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Minizide
Overview
What is Minizide?
MINIZIDE is a combination of MINIPRESS (prazosin hydrochloride) plus RENESE (polythiazide).
MINIPRESS (prazosin hydrochloride), a quinazoline derivative, is the first of that chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:
It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of MINIPRESS (prazosin hydrochloride) contains drug equivalent to 1 mg free base.
RENESE (polythiazide) is an orally effective, non-mercurial diuretic, saluretic, and antihypertensive agent.
It is designated chemically as 2-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-2-methyl-3-[[(2,2,2-trifluoroethyl)thio]methyl]-,1,1-dioxide, and has the following structural formula:
It is a white, crystalline substance insoluble in water, but readily soluble in alkaline solution.
Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Green 3, Red 3 and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.
What does Minizide look like?
What are the available doses of Minizide?
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What should I talk to my health care provider before I take Minizide?
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How should I use Minizide?
MINIZIDE is indicated in the treatment of hypertension. (See .)
Dosage: as determined by individual titration of MINIPRESS (prazosin hydrochloride) and RENESE (polythiazide). (See .)
Usual MINIZIDE dosage is one capsule two or three times daily, the strength depending upon individual requirement following titration.
The following is a general guide to the administration of the individual components of MINIZIDE:
What interacts with Minizide?
RENESE (polythiazide) is contraindicated in patients with anuria, and in patients known to be sensitive to thiazides or to other sulfonamide derivatives.
What are the warnings of Minizide?
MINIPRESS (prazosin hydrochloride)
MINIPRESS may cause syncope with sudden loss of consciousness. In most cases this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120–160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of MINIPRESS. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient's regimen with caution (see ). Hypotension may develop in patients given MINIPRESS who are also receiving a beta-blocker such as propranolol.
If syncope occurs, the patient should be placed in the recumbent position and treated supportively as necessary. This adverse effect is self-limiting and in most cases does not recur after the initial period of therapy or during subsequent dose titration.
Patients should always be started on the 1 mg capsules of MINIPRESS (prazosin hydrochloride). The 2 and 5 mg capsules are not indicated for initial therapy.
More common than loss of consciousness are the symptoms often associated with lowering of the blood pressure, namely, dizziness and lightheadedness. The patient should be cautioned about these possible adverse effects and advised what measures to take should they develop. The patient should also be cautioned to avoid situations where injury could result should syncope occur during the initiation of MINIPRESS therapy.
RENESE (polythiazide)
RENESE should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Thiazides may be additive or potentiative of the action of other antihypertensive drugs.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance, namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Medications such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop with thiazides as with any potent diuretic, especially with brisk diuresis, when severe cirrhosis is present, or during concomitant use of corticosteroids or ACTH.
Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate the metabolic effects of hypokalemia, especially with reference to myocardial activity.
Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in hepatic or renal disease). 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.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Insulin requirements in diabetic patients may be either increased, decreased, or unchanged. Latent diabetes mellitus may become manifest during thiazide administration.
Thiazide drugs may increase responsiveness to tubocurarine.
The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.
Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy.
Thiazides may decrease serum protein-bound iodine levels without signs of thyroid disturbance.
What are the precautions of Minizide?
Drug/Laboratory Test Interactions
In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary VMA of 17%. Therefore, false positive results may occur in screening tests for pheochromocytoma in patients who are being treated with prazosin. If an elevated VMA is found, prazosin should be discontinued and the patient retested after a month.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenic or mutagenic studies have been conducted with MINIZIDE. However, no carcinogenic potential was demonstrated in 18 month studies in rats with either MINIPRESS or RENESE at dose levels more than 100 times the usual maximum human doses. MINIPRESS was not mutagenic in genetic toxicology studies.
MINIZIDE produced no impairment of fertility in male or female rats at 50 and 25 mg/kg/day of MINIPRESS and RENESE respectively. In chronic studies (one year or more) of MINIPRESS in rats and dogs, testicular changes consisting of atrophy and necrosis occurred at 25 mg/kg/day (60 times the usual maximum recommended human dose). No testicular changes were seen in rats or dogs at 10 mg/kg/day (24 times the usual maximum recommended human dose). In view of the testicular changes observed in animals, 105 patients on long term MINIPRESS therapy were monitored for 17-ketosteroid excretion and no changes indicating a drug effect were observed. In addition, 27 males on MINIPRESS alone for up to 51 months did not have changes in sperm morphology suggestive of drug effect.
Use in Pregnancy
Pregnancy Category C. MINIZIDE was not teratogenic in either rats or rabbits when administered in oral doses more than 100 times the usual maximum human dose. Studies in rats indicated that the combination of RENESE (40 times the usual maximum recommended human dose) and MINIPRESS (8 times the usual maximum recommended human dose) caused a greater number of stillbirths, a more prolonged gestation, and a decreased survival of pups to weaning than that caused by MINIPRESS alone. There are no adequate and well controlled studies in pregnant women. Therefore, MINIZIDE should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether MINIPRESS or RENESE is excreted in human milk. Thiazides appear in breast milk. Thus, if use of the drug is deemed essential the patient should stop nursing.
Pediatric Use
Safety and effectiveness in children has not been established.
What are the side effects of Minizide?
MINIPRESS (prazosin hydrochloride)
The most common reactions associated with MINIPRESS therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug.
The following reactions have been associated with MINIPRESS, some of them rarely. (In some instances exact causal relationships have not been established.)
Gastrointestinal:
Cardiovascular:
Central Nervous System:
Dermatologic:
Genitourinary:
EENT:
Other:
Single reports of pigmentary mottling and serous retinopathy, and a few reports of cataract development or disappearance have been reported. In these instances, the exact causal relationship has not been established because the baseline observations were frequently inadequate.
In more specific slit-lamp and funduscopic studies, which included adequate baseline examinations, no drug-related abnormal ophthalmological findings have been reported.
Literature reports exist associating MINIPRESS therapy with a worsening of pre-existing narcolepsy. A causal relationship is uncertain in these cases.
RENESE (polythiazide)
Gastrointestinal:
Central Nervous System:
Hematologic:
Dermatologic:
Cardiovascular:
Other:
What should I look out for while using Minizide?
RENESE (polythiazide) is contraindicated in patients with anuria, and in patients known to be sensitive to thiazides or to other sulfonamide derivatives.
What might happen if I take too much Minizide?
How should I store and handle Minizide?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArraySodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.Sodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.Sodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.Sodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.Sodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.Sodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.Sodium Iodide I-123 capsules for oral administration are supplied as follows:Product No. 2031 - 3.7 MBq (100 µCi) - orange capsule - NDC 17156-201-05Product No. 2032 - 7.4 MBq (200 µCi) - orange/white capsule - NDC 17156-522-05At calibration time, each capsule has an activity of 3.7 MBq (100 µCi) or 7.4 MBq (200 µCi). Each gelatin capsule contains not more than 20 µg sodium hydroxide and not more than 1 g of sucrose. Each capsule also contains FD&C Yellow No. 6.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(c) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.The single dose capsule is supplied with a desiccant in a plastic container that is enclosed in a labeled lead shield.One extra shield label is supplied with each single capsule for attachment to a shielded container other than the one in which the drug product is supplied. The capsule should be stored at room temperature below 30°C, 86°F. The expiration date has been determined to be 24 hours after calibration time and date.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
MINIZIDE produces a more pronounced antihypertensive response than occurs after either prazosin hydrochloride or polythiazide alone in equivalent doses.
Non-Clinical Toxicology
RENESE (polythiazide) is contraindicated in patients with anuria, and in patients known to be sensitive to thiazides or to other sulfonamide derivatives.Steady-state serum concentrations of tricyclic antidepressants are reported to fluctuate significantly when cimetidine is either added or deleted from the drug regimen. Serious anticholinergic symptoms (severe dry mouth, urinary retention, blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressants when cimetidine is added to the drug regimen. In addition, higher-than expected steady-state serum concentrations of tricyclic antidepressants have been observed when therapy is initiated in patients already taking cimetidine.
In well-controlled patients undergoing concurrent therapy with cimetidine, a decrease in the steady-state serum concentrations of tricyclic antidepressants may occur when cimetidine therapy is discontinued. The therapeutic efficacy of tricyclic antidepressants may be compromised in these patients when cimetidine is discontinued. Several of the tricyclic antidepressants have been cited in these reports.
There have been greater than 2-fold increases in previously stable plasma levels of other antidepressants, including nortriptyline, when fluoxetine hydrochloride has been administered in combination with these agents. Fluoxetine and its active metabolite, norfluoxetine, have long half-lives (4 to 16 days for norfluoxetine), that may affect strategies during conversion from one drug to the other.
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs or sympathomimetic drugs.
The patient should be informed that the response to alcohol may be exaggerated.
In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary VMA of 17%. Therefore, false positive results may occur in screening tests for pheochromocytoma in patients who are being treated with prazosin. If an elevated VMA is found, prazosin should be discontinued and the patient retested after a month.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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