Alfuzosin Hydrochloride Extended Release

ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE- alfuzosin hydrochloride tablet
Camber Pharmaceuticals

1 INDICATIONS AND USAGE

Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

1.1 Important Limitations of Use

Alfuzosin hydrochloride is not indicated for the treatment of hypertension.

Alfuzosin hydrochloride is not indicated for use in the pediatric population.

2 DOSAGE AND ADMINISTRATION

The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.

3 DOSAGE FORMS AND STRENGTHS

Alfuzosin hydrochloride extended-release tablet 10 mg is available as off white, round, biconvex tablets debossed with ‘IG’ on one side and “302” on other.

4 CONTRAINDICATIONS

Alfuzosin hydrochloride is contraindicated for use:

5 WARNINGS AND PRECAUTIONS

5.1 Postural Hypotension

Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride. As with other alpha adrenergic antagonists, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. There may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride concomitantly with anti-hypertensive medication and nitrates. Care should be taken when alfuzosin hydrochloride is administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.

5.2 Patients with Renal Impairment

Caution should be exercised when alfuzosin hydrochloride is administered in patients with severe renal impairment (creatinine clearance < 30 mL/min) [see Use in Specific Populations ( 8.6) and Clinical Pharmacology ( 12.3)].

5.3 Patients with Hepatic Impairment

Alfuzosin hydrochloride is contraindicated for use in patients with moderate or severe hepatic impairment [see Contraindications ( 4), Use in Specific Populations ( 8.7) and Clinical Pharmacology ( 12.3)]. Although the pharmacokinetics of alfuzosin hydrochloride have not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride is administered to such patients [see Use in Specific Populations ( 8.7) and Clinical Pharmacology ( 12.3)].

5.4 Drug-Drug Interactions

Potent CYP3A4 Inhibitors: Alfuzosin hydrochloride is contraindicated for use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) since alfuzosin blood levels are increased [see Contraindications ( 4), Drug Interactions ( 7.1) and Clinical Pharmacology ( 12.3)].

Other alpha adrenergic antagonists: Alfuzosin hydrochloride is an alpha adrenergic antagonist and should not be used in combination with other alpha adrenergic antagonist [see Drug Interactions ( 7.2)].

Phosphodiesterase-5 (PDE5) Inhibitors: PDE5-inhibitors are also vasodilators. Caution is advised for concomitant use of PDE5-inhibitors and alfuzosin hydrochloride, as this combination can potentially cause symptomatic hypotension [see Drug Interactions ( 7.4)].

5.5 Prostatic Carcinoma

Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined to rule out the presence of carcinoma of the prostate prior to starting treatment with alfuzosin hydrochloride.

5.6 Intraoperative Floppy Iris Syndrome (IFIS)

IFIS has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

There does not appear to be a benefit of stopping alpha adrenergic antagonist therapy prior to cataract surgery.

5.7 Priapism

Rarely (probably less than 1 in 50,000), alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition [see Adverse Reactions ( 6.2) and Patient Counseling Information [ 17.3]).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.