inzirqo
Pharmaranks rates Inzirqo 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Inzirqo (Hydrochlorothiazide) is a thiazide diuretic used to treat Edema, Heart Failure, Hypertension, Nephrotic Syndrome.
Hydrochlorothiazide · by Novitium Pharma
Available as a generic: Hydrochlorothiazide
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Hydrochlorothiazide
- Drug class
- Thiazide Diuretic
- Form
- Powder
- Strength
- Hydrochlorothiazide 10MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- edema, heart failure, hypertension
- Manufacturer
- Novitium Pharma
- Half-life
- about 6 to 15 hours (the label reports a range, not a single number) (how long it stays in your system)
- What the pharmacy pays
- ~$0.91 for 30 — not your price
- FDA application
- NDA219141
What is Inzirqo?
From the FDA label:Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. The molecular formula is C 7 H 8 ClN 3 O 4 S 2 and the molecular weight is 297.74. INZIRQO (hydrochlorothiazide) is supplied in one strength as an off-white to light-brown colored powder for oral suspension. When reconstituted with 66 mL of water, the total volume of the suspension is 80 mL containing 10 mg/mL of hydrochlorothiazide, USP. In addition, INZIRQO contains the following inactive ingredients: anhydrous citric acid, caramel flavor (artificial flavor, caramel, maltodextrin, molasses, propylene glycol, salt and sucrose), cellulose, peppermint flavor (acacia and natural flavor), potassium sorbate, sucrose, talc and xanthan gum. structure
How to use
For the treatment of hypertension in adults: The recommended initial dose in adults is 25 mg orally daily given as a single dose. As needed, increase the dose to 50 mg orally daily, given as a single or two divided doses(2.1). For the treatment of edema in adults: The recommended adult dosage is 25 mg to 100 mg orally daily as a single or divided dose. Consider intermittent therapy to reduce the risk of electrolyte imbalances, i.e., administration on alternate days or on 3 to 5 days each week (2.2). For the treatment of hypertension and edema in pediatric patients: The recommended pediatric dosage is 1 mg/kg to 2 mg/kg orally per day in single or two divided doses. Do not exceed 37.5 mg per day in patients less than 2 years of age or 100 mg per day in children 2 to less than 13 years of age. Patients less than 6 months of age may require doses up to 3 mg/kg orally per day in two divided doses (2.1, 2.2). 2.1 Recommended Dosage for the Treatment of Hypertension The recommended initial dose in adults is 25 mg orally daily given as a single dose. As needed, increase the dose to 50 mg orally daily, given as a single or two divided doses. Pediatric Patients: The recommended dose in pediatric patients is 1 to 2 mg/kg per day in one or two divided doses not to exceed 37.5 mg in patients less than 2 years of age and 100 mg in patients 2 to less than 13 years of age. In pediatric…
Side effects
The following adverse reactions with INZIRQO are described elsewhere: Impaired Renal Function [see Warnings and Precautions (5.1)] Electrolyte Abnormalities [see Warnings and Precautions (5.2)] Metabolic Disturbances [see Warnings and Precautions (5.3)] Systemic Lupus Erythematosus [see Warnings and Precautions (5.4)] Acute Angle-Closure Glaucoma and Acute Myopia [see Warnings and Precautions (5.5)] Adverse reactions include hypokalemia, hyponatremia, hypomagnesemia, hyperglycemia, hyperuricemia, hyperlipidemia and hypotension. See Adverse Reactions (6) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Gastrointestinal: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis),…
Warnings
Important safety information
Monitor kidney function periodically (5.1) Monitor and correct serum electrolytes prior to use and monitor periodically (5.2). Monitor blood sugar, lipid levels, uric acid and calcium levels periodically. (5.3) Exacerbation or activation of systemic lupus erythematosus (5.4) Acute angle-closure glaucoma and acute myopia (5.5) 5.1 Impaired Renal Function Monitor kidney function periodically. Diuretics can cause hypovolemia which may precipitate acute kidney injury. Patients with chronic kidney disease, heart failure, or volume depletion may be at particular risk of developing acute renal failure on INZIRQO. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on INZIRQO. 5.2 Electrolyte Abnormalities INZIRQO can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, and hypochloremic alkalosis. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Hypokalemia is dose dependent. Monitor and correct serum electrolytes prior to use and monitor periodically. Discontinue INZIRQO if hypokalemia is associated with clinical symptoms (e.g., ECG changes, muscular weakness). 5.3 Metabolic Disturbances INZIRQO may increase blood sugar levels, affect diabetes control, and cause changes in the need for diabetes medication. INZIRQO may raise serum levels of cholesterol and triglycerides. Monitor blood sugar and lipid levels. INZIRQO may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Increases in serum uric acid are dose related. INZIRQO decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving INZIRQO. Discontinue thiazides before carrying out tests for parathyroid function. 5.4 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. 5.5 Acute Angle-Closure Glaucoma and Acute Myopia Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in acute angle closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions. 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 may result in permanent vision loss. Discontinue drug intake. Consider prompt medical or surgical treatments if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Who should not take Inzirqo
INZIRQO is contraindicated: In patients with anuria. In patients with hypersensitivity to hydrochlorothiazide or any ingredient in INZIRQO. In patients with hypersensitivity to sulfonamide-derived drugs. Anuria (4) Hypersensitivity to hydrochlorothiazide or any ingredient in INZIRQO (4) Hypersensitivity to sulfonamide-derived drugs (4)
Overdose — what happens if you take too much
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
NSAID: May lead to increased risk of renal impairment and loss of diuretic and antihypertensive effect (7.1). Cholestyramine and colestipol: Reduced absorption of thiazides (7.1) Lithium: Increased lithium concentrations and lithium toxicity (7.2) Antidiabetic drugs: Dosage adjustment of antidiabetic may be required (7.2) 7.1 Potential for Other Drugs to Affect INZIRQO Non-Steroidal Anti-Inflammatory Agents: Administration of a nonsteroidal anti-inflammatory agent, including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Therefore, when INZIRQO and nonsteroidal anti-inflammatory agents are used concomitantly, check to determine if the desired effect of the diuretic is obtained. Cholestyramine and Colestipol : Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Stagger the dosage of INZIRQO and the resin such that INZIRQO is administered at least 4 hours before or 4 to 6 hours after the administration of the resin. 7.2 Potential for INZIRQO to Affect Other Drugs Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of hydrochlorothiazide. Monitor serum lithium levels during concomitant use and adjust the lithium dose during concomitant administration or discontinuation of hydrochlorothiazide. Antidiabetic Drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required when coadministered with hydrochlorothiazide.
How long does Hydrochlorothiazide stay in your body?
The elimination half-life of hydrochlorothiazide is about 6 to 15 hours (the label reports a range, not a single number) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma ELIMINATION half-life. Plasma levels fall bi-exponentially: other FDA labels for hydrochlorothiazide combination products describe a distribution phase of roughly 2 hours before the ~10-hour (6-15 h) elimination phase — the elimination figure is the one given here. Hydrochlorothiazide is NOT a prodrug and is NOT metabolized, so there is no active metabolite that outlasts the parent; more than 95% of the absorbed dose is excreted unchanged in urine. Kidney impairment: the label states plainly that in patients with renal disease plasma concentrations are increased and the elimination half-life is PROLONGED — it does not quantify by how much. The label does not state a different half-life for older adults or for liver impairment, so no number should be assumed for those groups. Absorption (not elimination) is reduced in congestive heart failure. This is a pharmacokinetic figure about how long the drug stays in plasma; it is not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — HYDROCHLOROTHIAZIDE capsule, Clinical Pharmacology (Pharmacokinetics and Metabolism).
Drug class
May treat (source: NIH RxClass)
See how Inzirqo ranks — best-rated thiazide diuretic for:
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Inzirqo treat?
- Inzirqo (Hydrochlorothiazide) may be used to treat edema, heart failure, hypertension, nephrotic syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Inzirqo rated?
- pharmaranks gives Inzirqo a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Inzirqo cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.91 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Inzirqo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Inzirqo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Inzirqo?
- Inzirqo is marketed by Novitium Pharma. You can see Novitium Pharma's full profile, rating, and other products on pharmaranks.
- Is Inzirqo a brand-name or generic drug?
- Inzirqo is a brand-name product with the active ingredient Hydrochlorothiazide. Lower-cost generic equivalents containing Hydrochlorothiazide are available — ask your pharmacist.
- Is Inzirqo available over the counter?
- No. Inzirqo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Inzirqo come in?
- Inzirqo is currently marketed as powder, per the FDA's National Drug Code Directory.
- What class of drug is Inzirqo?
- Inzirqo is classified as thiazide diuretic, per the FDA's Established Pharmacologic Class.
- Is Inzirqo FDA-registered?
- Inzirqo is on record with the U.S. FDA under application number NDA219141. You can verify this on its official FDA label.
- Has Inzirqo been recalled by the FDA?
- Inzirqo has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Inzirqo safe?
- There's no single safe-or-not verdict. pharmaranks gives Inzirqo a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Inzirqo?
- Inzirqo's side effects are taken directly from its FDA label. From the label: The following adverse reactions with INZIRQO are described elsewhere: Impaired Renal Function [see Warnings and Precautions (5.1)] Electrolyte Abnormalities [see Warnings and Precautions (5.2)] Metabolic Disturbances [see Warnings and Precautions (5.3)] Systemic Lupus Erythematosus [see Warnings and… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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inzirqo
70/100