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Guanfacine Hydrochloride 2 mg Tablet, 30-count — NDC 70518-3516-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guanfacine Hydrochloride 2 mg Tablet, 30-count — NDC 70518-3516-0 (Billing 70518-3516-00)

by REMEDYREPACK INC. · 30 TABLET in 1 BLISTER PACK

This is a package of 30 tablets of Guanfacine Hydrochloride 2 mg Tablet from REMEDYREPACK INC., marketed since Sep 2022 and currently FDA-listed. It is this product's only package size.

NDC 70518-3516-00
🏷️ FDA NDC (as labeled) 70518-3516-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-3516-0
Product NDC 70518-3516
11-digit billing NDC 70518351600
RxCUI 197746
UNII 30OMY4G3MK
Application # ANDA214689
SPL Set ID 1b1063ba-fee3-4540-9139-db4b915f82e2
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-13
Route ORAL
Dosage form TABLET
Substance GUANFACINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 011984
GCN 32481
HICL code 000120
Ingredient (HICL) Guanfacine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4B
Therapeutic class — specific (HIC3) Antihypertensives, Sympatholytic
AHFS code 24:24.00.00
AHFS class Central Alpha-Agonists
FDB label name GUANFACINE 2 MG TABLET
FDB brand name Guanfacine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011984
  • GCN: 32481
  • HICL (First Databank): 000120
  • AHFS class code: 24:24.00.00
  • RxCUI (RxNorm): 197746
Why two NDCs? The FDA registers this code as 70518-3516-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-3516-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Imidazoline receptor agonists
How it works Adrenergic alpha2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GUANFACINE 2 MG TABLET Ingredient Guanfacine Hcl
📖 What it is MedlinePlus · NLM

Guanfacine tablets (Tenex) are used alone or in combination with other medications to treat high blood pressure. Guanfacine extended-release (long-acting) tablets (Intuniv) are used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in children. Guanfacine is in a class of medications called centrally acting alpha2A-adrenergic receptor agonists. Guanfacine treats high blood pressure by decreasing heart rate and relaxing the blood...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used for both, depending on which form you have. The regular (immediate-release) tablet is prescribed for high blood pressure. The extended-release version — brand name Intuni...
  • What is guanfacine actually used for — is it for ADHD or blood pressure?
  • No, Intuniv is not a stimulant at all. It works on a different part of the brain than medications like Adderall or Ritalin. That's actually one reason it's sometimes used alongside...
  • My child takes Intuniv for ADHD — is it a stimulant?
📖 Read our full Guanfacine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Guanfacine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Guanfacine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-3516-00 You're viewing this Main listing 30 TABLET in 1 BLISTER PACK 2022-09-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Guanfacine 2 mg 00591-0453-01 Actavis 100 tablets $0.267 — Availability likely —
Guanfacine Hydrochloride 2 mg 24979-0199-01 TWi 100 tablets $0.267 AB Availability likely —
Guanfacine 2 mg 27241-0243-01 Ajanta 100 tablets $0.267 AB Availability likely —
Guanfacine Hydrochloride 2 mg 29300-0459-01 Unichem 100 tablets $0.267 AB Availability likely —
Guanfacine 2 mg 42806-0296-01 Epic 100 tablets $0.267 AB Availability likely —
Guanfacine Hydrochloride 2 mg 50268-0374-15 AvPAK 50 tablets $0.267 AB Availability likely —
Guanfacine Hydrochloride 2 mg 53746-0713-01 Amneal 100 tablets $0.267 AB Availability likely —
Guanfacine 2 mg 59651-0841-01 Aurobindo 100 tablets $0.267 AB Availability likely —
Guanfacine Hydrochloride 2 mg 62135-0728-90 Chartwell 90 tablets $0.267 AB Availability likely —
Guanfacine Hydrochloride 2 mg 70700-0302-01 XIROMED, 100 tablets $0.267 AB Availability likely —
Guanfacine 2 mg 72319-0019-04 i3 100 tablets $0.267 AB Availability likely —
Guanfacine Hydrochloride 2 mg 65162-0713-03 Amneal 30 tablets — AB FDA listed —
Guanfacine 2 mg 67046-1655-03 Coupler 30 tablets — AB FDA listed —
Guanfacine Hydrochloride 2 mgthis 70518-3516-00 REMEDYREPACK 30 tablets — AB FDA listed —
Guanfacine 2 mg 70518-4488-00 REMEDYREPACK 30 tablets — AB FDA listed —
Guanfacine 2 mg 70518-4564-00 REMEDYREPACK 30 tablets — AB FDA listed —
Guanfacine Hydrochloride 2 mg 72603-0269-01 NORTHSTAR 100 tablets — AB FDA listed —
Guanfacine 2 mg 72888-0124-00 Advagen 1000 tablets — AB FDA listed —
Guanfacine 2 mg 73141-0019-04 A2A 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue
ShapeRound
ImprintU;46
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA214689 (ANDA)
Labeler code70518
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio1,527 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Guanfacine tablets are indicated in the management of hypertension. Guanfacine tablets may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

⏱️ Dosage and Administration 148 words ▾

DOSAGE AND ADMINISTRATION The recommended initial dose of guanfacine tablets when given alone or in combination with another antihypertensive drug is 1 mg daily given at bedtime to minimize somnolence. If after 3 to 4 weeks of therapy 1 mg does not give a satisfactory result, a dose of 2 mg may be given, although most of the effect of guanfacine tablets are seen at 1 mg (see CLINICAL PHARMACOLOGY ). Higher daily doses have been used, but adverse reactions increase significantly with doses above 3 mg/day.

The frequency of rebound hypertension is low, but it can occur. When rebound occurs, it does so after 2 to 4 days, which is delayed compared with clonidine hydrochloride. This is consistent with the longer half-life of guanfacine.

In most cases, after abrupt withdrawal of guanfacine, blood pressure returns to pretreatment levels slowly (within 2 to 4 days) without ill effects.

⛔ Contraindications 13 words ▾

CONTRAINDICATIONS Guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Adverse reactions noted with guanfacine hydrochloride are similar to those of other drugs of the central α 2 -adrenoreceptor agonist class: dry mouth, sedation (somnolence), weakness (asthenia), dizziness, constipation, and impotence. While the reactions are common, most are mild and tend to disappear on continued dosing. Skin rash with exfoliation has been reported in a few cases; although clear cause and effect relationships to guanfacine hydrochloride could not be established, should a rash occur, guanfacine hydrochloride should be discontinued and the patient monitored appropriately.

In the dose-response monotherapy study described under CLINICAL PHARMACOLOGY , the frequency of the most commonly observed adverse reactions showed a dose relationship from 0.5 to 3 mg as follows: Adverse Reaction Placebo n=59 0.5 mg n=60 1 mg n=61 2 mg n=60 3 mg n=59 Dry Mouth 0% 10% 10% 42% 54% Somnolence 8% 5% 10% 13% 39% Asthenia 0% 2% 3% 7% 3% Dizziness 8% 12% 2% 8% 15% Headache 8% 13% 7% 5% 3% Impotence 0% 0% 0% 7% 3% Constipation 0% 2% 0% 5% 15% Fatigue 2% 2% 5% 8% 10% The percent of patients who dropped out because of adverse reactions are shown below for each dosage group.

Placebo 0.5 mg 1 mg 2 mg 3 mg Percent dropouts 0% 2.0% 5.0% 13% 32% The most common reasons for dropouts among patients who received guanfacine were dry mouth, somnolence, dizziness, fatigue, weakness, and constipation. In the 12-week, placebo-controlled, dose-response study of guanfacine administered with 25 mg chlorthalidone at bedtime, the frequency of the most commonly observed adverse reactions showed a clear dose relationship from 0.5 to 3 mg as follows: Adverse Reaction Placebo n=73 0.5 mg n=72 1 mg n=72 2 mg n=72 3 mg n=72 Dry Mouth 5 (7%) 4 (5%) 6 (8%) 8 (11%) 20 (28%) Somnolence 1 (1%) 3 (4%) 0 (0%) 1 (1%) 10 (14%) Asthenia 0 (0%) 2 (3%) 0 (0%) 2 (2%) 7 (10%) Dizziness 2 (2%) 1 (1%) 3 (4%) 6 (8%) 3 (4%) Headache 3 (4%) 4 (3%) 3 (4%) 1 (1%) 2 (2%) Impotence 1 (1%) 1 (0%) 0 (0%) 1 (1%) 3 (4%) Constipation 0 (0%) 0 (0%) 0 (0%) 1 (1%) 1 (1%) Fatigue 3 (3%) 2 (3%) 2 (3%) 5 (6%) 3 (4%) There were 41 premature terminations because of adverse reactions in this study.

The percent of patients who dropped out and the dose at which the dropout occurred were as follows: Dose Placebo 0.5 mg 1 mg 2 mg 3 mg Percent dropouts 6.9% 4.2% 3.2% 6.9% 8.3% Reasons for dropouts among patients who received guanfacine were: somnolence, headache, weakness, dry mouth, dizziness, impotence, insomnia, constipation, syncope, urinary incontinence, conjunctivitis, paresthesia, and dermatitis. In a second 12-week placebo-controlled combination therapy study in which the dose could be adjusted upward to 3 mg per day in 1-mg increments at 3-week intervals, i.e., a setting more similar to ordinary clinical use, the most commonly recorded reactions were: dry mouth, 47%; constipation, 16%; fatigue, 12%; somnolence, 10%; asthenia, 6%; dizziness, 6%; headache, 4%; and insomnia, 4%.

Reasons for dropouts among patients who received guanfacine were: somnolence, dry mouth, dizziness, impotence, constipation, confusion, depression, and palpitations. In the clonidine/guanfacine comparison described in CLINICAL PHARMACOLOGY , the most common adverse reactions noted were as follows: Adverse Reactions Guanfacine (n=279) Clonidine (n=278) Dry Mouth 30% 37% Somnolence 21% 35% Dizziness 11% 8% Constipation 10% 5% Fatigue 9% 8% Headache 4% 4% Insomnia 4% 3% Adverse reactions occurring in 3% or less of patients in the three controlled trials of guanfacine hydrochloride with a diuretic were: Cardiovascular - bradycardia, palpitations, substernal pain Gastrointestinal - abdominal pain, diarrhea, dyspepsia, dysphagia, nausea CNS - amnesia, confusion, depression, insomnia, libido decrease ENT disorders - rhinitis, taste perversion, tinnitus Eye disorders - conjunctivitis, iritis, vision disturbance Musculoskeletal - leg cramps, hypokinesia Respiratory - dyspnea Dermatologic - dermatitis, pruritus,… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 95 words ▾

Drug Interactions The potential for increased sedation when guanfacine hydrochloride is given with other CNS-depressant drugs should be appreciated. The administration of guanfacine concomitantly with a known microsomal enzyme inducer (phenobarbital or phenytoin) to two patients with renal impairment reportedly resulted in significant reductions in elimination half-life and plasma concentration. In such cases, therefore, more frequent dosing may be required to achieve or maintain the desired hypotensive response.

Further, if guanfacine is to be discontinued in such patients, careful tapering of the dosage may be necessary in order to avoid rebound phenomena (see Rebound above).

🤰 Pregnancy 101 words ▾

Pregnancy Administration of guanfacine to rats at 70 times the maximum recommended human dose and to rabbits at 20 times the maximum recommended human dose resulted in no evidence of harm to the fetus. Higher doses (100 and 200 times the maximum recommended human dose in rabbits and rats respectively) were associated with reduced fetal survival and maternal toxicity. Rat experiments have shown that guanfacine crosses the placenta.

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.

🧒 Pediatric Use 95 words ▾

Pediatric Use Safety and effectiveness in children under 12 years of age have not been demonstrated. Therefore, the use of guanfacine hydrochloride in this age group is not recommended. There have been spontaneous postmarketing reports of mania and aggressive behavioral changes in pediatric patients with attention-deficit hyperactivity disorder (ADHD) receiving guanfacine hydrochloride.

The reported cases were from a single center. All patients had medical or family risk factors for bipolar disorder. All patients recovered upon discontinuation of guanfacine HCl.

Hallucinations have been reported in pediatric patients receiving guanfacine hydrochloride for treatment of attention-deficit hyperactivity disorder.

🧓 Geriatric Use 88 words ▾

Geriatric Use Clinical studies of guanfacine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).

🆘 Overdosage 177 words ▾

OVERDOSAGE Signs and Symptoms Drowsiness, lethargy, bradycardia and hypotension have been observed following overdose with guanfacine. A 25-year-old female intentionally ingested 60 mg. She presented with severe drowsiness and bradycardia of 45 beats/minute.

Gastric lavage was performed and an infusion of isoproterenol (0.8 mg in 12 hours) was administered. She recovered quickly and without sequelae. A 28-year-old female who ingested 30 - 40 mg developed only lethargy, was treated with activated charcoal and a cathartic, was monitored for 24 hours, and was discharged in good health.

A 2-year-old male weighing 12 kg who ingested up to 4 mg of guanfacine developed lethargy. Gastric lavage (followed by activated charcoal and sorbitol slurry via NG tube) removed some tablet fragments within 2 hours after ingestion, and vital signs were normal. During 24-hour observation in ICU, systolic pressure was 58 and heart rate 70 at 16 hours post-ingestion.

No intervention was required, and child was discharged fully recovered the next day. Treatment of Overdosage Gastric lavage and supportive therapy as appropriate. Guanfacine is not dialyzable in clinically significant amounts (2.4%).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Guanfacine hydrochloride is an orally active antihypertensive agent whose principal mechanism of action appears to be stimulation of central α 2 -adrenergic receptors. By stimulating these receptors, guanfacine reduces sympathetic nerve impulses from the vasomotor center to the heart and blood vessels. This results in a decrease in peripheral vascular resistance and a reduction in heart rate.

The dose-response relationship for blood pressure and adverse effects of guanfacine given once a day as monotherapy has been evaluated in patients with mild to moderate hypertension. In this study patients were randomized to placebo or to 0.5 mg, 1 mg, 2 mg, 3 mg, or 5 mg of guanfacine hydrochloride. Results are shown in the following table.

A useful effect was not observed overall until doses of 2 mg were reached, although responses in white patients were seen at 1 mg; 24 hour effectiveness of 1 mg to 3 mg doses was documented using 24 hour ambulatory monitoring. While the 5 mg dose added an increment of effectiveness, it caused an unacceptable increase in adverse reactions. Mean Changes (mm Hg) from Baseline in Seated Systolic and Diastolic Blood Pressure for Patients Completing 4 to 8 Weeks of Treatment with Guanfacine Monotherapy Mean Change S/D* Seated n = (range) Placebo 0.5 mg 1 mg 2 mg 3 mg 5 mg White Patients 11 to 30 -1/-5 -6/-8 -8/-9 -12/-11 -15/-12 -18/-16 Black Patients 8 to 28 -3/-5 0/-2 -3/-5 -7/-7 -8/-9 -19/-15 * S/D = Systolic/diastolic blood pressure Controlled clinical trials in patients with mild to moderate hypertension who were receiving a thiazide-type diuretic have defined the dose-response relationship for blood pressure response and adverse reactions of guanfacine given at bedtime and have shown that the blood pressure response to guanfacine can persist for 24 hours after a single dose.

In the 12-week, placebo-controlled dose-response study, patients were randomized to placebo or to doses of 0.5, 1, 2, and 3 mg of guanfacine, in addition to 25 mg chlorthalidone, each given at bedtime. The observed mean changes from baseline, tabulated below, indicate the similarity of response for placebo and the 0.5 mg dose. Doses of 1, 2, and 3 mg resulted in decreased blood pressure in the sitting position with no real differences among the three doses.

In the standing position, there was some increase in response with dose. Mean Decreases (mm Hg) in Seated and Standing Blood Pressure for Patients Treated with Guanfacine in Combination with Chlorthalidone Mean Change n = Placebo 63 0.5 mg 63 1 mg 64 2 mg 58 3 mg 59 SD* Seated -5/-7 -5/-6 -14/-13 -12/-13 -16/-13 SD* Standing -3/-5 -5/-4 -11/-9 -9/-10 -15/-12 *S/D = Systolic/diastolic blood pressure While most of the effectiveness of guanfacine in combination (and as monotherapy in white patients) was present at 1 mg, adverse reactions at this dose were not clearly distinguishable from those associated with placebo.

Adverse reactions were clearly present at 2 and 3 mg (see ADVERSE REACTIONS ). In a second 12-week placebo-controlled study of 1, 2 or 3 mg of guanfacine hydrochloride administered with 25 mg of chlorthalidone once daily, a significant decrease in blood pressure was maintained for a full 24 hours after dosing. While there was no significant difference between the 12 and 24 hour blood pressure readings, the fall in blood pressure at 24 hours was numerically smaller, suggesting possible escape of blood pressure in some patients and the need for individualization of therapy.

In a double-blind, randomized trial, either guanfacine or clonidine was given at recommended doses with 25 mg chlorthalidone for 24 weeks and then abruptly discontinued. Results showed equal degrees of blood pressure reduction with the two drugs and there was no tendency for blood pressures to increase despite maintenance of the same daily dose of the two drugs. Signs and symptoms of rebound phenomena were infrequent upon discontinuation of either drug.

Abrupt withdrawal of clo… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 86 words ▾

HOW SUPPLIED Guanfacine tablets, USP are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 2 mg – Light blue, mottled, round, flat-faced, beveled-edge, uncoated tablets debossed with "U" on one side and "46" on the other side. NDC: 70518-3516-00 PACKAGING: 30 in 1 BLISTER PACK Store at controlled temperature, between 20° and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 109 words ▾

DESCRIPTION Guanfacine tablets, USP are a centrally acting antihypertensive with α 2 -adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride and its molecular weight is 282.55. Its structural formula is: Guanfacine hydrochloride, USP is a white or almost white crystalline powder; sparingly soluble in water, methanol and ethanol.

The tablets contain the following inactive ingredients: 1 mg — colloidal silicon dioxide, corn starch, lactose monohydrate and stearic acid. 2 mg — colloidal silicon dioxide, corn starch, FD & C Blue No. 1 aluminum lake, lactose monohydrate and stearic acid.

FDA approved dissolution test specifications differ from USP. Image

💬 Information for Patients 77 words ▾

Information for Patients Patients who receive guanfacine hydrochloride should be advised to exercise caution when operating dangerous machinery or driving motor vehicles until it is determined that they do not become drowsy or dizzy from the medication. Patients should be warned that their tolerance for alcohol and other CNS depressants may be diminished. Patients should be advised not to discontinue therapy abruptly.

Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Like other antihypertensive agents, guanfacine hydrochloride should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or chronic renal or hepatic failure. Sedation Guanfacine hydrochloride, like other orally active central α 2 -adrenergic agonists, causes sedation or drowsiness, especially when beginning therapy. These symptoms are dose-related (see ADVERSE REACTION S).

When guanfacine hydrochloride is used with other centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines), the potential for additive sedative effects should be considered. Rebound Abrupt cessation of therapy with orally active central α 2 -adrenergic agonists may be associated with increases (from depressed on-therapy levels) in plasma and urinary catecholamines, symptoms of "nervousness and anxiety" and, less commonly, increases in blood pressure to levels significantly greater than those prior to therapy.

Information for Patients Patients who receive guanfacine hydrochloride should be advised to exercise caution when operating dangerous machinery or driving motor vehicles until it is determined that they do not become drowsy or dizzy from the medication. Patients should be warned that their tolerance for alcohol and other CNS depressants may be diminished. Patients should be advised not to discontinue therapy abruptly.

Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Laboratory Tests In clinical trials, no clinically relevant laboratory test abnormalities were identified as causally related to drug during short-term treatment with guanfacine hydrochloride. Drug Interactions The potential for increased sedation when guanfacine hydrochloride is given with other CNS-depressant drugs should be appreciated.

The administration of guanfacine concomitantly with a known microsomal enzyme inducer (phenobarbital or phenytoin) to two patients with renal impairment reportedly resulted in significant reductions in elimination half-life and plasma concentration. In such cases, therefore, more frequent dosing may be required to achieve or maintain the desired hypotensive response. Further, if guanfacine is to be discontinued in such patients, careful tapering of the dosage may be necessary in order to avoid rebound phenomena (see Rebound above).

Anticoagulants Ten patients who were stabilized on oral anticoagulants were given guanfacine, 1 - 2 mg/day, for 4 weeks. No changes were observed in the degree of anticoagulation. In several well-controlled studies, guanfacine was administered together with diuretics with no drug interactions reported.

In the long-term safety studies, guanfacine hydrochloride was given concomitantly with many drugs without evidence of any interactions. The principal drugs given (number of patients in parentheses) were: cardiac glycosides (115), sedatives and hypnotics (103), coronary vasodilators (52), oral hypoglycemics (45), cough and cold preparations (45), NSAIDs (38), antihyperlipidemics (29), antigout drugs (24), oral contraceptives (18), bronchodilators (13), insulin (10), and beta blockers (10). Drug/Laboratory Test Interactions No laboratory test abnormalities related to the use of guanfacine hydrochloride have been identified.

Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenic effect was observed in studies of 78 weeks in mice at doses more than 150 times the maximum recommended human dose and 102 weeks in rats at doses more than 100 times the maximum recommended human dose. In a variety of test models, guanfacine was not mutagenic. No adverse effects were observed in fertility studies in male and female rats.

Pregnancy Administration of guanfacine to rats at 70 times the maximum recommended human dose and to rabbits at 20 times the maximum recommended human dose resulted in no evidence of harm to the fetus. Higher doses (100 and 200 times the maxi… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 47 words ▾

Nursing Mothers It is not known whether guanfacine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when guanfacine hydrochloride is administered to a nursing woman. Experiments with rats have shown that guanfacine is excreted in the milk.

🧬 Pharmacokinetics ~1 min read ▾

Pharmacokinetics Relative to an intravenous dose of 3 mg, the absolute oral bioavailability of guanfacine is about 80%. Peak plasma concentrations occur from 1 to 4 hours with an average of 2.6 hours after single oral doses or at steady state. The area under the concentration-time curve (AUC) increases linearly with the dose.

In individuals with normal renal function, the average elimination half-life is approximately 17 hr (range 10 to 30 hr). Younger patients tend to have shorter elimination half-lives (13 to 14 hr) while older patients tend to have half-lives at the upper end of the range. Steady state blood levels were attained within 4 days in most subjects.

In individuals with normal renal function, guanfacine and its metabolites are excreted primarily in the urine. Approximately 50% (40 to 75%) of the dose is eliminated in the urine as unchanged drug; the remainder is eliminated mostly as conjugates of metabolites produced by oxidative metabolism of the aromatic ring. The guanfacine-to-creatinine clearance ratio is greater than 1.0, which would suggest that tubular secretion of drug occurs.

The drug is approximately 70% bound to plasma proteins, independent of drug concentration. The whole body volume of distribution is high (a mean of

6.3L/kg), which suggests a high distribution of drug to the tissues. The clearance of guanfacine in patients with varying degrees of renal insufficiency is reduced, but plasma levels of drug are only slightly increased compared to patients with normal renal function. When prescribing for patients with renal impairment, the low end of the dosing range should be used.

Patients on dialysis also can be given usual doses of guanfacine hydrochloride as the drug is poorly dialyzed.

🧬 Pharmacodynamics 135 words ▾

Pharmacodynamics Hemodynamic studies in man showed that the decrease in blood pressure observed after single-dose or long-term oral treatment with guanfacine was accompanied by a significant decrease in peripheral resistance and a slight reduction in heart rate (5 beats/min). Cardiac output under conditions of rest or exercise was not altered by guanfacine. Guanfacine hydrochloride lowered elevated plasma renin activity and plasma catecholamine levels in hypertensive patients, but this does not correlate with individual blood-pressure responses.

Growth hormone secretion was stimulated with single oral doses of 2 and 4 mg of guanfacine. Long-term use of guanfacine hydrochloride had no effect on growth hormone levels. Guanfacine had no effect on plasma aldosterone.

A slight but insignificant decrease in plasma volume occurred after one month of guanfacine therapy. There were no changes in mean body weight or electrolytes.

🔒 Drug Abuse and Dependence 18 words ▾

DRUG ABUSE AND DEPENDENCE No reported abuse or dependence has been associated with the administration of guanfacine hydrochloride.

📄 Package Label / Principal Display Panel 52 words ▾

DRUG: Guanfacine Hydrochloride GENERIC: Guanfacine Hydrochloride DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-3516-0 COLOR: blue SHAPE: ROUND SCORE: No score SIZE: 7 mm IMPRINT: U;46 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): GUANFACINE 2mg in 1 INACTIVE INGREDIENT(S): FD&C BLUE NO. 1--ALUMINUM LAKE LACTOSE MONOHYDRATE SILICON DIOXIDE STARCH, CORN STEARIC ACID MM1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
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REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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← 70518-3512-00 · REMEDYREPACK 70518-3517-00 · REMEDYREPACK →
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