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Quinapril Hydrochloride/hydrochlorothiazide (Quinapril Hydrochloride/hydrochlorothiazide)

Trade Name : Quinapril Hydrochloride/Hydrochlorothiazide

Lake Erie Medical DBA Quality Care Products LLC

TABLET, FILM COATED

Strength 2012.5 mg/1mg/1

QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Quinapril Hydrochloride/hydrochlorothiazide (Quinapril Hydrochloride/hydrochlorothiazide) which is also known as Quinapril Hydrochloride/Hydrochlorothiazide and Manufactured by Lake Erie Medical DBA Quality Care Products LLC. It is available in strength of 20; 12.5 mg/1; mg/1 per ml. Read more

Quinapril Hydrochloride/hydrochlorothiazide (Quinapril Hydrochloride/hydrochlorothiazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Quinapril hydrochloride/hydrochlorothiazide is a fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. n Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Itsu00a0molecular formula is CHNO. HCl and its structural formula is:
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  • Quinapril hydrochloride/hydrochlorothiazide tablets are indicated for the treatment of hypertension.u00a0 This fixed combination is not indicated for the initial therapy of hypertension (see ).n In using quinapril hydrochloride/hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see ).n n n n n n Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
  • Quinapril hydrochloride/hydrochlorothiazidetablets are contraindicated in patients who are hypersensitive to quinapril or hydrochlorothiazide and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.n Because of the hydrochlorothiazide components, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. n Do not co-administer aliskiren with quinapril hydrochloride/hydrochlorothiazide tablets in patients with diabetes.
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  • Quinapril hydrochloride/hydrochlorothiazidehas been evaluated for safety in 1571 patients in controlled and uncontrolled studies. Of these, 498 were given quinapril plus hydrochlorothiazide for at least 1 year, with 153 patients extending combination therapy for over 2 years. In clinical trials with quinapril hydrochloride/hydrochlorothiazide, no adverse experience specific to the combination has been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with quinapril or hydrochlorothiazide.n Adverse experiences were usually mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy because of adverse effects was required in 2.1% in patients in controlled studies. The most common reasons for discontinuation of therapy with quinapril hydrochloride/hydrochlorothiazidewere cough (1%; see ) and headache (0.7%).n Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 943 patients treated with quinapril plus hydrochlorothiazide in controlled trials are shown below.u00a0 n
  • Postmarketing Experience
  • Clinical Laboratory Test Findingsn- Serum Electrolytes:n- Arrayn- Arrayn- Arrayn- PBI and Tests of Parathyroid Function:n- Arrayn- Arrayn- Arrayn- Arrayn- Array
  • No specific information is available on the treatment of overdosage with quinapril hydrochloride/hydrochlorothiazide or quinapril monotherapy; treatment should be symptomatic and supportive. Therapy with quinapril hydrochloride/hydrochlorothiazide should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.u00a0n The oral median lethal dose of quinapril/hydrochlorothiazide in combination ranges from 1063/664 to 4640/2896 mg/kg in mice and rats. Doses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg.u00a0n Data from human overdoses of ACE inhibitors are scanty; the most likely manifestation of human quinapril overdosage is hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.u00a0n Laboratory determinations of serum levels of quinapril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of quinapril overdose.u00a0n No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of quinapril and its metabolites. Hemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat.u00a0n Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of quinapril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of quinapril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat quinapril overdose by infusion of normal saline solution.
  • As individual monotherapy, quinapril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg and hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of quinapril/hydrochlorothiazide combination therapy using quinapril doses of 2.5 to 40 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing dose of either component.n The side effects (see ) of quinapril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of quinapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens that combine low doses of hydrochlorothiazide with quinapril produce minimal effects on serum potassium. In clinical trials of quinapril/hydrochlorothiazide, the average change in serum potassium was near zero in subjects who received HCTZ 6.25 mg in the combination, and the average subject who received 10 to 40/12.5 to 25 mg experienced a milder reduction in serum potassium than that experienced by the average subject receiving the same dose of hydrochlorothiazide monotherapy.n To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.n n Patients whose blood pressures are not adequately controlled with quinapril monotherapy may instead be given quinapril/hydrochlorothiazide 10/12.5 or 20/12.5. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve blood pressure control with less electrolyte disturbance if they are switched to quinapril/hydrochlorothiazide 10/12.5 or 20/12.5.n n n n n For convenience, patients who are adequately treated with 20 mg of quinapril and 25 mg of hydrochlorothiazide and experience no significant electrolyte disturbances may instead wish to receive quinapril/hydrochlorothiazide 20/25.n n n n n Regimens of therapy with quinapril hydrochloride/hydrochlorothiazide tablets need not take account of renal function as long as the patientu2019s creatinine clearance is >30 mL/min/ 1.73 m (serum creatinine roughly u22643 mg/dL or 265 u00b5mol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides. Therefore, quinapril hydrochloride/hydrochlorothiazide tablets are not recommended for use in these patients.
  • Quinapril Hydrochloride/Hydrochlorothiazideu00a010 mg/12.5 mg* Tabletsn- Quinapril Hydrochloride/Hydrochlorothiazide 20 mg/12.5 mg* Tablets
  • NDC: 35356-998-60u00a0 Bottles of 60
  • NDC: 35356-998-90u00a0 Bottles of 90n n *Quinapril hydrochloride equivalent to 20 mg of quinapril.n n are Pink colored, round shaped, biconvex, film-coated tablets debossed with u2018Du2019 on one side and u201820u2019 on other side.n n *Quinapril hydrochloride equivalent to 20 mg of quinapril.n n 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from light.n Manufactured for:n n 2400 Route 130 NorthDayton, NJ 08810n Manufactured by:n n Hyderabadu2013500 072, Indian Revised: 10/2012
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