Guanfacine Hydrochloride (Guanfacine)

Trade Name : Guanfacine

Mylan Pharmaceuticals Inc.

TABLET

Strength 1 mg/1

GUANFACINE HYDROCHLORIDE Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Guanfacine Hydrochloride (Guanfacine) which is also known as Guanfacine and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 1 mg/1 per ml. Read more

Guanfacine Hydrochloride (Guanfacine) 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

Guanfacine tablets are a centrally acting antihypertensive with u03b1-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 to off-white crystalline powder; sparingly soluble in water and alcohol and slightly soluble in acetone.
Each tablet, for oral administration, contains guanfacine hydrochloride equivalent to 1 mg or 2 mg of guanfacine and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. In addition, the 2 mg tablets contain the following ingredient: FD&C Blue No.1 Aluminum Lake.

Guanfacine tablets are an orally active antihypertensive agent whose principal mechanism of action appears to be stimulation of central u03b1-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 tablets. 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.
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 mg, 1 mg, 2 mg 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 mg, 2 mg 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.
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 mg and 3 mg (see ).
In a second 12-week placebo-controlled study of 1 mg, 2 mg or 3 mg of guanfacine tablets 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 produced a rapid return of diastolic and especially systolic blood pressure to approximately pretreatment levels, with occasional values significantly greater than baseline, whereas guanfacine withdrawal produced a more gradual increase to pretreatment levels, but also with occasional values significantly greater than baseline.

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.

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

No data

Adverse reactions noted with guanfacine tablets are similar to those of other drugs of the central u03b1-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 tablets could not be established, should a rash occur, guanfacine tablets should be discontinued and the patient monitored appropriately.
In the dose-response monotherapy study described under , the frequency of the most commonly observed adverse reactions showed a dose relationship from 0.5 mg to 3 mg as follows:
The percent of patients who dropped out because of adverse reactions are shown below for each dosage group.
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 mg to 3 mg as follows:
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:
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 , the most common adverse reactions noted were as follows:
Adverse reactions occurring in 3% or less of patients in the three controlled trials of guanfacine with a diuretic were:
Arrayn- Cardiovascular:
Arrayn- Gastrointestinal:
Arrayn- CNS:
Arrayn- ENT disorders:
Arrayn- Eye disorders:
Arrayn- Musculoskeletal:
Arrayn- Respiratory:
Arrayn- Dermatologic:
Arrayn- Urogenital:
Arrayn- Other:
Adverse reaction reports tend to decrease over time. In an open-label trial of one yearu2019s duration, 580 hypertensive subjects were given guanfacine, titrated to achieve goal blood pressure, alone (51%), with diuretic (38%), with beta blocker (3%), with diuretic plus beta blocker (6%), or with diuretic plus vasodilator (2%). The mean daily dose of guanfacine reached was 4.7 mg.
There were 52 (8.9%) dropouts due to adverse effects in this 1-year trial. The causes were: dry mouth (n = 20), weakness (n = 12), constipation (n = 7), somnolence (n = 3), nausea (n = 3), orthostatic hypotension (n = 2), insomnia (n = 1), rash (n = 1), nightmares (n = 1), headache (n = 1), and depression (n = 1).
An open-label postmarketing study involving 21,718 patients was conducted to assess the safety of guanfacine tablets 1 mg/day given at bedtime for 28 days. Guanfacine tablets were administered with or without other antihypertensive agents. Adverse events reported in the postmarketing study at an incidence greater than 1% included dry mouth, dizziness, somnolence, fatigue, headache and nausea. The most commonly reported adverse events in this study were the same as those observed in controlled clinical trials.
Less frequent, possibly guanfacine tablets-related events observed in the postmarketing study and/or reported spontaneously include:
Body as a Whole:
Cardiovascular:
Central Nervous System:
Eye Disorders:
Gastrointestinal System:
Liver and Biliary System:
Musculo-Skeletal System:
Psychiatric:
Reproductive System, Male:
Respiratory System:
Skin and Appendages:
Special Senses:
Urinary System:
Rare, serious disorders with no definitive cause and effect relationship to guanfacine tablets have been reported spontaneously and/or in the postmarketing study. These events include acute renal failure, cardiac fibrillation, cerebrovascular accident, congestive heart failure, heart block, and myocardial infarction.

No reported abuse or dependence has been associated with the administration of guanfacine tablets.

No data

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 ). 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.

Guanfacine Tablets, USP are available containing guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg of guanfacine.
The 1 mg tablets are white, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
NDC 0378-1160-77bottles of 90 tablets
NDC 0378-1160-01bottles of 100 tablets
The 2 mg tablets are blue, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
NDC 0378-1190-77bottles of 90 tablets
NDC 0378-1190-01bottles of 100 tablets
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.
Revised: 5/2017GUAN:R7

NDC 0378-1160-77
Guanfacinen- Tablets, USPn- 1 mg*
Rx only u00a0u00a0u00a0u00a0u00a090 Tablets
*Each tablet contains guanfacinehydrochloride, USP equivalent to 1 mg of guanfacine.
Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
Usual Dosage:
Mylan Pharmaceuticals Inc.
Mylan.com
RM1160MM

NDC 0378-1190-77
Guanfacinen- Tablets, USPn- 2 mg*
Rx only u00a0u00a0u00a0u00a0u00a090 Tablets
*Each tablet contains guanfacinehydrochloride, USP equivalent to 2 mg of guanfacine.
Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Keep this and all medicationn- out of the reach of children.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
Usual Dosage:
Mylan Pharmaceuticals Inc.
Mylan.com
RM1190MM

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Guanfacine Hydrochloride (Guanfacine)

Trade Name : Guanfacine

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Guanfacine Hydrochloride (Guanfacine)

Trade Name : Guanfacine

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?