Rx Compound 4

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Rx Compound 4

from 49.99

Dispensed upon Prescription only

International Pharmacy is dedicated to follow and apply

USP General Chapter <795> Pharmaceutical Compounding Guidelines

for  Nonsterile Preparations

 

Patient Drug Education for Diltiazem Ointment

Diltiazem ointment (Cardizem) is a calcium channel class of medication we use to help heal anal fissures, promote wound healing, or treat external thrombosed hemorrhoids. The ointment relaxes the smooth muscle around the rectum and promotes blood flow to help the growth of new skin over the tear in the lining of the rectum. The ointment reduces anal canal pressure, which diminishes pain and spasm. We use a 2% concentration mixed with Lidocaine and Aloe Vera. It is only available at compounding pharmacies.

For fissures the ointment should be applied three times a day usually for six weeks and then one to two times a day for usually an additional six weeks. A pea size drop should be placed on the tip of your index finger and then the ointment is gently placed inside of the rectum. The finger should be inserted at least half its length and then swiped towards the fissure, located posteriorly or anteriorly, as it is removed. For an external thrombosis rub the ointment over the swollen area and then inside the rectum. The finger may be covered with a plastic glove or finger cot. You may use Vaseline to help coat the finger or dilute the ointment. If you are advised to place the ointment on a steroid suppository limit the steroids to one to two weeks in order to decrease the risk of infection.

It is important to continue the treatment for the entire time period. It takes up to two years to regain the normal skin strength associated with a fissure. Most thrombosis will resolve within two weeks. Physical exercise, standing, and prolonged sitting should be limited. You will be advised to add fiber to your diet, use stool softeners, increase water to 7-8 glasses per day, use daily relaxing baths or sitz baths for 10-20 minutes, and to avoid prolonged sitting and straining on the commode. Avoid trying to pass a dry stool by coating the rectum with a lubricant such as Vaseline.

In the beginning of treatment the anal fissure is very inflamed, which allows more of the ointment to get into the blood. Side effects are not common. Dizziness, headache, weakness, nausea, or swelling of the hands or feet may rarely occur. If any of these side effects persist or worsen, notify us promptly. Stop using the ointment and notify us if you should develop the rare side effects of severe dizziness, fainting, fast/pounding heartbeat, paleness, sweating, blurred vision, dry mouth, dark urine, bluish lips/skin/nails, unusual tiredness, severe weakness, irregular heartbeat, seizures, or chest pain. Serious allergic reactions are unusual, but seek immediate medical attention if you develop a rash, swelling, dizziness, or trouble breathing.

Provided by Hemorrhoid Centers of AmericaTM Version 2014-03
DTZ Ointment

Page 1 of 2

www.hcofamerica.com

Alan L. Goldman, MD, FACS 2500 Hospital Blvd., Suite 150 Roswell, Georgia 30076

(770) 442-3117 www.hcaatlanta.com

 

For external hemorrhoid thrombosis apply three times a day. Place a pea size amount on the bump and inside the rectum. Continue until the bump has resolved. For tag removal start the ointment on the day after the procedure. Gently apply the DTZ on the outside and inside three times per day until the wound has healed.

Tell us if you are allergic to Cardizem or any other calcium channel blocker, have severe anemia, low blood pressure, dehydration, chronic heart failure, cardiomyopathy, recent heart attack, or increased pressure in the brain. Do not use the ointment while driving or working around machinery if you are drowsy, dizzy, have lightheadedness, or blurred vision. Limit alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. The elderly may be more prone to dizziness and falling. There are not adequate studies to confirm the safety of Diltiazem in pregnant or breast feeding women. We recommend waiting at least one hour after applying the ointment before breast feeding.

Do not use the ointment if you are taking drugs for sexual problems (e.g., sildenafil, tadalafil, vardenafil). Use caution before taking cough-and-cold products, diet aids, or NSAIDs preparations because they may contain ingredients that could increase your blood pressure, cause a fast heartbeat, or increase chest pain (e.g., pseudoephedrine, phenylephrine, chlorpheniramine, diphenhydramine, clemastine, ibuprofen, and naproxen). Tell us if you take alcohol, alteplase, migraine drugs (ergotamine), water pills/diuretics such as furosemide or hydrochlorothiazide, or other drugs for high blood pressure (beta blockers, calcium channel blockers, ACE inhibitors).

Store the ointment at room temperature and keep away from light and moisture. Close the container tightly after each use. Do not store in the bathroom. Keep away from children and pets.

If you have any questions or problems please call our office. Thank you and we hope you are better soon.

Provided by Hemorrhoid Centers of AmericaTM Version 2014-03
DTZ Ointment

Page 2 of 2

www.hcofamerica.com

Alan L. Goldman, MD, FACS 2500 Hospital Blvd., Suite 150 Roswell, Georgia 30076

(770) 442-3117 www.hcaatlanta.com 

Topical diltiazem ointment in the treatment of chronic anal fissure.

Knight JS1, Birks MFarouk R.

Author information

Abstract

BACKGROUND:

Chronic anal fissure has traditionally been treated surgically. Initial enthusiasm for chemical sphincterotomy has waned because of poor outcomes with glyceryl trinitrate ointment. In this study the use of topical 2 per cent diltiazem ointment has been investigated as an alternative method of chemical sphincterotomy.

METHODS:

A prospective assessment of 71 consecutive patients with a chronic anal fissure treated with 2 per cent topical diltiazem ointment for a median duration of 9 (range 2--16) weeks was performed.

RESULTS:

Fifty-one patients (75 per cent) experienced healing of the fissure after 2--3 months of treatment with topical diltiazem. Seventeen patients who did not heal were treated for a further 8 weeks with topical diltiazem. Eight of these patients subsequently healed with diltiazem. Fifty-nine of 67 patients who completed follow-up therefore healed on diltiazem ointment. Four patients experienced perianal dermatitis and one patient experienced headaches. No other side-effects were recorded. After a median of 32 (range 14--67) weeks' follow-up following completion of treatment, 27 of 41 patients available remain symptom free. Six of seven patients with recurrent fissure were treated successfully by repeat chemical sphincterotomy.

CONCLUSION:

Topical 2 per cent diltiazem ointment used as an agent for chemical sphincterotomy for chronic anal fissure offers significant healing rates but does not have a significant side-effect profile, which may aid compliance to treatment. Early recurrences are common but usually amenable to further chemical sphincterotomy.

This product is sold upon a prescription only;

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Topical diltiazem ointment in the treatment of chronic anal fissure.

Knight JS1, Birks MFarouk R.

Author information

Abstract

BACKGROUND:

Chronic anal fissure has traditionally been treated surgically. Initial enthusiasm for chemical sphincterotomy has waned because of poor outcomes with glyceryl trinitrate ointment. In this study the use of topical 2 per cent diltiazem ointment has been investigated as an alternative method of chemical sphincterotomy.

METHODS:

A prospective assessment of 71 consecutive patients with a chronic anal fissure treated with 2 per cent topical diltiazem ointment for a median duration of 9 (range 2--16) weeks was performed.

RESULTS:

Fifty-one patients (75 per cent) experienced healing of the fissure after 2--3 months of treatment with topical diltiazem. Seventeen patients who did not heal were treated for a further 8 weeks with topical diltiazem. Eight of these patients subsequently healed with diltiazem. Fifty-nine of 67 patients who completed follow-up therefore healed on diltiazem ointment. Four patients experienced perianal dermatitis and one patient experienced headaches. No other side-effects were recorded. After a median of 32 (range 14--67) weeks' follow-up following completion of treatment, 27 of 41 patients available remain symptom free. Six of seven patients with recurrent fissure were treated successfully by repeat chemical sphincterotomy.

CONCLUSION:

Topical 2 per cent diltiazem ointment used as an agent for chemical sphincterotomy for chronic anal fissure offers significant healing rates but does not have a significant side-effect profile, which may aid compliance to treatment. Early recurrences are common but usually amenable to further chemical sphincterotomy.

USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations

Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children.  Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases.

Compounded drugs made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.

USP develops standards for compounding nonsterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. General Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations.

Important Updates:
The General Chapter was last revised in its entirety in USP 34–NF 29, which became official on May 1, 2011. A Revision Bulletin was issued on Nov. 22, 2013, with an official date of Jan. 1, 2014, to clarify that the maximum beyond-use dates in the chapter may be applied only to nonsterile preparations.
A future revision to General Chapter <795> will be proposed in the Pharmacopeial Forum for public comment to harmonize with USP General Chapter <800>.
Important Dates
- TBD: Revision proposed in the Pharmacopeial Forum for public comment
While General Chapter <795> is undergoing revision, the published version of the chapter which became official on Jan 1, 2014 is currently official.

Developing USP General Chapter <795>

USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process.

The USP Compounding Expert Committee is responsible for the development of General Chapter <795>. Review their work plan and past meeting summaries. General Chapter <795> is currently under review and being considered for revision. 

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