (Sandimmune). Cyclosporine may have more side effects if it is taken with dichlorphenamide.

  
  


• 
  

  primidone (Mysoline). Primidone may not be as effective if it is taken with dichlorphenamide, and seizure control may be reduced.

  
  


• 
  

  diflunisal (Dolobid). Diflunisal may increase both the activity and the side effects of dichlorphenamide.

  
  


• 
  

  aspirin, salsalate (Disalcid, Salflex, Salsitab, others), choline salicylate (Arthropan), magnesium salicylate (Doan's, Magan, Mobidin), and other aspirin-like products (salicylates). These medicines may also interact with dichlorphenamide, and special monitoring of your therapy may be necessary.

  
  


• 
  

  lithium (Lithobid, Eskalith, others). Dichlorphenamide may decrease the level of lithium in your blood. Special monitoring or a dosage adjustment may be necessary.

  
  

Drugs other than those listed here may also interact with dichlorphenamide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More dichlorphenamide resources

• Dichlorphenamide Drug Interactions
• Dichlorphenamide Support Group
• 0 Reviews for Dichlorphenamide - Add your own review/rating

Compare dichlorphenamide with other medications

• Glaucoma
• Glaucoma/Intraocular Hypertension

Where can I get more information?

• Your pharmacist has more information about dichlorphenamide written for health professionals that you may read.

What does my medication look like?

Dichlorphenamide is available with a prescription under the brand name Daranide. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Daranide 50 mg--round, yellow tablets

  
  

CalciDoc

CalciDoc may be available in the countries listed below.

Ingredient matches for CalciDoc

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of CalciDoc in the following countries:

• Germany

Colecalciferol

Colecalciferol is reported as an ingredient of CalciDoc in the following countries:

• Germany

International Drug Name Search

Gentamicina Genfar

Gentamicina Genfar may be available in the countries listed below.

Ingredient matches for Gentamicina Genfar

Gentamicin

Gentamicin is reported as an ingredient of Gentamicina Genfar in the following countries:

• Colombia


• Ecuador


• Peru

International Drug Name Search

Fluconazol AC Farma

Fluconazol AC Farma may be available in the countries listed below.

Ingredient matches for Fluconazol AC Farma

Fluconazole

Fluconazole is reported as an ingredient of Fluconazol AC Farma in the following countries:

• Peru

International Drug Name Search

Pilocarpin Puroptal

Pilocarpin Puroptal may be available in the countries listed below.

Ingredient matches for Pilocarpin Puroptal

Pilocarpine

Pilocarpine hydrochloride (a derivative of Pilocarpine) is reported as an ingredient of Pilocarpin Puroptal in the following countries:

• Austria

International Drug Name Search

Ambroxolo Actavis

Ambroxolo Actavis may be available in the countries listed below.

Ingredient matches for Ambroxolo Actavis

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxolo Actavis in the following countries:

• Italy

International Drug Name Search

Chlorhexidine Alcoolique Gilbert

Chlorhexidine Alcoolique Gilbert may be available in the countries listed below.

Ingredient matches for Chlorhexidine Alcoolique Gilbert

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Chlorhexidine Alcoolique Gilbert in the following countries:

• France

International Drug Name Search

Zyflox

Zyflox may be available in the countries listed below.

Ingredient matches for Zyflox

Ofloxacin

Ofloxacin is reported as an ingredient of Zyflox in the following countries:

• Indonesia

International Drug Name Search

Ebastina Teva

Ebastina Teva may be available in the countries listed below.

Ingredient matches for Ebastina Teva

Ebastine

Ebastine is reported as an ingredient of Ebastina Teva in the following countries:

• Spain

International Drug Name Search

Clobetasol Propionate

Ingredient matches for Clobetasol Propionate

Clobetasol

Clobetasol Propionate (BANM, USAN) is known as Clobetasol in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Supervit

Supervit may be available in the countries listed below.

Ingredient matches for Supervit

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Supervit in the following countries:

• Peru

International Drug Name Search

Vetrecal

Vetrecal may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Vetrecal

Sodium Phosphate

Sodium Phosphate is reported as an ingredient of Vetrecal in the following countries:

• New Zealand

International Drug Name Search

Desogestrel / Ethinylestradiol Biogaran

Desogestrel/Ethinylestradiol Biogaran may be available in the countries listed below.

Ingredient matches for Desogestrel/Ethinylestradiol Biogaran

Desogestrel

Desogestrel is reported as an ingredient of Desogestrel/Ethinylestradiol Biogaran in the following countries:

• France

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Desogestrel/Ethinylestradiol Biogaran in the following countries:

• France

International Drug Name Search

Astrocast

Astrocast may be available in the countries listed below.

Ingredient matches for Astrocast

Budesonide

Budesonide is reported as an ingredient of Astrocast in the following countries:

• Greece

International Drug Name Search

Clenbuterol Actavis

Clenbuterol Actavis may be available in the countries listed below.

Ingredient matches for Clenbuterol Actavis

Clenbuterol

Clenbuterol hydrochloride (a derivative of Clenbuterol) is reported as an ingredient of Clenbuterol Actavis in the following countries:

• Lithuania

International Drug Name Search

Nisural

Nisural may be available in the countries listed below.

Ingredient matches for Nisural

Nimesulide

Nimesulide is reported as an ingredient of Nisural in the following countries:

• Chile

International Drug Name Search

Robitussin Cold and Cough

Generic Name: dextromethorphan, guaifenesin, and pseudoephedrine (dex troe meth OR fan, gwye FEN e sin, soo doe e FED rin)

Brand Names: Altarussin CF, Ambifed-G DM, Relacon-DM NR, Robitussin Cold and Cough, Robitussin Pediatric Cough and Decongestant, Suda-Tussin DM, Touro CC, Touro CC-LD, Tussafed-LA

What is Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of dextromethorphan, guaifenesin, and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and chest congestion caused by the common cold or flu.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan, guaifenesin, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant, expectorant, or cough suppressant. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before using Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use this medicine if you are allergic to dextromethorphan, guaifenesin, or pseudoephedrine.

Before taking this medicine, tell your doctor if you are allergic to any drugs or if you have emphysema or chronic bronchitis. You may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take the medication with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant, expectorant, or cough suppressant.

Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


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  confusion, hallucinations; or

  
  


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  slow, shallow breathing.

  
  

Less serious side effects may include:

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  dizziness or headache,

  
  


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  a rash, or

  
  


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  nausea, vomiting, or stomach upset.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Robitussin Cold and Cough (dextromethorphan, guaifenesin, and pseudoephedrine)?

Before taking dextromethorphan, guaifenesin, and pseudoephedrine, tell your doctor if you are using any of the following drugs:

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  celecoxib (Celebrex);

  
  


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  cinacalcet (Sensipar);

  
  


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  darifenacin (Enablex);

  
  


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  imatinib (Gleevec);

  
  


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  quinidine (Quinaglute, Quinidex);

  
  


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  ranolazine (Ranexa)

  
  


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  ritonavir (Norvir);

  
  


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  sibutramine (Meridia);

  
  


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  terbinafine (Lamisil);

  
  


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  medicines to treat high blood pressure; or

  
  


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  antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

This list is not complete and there may be other drugs that can interact with dextromethorphan, guaifenesin, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Robitussin Cold and Cough resources

• Robitussin Cold and Cough Use in Pregnancy & Breastfeeding
• Robitussin Cold and Cough Drug Interactions
• Robitussin Cold and Cough Support Group
• 0 Reviews for Robitussin Cold and Cough - Add your own review/rating

• Ambi 60/580/30 Controlled-Release and Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Dextromethorphan/Guaifenesin/Pseudoephedrine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Robitussin Cold and Cough with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about dextromethorphan, guaifenesin, and pseudoephedrine.