Guanfacine Gaunfacine 1 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central alpha-2 Adrenergic Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
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💊 What it looks like
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🧪 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.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII PNR0YF693Y
A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
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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.
4 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.144 | $14.42 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3447 | $34.47 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Guanfacine 1 mg 00591-0444-01 | Actavis | 100 tablets | $0.144 | — | Availability likely | — |
| Guanfacine 1 mg 00904-7140-04 | Major | 30 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 24979-0198-01 | TWi | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine 1 mg 27241-0242-01 | Ajanta | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 29300-0458-01 | Unichem | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine 1 mg 42806-0048-01 | Epic | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 53746-0711-01 | Amneal | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine 1 mg 59651-0840-01 | Aurobindo | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 60687-0710-21 | American | 30 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 62135-0727-90 | Chartwell | 90 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 68094-0065-62 | Precision | 30 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine Hydrochloride 1 mg 70700-0301-01 | XIROMED, | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine 1 mgthis 72319-0018-04 | i3 | 100 tablets | $0.144 | AB | Availability likely | — |
| Guanfacine 1 mg 24658-0730-01 | PuraCap | 100 tablets | — | AB | FDA listed | — |
| Guanfacine Hydrochloride 1 mg 50090-6073-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Guanfacine 1 mg 63187-0302-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Guanfacine Hydrochloride 1 mg 65162-0711-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Guanfacine 1 mg 67046-1433-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Guanfacine 1 mg 70518-4333-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Guanfacine Hydrochloride 1 mg 72603-0268-01 | NORTHSTAR | 100 tablets | — | AB | FDA listed | — |
| Guanfacine 1 mg 72888-0123-00 | Advagen | 1000 tablets | — | AB | FDA listed | — |
| Guanfacine 1 mg 73141-0018-04 | A2A | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72319-0018-04 You're viewing this | 100 TABLET in 1 BOTTLE (72319-018-04) | 2023-11-08 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Guanfacine Tablets, USP are indicated in the management of hypertension. Guanfacine hydrochloride may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended initial dose of guanfacine hydrochloride 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 hydrochloride is 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 - 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 - 4 days) without ill effects.
⛔ Contraindications ▾
CONTRAINDICATIONS Guanfacine Tablets, USP is contraindicated in patients with known hypersensitivity to guanfacine hydrochloride.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions noted with guanfacine hydrochloride are similar to those of other drugs of the central 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=60 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: Adeverse Reactions 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 pateints 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, purpura,…
🔄 Drug Interactions ▾
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.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions No laboratory test abnormalities related to the use of guanfacine hydrochloride have been identified.
🧒 Pediatric Use ▾
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 hydrochloride.
Hallucinations have been reported in pediatric patients receiving guanfacine hydrochloride for treatment of attention-deficit hyperactivity disorder.
🧓 Geriatric Use ▾
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 ▾
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 ▾
CLINICAL PHARMACOLOGY Guanfacine Tablets, USP are an orally active antihypertensive agent whose principal mechanism of action appears to be stimulation of central 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 (mmHg) from Baseline in Seated Systolic and Diastolic Blood Pressure for Patients Completing 4 to 8 Weeks of Treatment with Guanfacine Monotherapy *S/D = Systolic/diastolic blood pressure Mean Change S/D* Seated n = (range) Placebo 0.5 mg 1 mg 2 mg 3 mg 5 mg White Patients 11-30 -1/-5 -6/-8 -8/-9 -12/-11 -15/-12 -18/-16 Black Patients 8-28 -3/-5 0/-2 -3/-5 -7/-7 -8/-9 -19/-15 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 *S/D = Systolic/diastolic blood pressure 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 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 clonidine produ…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Guanfacine Tablets, USP are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg—white round tablets, debossed “i3” on one side and “18” on the other side in bottles of 100 (NDC 72319-018-04). 2 mg—White round tablets, debossed “i3” on one side and “19” on the other side in bottles of 100 (NDC 72319-019-04). Store at controlled temperature, between 20°C and 25°C (68°F and 77°F).
Dispense in a tight, light-resistant container. Manufactured & distributed by: i3 Pharmaceuticals, LLC Warminster, PA, 18974 USA OS019-02, REV.0124 Revised: January 2024
📋 Description ▾
DESCRIPTION Guanfacine Tablets, USP are a centrally acting antihypertensive with α2-adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride is N-amidino- 2-(2,6-dichlorophenyl) acetamide hydrochloride and its molecular weight is 282.56. Its structural formula is: Guanfacine hydrochloride is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone.
Each tablet, for oral administration, contains guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg of guanfacine. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, pregelatinized starch and magnesium stearate. Guanfacine Tablets, USP meets USP Dissolution Test 2. chemical
💬 Information for Patients ▾
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.