Drugplain

Guanfacine Hydrochloride 1 mg/1

Guanfacine · TABLET · Amneal Pharmaceuticals of New York LLC

No Recall HistoryCurrently in Shortage
Plain English

Guanfacine Hydrochloride is a tablet containing guanfacine at 1 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.

Key Facts

Brand Name
Guanfacine Hydrochloride
Generic Name
Guanfacine
NDC Code (Product)
53746-711
Manufacturer
Amneal Pharmaceuticals of New York LLC
Strength
1 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA075109
Marketing Start
04/15/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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

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

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).

Adverse Reactions

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…

Frequently Asked Questions

What is Guanfacine Hydrochloride used for?

Guanfacine Hydrochloride contains Guanfacine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Guanfacine Hydrochloride a controlled substance?

Guanfacine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Guanfacine Hydrochloride?

The generic name for Guanfacine Hydrochloride is Guanfacine. There are 11 other brand versions of Guanfacine.

What is the NDC code for Guanfacine Hydrochloride 1 mg/1?

The NDC (National Drug Code) for Guanfacine Hydrochloride 1 mg/1 is 53746-711, listed by Amneal Pharmaceuticals of New York LLC.

Product NDC

53746-711

Package NDC

53746-711-01

Other Guanfacine Hydrochloride Dosages

Other Guanfacine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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